Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act, 4594-4705 [2016-31426]
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 68
[EPA–HQ–OEM–2015–0725; FRL–9954–46–
OLEM]
RIN 2050–AG82
Accidental Release Prevention
Requirements: Risk Management
Programs Under the Clean Air Act
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA), in response to Executive
Order 13650, is amending its Risk
Management Program regulations. The
revisions contain several changes to the
accident prevention program
requirements including an additional
analysis of safer technology and
alternatives as part of the process hazard
analysis for some Program 3 processes,
third-party audits and incident
investigation root cause analysis for
Program 2 and Program 3 processes;
enhancements to the emergency
preparedness requirements; increased
public availability of chemical hazard
information; and several other changes
to certain regulatory definitions and
data elements submitted in risk
management plans. These amendments
seek to improve chemical process safety,
assist local emergency authorities in
planning for and responding to
accidents, and improve public
awareness of chemical hazards at
regulated sources.
DATES: This final rule is effective on
March 14, 2017.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OEM–2015–0725. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
James Belke, United States
Environmental Protection Agency,
Office of Land and Emergency
Management, 1200 Pennsylvania Ave.
NW., (Mail Code 5104A), Washington,
DC 20460; telephone number: (202)
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SUMMARY:
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564–8023; email address: belke.jim@
epa.gov, or: Kathy Franklin, United
States Environmental Protection
Agency, Office of Land and Emergency
Management, 1200 Pennsylvania Ave.
NW., (Mail Code 5104A), Washington,
DC, 20460; telephone number: (202)
564–7987; email address:
franklin.kathy@epa.gov.
Electronic copies of this document
and related news releases are available
on EPA’s Web site at https://
www.epa.gov/rmp. Copies of this final
rule are also available at https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION:
The
contents of this preamble are:
I. General Information
A. Executive Summary
B. Does this action apply to me?
II. Background
A. Events Leading to This Action
B. Overview of EPA’s Risk Management
Program Regulations
III. Additional Information
A. Agency’s Authority for Taking This
Action
B. List of Regulated Substances
IV. Prevention Program Requirements
A. Incident Investigation and Accident
History Requirements
B. Third-Party Audits
C. Safer Technology and Alternatives
Analysis (STAA)
D. Stationary Source Location and
Emergency Shutdown
V. Emergency Response Preparedness
Requirements
A. Emergency Response Program
Coordination With Local Responders
B. Facility Exercises
VI. Information Availability Requirements
A. Disclosure Requirements to LEPCs or
Emergency Response Officials
B. Information Availability to the Public
C. Public Meetings
VII. Risk Management Plan Streamlining,
Clarifications, and RMP Rule Technical
Corrections
A. Revisions to § 68.160 (Registration)
B. Revisions to § 68.170 (Prevention
Program/Program 2)
C. Revisions to § 68.175 (Prevention
Program/Program 3)
D. Revisions to § 68.180 (Emergency
Response Program)
E. Technical Corrections
VIII. Compliance Dates
A. Summary of Proposed Rulemaking
B. Summary of Final Rule
C. Discussion of Comments
D. Compliance Date Examples
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act
(UMRA)
E. Executive Order 13132: Federalism
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
I. National Technology Transfer and
Advancement Act (NTTAA)
J. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
K. Congressional Review Act (CRA)
I. General Information
A. Executive Summary
1. Purpose of the Regulatory Action
The purpose of this action is to
improve safety at facilities that use and
distribute hazardous chemicals. In
response to catastrophic chemical
facility incidents in the United States,
including the explosion that occurred at
the West Fertilizer facility in West,
Texas, on April 17, 2013 that killed 15
people (on May 11, 2016, ATF ruled
that the fire was intentionally set.) 1
President Obama issued Executive
Order 13650, ‘‘Improving Chemical
Facility Safety and Security,’’ on August
1, 2013.2
Section 6(a)(i) of Executive Order
13650 requires that various Federal
agencies develop options for improved
chemical facility safety and security that
identify ‘‘improvements to existing risk
management practices through agency
programs, private sector initiatives,
Government guidance, outreach,
standards, and regulations.’’ One
existing agency program is the Risk
Management Program implemented by
EPA under section 112(r) of the Clean
Air Act (CAA) (42 U.S.C. 7412(r)).
Section 6(c) of Executive Order 13650
requires the Administrator of EPA to
review the chemical hazards covered by
the Risk Management Program and
expand, implement and enforce the Risk
Management Program to address any
additional hazards.
EPA proposed changes to its Risk
Management Program regulations (40
CFR part 68) on March 14, 2016 (81 FR
13637) after publishing a ‘‘Request for
Information’’ notice or ‘‘RFI’’ that
solicited comments and information
from the public regarding potential
changes to the Risk Management
1 See ATF Announces $50,000 Reward in West,
Texas Fatality Fire, https://www.atf.gov/news/pr/
atf-announces-50000-reward-west-texas-fatalityfire.
2 For more information on the Executive Order
see https://www.whitehouse.gov/the-press-office/
2013/08/01/executive-order-improving-chemicalfacility-safety-and-security.
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Program regulations (July 31, 2014, 79
FR 44604). While developing the
proposed rulemaking, EPA convened a
Small Business Advocacy Review
(SBAR) panel to receive input from
Small Entity Representatives (SERs).
EPA also hosted a public hearing on
March 29, 2016 to provide interested
parties the opportunity to present data,
views or arguments concerning the
proposed action.
The Risk Management Program
regulations have been effective in
preventing and mitigating chemical
accidents in the United States. However,
EPA believes that revisions could
further protect human health and the
environment from chemical hazards
through advancement of process safety
management based on lessons learned.
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2. Summary of the Major Provisions of
the Regulatory Action
This action amends EPA’s Risk
Management Program regulations at 40
CFR part 68. These regulations apply to
stationary sources (also referred to as
‘‘facilities’’) that hold specific
‘‘regulated substances’’ in excess of
threshold quantities. These facilities are
required to assess their potential release
impacts, undertake steps to prevent
releases, plan for emergency response to
releases, and summarize this
information in a risk management plan
(RMP) submitted to EPA. The release
prevention steps vary depending on the
type of process, but progressively gain
granularity and rigor over three program
levels (i.e., Program 1, Program 2, and
Program 3).
The major provisions of this rule
include several changes to the accident
prevention program requirements, as
well as enhancements to the emergency
response requirements, and
improvements to the public availability
of chemical hazard information. Each of
these revisions is introduced in the
following paragraphs of this section and
described in greater detail in sections IV
through VI, later in this preamble.
Certain revised provisions would
apply to a subset of the processes based
on program levels described in 40 CFR
part 68 (or in one case, to a subset of
processes within a program level). A full
description of these program levels is
provided in section II of this preamble.
a. Accident Prevention Program
Revisions
This action includes three changes to
the accident prevention program
requirements. First, the rule requires all
facilities with Program 2 or 3 processes
to conduct a root cause analysis as part
of an incident investigation of a
catastrophic release or an incident that
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could have reasonably resulted in a
catastrophic release (i.e., a near-miss).
This provision is intended to reduce the
number of chemical accidents by
requiring facilities to identify the
underlying causes of an incident so that
they may be addressed. Identifying the
root causes, rather than isolating and
correcting solely the immediate cause of
the incident, will help prevent similar
incidents at other locations, and will
yield the maximum benefit or lessons
learned from the incident investigation.
Second, the rule requires regulated
facilities with Program 2 or 3 processes
to contract with an independent thirdparty, or assemble an audit team led by
an independent third-party, to perform
a compliance audit after the facility has
an RMP reportable accident.
Compliance audits are required under
the existing rule, but are allowed to be
self-audits (i.e., performed by the owner
or operator of the regulated facility).
This provision is intended to reduce the
risk of future accidents by requiring an
objective auditing process to determine
whether the owner or operator of the
facility is effectively complying with the
accident prevention procedures and
practices required under 40 CFR part 68.
The third revision to the prevention
program adds an element to the process
hazard analysis (PHA), which is
updated every five years. Specifically,
owners or operators of facilities with
Program 3 regulated processes in North
American Industrial Classification
System (NAICS) codes 322 (paper
manufacturing), 324 (petroleum and
coal products manufacturing), and 325
(chemical manufacturing) are required
to conduct a safer technology and
alternatives analysis (STAA) as part of
their PHA, and to evaluate the
practicability of any inherently safer
technology (IST) identified. The current
PHA requirements include
consideration of active, passive, and
procedural measures to control hazards.
These revisions support the analysis of
those measures and adds consideration
of IST alternatives. The provision is
intended to reduce the risk of serious
accidental releases by requiring
facilities in these sectors to conduct a
careful examination of potentially safer
technology and designs that they could
implement in lieu of, or in addition to,
their current technologies.
b. Emergency Response Enhancements
This action also enhances the rule’s
emergency response requirements.
Owners or operators of all facilities with
Program 2 or 3 processes are required to
coordinate with the local emergency
response agencies at least once a year to
determine how the source is addressed
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in the community emergency response
plan and to ensure that local response
organizations are aware of the regulated
substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility to
respond to an accidental release of a
regulated substance.
Additionally, all facilities with
Program 2 or 3 processes are required to
conduct notification exercises annually
to ensure that their emergency contact
information is accurate and complete.
This provision is intended to reduce the
impact of accidents by ensuring that
appropriate mechanisms and processes
are in place to notify local responders
when an accident occurs. One of the
factors that can contribute to the
severity of chemical accidents is a lack
of effective coordination between a
facility and local emergency responders.
Increasing such coordination and
establishing appropriate emergency
response procedures can help reduce
the effects of accidents.
This action also requires that all
facilities subject to the emergency
response program requirements of
subpart E of the rule (or ‘‘responding
facilities’’) conduct field exercises and
tabletop exercises. The frequency of
these exercises shall be established in
consultation with local emergency
response officials, but at a minimum,
full field exercises will be conducted at
least once every ten years and tabletop
exercises conducted at least once every
three years. Responding facilities that
have an RMP reportable accident, and
document the response activities in an
after-action report comparable to the
exercise evaluation reports may use that
response to satisfy the field exercise
requirements. Furthermore, owner and
operators of responding facilities that
conduct exercises to meet other Federal,
state or local exercise requirements may
satisfy the RMP exercise requirements
provided that the scope of the exercise
includes the objectives of an RMP
exercise. The purpose of this provision
is to reduce the impact of accidents by
ensuring that emergency response
personnel understand their roles in the
event of an incident, that local
responders are familiar with the hazards
at a facility, and that the emergency
response plan is up-to-date. Improved
coordination with emergency response
personnel will better prepare responders
to respond effectively to an incident and
take steps to notify the community of
appropriate actions, such as shelter-inplace or evacuation.
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c. Enhanced Availability of Information
This action includes various
enhancements to the public availability
of chemical hazard information. The
rule requires all facilities to provide
certain basic information to the public,
upon request. The owner or operator of
the facility shall provide ongoing
notification of availability of
information elements on a company
Web site, social media platforms, or
through some other publicly accessible
means. The rule also requires all
facilities to hold a public meeting for
the local community within 90 days of
an RMP reportable accident. This
provision will ensure that first
responders and members of the
community have easier access to
appropriate facility chemical hazard
information, which can significantly
improve emergency preparedness and
their understanding of how the facility
is addressing potential risks.
EPA proposed requirements for
facilities to provide certain information
to the Local Emergency Planning
Committee (LEPC), Tribal Emergency
Planning Committee (TEPC)3 or other
local emergency response agencies.
However, rather than prescribe
information elements that must be
provided upon request, EPA is requiring
the owner or operator of a stationary
source to share information that is
relevant to emergency response
planning as part of the coordination
activities that occur annually between
facility representatives and local
emergency response agencies.
In addition to the major provisions
described previously in this section, this
action discusses comments received on
other aspects of the proposed action
including revisions to the list of
regulated substances, location of
stationary sources (related to their
proximity to public receptors),
requirements for emergency shutdown
systems, compliance dates, technical
corrections and revisions to the RMP
requirements.
3. Costs and Benefits
a. Summary of Potential Costs
Approximately 12,500 facilities have
filed current RMPs with EPA and are
potentially affected by the revised rule.
These facilities range from petroleum
refineries and large chemical
manufacturers to water and wastewater
treatment systems; chemical and
petroleum wholesalers and terminals;
food manufacturers, packing plants, and
other cold storage facilities with
ammonia refrigeration systems;
agricultural chemical distributors;
midstream gas plants; and a limited
number of other sources, including
Federal installations that use RMPregulated substances.
Table 1 presents the number of
facilities according to the latest RMP
reporting as of February 2015 by
industrial sector and chemical use.
TABLE 1—NUMBER OF AFFECTED FACILITIES BY SECTOR
Sector
NAICS codes
Total facilities
Chemical uses
Administration of environmental quality
programs (i.e., governments).
Agricultural chemical distributors/wholesalers.
Chemical manufacturing ..........................
Chemical wholesalers ..............................
Food and beverage manufacturing .........
Oil and gas extraction .............................
924 .....................................
1,923
Use chlorine and other chemicals for treatment.
111, 112, 115, 42491 ........
3,667
325 .....................................
4246 ...................................
311, 312 ............................
211 .....................................
1,466
333
1,476
741
Other ........................................................
44, 45, 48, 54, 56, 61, 72
247
Other manufacturing ................................
313, 326, 327, 33 ..............
384
Other wholesale .......................................
Paper manufacturing ...............................
423, 424 ............................
322 .....................................
302
70
Petroleum and coal products manufacturing.
Petroleum wholesalers ............................
324 .....................................
156
4247 ...................................
276
Utilities .....................................................
221 .....................................
445
Warehousing and storage .......................
493 .....................................
1,056
Store ammonia for sale; some in NAICS 111 and 115
use ammonia as a refrigerant.
Manufacture, process, store.
Store for sale.
Use—mostly ammonia as a refrigerant.
Intermediate processing (mostly regulated flammable
substances and flammable mixtures).
Use chemicals for wastewater treatment, refrigeration,
store chemicals for sale.
Use various chemicals in manufacturing process,
waste treatment.
Use (mostly ammonia as a refrigerant).
Use various chemicals in pulp and paper manufacturing.
Manufacture, process, store (mostly regulated flammable substances and flammable mixtures).
Store for sale (mostly regulated flammable substances
and flammable mixtures).
Use chlorine (mostly for water treatment) and other
chemicals.
Use mostly ammonia as a refrigerant.
Total ..................................................
............................................
12,542
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Table 2 presents a summary of the
annualized costs estimated in the
regulatory impact analysis.4 In total,
EPA estimates annualized costs of
$131.2 million at a 3% discount rate
and $131.8 million at a 7% discount
rate.
3 Note for the purposes of this document the term
TEPC can be substituted for LEPC, as appropriate.
4 A full description of costs and benefits for this
final rule can be found in the Regulatory Impact
Analysis—Accidental Release Prevention
Requirements: Risk Management Programs Under
the Clean Air Act, Section 112(r)(7). This document
is available in the docket for this rulemaking
(Docket ID Number EPA–HQ–OEM–2015–0725).
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TABLE 2—SUMMARY OF ANNUALIZED COSTS
[Millions, 2015 dollars]
3
(percent)
Provision
7
(percent)
Third-party Audits ....................................................................................................................................................
Incident Investigation/Root Cause ...........................................................................................................................
STAA ........................................................................................................................................................................
Coordination .............................................................................................................................................................
Notification Exercises ..............................................................................................................................................
Facility Exercises .....................................................................................................................................................
Information Sharing with the Public .........................................................................................................................
Public Meeting .........................................................................................................................................................
Rule Familiarization .................................................................................................................................................
$9.8
1.8
70.0
16.0
1.4
24.7
3.1
0.4
3.9
$9.8
1.8
70.0
16.0
1.4
24.7
3.1
0.4
4.6
Total Cost * .......................................................................................................................................................
131.2
131.8
* Totals may not sum due to rounding.
The largest average annual cost of the
final rule is the STAA costs ($70.0
million), followed by the exercise costs
($24.7 million), coordination ($16
million), and third-party audits ($9.8
million). The remaining provisions
impose average annual costs under $5
million each, including rule
familiarization ($3.9–4.6 million),
information sharing with the public
($3.1 million), incident investigation/
root cause analysis ($1.8 million),
notification exercises ($1.4 million), and
public meetings ($0.4 million).
b. Summary of Potential Benefits
EPA anticipates that promulgation
and implementation of this rule would
result in a reduction of the frequency
and magnitude of damages from
releases. Accidents and releases from
RMP facilities occur every year, causing
fires and explosions; damage to
property; acute and chronic exposures
of workers and nearby residents to
hazardous materials; and resulting in
serious injuries and death. Although we
are unable to quantify what specific
reductions may occur as a result of these
revisions, we are able to present data on
the total damages that currently occur at
RMP facilities each year. The data
presented is based on a 10-year baseline
period, summarizing RMP accident
impacts and, when possible, monetizing
them. EPA expects that some portion of
future damages would be prevented
through implementation of this final
rule. Table 3 presents a summary of the
quantified damages identified in the
analysis.
TABLE 3—SUMMARY OF QUANTIFIED DAMAGES
[Millions, 2015 dollars]
Unit value
10-year total
Average/year
Average/accident
On-site
Fatalities ...........................................................................................
Injuries .............................................................................................
Property Damage .............................................................................
$8.6
0.05
............................
$497.8
105.2
2,054.9
$49.8
10.5
205.5
$0.33
0.69
1.4
On-site Total .............................................................................
............................
2,657.9
265.8
1.8
Offsite
Fatalities ...........................................................................................
Hospitalizations ................................................................................
Medical Treatment ...........................................................................
Evacuations * ...................................................................................
Sheltering in Place * .........................................................................
Property Damage .............................................................................
8.6
0.4
0.001
0.0
0.0
............................
8.6
6.8
14.8
7.0
40.9
11.4
0.86
0.68
1.5
0.70
4.1
1.1
0.01
0.004
0.01
0.004
0.03
0.007
Offsite Total ..............................................................................
............................
89.5
8.9
0.06
Total ...................................................................................
............................
2,747.3
274.7
1.8
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* The unit value for evacuations is less than two hundred dollars and for sheltering in place is less than one hundred dollars so when expressed in rounded millions the value represented in the table is zero.
EPA monetized both on-site and
offsite damages. EPA estimated total
average annual on-site damages of
$265.8 million. The largest monetized
average annual on-site damage was onsite property damage, which resulted in
average annual damage of
approximately $205.5 million. The next
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largest impact was on-site fatalities
($49.8 million) and injuries ($10.5
million).
EPA estimated total average annual
offsite damages of $8.9 million. The
largest monetized average annual offsite
damage was from sheltering in place
($4.1 million), followed by medical
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treatment ($1.5 million), property
damage ($1.1 million), fatalities ($0.86
million), evacuations ($0.7 million), and
hospitalizations ($0.68 million).
In total, EPA estimated monetized
damages from RMP facility accidents of
$274.7 million per year. The 10-year
RMP baseline suggests that considering
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only the monetized impacts of RMP
accidents would mean that the rule’s
costs may outweigh the portion of
avoided impacts from improved
prevention and mitigation that were
monetized. The annualized cost of the
final rule (approximately $142 million
annually) is approximately 52% of the
average annual monetized costs in the
10-year baseline. However, the
monetized impacts omit many
important categories of accident impacts
including lost productivity, the costs of
emergency response, transaction costs,
property value impacts in the
surrounding community (that overlap
with other benefit categories), and
environmental impacts. Also not
reflected in the 10-year baseline costs
are the impacts of non-RMP accidents at
RMP facilities and any potential impacts
of rare high consequence catastrophes.
A final omission is related to the
information provision. Reducing the
probability of chemical accidents and
the severity of their impacts, and
improving information disclosure by
chemical facilities, as the provisions
intend, would provide benefits to
potentially affected members of society.
Table 4 summarizes four broad social
benefit categories related to accident
prevention and mitigation including
prevention of RMP accidents, mitigation
of RMP accidents, prevention and
mitigation of non-RMP accidents at
RMP facilities, and prevention of major
catastrophes. The table explains each
and identifies ten associated specific
benefit categories, ranging from avoided
fatalities to avoided emergency response
costs. Table 4 also highlights and
explains the information disclosure
benefit category and identifies two
specific benefits associated with it:
Improved efficiency of property markets
and allocation of emergency resources.
When considering the rule’s likely
benefits that are due to avoiding some
portion of the monetized accident
impacts, as well as the additional nonmonetized benefits described
previously, EPA believes the costs of the
rule are reasonable in comparison to its
benefits.
TABLE 4—SUMMARY OF SOCIAL BENEFITS OF FINAL RULE PROVISIONS
Broad benefit category
Explanation
Accident Prevention ...........................................
Accident Mitigation .............................................
Non-RMP accident prevention and mitigation ...
Prevention of future RMP facility accidents .....
Mitigation of future RMP facility accidents .......
Prevention and mitigation of future non-RMP
accidents at RMP facilities.
Prevention of rare but extremely high consequence events.
Avoided Catastrophes ........................................
Information Disclosure .......................................
Specific benefit categories
Provision of information to the public ..............
•
•
•
•
•
•
•
•
•
•
•
•
Reduced Fatalities.
Reduced Injuries.
Reduced Property Damage.
Fewer People Sheltered in Place.
Fewer Evacuations.
Avoided Lost Productivity.
Avoided Emergency Response Costs.
Avoided Transaction Costs.
Avoided Property Value Impacts.*
Avoided Environmental Impacts.
Improved efficiency of property markets.
Improved emergency response resource allocation.
* These impacts partially overlap with several other categories such as reduced health and environmental impacts.
B. Does this action apply to me?
This rule applies to those facilities
(referred to as ‘‘stationary sources’’
under the CAA) that are subject to the
chemical accident prevention
requirements at 40 CFR part 68. This
includes stationary sources holding
more than a threshold quantity (TQ) of
a regulated substance in a process. Table
5 provides industrial sectors and the
associated NAICS codes for entities
potentially affected by this action. The
Agency’s goal is to provide a guide for
readers to consider regarding entities
that potentially could be affected by this
action. However, this action may affect
other entities not listed in this table. If
you have questions regarding the
applicability of this action to a
particular entity, consult the person(s)
listed in the introductory section of this
action under the heading entitled FOR
FURTHER INFORMATION CONTACT.
TABLE 5—INDUSTRIAL SECTORS AND ASSOCIATED NAICS CODES FOR ENTITIES POTENTIALLY AFFECTED BY THIS ACTION
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Sector
NAICS code
Administration of Environmental Quality Programs ...........................................................................................
Agricultural Chemical Distributors:
Crop Production ..........................................................................................................................................
Animal Production and Aquaculture ...........................................................................................................
Support Activities for Agriculture and Forestry Farm .................................................................................
Supplies Merchant Wholesalers .................................................................................................................
Chemical Manufacturing ....................................................................................................................................
Chemical and Allied Products Merchant Wholesalers .......................................................................................
Food Manufacturing ...........................................................................................................................................
Beverage Manufacturing ....................................................................................................................................
Oil and Gas Extraction .......................................................................................................................................
Other 5 ................................................................................................................................................................
Other manufacturing ..........................................................................................................................................
Other Wholesale:
Merchant Wholesalers, Durable Goods ......................................................................................................
Merchant Wholesalers, Nondurable Goods ................................................................................................
924.
111.
112.
115.
42491.
325.
4246.
311.
3121.
211.
44, 45, 48, 54, 56, 61, 72.
313, 326, 327, 33.
423.
424.
5 For descriptions of NAICS codes, see https://
www.census.gov/cgi-bin/sssd/naics/naicsrch.
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4599
TABLE 5—INDUSTRIAL SECTORS AND ASSOCIATED NAICS CODES FOR ENTITIES POTENTIALLY AFFECTED BY THIS
ACTION—Continued
Sector
NAICS code
Paper Manufacturing ..........................................................................................................................................
Petroleum and Coal Products Manufacturing ....................................................................................................
Petroleum and Petroleum Products Merchant Wholesalers ..............................................................................
Utilities ................................................................................................................................................................
Warehousing and Storage .................................................................................................................................
II. Background
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A. Events Leading to This Action
Recent catastrophic chemical facility
incidents in the United States prompted
President Obama to issue Executive
Order 13650, ‘‘Improving Chemical
Facility Safety and Security,’’ on August
1, 2013.6 The purpose of the Executive
Order is to enhance the safety and
security of chemical facilities and
reduce risks associated with hazardous
chemicals to owners and operators,
workers, and communities. The
Executive Order establishes the
Chemical Facility Safety and Security
Working Group (‘‘Working Group’’), cochaired by the Secretary of Homeland
Security, the Administrator of EPA, and
the Secretary of Labor or their
designated representatives at the
Assistant Secretary level or higher, and
composed of senior representatives of
other Federal departments, agencies,
and offices. The Executive Order
requires the Working Group to carry out
a number of tasks whose overall aim is
to prevent chemical accidents. In
addition to the tragedy at the West
Fertilizer facility in West, Texas, on
April 17, 2013,7 a number of other
incidents have demonstrated a
significant risk to the safety of American
workers and communities. On March
23, 2005, explosions at the BP Refinery
in Texas City, Texas, killed 15 people
and injured more than 170 people.8 On
April 2, 2010, an explosion and fire at
the Tesoro Refinery in Anacortes,
Washington, killed seven people.9 On
6 For more information on the Executive Order
see https://www.whitehouse.gov/the-press-office/
2013/08/01/executive-order-improving-chemicalfacility-safety-and-security.
7 CSB. January 2016. Final Investigation Report,
West Fertilizer Company Fire and Explosion, West,
TX, April 17, 2013. REPORT 2013–02–I–TX. https://
www.csb.gov/west-fertilizer-explosion-and-fire-/. On
May 11, 2016, ATF ruled that the fire was
intentionally set. See ATF Announces $50,000
Reward in West, Texas Fatality Fire, https://
www.atf.gov/news/pr/atf-announces-50000-rewardwest-texas-fatality-fire.
8 U.S. Chemical Safety and Hazard Investigation
Board (CSB). March 2007. Investigation Report:
Refinery Explosion and Fire, BP, Texas City, Texas,
March 23, 2005. Report No. 2005–04–I–TX. https://
www.csb.gov/assets/1/19/CSBFinalReportBP.pdf.
9 CSB. May 2014. Investigation Report:
Catastrophic Rupture of Heat Exchanger, Tesoro
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August 6, 2012, at the Chevron Refinery
in Richmond, California, a fire involving
flammable fluids endangered 19
Chevron employees and created a large
plume of highly hazardous chemicals
that traveled across the Richmond,
California, area.10 Nearly 15,000
residents sought medical treatment due
to the release. On June 13, 2013, a fire
and explosion at Williams Olefins in
Geismar, Louisiana, killed two people
and injured many more.11
Section 6 of the Executive Order is
entitled ‘‘Policy, Regulation, and
Standards Modernization.’’ This section,
among other things, requires certain
Federal agencies to consider possible
changes to existing chemical safety and
security regulations. To solicit
comments and information from the
public regarding potential changes to
EPA’s Risk Management Program
regulations (40 CFR part 68), on July 31,
2014, EPA published an RFI (79 FR
44604). Information collected through
the RFI informed the proposed
rulemaking that was published on
March 14, 2016 (81 FR 13637).
EPA received a total of 61,716 public
comments on the proposed rulemaking.
Several public comments were the
result of various mass mail campaigns
and contained numerous copies of
letters or petition signatures.
Approximately 61,467 letters and
signatures were contained in these
several comments. The remaining
comments include 235 submissions
with unique content, 10 duplicate
submissions, and 4 non-germane
submissions. In addition to these public
submissions, EPA also received 8
Anacortes Refinery, Anacortes, Washington, April
2, 2010. Report No. 2010–08–I–WA. https://
www.csb.gov/assets/1/7/Tesoro_Anacortes_2014May-01.pdf.
10 CSB. January 2014. Regulatory Report: Chevron
Richmond Refinery Pipe Rupture and Fire, Chevron
Richmond Refinery #4 Crude Unit, Richmond,
California, August 6, 2012. Report No. 2012–03–I–
CA. https://www.csb.gov/assets/1/19/CSB_Chevron_
Richmond_Refinery_Regulatory_Report.pdf.
11 CSB. October 2016. Case Study: Williams
Geismar Olefins Plant Reboiler Rupture and Fire,
Geismar, Louisiana. Incident Date: June 13, 2013,
No. 2013–03–I–LA. US Chemical Safety and Hazard
Investigation Board, Washington, DC https://
www.csb.gov/williams-olefins-plant-explosion-andfire-/.
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322.
324.
4247.
221.
493.
written comments and had 22 members
of the public provide verbal comments
at a public hearing on March 29, 2016.
Discussion of public comments can be
found in topics included in this final
rule and in the Response to Comments
document,12 available in the docket for
this rulemaking.
B. Overview of EPA’s Risk Management
Program Regulations
Both EPA’s 40 CFR part 68 RMP
regulation 13 and Occupational Safety
and Health Administration’s (OSHA) 29
CFR 1910.119 Process Safety
Management (PSM) standard were
authorized in the CAA Amendments of
1990. This was in response to a number
of catastrophic chemical accidents
occurring worldwide that had resulted
in public and worker fatalities and
injuries, environmental damage, and
other community impacts. OSHA
published the PSM standard in 1992 (57
FR 6356, February 24, 1992), as required
by section 304 of the 1990 CAAA, using
its authority under 29 U.S.C. 653.
The 1990 CAA Amendments added
accidental release provisions under
section 112(r). The statute required EPA
to develop a list of at least 100 regulated
substances for accident prevention and
related thresholds (CAA section
112(r)(3) through (5)), and authorized
EPA to issue accident prevention
regulations (CAA section 112(r)(7)(A)).
The statute also required EPA to
develop ‘‘reasonable regulations’’
requiring facilities with over a TQ of a
regulated substance to undertake
accident prevention steps and submit a
‘‘risk management plan’’ to various
local, state, and Federal planning
entities (CAA section 112(r)(7)(B)).
12 2016. EPA Response to Comments on the 2016
Proposed Rulemaking Amending EPA’s Risk
Management Program Regulations. This document
is available in the docket for this rulemaking.
13 40 CFR part 68 is titled, ‘‘Chemical Accident
Prevention Provisions,’’ but is more commonly
known as the ‘‘RMP regulation,’’ the ‘‘RMP rule,’’
or the ‘‘Risk Management Program.’’ This document
uses all three terms to refer to 40 CFR part 68. The
term ‘‘RMP’’ refers to the document required to be
submitted under subpart F of 40 CFR part 68, the
Risk Management Plan. See https://www.epa.gov/
rmp for more information on the Risk Management
Program.
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EPA published the RMP regulation in
two stages. The Agency published the
list of regulated substances and TQs in
1994 (59 FR 4478, January 31, 1994) (the
‘‘list rule’’) 14 and published the RMP
final regulation, containing risk
management requirements for covered
sources, in 1996 (61 FR 31668, June 20,
1996) (the ‘‘RMP rule’’).15 16 Both the
OSHA PSM standard and the EPA RMP
rule aim to prevent or minimize the
consequences of accidental chemical
releases through implementation of
management program elements that
integrate technologies, procedures, and
management practices. In addition to
requiring implementation of
management program elements, the
RMP rule requires covered sources to
submit (to EPA) a document
summarizing the source’s risk
management program—called a Risk
Management Plan (or RMP). The RMP
rule required covered sources to comply
with its requirements and submit initial
RMPs to EPA by June 21, 1999. Each
RMP must be revised and updated at
least once every five years from the date
the plan was initially submitted.
EPA later revised the list rule and the
RMP rule. EPA modified the regulated
list of substances by exempting
solutions with less than 37%
concentrations of hydrochloric acid (62
FR 45130, August 25, 1997). EPA also
deleted the category of Department of
Transportation Division 1.1 explosives,
and exempted flammable substances in
gasoline used as fuel and in naturally
occurring hydrocarbon mixtures prior to
initial processing (63 FR 640, January 6,
1998).
EPA subsequently modified the RMP
rule five times. First, in 1999, EPA
revised the facility identification data
and contact information reported in the
RMP (64 FR 964, January 6, 1999). Next,
EPA revised assumptions for the worst
case scenario analysis for flammable
substances and clarified what the
Agency means by chemical storage not
incidental to transportation (64 FR
28696, May 26, 1999). After the
Chemical Safety Information, Site
Security and Fuels Regulatory Relief Act
(CSISSFRRA) was enacted on August 5,
1999, EPA excluded regulated
14 Documents and information related to
development of the list rule can be found in the
EPA docket for the rulemaking, docket number A–
91–74.
15 Documents and information related to
development of the RMP rule can be found in EPA
docket number A–91–73.
16 40 CFR part 68 applies to owners and operators
of stationary sources that have more than a TQ of
a regulated substance within a process. The
regulations do not apply to chemical hazards other
than listed substances held above a TQ within a
regulated process.
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flammable substances when used as a
fuel or held for sale as a fuel at a retail
facility (65 FR 13243, March 13, 2000).
Later, EPA restricted access to offsite
consequence analysis (OCA) data for the
public and government officials to
minimize the security risks associated
with posting the information on the
Internet (65 FR 48108, August 4, 2000).
Finally, EPA revised the RMP executive
summary to remove a requirement to
describe the OCA; revised reporting
deadlines for RMP reportable accidents
and emergency contact changes; and
made other minor revisions to RMP
facility contact information (69 FR
18819, April 8, 2004).
The RMP rule establishes three
‘‘program levels’’ for regulated
processes:
Program 1 applies to processes that
would not affect the public in the case
of a worst-case release and that have
had no accidents with specific offsite
consequences within the past five years.
Program 1 imposes limited hazard
assessment requirements, requires
coordination with local response
agencies, and requires submission of an
RMP.
Program 2 applies to processes not
eligible for Program 1 or subject to
Program 3, and imposes streamlined
prevention program requirements,
including safety information, hazard
review, operating procedures, training,
maintenance, compliance audits, and
incident investigation elements.
Program 2 also imposes additional
hazard assessment, management, and
emergency response requirements.
Program 3 applies to processes not
eligible for Program 1 and either subject
to OSHA’s PSM standard under Federal
or state OSHA programs or classified in
one of ten specified industry sectors
identified by their 2002 NAICS codes
listed at § 68.10(d)(1). These industries
were selected because they had a higher
frequency of the most serious accidents
as compared to other industry sectors.
The ten NAICS codes and the industries
they represent are 32211 (pulp mills),
32411 (petroleum refineries), 32511
(petrochemical manufacturing), 325181
(alkalies and chlorine manufacturing),
325188 (all other basic inorganic
chemical manufacturing), 325192
(cyclic crude and intermediate
manufacturing), 325199 (all other basic
chemical manufacturing), 325211
(plastics material and resin
manufacturing), 325311 (nitrogenous
fertilizer manufacturing), or 32532
(pesticide and other agricultural
chemicals manufacturing).17 Program 3
17 NAICS codes 325181 and 325188 are now
combined and represented as revised NAICS code
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imposes elements nearly identical to
those in OSHA’s PSM standard as the
accident prevention program. The
Program 3 prevention program includes
requirements relating to process safety
information (PSI), PHA, operating
procedures, training, mechanical
integrity, management of change (MOC),
pre-startup review, compliance audits,
incident investigations, employee
participation, hot work permits, and
contractors. Program 3 also imposes the
same hazard assessment, management,
and emergency response requirements
that are required for Program 2.
The RMP rule has been effective in
preventing and mitigating chemical
accidents in the United States and
protecting human health and the
environment from chemical hazards.
However, major incidents, such as the
West, Texas explosion,18 highlight the
importance of reviewing and evaluating
current practices and regulatory
requirements, and applying lessons
learned from other incident
investigations to advance process safety
where needed.
III. Additional Information
A. Agency’s Authority for Taking This
Action
The statutory authority for this action
is provided by section 112(r) of the CAA
as amended (42 U.S.C. 7412(r)). Each of
the portions of the Risk Management
Program rule we are amending in this
document are based on EPA’s
rulemaking authority under section
112(r)(7) of the CAA (42 U.S.C.
7412(r)(7)). A more detailed discussion
of the underlying statutory authority for
the current requirements of the Risk
Management Program rule appears in
the action that proposed the Risk
Management Program (58 FR 54190,
54191–93, October 20, 1993). The
prevention program provisions
discussed in this preamble (auditing,
incident investigation, and safer
technologies alternatives analysis)
address the ‘‘prevention and detection
of accidental releases.’’ The emergency
coordination and exercises provisions in
this rule modify existing provisions that
provide for ‘‘response to such release by
the owners or operators of the sources
of such releases’’ (CAA section
112(r)(7)(B)(i)). This paragraph in the
325180 in the 2012 and 2017 code versions (other
basic inorganic chemical manufacturing). NAICS
code 325192 is now revised NAICS code 325194
(cyclic crude, intermediate, and gum and wood
chemical manufacturing) in the 2012 and 2017 code
versions.
18 CSB. January 2016. Final Investigation Report,
West Fertilizer Company Fire and Explosion, West,
TX, April 17, 2013. REPORT 2013–02–I–TX. https://
www.csb.gov/west-fertilizer-explosion-and-fire-/.
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statute calls for EPA’s regulations to
recognize differences in ‘‘size,
operations, processes, class and
categories of sources.’’ In this document,
we maintain the distinctions in
prevention program levels and in
response actions authorized by this
provision. The information disclosure
provisions discussed in this document
generally assist in the development of
‘‘procedures and measures for
emergency response after an accidental
release of a regulated substance in order
to protect human health and the
environment.’’ This information
disclosure ensures the emergency plans
for impacts on the community are based
on more relevant and accurate
information than would otherwise be
available and ensures that the public
can become an informed participant in
such emergency planning.
Various commenters suggested that
particular provisions of the proposed
rulemaking were not consistent with
CAA section 112(r) or other relevant
statutes. We address these comments in
each relevant section of the preamble
and in the Response to Comments
document,19 available in the docket for
this rulemaking. Some commenters also
suggested that EPA has not complied
with the requirements in CAA section
112(r)(7)(D) for the Administrator to
‘‘consult with the Secretary of Labor and
the Secretary of Transportation’’ and
‘‘coordinate any requirements under
this paragraph with any requirements
established for comparable purposes by
the Occupational Safety and Health
Administration or the Department of
Transportation.’’
EPA disagrees with these comments.
Under section 6 of Executive Order
13650, ‘‘Improving Chemical Facility
Safety and Security,’’ the Executive
Order Working Group, chaired by EPA,
OSHA, and Department of Homeland
Security (DHS), was tasked with
enhancing safety at chemical facilities
by identifying key improvements to
existing risk management practices
through guidance, policies, procedures,
outreach, and regulations. As part of
this task, the Working Group conducted
extensive interagency coordination, and
solicited public comment on potential
options for improving chemical facility
safety. EPA’s coordination efforts
included discussions with numerous
Federal agencies, including OSHA and
the Department of Transportation
(DOT), on potential changes to the Risk
Management Program rule. As EPA
19 2016. EPA Response to Comments on the 2016
Proposed Rulemaking Amending EPA’s Risk
Management Program Regulations. This document
is available in the docket for this rulemaking.
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explained in the preamble to the
proposed rulemaking, the OSHA PSM
standard and EPA RMP regulation are
closely aligned in content, policy
interpretations, Agency guidance, and
enforcement. Since the inception of
these regulations, EPA and OSHA have
coordinated closely on their
implementation in order to minimize
regulatory burden and avoid conflicting
requirements for regulated facilities.
This coordination has continued
throughout the development of this rule
and on OSHA’s initial steps toward
proposing potential changes to the PSM
standard. EPA’s coordination with DOT
was less extensive because nothing in
this rule changes its basic applicability
provisions, which apply the rule only to
stationary sources, and exclude
transportation. However, EPA continues
to coordinate with DOT through
ongoing Executive Order activities,
which includes updates on RMP
regulatory development, and this
coordination is sufficient to meet EPA’s
obligations under CAA section
112(r)(7)(D). As with OSHA, EPA has a
long history of close coordination with
DOT on implementation of the RMP,
particularly where potential
transportation-related issues arise, and
the Agency fully intends for such
coordination to continue.
B. List of Regulated Substances
As part of its work under Executive
Order 13650, the Working Group
solicited public comment on potential
changes to the list of regulated
substances for the Risk Management
Program, including what actions to take
to address ammonium nitrate (AN). EPA
did not propose revisions to the list of
regulated substances. Instead, EPA
explained the actions other agencies in
the Executive Order Working Group are
considering to address AN and
indicated that EPA will coordinate any
potential changes to the list of
substances in 40 CFR part 68 with the
actions of these other agencies. EPA
received several comments related to
revising the list of regulated substances
and whether to expand the list to
include AN.
1. Discussion of Comments on the List
of Regulated Substances
A couple of commenters expressed
support for expanding the scope of
regulated substances under the RMP
rule. One private citizen stated that EPA
should broaden the range of chemicals
covered under RMP and account for
effects on vulnerable populations
including children and the elderly. A
professional organization asserted that
EPA should update the list of regulated
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4601
substances and require facilities to
‘‘evaluate the risk of a reactive chemical
accident and take appropriate measures,
even if the chemicals in question are not
on the list.’’
However, multiple commenters
supported EPA’s decision not to revise
the list of regulated substances in this
action. These commenters opposed
adding toxic or flammable substances to
the list of regulated substances in a
separate action. One industry
commenter opposed the addition of
combustible dust to the list, arguing that
it is already regulated under OSHA and
constitutes a low risk to the public.
EPA will consider these comments
when determining whether to propose
revisions to the list of substances.
2. Discussion of Comments on AN
Many commenters supported
regulating AN in the RMP rule. Several
commenters requested that EPA
consider the danger to the public from
AN, and other reactive chemicals, in its
rulemaking. A state agency further
asked EPA to ensure that calculations
for the OCA consider the unique
explosive characteristics of fertilizer
grade ammonium nitrate (FGAN) and
develop specific RMP guidance for
regulated FGAN facilities. One
commenter supported adding AN to the
list of regulated substances but
requested unique requirements for AN
formulated as an explosive or blasting
agent and FGAN. Another commenter
claimed that EPA failed to address
Executive Order 13650 by failing to
address AN in the proposed rulemaking.
However, EPA also received
comments opposed to adding AN to the
list of regulated substances. One
commenter stated that EPA didn’t have
authority to regulate FGAN under the
CAA and urged the Agency against
including FGAN under the RMP
regulations. Another commenter
supported EPA’s decision not to change
current threshold quantities and toxic
endpoints.
An industry trade association
requested EPA’s support and
recognition of its voluntary private
sector comprehensive inspection and
assessment organization and FGAN
guidelines for fertilizer retail facilities.
EPA acknowledges that there is both
support and opposition to regulating AN
and will consider these comments when
determining whether to take further
action on this issue. In the interim, EPA
encourages fertilizer retailers to review
and use existing guidance. OSHA
compiles several resources on their
Fertilizer Industry Guidance on Storage
and Use of Ammonium Nitrate Web
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page at https://www.osha.gov/dep/
fertilizer_industry/.
EPA disagrees with the commenter
that indicated that EPA failed to address
Executive Order 13650 when we chose
not to propose to list AN in the list of
regulated substances for the RMP
regulations. In the proposed rulemaking,
EPA explained that other agencies,
including OSHA and DHS, are
considering modifications to their
regulations, and EPA will coordinate
any potential changes to the list of
substances in 40 CFR part 68 with the
actions of these other agencies.
IV. Prevention Program Requirements
A. Incident Investigation and Accident
History Requirements
1. Summary of Proposed Rulemaking
a. Definitions, § 68.3
EPA proposed to revise the definition
of ‘‘catastrophic release’’ in § 68.3 to
include impact categories identical to
the description of accidental releases
required to be reported under the
accident history reporting requirements
in § 68.42. The proposed definition, in
§ 68.3, would replace the phrase ‘‘that
presents imminent and substantial
endangerment to public health and the
environment’’ with impacts categories
including impacts that resulted in:
• On-site: Deaths, injuries, or
significant property damage; or
• Offsite: Known deaths, injuries,
evacuations, sheltering in place,
property damage, or environmental
damage.
EPA proposed to define ‘‘root cause’’
in § 68.3 to mean a fundamental,
underlying, system-related reason why
an incident occurred that identifies a
correctable failure(s) in management
systems.
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b. Incident Investigation Sections,
§§ 68.60 and 68.81
EPA proposed a number of revisions
to the incident investigation provisions.
EPA proposed to revise § 68.60, which
is applicable to Program 2 processes,
and § 68.81, which is applicable to
Program 3 processes, by revising
paragraph (a) to add subparagraphs
(a)(1) and (a)(2) to better clarify the
scope of incidents that must be
investigated. Proposed subparagraph
(a)(1) applied to an incident that
resulted in a catastrophic release and
clarifies that the owner or operator must
investigate the incident even if the
process involving the regulated
substance is destroyed or
decommissioned. Proposed
subparagraph (a)(2) applied to a nearmiss, which is an incident that could
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reasonably have resulted in a
catastrophic release. EPA also proposed
removing the phrase ‘‘of a regulated
substance’’ from paragraph (a) because it
is duplicative. The definition of
‘‘catastrophic release’’ refers to releases
of regulated substances.
EPA also proposed to add a new
paragraph (c) to § 68.60 requiring that an
incident investigation team be
established and consist of at least one
person knowledgeable in the process
involved and other persons with
appropriate knowledge and experience
to thoroughly investigate and analyze
the incident. This is similar to the
existing requirement in § 68.81(c) for
Program 3 processes. EPA proposed that
current § 68.60(c) through (f) would
become § 68.60(d) through (g).
EPA proposed to revise the
redesignated paragraph (d) in § 68.60
and current paragraph (d) in § 68.81 to
revise the incident investigation report
requirements. EPA proposed to change
the word ‘‘summary’’ to ‘‘report’’ and
require facility owners or operators to
complete incident investigation reports
within 12 months unless the
implementing agency approves, in
writing, an extension of time.
In addition, EPA proposed to amend
and add new subparagraphs in the
redesignated paragraph (d) in § 68.60
and current paragraph (d) in § 68.81
requiring additional elements in an
incident investigation report.
Specifically, EPA proposed to:
• Revise paragraph (d)(1) to require
the time and location of the incident in
the investigation report;
• Revise paragraph (d)(3) to specify
that the description of the incident be in
chronological order and provide all
relevant facts;
• Add paragraph (d)(4) to require that
the investigation report include the
name and amount of the regulated
substance involved in the release or
near miss and the duration of the event;
• Add paragraph (d)(5) to require a
description of the consequences, if any,
of the incident;
• Add paragraph (d)(6) to require a
description of emergency response
actions taken;
• Renumber current paragraph (d)(4)
to (d)(7) and require additional criteria
related to the factors contributing to the
incident, including the initiating event,
direct and indirect contributing factors,
and root causes. EPA also proposed to
add language to paragraph (d)(7) to
require that root causes be determined
through the use of a recognized method.
• Renumber the current paragraph
(d)(5) to (d)(8) and add language to
require a schedule for addressing
recommendations resulting from the
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investigation to be included in the
investigation report.
Finally, in the redesignated § 68.60(g),
EPA proposed to add the word incident
before investigation and change
‘‘summaries’’ to ‘‘reports’’ for
consistency.
c. Accident History, § 68.42
EPA also proposed to amend the fiveyear accident history section to require
reporting of categories of root causes
identified in the root cause analysis
proposed to be required in
§§ 68.60(d)(7) and 68.81(d)(7).
d. Hazard Review, § 68.50
For the Hazard review section, EPA
proposed to amend subparagraph (a)(2)
by adding a phrase at the end to require
the owner or operator to consider
findings from incident investigations.
e. Process Hazard Analysis (PHA),
§ 68.67
In the PHA section, EPA proposed to
add subparagraph (c)(2) to require the
owner or operator to address findings
from incident investigations, as well as
any other potential failure scenarios
(e.g., incidents that occurred at other
similar facilities and or processes,
failure mechanisms discovered in
literature or from other sources of
information).
f. Updates, § 68.190
In the Updates section, EPA proposed
to amend paragraph (c) to require the
owner or operator to report any
accidents covered by § 68.42 and
conduct incident investigations required
under § 68.60 and/or § 68.81 prior to deregistering a process or stationary source
that is no longer subject to the RMP
rule.
2. Summary of Final Rule
EPA is not finalizing the proposed
definition for catastrophic release and is
instead maintaining the existing
definition. Additionally, EPA is
finalizing a modified version of the
proposed definition of the term ‘‘root
cause.’’ In the final definition EPA
deleted the phrase ‘‘that identifies a
correctable failure(s) in management
systems.’’
EPA is not finalizing the proposed
revisions to the five-year accident
history section in the final rule.
EPA is finalizing the following
provisions as proposed:
• Hazard review section, § 68.50;
• Incident investigation section
§§ 68.60 and 68.81;
• Process hazard analysis (PHA)
section, § 68.67, to add subparagraph
(c)(2).
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• Updates section, § 68.190.
3. Discussion of Comments and Basis for
Final Rule Provisions
EPA’s rationale for modifying the
accident investigation provisions to
explicitly require root cause analysis for
investigations of catastrophic releases
and near miss events and to have the
findings of these investigations
integrated into the PHA remains
generally the same as in the proposed
rulemaking. In the discussion that
follows and in the Response to
Comment document, we explain the
modifications to our approach and the
basis for these modifications.20 The
most significant change in approach is
to retain the catastrophic release
definition. As became apparent in the
comments, our view that having a
common definition of reportable
accidental release and catastrophic
release would simplify and clarify
compliance was outweighed by the
potential burden of inadvertently
expanding the number of investigated
accidental releases. We continue to
require investigations of near misses,
but have provided additional guidance
as to what we intend by the term. Other
changes from the proposal are similarly
intended to clarify terms used in the
rule. Identification of root cause
categories in accident history reporting
has been eliminated because identifying
root cause categories only provides
limited information for understanding
the root cause which is best attained by
reviewing the complete incident
investigation report. Implementing
agencies and/or local emergency
planners may still obtain the
investigation report through direct
contact with the facility. The changes
we adopt in this final rule strike a
balance between ensuring facilities and
planners learn about the causes of
catastrophic releases and near misses
while also better targeting the reporting
to minimize burden.
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a. Definitions
Catastrophic release. Although EPA
received some support for the proposed
definition of ‘‘catastrophic release,’’
many commenters were opposed to the
revision. Many commenters, including
government agencies, industry trade
associations, and facilities, argued that
EPA’s proposed definition of
‘‘catastrophic release’’ (1) expands its
scope, rather than clarifying it, (2) is
redundant of OSHA’s authority to
20 2016. EPA Response to Comments on the 2016
Proposed Rulemaking Amending EPA’s Risk
Management Program Regulations. This document
is available in the docket for this rulemaking.
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regulate workplace safety by including
on-site damage or injuries, and (3)
exceeds the CAA authority to regulate
only ambient air beyond a facility’s
property.
EPA also received some comments
identifying other concerns with the
proposed change to the definition of
‘‘catastrophic release.’’ Some
commenters, including a few facilities,
said that the proposed definition is too
vague, and some commenters noted that
terms such as ‘‘injuries,’’ ‘‘significant
property damage,’’ ‘‘environmental
damage,’’ and ‘‘major’’ are not defined.
A facility and a private citizen
commented that the wording of the
definition implies that a ‘‘catastrophic
release’’ could include a fire, regardless
of whether an actual release of regulated
material occurs due to the fire, and also
implies that releases involving on-site
environmental damage would not be
considered catastrophic.
Many commenters, including a state
government agency, facilities, and
industry trade associations, argued that
EPA’s proposed definition of
‘‘catastrophic release’’ would regulate
workplace safety concerns that are
outside EPA’s authority to regulate
under the CAA. Commenters asserted
that EPA has authority to address
through regulation and enforcement
offsite impacts of facility releases, not
on-site impacts. A facility asserted that
the proposed definition inappropriately
expands the scope of EPA’s reach into
workplace safety by requiring
investigations of releases that would
also include impacts to on-site workers
or property. An industry trade
association stated that the definition
ignores Congress’s express prohibition
against EPA ‘‘exercising statutory
authority to prescribe or enforce
standards or regulations affecting
occupational safety and health.’’ This
commenter further argued that on-site
injuries should be excluded from the
proposed definition because OSHA
already has jurisdiction in this area and
because these often do not pose any risk
to public health or the environment.
A facility stated that the proposed
revision directly contradicts EPA’s longheld interpretation that the references in
section 112(r)(2)(A) to ‘‘ambient’’ air
limit the Agency’s authority to activities
with offsite consequences. The
commenter asserted that in the
proposed rulemaking the EPA does not
acknowledge the contradiction from its
previous position or explain what new
statutory authority exists or why it now
has the authority to regulate workplace
incidents.
Due to the large number of comments
opposing the proposed revision to the
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definition of ‘‘catastrophic release,’’
EPA has decided not to finalize the
proposed language. EPA believed that
providing a consistent trigger for
accident investigations and reportable
accidents under the accident history
requirements of § 68.42 would simplify
compliance for the regulated
community. EPA acknowledges that the
proposed revision may have
inadvertently expanded the definition
and therefore the type of accident that
could trigger an investigation. Some
reportable incidents under the accident
history provision may not pose an
imminent and substantial threat to
public health and the environment (see
40 CFR 68.3 (Catastrophic release)). Due
to EPA’s decision to retain the existing
‘‘catastrophic release’’ definition and
not go forward with the proposed
revision, the authority issues raised in
comments are moot. However, contrary
to one commenter’s claim, it has never
been EPA’s position that the references
in section 112(r) to ‘‘ambient’’ air limit
the Agency’s authority to regulate only
activities with offsite consequences. On
the contrary, it has been the Agency’s
longstanding position that incidents that
primarily or even exclusively impact
on-site receptors are potentially relevant
to protection of the public and the
environment from the risks of an
accidental release. As EPA explained in
the Response to Comments document
for the original RMP rule, certain on-site
accident impacts are relevant because
they ‘‘may reflect safety practices at the
source’’ and because ‘‘accidental
releases from covered processes which
resulted in deaths, injuries, or
significant property damage on-site,
involve failures of sufficient magnitude
that they have the potential to affect
offsite areas.’’ 21
For similar reasons, requiring
investigation of accidents with on-site
impacts is not redundant to OSHA’s
authority when such accidents have the
potential to affect offsite areas.
Root cause. Many commenters
opposed the proposed definition of
‘‘root cause.’’ These commenters, which
included industry trade associations,
facilities, and a private citizen, said that
EPA should revise the definition of
‘‘root cause’’ to remove ‘‘system-related’’
and ‘‘management system,’’ reasoning
that not all incidents are due to system
failures. One commenter also stated that
the definition assumes that there is only
21 EPA, Risk Management Plan Rule: Summary
and Response to Comments, Excerpt from Volume
1: Table of Contents, Introduction, and Sections 3,
16 and 17. May 24, 1996, pp 3–11 and 17–4.
Document No. EPA–HQ–OEM–2015–0725–0153,
https://www.regulations.gov/document?D=EPA-HQOEM-2015-0725-0153.
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one root cause and that the failure is
correctable, when there can be many
causes and the investigators may not be
able to determine what is ‘‘correctable.’’
An association of government agencies
agreed that the investigation should
identify all root causes of failure,
regardless of whether they are deemed
correctable or related to the
management system. An industry trade
association stated that EPA should not
define ‘‘root cause’’ and instead should
defer to facilities to rely on standard
definitions from independent safety
organizations. Another industry trade
association also argued that EPA does
not need to define ‘‘root cause’’ because
current incident investigator
requirements, which call for the
investigator to uncover ‘‘the factors that
contributed to the incident,’’ are
sufficient. Other industry trade
associations commented that it is very
misleading and may lead to incorrect
enforcement proceedings to require a
facility to identify a management system
failure as a root cause of incidents
whose true root cause is a design
deficiency, equipment failure, or misuse
of equipment.
EPA agrees with some of the
comments, and is finalizing the
proposed definition of ‘‘root cause’’
with modifications. EPA deleted the
language regarding identifying
correctable failure(s) in management
systems. In response to the comment
that the definition assumes that there is
only one root cause, EPA agrees that
there are often multiple root causes. The
final rule defines ‘‘root cause’’ in the
singular, but does not preclude the
possibility of more than one root cause.
EPA agrees with the comments that
support investigations identifying all
root causes, and the Agency notes that
the root cause requirements in the final
rule require the owner or operator to
identify ‘‘root causes.’’
b. Accident History Reporting
Some government agencies, an
industry trade association, and a
professional association agreed that the
RMP accident history should include
the root causes of incidents. However,
other commenters, including industry
trade associations and a facility, stated
that the existing reporting requirements
in § 68.42 are sufficient, and that
requiring root cause reporting in the
five-year accident history is an
additional burden that is not offset by
improved performance.
Although EPA believes there could be
some benefit to identifying root cause
categories within a facility’s accident
history, in most cases, the Agency
believes the incident investigation
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report must be reviewed in order to
fully understand root causes attributed
to that incident. Implementing agency
officials can obtain investigation reports
during inspections or by using the
Agency’s information gathering
authorities when needed. Therefore,
EPA did not finalize the proposed
requirement.
c. Changes to Hazard Review (§ 68.50)
and Process Hazard Analysis (PHA)
(§ 68.67) Requirements
Hazard review and PHA. Some
commenters, including several
government agencies, a professional
organization, and an industry trade
association, supported the requirement
to include incident investigation
findings in the hazard review. Other
commenters opposed the requirement.
Some of these commenters stated that
the OSHA PSM standard already
requires PHAs to address previous
incidents, and EPA’s changes are
therefore unnecessary. One industry
trade association commented that, as
written, the proposal would require
facilities to include all findings from all
investigations for the facility’s entire
history.
Another commenter argued that
incident investigation findings should
not be required for PHAs because PHA
teams typically use established
techniques and requiring the ‘‘findings
from incident investigations’’ to be
included would not be a good fit for
these types of assessments.
EPA disagrees with commenters and
is finalizing these requirements as
proposed, so that findings from incident
investigations are considered when
hazard reviews are conducted. EPA
notes that the basic purpose of a hazard
review is to identify what process
equipment malfunctions or human
errors could potentially lead to
accidental releases, and then to identify
what safeguards are needed in order to
prevent such malfunctions and errors
from occurring. An obvious source of
information about such malfunctions
and errors is information gained from
investigating incidents that have
previously occurred within the covered
process. For this reason, the Program 3
analog to the hazard review, the PHA,
already requires the owner or operator
to identify any previous incidents that
had a likely potential for catastrophic
consequences when conducting the
PHA.
EPA therefore not only disagrees with
the commenter who stated that
including findings from incident
investigations within the PHA ‘‘would
not be a good fit’’ for the PHA (as the
existing rule already contains this
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requirement), but also believes that this
requirement should be incorporated into
the hazard review. EPA also disagrees
that widely-used PHA (or hazard
review) techniques preclude
consideration of prior incidents—all
PHA and hazard review techniques that
EPA is aware of are easily adapted to
allow consideration of prior incident
scenarios. The commenter provided the
example of the Hazard and Operability
Study (HAZOP) PHA technique as an
example of a technique for PHAs that is
widely accepted but does not consider
prior incidents. EPA disagrees that the
HAZOP may not be adapted to consider
prior incident causes. In fact, this PHA
technique, which EPA acknowledges is
widely used, is specifically intended to
identify process deviations that can lead
to undesirable consequences, as well as
the causes and consequences of such
deviations, and safeguards necessary to
protect against the deviation from
occurring. Incident scenarios are a key
source of knowledge for conducting this
technique. According to the Center for
Chemical Process Safety (CCPS)
‘‘Guidelines for Hazard Evaluation
Procedures—Second Edition with
Worked Examples’’ (AIChE/CCPS, 1992,
pp 143) ‘‘the knowledge-based HAZOP
Analysis study can help ensure that the
company’s practices, and therefore its
experience, have indeed been
incorporated in the design.’’ The CCPS
Guidelines also provide a specific
example of how incident information
can be incorporated into the HAZOP:
As a more specific example, consider the
discharge from a centrifugal pump. The
guide-word HAZOP approach would apply
the guide word ‘‘Reverse’’ to identify the
need for a check valve. The knowledge-based
HAZOP approach might also identify the
need for a check valve because an actual
problem was experienced with reverse flow
. . . [emphasis added].
In response to the comment regarding
the requirements of OSHA PSM, EPA
notes that this final rule requirement is
applicable to Program 2 covered
processes, which are not subject to the
OSHA PSM standard.
Other potential failure scenarios.
Some commenters opposed including
‘‘other potential failure scenarios’’ in the
process hazards analysis (PHA). A state
agency and an industry trade
association stated that it is unclear what
‘‘any other potential failure scenarios’’
means. The state agency also said that
facilities may not have access to or
knowledge of issues at similar facilities.
A facility said that EPA should provide
a clearinghouse of ‘‘potential failure
scenarios’’ so that facilities will have
access to them. An industry trade
association commented that a literature
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review would not provide much
information and would be costly to
conduct.
In response, as stated in the preamble
to the proposed rulemaking, other
potential failure scenarios can include
incidents that occurred at other similar
facilities and or processes, failure
mechanisms discovered in literature, or
from other sources of information. EPA
believes that it is appropriate to research
information about other potential
scenarios and consider these scenarios
when conducting a (PHA). Regarding
the comment to provide a clearinghouse
of scenarios, given the variety of
processes and stationary sources, and
ongoing changes to technologies, it
would be difficult to establish a onestop resource that would identify all
potential failure scenarios for all
processes covered under the rule.
However, EPA believes that owners and
operators are in the best position to
obtain incident information relevant to
their own covered processes. In most
cases, industry trade associations will
be a useful source for this information.
Such information is also commonly
available in trade journals, at industry
conferences, in industry newsletters, in
the Chemical Safety Board’s accident
investigation reports, in reference
publications (e.g., Lees’ Loss Prevention
in the Process Industries 22), and
through other professional networks.
EPA therefore believes that information
about other potential failure scenarios
that are potentially relevant to a covered
process should not be costly for the
owner or operator to conduct and will
benefit both the regulated stationary
sources and its surrounding community.
Regarding the comment that this
provision will require the owner or
operator to review findings from all
incident investigations for the facility’s
entire history—EPA agrees that the
owner or operator should review all
available incident information, but
notes that the rule does not require the
owner or operator to retain incident
investigation reports for more than five
years. However, if the owner or operator
has access to incident information
beyond that period, they should
incorporate it into their hazard review
as appropriate.
d. Destroyed or Decommissioned
Processes
EPA received various comments
regarding the proposed rulemaking’s
requirement for investigation of
22 Lees, Frank P. 2012. Loss Prevention in the
Process Industries, Fourth Edition. ButterworthHeinemann. https://www.sciencedirect.com/science/
book/9780123971890.
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incidents that resulted in destruction or
decommissioning of a process. Several
commenters, including local agencies,
facilities, an advocacy group, and an
association of government agencies,
expressed support for the requirement
that an incident investigation with a
root cause analysis be performed for
incidents involving processes units that
were destroyed or will be
decommissioned. A local agency and a
facility explained that this information
could improve safety for other processes
at the same facility or at other facilities.
EPA also received comments
opposing incident investigations for
destroyed or decommissioned
processes. A facility and industry trade
associations commented that there is no
benefit to requiring investigations in
cases where a process is
decommissioned or destroyed.
EPA also received comments in
opposition to registration requirements
for decommissioned processes. A
facility and an industry trade
association said that there is no
incremental safety benefit to requiring a
destroyed or decommissioned unit to
remain registered under RMP until after
the incident investigation is complete.
The commenters argued that this
requirement imposes additional
paperwork burdens without any
additional safety benefit.
EPA is finalizing this requirement as
proposed. The Agency agrees with the
commenters who support this
requirement because it will ensure that
when incidents occur, particularly
incidents so severe that the owner or
operator elects to decommission the
process involved or where the process is
destroyed in the incident, lessons are
learned as a result, both for the benefit
of the owner/operator, and potentially
for other stationary sources with similar
processes.
In response to the comments opposed
to the registration requirements for
decommissioned processes, EPA
believes that the additional paperwork
burden regarding such requirements is
minimal, as the processes would have
already been registered in the source’s
most recent RMP. New accident history
information may be added to the RMP
without performing a full update.
Following that correction, if the affected
process has been decommissioned or
destroyed, and if the source has
multiple covered processes, the owner
or operator would update their RMP to
reflect the loss of the affected process
(this would be required whether or not
the incident was investigated). If the
affected process was the only process at
the source, after completing the
investigation and correcting the existing
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4605
RMP, the owner or operator would
submit a deregistration notice for the
source to EPA. Deregistration is already
required by § 68.190(c) when a source is
no longer subject to Part 68. Therefore,
from a paperwork standpoint, the
primary effect of this change would be
the timing of when deregistration
occurs. EPA believes the potential
benefits of the knowledge gained from
the incident investigation warrant this
delay in deregistering a source.
e. Near Misses
In the proposed rulemaking, EPA did
not propose a definition for the term
‘‘near miss,’’ although EPA did include
the term in proposed revisions to
§§ 68.60 and 68.81, paragraph (a)(2), in
the phrase: ‘‘Could reasonably have
resulted in a catastrophic release (i.e.,
was a near miss).’’ EPA also sought
public comment on whether to include
a formal definition for the term. EPA
received comments both supporting and
opposing a definition of ‘‘near miss.’’
Requests to define ‘‘near miss.’’
Several commenters, including
government agencies, industry trade
associations, facilities, and an advocacy
group, recommended defining ‘‘near
miss’’ to reduce vagueness, uncertainty
around which incidents require
investigation, and the reliance on
owners and operators to define the term.
A local agency and an industry trade
association suggested providing
examples of near misses in guidance. A
local agency said that EPA should
clarify whether a release is considered
a ‘‘near miss’’ if it was a controlled
release. Other commenters, including a
state agency and an industry trade
association, opposed a regulatory
definition of the term, stating that
facilities should be permitted to
determine what qualifies as a ‘‘near
miss’’ that requires investigation. A state
agency also said that EPA should not
define ‘‘near miss’’ because it would be
challenging to provide a definition that
is suitable for all industry sectors. An
industry trade association stated that the
rule raises constitutional due process
concerns because the rule lacks
specificity to define the ‘‘near miss’’
standard and fails to provide adequate
notice to the regulated community as to
what the RMP rule will require.
EPA is finalizing the language in
paragraph (a)(2) of §§ 68.60 and 68.81 as
proposed, and has elected not to finalize
a regulatory definition of ‘‘near miss’’ to
identify incidents that require
investigation. The criteria for
determining incidents that require
investigation will continue to include
events that ‘‘could reasonably have
resulted in a catastrophic release.’’
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Under the final rule, this criterion,
rather than a definition of ‘‘near miss,’’
applies to determine which incidents
require investigation. However, the rule
makes clear that a ‘‘near miss’’ is an
example of an event that ‘‘could
reasonably have resulted in a
catastrophic release.’’ EPA agrees with
commenters who said it would be
difficult to address in a single definition
the various types of incidents that may
occur in RMP-regulated sectors that
should be considered near misses, and
therefore be investigated. Instead,
facility owners or operators will need to
decide which incidents ‘‘could
reasonably have resulted in a
catastrophic release.’’ This may be based
on the seriousness of the incident, the
process(es) involved, and the specific
conditions and circumstances involved.
In the 1996 Response to Comments on
the original rule, EPA acknowledged
that the range of incidents that
reasonably could have resulted in a
catastrophic release is very broad and
cannot be specifically defined.23 EPA
decided to leave it up to the owner or
operator to determine whether an
incident could reasonably have resulted
in a catastrophic release and to
investigate such incidents.
EPA understands from the comments
that there was some uncertainty about
the term near miss. EPA’s experiences
with RMP facility inspections and
incident investigations show there have
been incidents that were not
investigated, even though under slightly
different circumstances, the incident
could have resulted in a catastrophic
release. While most of these events did
not result in deaths, injuries, adverse
health or environmental effects, or
sheltering-in-place, the Agency believes
that in some cases, if circumstances had
been slightly different, a catastrophic
release could reasonably have occurred.
As described in the preamble to the
proposed rulemaking, and as noted by
one commenter, there is a CCPS
definition of ‘‘near miss.’’ CCPS defines
a ‘‘near miss’’ as an event in which an
accident causing injury, death, property
damage, or environmental impact, could
have plausibly resulted if circumstances
had been slightly different.
For example, a runaway reaction that
is brought under control by operators is
a near miss that may need to be
investigated to determine why the
problem occurred, even if it does not
directly involve a covered process both
because it may have led to a release
23 EPA. May 24, 1996. Risk Management Plan
Rule, Summary and Response to Comments.
Volume 1, p. 16–4. Docket No. A–91–73, Document
No. IX–C–1.
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from a nearby covered process or
because it may indicate a safety
management failure that applies to a
covered process at the facility.
Similarly, fires and explosions near or
within a covered process, any
unanticipated release of a regulated
substance, and some process upsets
could potentially lead to a catastrophic
release.
CCPS’s ‘‘Process Safety Leading and
Lagging Metrics—You Don’t Improve
What You Don’t Measure’’ explains that
a near miss has three essential
elements.24 These include:
• An event occurs, or a potentially
unsafe situation is discovered;
• The event or unsafe situation had
reasonable potential to escalate; and
• The potential escalation would
have led to adverse impacts.
The CCPS document and the CCPS
‘‘Guidelines for Investigating Chemical
Process Incidents’’ contain many
examples of near misses, which can be
an actual event or discovery of a
potentially unsafe situation.25 Examples
of incidents that should be investigated
include some process upsets, such as:
excursions of process parameters
beyond pre-established critical control
limits; activation of layers of protection
such as relief valves, interlocks, rupture
discs, blowdown systems, halon
systems, vapor release alarms, and fixed
vapor spray systems; and activation of
emergency shutdowns.
Near misses should also include any
incidents at nearby processes or
equipment outside of a regulated
process if the incident had the potential
to cause a catastrophic release from a
nearby regulated process. An example
would be a transformer explosion that
could have impacted nearby regulated
process equipment causing it to lose
containment of a regulated substance.
Near misses could also include process
upsets such as activation of relief
valves, interlocks, blowdown systems,
or rupture disks.
The intent is not to include every
minor incident or leak, but focus on
serious incidents that could reasonably
have resulted in a catastrophic release,
although EPA acknowledges this will
require subjective judgment. EPA will
update existing RMP guidance to reflect
the revised RMP requirements and will
provide guidance to identify what types
24 CCPS. January 2011. Process Safety Leading
and Lagging Metrics—You Don’t Improve What You
Don’t Measure, p. 36. CCPS, American Institute of
Chemical Engineers, New York, NY. John Wiley and
Sons. https://www.aiche.org/sites/default/files/docs/
pages/CCPS_ProcessSafety_Lagging_2011_2-24.pdf.
25 CCPS. March 2003. Guidelines for Investigating
Chemical Process Incidents, 2nd ed., p. 68.
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of incidents could be considered near
misses.
The concept of ‘‘near miss’’ has a
meaning in industry and in the
chemical engineering profession. In this
preamble and in guidance, EPA has
explained the concept and has
identified sources that explain the term,
and EPA believes that this satisfies any
due process concerns raised by
commenters related to the definition of
this term. These sources put the
regulated community on notice of EPA’s
expectations under the rule and thus
also address the due process concerns
raised by commenters regarding notice
to the regulated community as to what
the RMP rule will require. EPA expects
that by expanding the root cause
analysis requirement to near misses that
could have resulted in a catastrophic
incident, some stationary sources will
be able to take corrective actions before
another similar, but catastrophic
incident occurs in the future. For
example, as discussed in the March 14,
2016 RMP proposed rulemaking (81 FR
13637), incidents at Tosco Refinery,
Georgia Pacific, Shell Olefins, Morton
International, BP Texas City Refinery
and Millard Refrigerated Services all
involved near-misses or less serious
incidents involving the same cause as
the later catastrophic release.
Industry suggestions for clarifying
near misses. A few industry trade
associations commented that the
examples of near misses that EPA
provided in the NPRM, such as
excursions of process parameters and
activation of protections devices such as
relief valves, should not be considered
‘‘near misses.’’ The commenters said
that many of these examples are
safeguards that are designed to be used
to prevent catastrophic releases. An
industry trade association also proposed
a definition of ‘‘near miss’’ that would
be limited only to scenarios where the
final safeguard or layer of protection is
activated, such that a release would
have occurred if not for that control.
In response to these comments, EPA
agrees that not all excursions of process
parameters outside control levels or all
instances of protective device activation
should necessarily be considered to be
near misses. EPA expects that activation
of protective devices should be
investigated when the failure of such
devices could have reasonably resulted
in a catastrophic release. However, EPA
does not agree that near miss
investigations should only include
situations that resulted in activation of
a final safeguard or layer of protection.
This may be appropriate in some cases,
but in others, multiple layers of
protection may quickly fail. EPA
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believes that owners and operators must
use reasonable judgement to decide
which incidents, if they had occurred
under slightly different circumstances,
could reasonably have resulted in a
catastrophic release, and investigate
those incidents.
f. Investigation Timeframe
EPA received many comments in
support of a shorter investigation
timeframe. Many commenters,
including a local agency and a
professional association, stated that 12
months is too long to complete most
investigations, and some commenters
said that the timeframe should be
shortened to five or six months. Some
commenters also stated there should be
a shorter timeframe, but with the ability
to request an extension.
Other commenters, including state
and local agencies and industry trade
associations, said that EPA should allow
for 12 months to complete an
investigation and also allow extensions
for especially large or complex
incidents. Some commenters also
recommended requiring interim reports.
An industry trade association asked
EPA to clarify that the 12-month period
is only for completing the investigation
report, not for implementing the
recommendations in the report.
Other commenters, including
facilities and industry trade
associations, said that EPA should not
impose any deadline for completing
incident investigations. A few
commenters, including a facility and
industry trade associations, commented
that an arbitrary deadline does not
account for the complexity of the
incident, the types of process units
involved, or the need to retain outside
consultants or experts to complete the
investigation.
After considering these comments,
EPA has decided to finalize the
requirement to complete incident
investigations within twelve months as
proposed. EPA believes that this
timeframe will provide a reasonable
amount of time to conduct most
investigations, while also ensuring that
investigation findings are available
relatively quickly in order to assist in
preventing future incidents. For very
complex incident investigations that
cannot be completed within 12 months,
EPA is allowing an extension of time if
the implementing agency approves such
an extension, in writing. EPA
encourages owners and operators to
complete incident investigations as soon
as practicable, and believes that 12
months is typically long enough to
complete even complex incident
investigations. However, EPA provided
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flexibility for facilities to request more
time to complete investigations when
they consult with their implementing
agency and receive written approval for
an extension.
g. Incident Investigation Team
Some commenters, including a
Federal agency, local government
agencies, an association of government
agencies, and an industry trade
association, supported the proposed
requirements under § 68.60(c) for the
owner or operator of a Program 2
process to establish an incident
investigation team consisting of at least
one person knowledgeable in the
process involved and other persons with
appropriate knowledge and experience
to thoroughly investigate and analyze
the incident. Other commenters
opposed these requirements. A facility
commented that the incident
investigation team requirements are
unnecessary because they are already
covered by the OSHA PSM standard. A
private citizen commented that the
requirement assumes that all
investigations will be conducted by a
team, when it is possible for a
competent individual to perform all
aspects of the investigation if given
access and support by the facility owner
or operator. The commenter also stated
that although the proposed rulemaking
provides significant information on who
may perform a third-party audit, it does
not specify the qualifications of persons
who may perform investigations and
certify investigation reports.
EPA is finalizing the Program 2
incident investigation requirements, as
proposed. The Agency agrees with the
commenters who support requiring at
least one person on the investigation
team to be knowledgeable in the process
involved and other persons with
appropriate knowledge and experience
in incident investigation techniques, as
EPA believes these provisions are
necessary to ensure that facilities
thoroughly investigate and analyze
incidents and their root causes.
EPA disagrees that these incident
investigation team requirements are
already covered by the OSHA PSM
standard. The requirements for Program
3 processes in the current rule already
include a provision for incident
investigation teams; however, the
incident investigation team
requirements in this rule apply to
Program 2 processes, which by
definition are not covered by the OSHA
PSM standard. EPA agrees that the
requirement assumes that all
investigations will be conducted by a
team. EPA believes that all incident
investigations, whether conducted on
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Program 2 or Program 3 processes,
should involve a team of at least two
people, particularly given the
requirement under the final rule for
investigations to include analysis of root
causes. However, beyond the
requirements specified in the final rule
(i.e., to establish an investigation team
consisting of at least one person
knowledgeable in the process involved
and other persons with appropriate
knowledge and experience to
thoroughly investigate and analyze the
incident), the Agency does not believe
it is necessary to specify additional
qualification criteria for incident
investigation team members.
h. Root Causes
Support for root cause requirements.
Many commenters, including
government agencies, advocacy groups,
a facility, and others, expressed support
for the requirements to determine root
causes through the use of a recognized
method and to include information on
root causes in investigation reports. The
commenters supported these provisions
as a way to prevent future incidents.
Most of these commenters also
expressed support for applying the root
cause analysis requirement to both
catastrophic release incidents and to
incidents that could reasonably have
resulted in a catastrophic release (i.e.
near misses). These commenters stated
that conducting root cause analysis on
near misses would allow the owner or
operator to identify and make corrective
actions before a catastrophic incident
occurs. Some commenters also
supported EPA’s proposal to allow the
use of any recognized method to
complete a root cause analysis.
EPA agrees with these comments and
believes that requiring root cause
analyses for catastrophic releases and
near misses, and including root cause
information in incident investigation
reports is vital for understanding the
nature of these events. EPA is finalizing,
as proposed, the requirements that root
causes must be determined through the
use of a recognized method and that
information on root causes must be
included in investigation reports. As
previously noted, however, the final
rule includes a modified version of the
proposed definition of the term ‘‘root
cause.’’ The phrase ‘‘that identifies a
correctable failure(s) in management
systems’’ from the proposed definition
has been deleted.
Opposition for root cause
requirements. EPA also received many
comments opposing the proposed root
cause analysis requirements. Some
commenters, including industry trade
associations and Federal agencies, said
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that requiring the owner or operator to
conduct a root cause analysis versus
other investigation methods is
unnecessary. Some of these commenters
also argued that root cause analysis
assumes that there is an underlying
management or system-related cause
behind every incident, which may not
be the case and which EPA has failed to
prove. An industry trade association
and a facility stated that EPA should not
require facilities to select from a
predetermined list of root causes so as
to avoid forcing them to fit their
findings into a category that may not be
appropriate.
Regarding these comments, EPA
agrees that root cause analysis may
result in identifying causes that are not
always an underlying management or
system-related cause, but still believes
that the analysis is necessary to
understand why the accident occurred
so that the causes can be addressed.
Therefore, we have modified the
definition of ‘‘root cause’’ to remove the
phrase ‘‘that typically identifies a
correctable failure(s) in management
systems’’ in order to remove the
implication that all incidents involve
correctable management system failures.
EPA also notes that the final rule does
not require facilities to select from a
predetermined list of root causes or
force them to fit their findings into an
inappropriate category.
Many commenters argued that EPA
should not require root cause analyses
for near misses. A Federal agency,
industry trade associations, and some
facilities stated that EPA should not
require root cause analyses for near
misses because the requirement would
increase compliance burdens and costs
on facilities and take attention away
from other safety activities. A few
industry trade associations also argued
that the quality of safety reviews will be
diluted by applying the requirement to
low-consequence, high-frequency
events. One industry trade association
stated that requiring a root cause
analysis for near misses creates a false
equivalency between near misses and
actual catastrophic releases.
While EPA acknowledges that
requiring root cause analyses for near
misses may impose some additional
burden on facilities, the Agency
disagrees that the burden is
unwarranted or that it will take
attention away from other safety
activities. The Agency notes that
catastrophic release near miss events are
infrequent events, and therefore do not
typically divert attention from other
safety activities. However, EPA believes
that investigation of such incidents,
when they occur, should be a high
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priority safety activity for regulated
stationary sources, because these
investigations can lead to the correction
of problems which could ultimately
prevent much more serious and costly
catastrophic release incidents.
EPA also disagrees that the final rule
applies the root cause investigation
requirement to low-consequence, highfrequency events. The final rule requires
root cause investigations only for
incidents that resulted in, or could
reasonably have resulted in, a
catastrophic release. Such incidents are
unusual. Based on accident history
information reported to EPA, most
regulated sources have never
experienced a catastrophic release
incident, and the Agency also believes
that near misses will also be relatively
rare events. The final rule does not
presume any ‘‘equivalency’’ between
near misses and actual catastrophic
releases. The Agency notes that actual
catastrophic releases may be more
difficult to investigate if the incident
requires extensive cleanup, damage
assessment, evidence collection, etc.—
activities that are unlikely to be
necessary for near miss events.
However, lessons learned from
catastrophic releases and near misses
should both benefit the source and its
surrounding community, whether or not
such events are viewed as equivalent.
Root cause requirements for Program
2 facilities. Some commenters opposed
requiring root cause analyses for
Program 2 processes. An industry trade
association said that since most
incidents happen at facilities with
Program 3 facilities, it is unnecessary to
expand this requirement to Program 2
facilities. Another industry trade
association said root cause analyses
should only be required at Program 3
facilities because the methodology is
most appropriate for complex incidents.
While it is true that most RMPreportable incidents occur at Program 3
processes, EPA decided that there was
little justification for limiting the root
cause requirements to only Program 3
processes, because some serious
accidents also occur at Program 2
processes. Also, the Agency notes that
some of the accidents at Program 2
processes occur at publicly owned water
and wastewater treatment facilities that
are not in Program 3 only because they
are not located in a state with an OSHAapproved State Plan. Unlike state and
local government employees at facilities
in states with OSHA-approved State
Plans, state and local government
employees at facilities in states under
Federal OSHA authority are not covered
by the OSHA PSM standard. This
results in regulated processes at these
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sources being placed in Program 2, even
though the processes generally pose the
same risk as similar processes at
publicly owned water or wastewater
treatment processes that are located at
sources in OSHA State Plan states.
Incident investigation methodology.
One commenter argued that EPA does
not have authority to specify a specific
incident investigation and analysis
methodology and should remove all
references to or requirement for any
named investigation or analysis method
from its proposed rulemakings. The
commenter cited various provisions of
the CAA and the language within the
Memorandum of Understanding
between CSB and EPA and asserted that
CSB is the lead entity for accident
investigations and has the authority to
specify a named investigation method.
Other commenters, including a state
agency and facilities, said that EPA has
not provided examples of how to
determine what is a recognized method
or which consensus bodies are to be
used to determine recognized methods.
EPA disagrees with these comments.
While the final rule does not require use
of a specific incident investigation or
analysis method (the final rule allows
the owner or operator to determine root
causes using ‘‘a recognized method’’),
nothing in the CAA precludes EPA from
requiring sources to conduct incident
investigations. Contrary to the
commenter’s suggestion, the legislative
history specifically contemplates EPA
requiring accident investigations (see
Senate Report at 242–43 26). The Agency
notes that the existing RMP rule already
contains such a requirement applicable
to Program 2 and Program 3 processes.
Like other risk management provisions,
CAA section 112(r)(7)(B)(i) requires
investigation requirements to be
reasonable, but nothing in the statute
otherwise limits EPA from requiring the
investigation to address the issue of the
underlying root cause of the accident.
Nothing in this final rule interferes
with the ability of the CSB to conduct
its accident investigations. The incident
investigation provision we adopt is
designed to have the facility learn from
its accidents and near misses in order to
identify ways to improve the facility’s
prevention program. The root cause
investigations in this rule serve a
distinct purpose from the oversight
purposes of the CSB.
EPA also disagrees that we should
specify recognized investigation
methods or point to specific governing
26 Senate Committee on Environment and Public
Works, Clean Air Act Amendments of 1989, Senate
Report No. 228, 101st Congress, 1st Session
(1989)—‘‘Senate Report’’.
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bodies for such methods. Investigation
methods evolve over time, and new
methods may be developed, so any list
promulgated by EPA in this rule may
soon be obsolete. The Agency took a
similar approach in the PHA
requirements for the existing rule,
where it listed several potential
methods, but also included the option to
use an appropriate equivalent
methodology. EPA recommends that
owners and operators consult available
literature on root cause investigation.
For example, CCPS has published
Guidelines for Investigating Chemical
Process Incidents, which provides
extensive guidance on incident
investigations, near miss identification,
root cause analysis, and other related
topics.27
i. Other Incident Investigation Report
Requirements
A few commenters, including a
Federal agency, expressed support for
the proposal to require additional
information to be included in incident
investigation reports. Several other
commenters expressed opposition to
various proposed incident investigation
report requirements. A facility said that
EPA’s proposed changes are
unnecessary because each of the
proposed items is already required
under the OSHA PSM standard. Some
industry trade associations opposed
requiring facilities to include the results
of the root cause analysis in the incident
investigation report, saying this could
increase the likelihood of lawsuits
against the facility if those reports are
made public, or could result in the
release of confidential business
information.
EPA believes that providing the
additional required information is vital
for understanding the nature of the
incident and should be included in the
incident investigation report. Some
facility owners or operators may already
voluntarily include root cause
information and other elements required
under this rule (e.g., time and location
of incident, name and amount of
substance involved in the release, etc.)
in incident investigation reports
prepared to comply with the RMP rule.
However, §§ 68.60 and 68.81 are being
revised to require this information to
ensure clarity and consistency among
reports. While the OSHA PSM standard
contains the same incident investigation
reporting requirements as the existing
RMP rule for Program 3 processes, prior
to this rule, neither regulation required
27 CCPS 2003. Center for Chemical Process Safety,
Guidelines for Investigating Chemical Process
Incidents, 2nd Edition, NY: AIChE.
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reporting of root cause information nor
the other report elements required in
this rule. EPA disagrees with the
conjecture that there may be an
increased possibility of lawsuits is a
good reason not to include root causes
and other factual incident information
in incident investigation reports. We
note that the current rule requires a
report that discusses factors
contributing to the incident and
recommendations resulting from the
investigation, so to the extent that
litigants would seek to use reports to
establish cause or preventability of an
incident, the litigation risk is there
already. To the extent that the root
cause discussion contains CBI, the
existing rule provides methods for
asserting CBI claims. Identifying root
causes can prevent future incidents,
thereby reducing accidental release
impacts.
B. Third-Party Audits
EPA proposed to require owners or
operators of certain RMP facilities to
perform third-party audits, in order to
prevent accidents and ensure
compliance with part 68 requirements.
The third-party audits are similar to the
compliance audits already required by
§§ 68.58 and 68.79, but EPA expects that
independent compliance audits will
assist stationary sources to come fully
into compliance with the applicable
prevention program requirements. The
details of these requirements are
described further.
1. Summary of Proposed Rulemaking
a. Definitions
EPA proposed to define ‘‘third-party
audit’’ in § 68.3 as a compliance audit
conducted pursuant to the requirements
of § 68.59 and/or § 68.80, by an entity
(individual or firm) meeting the
competency, independence and
impartiality criteria in those sections.
b. Compliance Audit Requirements
Under §§ 68.58 and 68.79
EPA proposed changes to §§ 68.58
and 68.79 to require third-party
compliance audits for both Program 2
and Program 3 processes, under certain
conditions and to clarify existing
requirements for compliance audits.
EPA proposed to edit §§ 68.58(a) and
68.79(a) to add the language ‘‘for each
covered process’’ to clarify that all
compliance audits, self and third-party,
shall address compliance with the
provisions of Subpart C or D for each
covered process. EPA also added a
sentence at the end of the paragraph to
reference when a compliance audit must
be a third-party audit.
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EPA also proposed to add paragraphs
(f) through (h) in §§ 68.58 and 68.79.
Paragraph (f) identified third-party audit
applicability. EPA proposed that the
next required compliance audit for an
RMP facility would be a third-party
audit when one of the following
conditions apply:
• An accidental release, meeting the
criteria in § 68.42(a), from a covered
process has occurred; or
• An implementing agency requires a
third-party audit based on
noncompliance with the requirements
of this subpart, including when a
previous third-party audit failed to meet
the competency, independence, or
impartiality criteria of § 68.59(b) or
§ 68.80(b).
Proposed paragraph (g) described the
procedure when an implementing
agency requires a third-party audit and
proposed an internal appeals process.
EPA proposed to require an
implementing agency to provide written
notice to the facility owner or operator
stating the reasons for the implementing
agency’s preliminary determination that
a third-party audit is necessary. The
owner or operator would have an
opportunity to respond by providing
information to, and consulting with, the
implementing agency. The
implementing agency would then
provide a final determination to the
owner or operator. If the final
determination requires a third-party
audit, the owner or operator would have
an opportunity to appeal the final
determination. EPA proposed that the
implementing agency would provide a
written, final decision on the appeal to
the owner or operator after considering
the appeal.
Proposed paragraph (h) described the
schedule for completing third-party
audits. The proposed language required
the audit and associated report to be
completed, and submitted to the
implementing agency within 12 months
of when any third-party audit is
required or within three years of
completion of the previous compliance
audit, whichever is sooner. The
provision also allowed an implementing
agency to specify a different schedule.
c. Third-Party Compliance Audit
Requirements in §§ 68.59 and 68.80
EPA proposed new §§ 68.59 and
68.80, which included requirements for
both third-party compliance audits and
third-party auditors. In paragraph (a),
EPA proposed that owners or operators
engage a third-party auditor to evaluate
compliance with the provisions of
subpart C or D (as applicable) when the
applicability criteria of § 68.58(f) or
§ 68.79(f) are met.
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Auditor qualifications. In paragraph
(b), EPA proposed third-party auditor
qualifications and required facility
owners and operators to document that
the third-party auditor or audit team
meets competency and independence
criteria of the rule. Specifically, EPA
proposed that facility owners or
operators determine and document that
the third-party auditors meet the
competency criteria in paragraph (b)(1)
and the independence criteria in
paragraph (b)(2).
EPA proposed competency criteria for
auditors, requiring third-party auditors
to be:
• Knowledgeable with the
requirements of part 68;
• Experienced with the facility type
and processes being audited and the
applicable recognized and generally
accepted good engineering practices
(RAGAGEP);
• Trained or certified in proper
auditing techniques; and
• A licensed Professional Engineer
(PE) or include a licensed PE on the
audit.
EPA also proposed independence and
impartiality criteria that would apply to
the third-party auditor or auditing team,
and to each audit team member,
individually. Specifically, the criteria
would have required the auditor/audit
team to:
• Act impartially when performing all
activities under this section;
• Receive no financial benefit from
the outcome of the audit, apart from
payment for the auditing services;
• Not have conducted past research,
development, design, construction
services, or consulting for the owner or
operator within the last 3 years. For
purposes of this requirement, consulting
does not include performing or
participating in third-party audits
pursuant to § 68.59 or § 68.80;
• Not provide other business or
consulting services to the owner or
operator, including advice or assistance
to implement the findings or
recommendations in an audit report, for
a period of at least 3 years following
submission of the final audit report;
• Ensure that all personnel involved
in the audit sign and date the conflict
of interest statement in § 68.59(d)(8);
and
• Ensure that all personnel involved
in the audit do not accept future
employment with the owner or operator
of the stationary source for a period of
at least 3 years following submission of
the final audit report. For purposes of
this requirement, employment does not
include performing or participating in
third-party audits pursuant to § 68.59 or
§ 68.80.
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In addition, in paragraph (b)(3), the
proposed rulemaking required the
auditor to have written policies and
procedures to ensure that all personnel
comply with the applicable
competency, independence, and
impartiality requirements.
Audit report. EPA proposed
requirements for the audit report in
paragraph (c). In paragraph (c)(1) EPA
specified the scope and content of these
reports, including a statement to be
signed by the third-party auditor
certifying that the third-party audit was
performed in accordance with the
requirements of subpart C or D, as
applicable. EPA also proposed to
require that the final third-party audit
reports identify any adjustments made
by the third-party auditor to any draft
third-party audit reports provided to the
owners or operators for their review or
comment.
Proposed paragraph (c)(2) included
requirements for third-party auditors to
retain reports and records. Proposed
paragraph (c)(3) required the audit
report to be submitted to the
implementing agency at the same time,
or before, it is provided it to the owner
or operator. Proposed paragraph (c)(4)
provided that the audit report and
related records could not be claimed as
attorney-client communications or as
attorney work products, even if written
for or reviewed by legal staff.
Third-party audit findings. EPA
proposed in paragraph (d)(1), to require
owners or operators, as soon as possible,
but no later than 90 days after receiving
the final audit report, to determine an
appropriate response to each of the
findings in the audit report, and develop
and provide to the implementing agency
a findings response report. EPA
proposed that the findings response
report would include:
• A copy of the final audit report;
• An appropriate response to each of
the audit report findings;
• A schedule for promptly addressing
deficiencies; and
• A statement, signed and dated by a
senior corporate officer, certifying that
appropriate responses to the findings in
the audit report have been identified
and deficiencies were corrected, or are
being corrected, consistent with the
requirements of subpart C or D of 40
CFR part 68.
EPA proposed in paragraph (d)(2), to
require the owner or operator to
implement the schedule to address
deficiencies identified in the audit
findings response report, and document
the action taken to address each
deficiency, along with the date
completed.
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Proposed paragraph (d)(3) required
the owner or operator to provide a copy
of documents required under
paragraphs (d)(1) and (d)(2) to the owner
or operator’s audit committee of the
Board of Directors, or other comparable
committee, if one exists.
Recordkeeping. Finally, EPA
proposed recordkeeping requirements
for the owner or operator in paragraph
(e). The proposal would have required
the owner or operator to retain records
at the stationary source, including: The
two most recent third-party audit
reports, related findings response
reports, documentation of actions taken
to address deficiencies, and related
records; and copies of all draft thirdparty audit reports. Those sections
would further have required the owner
or operator to provide draft third-party
audit reports, or other documents, to the
implementing agency upon request.
EPA proposed that requirements would
not apply to any documents that are
more than five years old.
2. Summary of Final Rule
Regulated entities must engage a
third-party to conduct an independent
compliance audit when they (1) have an
RMP reportable accident or (2) have
been notified by an implementing
agency of a determination of either
conditions that could lead to an
accidental release or problems with a
prior third-party audit.
EPA is finalizing the proposed
requirements for third-party auditors
with modifications that include:
• Revising the applicability criteria
for third-party audits required by
implementing agencies from
noncompliance to conditions that could
lead to an accidental release;
• Providing for a third-party audit
team, led by an independent third-party,
which may now include a wide variety
of additional, non-independent
personnel, including facility employees
and other personnel;
• Eliminating the competency
criterion that the auditor be a PE;
• Revising the third-party auditor
independence criteria to increase the
number and diversity of qualified and
available auditors; and
• Removing the requirement that
either or both draft and final audit
reports be submitted to implementing
agencies.
EPA believes these changes address
many of the most significant public
comments EPA received on the
proposed third-party audit
requirements.
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a. Definitions
In the final rule, EPA revised the
definition of ‘‘third-party audit’’ to
reflect the changes in §§ 68.59 and
68.80, which, when applicable, require
that an owner or operator must either
engage a third-party auditor or assemble
an auditing team led by a third-party
auditor. EPA also deleted the reference
to impartiality, because impartiality is a
criterion under the independence
criteria in §§ 68.59(c)(2) and 68.80(c)(2)
and there is no need to highlight this
term individually.
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b. Compliance Audit Requirements
Under §§ 68.58 and 68.79
EPA is finalizing paragraph (a) as
proposed. This includes clarifying
language ‘‘for each covered process’’
added to §§ 68.58(a) and 68.79(a).
EPA is finalizing the applicability
requirements set forth in §§ 68.58(f)(1)
and 68.79(f)(1) as proposed but modifies
the criterion in §§ 68.58(f)(2) and
68.79(f)(2) to apply when an
implementing agency requires a thirdparty audit due to conditions at the
stationary source that could lead to an
accidental release of a regulated
substance, or when a previous thirdparty audit failed to meet the
competency or independence criteria of
§ 68.59(c).
EPA is also finalizing the
implementing agency notifications and
appeals process in paragraph (g), as
proposed. However, the final rule
language includes minor editorial
revisions. The language of subparagraph
(g)(1) requires the implementing agency
to provide written notice to the owner
or operator that describes the basis for
the determination. The language of
§§ 68.58(g)(3) and 68.79(g)(3) was
modified to delete the unnecessary
phrase ‘‘of this section.’’
EPA has modified and clarified the
schedule for completing a third-party
audit in paragraph (h) as follows:
• EPA deleted the language requiring
the auditor to submit the audit report to
the implementing agency.
• The final rule requires a third-party
audit to be completed within 12
months, unless a different timeframe is
specified by the implementing agency.
However, EPA made changes to simplify
and clarify the schedule requirements.
Æ Subparagraph (h)(1) requires a
third-party audit to be completed within
12 months of an RMP reportable
accident.
Æ Subparagraph (h)(2) requires a
third-party audit to be completed within
12 months of the date of the
implementing agency’s final
determination, or if appealed, within 12
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months of the date of the final decision
on the appeal.
c. Third-Party Compliance Audit
Requirements in §§ 68.59 and 68.80
EPA is finalizing paragraph (a) as
proposed but modified the language
slightly to clarify that the owner or
operator shall engage a third-party to
conduct an audit to evaluate compliance
with subpart C or D as applicable.
Third-party auditors and auditing
teams. In the final rule, EPA added
paragraph (b) to provide options for
assembling a third-party auditor or an
audit team. In addition to engaging a
fully independent third-party auditing
firm, owners or operators may assemble
auditing teams that include competent
and independent third-party auditor
team leaders and other qualifying, nonindependent personnel. The owner or
operator shall either:
• Engage a third-party auditor
meeting all of the competency and
independence criteria of the rule
(subparagraph (b)(1)); or
• Assemble an auditing team, led by
a third-party auditor meeting all of the
competency and independence criteria.
The team may include:
Æ Other employees of the third-party
auditor firm meeting the independence
criteria of the rule; and
Æ Other personnel not employed by
the third-party auditor firm
(subparagraph (b)(2)).28
Auditor qualifications. The final rule
retains the third-party auditor
qualification requirements in paragraph
(b) of the proposed rulemaking but
redesignated as paragraph (c). The
qualification requirements set forth in
this paragraph apply only to the thirdparty auditors. The third-party auditor
qualifications are clarified and modified
as described further in this preamble.
In the final rule, EPA simplified the
introductory paragraph to indicate that
the owner or operator shall determine
and document that the third-party
auditor(s) meets the competency and
28 ‘‘Other personnel’’ may be facility personnel,
personnel from any other facilities owned or
controlled by the owner or operator, and/or any
non-independent second or third-party consultants
or contractors the owners or operators choose to
include on the auditing teams they assemble under
subparagraph (b)(2). In addition, the auditing teams
may include other employees of the third-party
auditor firm who meet the independence criteria of
subparagraph (c)(2). Such personnel need not
individually meet the final rule’s third-party
auditor competency criteria as long as the
independent third-party audit team leader,
pursuant to his/her evaluation of audit team
member competencies under subparagraph (d)(2),
determines that the full audit team includes all of
the competencies required to successfully complete
the audit pursuant to the requirements in the final
rule.
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independence requirements set forth in
the subparagraphs.
Subparagraph (c)(1) identifies
competency criteria that apply to thirdparty auditors.29 EPA is finalizing the
competency criteria as proposed, except
to delete the requirement for a licensed
PE to conduct the audit or participate on
the audit team.
Subparagraph (c)(2) identifies
independence criteria that apply to
third-party auditors. EPA is amending
and finalizing the proposed
independence criteria as follows:
• EPA is deleting the phrase ‘‘and
impartiality’’ from the title because the
impartiality requirement is listed as one
of several criteria, and it is unnecessary
to highlight the term separately.
• EPA clarified that retired employees
qualify as third-party auditors when
financial attachments are limited to
retirement and/or health plans.
• EPA revised the timeframe that
limits third-party auditors past and
future research, development, design,
construction services, or consulting
services to two years. EPA further
clarified that if the firm employs
personnel that did conduct these
services within the prescribed
timeframe, then these personnel may
not participate in the audit.
• The final rule requires third-party
audit personnel to sign and date a
conflict of interest statement
documenting that they meet the
independence criteria.
• The limitation regarding future
employment with the owner or operator
has been modified to apply to only
third-party personnel involved in the
audit and the timeframe decreased to
two years.
EPA is finalizing subparagraph (c)(3),
as proposed, to require auditors to have
written policies and procedures to
ensure that all personnel comply with
the qualification criteria—except to
delete the word impartiality from the
criteria description.
Third-party auditor responsibilities.
EPA is adding requirements for the
owner or operator to provide certain
responsibilities to the third-party
auditor.30 Paragraph (d) requires the
29 The competency criteria do not apply to other
personnel, not employed by the third-party auditor
firm, that participate on the auditing team (e.g.,
facility personnel).
30 EPA is finalizing auditor responsibilities to
ensure that third-party auditors maintain certain
responsibilities when audit teams are comprised of
both third-party auditor personnel and other
personnel. EPA did not propose roles and
responsibilities for independent third-party
auditors because, in the proposed approach,
independent third-party auditors were responsible
for conducting all auditing activities.
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owner or operator to ensure that the
third-party auditor:
• Manages the audit and participates
in audit initiation, design,
implementation, and reporting;
• Determines appropriate roles and
responsibilities for the audit team
members based on the qualifications of
each team member;
• Prepares the audit report and where
there is a team, documents the full audit
team’s views in the final audit report;
• Certifies the final audit report and
its contents as meeting the requirements
of the rule; and
• Provides a copy of the audit report
to the facility owner or operator.
Audit report. EPA is redesignating
and finalizing audit report requirements
under paragraph (e) of the final rule
with modifications. EPA reorganized
and added one report requirement to the
proposed subparagraphs (c)(1)(i) to
(c)(1)(v). These are subparagraphs (e)(1)
to (e)(6) in the final rule.
EPA also amended the audit report
provisions in the final rule to simplify
the applicable provisions and simplify
the requirements for preparing and
handling the third-party audit reports:
• Subparagraph (e)(1) requires the
report to identify all persons
participating on the audit team,
including their employers and/or
affiliations. The report must also
document that third-party auditors meet
the competency criteria of the rule; 31
• EPA added an additional
requirement under subparagraph (e)(2)
for the auditor to describe in the report,
or incorporate by reference, policies and
procedures to ensure all third-party
personnel comply with the competency
and independence criteria of the rule;
• Proposed subparagraphs (c)(ii) and
(c)(iii) are finalized as proposed and
redesignated as (e)(3) and (e)(4). The
report must document the auditor’s
compliance evaluation for each covered
process and document the findings of
the audit, including any identified
deficiencies;
• Subparagraph (e)(5) requires the
report to summarize any significant
revisions between draft and final
versions of the report;
• Subparagraph (e)(6) requires the
auditor or audit team leader to sign and
date a certification. The certification is
finalized as proposed except to remove
the last sentence that acknowledges
penalties for submitting false
information;
31 Note-only
third-party auditors must meet the
competency criteria of the rule-does not apply to
other personnel on an audit team.
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• EPA deleted the provision that
required the auditor to maintain copies
of all reports and records; 32
• EPA deleted the provision that
required the auditor to submit the report
to the implementing agency at the same
time as it would be provided to the
owner or operator; and
• EPA deleted the provision limiting
attorney-client privilege.
Third-party audit findings. EPA is
finalizing requirements for the owner or
operator to prepare a findings response
report; develop a schedule to address
deficiencies; and submit the findings
response report and schedule to the
Board of Directors. These requirements
are redesignated to paragraph (f) of the
final rule with the following
modifications to the findings response
report:
• EPA deleted the proposed
requirement to submit the findings
response report to the implementing
agency; and
• EPA amended the owner/operator
certification in the findings response
report to add a sentence indicating that
the owner or operator has engaged a
third-party to perform or lead an audit
team to conduct a third-party audit in
accordance with the requirements of 40
CFR 68.80. EPA also modified the final
sentence of the certification to clarify
that submitting false information
includes making false material
statements, representations, or
certifications.33
EPA is finalizing requirements in
subparagraph (f)(2) to develop a
schedule to address deficiencies as
proposed, except to modify the title of
the provision to schedule
implementation and correct citations to
redesignated paragraphs.
EPA is also finalizing the requirement
in subparagraph (f)(3) to submit the
findings response report and
implementation schedule to the board of
directors as proposed with minor
modifications to update citations to
redesignated paragraphs, and capitalize
Board of Directors in the title. In
addition, the end of the last sentence
was changed to reference a comparable
committee, or individual, if applicable.
Recordkeeping. EPA is finalizing the
recordkeeping requirements as proposed
in paragraph (d) with the following
modifications:
32 EPA retains its authority under Section 114 of
the CAA to require regulated entities to make such
records available to the Agency, as appropriate,
upon request or during inspections. EPA is
finalizing recordkeeping requirements under
paragraph (g) of the final rule.
33 This change was made to track the language of
Section 113(c)(2)(A) of the CAA which makes it
illegal for regulated entities to ‘‘make any false
material statement, representation, or certification.’’
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• The paragraph has been
redesignated as paragraph (g) in the
final rule;
• EPA eliminated the proposed
subparagraphs and moved the language
of proposed subparagraph (e)(1) into the
main paragraph with edits to clarify that
the owner or operator shall retain at the
stationary source the two most recent
final third-party audit reports;
• EPA eliminated the proposed
requirement for owners or operators to
retain copies of all draft third-party
audit reports (subparagraph (e)(2) of the
proposed rulemaking); and
• EPA amended the recordkeeping
provision for Program 3 processes in
§ 68.80(e) to delete the sentence that
applied the recordkeeping provisions to
any documents that were five-years old
or less. This revision is consistent with
current recordkeeping compliance
audits under § 68.79(e) and corrects an
error in the proposed rulemaking text.
3. Discussion of Comments and Basis for
Final Rule Provisions
Several comments supported the
proposed third-party audit
requirements, including one stating that
the commenter found that internal
audits often fail to identify systemic
process safety deficiencies. However,
many commenters opposed the
proposed third-party compliance audit
provisions, including some who
expressed general opposition, reasoning
that existing requirements and
mechanisms are working. Some
comments argued that the costs
outweigh the benefits associated with
this provision or that audits by internal
resources are more cost-effective and
less disruptive, while still providing
adequate assessment and encouraging
compliance.
EPA has retained a third-party audit
requirement in the final rule. We
continue to rely on the rationale
expressed in the proposed rulemaking.
However, in the final rule, we have
modified the requirements for the audit
team to expand the potential
membership while still retaining the
critical role of the independent auditor
in the review of the compliance
program. In the discussion that follows
and in the Response to Comment
document, we explain the modifications
to our approach and the basis for these
modifications.34 While the RMP rule
does not prohibit accidental releases, an
accidental release can be an indication
of a prevention program that both needs
34 2016. EPA Response to Comments on the 2016
Proposed Rulemaking Amending EPA’s Risk
Management Program Regulations. This document
is available in the docket for this rulemaking.
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improvement and that may benefit from
an audit by someone independent from
the source’s historic program and the
management of the source. The
requirements finalized in this rule are
not based on a wide finding that the
original compliance audit requirement
of the RMP rule does not have value;
instead, we promulgate this requirement
to target a subgroup that have had
indications of potential problems not
detected and addressed by the
traditional audit structure.
EPA believes it is appropriate to
require a subset of RMP-regulated
facilities to engage competent and
independent third-party auditors
following an RMP-reportable accident or
identification of conditions at the
stationary source that could lead to an
accidental release of a regulated
substance. The purpose of the thirdparty audit is to assist the owners and
operators in determining whether
facility procedures and practices to
comply with subparts C and/or D of the
RMP rule (i.e., the prevention program
requirements) are adequate and being
followed. Thus, EPA is finalizing
requirements for third-party audits
when required under § 68.58 and/or
§ 68.79, to require that owners and
operators ensure that third-party
auditors meet qualification criteria,
audits are conducted and documented,
and findings are addressed pursuant to
the requirements of § 68.59 and/or
§ 68.80, as applicable. EPA notes that
under part 68, sources with any Program
2 and/or Program 3 processes are
already required to conduct compliance
audits every three years. This rule does
not change the requirement that RMP
facilities regularly conduct RMP
compliance audits but provides only
that, in specific situations, those audits
be performed by a third-party or a team
led by a third-party, pursuant to the
schedule in § 68.58(h) and/or § 68.79(h)
of the rule.
EPA considered, but did not adopt,
changes to the final rule that would
establish additional processes or
programs under which EPA or other
regulatory agencies must first approve
or credential third-party auditors before
owners or operators can engage them.
Nor did EPA modify the rule to
establish or reference additional
independent auditor accreditation
programs or auditor accreditation
oversight committees or otherwise
require potential third-party auditors to
be accredited by an independent
auditing or accreditation body before
owners or operators may engage the
auditors under this rule. For some
programs, external accreditation of
third-party auditors adds additional
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rigor to the process of ensuring the
competence and independence of the
auditors but such external accreditation
can be time-consuming and add
financial costs. EPA believes that the
level of effort and resources necessary to
establish these programs would cause
unnecessary delays in implementing
third-party compliance audit
requirements and are not warranted for
the small universe of facilities that may
be subject to these requirements.
Comments on significant issues relating
to third-party audits are summarized
and discussed further in this preamble.
The following also discusses EPA’s
basis for the third-party audit provisions
adopted in this final rule.
a. Third-Party Auditing Constitutional
Law and Agency Authority Issues
EPA’s enforcement authority. Several
commenters stated that EPA should rely
on its existing enforcement authority,
including the ability to require thirdparty audits in particular enforcement
proceedings, rather than requiring thirdparty audits more generally. Another
encouraged EPA to focus on enforcing
existing audit requirements. Similarly,
another recommended that EPA address
facilities deemed to be incapable of
performing objective self-auditing
through EPA’s enforcement authorities.
One commenter argued that the
proposed third-party audit requirements
violate the U.S. Constitution’s Fifth
Amendment Due Process Clause
because the proposal seeks to outsource
EPA’s inspectional duties to a thirdparty and force facility owners or
operators to accept and implement the
third-party’s findings without processes
to protect the due process rights of those
subject to the audits. A few commenters
stated that the proposed third-party
auditing provisions are an unlawful and
unconstitutional circumvention of
Congressional appropriations limits on
EPA’s enforcement budget. Specifically,
the commenters argued that the AntiDeficiency Act prohibits EPA from
augmenting its enforcement budget by
mandating that third parties oversee the
RMP program.
EPA disagrees with the commenters.
Third-party audits do not constitute
enforcement, nor do they substitute for
inspections by implementing agencies,
and as such, EPA believes that they do
not violate either the Due Process
Clause of the Fifth Amendment, or the
Anti-Deficiency Act. In addition, as
discussed further in this preamble, EPA
believes that there is no violation of the
Due Process Clause of the Fifth
Amendment regarding implementation
of third-party audit findings.
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The third-party audits required in this
final rule are compliance audits, similar
to the current self-audit requirements,
only conducted by a team led by a thirdparty auditor. The Senate Environment
and Public Works Committee identified
program audits ‘‘by company personnel
. . . or outside consultants’’ as an
element of prevention program rules
within the range of authorities provided
EPA. See Senate Report at 243.35 The
findings of a third-party audit are
intended to identify noncompliance that
was not discovered by facility personnel
during self-audits, and are not intended
primarily to bring such findings to the
attention of government regulators. In
fact, the audits are designed primarily to
benefit owners or operators by assisting
them to identify both actual
noncompliance as well as operational or
equipment deficiencies, previously
unidentified risk factors, and accident
release and/or regulatory
noncompliance precursor conditions
which, if uncorrected, could lead to
releases and/or enforcement actions.
Proactively addressing deficiencies, risk
factors, and precursor conditions to
accidental releases and regulatory
noncompliance will provide financial,
regulatory, and environmental benefits
for facility owners and operators and
communities. EPA has reasonably
targeted third-party audit requirements
at facilities that have had RMP
reportable incidents that may
demonstrate weaknesses in prior selfassessments and at facilities of
heightened concern for implementing
agencies.
Furthermore, third-party compliance
audits in no way constitute regulatory
inspections of, or enforcement at, RMPregulated facilities. This rule is clear
that third-party auditors’ or third-party
audit teams’ findings are not, in and of
themselves, determinations of
regulatory violations. Nor are the audit
reports or related documentation
required to be automatically submitted
to implementing agencies. EPA believes
there is no violation of the Due Process
Clause of the Fifth Amendment
regarding implementation of third-party
audit findings. Owners or operators
must address all third-party audit
findings, the rule provides that
addressing the audit findings may
include, where appropriate, determining
that some specific findings were based
on incorrect factual assumptions or
were otherwise inappropriate to
implement. Thus, as described further
35 Senate Committee on Environment and Public
Works, Clean Air Act Amendments of 1989, Senate
Report No. 228, 101st Congress, 1st Session 211
(1989)—‘‘Senate Report.’’
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in this preamble, the owner or operator
of a stationary sources may determine
an appropriate response to the findings
in the audit report, and are not required
to accept findings when they can
justifiably decline to adopt them, and
EPA believes that determining
appropriate responses, and addressing
of deficiencies, risk factors, and
precursor conditions to accidental
releases and regulatory noncompliance
pursuant to the third-party audit
regulatory requirements, do not
constitute violations of the Due Process
Clause of the Fifth Amendment.
Finally, nothing in this rule relieves
the EPA of any of its responsibilities
under the CAA or implies that EPA will
not continue to use its enforcement
authorities under the CAA or devote
resources to monitoring and enforcing
this rule. The third-party auditing
regulatory requirements simply ensure
that regulated entities will, in a
carefully-defined subset of
circumstances, take reasonable
measures to assess and ensure their own
compliance.
Security and CBI concerns. A few
commenters expressed security
concerns associated with third-party
compliance audits. One commenter was
concerned with ensuring proper
treatment of confidential information by
third-party auditors, and asserted that
the proposed rulemaking does not
address whether or not a facility will be
able to limit the release of sensitive
information once a third-party auditor is
involved. Another comment was
received stating that facility and process
security are concerns for the commercial
explosives industry, and recommended
that EPA eliminate the third-party audit
requirements. This commenter reasoned
that internal staff at explosives sites
would have undergone mandatory
background checks but third-party
auditors wouldn’t necessarily be subject
to the same security screening. A few
commenters stated that attempts to find
auditors with appropriate security
clearances would further limit the pool
of available qualified auditors. One
commenter asserted that the third-party
compliance audit requirements create
legal concerns given that the third
parties would be privy to potential CBI
or information that should be protected
under attorney-client privilege.
EPA acknowledges commenters
concerns; however, facility owners or
operators routinely obtain and review
the internal policies, procedures, and
qualifications of a wide range of
consultants and contractors before
engaging them in order to assess their
qualifications to perform consulting or
contractual services. EPA is confident
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owners and operators will be able to
ensure that third-party auditor
personnel meet applicable security
criteria.
Regarding concerns that the thirdparty compliance audit requirements
create legal concerns given that the
third-parties would be privy to potential
CBI, the contracts or other agreements
between owner/operators and thirdparty auditors can address how any
potential confidential business
information is handled by the thirdparty.
With regard to information that
arguably should be protected under
evidentiary privileges, EPA’s view is
that the third-party audit reports and
related records under this rule, like
other documents prepared pursuant to
part 68 requirements, such as process
safety information, PHAs, operating
procedures and others, are not
documents produced in anticipation of
litigation. With respect to the attorneyclient communication privilege
specifically, the third-party auditor is
arms-length and independent of the
stationary source being audited. The
auditor lacks an attorney-client
relationship with counsel for the
audited entity. Therefore, in EPA’s
view, neither the audit report nor the
records related to the audit report
provided by the third-party auditor are
attorney-client privileged (including
documents originally prepared with
assistance or under the direction of the
audited source’s attorney). Nevertheless,
EPA recognizes that the ultimate
decision maker on questions of
evidentiary privileges are the courts.
Therefore, this rule does not contain a
specific regulatory provision prohibiting
assertion of these privileges.
b. Requirement To Conduct Compliance
Audit for Each Covered Process
EPA received several comments
regarding the clarification in §§ 68.58(a)
and 68.79(a) of the proposed rulemaking
that all RMP audits must address ‘‘each
covered process’’ at a facility. Some
commenters opposed this clarification.
A few commenters indicated that this
would be a change, and asserted that
EPA has endorsed guidance from the
CCPS allowing facilities with a large
number of covered processes to audit a
representative sample of processes.
One commenter argued that it was
punitive for an accidental release from
one process to automatically trigger a
third-party audit requirement for all
covered processes. A few commenters
stated that requiring that all RMPcovered processes at the facility be
audited regardless of what process
triggered the requirement to perform the
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third-party audit would result in
duplication of efforts with little benefit
where processes at multi-process
facilities are on different auditing
schedules and third-parties are required
to audit processes that were recently
audited and not related to the incident
that triggered the third-party audit. One
commenter stated that requiring audits
of processes that are not part of an
incident would tie-up plant resources
for longer than needed, which was
particularly notable to the commenter
because these processes would very
likely still be operating after the
incident and at the time of the audit.
Finally, commenters asserted that it is
unfair and more burdensome to require
larger facilities with multiple processes
to audit each covered process, arguing
that they would essentially be auditing
all the time, where small facilities with
one or two processes would have a
lesser auditing burden.
EPA disagrees with commenters that
believe it is punitive or redundant to
require an audit of all RMP-covered
processes at the facility, including those
not involved in an RMP-reportable
accident. Under existing rules, each
facility compliance audit must address
each covered process at least every three
years. The third-party audit required
under this rule simply replaces the next
scheduled self-compliance audit, which
must address each covered process.
EPA has consistently maintained that,
at least every three years, owners or
operators must, under the RMP rule,
certify that they have evaluated
compliance with the prevention
program requirements for each covered
process. ’’In EPA’s General Risk
Management Guidance, issued in 2004
and updated in 2009, in Chapter 6,
‘‘Prevention Program (Program 2)’’
Section 6.7 ‘‘Compliance Audits
(§ 68.58)’’, under the heading ‘‘What Do
I Need to Do?’’ it states ‘‘At least every
three years, you must certify that you
have evaluated compliance with the
prevention program requirements for
each covered process’’ [emphasis
added]. In addition, Chapter 7 of this
guidance, ‘‘Prevention Program
(Program 3)’’ Section 7.9 ‘‘Compliance
Audits (§ 68.79),’’ states ‘‘You must
conduct an audit of the process to
evaluate compliance with the
prevention program requirements at
least once every three years.’’ While
EPA does list the 1993 edition of CCPS
Guidelines for Auditing Process Safety
Management Systems as a reference
source within this guidance, EPA
disagrees that the CCPS guidelines
endorse allowing large facilities to audit
a representative sample of covered
processes.
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EPA has also clearly stated its
position within the Notice of Proposed
Rulemaking preamble for the initial
RMP regulation, and in the Response to
Comments for that rule. In response to
a question concerning whether facilities
could stagger compliance audits where
there are multiple processes at a facility,
EPA stated, in the Response to
Comments document, that a source
‘‘may choose to audit different processes
on different schedules (if) over each
three-year period, all covered processes
are audited.’’ 36 Furthermore, while
OSHA’s original PSM compliance audit
guidelines may have allowed for
auditing a sample of processes, the
current guidelines are consistent with
EPA’s General Risk Management
Guidance. See OSHA’s ‘‘Appendix C to
§ 1910.119—Compliance Guidelines and
Recommendations for Process Safety
Management (Nonmandatory).’’ EPA’s
decision to retain, in §§ 68.59(e)(3) and
68.80(e)(3) of the final rule, the
requirements for the third-party audit
reports to document the auditor’s
evaluation, for each covered process, of
the owner or operator’s compliance with
the prevention program provisions is
thus consistent with both the initial
RMP rule and EPA’s longstanding
interpretation of the scope of the rule.
EPA also disagrees with commenters’
burden argument for larger companies
and facilities with a larger number of
processes. These larger facilities
typically also have more personnel and
resources, where smaller facilities with
fewer processes may have fewer
employees, so the burden of auditing is
proportionate for these facilities.
Furthermore, larger facilities with more
processes, in general, are likely to have
more potential opportunities for
accidental releases due to their size,
complexity, and scale of operations.
Therefore, it is appropriate for such
facilities’ auditing responsibilities to be
commensurate to their size, complexity,
and scale of operations.
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c. Third-Party Audit Applicability
Some commenters generally
supported the proposed applicability
requirements. However, many
commenters opposed the requirements,
requesting that EPA narrow, limit, or
eliminate these requirements.
RMP-reportable accident criterion. A
commenter encouraged EPA to develop
a narrower range of circumstances that
can trigger a third-party audit to ensure
they will not become an overwhelming
36 EPA. May 24, 1996. Risk Management Plan
Rule, Summary and Response to Comments.
Volume 1, p. 15–2. Docket No. A–91–73, Document
No. IX–C–1.
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compliance function, and detract from
the performance-based aspects of RMP.
Other commenters recommended
limiting the requirements to: Releases
that result in offsite impacts, such as
offsite deaths, serious injuries, or
significant environmental
contamination; Program 3 facilities;
facilities with multiple releases or
multiple major accidents; or incidents
that result in significant impacts to
workers, or to the community. Another
commenter stated that third-party audits
should not be required automatically,
but should only be required if the
facility has experienced an accidental
release that meets the criteria in
§ 68.42(a) and EPA makes the
determination that there is good cause
for the audit, in light of the particular
circumstances and facts surrounding the
release in question. One commenter
stated that the accidental release trigger
was not an effective way to improve
public safety and urged EPA to adopt a
more proactive and targeted approach.
EPA disagrees with commenters that
third-party compliance audits will
become an overwhelming compliance
function. EPA has limited applicability
of third-party audits to circumstances in
which an RMP reportable accident has
occurred or where conditions exist at
the source that could lead to a release.
In responding to the previous
comments, it is necessary to provide
context for how infrequently third-party
auditing will, in practice, be necessary
under the final rule, both in absolute
numbers of such audits and their
number relative to the full universe of
RMP-regulated stationary sources
already subject to the RMP rule’s selfauditing requirements.
Currently, there are approximately
12,000 stationary sources with Program
2 and/or Program 3 processes. The final
rule requires third-party compliance
audits only under the following two
conditions:
• If there has been an RMP reportable
accident (i.e., an accidental release from
an RMP facility meeting the five-year
accident history criteria as described in
§ 68.42(a)); or
• If an implementing agency makes a
determination that a third-party audit at
an RMP facility is necessary, based on
conditions ‘‘that could lead to an
accidental release of a regulated
substance’’ or a prior third-party audit at
the facility.
EPA does not expect these criteria to
impact a large percentage of stationary
sources with Program 2 and/or Program
3 processes. For example, comparing the
number of facilities which in past years
have had an RMP reportable accident
(averages approximately 150/year), with
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4615
the number of current stationary sources
with Program 2 and/or Program 3
processes, would represent less than 2%
of stationary sources subject to this
requirement, due to an accident, on an
annual basis. For more information on
the number of RMP reportable accidents
over a ten-year period see section IX.A
of this preamble.
EPA also disagrees with suggestions
to limit the applicability of third-party
compliance audits to releases with
offsite impacts, deaths, injuries, or
significant environmental impacts. The
purpose of the third-party audit is to
help reduce the risk of future accidents
by requiring an independent and
objective audit to determine whether the
owner or operator of the facility is
effectively meeting the prevention
program requirements of the RMP rule.
Stationary sources that have had
accidents and/or substantial
noncompliance with Risk Management
Program requirements may pose a
greater risk to the surrounding
communities. EPA agrees that releases
with offsite impacts, deaths, injuries, or
significant environmental impacts are
potential indicators of noncompliance
with RMP prevention program
requirements. But so are accidental
releases that involve significant
property damage on-site, or known
offsite evacuations, sheltering in place,
property damage, or environmental
damage of any degree.
The existing self-audit requirements
under §§ 68.58 and 68.79 incorporate a
proactive evaluation of prevention
program requirements for Program 2 and
Program 3 processes. However, when a
facility has an accidental release or
noncompliance that could lead to an
accidental release of a regulated
substance, EPA has determined that
further self-auditing may be insufficient
to prevent accidents and ensure safe
operation. Therefore, we believe it is
appropriate to require such stationary
sources to undergo third-party auditing
to better assist owners and operators
and implementing agencies to
determine whether the procedures and
practices developed by the owner and/
or operator under subparts C and/or D
of the RMP rule (i.e., the prevention
program requirements) are adequate and
being followed. EPA believes this
approach will improve public safety
overall by preventing future accidents at
the source.
Overlap between incident
investigations and third-party audits.
Many commenters recommended that
EPA focus on incident investigations
after accidental releases rather than
third-party audits. Some commenters
reasoned that incident investigations are
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the activities that are most likely to
mitigate both the severity of future
incidents and the potential for
recurrence. Some commenters stated
that third-party audits should not be
required when an incident investigation
is also required because both of these
activities require substantial internal
resources and the incident investigation
is more responsive to health and safety
concerns. Some commenters also stated
that requiring a facility to conduct the
third-party audit after an accidental
release has the potential to dilute
resources from the facility’s efforts to
complete a comprehensive incident
investigation and implement associated
improvements. One commenter
suggested that an incident investigation
be required immediately after a
catastrophic release but not a third-party
audit, and that EPA could then require
the stationary source’s next three-year
compliance audit (after the completion
of the incident investigation) to have
some degree of independence to assess
the effectiveness of the changes made in
response to the incident investigation.
EPA disagrees with commenters.
Following an accident, incident
investigations often reveal that facilities
have deficiencies in some prevention
program requirements related to that
process. Incident investigations
generally only evaluate the affected
process, and do not necessarily address
all covered processes at a facility, or
even all prevention program elements
for the affected process. However,
compliance audits entail a systematic
evaluation of the full prevention
program for all covered processes, and
EPA expects that third-party audits
should identify deficiencies in any other
covered processes at such facilities.
EPA believes that conducting the
third-party compliance audits
immediately after an accidental release
is necessary to identify and correct
existing noncompliance at prevention
program facilities that could lead to
future releases. EPA acknowledges that
conducting third-party audits at the
same time as incident investigations
may impact the availability of facility
resources for these activities. However,
this is not a sufficient argument to delay
the independent audit. Facilities may
hire personnel from different firms to
conduct the two activities or, for some
facilities with knowledgeable internal
staff to conduct investigations, they may
only need to hire the third-party.
Although we agree with the
commenter that suggested that
compliance audits assess the
effectiveness of changes made in
response to an incident investigation,
we disagree that this assessment must
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be made by a third-party. The owner or
operator will resume the three-year
schedule to conduct self-compliance
audits after the third-party audit and, at
that time, the facility owner or operator
may consider the findings of the
incident investigation and the thirdparty compliance audit when assessing
compliance with prevention program
requirements.
Implementing agency criterion. Many
commenters argued that the third-party
audit trigger associated with
implementing agency findings of
noncompliance should either be
eliminated or significantly revised.
Commenters expressed concerns with
allowing an implementing agency to
require a third-party audit based on a
noncompliance determination.
Commenters were also concerned about
the potential for inconsistent or
arbitrary decisions by implementing
agencies, and a few commenters were
concerned about the potential for abuse
of this mechanism by implementing
agencies. One commenter expressed due
process concerns related to the triggers
for third-party compliance audits,
stating that the proposed rulemaking
fails to provide the regulated facility an
opportunity to contest implementing
agency allegations of noncompliance.
Commenters also requested clarification
on whether an implementing agency
could require a third-party compliance
audit following a site inspection by the
implementing agency.
In response to comments, EPA has
revised the third-party audit
applicability criterion by requiring the
implementing agency to base a
determination on conditions at the
stationary source that could lead to an
accidental release of a regulated
substance, rather than on
noncompliance. An implementing
agency may determine that a third-party
audit is necessary following inspections,
audits, or facility visits, if conditions are
observed at the stationary source that
could lead to an accidental release of a
regulated substance. The implementing
agency may choose to take other action
following an inspection, as appropriate.
Conditions at a stationary source that
could lead to an accidental release may
include, but are not be limited to,
significant deficiencies with process
equipment containing regulated
substances, such as unaddressed
deterioration, rust, corrosion,
inadequate support, and/or other lack of
maintenance that could lead to an
accidental release. The presence of
small ‘‘pinhole’’ releases, that do not
meet the criteria in § 68.42(a) for RMPregulated accidental releases, could also
constitute conditions that could lead to
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a larger accidental release of a regulated
substance. The occurrence of several
prior accidental releases that did not
meet the reporting criteria in § 68.42(a)
at or from a facility could also constitute
conditions which could lead to
potentially more severe accidental
releases. These releases may be a
potential indicator that an owner or
operator is not complying with RMP
prevention program requirements and
would benefit from a third-party audit
to prevent future accidental releases.
EPA believes that having the
implementing agency evaluate whether
conditions exist that could lead to an
accidental release better addresses the
types of situations where a third-party
audit would be most effective and will
minimize the potential for inconsistent
or arbitrary decisions made by
implementing agencies. EPA also
believes that the revised criterion is
responsive to commenters’ requests to
narrow the applicability of these
requirements. The criterion focuses on
conditions with the potential to lead to
accidental releases, rather than
authorizing implementing agencies to
require third-party audits under a
potentially wide range of circumstances,
including minor noncompliance.
In the final rule, a facility owner or
operator has an opportunity to challenge
the underlying findings when an
implementing agency requires a thirdparty audit. Sections 68.58(g) and
68.79(g) describe the notification and
appeals process. The implementing
agency must provide written notice to
the facility owner or operator that
describes the basis for the implementing
agency’s determination. Within 30 days,
the owner or operator may consult with,
and provide information and data to the
implementing agency on the
preliminary determination. The
implementing agency will then consider
this information and provide a final
determination to the owner or operator.
EPA believes this appeal process
provides due process to the owner or
operator and is sufficient to eliminate
any potential inconsistent use or abuse
of authority.
Previous third-party audit criterion. A
few commenters suggested deleting the
failure of a previous third-party audit to
meet the competency, independence, or
impartiality criteria as a criterion for
potentially requiring a subsequent thirdparty audit. These commenters reasoned
that EPA has not shown that the auditor
criteria will necessarily lead to better
outcomes. A commenter questioned
whether it was reasonable for EPA to
declare a previous audit that was
otherwise conducted in good faith, to be
null and void, arguing that stationary
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sources could find it burdensome and
difficult to track auditor qualification
criteria.
EPA disagrees with commenters’
assertions that stationary sources will
find it burdensome or difficult to apply
the third-party auditor competency and
independence criteria in this rule to
identify qualified third-party auditors.
See sections IV.B.3.i and IV.B.3.j of this
preamble for a discussion of auditor
qualifications in the final rule as well as
an explanation for why EPA believes
that independent auditors can provide a
fresh perspective on compliance audits
that will enable an owner or operator to
improve the source’s risk management
program.
If the implementing agency has
concerns about a previous third-party
audit, which involved an auditor that
failed to meet the qualification criteria
for competency and independence, and
the agency is concerned about the
quality and/or adequacy of the audit
and/or its findings, then the
implementing agency may choose to
require that another third-party audit be
conducted. The final rule establishes a
procedure for owners or operators to
challenge the regulators’
determinations.
Regarding the comment concerning
auditor criteria leading to better
outcomes, this issue was addressed in
the preamble to the proposed
rulemaking, and is also discussed
extensively in section IV.B.3.h of this
preamble.
Alternative criteria suggestions. EPA
received a comment recommending that
EPA require third-party compliance
audits for all Program 2 and Program 3
facilities every three years, reasoning
that this alternative option is a more
preventative measure than the proposed
applicability.
A few commenters, including a state
government agency, suggested that EPA
consider limiting the requirement to
perform third-party audits to specific
NAICs codes. Some of these
commenters further recommended that
certain types of facilities be excluded
from the requirement, including water
and wastewater treatment facilities and
retail anhydrous ammonia facilities. A
local government agency commented
that EPA should consider limiting the
requirement to perform third-party
audits to the petroleum manufacturing,
chemical manufacturing, and paper
manufacturing industries only.
As part of the SBAR panel process for
the proposed rulemaking, SERs
suggested that EPA consider excluding
or exempting small businesses from the
rule’s third-party auditing requirements
or providing small businesses with
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special flexibility to use less-than-fullyindependent third-party auditors such
as retired facility employees not
otherwise meeting all of the proposed
rulemaking’s independence criteria. The
SERs noted that the requirements in the
proposed rulemaking for every member
of the third-party auditing team to
individually meet all of the proposed
rulemaking’s competency and
independence criteria would be
especially costly and burdensome to
small businesses.
EPA disagrees with the suggestion to
require all facilities with Program 2 and/
or Program 3 processes conduct thirdparty compliance audits every three
years, because the Agency believes that
this would impose a very large
economic burden on the regulated
industry. EPA is also concerned that
there may not be a sufficient number of
independent auditors available to
perform third-party audits at the
frequency that this approach would
demand.
Upon review of these comments in
the context of EPA’s overall approach to
this rule, EPA has determined that it is
unnecessary to add an exceptions or
exemptions process for third-party
auditor competency and independence
to the final RMP rule, or to exempt
small facilities or facilities within select
industry sectors from the third-party
auditing requirements. First, EPA
expects that the current approach to
require third-party audits following an
RMP reportable accident, or based upon
an implementing agency’s
determination, will impact
approximately 150 facilities per year. In
the Initial Regulatory Flexibility
Assessment (IRFA) 37 for the proposed
rulemaking, EPA determined that
relatively few small businesses have
reportable accidents and therefore this
provision will typically not apply to
small facilities. Therefore, it is
unnecessary to exempt small facilities
or revise the auditor qualifications for
small facilities.
Additionally, EPA believes that the
revised third-party auditor
qualifications in this final rule will
make it easier for owners and operators
to find suitable third-party auditors and
third-party audit team leaders to comply
with the third-party audit provisions,
making it unnecessary to add additional
exceptions or an exception process to
the final rule. EPA agrees with
37 The IRFA can be found in Chapter 7 of the
Regulatory Impact Analysis for Proposed Revisions
to the Accidental Release Prevention Requirements:
Risk Management Programs Under the Clean Air
Act, Section 112(r)(7). This document is available
in the docket for this rulemaking (Docket ID
Number EPA–HQ–OEM–2015–0725).
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4617
commenters’ requests to provide
additional flexibility to allow retired
facility employees to conduct a thirdparty audit and has revised the auditor
qualification criteria to address this
request (see section IV.B.3.j of this
preamble for more information).
Finally, EPA disagrees with
commenters that request EPA exclude
facilities within specific sectors from
third-party applicability. EPA based
applicability of third-party audits on
whether a source had an RMP reportable
accident or whether conditions exist
that could lead to an accidental release.
EPA believes that these criteria are
potential indicators for noncompliance
with prevention program requirements
and therefore warrant an evaluation by
a third-party. If a specific industry
sector does not typically have accidental
releases, then this provision will not
likely apply. Furthermore, EPA
modified the third-party auditor
qualification criteria to make it simpler
for all businesses, small, medium, and
large and in all sectors, to find qualified
third-party auditors. Therefore, it is
unnecessary to exclude or limit thirdparty audit applicability to specific
industry sectors.
d. Implementing Agency Notification
and Appeals
A few commenters asserted that the
appeals process associated with thirdparty compliance audits is insufficient.
One commenter stated that the proposed
appeals process does not preclude the
excessive or baseless use of the claim by
agency staff nor detail the quality or
quantity of information that a facility
could present to overcome an agency’s
determination and the requirement to
perform a third-party audit.
Commenters also recommended adding
an additional independent party to the
appeals process. One commenter stated
that EPA should clearly provide for
judicial review of decisions on appeals
by including regulatory language
specifying that EPA’s decision
‘‘constitutes final agency action for
purposes of judicial review.’’ Another
commenter stated that EPA should make
the deadline for appeals at least 60 days
and should expressly provide for
extensions.
EPA disagrees with the comments
requesting an independent party be
added to the appeals process. This
approach would create unacceptable
delays while the implementing agency
and the facility identifies an appropriate
third-party. EPA believes the appeals
process set out in the final rule provides
sufficient opportunities for the owner or
operator to challenge an implementing
agency’s determination.
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Sections 68.58(g) and 68.79(g)
describe the notification and appeals
process for when an implementing
agency requires a third-party audit. The
implementing agency must provide
written notice to the facility owner or
operator that describes the basis for the
implementing agency’s determination.
Within 30 days, the owner or operator
may consult with, and provide
information and data to, the
implementing agency on the
preliminary determination. The
implementing agency will then consider
this information and provide a final
determination to the owner or operator.
Then there is an appeals process, in
which the owner or operator may appeal
the final determination to the EPA
Regional Administrator, or for
determinations made by other
implementing agencies, the
administrator or director of such
implementing agency.
It is important to note that the final
determination regarding the
applicability of these provisions is not
an enforcement determination. It is a
notification regarding the applicability
of an existing regulatory requirement, a
requirement that does not apply to all
stationary sources, all the time, but
when an agency determines that it
would apply, the owner or operator is
notified, given an opportunity to
consult, and appeal further within the
agency. Part 68 already includes final
agency determinations regarding
regulatory requirements in Section
68.220, and the process set out in this
final rule for appeals of third-party audit
determinations is similar.
In response to comments about the
short time frames, EPA has determined
that the 30-day timeframe to submit an
appeal, which follows an initial 30-day
time period for the owner or operator to
provide information and data to, and
consult with, the implementing agency,
is adequate and will ensure timely
consideration of the information
presented. EPA believes there is
sufficient time built into the initial
notification and consultation process,
and the subsequent appeals process,
particularly considering that the
provisions apply to third-party audits
required due to accidents or conditions
at the facility that could lead to an
accidental release of a regulated
substance, and taking into account the
need, in these circumstances, to take
prompt action to identify and correct
deficiencies.
e. Schedule for Conducting a ThirdParty Audit
One commenter supported the
proposed 12-month timeframe to
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complete a third-party audit. However,
a few commenters opposed the
proposed schedule. One commenter
said that it would not be reasonable or
appropriate to require completion of an
audit report within twelve months by
default. Some comments suggested
modifying the rule to allow extensions
of time to conduct third-party audits.
Some comments sought clarification
concerning the timing of a third-party
audit. One commenter stated that the
proposal seems to include inconsistent
requirements for the required timing of
third-party audits. Another commenter
stated that, although it seems that EPA
intended to require the third-party audit
to be completed within 12 months of a
triggering event, the deadline would be
even sooner if the next scheduled
triennial compliance audit is fewer than
12 months away. A few commenters
encouraged EPA to clarify that
conducting a third-party audit would
count as the scheduled compliance
audit and reset the clock on the threeyear compliance audit schedule.
In response to comments, EPA has
revised the regulatory text to clarify that
the schedule for conducting a thirdparty audit, unless a different timeframe
is specified by the implementing
agency, is within 12 months of an RMP
reportable accident or within 12 months
of the date of the implementing agency’s
final determination. If the final
determination is appealed, the thirdparty audit is required within 12
months of the date of the final decision
on the appeal. EPA believes that the 12month timeframe in the final rule
provides sufficient time for owners or
operators to complete a third-party audit
while avoiding unnecessary delays in
identifying and addressing
noncompliance. Additionally, the final
rule allows the implementing agency to
specify a different timeframe for
conducting third-party audits. This
allows flexibility for an implementing
agency to grant an extension, or to
specify a shorter timeframe, to complete
the audit, as appropriate. For example,
an implementing agency may grant an
extension if a source can demonstrate
that it has had difficulty finding a
qualified third-party auditor to conduct
or lead the audit team, or that the audit
will require extra time due to the
complexity or number of processes, due
to extensive damage to the facility
following an incident, or due to
resource constraints. Alternatively, the
implementing agency may specify a
shorter timeframe to complete the audit
after considering the severity of the
release or determining that unsafe
conditions exist at the source.
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EPA acknowledges that in some cases,
the default result of these timeframes
may be that a gap of greater than three
years may occur between completion of
the previous compliance audit and a
subsequent third-party audit (e.g., if an
accident triggering a third-party audit
occurs shortly before the facility’s next
regular compliance audit is due). In
these cases, the owner or operator will
still have 12 months to complete the
third-party audit unless a different
timeframe is specified by the
implementing agency. Finally,
stationary sources are required to audit
compliance at least every three years,
and a third-party compliance audit
counts toward meeting this recurring
requirement for purposes of determining
the timing of the stationary source’s
next compliance audit.
f. Process by Which Owners or
Operators Select Third-Party Auditors
In the preamble to the proposed
rulemaking, EPA sought comment on
potential alternative approaches to
determining auditor competency and
independence, such as requiring thirdparty auditors to be accredited by EPA
or an independent auditing or
accreditation body or board. EPA
received a range of public comments on
this issue. Commenters disagreed about
whether facility owners and operators
should be responsible for determining
and documenting third-party auditor
qualifications for competence and
independence. A few commenters,
including local agencies and industry
trade associations, supported having the
facility, rather than a regulatory agency,
determine their third-party auditors’
qualifications. Another industry trade
association agreed that auditor
competency should be determined and
documented by individual owners and
operators but asserted that it should be
the auditors’ responsibility to determine
whether they qualify as independent.
Other commenters, however, including
a state agency, facilities, and industry
trade associations, asserted that it is
burdensome to the owners and
operators to require them to self-select
qualified auditors that they determined
to be competent and independent. One
commenter stated that a facility cannot
easily obtain and review a third-party
auditing firm’s internal policies and
procedures each time it engages a thirdparty auditor. Two commenters further
questioned whether facility owners and
operators would be sufficiently able to
assess a third-party’s qualifications to
perform the required audits.
A few commenters expressed support
for establishing an accreditation
program for auditing firms while others
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stated that determinations of third-party
auditor competency and independence
are more properly performed by
regulatory agencies. A state agency
suggested, as an alternative, establishing
an auditor oversight committee to
include representatives from the facility,
local agencies, and the community.
Another state agency commented that
an oversight committee would be
needed to ensure that the process is
truly independent if the auditor is hired
by the owner or operator and not by the
implementing agency. One commenter
suggested that EPA approve third-party
auditors based on technical and other
qualifications and provide a list of those
determined to be acceptable to industry.
Some local agencies suggested that the
implementing agency should approve or
assist the facility in selecting a thirdparty auditor. One local agency stated
that existing accreditation from a
recognized auditing body should be
allowed but not be the only prerequisite
for being qualified to conduct a thirdparty audit. An advocacy group
suggested that if an auditor failed to
identify a crucial hazard that could have
prevented a catastrophic event, the
auditor should lose its accreditation
until it corrects the problems that led to
the failure.
EPA has considered these comments
and believes that establishing an
accreditation program for third-party
auditors would add time and costs to
the process of third-party auditor
selection and engagement. Therefore, in
this final rule EPA has elected, instead,
to focus on streamlining the auditor
competency and independence criteria.
Owners and operators are responsible
for determining and documenting that
the third-party auditors are qualified
pursuant to the rule’s competency and
independence criteria. EPA believes this
approach is consistent with
commenters’ requests that the process
for engaging the auditors should be
straightforward and allow for reasonable
judgement of the owner or operator in
selecting third-party auditors. Owners
and operators routinely obtain and
review the internal policies, procedures,
and qualifications of a wide range of
consultants and contractors before
engaging them in order to assess their
qualifications to perform consulting or
contractual services. EPA is confident
that owners and operators will be able
to assess third-party auditor
qualifications in a similar manner.
g. Auditors and Audit Team Structure
In the preamble to the proposed
rulemaking, EPA invited comment on
how to determine the roles and
responsibilities for third-party auditors
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and how to structure third-party audit
teams. Many commenters, including a
Federal government agency, a state
government agency, facilities, and
industry associations, stated that
facilities should have the flexibility to
utilize internal staff who are much more
familiar with the facility and covered
processes than outside consultants. A
facility commented that in the past it
has used third-party auditors and
determined that the facility’s existing
internal audit process provided an audit
of equal or greater value than that of the
third-party. Industry trade associations
also asserted that the use of facility staff
was more effective than third-party
auditors because crucial time is not lost
in learning about the facility. Another
industry trade association stated that, in
addition to identifying deficiencies, the
most effective audits identify
opportunities for improvement, which
the commenter asserted is why audits
that are conducted by or overseen by
corporate staff or staff from other
facilities within a company with similar
processes can be more effective than
strictly third-party audits. A
professional association stated that
companies must determine their own
policies, procedures, and programs for
performing audits. Similarly, an
industry trade association stated that
owners and operators should be allowed
to choose whether in-house personnel
or a third-party auditor conduct the
compliance audit, as long as the
organization can demonstrate that the
auditor is qualified.
Industry trade associations
commented that EPA’s proposed
approach may have unintended
consequences on the effectiveness of
audits by setting up an adversarial
relationship between the regulated
facility and the third-party auditor and
creating a scenario that discourages the
free flow of information between the
facility and the auditor. Furthermore, an
industry trade association commented
that this fundamental change to the
RMP audit program will likely cause
companies to separate RMP and PSM
audits. The commenter argued that such
a change would demonstrate that EPA
had failed in this rulemaking to satisfy
its statutory obligation to develop a
coordinated approach with OSHA. An
individual commenter recommended
the Institute of Nuclear Power
Operations evaluation team model,
which is a hybrid of a self-audit and a
third-party audit by well qualified
individuals. An industry trade
association suggested setting up an
industry sharing option (similar to the
Occupational Safety and Health
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Administration’s Voluntary Protection
Program, which uses qualified
personnel from other regulated facilities
or company employees from a different
plant to perform audits at facilities
being evaluated under the program) in
lieu of third-party auditing firms.
A Federal government agency
recommended that third-party auditors
be required to consult with facility
employees and their representatives
when conducting audits, reasoning that
this requirement would be consistent
with the language in the CAA at 29
U.S.C. 651 et seq. and EPA guidance on
worker participation during EPA audits
and inspections. And although opposed
to the proposed requirement for thirdparty audits, an industry trade
association asserted that there can be
value in having/adding a third-party
individual on or in coordination with a
self-audit team, reasoning that the
addition of the third-party auditor
contributes to the development of the
internal experts and expertise.
In response to commenters’
suggestions to allow more flexibility on
the composition of the audit team, EPA
is finalizing an approach that allows
owners or operators to meet their thirdparty auditing obligations either by:
• Engaging third-party auditors
meeting all applicable competency and
independence criteria, as originally
proposed, or
• By assembling an auditing team
which is led by a third-party auditor but
may include other audit team members.
The audit team may be comprised of:
Æ A team leader—this must be an
employee of the third-party auditor firm
who meets all of the competency and
independence criteria of the rule;
Æ Other employees of the third-party
auditor firm—these personnel must
meet the independence criteria of the
rule; and
Æ Other personnel not employed by
the third-party auditor firm (e.g. facility
personnel or employees of another
consulting firm with specialized
expertise). These personnel are not
required to meet the competency and/or
independence criteria of the rule.
EPA agrees with commenters who
suggest that allowing facility personnel
and other knowledgeable but nonindependent contractors and
consultants to participate in the audit
would improve the audit teams’
performance and outcomes. This change
addresses, among other things, the
commenters’ concerns that requiring the
audit team and all of its individual
members to meet the full independence
criteria would exclude too many
potential team members with critical
sector or facility-specific experience.
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This approach allows qualified
personnel from other regulated facilities
or company employees to participate in
the audit and enables facility personnel
to provide input during the compliance
audit.
Although some commenters suggested
that facility’s existing internal audit
process provided an audit of equal or
greater value than that of a third-party,
EPA believes that an independent,
third-party perspective can provide
insight on the facility’s risk management
program that may not otherwise be
identified during an internal
compliance audit. EPA further disagrees
that this change to the RMP audit
program will cause companies to
separate RMP and PSM audits. EPA
believes that the flexible approach for
assembling a third-party audit that
includes both independent and facility
personnel will allow facilities to
continue to conduct RMP and PSM
audits simultaneously, as appropriate.
h. Auditor Qualifications and
Responsibilities
General comments on qualification
criteria. Many commenters stated that
the requirements in the proposed
rulemaking for every member of the
third-party auditing team to
individually meet all of the proposed
rulemaking’s competency and
independence criteria will severely
reduce the number of qualified auditors
available and raise the costs of auditing
for facilities. One facility argued that the
auditor qualification requirements are
arbitrary and should be withdrawn.
Specifically, the commenter described
the findings from the EPA-Wharton
pilot study and concluded that this
study undermines EPA’s assertion in the
proposal that rigid qualifications are
necessary for a successful RMP thirdparty audit program. A professional
association recommended that EPA
require companies to develop,
implement, and maintain effective
policies, procedures, and programs for
performing RMP audits. Such policies,
procedures, and programs could
themselves establish basic third-party
auditor competency and independence
criteria.
EPA agrees with commenters that the
proposed qualification criteria could
limit availability of qualified auditors
and raise costs of audits. Therefore, EPA
is finalizing an approach that allows
owners or operators to comply with
third-party auditing requirements either
by engaging third-party auditors that
meet all applicable competency and
independence criteria, as originally
proposed; or by assembling an auditing
team, led by a third-party auditor, that
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includes other personnel (e.g.,
consultants or facility employees).
EPA disagrees with commenters who
argue that auditor qualifications are
unnecessary for a successful third-party
audit program. EPA’s goal, in proposing
criteria for auditor qualifications, was to
ensure clarity and objectivity as to the
minimum expected standards thirdparty auditors must meet for
competency and independence. Since
EPA is not finalizing requirements for
third-party auditors to be qualified or
accredited by an outside independent
accreditation board, nor to meet
competency and independence criteria
in external consensus standards or
protocols, the final rule must
necessarily specify third-party auditor
competency and independence criteria.
Such criteria are necessary to ensure
that owners and operators are able to
successfully identify and engage fully
qualified, competent and independent
third-party auditors.
Consensus standards. EPA did not
propose that consensus standards apply
to third-party audits or auditors.
However, in the preamble to the
proposed rulemaking, EPA sought
comment regarding potentially relevant
and applicable consensus standards and
protocols that might apply to the thirdparty auditors or audits that could be
incorporated into the rule. Some
commenters recommended that EPA use
existing guidelines and standards
including the CCPS ‘‘Guidelines for
Auditing Process Safety Management
Systems’’ and National Fire Protection
Association codes and standards. One
commenter stated that establishing
protocols for auditing would assist in
ensuring that a third-party audit is being
performed to some type of recognized
standard. However, the commenter
stated that it is not aware of the
establishment of such a standard at this
time and noted that EPA might be
required to work with a standard setting
organization to develop the standard, if
such a standard was to be provided to
facilities and auditors. One commenter
stated that the International Code
Council (ICC) administers exams for
building, fire, plumbing, and many
other trade inspectors. An industry
trade association commented that it
opposed a requirement that consensus
standards and protocols be incorporated
into compliance audits and asserted that
such a requirement was not within the
scope of Executive Order 13650.
A few commenters, including a local
government agency, noted that
consensus standards may result in the
bar for acceptable procedures being set
low. Although noting that consensus
standards could offer some minimum
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criteria to follow, a commenter stated
that applying consensus standards to
third-party compliance audits could be
problematic because they are the lowest
high-bar industry has agreed to, which
runs the risk of lowering the bar for
select companies or the consultants
hired to perform the audit.
EPA acknowledges that consensus
standards and protocols are referenced
in a range of Federal and state
regulations and can play useful roles in
third-party verification programs.
California’s Underground Storage Tank
program is an example of a program that
relies on consensus standards in which
designated operators are required to
pass an exam administered by the ICC
in order to be certified to conduct
audits.38 However, EPA has determined
that reference to such standards and
protocols is unnecessary for third-party
compliance audits conducted under this
rule because the final rule identifies
qualification criteria for competency
and independence for third-party
auditors and third-party auditor team
leaders.
EPA is also finalizing third-party
auditor responsibilities in §§ 68.59(d)
and 68.80(d). This provides the thirdparty auditor with minimum
expectations for conducting the
compliance audit. The owner or
operator shall ensure that the thirdparty auditor:
• Manages the audit and participates
in audit activities including: Initiation,
design, implementation, and reporting;
• Determines appropriate roles and
responsibilities for the audit team
members;
• Prepares the audit report and
ensures all audit team members’ views
are reflected in the final audit report;
• Certifies the final audit report and
its contents as meeting the requirements
of the rule and
• Provides a copy of the audit report
to the facility owner or operator.
Third-party auditors must evaluate
the audit team members’ qualifications
to determine appropriate audit roles and
responsibilities in order to produce
audit outcomes and final audit reports
meeting the applicable rule
requirements. This approach recognizes
that audit team members may have
varying levels of knowledge and
experience with the RMP rule
requirements, the stationary source
being audited, the applicable or relevant
38 See, e.g., CA UST Regulations (CCR, Title 23,
Division 3, Chapter 16), Amended and Effective
July 1, 2012) at § 2715 (Certification, Licensing, and
Training Requirements for Underground Storage
Tank Owners, Operators, Installers, Service
Technicians, and Inspectors). https://www.swrcb.ca.
gov/ust/regulatory/docs/title23_d3_c16.pdf
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engineering practices, and proper
auditing techniques. EPA believes it is
appropriate for the third-party auditor to
be responsible for these determinations
and that this approach allows the
owners or operators and the third-party
audit team leader to successfully
collaborate to assemble an effective
auditing team.
i. Third-Party Auditor Competency
Criteria
Almost all of the public comments on
the proposed third-party auditor
competency criteria focused on the
requirement for the auditor to be a
licensed Professional Engineer (PE) or
include a licensed PE on the audit team.
PE organizations supported the
proposed requirement arguing that
many facilities that would require thirdparty audits are designed, constructed,
and maintained by PEs, who are subject
to professional ethical standards that
require objectivity. Some of these
commenters described the supply of PEs
as being sufficient to meet the demand
for the third-party auditors under the
approach in the proposed RMP rule.
However, a large number of
commenters opposed the proposed PE
competency criterion. Many
commenters stated that they saw no
value in requiring a PE because PEs do
not specifically have process safety or
auditing skills. Several commenters
questioned whether there are a
sufficient number of PEs with
appropriate experience to meet the need
for RMP audits. As an industry trade
association observed, even though the
number of PEs may be large, there may
be an insufficient number of PEs that
have third-party audits as an area of
expertise. A facility asserted that every
PE cannot practice in every state, and if
a PE is part of the audit team, he or she
must be licensed in the state affected by
the RMP incident.
As part of the feedback for the SBAR
Panel for the proposed rulemaking,
SERs suggested that EPA consider
allowing other qualified, credentialed
personnel besides PEs to qualify as
third-party auditors. Such other
personnel could, SERs suggested, be
degreed chemists, degreed chemical
engineers, Certified Safety Professionals
(CSP), Certified Industrial Hygienists
(CIH), Certified Fire Protection
Specialists (CFPS), Certified Hazardous
Materials Managers (CHMM), Certified
Professional Environmental Auditors
(CPEA) or Certified Process Safety
Auditors (CPSA). SERs indicated that
these credentials also include ethical
obligations to provide sound
independent advice. Many other
commenters also suggested that
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professionals with process safety
management experience who have other
credentials subject to ethical standards
should also be allowed to give facilities
a larger choice for their third-party
auditors. Another facility and an
industry trade association commented
argued that the owner or operator is in
the best position to assess who is
qualified to perform the audit. Two
commenters characterized the EPAWharton Pilot Study on Third-Party
Audits 39 as suggesting that relevant
industry and process specific
experience, training, and regulatory
knowledge are the essential
qualifications of RMP auditors and that
the PE requirement should be
withdrawn.
EPA agrees with commenters that
stated it is unnecessary for third-party
auditors to be PEs and that a variety of
qualified personnel can potentially be
effective third-party auditors or thirdparty audit team leaders. Consequently,
EPA deleted the PE requirement from
the final rule. EPA believes it is
sufficient for the third-party auditor or
third-party audit team leader to be:
• Knowledgeable with the
requirements of the RMP rule;
• Experienced with the stationary
source type and processes being audited
and applicable recognized and generally
accepted good engineering practices;
and
• Trained or certified in proper
auditing techniques.
Third-party auditors can meet the
requirement to be knowledgeable with
the RMP rule requirements, and the
requirement to be experienced with the
stationary source type and processes
being audited and applicable recognized
and generally accepted good
engineering practices through a variety
of ways, including prior experience and
training. Third-party auditors can meet
the requirement to be trained or
certified in proper auditing techniques
by completing courses in environmental
or safety auditing, obtaining
certifications from recognized
professional bodies, or having prior
process safety auditing experience.
EPA has also established third-party
auditor responsibilities in §§ 68.59(d)
and 68.80(d). If the third-party auditor
39 EPA conducted a pilot study with the Wharton
School of the University of Pennsylvania on the
efficacy of voluntary third-party RMP audits. For
relevant reports from this pilot, see R. Barrish, R.
Antoff, & J. Brabson, Dep’t of Natural Resources &
Env. Control, Third Party Audit Pilot Project in the
State of Delaware, Final Report (June 6, 2000)
https://opim.wharton.upenn.edu/risk/library/2000_
RAB,RA,JB_3rdPartyAudit_Delaware.pdf and EPA
Region 3, Third-Party Pilot Project in the
Commonwealth of Pennsylvania, Final Report
(February 2001).
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4621
believes that a necessary skill or
expertise is lacking in the auditing team,
the owner or operator and third-party
auditor are responsible for augmenting
the audit team with the additional team
members needed to supply the missing
skill or expertise. For example, an
owner or operator may choose to
designate an employee competent in
using an infrared camera to participate
on a third-party auditing team. Such an
audit team member would be
acceptable, even though the individual
does not meet the independence criteria
and lacks specific knowledge of the
stationary source type and processes
being audited, as long as the third-party
audit team leader evaluates the
employee’s qualifications to perform the
specific role the employee will perform
in the audit. The same standard would
also apply to the participation of any
other personnel the owner or operator
might choose to include when
assembling the third-party audit team.
j. Third-Party Auditor Independence
Criteria
A few commenters, including a
Federal and two local government
agencies, supported the proposed
provisions for ensuring auditor
independence. Some local government
agencies agreed that the proposed
requirement for auditors to have written
policies and procedures to ensure that
personnel comply with the proposed
competency, independence, and
impartiality requirements is
appropriate. Several commenters,
however, warned that the independence
criteria would be difficult to monitor
and enforce. Conversely, many
commenters opposed the third-party
auditor independence criteria, arguing
that the criteria are too restricted and
will limit the availability of third-party
auditors and the quality of the audits.
Availability of third-party auditors.
Some commenters warned that the
proposed auditor independence criteria
would have the unintended
consequence of reducing the quality of
the audits and/or the availability of
sufficiently qualified auditors. A few
commenters suggested that the lack of
ability for employees to participate on
the audit team could lead to an
adversarial relationship, inhibiting the
impartial fact-finding an audit is
supposed to facilitate. Some
commenters stated that the
independence criteria would, in
practice, discourage open and
productive auditor-source dialog, that
auditor unfamiliarity with the audited
facilities could turn the audits into
‘‘check-the-box’’ exercises, and that new
and unfamiliar auditors will feel
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pressure to be ‘‘trigger happy’’ on
finding deficiencies. An industry trade
association suggested that facilities
should be allowed to petition for a
relaxation of these requirements if
auditors cannot be identified.
As part of the SBAR Panel process,
some SERs raised concerns about the
extent of the independence criteria and
suggested this would limit the
availability of qualified auditors.
Specifically, these SERs were concerned
that the independence criteria would
rule out, as third-party auditors, all of
the members of any auditing firm
employing any personnel who
previously worked for or otherwise
engaged in consulting services with the
owner or operator. This was deemed
problematic because, in the SERs’
experience, many, if not most, otherwise
qualifying audit firms hire retired
personnel specifically because the
personnel have sector, company, and/or
facility-specific experience with firms
subject to the RMP rule. Numerous
other commenters observed that
consulting firms perform a wide variety
of work for RMP facilities of which only
a fraction is auditing but the new
restrictions could cause those firms to
exit the auditing market rather than risk
losing their other business lines.
In order to address concerns about the
availability of auditors, EPA modified
the third-party auditor independence
criteria in the final rule to enable more
firms and individuals to qualify as
third-party auditors or third-party audit
team leaders. The final rule
modifications provide additional
flexibility while still ensuring that audit
teams are managed and operated
independently to produce the types of
enhanced audit outcomes commonly
associated with independent auditors
per the literature and evidence
described in the preamble to the
proposed rulemaking and in this
document.
EPA made many significant changes
to the third-party independence criteria.
The most significant modification to the
third-party audit requirements is that
only employees of the independent
third-party audit firm must meet the
independence criteria of § 68.59(c)(2)
and/or § 68.80(c)(2). For third-party
audit teams, the team leader must meet
both the competency and independence
criteria of § 68.59(c) and/or § 68.80(c)
and all other employees of the thirdparty auditor firm that participate on the
team need only meet the independence
criteria. Third-party audit teams may
also include other personnel, such as
consultants or facility employees and
these personnel are not subject to the
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third-party qualification criteria of the
final rule.
EPA also revised the timeframe
within which third-party auditors
cannot provide business or consulting
services to two years. EPA also added
language indicating that if a third-partyfirm employs personnel who have
provided business or consulting services
to the facility within the prescribed
timeframe (i.e. within two years of the
audit) then the third-party audit firm
must ensure that these personnel do not
participate on the audit team.
Additionally, EPA clarified in
regulatory language the circumstances
in which a retired employee may
participate in a third-party audit.
Viewed as a whole, these changes serve
to increase the types of personnel who
may potentially serve as independent
third-party auditors. Therefore, EPA
believes it will be unnecessary for
facility owners or operators to petition
for a relaxation of auditor qualifications.
Criteria limiting past and future
business or consulting services and
future employment. A large number of
commenters specifically opposed the
proposed independence provisions,
particularly the requirement that an
auditor cannot have provided other
consulting services to the owner or
operator in the prior three years and
cannot accept future employment for
three years following submission of the
final audit report. Some commenters
stated that third-party auditing is
entirely unnecessary for RMP facilities
because there is no evidence to believe
that internal auditors working for, or
employed by, facility owners or
operators would deliberately fail to
conduct honest and complete audits
because of their prior, current, or future
financial or employment ties to the
owners or operators. Many commenters
stated that to disqualify auditors who
have performed certain services for the
owner or operator of a facility within
the past three years would disqualify
those auditors who are most familiar
with a source’s operations, and facilities
would be forced to select auditors who
are unfamiliar with the facility and its
processes. Many commenters
emphasized that audit teams should
include personnel with direct, personal
familiarity with the facility (including
facility employees) to ensure effective
RMP compliance audits. Commenters
stated that this could be of concern
particularly for plants with complex
engineered processes requiring sitespecific expertise.
In response to these comments, in the
final rule EPA has modified the threeyear prohibition on auditors providing
prior consulting services to (other than
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auditing services) or subsequently being
employed by the owner or operator to a
two-year prohibition. This prohibition
applies only to employees of the thirdparty auditor firm. Owners or operators
can assemble a third-party audit team
led by a third-party auditor that meets
both the competency and independence
criteria of the final rule. The third-party
audit team can also include other nonindependent personnel such as current
or former employees of the facility or
other persons with prior site-specific
experience. This revision, itself, will
enable a much broader and more diverse
set of auditors to serve on the audit
teams, including knowledgeable facility
personnel, other personnel employed at
different facilities owned by the
regulated company, and a variety of
second or third-party personnel such as
consultants and contractors. Only
employees of the third-party auditor
firm leading the audit team are subject
to the independence criteria of the final
rule and only the individual leading the
third-party audit team is subject to both
the competency and independence
criteria of the final rule.
Retired employees. Commenters and
SERs supported allowing company
retirees to participate on audit teams.
EPA agrees with commenters. EPA
modified the final rule to clearly
identify that retired employees who
otherwise satisfy the third-party auditor
independence criteria may still qualify
as independent if their sole continuing
financial attachments to the owner or
operator are employer-financed or
managed retirement and/or health
plans. This revision clarifies that
owners or operators can hire retired
employees with specialized knowledge
or experience with the source type or
facility to participate in third-party
audits.
Effectiveness of self-audits. Three
trade associations stated that EPA failed
to adequately demonstrate through
statistical or other analyses that the
RMP rule’s self-auditing requirement
was deficient or that independent
auditor certification is necessary. Some
commenters stated that the proposed
third-party auditing requirements and
criteria are unnecessary because the
record does not demonstrate widespread
RMP self-auditing-related fraud. One
association referenced the CSB’s report
on the Texas City refinery accident as
suggesting that management’s failure to
implement prior self-audit
recommendations is of greater concern
than self-audit inadequacy, per se.
While third-party auditing is useful
for minimizing the potential for
fraudulent behavior or reporting, EPA
believes that helping to prevent or
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minimize fraud is but one positive
independent third-party auditing
outcome. In fact, the third-party
auditing requirements are intended to
improve auditing practices and
outcomes by also correcting biases
shown by the literature to be associated
with self-auditing. These biases are
compelling precisely because they are
not the hallmark solely of fraudulent
firms but are exhibited commonly by
entities with no overt or covert
malicious intent to be inaccurate or
unfair in their auditing or reporting.40
EPA’s recent experience demonstrates
that in some cases self-auditing is
deficient. In the preamble to the
proposed rulemaking, EPA referenced
enforcement settlements requiring thirdparty auditing of settlement agreement
implementation and compliance at
facilities handling CAA section 112(r)
chemicals. One such settlement is the
administrative order on consent issued
by Region 1, in 2015, to Mann
Distribution LLC and 3134 Post Road
LLC (Respondents) to address Resource
Conservation and Recovery Act (RCRA)
and CAA section 112(r)(1) (the ‘‘general
duty clause’’) violations found during
an April 4, 2013 inspection at a
chemical distribution facility in
Warwick, Rhode Island. Like the Risk
Management Program requirements,
section 112(r)(1) of the CAA addresses
safe operation and prevention of
accidental releases. Unsafe conditions
found during the inspection included,
among other things, failure to have a fire
suppression system, failure to inspect a
fire alarm, co-location of incompatible
chemicals, and many RCRA generator
violations. The facility also had a prior
history of noncompliance. The order
required Respondents to, among other
things, implement an independent
third-party inspection program. The
Respondents agreed to the program
because they wanted to maximize the
benefits of implementing the
administrative order on consent by
accelerating the improvement of the
culture of compliance and safety at the
facility.
Since the proposed rulemaking was
published, EPA has received and
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40 See,
e.g.: (1) Short, Jodi L., and Michael W.
Toffel, The Integrity of Private Third-party
Compliance Monitoring, Harvard Kennedy School
Regulatory Policy Program Working Paper, No.
RPP–2015–20, November 2015. (Revised December
2015) https://www.hbs.edu/faculty/Pages/
item.aspx?num=50186; (2) Lesley K. McAllister,
Regulation by Third-Party Verification, 53 B.C. L.
Rev. 1 (2012). https://lawdigitalcommons.bc.edu/cgi/
viewcontent.cgi?article=3182&context=bclr; (3)
Esther Duflo et al., Truth-Telling by Third-Party
Auditors and the Response of Polluting Firms:
Experimental Evidence From India, 128 Q.J. Econ.
1499, 1499 (2013) https://qje.oxfordjournals.org/
content/128/4/1499.abstract.
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reviewed the Mann independent thirdparty inspection team’s audit reports.
These reports state that the third-party
team found several compliance and
safety issues the facility owner and
operator had not independently found
or corrected. The suite of audits
uncovered and tracked the correction of
these deficiencies. EPA has also
received feedback from a facility
representative and its third-party
auditor about the program. All of the
involved parties—EPA, facility
representative, and the third-party
auditor—agreed that the new and
independent third-party auditing
required pursuant to the enforcement
order was beneficial for both correcting
specific deficiencies and improving a
culture of compliance. The suite of four
third-party inspections improved the
company’s hazardous materials
management plan, plan implementation,
and emergency response program. As of
March 2016, corrections to issues
identified by the third-party auditors
produced results including safer storage
of chemicals that are oxidizers,
improved integrity testing and
maintenance of chemical storage tanks;
better emergency egress, training, and
coordination with the fire department;
and improvements in container storage
(such as better labeling and more aisle
space). After a year of audits, the audit
team leader provided some constructive
suggestions about how EPA could
modify third-party audit requirements
in the future. For example, she felt that
one of the order’s auditor independence
criterion (a five-year ban on future work
with the company) was excessive as
such a requirement, in light of New
England’s contracting manufacturing/
industrial market, might serve as a
disincentive to the participation as
third-party auditors by highly qualified
professionals and firms. Also, although
this order did not require that the audit
team include a PE, the auditor said she
was aware that EPA was considering
requiring PEs for future audits and
believed that such a requirement would
be unnecessary because good practice
suggests that team make-up and
qualifications should be determined on
a case-by-case basis.
EPA agrees with the commenters
stating that auditors with facilityspecific experience can contribute
insights that independent auditors
lacking such experience would be
unlikely to contribute. EPA addressed
this comment in the final rule by,
among other things, modifying the final
rule to allow owners or operators to
include non-independent employees,
contractors, or consultants with facility-
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4623
specific experience on the third-party
auditing teams.
EPA continues, however, to believe
that the ‘‘fresh eyes’’ and perspectives
that third-parties contribute to audit
teams support the approach in this rule
to third-party auditing for the small
subset of RMP facilities that have RMP
reportable accidents or conditions at
their stationary sources that could lead
to an accidental release of a regulated
substance. In this context, EPA has
assessed available empirical research
suggesting why independent auditors
lacking prior facility-specific experience
can actually produce better audit
outcomes than personnel with prior
site-specific experience. This research
suggests independent personnel can
audit the facilities they monitor with
‘‘fresh eyes’’ and thus be more likely to
identify issues of concern. While the
research that follows primarily involves
government inspectors, EPA believes
that the findings correlate to designing
effective third-party auditing programs.
One such study concerns the
relationship of inspector experience and
product recalls in the medical device
industry.41 The study’s authors explain:
Plant inspections enable supply chain
partners to manage quality risk in global
supply chains. However, surprisingly little
research examines the behavioral aspects of
inspectors’ work. Drawing on insights from
the experience, learning, and complacency
literatures, we examine the how well plant
inspection outcomes predict future recalls
and analyze the effect of inspector experience
on both the information content of plant
inspections as well as the prevalence of
product recalls. Using secondary data
spanning a 7-year period in the medical
device industry and a recurrent event Cox
Proportional Hazard model, our results show
that inspection outcomes contain information
and hence predict future product recalls, and
that this relationship is moderated by
inspector experience. . . . [T]he hazard of
recalls at a plant increases if the same
inspector continues to inspect the plant,
independent of the inspection outcome.
Recall hazard increases by 48% the second
time an inspector visits a plant, and 63% by
the third visit. These results indicate the
need to rotate inspectors among plants and
have important implications for managers,
regulatory agencies, and theory.
The authors’ views on the drivers for
these outcomes are informative.
Although significant literature exists
indicating that sending the same auditor
or inspector to repeatedly inspect a
facility can lead to familiarity, that
41 Ball, George and Siemsen, Enno and Shah,
Rachna; Inspector Experience and Product Recalls
in the Medical Device Industry (June 2, 2014).
Available at https://ssrn.com/abstract=2445022,
https://dx.doi.org/10.2139/ssrn.2445022, or https://
papers.ssrn.com/sol3/papers.cfm?abstract_
id=2445022.
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weakens an auditor’s independence and
compromises audit outcomes,42 these
were not the above study’s primary
findings. Rather, the authors found that
the worsening inspection outcomes over
time were likely primarily due to
inspector complacency. In the authors’
words,
The stale, routine nature of the job, and the
familiarity which comes from repeat visits to
a site, can lead to complacency and lower the
information contained in an inspection, even
when the investigator has no clear incentive
to ‘go easier’ on an inspection site.
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These complacency effects ‘‘may
outweigh the benefits [such repeat visits
have on inspector] learning.’’ Another
analysis of 426,831 unannounced
inspections by state government
inspectors from July 2003 through
March 2010 found that new inspectors
tend to have ‘‘fresher eyes’’ in their first
visit to a restaurant, reporting 12.7–
17.5% more violations than the second
visit of a repeat inspector, and that this
effect is more pronounced when the
previous inspector had a longer
relationship with the restaurant.43
Findings such as these, and the policy
implications that flow from such
studies, address human behavioral and
psychological influences that appear to
be common to inspection and auditing
regimes. Thus, although not expressly
required by this rule, EPA encourages
owners or operators, when assembling
both third-party audit teams and
conducting self-audits under the RMP
rule, to include on their teams a mix of
personnel previously familiar, and
unfamiliar, with the specific facilities
they are tasked with auditing.
Finally, EPA agrees with commenters
that it is critical that facility owners and
operators implement corrective actions
to address findings from compliance
audits. Therefore, the final rule requires
the owner or operator to certify in the
findings response report that
deficiencies are being corrected. As an
additional measure to ensure
accountability, EPA is also requiring a
copy of the findings response report and
schedule to implement deficiencies to
be submitted to the auditing committee
42 See, e.g., Abigail Brown, The Economics of
Auditor Capture, Edmond J. Safra Center for Ethics,
Harvard University (Nov. 8, 2011) at https://
abigailbrown.files.wordpress.com/2009/08/auditorcapture-111108.pdf (‘‘[T]here does not need to be
an explicit exchange of bribes to sustain a collusive
equilibrium, suggesting that social norms and
psychological biases reinforce rational action and
allow profitable collusion to occur with little
conscious intent.’’ Id. at Abstract).
43 Ginger Zhe Jin & Jungmin Lee, A Tale of
Repetition: Lessons from Florida Restaurant
Inspections, National Bureau of Eco. Research
Working Paper No. 20596 (Oct. 2014). https://
www.nber.org/papers/w20596.
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of the Board of Directors or other
comparable committee or individual, if
applicable.
Validity of examples of third-party
audits. Commenters sought to criticize
the many examples of third-party
auditing provided by EPA in the
preamble to the proposed rulemaking,
including mandatory and voluntary
programs by regulators and industry
trade associations, on the grounds that
these other regulations and programs
operate in a different context from that
of the RMP rule (i.e., that the literature
and empirical data on the effectiveness
of third-party auditing cited by EPA do
not specifically address regulatory
compliance auditing at RMP facilities).
These commenters stated that most or
all of EPA’s examples of other Federal,
state, and voluntary or industry
independent auditing do not relate to
RMP rule compliance, and therefore
limit the transferability of these
programs’ design features and outcomes
to the RMP context. The associations
further stated that there is no evidence
showing:
• A systemic problem with RMP
facilities’ self-audits or that employees
or contractors act unethically or are
biased;
• A lack of auditor independence
creates bias leading to accidents;
• Third-party audits would have
successfully prevented past accidental
releases; or
• The root causes of a significant
number of past accidents at RMP
facilities were deficient self-audits.
EPA disagrees with commenters.
Because RMP facilities were not
previously required to have third-party
compliance audits, statistically valid
outcome data specifically on RMP rule
third-party auditing does not currently
exist. As EPA has described, however,
there is a considerable and growing
body of literature and empirical data on
the effectiveness of third-party auditing,
generally. These literature and data
occur in many contexts that involve a
diverse set of statutes and voluntary
standards. In fact, some of these
contexts are similar to RMP auditing.
In the preamble to the proposed
rulemaking, EPA presented many
examples of Federal and state agencies
and trade association third-party
verification programs. Like the RMP
rule, some of those programs are
expressly described by their managers
as designed to improve regulatory
compliance, prevent or reduce risks, or
improve safety at the same or similar
facility types and operations as are
regulated by the RMP rule. These
programs reflect industry recognition
that third-party auditing does, in fact,
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produce better outcomes relative to selfauditing in a variety of settings. Such
programs include: 44
• Responsible Care. This program is
described by ACC as identifying, and
acting to address potential hazards and
risks associated with their products,
processes, distribution and other
operations.45 Responsible Care’s
Guiding Principles include ‘‘mak[ing]
continual progress toward a goal of no
accidents, injuries or harm to human
health and the environment from
products and operations and openly
report health, safety, environmental and
security performance.’’ 46 The
Responsible Care management system
process includes mandatory
certification, by auditors described by
ACC as accredited and independent, to
ensure the program participants have a
structure and system in place to
measure, manage and verify
performance.47 The Responsible Care
Web site provides, ‘‘A key part of the
Responsible Care Management System
process is mandatory certification by an
independent, accredited auditor.’’ 48
• The API Process Safety Site
Assessment Program (PSSAP).
According to API, the PSSAP ‘‘is
focused on higher risk activities in
petroleum refining and petrochemical
facilities. This program primarily
involves the assessment of a site’s
process safety systems by independent
and credible third-party teams of
industry-qualified process safety expert
assessors.’’ 49 Using industry-developed
protocols, API describes the process
safety site assessments as evaluating the
quality of written programs and
effectiveness of field implementation for
the following process safety areas that
44 EPA has not formally evaluated these programs
and standards or their outcomes. This discussion is
not a formal Agency review or endorsement.
45 ACC. 2012. Responsible Care Product Safety
Code. https://responsiblecare.americanchemistry.
com/Product-Safety-Code/.
46 ACC Responsible Care Guiding Principles.
https://responsiblecare.americanchemistry.com/
ResponsibleCare/Responsible-Care-ProgramElements/Guiding-Principles/.
47 Certification must be renewed every three
years, and companies can choose one of two
certification options. RCMS® certification is
intended to verify that a company has implemented
the Responsible Care Management System.
RC14001® certification combines Responsible Care
and ISO 14001 certification. See https://responsible
care.americanchemistry.com/Responsible-CareProgram-Elements/Management-System-andCertification and https://responsiblecare.american
chemistry.com/Responsible-Care-ProgramElements/Process-Safety-Code/Responsible-CareProcess-Safety-Code-PDF.pdf.
48 ACC Responsible Care Management System.
https://responsiblecare.americanchemistry.com/
Management-System-and-Certification/.
49 API. 2015. PSSAP. https://www.api.org/∼/
media/Files/Certification/PSSAP/PSSAP-Brochure.
pdf?la=en.
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will be evaluated: Process Safety
Leadership; MOC; Mechanical Integrity
(focused on fixed equipment); Safe
Work Practices; Operating Practices;
Facility Siting; Process Safety Hazards;
and HF Alkylation/RP 751.50
• Center for Offshore Safety (COS).
This strategy for promoting safety and
protection of the environment includes
third-party auditing and certification of
the COS member company’s SEMS and
accreditation of the organizations (Audit
Service Providers) providing the audit
services. The Center serves the U.S.
offshore oil and gas industry with the
purpose of adopting standards of
excellence to ensure continuous
improvement in safety and offshore
operational integrity. The third-party
audits are intended to ensure that COS
member companies are implementing
and maintaining Safety and
Environmental Management Systems
(SEMS) throughout their deepwater
operations.51 COS states expressly that
‘‘the highest level of safety for offshore
drilling, completions, and operations [is
promoted through] independent thirdparty auditing and certification.’’ 52
• ChemStewards®. ChemStewards is
a SOCMA program intended to promote
continuous performance improvement
in batch chemical manufacturing. The
program offers a three-tiered approach
to participation. Each tier includes a
third-party verified management
system.53 On its Web site, SOCMA
describes the environmental benefits of
the program as including improving
environmental performance, decrease
releases and waste disposal costs, and
positioning members to meet current
and future compliance requirements.54
The associated training materials
explain the on-site audit elements of the
third-party verification program.55
Additionally, the supporting literature
and data described by EPA in the
proposed rulemaking preamble remain
relevant to RMP compliance auditing,
notwithstanding the varied contexts
they describe, because such literature
addresses cross-cutting human biases
and behaviors, common to all auditor
and audit types, that can be addressed
50 API. 2015. PSSAP. https://www.api.org/
certification-programs/process-safety-siteassessment-programs.
51 COS. 2013. See https://www.centerforoffshore
safety.org/auditInfo.html.
52 COS. 2015. See https://www.centerforoffshore
safety.org/About.
53 SOCMA. 2015. See https://www.socma.com/
ChemStewards/.
54 SOCMA, 2016. See Benefits of Implementing
ChemStewards®. https://www.socma.com/chem
stewards/about/benefits.
55 SOCMA. See https://www.socma.com/Portals/0/
Files/ChemStewards/ChemStewards_101_
Training.pdf.
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or corrected through independent thirdparty auditing.56 EPA thus finds that the
state of the science, evidence, and data
on the effectiveness of independent
third-party auditing programs supports
requiring independent third-party
audits for RMP facilities with accidental
releases or conditions that could lead to
an accidental release of a regulated
substance.
k. Third-Party Audit Report
Draft reports. EPA received numerous
comments regarding the proposed thirdparty audit reporting requirements.
While no commenters objected to the
requirement to prepare an audit report,
most commenters opposed the proposed
requirements to submit draft and final
reports to the implementing agency.
Many commenters felt that a
requirement to submit draft reports
before they have been vetted by internal
operations and management teams
could have the unintended consequence
of incomplete or inaccurate information
being distributed. Some of the
commenters added that the owner or
operator should be able to ensure that
the audit report does not contain
confidential business information.
Finally, some commenters stated that
the proposed requirement to document
all changes made by the owner or
operator to audit report drafts would
chill communications and information
exchange during audits.
EPA agrees with commenters. The
final rule requires the third-party
auditor to prepare an audit report and
provide it to the owner or operator, but
does not require that the draft or final
reports be submitted to the
implementing agency. However, the
third-party auditor must summarize in
the audit report any significant revisions
between draft and final versions of the
report.
Submitting reports to the
implementing agency. Many
commenters, including industry trade
associations and facilities, objected to
the proposed requirement that third
parties submit their reports to the
implementing agency at the same time,
or before, the reports are sent to the
56 See, esp.: (1) Short, Jodi L., and Michael W.
Toffel, The Integrity of Private Third-party
Compliance Monitoring, Harvard Kennedy School
Regulatory Policy Program Working Paper, No.
RPP–2015–20, November 2015. (Revised December
2015) https://www.hbs.edu/faculty/Pages/item.aspx
?num=50186; (2) Lesley K. McAllister, Regulation
by Third-Party Verification, 53 B.C. L. Rev. 1 (2012).
https://lawdigitalcommons.bc.edu/cgi/viewcontent.
cgi?article=3182&context=bclr; (3) Esther Duflo et
al., Truth-Telling by Third-Party Auditors and the
Response of Polluting Firms: Experimental
Evidence From India, 128 Q.J. Econ. 1499, 1499
(2013) https://qje.oxfordjournals.org/content/128/4/
1499.abstract.
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4625
source. These commenters felt that this
would prevent facilities from being
allowed to correct factual errors or
present evidence that the auditors either
missed or were not aware of, which
could markedly change the audit’s
recommendations. Some commenters
who opposed distribution of audit
reports to the implementing agency
warned of the potential release of
confidential business information.
EPA agrees with commenters and
deleted provisions that require the
third-party auditor to submit audit
reports to the implementing agency.
Attorney-client communications. EPA
received several comments regarding
the proposed limitation on claiming the
audit report and related records as
attorney-client communications or
attorney work products. One commenter
agreed with EPA that the audit report
should not be protected from disclosure
under the attorney-client privilege.
Many commenters opposed EPA’s
proposal to prohibit companies from
asserting attorney-client privilege and
attorney work product privilege over
third-party audits and related
documents. The commenters argued
that EPA lacked authority to do this and
that these privileges are essential for
purposes of legal representation. One
commenter stated that attorney-client
privilege is a long-established commonlaw rule of evidence, and asserted that
any attempt to abrogate it across the
board is likely a violation of the Sixth
Amendment. Similarly, another
commenter stated that the proposed
limitations on attorney-client privilege
seem contrary to due process and legal
rights that should be afforded the owner
or operators of the facility.
It remains EPA’s position, as stated in
the preamble to the proposed
rulemaking, that with respect to the
attorney work product privilege, the
audit report and related records are
produced to document compliance.
Audit reports and related records are
similar to other documents prepared
pursuant to RMP rule requirements (e.g.,
process safety information, PHAs,
operating procedures) and are not
produced in anticipation of litigation.
They are analogous to work or
management practice records that show
a regulated operation was performed.
With respect to the attorney-client
communication privilege, the thirdparty auditor is arms-length and
independent of the stationary source
being audited. The auditor lacks an
attorney-client relationship with
counsel for the audited entity.
Therefore, in EPA’s view, neither the
audit report nor the records related to
the audit report provided to the third-
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party auditor, including documents
originally prepared with assistance or
under the direction of the audited
source’s attorney, should be considered
attorney-client privileged. Nevertheless,
EPA recognizes that the ultimate
decision makers on questions of
evidentiary privileges are the courts.
Therefore, this rule does not contain a
specific regulatory provision prohibiting
assertion of these privileges.
l. Findings Response Report,
Timeframe, and Response to Audit
Findings
EPA received several comments
relating to the proposed requirement for
the owner or operator to develop a
findings response report within 90 days
of receiving the final audit report, and
to provide the report to the
implementing agency and the owner or
operator’s audit committee of the Board
of Directors. EPA also received
comments opposing various aspects of
the proposed requirements for findings
response reports.
Timeframe. Some commenters
supported these proposed requirements.
One commenter urged EPA to shorten
the required reporting from 90 days to
30 days, arguing that deficiencies in
compliance indicate a risk of a
catastrophic release that could harm the
facility, its employees, and the
community. The commenter reasoned
that 30 days is enough time to review
the audit report and develop a schedule
to address deficiencies.
Other commenters objected to the
proposed timeframe for preparing and
submitting the findings response report,
stating that 90 days provides for an
insufficient timeframe for preparing the
report. A few commenters
recommended a six-month timeframe.
One commenter asserted that EPA has
not demonstrated that a 90-day period
to develop a findings response report is
achievable. As an alternative to
extending the timeframe for all
facilities, a few commenters urged EPA
to consider allowing facilities to obtain
extensions as needed to adequately
address the concerns raised by thirdparty auditors.
EPA is finalizing the requirement that
the owner or operator prepare a findings
response report as soon as possible, but
no later than 90 days after receiving the
final audit report as proposed. EPA
believes this timeframe is appropriate
for the owner or operator to consider the
findings of the audit report and
determine a response to each of the
audit’s findings. This approach allows
the owner or operator an opportunity to
establish a schedule to implement
corrective actions that can extend
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beyond the 90-day period for
developing the findings response report
and balances the need to promptly
respond to the audit findings. EPA notes
that, in many instances, an owner or
operator may receive prior information
about the audit’s findings before
receiving a final audit report,
particularly when the third-party audit
team includes facility personnel. This
will give the owner or operator
additional time to consider its
responses.
Submitting findings response report to
implementing agency. Some
commenters opposed the proposed
requirement to submit a findings
response report to the implementing
agency. One such commenter stated that
EPA has not demonstrated a need for
universal submission of an action plan
to respond to audit findings and
schedule. Commenters also expressed
legal concerns about the findings
response report. These commenters
raised concerns about not being able to
dispute purported violations or
deficiencies identified by third-party
auditors. Some commenters asserted
that refusing to afford companies the
opportunity to dispute audit findings
raises fundamental due process
concerns.
EPA agrees with the commenters and
has eliminated the requirement to
submit findings response reports to the
implementing agency in the final rule.
The audit report, findings response
report and related records must be
retained at the stationary source in
accordance with the recordkeeping
requirements in §§ 68.59(g) and
68.80(g).
Eliminating the requirement to submit
the findings response report to the
implementing agency also responds to
commenters legal concerns. The owner
or operator can determine an
appropriate response to each of the
audit report findings. This is similar to
existing self-compliance audit
requirements for the owner or operator
to promptly determine and document an
appropriate response to each of the
findings of the compliance audit.
In addition, there is no need for a
process to dispute findings as the
relevant requirement in the final rule for
each of the findings in the audit report
is to determine an appropriate response.
In determining an appropriate response,
owners or operators may follow EPA’s
existing guidance for addressing PHA
team findings and recommendations,
which is based on OSHA’s 29 CFR
1910.119, Process Safety Management of
Highly Hazardous Chemicals—
Compliance Guidelines and
Enforcement Procedures for resolving
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such findings.57 Under these guidelines,
EPA considers an owner or operator to
have resolved a finding or deficiency
when the owner or operator either has
adopted or implemented the associated
recommendations or has justifiably
declined to do so. An owner or operator
can justifiably decline to adopt a
recommendation where the owner or
operator can document, in writing and
based upon adequate evidence, that one
or more of the following conditions is
true:
• The analysis upon which the
recommendation is based contains
material factual errors;
• The recommendation is
unnecessary to protect public health
and safety or the health and safety of the
owner or operator’s employees, or the
employees of contractors;
• An alternative measure would
provide a sufficient level of protection;
or
• The recommendation is infeasible.
Where a recommendation is rejected,
the owner or operator must
communicate this to the audit team and
expeditiously resolve any subsequent
recommendations of the team. Provided
that the owner or operator addresses the
audit report’s findings by implementing
the findings or by justifiably declining
to do so, the owner or operator complies
with the requirement. If an
implementing agency concludes that a
justification is inadequate and brings an
enforcement action regarding this
requirement, then the owner or operator
may dispute the enforcement action
through the normal adjudication
process.
m. Owner or Operator Certification to
Findings Response Report
Certification burden. EPA received
comments regarding the certification to
the findings response report. A few
commenters opposed the proposed
certification requirement. Some
commenters argued that the certification
requirement increases the regulated
community’s burden, but provides no
corresponding benefit. Other comments
urged EPA to incorporate the
‘‘reasonable inquiry’’ concept from Title
V compliance certifications into the
proposed certification framework. These
commenters described the ‘‘reasonable
57 See page 7–7 of EPA’s General Guidance on
Risk Management Programs for Chemical Accident
Prevention (40 CFR part 68), EPA–550–B–04–001,
April 2004 https://www.epa.gov/rmp/guidancefacilities-risk-management-programs-rmp; and
replacement pages B–21 and B–22 of OSHA 29 CFR
1910.119, Process Safety Management of Highly
Hazardous Chemicals—Compliance Guidelines and
Enforcement Procedures CPL 2–2.45A CH–1,
September 13, 1994 https://www.osha.gov/OshDoc/
Directive_pdf/CPL02-02-045_CH-1_20150901.pdf.
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inquiry’’ concept as requiring
certification based on ‘‘information and
belief formed after reasonable inquiry.’’
The commenters argued that this was
necessary because a senior official
signing a certification could not be
expected to have or obtain personal
knowledge of all the facts potentially
relevant to the findings response report.
Similarly, a facility encouraged EPA to
coordinate the certification statement in
this rule with the certification statement
that is already required under CAA Title
V. One commenter stated that EPA’s
rules regarding self-audits impose a less
stringent certification requirement, and
recommended that a less stringent
standard may be appropriate here, too,
if the third-party compliance audit
provisions are finalized.
In this rule, EPA is requiring a senior
corporate officer, or an official in an
equivalent position, to certify in the
findings response report that:
• He or she engaged a third-party to
perform or lead an audit team to
conduct a third-party audit in
accordance with the requirements of 40
CFR 68.59 or 68.80,
• The attached RMP compliance
audit report was received, reviewed,
and responded to under the senior
officer’s direction or supervision by
qualified personnel, and
• Appropriate responses to the
findings have been identified and
deficiencies were corrected, or are being
corrected, consistent with the
requirements of subparts C or D of 40
CFR part 68.
EPA believes these requirements and
the associated certification are
consistent with equivalent certification
requirements in many EPA regulations,
including in the CAA Title V
regulations (40 CFR 70.5(d).58)
EPA agrees that senior corporate
officials do not necessarily have high
levels of technical expertise; however,
these officials and entities include key
managers responsible for establishing
internal corporate accountability and
overseeing corporate prioritization,
budgeting, and operations. Indeed, the
Security and Exchange Commission
(SEC) requires other specified
documents to be provided to such
individuals, committees, and boards for
similar reasons.59 Finally, EPA believes
58 ‘‘(d) Any application form, report, or
compliance certification submitted pursuant to
these regulations shall contain certification by a
responsible official of truth, accuracy, and
completeness. This certification and any other
certification required under this part shall state
that, based on information and belief formed after
reasonable inquiry, the statements and information
in the document are true, accurate, and complete.’’
59 Under Section 3(a)(58) of the Exchange Act as
added by Section 205 of the Sarbanes-Oxley Act,
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that the certification will minimize
corporate failures to properly address
and implement compliance audit
findings and recommendations.
Adopting a less stringent standard
would not be appropriate. EPA expects
that the senior corporate official
certification of the audit findings will
improve facility and public confidence
that third-party audit report findings
and recommendations are promptly and
properly addressed.
Senior corporate officer or equivalent
official. Comments were received
requesting clarification of the terms
‘‘senior corporate officer, or official in
an equivalent position.’’ Some
commenters recommended that EPA
incorporate the ‘‘responsible official’’
definition from the CAA’s Title V
operating permit program for major
stationary sources which allows for
certification by corporate leadership or
a ‘‘duly authorized representative’’
appointed by corporate officials.
One commenter stated that the
certification requirement risks
infringing on the senior corporate
official’s Fifth Amendment privilege
against self-incrimination. The
commenter stated that the Supreme
Court has held that the privilege
protects against compulsory disclosures
to the government when those
disclosures have ‘‘the direct and
unmistakable consequences of
incriminating’’ the disclosing party, and
concluded that the proposed
certification requirement may compel
precisely those sorts of disclosures. The
commenter went on to state that the
certification necessarily admits the
existence of ‘‘deficiencies’’ which can
only be interpreted as violations of the
CAA and which could certainly be a
significant link in a chain of evidence
tending to establish guilt in a criminal
case. One commenter also argued that
the certification requirement raises First
Amendment concerns by compelling
speech that does not serve a sufficient
government interest to avoid running
afoul of the right to free speech because
it is unclear what government interest
the certification advances and the
relevant section of the rule is not
narrowly tailored to that interest.
the term audit committee is defined as ‘‘[a]
committee (or equivalent body) established by and
amongst the board of directors of an issuer for the
purpose of overseeing the accounting and financial
reporting processes of the issuer and audits of the
financial statements of the issuer’’ (if no such
committee exists with respect to an issuer, the
entire board of directors of the issuer). See
Securities and Exchange Commission, 17 CFR
240.10A–3—Listing standards relating to audit
committees (68 FR 18818, April 16, 2003, as
amended at 70 FR 1620, January 7, 2005; 73 FR 973,
January 4, 2008).
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EPA disagrees with this
recommendation to allow delegation of
the certification to a duly authorized
representative. The certification
indicates that the compliance audit
report was received, reviewed, and
responded to under the senior corporate
officer’s direction or supervision by
qualified personnel. Similar to the
requirement to submit the findings
response report to the audit committees
of the Board of Directors, a senior
corporate official ensures accountability
and overseeing corporate prioritization,
budgeting, and operations.
Furthermore, the language of the
certification cites the actions that are
taken by the owner or operator pursuant
to these requirements, and includes,
among other things, a statement that
based on personnel knowledge and
experience, or inquiry of personnel
involved in evaluating the report
findings and or inquiry of personnel
involved in evaluating the report
findings and determining appropriate
responses to the findings, the
information submitted herein is true,
accurate, and complete. This language is
equivalent to the language in
certifications that support submissions
under Title V of the CAA. EPA
continues to believe that it is important
for a senior corporate official, or an
official in an equivalent position, sign
such a certification, ensuring that the
owner or operator is aware of the
findings and responses, and will be
correcting the deficiencies, pursuant to
these requirements. For smaller entities
without corporate officials, the official
in an equivalent position for purposes of
this requirement may include the owner
or operator, or designated
representatives of the owner or operator,
including facility manager, operations
manager, or another official at or above
that level. Regarding comments
concerning self-incrimination in
connection with the certification
requirement, the certification does not
contain an acknowledgement of a
violation. It merely describes the actions
taken by the owner or operator pursuant
to the third-party audit requirements,
and states that the information
submitted is true, accurate, and
complete. The certification and report
are not required to be automatically
submitted to the implementing agency.
n. Schedule Implementation
EPA received comments supporting
the proposed requirement for owners
and operators to ‘‘promptly’’ address
deficiencies noted in audit reports. A
few commenters stated that there should
be no specific timeframe for addressing
deficiencies identified during a third-
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party audit, reasoning that there will be
a wide variety of possible site-specific
actions that an owner or operator may
take to address audit findings. Another
commenter believed it was appropriate
to require ‘‘prompt’’ correction of
deficiencies, but encouraged EPA to
provide guidelines on what would be
considered ‘‘prompt’’ action.
Some commenters recommended
specific timeframes for addressing
deficiencies. One commenter
recommended that deficiencies be
corrected ‘‘promptly’’ and no later than
six months absent a written extension
from EPA. A few commenters
recommended that facilities be required
to promptly implement corrective
actions and that deficiencies be
addressed within 18 months. However,
some of these commenters stated that
facilities should be given the
opportunity to request an extension, if
needed, from the implementing agency.
Another commenter recommended that
facilities be given 24 months to correct
deficiencies after the facility has
identified an appropriate response, with
the deficiencies presenting the highest
risk of injury being addressed first.
One commenter recommended that
EPA allow stationary sources to develop
a reasonable schedule for correcting
audit findings that would be based on
the types of audit findings and the
resulting efforts to implement them
appropriately, rather than at a pace that
may impede sound and sustainable
implementation processes. One
commenter stated that the proposal does
not account for the likelihood that plans
and schedules for addressing
deficiencies may need to change. To
account for needed changes, the
commenter recommended that EPA
should clarify that the details of the
schedule are not binding.
EPA disagrees with commenters that
suggested incorporating a prescribed
schedule for addressing findings in the
final rule and we are finalizing the
schedule implementation provision of
§§ 68.59(f)(2) and 68.80(f)(2) as
proposed. The owner or operator’s
third-party audit findings response
report must include ‘‘a schedule for
promptly addressing deficiencies’’ but
does not prescribe a specific timeframe
or due dates by which the deficiencies
must be addressed. Thus, under the
final rule, the owner or operator must
exercise best judgement to determine
how, and when, to prioritize and
address actions, consistent with the
normal definition of ‘‘promptly’’ as
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meaning quickly, without delay.60 EPA
finds that this approach best provides
the flexibility owners or operators will
need to address a potentially very wide
range of deficiencies and other findings
noted in third-party audit reports. This
allows the facility owner or operator to
develop a reasonable schedule for
correcting audit findings that would be
based on the types of audit findings and
the resulting efforts to implement them
appropriately.
EPA also disagrees with commenters’
suggestions to request a schedule
extension from the implementing
agency. The implementing agency will
not receive a copy of the final audit
report or findings response report and
therefore it is inappropriate to request
an extension to address deficiencies
identified in the findings response
report. In the event that a schedule must
change due to unforeseen
circumstances, EPA recommends that
the owner or operator document the
reasons for the change and update the
schedule to reflect revised dates.
o. Submitting Reports to the Board of
Directors
EPA received comments both
supporting and opposing the proposed
requirement to submit the audit report
to the audit committee of the Board of
Directors. Those in support reasoned
that it will make the Board of Directors
aware of the deficiencies, and noted that
the requirement will allow the Board of
Directors the opportunity to properly
budget for corrective actions.
Several commenters, including
facilities and industry trade
associations, opposed the proposed
requirement to submit the audit report
to the Board of Directors, arguing that it
is generally unnecessary or
inappropriate to do so. These
commenters stated that the requirement
would unduly constrain facilities that
may have other processes to involve
facility leadership in responding to
findings from third-party audits.
Similarly, an industry trade association
reasoned that this requirement subverts
company policy established under the
rule’s management provisions and that
the program would be most effective if
each company is allowed to determine
the most appropriate chain of command
and reporting. The commenter also
warned that such a requirement could
set a precedent for other regulatory
programs, which could result in Boards
of Directors receiving a deluge of
technical information that they do not
60 See definition of ‘‘promptly,’’ Cambridge
English Dictionary, at https://dictionary.cambridge.
org/us/dictionary/english/promptly.
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have time to address and that they are
in no position to interpret.
One commenter recommended that
EPA provide definitions for Board of
Directors and audit committee to avoid
ambiguity. The commenter also
recommended that EPA specify a
timeframe for this report to be submitted
to the Board’s audit committee.
Furthermore, the commenter urged EPA
to address how this requirement would
be documented as completed or what
documentation would be required to
demonstrate that the owner or operator
does not have an audit committee or
comparable committee.
Boards of Directors and their audit
committees play an important role in
establishing internal corporate
accountability and overseeing corporate
prioritization, budgeting, and
operations. EPA believes that providing
the audit committee of the Board of
Directors with third-party audit findings
will ensure the committees and their
Boards of Directors are aware of any
deficiencies and have the opportunity to
properly budget for any required
corrective actions in a timely manner.
EPA expects that this approach will
improve facility and public confidence
that third-party audit report findings
and recommendations are promptly and
properly addressed.
Therefore, the final rule requires the
owner or operator to immediately, upon
its completion, provide to the audit
committee of the Board of Directors, or
other comparable committee or
individual, if applicable a copy of the:
• Findings response report; and
• Implementation schedule to address
deficiencies identified in the audit
findings response report.
EPA does not agree that we should
define ‘‘Board of Directors’’ and ‘‘audit
committee.’’ Facility owners or
operators should consider their
corporate structure to determine if there
is, in fact, a committee or individual
that may serve to oversee auditing and
compliance oversight. The closing
clause in §§ 68.59(e)(3) and 68.80(e)(3),
‘‘if applicable,’’ replaces the
corresponding language in the proposed
rulemaking, ‘‘if one exists.’’ ‘‘If
applicable,’’ in this context, is intended
to clarify that owners or operators not
otherwise required by law to have an
audit committee of the Board of
Directors or that have not, otherwise,
established or designated a comparable
committee or individual, are not subject
to the requirements in §§ 68.59(e)(3) and
68.80(e)(3).
Finally, in response to concerns about
demonstrating compliance with this
requirement, EPA recommends that the
facility document how the owner or
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operator complied with this
requirement and maintain that
documentation with the findings
response report. This may include
identifying who received a copy of the
report and the date it was provided. If
there is no audit committee of the Board
of Directors or a comparable committee
or individual, then the owner or
operator should consider documenting
that no committee or individual exists.
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p. Third-Party Audit Recordkeeping
Some commenters supported the
proposed third-party audit
recordkeeping requirements. However,
some commenters opposed the
requirement to retain copies of the draft
audit report. A few commenters
opposed the requirement that records be
retained at the stationary source.
EPA agrees with commenters that
opposed maintaining draft audit reports.
Therefore, EPA is not finalizing the
proposed requirement in §§ 68.59(e)(2)
and 68.80(e)(2) for owners or operators
to retain copies of all draft third-party
audit reports. The final rule requires
that the owner or operator retain as
records certain documents at the
stationary source, including the two
most recent final third-party audit
reports, related findings response
reports, documentation of actions taken
to address deficiencies, and related
records. The final audit report must
include a summary of any significant
revisions between draft (if any) and final
versions of the report.
The final rule also requires the owner
or operator to retain records at the
stationary source in order to ensure that
records are readily available to
stationary source staff to review and
utilize and for implementing agency
inspectors to access during site
inspections. These documents may be
retained electronically as long as they
are immediately and easily accessible to
the owner or operator and the owner or
operator retains the signed original
documents, where appropriate.
q. Other Comments
One commenter encouraged EPA to
correct what it described as a
grammatical error within §§ 68.58(a)
and 68.79(a). Specifically, the
commenter urged EPA to correct the
plural reference to the owner or operator
by changing the word ‘‘they’’ to ‘‘it’’ to
make it clear that only one of the
entities needs to conduct an audit.
EPA is not making this recommended
revision. Both the owner and operator
are responsible to evaluate compliance
with the prevention program
requirements of the rule and we do not
believe that this language has been
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confusing. However, to clarify, we do
agree that as long as the audit is
performed, only one of the entities
needs to have conducted the audit.
C. Safer Technology and Alternatives
Analysis (STAA)
1. Summary of Proposed Rulemaking
EPA proposed to modify the PHA
provisions in § 68.67 by adding
paragraph (c)(8) to require certain
industry sectors to conduct a safer
technology and alternatives analysis
(STAA) and to evaluate the feasibility of
any inherently safer technology (IST)
identified. EPA proposed to limit the
requirement to owners or operators of
facilities with Program 3 regulated
processes in North American Industrial
Classification System (NAICS) codes
322 (paper manufacturing), 324
(petroleum and coal products
manufacturing), and 325 (chemical
manufacturing).
In the proposed rulemaking, EPA
specified that the STAA would
consider, in the following order of
preference:
• IST or inherently safer design (ISD),
• Passive measures,
• Active measures, and
• Procedural measures.
EPA further indicated that the owner
or operator would be able to evaluate a
combination of these risk management
measures to reduce risk at the process.
EPA also proposed to add several
definitions that relate to an STAA in
§ 68.3. EPA proposed active measures to
mean risk management measures or
engineering controls that rely on
mechanical, or other energy input to
detect and respond to process
deviations. Some examples of active
measures included alarms, safety
instrumented systems, and detection
hardware (such as hydrocarbon
sensors).
EPA proposed feasible to mean
capable of being successfully
accomplished within a reasonable time,
accounting for economic,
environmental, legal, social, and
technological factors. EPA further
clarified in the definition that
environmental factors would include
consideration of potential transferred
risks for new risk reduction measures.
For inherently safer technology or
design, the proposed definition meant
risk management measures that:
• Minimize the use of regulated
substances,
• Substitute less hazardous
substances,
• Moderate the use of regulated
substances, or
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• Simplify covered processes in order
to make accidental releases less likely or
the impacts of such releases less severe.
The proposed definition of ‘‘passive
measures’’ meant risk management
measures that use design features that
reduce the hazard without human,
mechanical, or other energy input. EPA
provided examples of passive measures
that included pressure vessel designs,
dikes, berms, and blast walls.
Finally, EPA proposed procedural
measures to mean risk management
measures such as policies, operating
procedures, training, administrative
controls, and emergency response
actions to prevent or minimize
incidents. EPA sought comment on
these proposed revisions.
2. Summary of Final Rule
After review and consideration of
public comments, EPA is finalizing the
STAA provision in § 68.67(c)(8), and
related definitions in § 68.3, as
proposed, with the following
modifications:
• EPA is substituting the term
‘‘practicability’’ for ‘‘feasibility’’ in
proposed § 68.67(c)(8)(ii) of the PHA
requirements;
• EPA is substituting the term
‘‘practicability’’ for ‘‘feasible’’ in the
definition in § 68.3 and substituting the
phrase ‘‘the capability’’ for ‘‘capable,’’
while retaining the remaining definition
as proposed; and
• EPA is revising the definition of
‘‘passive measures’’ by clarifying that
these measures not only reduce a hazard
but reduce the frequency or
consequence of a hazard.
Significant comments on the proposed
STAA provisions and related definitions
are discussed in section IV.C.3 of this
preamble.
3. Discussion of Comments and Basis for
Final Rule Provisions
Many commenters from
environmental advocacy groups and
some state agencies expressed support
for the proposal to require an STAA to
improve process safety. However, some
believed that implementation of feasible
safer alternatives, particularly IST,
should be required and that STAA
requirements should apply to a greater
universe of facilities and not just those
in the chemical manufacturing,
petroleum refining and paper
manufacturing industries. Many
commenters, mostly from industry,
requested that EPA remove IST and
design requirements from the rule
entirely for a variety of reasons, or
requested significant clarifications to
applicability if the STAA provision is
finalized.
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As noted previously, except for
substituting the term ‘‘practicable’’ for
‘‘feasible’’ and some other definition
changes, EPA is finalizing the STAA
provisions as proposed. We continue to
rely on the rationale expressed in the
proposed rulemaking. In the discussion
that follows and in the Response to
Comment document, we explain our
consideration of the comments and our
analysis and response.61
We recognize there may be multiple,
rational approaches to STAA. We
determined that it was reasonable to
require STAA for sectors that have had
a high per facility incidence of
reportable accidental releases and where
the complexity and variety of methods
of chemical handling demonstrate the
potential for process safety revisions.
We do this in part to balance potential
accidental release rate reduction and
cost. There are some sectors, such as
water treatment, with known ISTs that
we do not require to evaluate or
implement ISTs under this rule. In the
water treatment sector in particular, the
sector’s lower accidental release rates do
not demonstrate that requiring
thousands of facilities to conduct STAA
would result in a significant drop in
accidental releases.62 In contrast, even if
some of the sectors we have identified
for the STAA requirement already may
have voluntarily undertaken an STAA
approach (at least at new facilities),
accidental release rates remain higher
for these industries, technologies
advance over time, and ensuring a
minimum level of application of the
STAA approach limits the disincentives
for sector members to be leaders in
adoption of safer technologies. We do
not mandate the adoption of any IST
found to be practicable in part because
we recognize that a passive measure or
other approach on the STAA hierarchy
may also be effective at risk reduction;
we continue to leave the adoption of
particular accident prevention
approaches to owners’ and operators’
reasonable judgment. We discuss other
factors that have led us to select
particular industries for STAA and
particular requirements in our STAA
61 2016. EPA Response to Comments on the 2016
Proposed Rulemaking Amending EPA’s Risk
Management Program Regulations. This document
is available in the docket for this rulemaking.
62 An intentionally-caused release through the
criminal act of a third-party would be an accidental
release because the emission would be
unanticipated from the perspective of the owner or
operator of the stationary source. Where the
location of a water treatment source could expose
large populations to regulated substances, we
believe it is appropriate for such sources to work
with local emergency planners and homeland
security officials to reduce the risk. Nevertheless,
such isolated cases do not justify a mandate across
the industry in place of a case-specific review.
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approach in response to particular
comments.
a. Legal Issues
Various commenters raised potential
legal issues or challenges regarding the
STAA requirements based on CAA
authority, Congressional intent,
deficient analysis or substantiation,
vagueness of requirements, and
jurisdiction.
Several industry associations and
individual companies commented that
EPA lacked the legal authority to require
assessment of STAA in general and IST/
ISD in particular. One argued that the
authority for RMPs rests in
subparagraph (B) of CAA section
112(r)(7), while the authority for design
and equipment changes rests in
subparagraph (A). Several argued that
EPA did not adequately explain its
change of position from the one adopted
in the 1996 final RMP rule, which did
not require the assessment or
implementation of IST. In light of EPA’s
position that the 1996 final RMP rule
and EPA’s program implementation
provided incentives to adopt IST, some
argued that requiring STAA analysis
without requiring implementation of
changes would offer no new benefit to
public health and safety; these
commenters suggested that IST had
been informally used already for
decades where it was feasible. Another
commenter said the STAA requirement
could effectively ban certain chemicals
without the authority to do so. Others
noted that IST consideration would lead
to increased liability issues for facilities
because, even if a source was not
required to implement IST by rule,
should an accident happen, plaintiffs
could cite the failure to adopt the IST
in a court case. A commenter criticized
the requirement as too amorphous to be
meaningfully implemented and
enforced in a non-arbitrary manner.
Other commenters said IST is more
properly within the authority of OSHA,
that EPA’s record did not reveal
consultations and coordination with
OSHA as required by CAA section
112(r)(7)(D), and that subsequent to the
enactment of the 1990 CAA
Amendments, Congress had denied both
EPA and DHS the authority to require
IST when it rejected bills requiring or
authorizing IST.
In contrast to the comments discussed
previously, a coalition of
environmental, labor, community and
other public groups, as well as a mass
mail campaign, commented that EPA
must adopt STAA in its final rule not
only for NAICS codes we proposed but
for all facilities where STAA is feasible.
In the commenters’ view, the proposed
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amendments are inconsistent with the
statute’s prevention objectives and its
preference for measures that completely
eliminate potential hazards because
only certain sectors are required to
undertake STAA while others only have
requirements imposed after accidental
releases. Additionally, the commenters
argue that the authority to ‘‘make
distinctions’’ among classes of facilities
in CAA section 112(r)(7)(A) and to
‘‘recognize differences’’ among types of
sources in CAA section 112(r)(7)(B) does
not include the authority to exempt
entire sectors from STAA; even if the
statute gave such authority, EPA failed
to explain how it is relying on that
authority. Finally, the commenters
contended EPA’s action was arbitrary
and capricious by failing to account for
the significant value STAA could
provide to facilities, workers, and
communities by not only removing
hazards but by saving money through
removing potential liability and
sometimes improving industrial
efficiency.
EPA disagrees with the comments that
the CAA does not authorize the STAA
provisions of this final rule. Both
subparagraphs (A) and (B) of CAA
section 112(r)(7) authorize STAA and
IST in particular. EPA cited all of
paragraph (7) as authority for ‘‘[e]ach of
the portions of the Risk Management
Program rule we propose to modify.’’ 81
FR 13646, March 14, 2016.63 The
authority section for 40 CFR part 68
references CAA section 112(r) and is not
limited to particular paragraphs and
subparagraphs. The proposed
rulemaking also noted that
subparagraph (A) had been invoked in
the rulemaking petition on IST.
Therefore, EPA provided sufficient
notice that we contemplated action
under any authority under CAA section
112(r)(7). Nevertheless, we also view
that our authority to require STAA
assessments or an IST review is
consistent with subparagraph (B). Under
subparagraph (B), EPA has broad
authority to develop ‘‘reasonable
regulations . . . for the prevention of
accidental releases.’’
Further support for IST can be found
in both the Conference Report
accompanying the 1990 CAA
Amendments and the Senate Report
explaining the provisions of the Senate
bill that closely mirrors enacted
provisions. In discussing the ‘‘Hazard
Assessments’’ required by section
63 We note that our more extensive discussion of
authority for the RMP rule provided in the 1993
proposal focused on CAA 112(r)(7)(B)(i) and (ii), 58
FR 54191–93 (October 20, 1993), which the
proposal for the Modernization rule referenced for
additional authority discussion.
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112(r)(7)(B), the Conference Report
specifies that such assessments ‘‘shall
include . . . a review of the efficacy of
various release prevention and control
measures, including process changes or
substitution of materials.’’ 64 Conference
Report at 340–41. The STAA analysis is
such a review.65 The Senate Report
identifies as ‘‘release prevention
measures’’ many of the techniques that
are now known as IST—substitution of
less hazardous materials, reduction in
the severity of the conditions of
processing and complexity of the
process, and decreasing volumes of
chemicals in storage.66 Senate Report at
242. That subsequent Congresses did
not enact additional legislation on IST
is irrelevant to what was enacted and
intended at the time of enactment.
The proposed rulemaking, 81 FR
13646, March 14, 2016, provided an
extensive discussion of developments
concerning IST since the 1996 final
RMP rule. As we explained, EPA
adopted a rule in 1996 that provided
incentives for IST without a specific
mandate to either conduct studies of IST
or implement IST measures. From 1996
on, EPA has recognized that good PHA
techniques will often identify
opportunities to make new and existing
processes and operation inherently
safer. However, in the 1996 rule and
thereafter, we also recognized that IST
is not the only way to prevent accidents,
and that sometimes IST can be
impractical, especially for existing
sources.
The STAA approach we adopt in this
action places IST in a hierarchy that
allows for sources to choose non-IST
approaches to accident prevention, such
as passive mitigation, active mitigation,
and administrative controls. While the
EPA did not, in 1996, expressly require
facilities to analyze and implement IST
specifically, this rule places IST in a set
of options to be studied. EPA relies on
sources making rational decisions once
presented with STAA studies and
selecting prevention approaches that
optimize the cost of the measures taken
and costs avoided (e.g., liability,
64 H. Rep. 101–952, Clean Air Act Amendments
of 1990 Conference Report to Accompany S. 1630,
101st Cong., 2d Session, 340–41. October 26, 1990.
65 EPA chose to incorporate into the prevention
program provisions several of the hazard
assessment elements mentioned in the conference
report and to limit the hazard assessment portions
of 40 CFR subpart B to the offsite consequence
analysis and accident history in order to better
conform the RMP rule to the format of the PSM
rule. 58 FR 54194 (October 20, 1993).
66 Clean Air Act Amendments of 1989, Report of
the Committee on Environment and Public Works,
U.S. Senate together with Additional and Minority
Views to Accompany S. 1630. S. Report No. 101–
228. 101st Congress, 1st Session, p. 242, December
20, 1989.
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operational efficiency, image). Such an
approach is similar to the approach to
energy assessments recently taken in the
major source and area source boiler
rules under CAA section 112(d) and
affirmed in U.S. Sugar Corp v. EPA.67
We acknowledge that many sources
have conducted STAA analyses already.
For these sources, the cost of
implementing the new STAA
requirement should be lessened. The
requirement we promulgate in this rule
captures those slower in considering
IST in high accident industries rather
than harms leaders. There are no
specific chemicals banned by this final
rule. While we recognize that
companies have moved away from
certain processes, such as those that
involve the storage of large quantities of
methyl isocyanate, in order to make
facilities safer, we leave process design
decisions to the reasonable judgment of
owners and operators under this action.
EPA disagrees with the comments
concerning IST being more properly
within the authority of OSHA. It is plain
from the history of the 1990
Amendments that both agencies were
given authority to prevent accidents,
and that Congress contemplated EPA
adopting some IST measures as
appropriate. Furthermore, EPA has a
history of prior coordination with
OSHA to define and promote STAA
when developing the EPA and OSHA,
Chemical Safety Alert: Safer Technology
and Alternatives (EPA 550–F–15–003;
June 2015).68
Not only for STAA, but also for other
provisions of this final rule, the record
adequately reflects EPA’s coordination
and consultation with Department of
Labor (DOL)/OSHA and DOT. As an
initial matter, both DOL and DOT were
part of the Working Group under
Executive Order 13650. That order and
report of the Working Group reflect
consultation and direction regarding the
development of the this final rule.
Second, we note that EPA’s decision to
not consider the regulation of AN at this
time explicitly is based on an effort to
coordinate any potential regulatory
requirements for this substance with
actions contemplated by other agencies,
including OSHA. Third, while the
content of interagency deliberations are
not for the record for judicial review
under CAA section 307(d), multiple
agencies have an opportunity to review
a draft rule under Executive Order
12866 Regulatory Planning and Review.
Finally, OSHA had representatives
67 United States Sugar Corp. v. EPA, 830 F.3d 579
(D.C. Cir. 2016).
68 https://www.epa.gov/sites/production/files/
2015-06/documents/alert_safer_tech_alts.pdf.
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4631
attend the SBAR panel which discussed
the development of the proposed
rulemaking. All of this is a matter of
public record in the docket for this
rulemaking.
Consistent with the structure of the
RMP rule, EPA has placed IST among
the methods a facility may choose to
adopt to prevent accidents. Commenters
who argue that we have failed to require
accident prevention by not mandating
the adoption of IST measures for all
facilities wherever feasible fail to
acknowledge that non-IST methods for
preventing accidents may be reasonable
in some circumstances. To the extent
that these regulations are imposed
under subparagraph (B), these
regulations have an overriding
requirement to be reasonable. While it is
true that similar quantities of chemicals
under the same conditions present
similar hazards regardless of sector,
various sectors present different
likelihood of release. Some sectors
handle chemicals differently under
conditions that are more likely to lead
to severe releases. The record reflects
that the likelihood of severe accidents is
greater in the sectors that must conduct
STAA analysis under this final rule.
Thus, it is reasonable to have different
requirements for these sectors than for
others. Independent of whether any new
IST/ISD is adopted, there is a cost to
conducting an STAA analysis. EPA has
reasonably limited STAA analysis
requirements to sectors that we view as
most likely to likely to have more
frequent, severe releases that are most
likely to be benefit from STAA review.
Inherent in our approach is
distinguishing among classes and types
of facilities. We expect that the adoption
of STAA analysis requirements in this
final rule will advance IST not only in
the sectors targeted by the rule, but also
more generally as experience is gained
and opportunities for technology
transfer are developed.
b. Applicability
Limiting applicability of STAA
provisions. While some commenters
supported EPA’s proposal to limit
applicability of STAA provisions to the
petroleum refining, chemical
manufacturing, and paper
manufacturing sectors, other
commenters objected to this aspect of
the proposal. Many commenters,
including a mass mail campaign joined
by approximately 300 commenters,
expressed concern that the proposed
rulemaking arbitrarily determined
which industries have feasible and
worthwhile alternatives, and which
communities and facilities would
benefit from STAAs. These commenters
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asserted that limiting the requirement to
certain industry sectors would exempt
other sectors that pose a significant
threat to the public. Commenters argue
that focusing on accident rate to target
sectors for STAA was not a credible way
to forecast and prevent rare catastrophic
events that tend to fall out of existing
patterns.
Some commenters urged EPA to apply
the STAA requirement to all sources, or
all Program 3 sources. Other
commenters, including another mass
mail campaign joined by approximately
17,250 commenters, recommended that
EPA require assessment and
implementation of STAA for industries
where safer alternatives are feasible or
well demonstrated, such as water
supply, wastewater treatment, power
generation, food and beverage
manufacturing, and others. Several
other commenters indicated that EPA
should apply the STAA provisions to
facilities with the largest worst case
scenario populations, or to the 2,000
high-risk facilities cited in EPA’s 2017–
2019 National Enforcement Initiative
(NEI). A few commenters suggested that
EPA implement a pilot program
requiring IST implementation for a
subset of sectors considered extremely
high risk, such as wastewater or
drinking water treatment plants, bleach
plants, refineries using hydrogen
fluoride and for those facilities among
the 2,000 high-risk facilities cited in the
EPA’s NEI 2017–2019 proposal. A few
commenters believe that the proposed
STAA requirements have failed to
address the disproportionate health and
safety threats in communities of color
and low-income communities, and want
the STAA provisions to apply to all
RMP facilities.
In this rule, EPA is finalizing the
STAA provisions as proposed, which
limits applicability of the STAA
requirements to Program 3 processes in
the petroleum refining, chemical
manufacturing, and paper
manufacturing sectors. EPA does not
believe that the final provisions have
been limited arbitrarily, or that the
Agency’s decision to limit applicability
of the STAA provisions to the
petroleum refining, chemical
manufacturing, and paper
manufacturing sectors implies that other
sectors do not have viable safer
technology alternatives. In the proposed
rulemaking, EPA acknowledged that
most RMP-regulated sectors could
identify safer technologies and
alternatives. However, the Agency
proposed to limit the applicability of the
STAA provisions to facilities in
complex manufacturing sectors with
high accident rates. EPA took this
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approach in order to target these
provisions to the industrial sectors with
the potential to achieve the greatest
safety improvements through
consideration of safer technology
alternatives. EPA explained that sources
involved in complex manufacturing
operations have the greatest range of
opportunities to identify and implement
safer technology, particularly in the area
of inherent safety, because these sources
generally produce, transform, and
consume large quantities of regulated
substances under sometimes extreme
process conditions and using a wide
range of complex technologies.
Therefore, such sources can often
consider the full range of inherent safety
options, including minimization,
substitution, moderation, and
simplification, as well as passive, active,
and procedural measures. Further, EPA
noted that RMP facilities in the three
selected sectors have been responsible
for a relatively large number of
accidents, deaths, and injuries, and the
most costly property damage.69
Facilities in these sectors also have
significantly higher accidents rates as
compared to other sectors.70 EPA agrees
that there is no way to forecast rare
catastrophic events; however, we
believe it is appropriate to target sectors
that have had a large number of
accidents and have the greatest
opportunity to identify safer
technologies.
While EPA does not believe it is
necessary to require all sources, all
Program 3 sources, or all sources in
industry sectors where feasible safer
technology alternatives have been
identified to perform an STAA, the
Agency encourages such sources to
consider performing an STAA, and to
determine practicability of IST or ISD
considered, even if they are not subject
to the STAA provisions of the final rule.
EPA does not agree that only sources
with large worst-case scenario
populations, or only sources on EPA’s
high risk facility list should be required
to comply with the STAA provisions.
EPA believes it is not appropriate to
apply the STAA provisions only to
sources with specified worst case
69 For more information, see Chapter 6 of the
Regulatory Impact Analysis—Accidental Release
Prevention Requirements: Risk Management
Programs Under the Clean Air Act, Section
112(r)(7). This document is available in the docket
for this rulemaking (Docket ID Number EPA–HQ–
OEM–2015–0725).
70 For more information, see EPA, January 27,
2016. Technical Background Document for Notice
of Proposed Rulemaking: Risk Management
Programs under the Clean Air Act, Section
112(r)(7). This document is available in the docket
for this rulemaking (Docket ID Number EPA–HQ–
OEM–2015–0725).
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scenario populations for several reasons.
First, EPA’s OCA requirements allow
regulated facilities to use any
commercially or publicly available air
dispersion modeling techniques,
provided the techniques account for the
modeling conditions specified in the
rule and are recognized by industry as
applicable as part of current practices.
This flexibility can result in two similar
facilities obtaining significantly
different endpoint distances (and
vulnerable zone populations) simply
through choosing different modeling
techniques. By linking the STAA
requirement to the worst case scenario,
EPA could inadvertently cause some
facilities to recalculate their OCA using
a different modeling approach, simply
to avoid the STAA requirement, and
without actually implementing process
changes that might reduce the facility’s
worst case scenario. Second, linking the
STAA requirement to large worst case
scenario populations would effectively
bias the applicability of the requirement
to facilities in densely populated areas,
and potentially exempt equally
hazardous facilities in or near less
densely populated communities. Third,
this application of the STAA
requirement would disregard the criteria
that EPA has used in the proposed
rulemaking—accident history and
facility complexity, which EPA believes
provide a stronger rationale for limiting
the applicability of the requirement. In
addition, EPA believes that targeting the
STAA requirements to the larger and
more complex processes will benefit
minority communities, who are located
closer to larger facilities with more
complex chemical processes and who
bear a larger portion of risk from
chemical accidents. Lastly, distribution
of worst-case scenario population
information is restricted under the CAA,
and this would effectively prohibit the
public from knowing which facilities
are required to perform an STAA.
For similar reasons, EPA does not
agree with commenters’ suggestions to
develop a pilot program to apply to a
subset of high risk facilities or to apply
the STAA requirement to facilities on
EPA’s high risk facility list. This list is
generated, in part, using worst case
scenario population information
(chemical quantities and accident
history are also considered, although
sector accident frequency is not), and
therefore the list may not be publicized
by EPA.
Apply to facilities using different
incident rate methodology. Several
commenters objected to EPA’s
methodology for selecting industrial
sectors subject to STAA requirements
using an incident rate based on the
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number of RMP-reportable accidents per
facility in the industry sector. These
commenters expressed concern that the
proposal to require STAAs from only
three NAICS codes is based on an
incorrect approach to, and
interpretation of, incident rates. An
industry trade association commented
that looking at the number of accidents
per facility does not allow for direct
comparisons as it does not account for
the relative number of employees at a
facility. This commenter argued that
EPA should recalculate this value using
the number of accidents per hours
worked or the number of accidents per
full time worker, and reasoned that such
a calculation would be more consistent
with the incident rate calculations
conducted by the Occupational Safety
and Health Administration (OSHA) and
the Bureau of Labor Statistics (BLS).
Another industry trade association
remarked that EPA’s methodology
ignores not only the size of the facility
but also the quantity of chemicals and
the number of covered process units at
a given facility. According to this
commenter, upon normalizing the
petroleum refining sector’s accident rate
to account for the number of process
units and the diversity of facilities being
compared, the accident rate for this
sector is lower than for most other
sectors. The commenter also expressed
concern that EPA’s proposal to subject
this sector to the STAA requirement
ignores the industry’s significant recent
safety improvements that EPA itself has
noted in the NPRM, and that industries
such as poultry processing have higher
incident rates than petroleum refining
or chemical manufacturing, even though
these industries are not subject to the
STAA requirement.
A trade association representing the
paper manufacturing industry urged
EPA to remove the STAA requirement
for that sector. The industry trade
association stated that paper
manufacturing should not be considered
a ‘‘complex’’ manufacturing process,
and cited EPA’s Technical Background
Document 71 which, according to the
commenter, does not categorize paper
manufacturing facilities as ‘‘complex.’’
Additionally, the commenter remarked
that the paper manufacturing industry
has a much lower level incident risk
than other sectors based on injuries
offsite, and stated that of the roughly
15,000 offsite injuries mentioned by
EPA, the paper manufacturing industry
71 EPA. January 27, 2016. Technical Background
Document for Notice of Proposed Rulemaking: Risk
Management Programs under the Clean Air Act,
Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number
EPA–HQ–OEM–2015–0725).
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was responsible for only two. Citing
Exhibit 6–4 of EPA’s Regulatory Impact
Analysis for the proposed rulemaking,
the commenter asserted that the entire
U.S. paper manufacturing sector has
been responsible for the fewest offsite
injuries out of any industrial sector over
the ten-year study period. This
commenter concluded that
implementing the requirement for the
paper industry would not enhance
public safety, and that the industry has
made significant strides to increase
safety procedures in recent years.
Another commenter stated that EPA’s
use of routine incident rates in selecting
industry sectors to conduct STAAs was
faulty because frequent smaller
incidents cannot be used to reliably
predict infrequent catastrophic events.
EPA acknowledges that there were
other possible methods of selecting
industry sectors that would be subject to
STAA requirements. All of the methods
offered by commenters—normalizing
accident rates by FTE, number of
process units, chemical quantities,
etc.—were considered but ultimately
rejected by the Agency. EPA does not
believe normalizing accident rates by
FTE or chemical quantity is appropriate
because prior research has shown that
the interaction between these factors
and incident rates is complex, and that
none of these variables, by itself, is a
suitable proxy for the relative risk of a
catastrophic chemical release incident
at a facility.72 Likewise, selecting
industry sectors for applicability of the
rule’s STAA provisions using an
approach similar to that used for OSHA
personal injury statistics (e.g., OSHA
lost workday injury and illness rates)
would not identify sectors with higher
chemical process risks. These OSHA
rate data generally scale directly with
the number of employees because most
of the incidents measured in these
metrics involve single-person injuries
(e.g., overexertion, sprains and strains,
slips, trips, falls, injuries due to contact
with objects and equipment, etc.).73 In
other words, facilities with more
employees are more likely to suffer
higher amounts of these ‘‘lost workday’’
injuries, but not necessarily higher
numbers of chemical release incidents.
Furthermore, EPA chose not to
normalize accident rates by the number
72 Elliott, M.R., Kleindorfer, P.R., and Lowe, R.A.,
The Role of Hazardousness and Regulatory Practice
in the Accidental Release of Chemicals at U.S.
Industrial Facilities, Risk Analysis, Vol. 23, No. 5,
2003.
73 See, e.g., ‘‘Nonfatal Occupational Injuries and
Illnesses Requiring Days Away from Work, 2014,’’
U.S. Department of Labor, Bureau of Labor
Statistics, November 19, 2015. Available at https://
www.bls.gov/news.release/osh2.nr0.htm.
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4633
of process units for two reasons. First,
regulated sources have significant
discretion in determining covered
process boundaries—some petroleum
refineries and large chemical
manufacturing facilities containing
numerous unit process operations have
chosen to consider their entire plant as
a single covered process, while other
similar plants have divided their
stationary source into dozens of
different covered processes. Therefore,
normalizing accident rates by the
number of processes could result in a
less accurate reflection of a sector’s
historical accident propensity. More
importantly, even if a higher accident
rate at a large facility is due, in part, to
the facility having more covered
processes, that fact does not reduce its
risk to the surrounding community. For
the community, it is the frequency of
accidents at its neighbor that matters,
not the rate per process. In fact, the
relatively higher likelihood of
accidental releases at such sources
further warrants their consideration,
and potential application, of safer
alternative technologies.
EPA disagrees that its approach
ignores recent safety improvements on
the part of the petroleum refining sector.
The Agency views the application of
safer technology alternatives as an
approach to hazard control that can be
applied throughout the life-cycle of a
facility. A facility’s recent
implementation of a safer technology
alternative does not foreclose
consideration of additional safer
technologies in the future. Facilities that
have already implemented safer
technology alternatives should
document their implementation in their
next PHA, determine whether there is
additional information that should be
considered in their STAA, and continue
to consider additional safer alternatives
during subsequent PHA re-validation
cycles.
EPA agrees that the poultry
processing sector, when that sector is
considered separately from other food
and beverage industry sectors, has a
slightly higher RMP facility incident
rate than the petroleum refining sector.
However, EPA did not include the
poultry processing sector under the final
rule STAA provision because the
poultry processing sector, by itself, does
not delineate a meaningful
technological subgrouping of RMP
facilities. Poultry processing facilities
are just one of many different types of
food and beverage manufacturing and
processing facilities covered under the
RMP regulation. The common
technology among these facilities that
results in their coverage under the RMP
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regulation is ammonia refrigeration.
While EPA is aware that some RMP
facilities in the poultry processing
sector have had serious chemical
accidents, the Agency does not believe
that these accidents are usually related
to the fact that these facilities process
poultry. Rather, they generally relate to
the design, maintenance, or operation of
the ammonia refrigeration system at the
facility, and are similar to the causes of
accidents involving ammonia
refrigeration systems at other types of
food and beverage processing facilities.
Therefore, when considering the
accident rates of RMP-covered poultry
processing facilities, EPA believes the
proper approach is to combine RMP
facilities in this sector with RMP
facilities in all other sectors in the food
and beverage industry, as indicated in
the RIA for the final rule.74 When this
is done, the accident frequency for the
food and beverage manufacturing sector
is significantly lower than the accident
frequency for the petroleum refining
sector.
EPA disagrees with the commenter
that argued the paper manufacturing
sector should be exempt from the STAA
provision of the final rule because the
sector has had fewer accidents with
offsite injuries, or because the sector
was not characterized as ‘‘complex’’ by
EPA’s economic analysis. While it is
true that the paper manufacturing sector
has had fewer accidents with offsite
injuries than other sectors, this is partly
due to the relatively small number of
RMP facilities (70) in the paper
manufacturing sector. Additionally, the
great majority of the offsite injuries
reported by RMP facilities resulted from
a single accident at the Chevron
Richmond refinery, therefore it is
inappropriate to compare offsite injuries
from the paper manufacturing sector to
the total of all offsite injuries that
occurred during the ten-year period
analyzed.75
More importantly, offsite injury is
only one of several types of accident
74 Regulatory Impact Analysis—Accidental
Release Prevention Requirements: Risk
Management Programs Under the Clean Air Act,
Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number
EPA–HQ–OEM–2015–0725).
75 According to the CSB, ‘‘approximately 15,000
people from the surrounding communities sought
medical treatment at nearby medical facilities for
ailments including breathing problems, chest pain,
shortness of breath, sore throat, and headaches.
Approximately 20 of these people were admitted to
local hospitals as inpatients for treatment.’’ CSB,
January 2015, Final Investigation Report: Chevron
Richmond Refinery Pipe Rupture and Fire, Chevron
Richmond Refinery #4 Crude Unit, Richmond,
California, August 6, 2012, Report No. 2012–03–I–
CA, https://www.csb.gov/assets/1/16/Chevron_
Final_Investigation_Report_2015-01-28.pdf.
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consequences that require reporting
under the RMP rule. Other reportable
consequences include deaths, injuries,
and significant property damage on-site,
and known offsite deaths, evacuations,
sheltering-in-place, property damage
and environmental damage. When all
RMP-reportable accident consequences
for a sector are considered, and
normalized by the number of sources in
the sector, the paper manufacturing
sector has the second highest accident
rate among all sectors regulated under
the RMP rule. EPA believes this
approach is a better gauge of the
historical accident propensity for a
sector than considering only accidents
with offsite injuries.
While it is also true that EPA did not
characterize the paper manufacturing
sector as ‘‘complex’’ in the Technical
Background Document 76 and for
estimating the costs of most rule
provisions within the RIA, it did do so
for purposes of the STAA provision, and
arguably could have done so for all rule
provisions. Paper manufacturing
facilities, and particularly large
integrated pulp and paper mills, are
clearly more complex than most other
RMP facilities, which only involve
chemical storage (e.g., agricultural
ammonia distribution facilities) or
simple chemical processes (e.g., water
treatment). The main purpose for EPA’s
broad characterization of certain sectors
as ‘‘complex’’ and all others as ‘‘simple’’
for certain rule provisions within the
RIA was because the Agency judged that
the cost of implementing those rule
provisions would vary primarily by the
complexity of the processes involved,
and that a rough two-tier division of
regulated sources (e.g., simple vs.
complex) would suffice to establish cost
estimates for those rule provisions.
However, EPA did not use this two-tier
division for purposes of estimating the
costs of the rule’s STAA provision. For
the STAA provision, EPA included
paper manufacturing as a sector that
involves ‘‘complex manufacturing
operations.’’ EPA chose to apply the
STAA requirement to sources involved
in complex manufacturing operations
because these sources have the greatest
range of opportunities to identify and
implement safer technology,
particularly in the area of inherent
safety. These sources generally produce,
transform, and consume large quantities
of regulated substances under
sometimes extreme process conditions
76 EPA. January 27, 2016. Technical Background
Document for Notice of Proposed Rulemaking: Risk
Management Programs under the Clean Air Act,
Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number
EPA–HQ–OEM–2015–0725).
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and using a wide range of complex
technologies. For more information, see
the preamble discussion in the proposed
rulemaking at 81 FR 13688, March 14,
2016.
EPA disagrees that the agency used
‘‘routine’’ incident rates to select
industry sectors covered by the STAA
provision. Accidents meeting EPA
reporting criteria include accidental
releases from covered processes that
result in deaths, injuries, and significant
property damage on-site, and known
offsite deaths, injuries, evacuations,
sheltering-in-place, property damage
and environmental damage. EPA believe
that such accidents generally either
resulted in, or could reasonably have
resulted in, a catastrophic release of a
regulated substance, and are therefore
an appropriate criterion to consider
when identifying industrial sectors that
may benefit public safety the most by
analyzing safer alternative technologies.
Eliminate or exempt batch toll
chemical manufacturers. In the context
of exempting batch toll processors from
the STAA provision, some commenters
recommended that processes governed
by government agency specifications or
through a contractual relationship with
a customer should not be subject to the
STAA provision because in these cases,
the customer specifies the
manufacturing process. According to
one commenter, the customer is subject
to regulation, often from the FDA or
EPA. An industry trade association
requested that EPA explicitly state in
the body of the regulation that the
STAA requirement would not apply to
processes in whole or in part specified
by a government agency or through any
contractual obligation.
EPA disagrees with the suggestion to
exempt batch toll manufacturers from
the STAA requirement. Safer technology
alternatives include many options
beyond chemical substitution. For
example, IST could involve
minimization of stored raw material
chemicals, making process changes that
make it less likely to release the
chemical (moderation), or reducing
complexity in the process in order to
make accidents less likely
(simplification). Therefore, even where
a contractual relationship or regulation
requires a regulated batch toll
manufacturing facility to use a
particular regulated substance in
specified quantities, owners and
operators of batch toll manufacturing
facilities should still consider other
potential IST measures besides chemical
substitution. The facility must also
consider potential safer alternatives
beyond IST, such as passive measures
instead of or in combination with active
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measures, or active measures instead of
procedural measures. Toll
manufacturers may use RMP chemicals
for purposes in addition to making a
formulated product, such as for cleaning
equipment, wastewater treatment or
refrigeration, for which chemical
substitution may not be prohibited by
regulation or contractual relationship.
Also, the final rule does not require
regulated sources to implement IST or
ISD considered, so there is no conflict
between this final rule and other
regulations that may apply to RMPregulated facilities subject to STAA
requirements. For example, an owner or
operator would be in compliance with
the STAA requirement to consider
potential chemical substitution as part
of the analysis if he or she determines
that a chemical substitution is not
practicable because the substitution is
prohibited by another regulation The
owner or operator would still need to
consider other types of IST
(minimization, moderation, or
simplification), and passive, active, and
procedural measures in the analysis.
Applicability to water treatment
facilities. Some commenters, including
professionals and a mass mail campaign
joined by approximately 300
commenters, urged that water supply
and wastewater treatment facilities
should be subject to the proposed STAA
provision. A number of commenters
expressed concern about threats posed
by water and wastewater facilities and
related operations. Several commenters
asserted that technologically and
economically feasible alternatives are
available for water supply and
wastewater treatment facilities, and
suggested that exploring the
implementation of these alternatives
would be beneficial for the safety of
workers, personnel, and communities
associated with the facilities. One
commenter stated that the costs for
water facilities to convert to safer
alternatives are feasible, and remarked
that it is possible to adopt IST without
disrupting operations.
Alternatively, a few industry trade
associations and government
organizations stated that STAA should
not be applied to water facilities citing
that any STAA requirement would be
repetitive and counterproductive and
that drinking water utilities already
have to consider a variety of public
health and safety factors under the Safe
Drinking Water Act (SDWA).
EPA disagrees with commenters who
suggest subjecting water and wastewater
treatment facilities to STAA
requirements. EPA’s approach to
applying the STAA requirement was to
identify industry sectors with the
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greatest accident frequency at RMPregulated facilities within the sector,
and with the greatest opportunity to
apply STAA risk management measures.
While EPA agrees that water supply and
wastewater treatment facilities often
have feasible alternatives available,
according to RMP accident history data,
the sector is among the least accidentprone sectors covered under the risk
management program. Therefore, the
final rule does not apply the STAA
requirement to the water and
wastewater treatment sector. EPA
acknowledges that drinking water
utilities already may have considered
alternative technologies for their
disinfection process while addressing
safety and health considerations, risk
tradeoffs and compliance with the
SDWA.
Limit applicability to major process
changes or after accidents. A few
commenters want EPA to consider
having a requirement similar to that
required by Contra Costa County for
facilities to conduct an STAA whenever
major process changes are proposed and
in the aftermath of accidents, when
there are often significant opportunities
for making process improvements as
equipment is rebuilt or repaired. One
commenter noted that the CCHS
program requires an ISS analysis during
the design of new processes, for PHA
recommendations, or for major changes
resulting from incident investigation
recommendations, root cause analysis or
MOC review that could reasonably
result in a major chemical accident or
release. This commenter noted that
California’s proposed refinery
regulations are following the same
requirements as the CCHS program.
Other commenters recommended that
instead of requiring STAA analyses at
least every five years in conjunction
with the a PHA revalidation, EPA
should require the analysis only after
accidents.
Another commenter recommended
modifying the wording in section
68.67(c)(8) to limit the provisions to
new processes or major modifications to
existing processes. The commenter also
remarked that stationary sources’
management of change (MOC) programs
should be updated to account for
process changes and allow for
reassessment of the IST analysis. The
commenter concluded that this will
ensure that existing IST components are
not removed, replaced, or changed
without revalidating the IST feasibility
criteria.
EPA disagrees that the STAA
requirement should be triggered only by
a major process change. While the
Agency acknowledges that a major
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4635
process change could be an opportune
time to evaluate safer technology
alternatives, the Agency is concerned
that requiring STAA reviews only after
major process changes could result in
some processes rarely or never being
evaluated for safer technology
alternatives. This could occur if few or
no major changes occurred during the
life of the process. Also, limiting the
STAA to only major process changes
could create a disincentive to upgrading
processes if facilities chose not to make
improvements to avoid having to
perform an STAA. EPA is also
concerned that there is no common
definition or understanding of the term
‘‘major process change’’ that could
easily be applied to the wide range of
processes affected by the STAA
requirement. Therefore, while EPA
agrees that integrating STAA reviews
into a facility’s MOC program (and other
prevention programs) may often be
beneficial, the Agency believes it is
appropriate to incorporate the STAA
provision into the PHA section of
§ 68.67, rather than the MOC section of
§ 68.75. Nevertheless, EPA encourages
owners and operator to also consider
safer technology alternatives whenever
major process changes are planned.
EPA is revising the PHA requirements
in § 68.67 to require that the PHA
address findings from incident
investigations as well as any other
potential failure scenarios. Other
potential failure scenarios may include
those introduced from major process
changes or new designs or those
discovered as a result of an accident
investigation. Thus, EPA believes that
the PHA with its requirement to
encompass IST review as part of the
PHA process, would cover the same
process changes whether they result
from an incident investigation, MOC
action or other process change.
Finally, EPA disagrees that the STAA
requirement should be triggered only by
accidental releases. Although the
Agency agrees that accidental releases
may indeed signal to the owner or
operator that safer technology
alternatives should be considered, the
Agency prefers that owners and
operators evaluate safer technologies
before accidents occur, with the aim of
ultimately preventing such accidents.
Also, similar to the Agency’s objection
to requiring STAA reviews only after
major process changes, requiring an
STAA only after an accident would
mean that many processes subject to
this provision may never undergo an
STAA.
Limit applicability of STAA
requirements to the design phase of a
process. Several commenters, including
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industry trade associations suggested
that EPA should not require STAAs for
existing facilities or processes.
Numerous commenters, including
facilities, industry trade associations,
local agencies, and a Federal agency,
stated that an STAA is more appropriate
during the design phase of a new
process or facility, or during significant
modifications. Some commenters,
including a local agency, encouraged
EPA to require STAAs to consider the
highest level of hazard control (referring
to the ‘‘hierarchy of controls’’) that is
feasible during the design phase or
whenever a facility makes a change.
Another commenter stated that adding a
new regulatory requirement,
particularly for existing operations, is
unnecessary to address inherently safer
design, and that safer technology
reviews should not be part of a PHA.
In contrast, other commenters urged
that safer technologies analyses are an
ongoing need and should not be limited
to new facilities. A state agency and an
individual urged that IST should be
performed for all new projects,
processes, or stationary sources
throughout various phases of a project’s
life cycle. According to the commenter,
performing a separate IST analysis for
the entire existing process
approximately every five years allows
evaluators to see the big picture rather
than just the minute details associated
with a typical PHA process.
EPA disagrees that STAA analyses
should only be required during the
initial design phase of a facility. While
the greatest potential opportunities for
using IST occur early in process design
and development, many IST options
may still be practicable after the initial
design phase. Furthermore, STAA
involves more than just IST. Safer
technology alternatives also include
passive measures, active measures, and
procedural measures, and these
measures can be modified and improved
after the initial design of a facility. EPA
notes that many RMP-regulated facilities
were originally constructed decades ago,
yet major enhancements have been
reported in some plants that have been
operating for many years.77 CCPS
explains that inherently safer strategies
can be evaluated throughout the
lifecycle of a process, including
operations, maintenance and
modification, and EPA agrees with this
approach.
Lastly, EPA disagrees that the PHA is
not an appropriate risk management
77 CCPS. 2009. Inherently Safer Chemical
Processes: A Life Cycle Approach, 2nd ed.,
American Institute of Chemical Engineers, CCPS
New York, Wiley, p. 25.
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program element in which to integrate
the STAA. EPA believes that safer
technologies can and should be
evaluated during the full life-cycle of a
covered process, and the PHA is the
fundamental and recurring risk
management program element
concerned with overall analysis and
control of process hazards. By
integrating the STAA with the PHA,
every process subject to the provision
will undergo an STAA, every five years.
EPA believes that five-year revalidation
will give the owner or operator the
opportunity to identify new risk
reduction strategies, as well as revisit
strategies that were previously
evaluated to determine whether they are
now practicable.
Owners and operators of new
construction facilities that will be
subject to the RMP rule should consider
performing the STAA portion of their
initial PHA well enough in advance of
facility construction so that the full
range of inherently safer designs is
considered, and include this evaluation
in the initial PHA for the process.
c. Definitions
Feasible definition. Many
commenters, including a facility, several
trade associations and an environmental
advocacy group, remarked that EPA did
not sufficiently explain any of the five
factors (‘‘economic, environmental,
legal, social and technological’’) for
facilities to consider in the proposed
definition of ‘‘feasible,’’ and asserted
that the examples provided by EPA are
unhelpful and vague. The commenters
argue that the proposed rulemaking
does not provide sufficient guidance on
the feasibility component of the STAA
review. As such, the commenters
conclude that these factors are so
expansive and vague that they do not
provide any clear guidance as to how
feasibility of IST should be determined,
and therefore have no place in the RMP
rule. According to one commenter, even
if the five measures are properly
defined, they do not address the full
range of issues in the operational life of
a project rather than just the processing
phase.
A mass mail campaign joined by
approximately 300 commenters warned
that ‘‘accounting for’’ these factors could
be used as an excuse to avoid necessary
implementation measures.
An industry trade association said
that it does not want EPA to elaborate
further on the proposed STAA
requirement. One commenter stated that
it would be very subjective and difficult
to prescribe in regulations what is
‘‘feasible’’ for a facility and that any
‘‘one-size fits all’’ approach to process
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safety would limit employers’ ability to
react to real facts on the ground. In
regards to incorporating ISTs into safety
programs, the commenter asserted that
only facility operators know whether
IST is appropriate given the
complexities of their unique operating
environments, and no one program will
work for all facilities.
EPA believes that the same tools and
methods that facilities currently use for
their PHA can be used to identify and
measure hazards and risks of any safer
alternative options. Further explanation
of the economic, environmental, legal,
social and technological factors
included in the ‘‘practicability’’
definition of this final rule can be found
in NJDEP’s Guidance for Toxic
Catastrophe Prevention Act (TCPA)Inherently Safer Technology (IST)
Review, Attachment 1 Feasibility
guidance.78
EPA did not define the various
factors, such as ‘‘economic’’ or ‘‘social’’
used in the proposed definition of
‘‘feasible’’ or in the revised term
‘‘practicability.’’ The examples in the
proposed rulemaking preamble are
taken from the guidelines provided by
CCPS, and are not exclusive of other
situations. EPA believes that the
definition of ‘‘practicability’’ in the final
rule provides sufficient flexibility for
the owner or operator to determine
whether an IST or ISD considered could
be successfully accomplished. EPA does
not believe that we should further
define ‘‘economic or social factors’’ in
the rule because further specificity of
these terms would likely be too
prescriptive and would not encompass
all the possible conditions and
outcomes that might be encountered
when determining the practicability of
an IST or ISD considered in the STAA.
EPA expects that facility owners and
operators will use their expertise and
make reasonable judgements when
considering the appropriate meaning of
economic or social factors so that any
decisions regarding possible
implementation of IST is not driven
towards changes that would cause
unintended adverse consequences.
Finally, EPA disagrees with
commenters’ assertion that accounting
for the factors in the definition of
‘‘practicability’’ could be used as an
excuse to avoid necessary
implementation measures. EPA is not
requiring IST or ISD implementation in
the final rule and, therefore, further
clarifying the practicability definition
will not impact IST or ISD
implementation.
78 https://www.nj.gov/dep/enforcement/tcpa/
downloads/IST_guidance.pdf.
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Consistency of feasible definition with
other programs. A commenter
encouraged EPA to incorporate the
definition of ‘‘feasibility’’ provided in
the Contra Costa County Safety Program
Guidance Document. Another
commenter stated that the proposed
definition of ‘‘feasibility’’ is consistent
with California’s proposed California
Accidental Release Prevention (CalARP)
regulations and the Contra Costa County
and the City of Richmond’s Industrial
Safety Ordinances. However, a state
agency, commented that there is an
inconsistency with CalARP’s definition
of ‘‘feasible’’ in that the proposed EPA
definition omits the terms ‘‘health’’ and
‘‘safety,’’ and the commenter
encouraged EPA to add these terms to
the list of factors to consider in a
determination of feasibility.
EPA based the feasible definition on
the CCHS definition of ‘‘feasible’’ but
modified the definition to add language
acknowledging that environmental
factors include a consideration of the
potential to transfer risks or introduce
new risks to a process or source. The
practicability definition in the final rule
maintains this language.
EPA disagrees with the suggestion to
add the terms ‘‘health’’ and ‘‘safety’’ to
the definition. The primary reason for
EPA to consider ISTs in a STAA is to
reduce risks to health and safety of the
public by mitigating the frequency and
severity of accidental releases. EPA
believes this is adequately addressed in
the definition of ‘‘inherently safer
technology or design’’ of this final rule
and including these factors in the
definition of ‘‘practicability’’ would be
redundant.
Suggested revisions to feasible
definition. One commenter argued that
the term ‘‘within a reasonable time’’ in
the definition of ‘‘feasible’’ could allow
facilities to avoid implementation, and
urged EPA to exclude a time based
factor from the final definition. This
commenter also argued that EPA should
not make any level of cost, no matter
how minimal, an excuse to not
implement any IST measures, but rather
should recognize that IST measures
should be implemented unless doing so
would cause an extremely serious
adverse economic effect, such as a
facility shutdown. A facility noted that
the proposed feasibility analysis does
not allow sufficient time to complete the
necessary work and recommended that
the timeframe be determined on a case
by case basis. A state agency
commented that the feasibility of an IST
must consider factors such as timeliness
of implementation and costs. This
commenter expressed concern that the
definition of ‘‘feasible’’ would allow for
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the implementation of IST options that
may not be economically justifiable
compared to other equally protective
options.
Some commenters recommended
deleting the explanation of
environmental factors in the feasible
definition. These commenters warned
that this language is too specific in
comparison with the general terms
included in the definition. One
commenter expressed concern that the
language shows an industry bias and
suggested using the following
alternative definition: ‘‘Feasible means
capable of being successfully
accomplished within a reasonable time,
accounting for economic,
environmental, legal, social, and
technological factors weighed against
the immediate and long-term benefits to
safety and health. A claim of
infeasibility shall not be based solely on
evidence of reduced profits.’’
EPA disagrees with the commenters.
Cost is a consideration when
determining whether a risk management
measure can be successfully
accomplished and because EPA is not
requiring implementation of any IST,
we see no reason to exclude this factor
from a practicability determination. EPA
also disagrees with the suggestion to
limit consideration of reduced profits
when assessing a risk management
measure because the Agency believes
that cost is a valid consideration for
practicability. Identifying an amount of
an allowable cost for an IST is not
something that can be prescribed in the
regulation because cost decisions are
highly dependent on the economics
involving a particular process, facility
and industry.
EPA also disagrees that incorporating
consideration of a reasonable timeframe
will allow facilities to avoid
implementation. EPA is not requiring
IST implementation and we
acknowledge that there may exist
practical limits on whether some
projects or process designs can be done
to enhance safety. If a risk management
measure cannot be accomplished within
a reasonable time, then the facility
should ensure that other safeguards are
in place to prevent accidents instead of
relying on the uncertainty of completing
a long-term project that is dependent on
future conditions such as process
design, operating budgets, etc.
Finally, as other commenters have
noted, some ISTs involving chemical
substitution or significant process
redesign can result in new hazards or
risks being introduced, and these should
be considered when deciding the
practicability of an IST. Thus, EPA is
retaining the explanation of
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4637
environmental factors in the
practicability definition in this final
rule.
Definition should be stronger than
OSHA definition of ‘‘feasible.’’ One
commenter urged EPA to adopt a
definition that is stronger than or at
least as protective of health and safety
as the OSHA definition of ‘‘feasible’’ to
provide an appropriate minimum level
of protection under CAA—42 U.S.C.
7412(r)(7) that EPA should not go
below. The commenter states that under
the OSHA standard, a protective
measure is technologically feasible if,
using existing technology or technology
that is reasonably expected to be
developed, a typical facility could
achieve the standard in most operations
most of the time. Additionally, the
protective measure is economically
feasible if its costs do not threaten the
existence or competitive structure of an
industry. The commenter contends that
OSHA’s definition has been interpreted
by courts to mean that the mere expense
of a measure, alone, cannot trump the
implementation of safety measures that
are ‘‘capable of being done.’’ The
commenter believes that EPA should
not set a weaker definition that would
make it less likely that IST or other
prevention measures would be
implemented under § 7412(r) than
under OSHA’s definition. Doing so
would be both inconsistent with the
objectives of § 7412(r) to protect the
public and with the existing framework
facilities follow under OSHA
requirements, could lead to confusion
for facilities and in the courts, and
result in an overall reduction in safety
measures.
EPA disagrees with the commenter
and believes the approach in the final
rule to consider the practicability of IST
or ISD considered is consistent with the
intent of CAA and will not lead to an
overall reduction in safety measures.
The current rule already requires the
PHA to consider active, passive and
procedural risk management measures
in § 68.67; however, the requirements
do not prescribe exactly which type or
exactly what engineering and
administrative controls must be
implemented. The regulations allow
facilities to use their specific knowledge
and expertise of the process to meet the
PHA requirement to ‘‘identify, evaluate
and control the hazard’’ [emphasis
added]. EPA is finalizing a requirement
for certain sectors to conduct a STAA
that also considers IST in the hierarchy
of controls. However, requiring facilities
to implement IST instead of using
passive, active or procedural safeguards
can involve extensive and very
expensive changes to a facility’s
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process, depending on the IST,
especially if it involves substitution of
alternative chemicals and/or major
process redesign. EPA believes that a
practicability consideration should
address whether an IST or ISD can be
accomplished technologically, is
economically possible, does not result
in an increase in hazards or other risks
that cannot be controlled, or cannot be
successfully accomplished because of
other considerations. Therefore, EPA
disagrees that the practicability
definition should be stronger than (or
even similar to) OSHA’s interpretation
of feasible.
Harmonize feasible definition with
OSHA. A facility noted that the
proposed definition of ‘‘feasible’’ in
§ 68.3 could cause the potential for
confusion because the proposed
rulemaking preamble states that OSHA
has indicated that it would be unable to
adopt the term feasible, as defined in
this notice, under its PSM standard if
OSHA considers similar revisions
involving IST. This is an illustration of
the need to harmonize the requirements
of EPA RMP requirements with that of
OSHA PSM.
A few commenters, including
facilities and industry associations,
urged harmonization with OSHA’s
definition of ‘‘feasibility’’ and
requirements. A facility and an industry
trade association warned of the
confusion that could ensue if
‘‘feasibility’’ is defined inconsistently
between EPA and OSHA, and
encouraged EPA to use the term
‘‘practicability’’ instead. Similarly, an
industry trade association urged EPA to
use the term ‘‘practical’’ in place of
‘‘feasible.’’ The industry trade
association argued that what is deemed
feasible is often not practical for a
number of reasons, and asserted that
any decision to alter a technology
involves a complex variety of factors
such as operating costs, associated risk,
energy consumption and greenhouse gas
emissions. The commenter concluded
that only facility owners should
ultimately be able to define what is
feasible or practical for their facility. In
contrast, a state agency encouraged use
of the term ‘‘feasible’’ rather than
‘‘practical.’’ An industry trade
association asserted that neither term
should be the basis for the analysis.
EPA agrees with commenters and is
revising the rule to replace the term
‘‘feasible’’ with ‘‘practicability.’’ EPA
proposed to use the term ‘‘feasibility’’ as
part of the STAA analysis as it is
already widely used in the technical
literature discussing IST. However,
because OSHA is considering similar
revisions to its PSM standard involving
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IST and in order to eliminate the
potential for confusion of different
meanings of the term ‘‘feasible,’’ 79 EPA
has decided to use the term
‘‘practicability’’ while retaining the
same definition and meaning used for
‘‘feasible’’ in the proposed rulemaking.
Hierarchy of controls. A commenter
noted that California’s proposed
regulations for refineries and EPA’s
proposed regulations would require that
the facility look for inherently safer
means to reduce the hazards, but if there
is not a means to reduce the hazard, the
facility would go through a hierarchy of
prevention methods and select the
highest level of prevention. This
commenter and another requested that
EPA use the term ‘‘Hierarchy of
Control,’’ which is a term that is already
understood, instead of adding a brand
new term.
EPA does not use the term hierarchy
of control (nor substitutes a new term
for it) but instead explicitly explains the
concept in the regulation by stating that
the owner or operator shall consider risk
management measures in the following
order of preference:
• Inherently safer technology or
design,
• Passive measures,
• Active measures, and
• Procedural measures.
EPA believes this is consistent with
proposed CalARP regulations 80 for
Hierarchy for Hazard Control Analysis,
which require refineries to eliminate
hazards using first order inherent safety
measures; to reduce any remaining
hazards using second order inherent
safety measures; and to address any
remaining risks in the following
sequence and priority by using passive
safeguards, active safeguards, and
procedural safeguards.
Passive measures. A commenter
recommended revising the definition of
‘‘passive measures’’ to ‘‘mean risk
reduction measures designed to reduce
the probability or the consequences of
an accidental regulated chemical release
without human intervention’’ to better
reflect that EPA probably meant
‘‘reducing the hazard’’ as an aspect of
risk management. The commenter views
‘‘hazard’’ as the inherent capacity of a
substance to cause an adverse effect,
while ‘‘risk’’ is the probability that an
adverse effect will occur, if one uses
OSHA’s definition of the terms. In
addition, the commenter said that the
79 81
FR 13667, March 14, 2016.
80 Draft California Accidental Release Prevention
Program (ARP) Regulations, California Governor’s
Office of Emergency Services. July 5, 2016, p. 83
https://www.caloes.ca.gov/FireRescueSite/
Documents/
CalARP%20Proposed%20Regs%202016.pdf.
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definition of ‘‘other energy inputs’’
needs revision, and suggested replacing
the phrase ‘‘energy inputs’’ with
‘‘human intervention’’ to meet the intent
of the definition. This commenter
expressed concern that the word
‘‘other’’ in the phrase ‘‘other energy
input’’ mischaracterizes pressure vessel
designs, dikes, etc. as energy inputs.
This commenter also suggested that
passive ‘‘design features’’ could include
mechanical or energy intervention
measures and the commenter cited
examples such as automatic fire
suppression systems and automatic
vapor ignition.
EPA agrees with the commenter’s
suggestion to revise the definition of
‘‘passive measures’’ to address the
frequency and consequence of the
hazard. EPA based the proposed
definition of ‘‘passive measures’’ on the
definition used by CCPS, which defined
‘‘passive’’ as ‘‘minimizing the hazard
through process and equipment design
features that reduce either the frequency
or consequence of the hazard without
the active functioning of any device, i.e.,
providing a dike wall around a storage
tank of flammable liquids.’’ 81 Thus the
intent of the CCPS definition appears to
be on aspects of both hazard and risk
reduction. EPA is modifying the
‘‘passive measures’’ definition in the
final rule to clarify that passive
measures reduce the frequency or
consequence of the hazard.
EPA disagrees that the word ‘‘other’’
in ‘‘other energy inputs’’ characterizes
pressure vessel designs and dikes as
energy inputs and also disagrees that
passive design features would include
automatic fire suppression systems or
automatic vapor ignition (in which a
flare is ignited). These types of measures
would most likely be considered to be
active measures. CCPS, in their
Guidelines for Hazard Evaluation
Procedures,82 cites a fire protection
system as an active safeguard because a
fusible link or other engineered device
must function to successfully trip the
system.
IST/ISD. A number of commenters,
requested clarification on the definition
of IST, ISD or Inherently Safer
Measures. A few wanted clarification as
to what would qualify as ‘‘safer’’ in this
context. One labor union expressed
general support for the proposed
definition of IST. One commenter asked
81 CCPS. 2009, Inherently Safer Chemical
Processes: A Life Cycle Approach. 2nd ed., p. 10.
https://www.regulations.gov/document?D=EPA-HQOEM-2015-0725-0253.
82 CCPS. 2008, Guidelines for Hazard Evaluation
Procedures. 3rd ed., p. 234. https://www.aiche.org/
ccps/publications/books/guidelines-hazardevaluation-procedures-3rd-edition.
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EPA to ensure that there is a distinction
between IST and less effective controls
and management methods. This
commenter argued that chemical
substitution and process changes are the
most effective methods to protect
workers and the public from incidents
and that these ‘‘inherently’’ safer
options should be distinguished from
less effective controls and management
methods. The commenter cited lesser
effective controls from the NJDEP IST
compliance, such as safer extremely
hazardous substance risk location,
protection of storage vessels from
weather conditions, changes in truck
traffic patterns, addition of EHS leak
detectors, use of closed circuit
television systems, labeling of valves
and equipment, revising procedures,
installing a simulation training station,
and adding light towers for EHS leak
alarms. The commenter requested that
EPA develop a precise definition for IST
and Inherently Safer Design (ISD).
EPA disagrees with the commenters’
suggestions to provide a distinction
between IST and other controls and
management methods. EPA believes that
determining effective risk management
strategies for a facility is a site-specific
determination and EPA encourages any
improvement that will could lead to
inherently safer conditions. Therefore,
EPA is finalizing the definition of IST/
ISD as proposed.
EPA based its definition of inherently
safer technologies (IST) or design (ISD)
on the four inherently safer strategies as
explained in the Inherently Safer
Chemical Processes: A Life Cycle
Approach by CCPS.83 These four types
of strategies have been widely
recognized by the industry and best
encompass the concepts and principles
of applying inherent safety, which
focuses on eliminating or reducing the
hazards associated with a set of
conditions.
As the 2010 CCPS Final Report:
Definition for Inherently Safer
Technology (IST) in Production,
Transportation, Storage and Use 84
states:
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IST (Inherently Safer Technology), also
known as Inherently Safer Design (ISD),
permanently eliminates or reduces hazards to
avoid or reduce the consequences of
incidents. IST is a philosophy, applied to the
design and operation life cycle, including
83 CCPS. 2009, Inherently Safer Chemical
Processes: A Life Cycle Approach. 2nd ed., https://
www.regulations.gov/document?D=EPA-HQ-OEM2015-0725-0253.
84 CCPS. July 2010. Final Report: Definition for
Inherently Safer Technology in Production,
Transportation, Storage, and Use, https://
www.regulations.gov/document?D=EPA-HQ-OEM2015-0725-0274.
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manufacture, transport, storage, use, and
disposal. IST is an iterative process that
considers such options, including
eliminating a hazard, reducing a hazard,
substituting a less hazardous material, using
less hazardous process conditions, and
designing a process to reduce the potential
for, or consequences of, human error,
equipment failure, or intentional harm.
[emphasis added]
4639
d. General Comments on STAA
Requirements
Suggestions for minimal elements for
STAA methodology. An environmental
advocacy group noted that in the
proposed rulemaking, EPA states that
owners and operators may use ‘‘any
available methodology or guidance’’ to
conduct their STAA, but urged EPA to
define the minimum basic elements that
owners or operators must include in
their STAA. The commenter believed
the STAA should include an analysis of
the technical, economic, legal/
regulatory, social, and hazards
implications of each major technology
option, and noted that the sample
methodologies and guidance listed in
the proposed rulemaking may not
include all of these elements. The
commenter urged EPA to require the
economic analysis to include potential
liabilities, costs, avoided costs, and
savings associated with each major
STAA option evaluated.
EPA does not believe it should specify
factors other than those already present
in the PHA and STAA requirements,
including the definition of
‘‘practicability.’’ EPA believes that
various resources and guidance exist (as
well as existing PHA methodologies,
such as HAZOP, What-If? Method, or
checklists or a combination of these as
discussed in Chapter 8 of CCPS’ book,
Inherently Safer Chemical Processes: A
Life Cycle Approach 86) that can assist
facilities in understanding how IST can
reduce hazards and risk and in
determining practicability of IST or ISD
considered in the STAA. Facilities can
follow, for example, guidance for IS
Review Documentation found in CCPS’s
Inherently Safer Chemical Processes,
which suggests documenting the
summary of the approach used for the
IS review (i.e., methodology, checklist,
etc.), names and qualifications of the
review team, IS alternatives considered,
as well as those already implemented or
included in the design, results of each
consideration including those not
considered and why, documentation of
feasibility and rationale for rejection of
IS opportunities.
While some facilities may choose to
conduct an economic analysis of
potential liabilities, costs, avoided costs,
and savings associated with each major
STAA option evaluated, EPA is only
requiring facilities to determine whether
IST is practicable and document this
determination. It may not be always be
possible to estimate avoided costs and
savings for a particular IST.
STAA is not a suitable replacement
for other prevention program measures.
An association of governments
expressed concern that analyses will not
prevent accidents because human
factors such as operational bias towards
production rather than safety, failures to
manage changes, failures to provide
adequate training for employees and
failures to follow standards cannot be
eliminated by a safer technology
analysis. The association warned that
the analysis could be used as a
substitute for appropriate emergency
preparedness and accident prevention
programs. The commenter also believed
that adoption of safer technology
without a holistic review of risk
transfers might be dangerous.
EPA does not believe or intend that a
safer technology analysis as part of the
exiting PHA would negate the need or
requirements for facilities to follow
other RMP rule provisions, such as
training, managing change, and
following RAGAGEP. Rather this
analysis is designed to supplement or
enhance the ways that hazards or risks
of an accidental release can be
eliminated or reduced by possibly more
rigorous risk reduction measures.
85 NJDEP TCPA. March 29, 2012. NJ Title 7,
Chapter 31 TCPA Program Consolidated Rule
Document, https://www.nj.gov/dep/rules/rules/
njac7_31.pdf.
86 CCPS. 2009. Inherently Safer Chemical
Processes: A Life Cycle Approach, 2nd ed.,
American Institute of Chemical Engineers, CCPS
New York, Wiley.
The CCPS guidance is organized by
these four strategies and provides many
examples of each type of strategy.
NJDEP also uses descriptions of the four
strategies to identify available IST
alternatives in their inherently safer
technology review requirements.85
Although some NJ facilities may have
reported some controls that others might
not strictly view as IST, EPA does not
believe that IST should be limited only
to chemical substitution and process
changes. Some changes such as better
labeling of equipment are cited as
examples of process simplification in
CCPS’ IST Checklist. Changes involving
transportation of chemicals and storage
location are also cited in the checklist
because inherent safety can involve
reduction of hazard, and does not
require complete elimination of a
hazard.
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Facilities can evaluate the feasibility of
potential safer technologies and this
evaluation can and should take into
account any known transfers of risk, as
well as other considerations. For this
reason, EPA is not prescribing that
facilities adopt any particular safer
alternative and is allowing any decision
on implementation of IST to be made
based upon a facility’s judgement using
accepted hazard analysis and their
knowledge of their processes, hazards,
risks and methods to control hazards.
EPA does not believe the analysis could
be used as a substitute for appropriate
emergency preparedness and accident
prevention programs—existing
requirements in these areas are still in
place and this final rule also provides
more emphasis on emergency
coordination and response (for more
information see section V of this
preamble).
STAA guidance, regulatory incentives
and voluntary partnership programs. An
industry trade association suggested the
establishment of a working group to
develop decision framework and
guidance materials for STAAs. The
commenter remarked that creation of a
working group would be more effective
than mandating RMP facilities to
conduct STAAs with insufficient
guidance. A commenter recommended
that the working group should consider
existing voluntary programs that
include a safer alternatives assessment,
and should consider the possibility of
establishing a public-private
partnership. The commenter further
explained that the working group
should explore how EPA could leverage
these programs by providing regulatory
incentives to those who participate in
and fulfill the requirements of the
voluntary programs. The commenter
also suggested that a partnership could
be created based on the core principles
adopted by industry (i.e., stewardship)
programs and the lessons learned from
existing and past voluntary partnership
programs. The commenter stated that
such a program could provide technical
assistance and tools to help create
awareness and instill a quality culture
of safety and security. The commenter
provided a white paper with more
detailed discussion on the potential
purposes, components, incentives and
requirements for a voluntary
partnership program to improve
chemical safety and security.
EPA appreciates the commenters’
suggestions for developing guidance,
regulatory incentives and partnership
programs for STAAs. EPA is finalizing
a regulatory provision requiring
Program 3 industry sectors in NAICS
codes 322, 324, and 325 to conduct an
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STAA as part of the PHA and determine
the practicability of IST or ISD
considered. EPA disagrees that STAA
should be limited to a voluntary
partnership program; however, EPA will
further consider the merits of a potential
voluntary partnership program with
industry to engage in improved process
safety practices.
EPA believes the STAA requirements
are flexible and allow the use of
industry expertise to best decide which
safer technologies and alternatives to
consider, and to determine the
practicability of IST or ISD considered
in the STAA. EPA will develop
guidance for complying with RMP PHA
and STAA requirements before sources
must comply with the STAA provision
required in this action. A draft of this
guidance will be available for public
comment.
Making STAA information available
to LEPCs. A facility is concerned that
the proposed requirement to share
information pertaining to inherently
safer technology or design with the local
LEPC would require specific detailed
information that the LEPC may not
consider relevant. While the facility
expressed willingness to share
appropriate information with the LEPC,
the facility does not believe the LEPC
would be interested in the minute
details of the changes in process units.
An industry trade association stated that
not requiring implementation while
requiring facilities to provide LEPCs the
date of implementation or planned
implementation could cause confusion.
EPA agrees that providing LEPCs with
detailed information regarding process
changes involving IST or ISD may not
always be relevant or necessary to
community emergency preparedness or
can be confusing. The final rule
eliminates the proposed requirements
under § 68.205 to provide information to
the LEPC, upon request (including IST
information). For more information
about how the final rule addresses
sharing information with LEPCs or
emergency response officials, see
section VI.A. of this preamble.
e. Including STAA as a PHA
Requirement
Appropriateness of PHA techniques
or process for STAA. A few local
agencies expressed support for STAA
measures being used as a method of
addressing PHA recommendations.
Commenters, including a local agency,
encouraged the review of the STAA at
least every five years.
However, several commenters
opposed including STAA in the PHA.
Two trade associations commented that
requiring PHA teams to evaluate the
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feasibility of IST has the potential to
undermine the effectiveness of the PHA
process. The commenters argued that
regulating IST is infeasible because
there is no simple answer when it
comes to managing risk. The same two
trade associations and one facility
asserted that a PHA review of an
existing process considers the adequacy
of the existing controls for that process
while an IST review is entirely different.
The commenters believe an IST review
involves a comparison to a different
technology and an operation-specific
and site-specific evaluation based on
engineering judgment, in which many
variables are considered that include
hazards, the location of the facility,
surrounding populations, exposures,
technical feasibility and economic
feasibility. A state agency and an
industry trade association warned that
requiring STAA during the PHA would
be inappropriate because the structure
of a PHA does not facilitate such an
analysis.
A facility expressed concern that none
of the PHA methodologies described in
the NPRM require this type of
comparison, arguing that IST/ISD
methodologies are similar, but not
identical, to PHA analysis techniques.
The facility stated that it would be
wrong to assume that STAA can be
directly incorporated into existing PHA
methodologies. A trade association
commented that in order to have PHA
team members perform a comparative
analysis on alternatives, the PHA team
would be required to compile relevant
process safety information for the
alternatives in order to perform the IST
analysis.
One commenter believes that IST
needs to be evaluated outside of the
PHA process because the node-to-node
hazard and operability study (HAZOP)
approach is minutely focused, does not
look at the bigger picture and reduces
the impact of IST to localized risk
reduction measures rather than making
the whole process inherently safer. The
commenter stated that a separate IST
analysis for the entire existing process is
needed and could be performed every
five years but separately from the PHA
since different team participants (such
as technical experts) are usually needed.
One trade association and a facility
believed that IST analyses are not
practical to conduct as part of a PHA for
a defined process with defined
chemicals. The commenters claimed
that to consider a substitute, a facility
operator would need to design the new
process before being able to conduct the
analysis. Some facility commenters
reasoned that design and hazard reviews
for new facilities can take place years
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before any PHA. An industry trade
agency suggested that EPA should
include appropriate lead-time and
grandfathering provisions so as not to
disrupt projects already in the design or
construction phase. Finally, an industry
trade association asserted that IST
decisions are very complex and should
not be determined by any government
agency, and recommended that EPA
delete the proposed STAA provisions.
EPA believes that IST analysis can be
incorporated in the existing RMP PHAs
by using PHA techniques such as
HAZOP, What-If? Method, or checklists
or a combination of these as discussed
in Chapter 8 of CCPS’ book, Inherently
Safer Chemical Processes: A Life Cycle
Approach.87 These techniques
themselves are not requirements, but
tools available to help the facility owner
or operator to identify, evaluate and
control the hazards involved in the
process.
While developing the original RMP
rule, EPA noted some commenters
strongly opposed any requirement for
safer technology analyses because PHA
teams regularly suggest viable, effective
(and inherently safer) alternatives for
risk reduction. In the preamble to the
original RMP rule, EPA agreed with
these commenters, indicating that
‘‘application of good PHA techniques
often reveals opportunities for
continuous improvement of existing
processes and operations without a
separate analysis of alternatives.’’ 88
While these comments in 1996 led us to
not require STAA in the original rule,
further developments in STAA, and
EPA’s own experience with
implementation of the rule, now
indicate that a specific mandate to
conduct STAA reviews as part of the
PHA will encourage facilities who were
performing PHAs that were of lower
quality but legally compliant with the
old rule, to perform better PHAs.
Therefore, EPA disagrees with
commenters that argue it is not
appropriate to include an STAA in the
PHA. In fact, the RMP PHA
requirements include other aspects of an
analysis that is typically associated with
process design. For example, the PHA
must also address stationary source
siting issues which involve the location
and proximity of the source to local
population and their numbers.
Nevertheless, EPA agrees that for
situations where an IST would involve
a new process that is entirely different
87 CCPS. 2009. Inherently Safer Chemical
Processes: A Life Cycle Approach, 2nd ed.,
American Institute of Chemical Engineers, CCPS
New York, Wiley.
88 See 61 FR 31699, June 20, 1996.
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from the current process, the process
design would have to exist or be
developed, and process safety
information be compiled, to conduct a
PHA for this new process. EPA does not
expect facility owners or operators to
research and create new process designs
or conduct research into all possibilities
for the use of new chemicals. Instead,
the STAA should focus on the known
and existing substitute processes and
chemicals that have been demonstrated
to be in use commercially.
If a facility is considering a chemical
substitution or process change that
involves a significant redesign of their
process, such efforts involved with
redesign and its evaluation may need to
be undertaken as part of a practicability
study.89 The definition of
‘‘practicability’’ allows for consideration
of technological factors, which could
include whether the potential safer
alternative can be designed and
operated to meet the process functions
needed. However, not all IST involves
substituting a chemical or an entirely
new process and there are other types of
other IST measures (minimization,
moderation or simplification) that can
be considered to address various points
within the current process where
hazards and risks exist. Furthermore,
the final rule does not require the
facility to implement IST measures.
Facilities may, if desired, conduct a
separate IST analysis of each covered
process, outside of the PHA, if desired,
as long as it is done in same timeframe
as the PHA and the results are
documented. If a facility does not have
staff capable to identify and evaluate
alternatives, the facility owner or
operator may require outside assistance
from engineering firms or consultants.
The RMP PHA requirements require
the facility owner or operator to identify
risk management measures that
eliminate or reduce the risks from the
process hazards. If the facility has
already performed such IST analysis in
the past, then the owner or operator
should consider these analyses when
updating or revalidating their PHAs and
determine whether there is new
information that should be considered
as part of conducting the current STAA.
Involvement and training of
employees and team members. An
industry trade association expressed
89 EPA modified the final rule to replace the term
‘‘feasible’’ defined in § 68.3 with ‘‘practicability.’’
When evaluating the practicability of an IST, the
facility owner or operator would determine whether
the IST is capable of being successfully
accomplished within a reasonable time, accounting
for economic, environmental (including
consideration of potential transferred risks for new
risk reduction measures), legal, social, and
technological factors.
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concern about the potential experience
limitations of the PHA team. The
commenter stated that team members
may lack the expertise required to assess
all alternative technologies, and said
that in the case of inadequate
experience the STAA should be
considered within the management of
change element of the RMP and the
facility’s ongoing risk assessment
analysis. Two trade associations
commented that a PHA and an IST
analysis serve two entirely different
engineering functions and the teams
that conduct these reviews are staffed
differently. The two associations further
commented that small facilities do not
have staff design engineers to conduct
an IST review, which means the facility
would be required to absorb the cost of
retaining them even though there is no
requirement that their findings be
implemented.
One Federal agency commented that
throughout the SBAR panel process,
SERs noted that this analysis would
require additional staffing such as
design engineers, in addition to the
chemical and mechanical engineers
already staffed for PHA analyses. The
SERs added that most small facilities do
not have design engineers on staff and
as a result, would need to incur
additional expenses to retain them.
Another commenter stated that
conducting a full IST/ISD review based
on yet-unproven technologies typically
is an extremely complex endeavor
(particularly for a chemical production
process), and would require very
different PHA teams that could
adequately assess IST/ISD (e.g., to
adequately study how the hypothetical
use of new IST/ISD might create
additional, unanticipated hazards
throughout a process).
Another commenter suggested that
the PHA/hazard review team should be
properly educated in inherent safety
analysis. A professional organization
encouraged the participation of workers
in the STAA process, but urged that
these employees must have proper
training and education to participate.
Some commenters recommended
engaging workers in the alternatives and
feasibility assessment process and
making sure they have the ability to
report anonymously and hold
whistleblower authority. One
commenter urged EPA to explicitly state
that union representatives and workers
can participate fully in the STAA.
EPA believes that limiting the
applicability of the STAA requirement
to only those facilities in Program 3 in
the petroleum and coal products
manufacturing (NAICS code 324),
chemical manufacturing (NAICS code
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325) and paper manufacturing (NAICS
codes 322) minimizes the burden of the
requirement for many small businesses.
Of those approximately 1,557 facilities
that are subject to the STAA
requirements, approximately 40% of
them are owned by small entities,
however, about 86% of these small
entity-owned facilities have 20 or more
full-time equivalent employees.90 EPA
agrees that team members conducting an
STAA should be properly trained and
knowledgeable on how to conduct the
analysis. The facility owner or operator
is responsible for ensuring that facility
personnel have the proper training to
conduct STAAs or hire consultants with
the appropriate qualifications. EPA
expects that some facilities in NAICS
codes 322, 324, and 325 will have staff
qualified to conduct the analysis. If the
facility owner or operator determines
that two different teams should conduct
the PHA and STAA, then they may
choose to conduct a separate STAA of
each entire process, outside of the PHA
as long as it is done in same timeframe
as the PHA and the results are
documented.
As discussed in the RIA, the technical
practicability assessment considers the
extent of process redesign, its
engineering implications, and possible
costs. EPA estimates that most facilities
except the large facilities in NAICS
codes 322, 324, and 325 will seek help
from consultants (i.e., engineering firms)
to conduct STAA and determine the
practicability of IST/ISD considered.
However, EPA does not expect facilities
to spend resources evaluating
hypothetical untested alternatives that
they believe are not proven within their
industry.
Finally, the final rule provides facility
owners or operators the flexibility to use
facility personnel with expertise and
experience with facility processes and
their industry to conduct STAAs and
determine the practicability of IST/ISD
considered. However, EPA does not
believe the RMP rule is the appropriate
mechanism to address worker rights or
whistleblower protections.
Overlap or conflict with PHA analysis.
A few industry trade associations and a
facility expressed concern that an IST
analysis would detract from the goal
and focus of the PHA process to identify
hazards to be addressed and to identify
opportunities for continuous
improvement of operations. For
example, one commenter was concerned
that in an effort to ensure compliance
90 Regulatory Impact Analysis, Accidental Release
Prevention Requirements: Risk Management
Programs Under the Clean Air Act, Section
112(r)(7), using data from Exhibit 7–3 and 7–5.
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with new safer alternative technology
analysis regulations, PHA teams may be
distracted from identifying and
addressing the hazards of existing
processes by spending too much time
assessing potential alternative
technologies with which they have no
experience. Two commenters
elaborated, stating that requiring IST or
ISD ‘‘consideration’’ based on a laundrylist of ‘‘factors’’ would substantially
increase the already extensive time that
is required to complete a PHA, and
favor subjective reviews over objective
reviews of actual safety problems and
the most direct and timely techniques
required to resolve them.
EPA disagrees with the commenters.
The RMP PHA requirements are not
only to identify hazards but also to
incorporate measures to reduce or
mitigate those hazards. Under § 68.67(a),
the rule requires the owner or operator
to identify, evaluate and control the
hazards involved in the process. Several
commenters acknowledge that some
companies already evaluate ‘‘safer
alternatives’’ during their PHAs when it
is efficient to consider fundamental
process changes. EPA disagrees that
consideration of additional inherently
safer measures necessarily precludes
addressing hazards and applying other
risk reduction measures in the hierarchy
of controls. If facility owners or
operators are concerned that an IST
assessment could preclude other aspects
of the PHA, they may choose to conduct
the STAA separately from the PHA, as
long as it is performed on the same
timeframe and documented.
IST already incorporated as part of
PHA or otherwise considered. Another
industry trade association remarked that
STAA requirements are already a
component of the PHA and concluded
that costs of the new requirement would
be redundant, but that these costs are
incommensurate with the much lower
risks faced by facilities in their industry.
One trade association disagrees with
requiring STAA as part of the PHA
because currently approved PHA
methodologies already provide for
successful risk mitigation (reducing
risks to personnel and the environment
to ‘acceptable’ levels), including the
consideration of inherently safer design
technologies by the PHA team where
appropriate. A commenter noted that
some companies already evaluate ‘‘safer
alternatives’’ during their PHAs when it
is efficient to consider fundamental
process changes. However, they
consider available, proven technologies,
not ‘‘potentially’’ safer technology that
may be noted in literature, but not yet
in use anywhere within their industry.
Another industry trade association
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remarked on the importance of process
safety information for alternatives and
its availability to the PHA team. A
process safety organization commented
that they believe the existing provisions
to conduct a PHA automatically
includes the team to consider safer
alternatives as appropriate and
applicable. An industry trade
association said that many of the
activities being reported as IST in
NJDEP’s IST Implementation Summary,
were activities that already occur as a
matter of course in most facilities.
A facility and multiple industry trade
associations remarked that other
programs such as the Department of
Homeland Security’s Chemical Facility
Anti-Terrorism Standards (CFATS)
already provide incentives for facilities
to promote safe practices, and
implement safer alternatives and
designs. Several commenters urged EPA
to avoid burdensome requirements that
overlap with the CFATS program at
additional cost without added benefit.
An industry trade association noted that
CFATS allows facilities to move to a
lower risk tier or out of the program if
risk profiles are reduced and
vulnerabilities are minimized, resulting
in roughly 3,000 facilities that have
changed processes or inventories in
ways that have enabled them to be
excluded from the program. This
commenter notes that DHS’s risk
performance-based approach does not
mandate solutions, recognizes the
unique situation of each facility, and
embraces a public-private sector effort
for implementation of safer measures.
The commenter further indicated that
mandating the adoption of governmentselected ISTs would be unduly
burdensome, particularly for smaller
chemical facilities, and could hinder
their overall efforts at improving
security.
While EPA recognizes that some
facilities may already consider ISTs as
part of a PHA, whether as part of a
voluntary program or through other
incentives, EPA believes that all
facilities in NAICS 322, 324, and 325
industry sectors should consider IST to
ensure that they are considering all the
options to operate their facility safer.
EPA expects that these regulatory
requirements will raise industry
awareness of IST possibilities and will
reduce risk. EPA is not mandating
implementation or adoption of any
particular IST and will rely on facility
expertise to reduce the hazard and
mitigate risk without causing
undesirable consequences such as
reducing product quality or transferring
risk to some other point in the supply
chain.
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Furthermore, EPA disagrees with
commenters that asserted that the STAA
requirements will overlap with other
regulatory requirements and result in an
increased burden with no corresponding
benefit. In its 2007 Interim Rule for
CFATS,91 DHS stated that Section 550
of the Homeland Security
Appropriations Act of 2007 prohibited
the Department from disapproving a site
security plan ‘‘based on the presence or
absence of a particular security
measure,’’ including ISTs.92 DHS noted
that, even so, covered chemical facilities
are certainly free to consider IST
options, and their use may reduce risk
and regulatory burdens. Therefore,
because DHS does not require IST or the
assessment of IST, EPA does not believe
there is an ‘‘overlap’’ in requirements.
Furthermore, DHS requirements address
site security measures, and not
measures designed to reduce accidental
releases.
Potential for risk tradeoff or risk
transfer. Some commenters, including
an association of government agencies
and an industry trade association,
encouraged a holistic review of IST to
avoid or minimize risk transfers. A few
commenters stated that, for example, a
facility adopting a safer technology may
increase transportation requirements of
hazardous materials and increase risks
of incidents outside of the facility,
including necessitating more exotic
emergency response equipment or
preparation. One commenter noted that
minimization frequently involves the
decrease of on-site storage and could
result in the potential for additional
shutdowns and startups due to
insufficient raw materials. The same
commenter further indicated that
substitution of a purportedly safer
alternative may introduce
environmental or safety risks that are
not realized until much later.
In contrast, an advocacy group urged
EPA to consider that the commenters
citing risk transfer are often industry
funded and, in the opinion of the
commenter, overlook risk transfer that is
caused by actions of the facilities
themselves. A process safety
organization stated that EPA should not
require an STAA as part of a new
prevention program, as part of the
existing PHA/hazard review, or as a
91 See 72 FR 17718, April 9, 2007, https://
www.gpo.gov/fdsys/pkg/FR-2007-04-09/pdf/E76363.pdf.
92 Section 550 has since been replaced by the
Protecting and Securing Chemical Facilities from
Terrorist Attacks Act of 2014, Public Law 113–254.
However, the prohibition on DHS disapproving a
security plan based on the presence or absence of
a particular security measure remains. See 6 U.S.C.
622(c)(1)(B).
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requirement under CAA section 112(r)
because the definition of ‘‘inherently
safer alternatives’’ has always been very
debatable and use of these alternatives
may not result in the overall reduction
of the total quantitative risk of the
facility. The organization expressed
concerns that a verbatim statement of
consideration and/or implementation of
inherent safer options has the potential
for unintended outcomes, such as risk
transfer, risk accumulation, increased
opportunities for terrorism, and other
undesirable tradeoffs. This commenter
recommended that EPA should not
require the IST analysis because few
technologies would be inherently safer
with respect to all hazards, there may
not be a clear implementation path for
all situations, and facilities would have
to address multiple tradeoffs in the
decision making process. The
commenter warned that improper
implementation of a ‘‘safer’’ alternative
may have negative consequences. Some
commenters note that an absolute safer
alternative is highly dependent on the
hazard, the process, the technology and
the facility. For every process there
could be different type of alternative
chemical use.
EPA recognizes the risk transfer
concerns raised by the commenters.
However, EPA believes that the final
rule allows the owner or operator to
consider the potential for quantitative
risk reduction, risk transfers and
tradeoffs when determining whether it
is practicable to implement ISTs or ISDs
considered. EPA agrees that some
technologies may not be inherently safer
with respect to all hazards, may not be
implementable for all situations and
may involve multiple tradeoffs in the
decision making process. IST is a
relative concept dependent on the
hazard, the technology, and the facility.
Therefore, EPA is requiring facilities to
only consider IST as a possibility for
addressing hazards rather than requiring
ISTs be implemented. The final rule
gives the facility owner or operator the
flexibility to assess IST as well as
passive, active, and procedural
measures to reduce risk associated with
a process and to determine the
practicability of any IST considered
based on various factors (including
those involving risk transference).
Current PHA requirements and other
risk reduction measures already
adequate address risks. Several facilities
and industry trade associations urged
that existing requirements and
principles, such as PHA and Layer of
Protection Analysis (LOPA), are
sufficient for determining if proper
safeguards are in place in existing
process units. Industry trade
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associations said that LOPA or similar
risk-based analyses are more easily
implemented and cost effective than
IST, and stated that risk-based analyses
also minimize risk shifting. A state
agency urged EPA to require a LOPA but
to ensure that it is clearly separated
from the STAA.
Some facilities and an industry trade
association remarked that industry has
proven capable of reducing hazards
from current operations by using active,
passive, or procedural measures. A
facility and an industry trade
association asked why the proposed
rulemaking is not specifically focused
on STAAs for new or potential
processes when, according to the
commenters, nothing indicates that IST
evaluations have become more
beneficial or less expensive for existing
process units since the 1996 RMP rule.
A facility asserted that current
regulations that require compliance
with RAGAGEP already ensure that
appropriate controls are implemented in
equipment and processes. One
commenter expressed concerns that the
STAA evaluation will become a
paperwork exercise that will not result
in any increase to safety. This
commenter suggests that EPA require a
review of safer technology or IST only
when the PHA results show that a
technology or design scenario does not
meet the company’s appropriate risk
tolerance/reduction requirements.
EPA believes that where feasible,
reducing or eliminating hazards through
change in materials, chemistry, or
process variables is preferable to adding
layers of safety to a process. While
layers of passive, active or procedural
controls will reduce the risk, they will
do nothing to reduce the nature of the
hazard itself. Failure of control devices
or human error can result in an
accidental release. However, an inherent
safer strategy seeks to preferentially
remove the hazard at the source, as
opposed to accepting the hazard and
attempting to mitigate the effects.93 In
addition to eliminating or reducing a
hazard, IST can also minimize the
impact of a release or terminate the
accident sequence before there are major
impacts on people, property or the
environment.
EPA agrees with other commenters
who have indicated that the PHA can
and should consider IST as hazard
reduction or risk management measures
where feasible and appropriate.
Opportunities for the application of the
93 CCPS. 2009, Inherently Safer Chemical
Processes: A Life Cycle Approach. 2nd ed.
American Institute of Chemical Engineers, Center
for Chemical Process Safety. pp. 10–11.
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inherently safer strategy of
simplification can be evaluated for each
safety device or procedure during a PHA
as well as in review of mechanical
integrity program practices and
procedures. CCPS provides examples for
this.94 Although we agree that the
general principles of PHA combined
with LOPA may at times be appropriate
to address the risk of an accidental
release, EPA believes that facility
owners or operators should consider IST
first in the hierarchy of risk reduction
measures to reduce and/or control the
hazards of a process.
Consideration of untested and
unproven technologies. One commenter
was concerned that any potential IST
considered should not have to include
untested and unproven technologies. An
industry trade association urged that
technology takes time to mature and
become acceptable and safe for
widespread use. Concerns were that
facilities might be encouraged to
substitute novel and untested controls
for existing controls and layers of
protection that are in place at existing
processes to control and manage risks,
detracting from actual safety
performance. One commenter was
concerned that operators should not be
required to update or replace technology
on a year-in, year-out basis simply
because new technologies are
introduced into the marketplace. One
commenter stated that any alternative
considered should be easy to be applied
and should have been properly tested.
EPA agrees that a facility owner or
operator may conclude that IST
measures that have not been tested or
used commercially should not be
considered. It may be difficult to
evaluate the practicability of
hypothetical technologies or those that
are still undergoing research and testing.
f. General Opposition to STAA
Benefits and cost of STAA not
adequately explained or justified.
Commenters warned that analysis of
existing facilities and processes is
unlikely to provide significant insights
or opportunities for safety improvement,
but may be very costly. A facility and
a number of trade associations asserted
that IST analysis would not
meaningfully increase safety. Stating
that safer technology would have been
adopted if it made business sense to do
so, a facility remarked that the STAA
requirement is unnecessary.
An industry trade association and a
facility expressed concern that the
94 CCPS. 2009, Inherently Safer Chemical
Processes: A Life Cycle Approach. 2nd ed.
American Institute of Chemical Engineers, Center
for Chemical Process Safety. pp. 112–113.
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process of retrofitting existing facilities
would be expensive and could result in
facilities shutting down. Several
commenters agreed with EPA
conclusions made in the 1996 RMP rule
regarding an IST analysis mandate
where the agency stated, ‘‘EPA does not
believe that a requirement that sources
conduct searches or analyses of
alternative processing technologies for
new or existing processes will produce
additional benefits beyond those
accruing to the rule already.’’ The
commenters, including a facility and
industry trade associations, warned that
EPA changed its position on whether or
not a mandatory IST analysis leads to
any incremental benefits, without any
clear rebuttal, analysis, explanation, or
substantiation of benefits from the
STAA and urged EPA to withdraw the
STAA mandate from the proposed
rulemaking. An industry trade
association, agreeing with EPA’s 1996
assessment, remarked that the new
conclusion was made without regard for
the nature of the reported accidents or
any scientific support. Many
commenters stated that requiring
STAAs would create a burden for
industries that would not produce any
significant benefits if the existing
process has already had risks addressed
by a PHA. A few commenters asserted
that, for most facilities, an IST analysis
would likely produce limited options
that would not justify the cost and effort
of the exercise itself.
Two industry trade associations
contend that there is no data to suggest
that requiring an STAA analysis
provides any measurable benefit or
reduces the frequency or severity of
incidents or any empirical studies
showing that STAA effectively improves
process safety. They believe that the
analysis of the New Jersey data for
facilities conducting IST analysis since
2008, shows no decrease in reportable
accidents and that revising the RMP rule
will likely have a negligible effect at
great cost to covered facilities.
Commenters asked whether or not
EPA’s analysis of the IST programs
implemented by New Jersey and Contra
Costa County has yielded any concrete
data demonstrating that the programs
have successfully reduced hazardous
safety risks over voluntary adoption.
One commenter urged EPA to withdraw
the proposed IST requirement until EPA
has conducted such an analysis.
Several trade associations commented
that the regulatory burden of requiring
costly IST reviews tends to stifle
innovation. The commenters asserted
that for those companies already looking
to improve safety by implementing IST
options, a formal IST review would add
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costs to a process by forcing them to
document the activities they are already
performing. They further indicated that
small operations might not have the
manpower or expertise to do this and
lack the resources to hire it out cost
effectively. The same commenters
further stated that for companies that do
not implement IST options, the IST
review becomes a ‘‘paper exercise’’
where they document why it is
‘‘infeasible’’ to implement these options.
Another commenter argued that if EPA
only intends for an analysis to be
conducted and not for the technologies
to be implemented, then the proposal
should be withdrawn on the basis that
it provides no benefit to the public.
One trade association commented that
there is no value in having a facility
perform an IST assessment if one was
already performed earlier in the
lifecycle of the process or to repeat the
same STAA every five years on the same
process. The association asserts that
nothing new will be learned from doing
so.
According to a facility and some
industry trade associations, the claim in
the proposed rulemaking preamble that
voluntary adoption of IST is becoming
more prevalent indicates that the
incremental benefits of mandatory
adoption are decreasing, which the
commenters remarked would be in line
with the 1996 decision not to require
IST analysis.
EPA believes that the STAA should
identify potential process changes
including IST that, if implemented,
would result in owners or operators
using less hazardous substances,
minimizing the amount of regulated
substances present in a process,
moderating process conditions,
reducing process complexity, or
implementing passive, active, or
procedural changes to make processes
safer. Such changes help prevent
accidents by either eliminating the
possibility of an accidental release
entirely, by making a process more
fault-tolerant, such that a minor process
upset or equipment malfunction does
not result in a serious accidental release,
and by reducing the severity of releases
that do occur. The STAA provision does
not actually require the owner or
operator to implement any changes, so
facilities will only incur additional costs
beyond the analysis when the benefits
of the change make adoption of the
change reasonable for the facility.
IST is widely recognized as a concept
or principle that can be used in process
safety management along with other
types of hazard reduction measures to
eliminate or reduce the frequency and/
or impact of accidents. As recognized in
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process safety technical literature, the
benefit of using practicable IST as the
first choice for accident prevention is
more likely permanent risk reduction.
Some trade associations agree that
individual companies often consider
inherently safer approaches or safer
alternatives as a matter of course. In
fact, one of the key elements under
ACC’s Responsible Care, Process Safety
Code 95 requires ACC member
companies to consider inherently safer
approaches as one of many risk
reduction measures when conducting a
process safety risk assessment.
Since 1996, EPA has seen that
advances in ISTs and safer alternatives
are becoming more widely available and
are being adopted by some companies.
Voluntary implementation of some ISTs
has been identified through surveys and
studies and potential opportunities have
been identified through EPA
enforcement cases and CSB incident
investigations.96 The Contra Costa
County Health Services (CCHS) and
New Jersey Department of
Environmental Protection (NJDEP) IST
regulations requirements to consider
IST have resulted in some facilities
adopting IST measures.97 The concept
of IST is more widely understood and
accepted within the chemical process
industry than it was 20 years ago.
Innovations and research in chemical
process safety have evolved and
continue to evolve. Industries change
and update their processes over time for
a variety of reasons and when possible,
EPA believes that opportunities to
improve chemical process safety using
all available means—not only passive,
active, and procedural measures—
should also be considered.
EPA disagrees that increasing
voluntary adoption of IST means that
incremental benefits of mandatory
adoption are decreasing. Benefits
derived by those implementing IST do
not negate any potential benefits from
those who have not. As stated in the
1996 rule, ‘‘EPA encourages sources to
continue to examine and adopt viable
alternative processing technologies,
system safeguards, or process
modifications to make new and existing
processes and operations inherently
safer.’’ 98 For those facilities who have
95 ACC. 2016. Responsible Care Process Safety
Code https://responsiblecare.americanchemistry.
com/Responsible-Care-Program-Elements/ProcessSafety-Code/Responsible-Care-Process-Safety-CodePDF.pdf.
96 For more information, see the preamble of the
proposed rulemaking at 81 FR 13663–13665, March
14, 2016.
97 For more information, see the preamble of the
proposed rulemaking at 81 FR 13665–13666, March
14, 2016.
98 See 61 FR 31700, June 20, 1996.
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not considered adopting any IST or have
only done so in limited fashion, EPA
believes that there is value in requiring
facilities with extremely hazardous
substances to evaluate whether they can
improve risk management of current
hazards through potential
implementation of ISTs or risk
management measures that are more
robust and reliable than ones currently
in use at the facility. For those facilities
who have already considered IST, EPA
believe facilities should re-evaluate
whether any improvements in hazard or
risk reduction can be made and we
believe the five-year re-validation
timeframe of the PHA is an appropriate
time period for such re-evaluation.
EPA did not perform any further
analysis of the NJDEP or Contra Costa
County IST data. The main purpose of
providing these reports was to
demonstrate that regulations involving
IST in these two jurisdictions resulted
in implementation of IST at some of
their facilities and to explain what types
of IST were implemented. NJDEP’s 2010
IST Implementation Summary report 99
on IST reports submitted by NJ facilities
since August 2008 is available in the
docket and discusses 143 additional IST
measures reported to have been
implemented or scheduled to be
implemented by 41 of the 85 facilities
submitting reports. CCHS and
Richmond CA annual performance
review and evaluation reports on the
Industrial Safety Ordinance include a
summary of Inherently Safer Systems
(ISS) results from their nine total
facilities, as well as the actual ISS data
reported by each facility. Three of these
reports are in the docket for this
rulemaking.100
Because the requirements involve
prevention of accidents before they
occur, it is difficult to provide a
quantitative assessment that the
requirement would reduce a certain
number of accidents. The assertion of
increase in the number of NJ accidents
reported cannot be explained as a result
of implementation or nonimplementation of IST because there are
other factors involved. For example, the
number of NJ facilities reporting over
the years varies, which can affect the
number of reportable accidents and not
all NJ facilities may have implemented
IST. In principle, because of the
‘‘inherentness’’ of any actual IST
changes, there should be a hazard and
99 https://www.regulations.gov/document?D=
EPA-HQ-OEM-2015-0725-0143.
100 https://www.regulations.gov/document?D=
VEPA-HQ-OEM-2015-0725-0147, https://www.
regulations.gov/document?D=EPA-HQ-OEM-20150725-0148, and https://www.regulations.gov/
document?D=EPA-HQ-OEM-2015-0725-0149.
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risk reduction for a particular RMP
chemical, because IST eliminates or
minimizes the opportunities for a
chemical release in a more rigorous
fashion than relying on a device or
human intervention. EPA recognizes
that IST will not eliminate all hazard or
risk and that reliance of other risk
reduction measures will probably still
be needed for other points in a process.
Contra Costa County commented that
it has seen improvements at existing
facilities with existing processes subject
to its ISS requirements.101 The county
indicated that facilities have eliminated
unnecessary vessels, shortened piping
and replaced chemicals with less toxic
chemicals. CCHS has seen that by
considering ISS, facilities have looked at
the highest level of risk reduction such
as using passive means (such as a
change in metallurgy) instead of relying
on administrative means (such as
increased piping inspections).
As some commenters indicated, some
facilities have been evaluating IST as a
best practice for decades and, in most
cases, have already taken steps to
implement beneficial technologies
where it is practicable and cost-effective
to do so. In those situations, where IST
was previously evaluated but not
implemented, facilities should review
the analysis to determine if new
information is available that would
affect the analysis. The facility should
document the STAA and practicability
of IST and ISD considered.
Inconsistent STAA implementation. A
facility remarked that the lack of clarity
and consensus about the methodology,
definitions or standards for STAA
would contribute to burden and could
lead to inconsistent implementation of
STAA across companies.
EPA does not expect to see ‘‘one-sizefits-all’’ implementation of STAA by
sources. The STAA requirements are not
prescriptive in nature, but more similar
to a performance-based standard (like
other provisions of the RMP regulations)
that give facilities the flexibility and
allow facility owners and operators to
exercise reasonable judgement to
determine what technology or risk
reduction measures work best for their
particular chemical use, process or
facility. However, in an effort to ensure
a consistent understanding of EPA’s
expectations for conducting an STAA
and determining practicability of IST
and IST considered, the rule defines
several terms related to the STAA, such
as practicability, inherently safer
technology or design, passives
measures, active measures and
101 https://www.regulations.gov/document?D=
EPA-HQ-OEM-2015-0725-0450.
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procedural measures. EPA has also cited
various references and technical sources
of information that explain the concepts
and principles of STAA and provided
examples.102
Impact to agribusinesses. One
commenter stated that the proposed
mandate for regulated facilities to
consider STAA as a part of the PHA,
and to evaluate the feasibility of IST,
will fail to generate tangible RMP
outcomes in the fertilizer industry or
with other ag-industry RMP regulated
chemicals, beyond what the current
PHA requirements and procedural
measures can accomplish in controlling
hazards. The commenter further
asserted that the administrative and
recordkeeping burden associated with
this portion of the proposed rulemaking
will undoubtedly increase costs on the
agribusiness industry at a time when
margins across the industry are thin to
non-existent. The same commenter
indicated that these requirements will
cause many small agricultural fertilizer
retail facilities to close.
EPA is not requiring agricultural
fertilizer retail facilities to perform
STAA and thus there should be no
burden to this particular industry as a
result of the STAA provision. The
STAA requirement in the PHA will only
apply to Program 3 facilities in chemical
manufacturing (NAICS code 324),
petroleum and coal products
manufacturing (NAICS code 325) and
paper manufacturing (NAICS code 322).
Feasibility costs. One trade
association stated that the cost of
determining feasibility was wholly
underestimated by EPA because
feasibility study costs can be quite large
depending upon the type of project, but
still be only a fraction of the cost of
what it would take to implement any
projects determined to be feasible. The
commenter noted that a typical project
consists of conceptual level design,
feasibility level design, and then
engineering and implementation. The
association member’s experience with
hundreds of projects is that the cost of
102 CCPS. 2009, Inherently Safer Chemical
Processes: A Life Cycle Approach. 2nd ed., https://
www.regulations.gov/document?D=EPA-HQ-OEM2015-0725-0253; CCPS. July 2010. Final Report:
Definition for Inherently Safer Technology in
Production, Transportation, Storage, and Use,
https://www.regulations.gov/document?D=EPA-HQOEM-2015-0725-0274; Contra Costa Hazardous
Materials Program. June 15, 2011. Industrial Safety
Ordinance Guidance Document, Attachment C—
Inherently Safer Systems Checklist. Contra Costa
County Health Services, Martinez, CA, https://www.
regulations.gov/document?D=EPA-HQ-OEM-20150725-0146; NJDEP. January 15, 2015. Guidance for
Toxic Catastrophe Prevention Act (TCPA),
Inherently Safer Technology (IST), https://www.
regulations.gov/document?D=EPA-HQ-OEM-20150725-0142.
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a conceptual level design is about 1% of
the total project cost and the cost of a
feasibility level design is 1% to 2% of
the total project cost.
EPA acknowledges that for some
industries, evaluation of chemical
substitution and process redesign will
involve a greater level of effort and
resources to consider the practicability
of such changes. EPA has revised the
cost estimates in the RIA to reflect the
greater effort involved in conducting
such practicability studies.
g. Model STAA Provisions After Other
Regulatory Programs
Several commenters suggested that
the STAA requirement align with
similar requirements by CCHS and
NJDEP. Some of these comments are
addressed under other STAA topic
headings, as appropriate. Other specific
comments are discussed further in this
preamble.
Establish qualifications for IST review
team. One commenter recommended
expanding on the NJDEP requirement
which specifies that an IST review team
should be ‘‘a team of qualified experts,
convened by the owner or operator,
whose members shall have expertise in
environmental health and safety,
chemistry, design and engineering,
process controls and instrumentation,
maintenance, production and
operations, and chemical process
safety.’’ This commenter also wanted
EPA to require the names, qualification,
and experience of team members to be
stated in the review report and to
explicitly specify that workers and
union representatives can fully
participate in the STAA. Another
commenter noted that the proposed
STAA requirement does not require
employee participation and stated that
employees have deep experience and
knowledge of the processes and are best
equipped to determine inherently safer
technology or design, but cautioned that
workers must have adequate education
and training to participate in STAAs.
EPA notes that § 68.67 requires the
PHA to be performed by a team with
expertise in engineering and process
operations, and the team shall include
at least one employee who has
experience and knowledge specific to
the process being evaluated. Also, one
member of the team must be
knowledgeable in the specific process
hazard analysis methodology being
used. These same qualifications apply to
team members involved in conducting
the STAA. EPA believes most PHA
reports already include the names and
qualifications of team members in the
report, and we do not believe it is
necessary to prescribe a regulatory
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requirement to address this issue. EPA
already requires Program 3 facilities to
consult with their employees and their
representatives on the conduct and
development of process hazard analysis
and on the development of other
elements of process safety management,
and EPA believes it would be
inappropriate to incorporate additional
provisions related to worker
participation in the PHA requirements
of § 68.67.
Establishing goals. A Federal agency
recommended incorporating a goal
setting requirement similar to that of
CCC’s ISO, expressing concern that a
lack of goal setting requirements could
allow regulatory requirements to be
satisfied even if analyses fail to identify
or control major hazards. The
commenter explains that there is no
RMP requirement to reduce risks to ‘‘as
low as reasonably practicable,’’ or
‘‘ALARP’’, while CCHS ISO requires
facilities to select and implement ISS to
the greatest extent feasible and as soon
as administratively practicable.
EPA disagrees with commenters. EPA
did base some components of the STAA
requirement on NJDEP and CCHS
regulations (see discussion in section in
IV.C.3.c Definitions of this preamble).
Also see further discussion in section in
IV.C.3.k of this preamble regarding
documentation of feasibility. NJDEP and
CCHS require a separate Inherently
Safer Technology review or Inherently
Safer Systems Analysis (ISSA), but NJ
requires IST updates (covering both new
and existing processes) on the same
schedule as the PHA. CCHS requires an
ISSA for existing and new processes
every five years, but the analysis can be
done as part of a PHA. CCHS also
requires that an ISSA for any major
changes (which could be result of
accident investigation). EPA is requiring
that the five-year PHA revalidation
address the findings from all incident
investigations required under section
68.81, as well as any other potential
failure scenarios.
EPA did not propose to require any
implementation of any IST. EPA
proposed to require facilities to
determine the feasibility of IST options,
but the final rule allows flexibility for
facility owners or operators to decide
whether to implement an IST in order
to allow them to balance the
appropriateness of the technology for
their process, costs, risk transfer and
other requirements that would have to
be met along with possible integration
with the use of existing risk reduction
measures in place. In the final rule, EPA
also replaced the term ‘‘feasibility’’ with
‘‘practicability.’’
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Requiring risk reduction to be ‘‘as low
as reasonably practicable (ALARP)’’ is a
standard that can be seen as stricter than
the ‘‘to the greatest extent feasible’’
requirement set by CCHS and could
require implementation of risk
reduction measures ‘‘except where they
are ruled out because they involve
grossly disproportionate sacrifices.’’ 103
EPA does not believe that adopting a
requirement that facilities reduce risks
to ‘‘ALARP’’ is advisable for the RMP
program because there are no set
standards to define what level of risk is
reasonably practicable for the variety of
chemicals, processes, and hazards
involved.
h. Feasibility
Insufficient guidance and clarity for
methodology for comparing risks. A
facility, a local agency, and industry
trade associations, among others,
remarked that IST cannot be
meaningfully and consistently
implemented because there is no
consensus in science or among the
industry on its definition, how to
implement it, or how to measure its
effect. Stating that the concept of IST is
vague, an industry trade association said
that multiple factors are taken into
account when making a determination
of feasibility, including materials used
for equipment.
One commenter stated that the
feasibility factors in the proposed STAA
provision also provide no guidance on
how to measure or balance risks or
hazards. This commenter notes that
there is no simple way to measure
whether one process is safer than
another or when a process is ‘‘safe
enough’’ as discussed in the July 2010
DHS report by CCPS. The commenter
indicated that the proposed rulemaking
does not address a multitude of critical
questions: What does the PHA team
measure? Does the team evaluate
reduction in particular hazards or in
overall risk? Is that reduction measured
quantitatively or qualitatively? Who or
what is the required beneficiary of that
reduction—the employees, the adjacent
community, the environment? What
level of risk is tolerable? If EPA requires
STAA analysis under the final RMP
rule, it will necessarily need to become
involved in measuring, evaluating, and
determining the tolerable level of risk. It
is unlikely that EPA has the expertise or
bandwidth to take this on.
EPA based its definition of IST upon
CCPS’ descriptions of inherently safer
strategies and its definition of
‘‘practicability’’ upon CCHS’ definition
103 https://www.hse.gov.uk/risk/theory/
alarpglance.htm.
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of ‘‘feasible’’ in their Industrial Safety
Ordinance. EPA has existing
requirements under § 68.67 for facilities
to evaluate and control hazards in the
process and to establish a system to
address the PHA’s team findings and
recommendations. Management
response to hazard evaluation studies
and recommended options involve risk
management considerations that are
developed based on a facility’s risk
tolerance criteria. EPA has not
prescribed how facilities define or
manage risk, whether it involves
conforming to minimum standards such
as codes or tries to reduce risk to as low
as reasonably practical or whether it
uses risk matrices or assesses qualitative
or quantitative risk. EPA expects only
that facilities consider IST as one of the
types of risk management measures
employed. Much of the structure of the
RMP rule requires owners and operators
to collect information and relies on
them to make reasonable judgments in
light of that information. The
requirement here is no different. EPA
only requires the analysis. There is no
mandate to implement IST under this
rule. For further information, EPA
recommends consulting Chapter 9—
Hazard Identification and Risk Analysis
in the 2007 CCPS Guidelines for Risk
Based Process Safety.104
Efforts involved for determining
feasibility. One commenter asserted that
EPA has failed to consider the
substantial complexity of the activities
it is proposing to require, and the
significant burden that will be placed on
facilities with multiple or complex RMP
regulated processes. The commenter
cited issues involved with many
chemical manufacturing processes that
involve multiple optimizations of
complicated reactions and integration of
many processes with each other. The
commenter cited as an example, the
efforts involved by the National
Academy of Sciences (NAS) to identify
and evaluate the many individual
alternative paths to methyl isocyanate
(MIC) production for potential safer
operations.105 The commenter stated
that each alternative then had
implications for the facility, the
customer, the surrounding community
and numerous other factors that needed
to be identified, considered and
104 CCPS. 2007. Guidelines for Risk Based Process
Safety. American Institute of Chemical Engineers,
CCPS, NY, Wiley. Chapter 9—Hazard Identification
and Risk Analysis.
105 National Research Council of the National
Academy of Sciences, The Use and Storage of
Methyl Isocyanate (MIC) at Bayer CropScience,
2012. https://www.nap.edu/catalog/13385/the-useand-storage-of-methyl-isocyanate-mic-at-bayercropscience.
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weighed carefully. The commenter
further explained that these factors
included the costs of the chemicals,
labor and energy requirements, new
capital expenditures, quality of the
product and revenues expected from its
production, environmental impacts
anticipated from the process, regulatory
constraints, environmental policy and
regulations and influence of local
community on company decision
making. The commenter indicated that
many of these characteristics involve a
substantial degree of uncertainty. The
commenter also stated that the
framework for decision-making
discussed by NAS is akin to the
proposed EPA requirement to perform a
feasibility analysis for all ISTs
considered. The commenter concluded
that under the EPA proposal, complex
chemical manufacturing RMP facilities
would be required to go through this
analysis multiple times for each and
every regulated process.
EPA believes a practicability
determination for any considered IST or
ISD is necessary to ensure the facility
owner or operator seriously considers
whether IST or ISD modifications could
further reduce risks and prevent
accidents at the facility. EPA expects
that facilities will only evaluate
chemical substitutes that have already
been shown to be commercially viable
and does not expect facility owners or
operators to expend a major effort on
hypothetical or untested chemical
substitutes or uses.
Insufficient time to complete a
feasibility analysis. One commenter
stated that when evaluating IST, a
facility owner may at times be able to
reject an alternative based on
determining a single basis of
infeasibility. The commenter asserted
that if there is no known rationale for
infeasibility, a facility may need to
conduct lengthy and costly engineering
studies, which would require a unit
revamp on an existing process unit. The
commenter further stated that under
such circumstances, feasibility or
practicality must consider unit
congestion and constructability in
addition to all of the issues associated
with a new process. The commenter
indicated that this need to perform
detailed engineering study/design, in
many cases, is indicative of
impracticability. The commenter
concluded that the proposed rulemaking
allows four years after the rule become
final for each PHA to consider IST/ISD
alternatives for covered processes and,
in the event the EPA decides to include
this requirement in the final rule,
facility owners should be allowed a
second PHA cycle, following the four-
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year applicability, where the
determination of feasibility or
practicality requires engineering studies
and design. Another commenter stated
that the feasibility analysis outlined in
the proposed regulation is ill-defined
and doesn’t allow sufficient time for the
work to be properly completed.
EPA allows that where a practicability
evaluation is complex and resource
intensive and may not be completed
within the four-year compliance
timeframe from the final rule or within
the five years between PHA reviews, a
facility should document during their
PHA review that the IST is under
consideration and that the practicability
of implementing the technology is
unknown and still undergoing
evaluation.
Practicability decisions made by
facilities or outside parties. An
environmental advocacy group argued
that, if decisions are left up to facilities
themselves, the economic interests of
the facilities will outweigh
considerations of public health. The
advocacy group concluded that an
independent body should be tasked
with reviewing facilities’ IST/ISD
evaluations to determine whether or not
such technologies are feasible and to
prevent facility self-regulation. One
local agency asserted that stationary
sources rather than a regulatory body
should determine the feasibility of ISD
and document their decision.
EPA disagrees that practicability
decisions should be made by outside
parties. These decisions are based on
site-specific circumstances that a thirdparty may not have the experience to
evaluate. EPA believes it would not be
practical for many reasons including:
The delay that may result in finding a
third-party to assess practicability; the
variety of factors that must be
considered in establishing a basis for
choosing an outside party (e.g. there
may not be enough qualified thirdparties with the expertise and resources
to evaluate the various options and
processes for the number of facilities
subject to this provision); and the need
to protect CBI and sensitive information
that could reveal security
vulnerabilities.
Feasible definition does not take into
account removal of existing safeguards.
One commenter stated that the proposed
definition for feasible precludes any
reasonable basis for replacing existing
controls and safeguards that have
already been identified and
implemented to address the risks. This
commenter believes that since all the
engineering and administrative controls
necessary to address risk have already
been identified and implemented in an
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operating plant, it is not appropriate to
require a repeated analysis of
alternatives that that are not feasible for
an operating plant.
EPA disagrees with the commenter.
The definition of ‘‘practicability’’ in the
final rule is not intended to be used to
judge the reasonableness or
effectiveness of existing risk reduction
measures, but whether new IST
measures could be implemented. The
STAA requirements allow a
combination of risk measures to be used
to achieve the desired risk reduction;
therefore, they do not necessarily
preclude the use of existing controls and
safeguards.
Feasibility factors go beyond scope of
a PHA. One commenter asserted that
requiring consideration of the five
factors mentioned in the proposed
definition of ‘‘feasibility’’ goes beyond
the scope of a PHA.
EPA disagrees. While the PHA
identifies the hazards, the RMP PHA
requirements require the facility to
identify the risk management measures
applicable to eliminating or reducing
the risks from the process hazards. EPA
believes that it is appropriate for a
facility to consider the five feasibility
(now practicability) factors (‘‘economic,
environmental, legal, social and
technological’’) for evaluating the
appropriateness of implementing for
potential IST measures because some
IST can involve significant costs or
involve impacts that go beyond the
facility.
Feasibility does not take into account
full supply chain. An industry trade
organization and a facility warned that
the proposed definition of ‘‘feasible’’
does not sufficiently consider costs and
benefits and fails to take into account
the full supply chain. Facilities
pressured to take these measures, such
as reducing inventories of products,
would prevent companies from meeting
customers’ needs. For example,
downstream users may not even be able
to receive an alternative product.
EPA disagrees that the practicability
determination does not allow facilities
to take into account costs and benefits
and the effect on the full supply chain.
The STAA requirements do not require
any implementation of any particular
IST. EPA expects that facility owners or
operators will seriously consider the
merits and consequences of ISTs for
their facilities and use their expertise
and judgement to ensure safety while
not severely affecting the economic
viability of their businesses. Facilities
can consider the effects in their supply
chain (downstream and upstream) when
evaluating potential IST options.
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i. IST Implementation
Several industry trade associations
and a facility expressed support for
EPA’s decision not to require
implementation of feasible safer
alternatives and noted that the best
approach would be to allow operators to
decide which measures, methods, or IST
components would be feasible at their
facilities. An industry trade organization
requested that EPA include language
stating that ‘‘the scope of the STAA for
a regulated process will be based on the
expert judgment of owners and
operators’’ because only the facility is
uniquely qualified to determine what
types of changes are feasible and
practical. The commenter cited an
example where reducing the volume of
chlorine dioxide on-site at a paper mill
may not be practical because a
minimum amount is needed to ensure
that production of pulp and paper can
continue when operation of the chlorine
dioxide generator is momentarily
disrupted due to maintenance or other
issues. The commenter also cited
another example in which eliminating
the use of chlorine dioxide for bleaching
may not provide the necessary
characteristics of the finished product.
Many commenters, including
multiple mass mail campaigns joined by
approximately 24,610 commenters and
advocacy groups, urged that upon
identifying alternatives in an analysis,
facilities should be required to switch to
the safest cost-effective chemicals and
technologies available. Among other
reasons, one commenter cited the need
to implement feasible alternatives
because the NAS report on the Bayer
CropScience accident stated that
feasible alternatives should be
attempted before moving on to
specification of risk management
equipment and procedures.106 This
commenter notes that existing
safeguards used have not prevented
accidents from occurring and that CAA
section 7412(r)(7)(B)(i), directs that
regulations and guidance under this
provision must ‘‘provide, to the greatest
extent practicable, for the prevention
and detection of accidental releases of
regulated substances and for response to
such releases.’’ [Emphasis added] In
addition, this commenter states that not
requiring implementation of IST also
creates a competitive disadvantage for
those facilities that do so voluntarily, as
compared to other facilities who will
avoid taking available preventative
safety measures to maximize short-term
profits. This commenter wants EPA to
106 National Research Council, The Use and
Storage of Methyl Isocyanate (MIC) at Bayer
CropScience, at 4–53 (2012).
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require a timeframe for implementation
of IST for those facilities who plan to
implement IST as this will prevent
accidents from happening sooner. A
commenter urged that required
implementation of feasible alternatives
would reduce the risks associated with
a catastrophic release, including from
terrorist attacks, and would be
important for protection of public
health.
One commenter wanted IST to be
implemented wherever feasible because
IST is likely to be more effective and
less costly in the long run than other
safeguards, noting that the existing rule
requires that facilities implement the
recommendations from a conventional
PHA. This commenter also stated that
EPA should model its implementation
requirements on California’s Contra
Costa County Industrial Safety
Ordinance, which directs companies to
‘‘select and implement each inherently
safer system identified to the greatest
extent feasible and as soon as
administratively practicable’’ or
consider California’s Department of
Industrial Relations current proposed
requirements for refineries which
directs each facility to ‘‘implement all
recommendations’’ from inherent safety
analyses, unless the facility can
demonstrate that a recommendation is
factually flawed or infeasible on
grounds other than cost alone.
An industry trade association said
that in their industry, operations are
diverse and are constantly evolving,
making it difficult to implement IST. A
few industry trade associations warned
that substitution is not a legitimate
option for their industries, for
manufacturing of agricultural products
or in fragrance industry, for example.
Stating that active ingredients in
fragrances are extremely specific and
non-fungible, an industry association
commented that any substitution of
fragrance ingredients should be done at
the point of design to minimize the
threat to fragrance businesses. The
commenter requested that EPA provide
a clear statement acknowledging the
infeasibility of substitution in the
fragrance industry. Some commenters
stated that the analysis would be of no
benefit for their facility because a
Federal permit requires it to use certain
processes.
EPA agrees that the facility is in the
best position to decide what safeguards
or risk reduction measure can be
employed to eliminate or reduce process
hazards. Facilities must consider
safeguards, in the following order of
preference: IST, passive, active or
procedural measures; however, the rule
does not automatically require the
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facility to implement the measures
preferentially in that order. EPA
recognizes that for any particular hazard
point, any one of the four types of
safeguards may not exist or may not be
practicable for a variety of reasons. EPA
also recognizes that facilities may wish
to employ more than one safeguard.
The purpose of the STAA requirement
is to ensure that facilities consider the
available options and for them to find
the best method for the facility to
address accidental releases. The
hierarchy of control methods in an
STAA analysis—IST/ISD, passive,
active, administrative—is consistent
with the language of CAA section
112(r)(7)(B)(i) in that it systematically
provides for the identification of
practicable control methods while also
recognizing that the regulation must be
reasonable. This approach is consistent
with the current PHA requirements
which provide flexibility for the owner
or operator to decide which safeguards
are appropriate to prevent accidental
releases. We expect STAA analyses to
lead to new control approaches at
sources where management finds such
approaches to be reasonable and
practicable.
EPA is not requiring implementation
of IST at any facility because we believe
that only the facility has the expertise
and resources to determine whether
implementation of any IST or ISD
should be undertaken, taking into
account that many factors must be
considered when substituting a
chemical or modifying a process,
including cost, risk transfers,
technological hurdles, etc. Facilities that
choose to adopt the use of IST or ISD
can eliminate or reduce hazards by
using different materials and/or process
conditions, which would make
accidental releases less likely, or the
impacts of such releases less severe. The
results of the practicability
determination must be documented as
part of the current PHA requirements in
§ 68.67(e), which requires the owner or
operator to document actions to be
taken and resolution of
recommendations.
Also EPA does not believe we should
establish a required timeframe for any
planned implementation of IST.
Planning, design, equipment
modification and cost to implement IST
can vary tremendously depending on
the technology and scope of the project
and could only be best determined by
the facility involved in such
implementation.
EPA acknowledges that chemical
substitution or whole design processes
may be not practicable for some
processes for a variety of reasons and
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that facilities should document these
reasons for any particular IST that were
considered by the facility for purposes
of complying with the STAA
requirements.
j. Security and Risk
Terrorism. A commenter cited an
increased risk of global and domestic
terrorism as a reason to broaden the
applicability of STAA requirements to
cover transportation and storage of
liquid chlorine. Another commenter
stated that the existing RMP provisions
already require the PHA team to
consider safer alternatives, and warned
that explicitly stating consideration or
implementation of IST can expose
facilities to risks, such as increased
opportunity for terrorism, risk transfer,
and risk accumulation. The commenter
remarked that chemicals handled are
highly dependent on the processes
employed, so it would be difficult or
impossible to identify an absolute safer
alternative. The commenter concluded
that facilities should asses the total risk
reduced by implementation and stated
that any alternative considered should
be easily applied and properly tested.
EPA acknowledges that transportation
and storage of liquid chlorine can pose
risks, not only from accidental releases,
but from intentionally caused releases.
However, EPA is limiting the scope of
applicability of the STAA requirements
in order to balance the regulatory and
administrative burdens of assessing IST
against the accident rate and possible
opportunities to employ IST because of
process complexity for various
industries. EPA believes that the
industries subject to the STAA
provisions are also more likely than
others to have the expertise and
resources to properly assess and
implement IST.
In response to the commenter’s
concern that explicitly stating
consideration or implementation of IST
can expose facilities to risks, EPA
believes that the STAA provisions in the
final rule provide enough flexibility for
owners and operators to consider a
hierarchy of risk management measures
to minimize the hazard of a process
without prescribing an approach that
could compromise facility security or
transfer or increase risks. The STAA
requirement does not require IST
implementation but instead allows the
facility owner or operator to determine
whether an IST considered would
achieve a reduction in risk, specific to
the hazard being addressed. More
specifically, the STAA requirement
allows for a combination of risk
management measures to be used to
achieve the desired risk reduction. This
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flexibility acknowledges that there is
not always an absolute safer alternative
to a chemical, which is highly
dependent on the process or application
and the chemical involved. EPA is also
requiring the facility to evaluate the
practicability of any IST or ISD
considered to account for economic,
environmental, legal, social, and
technological factors. Environmental
factors would include consideration of
potential transferred risks for new risk
reduction measures. This allows
facilities to carefully consider whether
an IST could create new risks or
security concerns, including those
involving terrorism.
Security concerns related to STAA
documentation. An industry trade
association urged that if (or when) IST
becomes applicable to a certain process,
methods should be available for
additional review. For example, the
commenter said that documentation of
safer technology information should be
considered from a homeland security
and critical infrastructure perspective.
EPA agrees that documentation that
could reveal vulnerabilities at an RMPregulated facility must be secured.
Therefore, although EPA is requiring
facility owners and operators to
document STAA and practicability
determinations, EPA is not requiring
this information to be submitted to
implementing agencies, LEPCs or local
emergency response officials. These
entities have the ability to request
documentation, at which point
representatives of the facility and the
requesting agency can discuss the
security concern and involve security
agencies as appropriate.
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k. STAA Documentation
Extent of STAA documentation. Some
commenters urged EPA to require
sufficient, detailed documentation of
feasibility and alternatives considered.
One commenter asserted that requiring
sufficient documentation of alternatives
would facilitate the incorporation of
safer design principles into the PHA and
would enhance the integrity of the
process and encouraged a more
extensive documentation of feasibility
similar to the program in Contra Costa
County, California. An advocacy group
suggested that entities should be
required to document economic benefits
as well and quantify specific economic
benefits of adopting safer options, such
as reduced liability and insurance costs,
public benefits such as savings to
municipalities for reduced emergency
response, and savings to workers and
affected residents for medical care,
property damage, etc.
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An industry trade association asserted
that any requirement for entities to
determine or document feasibility
would be beyond EPA’s authority and
would be inappropriate because it does
not provide sufficient detail of what
would be required in a ‘‘determination’’
or information about how the
determination was considered. An
industry trade association expressed
general opposition to a documentation
requirement. A state agency requested
clarification as to what type of
documentation would be required in
order to demonstrate compliance.
EPA is not specifying any particular
form of documentation for STAA given
the potential complexity of analysis,
variety of risk reduction measures
involved and the factors that may be
considered for feasibility and/or
implementation. Facilities should retain
any reports, analysis, findings and
recommendations used to comply with
the STAA requirements for the life of
the process as is required by § 68.67(g).
For IST/ISD measures considered,
facilities should document the analysis
and methodology used to evaluate or
consider IST, its feasibility and the
recommendations of the review team.
Facilities may follow, for example,
guidance for IS Review Documentation
found in CCPS’s Inherently Safer
Chemical Processes, which suggests
documenting the summary of the
approach used for the IS review (i.e.,
methodology, checklist, etc), names and
qualifications of the review team, IS
alternatives considered, as well as those
already implemented or included in the
design, results of each consideration
including those not considered and
why, documentation of feasibility and
rationale for rejection of IS
opportunities. Facilities must provide in
their RMP, any inherently safer
technology or design measures
implemented since the last PHA, if any,
and the technology category
(substitution, minimization,
simplification and/or moderation)
(§ 68.175(e)(7)).
CBI. A facility contended that changes
in process technology involving IST or
ISD could be considered CBI, have a
substantial impact on the strategic
competitive nature of their operation
and necessitates provisions to ensure
that CBI claims can be asserted for IST
or ISD implementation. An
environmental advocacy group stated
that facilities should have the ability to
withhold CBI based on existing
standards when they submit their STAA
to EPA.
EPA is not requiring the STAA or its
documentation within the PHA to be
automatically submitted to EPA nor to
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anyone else, but such analysis or
documentation must be kept as records
under the recordkeeping requirements
of § 68.200 and be available for
inspection or review by EPA. Owners or
operators may assert claims of CBI for
information requested by EPA following
the procedures in §§ 68.151 and 68.152
if the information meets the criteria set
forth in 40 CFR 2.301.
l. Availability and/or Submission of
STAA Documentation
Many commenters, including
multiple mass mail campaigns joined by
approximately 22,260 commenters, a
Federal agency, and advocacy groups,
stated that RMP facilities should be
required to submit their STAA
information to EPA. An environmental
advocacy group suggested that the
collection of STAAs is vital for the
establishment of a clearinghouse of safer
technology and alternatives and that
EPA should certify STAAs for accuracy
and completeness. One commenter
suggested that by requiring the
submission of STAAs to EPA, the
Agency will enhance the quality of
STAA assessments and feasibility
analysis. This commenter also believed
STAA submission would better inform
enforcement under the CAA’s General
Duty Clause by providing the Agency
with world class knowledge of feasible
safer alternatives and effects taken
under the EPA’s 2017–2019 NEI
approved on February 18, 2016.
Two local agencies stated that STAA
information should be retained on-site
at the facility for inspection or be
submitted upon request to be reviewed
by EPA and implementing agencies.
One commenter said that information
on IST should be maintained at the
stationary source.
In contrast, other commenters,
including multiple industry trade
associations, remarked that EPA should
not require RMP-regulated facilities to
submit STAA information to EPA. Some
industry trade associations argued that
EPA or any other implementing agency
will likely lack the required knowledge,
resources, or expertise to evaluate an
STAA or feasibility determination. An
industry trade association asserted that
EPA should have no role in analyzing or
approving the plans. An industry
association argued that any requirement
for approval of STAAs by EPA would be
too similar to a permitting program and
would thus be against Congress’ intent
as per CAA section 112(r)(7)(F).
Some commenters suggested that the
submitted STAA information should be
included in the RMP National Database
and facilities be allowed to withhold
CBI based on current RMP CBI
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protections and facility-specific,
element-specific, up-front substantiation
of security claims. A professional
organization encouraged EPA to use the
STAA summary information provided
in the RMPs to gather helpful data and
incorporate lessons learned. One
commenter reasoned that collection of
STAA data is necessary for EPA and
other regulatory agencies to carry out
their regulatory responsibilities.
Another commenter asserted that
incorporating summary STAA
information into RMPs will facilitate
knowledge of successful practices as
well as knowledge of barriers.
Two commenters suggested that EPA
collect information from facilities that
change program levels within RMP or
deregister entirely in order to collect
valuable lessons learned for future use
about IST preventive measures and
reducing on-site quantities. One
commenter expressed concern that the
current deregistration reason codes are
not sufficient to allow EPA to collect
basic information about lessons learned
from deregistered facilities and
suggested adding a code representing
‘‘implemented IST/ISO’’ paired with a
field to indicate the nature of the
change.
Some commenters wanted more
detailed information about STAA to be
provided in the RMP. Suggested
additional information included:
Descriptions of the alternatives
evaluated; description of each option
chosen for implementation and
timeline; reasons for not implementing
IST such as (1) cost; (2) technical
feasibility; (3) conflicts with other
regulatory requirements or good
practices; (4) other hazards; (5) other
(indicate reason) or by listing one of the
factors included in the definition of
‘‘feasible:’’ time, economic,
environmental, legal, social, or
technological; and an attestation and
checklist demonstrating a
comprehensive accounting of potential
benefits, savings, and avoided costs
associated with each major option.
One commenter recommended that an
independent body be in place to
carefully review the facilities’ IST/ISD
evaluations to assist in determining
whether or not such technologies are
feasible and to prevent facilities from
self-regulating.
Some commenters wanted STAA and
documentation to be made publicly
available, and allowed with reasonable
protections, for genuine CBI and trade
secrets. An advocacy group
recommended allowing public comment
and response on facilities’ STAAs. A
few commenters wanted STAA
summaries to be available to at-risk
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communities and the public both online
and offline, including at public
meetings required at § 68.210.
Reasons given by commenters for
providing public availability of STAA
included:
• To hold companies accountable and
facilitate significant process safety
changes with appropriate public
discussion and oversight from other
stakeholders;
• To ensure right-to-know and
transparency for affected workers and
communities;
• To provide comments on the STAA
and get implementing agency response;
• To have facilities that have adopted
IST receive public credit for their
positive steps; and
• To ensure opportunities for at-risk
communities to engage with facilities
about alternatives and prevention plans.
EPA is not requiring automatic
submission of STAA information or
documentation to EPA or requiring that
it be made available to the public. EPA
acknowledges there is much public
interest in having STAA and
documentation available to them, but
STAA will be part of a PHA which can
be a lengthy (e.g., the sectors subject to
STAA requirements have multiple
processes and some PHAs are hundreds
of pages) technically complex document
that could contain not only CBI, but
sensitive security information involving
process or equipment vulnerabilities.
Some commenters’ suggested solution of
having facilities sanitize submitted
documents and provide upfront
justification of CBI claims would entail
a significant level of burden upon
industry and EPA. It would not be
practical or good use of resources to
have thousands of documents submitted
to EPA, to any other body or with the
RMP submission. EPA can inspect
documents on-site or request their
submission from facilities as needed.
EPA believes that primary utility of
STAA information for the public is
whether or not facilities are
implementing IST and the nature of that
change. EPA is requiring that basic
information on IST being implemented
be provided in the RMP submission in
accordance with § 68.175(e)(7).
Facilities must provide in their RMP
any inherently safer technology or
design measures implemented since the
last PHA, if any, and the technology
category (substitution, minimization,
simplification and/or moderation). In
the event of a public meeting held after
an accident, EPA encourages facilities to
provide information about any IST or
other safer technology alternatives that
the facility is using or could be using
and suggests that the public use this
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forum to inquire about ISTs
implemented at the facility.
EPA is not adopting an approval
process for STAA analyses, either by an
independent board, by the
implementing agency, or by any
emergency planning entity. We
recognize nothing in the statute
prohibits the adoption of an approval
process. The language of CAA section
112(r)(7)(F) is directed towards the need
for an operating permit under Title V of
the CAA and therefore has no bearing
on whether the underlying substantive
rule may establish an approval process.
In CAA section 112(r)(7)(B)(iii), the
statute specifically requires EPA’s rules
to establish a system that provides for
review and, if necessary revision of
RMPs (see 40 CFR 68.220).
Nevertheless, the approach we adopt in
this final rule, which requires the owner
or operator to conduct a STAA review
and document its review in general and
its reasoning for not adopting
practicable IST/ISD, is consistent with
the overall approach of the RMP rule to
rely on the development and assessment
of information to lead owners and
operators to adopt reasonable measures
to prevent accidents.
m. Clearinghouse
Some commenters, including a
Federal agency, a state agency,
environmental advocacy groups, and a
local agency, supported the
establishment of a publicly available
online clearinghouse providing
information about the feasibility and
efficacy of safer substances and
processes. A Federal agency commented
that such a database would also be a
useful resource for insurers, chemical
process vendors, emergency responders,
academic researchers, and other
government agencies, such as OSHA.
One commenter remarked that such a
clearinghouse should be dedicated to
the topic of safer technology and
alternatives and should be managed by
either EPA, another Federal agency, or
an independent third-party rather than
industry-funded academics or
institutions. One commenter suggested
that a clearinghouse could be developed
by EPA or a third-party such as CCPS
or Texas A&M’s Mary Kay O’Connor
Process Safety Center.
A few industry trade associations
remarked that the creation of a
clearinghouse would be redundant with
some resources already publicly
available. For example, one trade
association asserted that it has
effectively created its own
clearinghouse through the publication
and maintenance of its own publicly
available publications, semi-annual
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conferences, and regular member
exchange forums. Additionally, this
organization stated that it hosts a
technology symposium every other year,
where members can learn about new
technologies, both from members
sharing their experiences and directly
from vendors and consultants. Another
trade association suggested that the
searchable database of all patents and
patent applications available from the
US Patent and Trademark Office can be
used as a clearing house for safer
technology and that information on
unpatented technologies is readily
available through the internet and other
means.
Another industry trade association
warned that a government clearinghouse
would not reduce chemical accidents
because each chemical process is highly
complex and unique and it would be
difficult to find value in a massive
database of technologies. A commenter
warned that any clearinghouse would be
required to have many ground rules so
as to clarify what factors were at play in
the IST decision. The commenter
expressed concern that the
clearinghouse could be harmful or not
useful if the information was selective
in detail because an IST selected by a
stationary source may be narrow in
scope for a specific set of risks to be
avoided or mitigated. The commenter
also stated that it is possible companies
would provide information lacking
enough detail to be useful. Another
commenter cautioned that one type of
technology, system or design that works
for one facility or process may not work
for another facility or process, due to
differing processes and other
conditions.
EPA is not finalizing a provision to
establish a clearinghouse in this rule.
EPA will further consider the comments
and suggestions on establishing a safer
technologies and alternatives
information clearinghouse should we
pursue an effort to develop and
establish such a clearinghouse in the
future. Currently, industry and other
stakeholders can share chemical safety
and security best practices, including
those involving safer technologies and
alternatives, at the Executive Order
13650 best practices Web site.107 EPA
encourages stakeholders to review
information shared through this forum
and to submit best practices on safer
alternatives or other best practices that
serve to improve chemical safety and
security.
107 https://www.osha.gov/
chemicalexecutiveorder/LLIS/.
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D. Stationary Source Location and
Emergency Shutdown
EPA discussed the importance of
location of stationary sources and their
emergency shutdown capabilities in the
preamble of the proposed rulemaking.
However, EPA did not propose any
provisions related to these issues.
1. Discussion of Comments on
Stationary Source Location
The location of stationary sources,
and the location and configuration of
regulated processes and equipment
within a source, can significantly affect
the severity of an accidental release. The
location of the stationary source in
relation to public and environmental
receptors may exacerbate the impacts of
an accidental release, such as blast
overpressures or concentrations of toxic
gases, or conversely may allow such
effects to dissipate prior to reaching
receptors. EPA requested comments on
whether to consider stationary source
location requirements for future
rulemakings, including the scope of
such requirements, or whether the
Agency should publish guidance. EPA
received multiple comments on this
issue.
Commenters indicated that EPA
should use stricter standards for
calculating blast radius areas for new
and existing facilities to ensure that
communities, schools, and hospitals are
outside of the blast impact. One
commenter stated that EPA should use
information availability requirements to
better inform and protect local
communities from accidents. A Federal
agency and state/local agency requested
that EPA consider the stationary source
location issue in future rulemakings. A
professional organization requested that
EPA consider a 2014 Fire Protection
Research Foundation report in future
requirements for stationary source
location.
Several commenters argued that
facilities should be located where no
damage could occur to people and
homes, asserting that the proposed
rulemaking does not go far enough to
ensure public safety. Some of these
commenters specifically mentioned the
Rancho LPG facility in San Pedro,
California, and asked that EPA review
the siting of this facility due to the
danger it poses to the surrounding
community.
A local agency and an advocacy group
asked that EPA consider IST or risk
reduction methodologies and the
importance of buffer zones in siting of
new stationary sources. Multiple state
and local agencies and an association of
government agencies requested new
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guidance and tools for localities to
clarify additional requirements for
stationary source location. One
commenter stated that EPA should
consider reverse 911 calls to public
receptors in setting requirements.
However, numerous commenters
opposed adding provisions to address
stationary source location issues in the
proposed rulemaking, citing OSHA’s
PSM regulations and the lack of
authority in the CAA. One commenter
stated that EPA should not propose any
additional requirements on the location
of stationary sources. Multiple
comments indicated that states and
localities, not EPA, should regulate the
siting of facilities.
EPA will consider these comments
when determining whether to develop
guidance or propose stationary source
location requirements in a future action.
2. Discussion of Comments on
Emergency Shutdown
The RMP regulation requires owners
and operators of stationary sources to
develop and implement written
operating procedures for the safe and
timely emergency shutdown of Program
2 and Program 3 processes, to ensure
operator training for these procedures,
and for maintaining the mechanical
integrity of emergency shutdown
systems. However, the regulation does
not explicitly require that all covered
processes must include emergency
shutdown systems.
EPA requested comment on whether
emergency shutdown system
requirements should be considered for
future rulemakings, including the scope
of such requirements, or whether the
Agency should publish guidance.
Many commenters supported
additional regulations and/or guidance
on emergency shutdown systems
regulations and/or guidance. Local
agencies stated that EPA should issue
regulations or guidance requiring that
all processes be built such that they can
be placed in a safe state during an
emergency. Another local agency
recommended that EPA publish
guidance on emergency shutdown
systems to assist regulated entities in
evaluating various alternatives, but
argued that including emergency
shutdown systems in a future
rulemaking would be infeasible for
existing locations. One commenter
stated that EPA should consider reverse
911 calls to public receptors in setting
requirements. A state/local agency
expressed support for emergency
shutdown systems requirements in a
future rulemaking, to include operating
procedures and annual testing.
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However, several commenters argued
that EPA should not propose any
additional requirements—regulations or
guidance—on emergency shutdown
systems. These commenters asserted
that existing regulation and facility
practices address emergency shutdown
issues. One commenter supported EPA’s
decision to forgo an emergency
shutdown system requirement, arguing
that exclusion is consistent with RMP’s
performance-based nature, but opposed
EPA’s suggestion to issue a guidance
document. Another commenter opposed
a ‘‘one-size-fits-all’’ rule or guidance for
emergency shutdown systems and
argued that EPA should propose specific
regulatory text in a future rulemaking
should it decide to regulate emergency
shutdown.
EPA will consider these comments
when determining whether to develop
guidance or propose emergency
shutdown system requirements in a
future action.
V. Emergency Response Preparedness
Requirements
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A. Emergency Response Program
Coordination With Local Responders
1. Summary of Proposed Rulemaking
EPA proposed to require owners or
operators of ‘‘responding’’ and ‘‘nonresponding’’ stationary sources to
coordinate response needs with local
emergency planning and response
organizations to ensure that resources
and capabilities are in place to respond
to an accidental release of a regulated
substance. Responding stationary
sources also would be required to
comply with the emergency response
program provisions of § 68.95 when the
outcome of coordination activities
demonstrated that local public
emergency response capabilities were
not adequate to appropriately respond
to an accidental release at the stationary
source, or when the LEPC or equivalent
requested in writing that the owner or
operator comply with the requirements
of § 68.95. ‘‘Non-responding’’ stationary
sources need not have complied with
§ 68.95 provided that the coordination
activities indicated that adequate local
public emergency response capabilities
are available to appropriately respond to
accidental releases at the source,
appropriate mechanisms are in place to
notify emergency responders when
there is a need for a response, and the
LEPC or equivalent has not requested in
writing that the owner or operator
comply with the requirements of
§ 68.95.
The proposed coordination provisions
would have required coordination to
occur at least annually, and more
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frequently if necessary to address
changes at the source, in the source’s
emergency action plan, in local
authorities’ response resources and
capabilities, or in the local community
emergency response plan. The owner or
operator would also have been required
to document coordination activities,
including the names of individuals
involved and their contact information,
dates of coordination activities, and the
nature of coordination activities. The
proposed coordination provisions of
§ 68.93 also would have required
sources with regulated toxic substances
to coordinate response actions with the
LEPC or equivalent, and sources with
only regulated flammable substances to
coordinate with the local fire
department. This language is similar to
the language in § 68.90(b)(1) and (2) of
the original rule, which requires that
sources with toxic substances held
above threshold quantities be included
in the community emergency response
plan developed under EPCRA, and
sources with only regulated flammable
substances held above threshold
quantities coordinate response actions
with the local fire department.
The proposed rulemaking retained all
emergency response program provisions
from § 68.95 of the original rule, and
made two additions. The first was to
modify § 68.95(a)(1)(i) to require that
release notification procedures included
procedures to notify Federal and state
emergency response agencies, in
addition to the existing rule’s
requirement to notify the public and
local emergency response agencies. The
second addition was to modify
§ 68.95(a)(4) to require the owner or
operator to review and update the
emergency response program annually,
or more frequently if necessary, to
incorporate recommendations and
lessons learned from emergency
response exercises, incident
investigations, or other available
information. The proposed rulemaking
also would have replaced the phrase
‘‘local emergency planning committee’’
with the acronym ‘‘LEPC.’’
2. Summary of Final Rule
In this rule, EPA has retained the
proposed term ‘‘Responding stationary
source’’ as a heading for § 68.90(a) and
‘‘Non-responding stationary source’’ as a
heading for § 68.90(b), as an indication
of whether or not a facility is required
to comply with the emergency response
program provisions of § 68.95. Section
68.90(a) is otherwise unchanged from
the existing rule, as are § 68.90(b)(1), (2),
and (3). EPA is also adopting as
proposed paragraphs § 68.90(b)(4) and
(5), which require the owner or operator
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of a non-responding stationary source to
perform the annual coordination
activities required under § 68.93, and
the emergency notification exercises
required under § 68.96(a), respectively.
The final rule adopts as proposed
§ 68.93, but with some changes, which
are discussed in the following sections.
Section 68.93 requires the owner or
operator to coordinate response needs
with local emergency planning and
response organizations to determine
how the source is addressed in the
community emergency response plan
and to ensure that local response
organizations are aware of the regulated
substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility to
respond to an accidental release of a
regulated substance.
Section 68.93(a) requires coordination
to occur at least annually, and more
frequently if necessary, to address
changes at the source, in the source’s
emergency response and/or emergency
action plans, and/or in the local
community emergency response plan.
Section 68.93(b) requires coordination
to include providing to the local
emergency planning and response
organizations, the facility’s emergency
response plan if one exists, emergency
action plan, updated emergency contact
information, and any other information
that local emergency response planning
and response organizations identify as
relevant to local emergency planning.
For responding stationary sources,
§ 68.93(b) also requires coordination to
include consulting with local
emergency response officials to
establish appropriate schedules and
plans for field and tabletop exercises
required under § 68.96(b). Lastly,
§ 68.93(b) require the owner or operator
to request an opportunity to meet with
the LEPC (or equivalent) and/or local
fire department as appropriate to review
and discuss these materials.
Section 68.93(c) adopts as proposed
the coordination documentation
provisions without revision. Under
§ 68.93(c), the owner or operator is
required to document coordination with
local authorities, including the names of
individuals involved in coordination
and their contact information, dates of
coordination activities, and the nature
of coordination activities.
EPA is finalizing several
modifications to § 68.95. EPA has
adopted the proposed addition to
§ 68.95(a)(1)(i), which requires that
release notification procedures include
procedures to notify Federal and state
emergency response agencies, in
addition to public and local emergency
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response agencies. The final rule also
adopts as proposed revisions to
§ 68.95(a)(4), with some modifications.
The final rule requires the owner or
operator to review and update the
emergency response plan as appropriate
based on changes at the source or new
information obtained from coordination
activities, emergency response
exercises, incident investigations, or
other available information, and ensure
that employees are informed of the
changes.
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3. Discussion of Comments and Basis for
Final Rule Provisions
Many commenters, including industry
trade associations, advocacy groups,
professional organizations, facilities,
Federal and state agencies, and others
supported EPA’s efforts to increase
emergency response program
coordination between facilities and
local responders. Other commenters
including industry trade associations
and regulated facilities stated the
proposal would potentially duplicate
other Federal or state requirements or
voluntary efforts, or suggested that EPA
should increase enforcement efforts
rather than impose additional
requirements in certain areas.
Although ATF ruled that the fire at
West Fertilizer in West, Texas was
intentionally set,108 the incident
highlighted the need for better
coordination between facility staff and
local emergency responders. The
approach EPA adopts in the final rule
retains the proposed rulemaking’s
promotion of coordination between
facilities and responders while
recognizing the concerns of many of the
commenters about LEPCs and owners
and operators making determinations
about the abilities and roles of owners
and operators as well as LEPCs. We
preserve local flexibility under our
approach. Public comments on each
proposed provision to the emergency
response coordination and emergency
response program provisions of Subpart
E are discussed further in this preamble,
along with EPA’s responses and
decisions for the final rule.
a. Designation of ‘‘Responding’’ and
‘‘Non-Responding’’ Stationary Sources
Some commenters objected to EPA’s
proposal to designate all sources as
either responding or non-responding
sources. These commenters pointed out
these discrete categories do not
accurately represent the realities of
emergency response, which can include
108 See ATF Announces $50,000 Reward in West,
Texas Fatality Fire, https://www.atf.gov/news/pr/
atf-announces-50000-reward-west-texas-fatalityfire.
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many different degrees of involvement
by facilities and local communities in
planning, preparing for and responding
to accidental release events. One
commenter stated that all facilities,
regardless of whether they are
responding or non-responding facilities,
should have a partnership with the
LEPC or local emergency responders.
Another commenter stated that even
facilities with full on-site emergency
response capability would likely rely on
local public responders to order and
manage shelter-in-place actions or
evacuations. Another commenter stated
that all facilities are responsible for and
must be prepared to deal with the
regulated substances they handle and
there should be no such thing as a ‘‘nonresponding’’ stationary source, but this
does not mean every facility needs a
technician-level hazmat response team.
This commenter stated that every
facility must be able to immediately
notify emergency response agencies
when a release having the potential to
impact the public occurs, take actions to
protect the lives of employees and the
public, minimize or contain the release,
and coordinate with local response
agencies who respond to the release.
EPA agrees there is a wide spectrum
of planning, preparedness, and response
arrangements available to facilities and
local communities, and the two
categories of ‘‘responding’’ and ‘‘nonresponding’’ facilities do not fully
capture this continuum. EPA also
acknowledges there is some overlap
between the obligations of nonresponding and responding facilities.
For example, both non-responding and
responding facilities must have
mechanisms or procedures in place to
notify emergency responders about
accidental releases, and both types of
sources must coordinate emergency
response activities with local
responders (and under the final rule,
these coordination activities must occur
annually and be documented, as further
described further in this preamble).
Because the outcome of coordination
activities may result in different types of
response arrangements involving
regulated facilities and communities,
EPA understands that a facility’s
designation as ‘‘responding’’ or ‘‘nonresponding’’ does not, by itself, explain
all facets of emergency preparedness
and response for the facility.
These designations are still useful,
however, because ‘‘responding’’
facilities must meet certain
requirements that ‘‘non-responding’’
facilities are not required to meet.
Responding facilities must comply with
all of the provisions of § 68.95, which
include developing an emergency
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response plan, developing procedures
for the use, inspection, and testing of
emergency response equipment,
conducting training for employees in
relevant procedures, and updating the
emergency response plan to reflect
changes at the source. Any facility that
plans to use its employees to take
response actions beyond those specified
in its emergency action plan under 29
CFR 1910.38 as a result of an accidental
release at the source—which could
include, for example, donning
emergency air breathing apparatus in
order to enter an area where a toxic gas
leak has occurred with the intention of
stopping or controlling the release—
would be expected to have obtained
appropriate equipment and training,
and to address these activities in its
emergency response program, even if
the facility is also relying on local
responders to supplement its own
response, or to manage offsite response
actions such as evacuations and
sheltering-in-place. Therefore, in the
final rule, EPA has retained the
proposed terms ‘‘Responding stationary
source’’ as a heading for § 68.90(a) and
‘‘Non-responding stationary source’’ as a
heading for § 68.90(b), as an indication
of whether or not a facility is required
to comply with the emergency response
program provisions of § 68.95.
b. Evaluating Resources and Capabilities
of Local Responders
The proposed rulemaking would have
made the owner or operator’s decision
to develop an emergency response
program contingent on the outcome of
local coordination activities. Under the
NPRM, in order to be a non-responding
facility, the owner or operator would
have been required not only to
coordinate with local responders and
have appropriate notification
mechanisms in place, but also to
confirm that adequate local public
emergency response capabilities are
available to appropriately respond to
any accidental release of the regulated
substances at the stationary source.
EPA received numerous comments
objecting to this provision. Many
commenters, including industry trade
associations, government agencies, an
association of government agencies,
facilities, and other commenters,
expressed concern over ambiguity in the
terms ‘‘adequate’’ response capabilities
and ‘‘appropriate’’ response. One
commenter noted that unless they are
notified by the LEPC or fire department,
facilities will not know when a change
in community response capabilities or
resources occurs. Another commenter
pointed out there is no accepted
standard for community emergency
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response capability applicable
nationwide, and that response resources
and capabilities can only be evaluated
in the context of the overall
community’s response plan.
EPA has not adopted this provision in
the final rule. While EPA believes it is
important for regulated facilities and
local responders to share information on
response resources and capabilities, the
Agency acknowledges the capabilities
and resources of local response
organizations are subject to numerous
influences, including other potential
demands within the community for
local response resources, local
government organization and budgets,
Federal, state, and local regulations, and
others. Few if any of these factors are
within the purview of the owners and
operators of individual regulated
facilities, and therefore in many cases,
owners and operators will not be in a
position to judge the adequacy of local
response capabilities and resources.
c. Developing an Emergency Response
Program Upon Receiving a Written
Request From the LEPC
The NPRM would also have required
the owner or operator to develop an
emergency response program in
accordance with § 68.95 upon receiving
a written request to do so from the LEPC
or local response authorities. Numerous
commenters objected to this provision.
These commenters indicated that the
provision would allow or incentivize
LEPCs to absolve themselves of their
emergency response obligations under
EPCRA, even if this may not be in the
best interest of the overall emergency
response. Several commenters stated
that allowing local authorities to ‘‘opt
out’’ of their responsibilities would
undermine the mission of those
authorities, and that relying on facilities
to fulfill emergency response obligations
if an LEPC ‘‘opts out’’ may not be within
these facilities’ authority or capability.
Several commenters also expressed
concern that EPA’s proposal did not
include criteria LEPCs must meet before
requesting a facility become a
responding facility. One commenter
representing an association of state
government response commissions
stated that this provision would cause
the vast majority of LEPCs to request
facilities become responding facilities.
EPA disagrees the proposed provision
would have absolved local responders
of their responsibilities under EPCRA or
allowed them to disregard their other
response obligations. The proposed
provisions would have had no effect on
local authorities’ community emergency
planning responsibilities under EPCRA.
Also, even in situations where regulated
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sources maintain full emergency
response capabilities, local responders
would still be responsible for managing
the aspects of the response external to
the source, such as community
evacuations and sheltering-in-place.
Nevertheless, EPA has decided not to
finalize this provision because of the
objections raised by commenters, and
because it would have allowed local
governments to place emergency
response program obligations on the
owners or operators of regulated
facilities without requisite knowledge of
the facility’s operations, business
practices, financial condition, and other
relevant factors. Also, commenters
pointed out that many facilities—
particularly small businesses—would as
a practical matter simply be unable to
manage all of their own response needs,
which could include maintaining a full
hazardous materials response team, as
well as firefighting capabilities. In the
preamble to the original rule, EPA
acknowledged that small businesses
would often be unable to manage these
duties.
d. Emergency Response Coordination
Activities
Many commenters, including industry
trade associations, advocacy groups,
facilities, government agencies,
professional organizations, and others
supported EPA’s proposed requirements
for improved emergency response
coordination between facilities and
local responders. Several commenters
recommended EPA clarify what is
meant by ‘‘coordination.’’ Some
commenters opposed EPA’s proposed
coordination requirements on the basis
that these activities were already
required under other regulations, or
were being carried out voluntarily.
Other commenters expressed concerns
about an historical lack of participation
by LEPCs in emergency response
coordination activities, or that the
proposed coordination provisions
would place increased burdens on local
responders.
In the final rule, EPA has adopted as
proposed the emergency response
coordination provisions of § 68.93, with
some changes. One significant change
relates to the modified applicability
provisions discussed previously. In
addition to removing the two provisions
from § 68.90 of the final rule that would
have made the owner or operator’s
decision to develop an emergency
response program contingent on the
outcome of local coordination activities,
and required the owner or operator to
develop an emergency response
program upon receiving a written
request to do so from the LEPC or local
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4655
response authorities, EPA has also
removed the proposed language in
§ 68.93 that placed the focus of
coordination on ensuring response
resources and capabilities are in place.
This language has been replaced with
language that places the focus of
coordination on sharing information
related to emergency planning.
EPA has also clarified what
coordination activities are required. In
the final rule, under § 68.93 the owner
or operator is required to provide local
authorities with information about the
regulated substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility to
respond to an accidental release of a
regulated substance. Section 68.93(a)
requires coordination to occur at least
annually, and under § 68.93(b), the
owner or operator is also required to
provide the facility’s emergency
response plan if one exists, the
emergency action plan required under
29 CFR 1910.38, updated emergency
contact information, and any other
information local emergency planning
and response organizations identify as
relevant to local emergency planning.
EPA notes that under 29 CFR
1910.38(b), OSHA requires emergency
action plans to be kept in writing,
unless an employer has 10 or fewer
employees, in which case they may
communicate the plan orally to
employees. Under the final rule, if the
owner or operator has a written
emergency action plan, that written plan
should be provided to local authorities,
but if the plan is an oral plan, the owner
or operator may also communicate the
plan orally to local authorities.
In requiring ‘‘any other information
that local emergency planning and
response organizations identify as
relevant to local emergency planning,’’
EPA is encouraging local emergency
officials to consider what other facility
information may aid them in preparing
for emergencies at the source beyond
those specific elements identified in
§ 68.93 and § 68.93(b), and request such
information from the owner or operator
when conducting annual coordination
activities. Such information could
include accident histories, portions of
incident investigation reports relevant
to emergency response, incident afteraction reports, records of notification
exercises, field and tabletop exercise
evaluation reports, etc. The owner or
operator is required to provide any
information requested by local
emergency planning and response
organizations, to the extent the
information is relevant to local
emergency planning.
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EPA disagrees with commenters who
suggested not adopting the proposed
emergency response coordination
requirements on the basis that they are
already required under other
regulations, or are being carried out
voluntarily. While it is true that in some
cases, other Federal or state regulations
contain emergency response
coordination provisions similar to those
in the final rule, many regulated sources
are not subject to other regulations with
requirements comparable to those in the
final rule. Also, in locations without
functional LEPCs, other local response
authorities may be carrying out local
emergency planning functions, and
these organizations may be unable to
rely on authorities granted to LEPCs
under EPCRA to obtain needed
information. Where regulated sources
are already subject to other Federal or
state emergency response coordination
requirements comparable to those in the
final rule, compliance with those
regulations may be used to demonstrate
compliance with the final rule, to the
extent the activities meet the specific
requirements of the rule. Similarly,
while EPA agrees that some facilities
may already voluntarily carry out the
coordination activities required under
the final rule, not all regulated facilities
do so. Facilities that already carry out
these activities voluntarily may also use
them to demonstrate compliance with
the final rule to the extent the activities
meet the specific requirements of the
rule.
EPA understands some communities
do not have functional LEPCs, but has
accounted for this possibility by
requiring coordination to be with ‘‘local
emergency planning and response
organizations.’’ This term is intended to
encompass all manner of local public
emergency planning and response
organizations. In many cases this will be
the LEPC, but in other cases it may be
a local emergency management agency,
a local fire department, or another local
response organization (or, if
appropriate, multiple organizations).
These non-LEPC planning entities can
use this provision to obtain necessary
planning information even when they
lack the authority granted LEPCs under
EPCRA 303(d)(3). Regardless of whether
or not their community has an active
LEPC, EPA expects owners and
operators of regulated sources to make
good faith efforts to carry out the
coordination activities required in the
final rule. If local emergency planning
and response organizations decline to
participate in coordination activities, or
the owner or operator cannot identify
any appropriate local emergency
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planning and response organization
with which to coordinate, the owner or
operator should document their
coordination efforts, and continue to
attempt to perform coordination
activities at least annually.
EPA is also aware that increasing
regulated facilities’ emergency response
coordination obligations will often place
increased demands on local emergency
planning and response organizations
through increased coordination requests
made by the owners or operators of
regulated sources located in their
communities. This is an unavoidable
consequence of increasing the owner or
operator’s emergency response
coordination obligations. However, the
final rule’s emergency response
coordination requirements are intended
to be a straightforward information
exchange for both regulated sources and
local response organizations, and
therefore should not be highly
burdensome for either party. Also, the
regulatory requirements for
coordination have been placed on the
owner or operator, rather than local
emergency planning and response
organizations. Therefore, local response
organizations are not obligated to
participate in the coordination activities
specified in the final rule. In our
estimate of the burden of the rule, we
have conservatively projected an
estimate of the cost of coordination on
local responders. EPA expects in most
cases, local responders will participate
in these coordination activities because
it is in their best interest to have up-todate information about the risks posed
by regulated stationary sources in their
community and sources’ emergency
response plans.
e. Frequency of Emergency Response
Ccoordination Activities
Many commenters, including state or
local agencies and industry trade
associations, expressed support for
EPA’s proposal to require annual
emergency response coordination
activities between owners and operators
and local emergency response officials.
Commenters noted such ongoing
coordination could help clarify roles
and responsibilities and refresh
contacts. Some commenters expressed
concerns that annual coordination may
be difficult or impractical if a source is
remote or if local authorities refuse to
participate. One commenter suggested
that coordination activities should occur
on a regular basis at an appropriate
frequency determined by the facility
and when there is a significant change
to the source’s emergency plan.
EPA has decided to finalize as
proposed the requirement at § 68.93(a)
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for coordination to occur at least
annually and more frequently if
necessary. EPA agrees with the majority
of commenters that believe that regular
ongoing coordination is useful to
address changes at the source and in the
local community emergency plan. EPA
believes most sources are located close
enough to local responders to make
annual coordination activities practical.
Where necessary, owners and operators
and local authorities may conduct
coordination activities remotely (e.g.,
using conference calls, webinars, email,
etc.). EPA does not agree the frequency
of coordination should be left
completely up to the source. Sources
and local response organizations may
choose to coordinate more frequently
than annually, but the Agency believes
annual emergency coordination between
regulated sources and local responders
is necessary to the development and
maintenance of effective response
plans,109 and unlikely to impose an
undue burden on any source.
f. Annual Coordination Meetings
In the proposed rulemaking, EPA did
not specifically propose to require that
the owner or operator ‘‘meet with’’ local
authorities to conduct annual
coordination. However, in the preamble
to the proposal, EPA did indicate that as
part of the coordination, the owner or
operator and the local response
authorities should ‘‘work together’’ to
determine who will respond if an
incident occurs, and what would be an
appropriate response. Additionally, in
the information availability section of
the preamble to the proposed
rulemaking, EPA requested comment on
whether the Agency should require
owners and operators to meet with
LEPCs and emergency responders.
Several commenters recommended EPA
clarify that coordination activities
should include regular meetings
between the owner or operator and local
authorities. These commenters noted
that such regular meetings would
provide opportunities for both parties to
exchange, update, and discuss
information relating to emergency
response planning. One commenter
noted that annual meetings would allow
the owner or operator to communicate
potentially security-sensitive
information needed for emergency
preparedness and response. A few
commenters noted that while they were
in favor of coordination meetings, the
owner or operator should not be held to
a requirement for such meetings in
situations where local authorities are
109 See preamble discussion in proposed
rulemaking, 81 FR 13671, March 14, 2016.
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unable or unwilling to participate.
Another commenter stated that
coordination meetings should occur, but
the frequency of such meetings should
be left up to the owner or operator and
local authorities to decide.
In § 68.93(b) of the final rule, as part
of the required annual coordination
activities, EPA is requiring the owner or
operator to request an opportunity to
meet with the local emergency planning
committee (or equivalent) and/or local
fire department. The purpose of the
annual coordination meeting is to allow
the owner or operator to update and
discuss the information being provided
to local authorities, and to allow local
authorities to provide the owner or
operator with updated information on
how the source is addressed in the
community emergency response plan.
The annual coordination meeting will
also provide an opportunity for local
authorities to request any other
information that may be relevant to
local emergency planning, and for the
owner or operator to provide this
information. In the final rule, EPA has
worded the meeting requirement to only
require the owner or operator to request
such a meeting, so that the owner or
operator would not be required to hold
a meeting if local authorities are unable
or unwilling to participate. The forum
for coordination meetings is left up to
the reasonable judgement of the owner
or operator and local response
authorities. They may choose to hold a
meeting specifically for this purpose, or
combine the coordination meeting with
another appropriate meeting, such as a
regularly scheduled LEPC meeting, if
both parties agree to the arrangement.
Where necessary, owners and operators
and local authorities may hold meetings
remotely (e.g., via conference call or
webinar).
g. Coordination of Exercise
Frequencies and Plans
In § 68.96(b) of the final rule the
owner or operator of a responding
stationary source is required, as part of
their emergency response coordination
activities, to consult with local
emergency response officials to
establish appropriate frequencies and
plans for tabletop and field exercises.
This provision was added because
numerous commenters, including
industry associations, facilities,
government agencies, and others,
objected to the potentially high burden
associated with conducting field
exercises every five years and tabletop
exercises every year. An association of
government agencies noted that
requiring field exercises every five years
and tabletop exercises every year would
place substantial burdens on LEPCs and
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response agencies, particularly as these
organizations are often composed of
volunteers. This commenter
recommended that the frequency and
scope of field and tabletop exercises be
determined as part of the coordination
process. EPA adopted a modified form
of this provision (which is discussed
further in the following preamble
section on Emergency Response
Exercises) in the final rule, and
therefore added language to § 68.93 (b)
to also require that for responding
stationary sources, coordination must
include consulting with local
emergency response officials to
establish appropriate schedules and
plans for field and tabletop exercises.
EPA understands there may be cases
where local emergency response
agencies are unable or unwilling to
coordinate with a regulated stationary
source on exercise frequencies and
plans, or to participate in exercises. In
such cases, the owner or operator may
establish appropriate exercise
frequencies and plans on their own,
provided they meet the minimum
requirements set forth in § 68.96. Also,
the owner or operator should revisit
their exercise schedules and plans at the
next annual coordination opportunity
with local response officials, so that
these officials are given an opportunity
for input on exercise schedules and
plans, even if they remain unable to
participate in the exercises.
h. Documentation of Coordination
Activities
Many commenters, including state
and local agencies and industry trade
associations, expressed support for
EPA’s proposal to require
documentation of coordination
activities. Several commenters
requested EPA clarify how facilities
should document coordination activities
when local responders are not available
or responsive to a facility’s attempts to
coordinate. Some commenters suggested
that EPA require facilities make a
reasonable attempt to make
arrangements to coordinate with local
responders and document any failure to
complete such arrangements. One
commenter suggested facilities should
be required to seek a written or
electronic acknowledgement from local
responders of coordination efforts, or, if
unavailable, document any efforts made
to coordinate. A few commenters
expressed opposition to the requirement
for documentation of coordination. One
indicated that such documentation
could ‘‘serve as a basis for mutual
accusations or second-guessing between
first responders and the RMP-regulated
facility in the aftermath of an
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4657
emergency.’’ Another indicated that fire
departments in California have found
CalARP requirements to document
emergency coordination to be a large
burden. A third commenter stated that
if facilities are included in the
community response plan, this should
be all the documentation needed to
demonstrate coordination.
EPA has decided to finalize the
requirement at § 68.93(c) for
coordination to be documented, as
proposed (the final rule reverses the
order that the coordination and
documentation provisions appear in the
regulatory text). The final rule does not
specifically require the owner or
operator to seek acknowledgement from
local responders of coordination efforts.
The owner or operator may seek such
acknowledgement if desired, but local
authorities are not required to provide
it. EPA believes the required
documentation elements, which include
the names of individuals involved in
coordination activities and their contact
information, the dates of coordination
activities, and the nature of
coordination activities, should clearly
demonstrate whether local responders
were involved in coordination, without
requiring any other specific
acknowledgement from local
responders. EPA agrees with
commenters that suggested the owner or
operator should document any
unsuccessful attempts to coordinate
with local response organizations. The
final rule does not specifically require
the owner or operator to document
unsuccessful coordination attempts, but
EPA believes it will be in the owner or
operator’s best interest to do so, and
allow the owner or operator to
demonstrate their good faith efforts to
conduct coordination activities in the
event an implementing agency requests
this information.
EPA does not agree with commenters’
objections to documentation of
coordination activities. If response to an
emergency goes badly, documentation
of prior coordination is more likely to
clarify deficiencies than obscure or
exacerbate them. The objection that
documentation could cause a large
burden on fire departments is not
applicable to this provision, as the
requirement for documentation in this
rule is placed on the owner or operator
rather than local responders, and in any
case, the Agency does not view the
documentation requirement as highly
burdensome. Most of the documents the
final rule requires the owner or operator
to provide to local authorities are either
already required to exist (i.e., emergency
response plan and emergency action
plan), or should require minimal effort
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to produce (i.e., updated emergency
contact information, names and contact
information of individuals involved in
coordination activities, dates of
coordination activities, and the nature
of coordination activities). EPA views
these documentation requirements as
straightforward and minimally
burdensome.
During coordination meetings, EPA
encourages owners and operators to
provide local emergency response
officials with additional documentation
relating to emergency planning if those
officials request it. The annual
coordination provisions require the
owner or operator to ensure local
response organizations are aware of the
regulated substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility to
respond to an accidental release of a
regulated substance. The final rule also
requires the owner or operator to
provide any other information local
emergency planning and response
organizations identify as relevant to
local emergency planning. In most
cases, the Agency believes the most
efficient way for the owner or operator
to provide such information is to not
only discuss it during annual
coordination meetings, but also to
provide appropriate documentation to
local authorities.
Lastly, EPA does not agree that a
facility’s inclusion in the community
response plan is sufficient
documentation to demonstrate annual
coordination. EPA notes that
community emergency response plans
are not prepared or maintained by
stationary sources, and that EPCRA does
not require community emergency plans
to be updated annually. Without regular
emergency response coordination
activities involving local authorities, the
owner or operator could remain
unaware of important changes in the
community emergency plan, and local
responders could remain unaware of
changes at the source that could
potentially affect the response to an
accidental release.
EPA believes there is a wide range of
potential outcomes from emergency
response coordination activities, but the
primary purpose of such coordination
should be the regular sharing of
information between the owner or
operator and local response authorities.
Both the owner or operator and local
responders should benefit from this
exchange by becoming more aware of
each organization’s response
capabilities, resources, and procedures.
Based on these increased coordination
activities, both regulated sources and
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local response organizations will be
better able to adapt their response plans
and procedures to updated information.
This information exchange could also
prompt some facilities to enhance their
existing response capabilities, and even
to develop a full emergency response
program where none previously existed.
Conversely, such increased coordination
could result in local authorities, in
consultation with an owner or operator,
deciding that local public responders
are better positioned to respond to
releases of regulated substances at the
source than the facility itself.
Additionally, coordination could lead to
development of mutual aid agreements
with neighboring facilities,
arrangements with response contractors,
or other means to improve community
and/or facility response plans,
procedures, and resources. Such
measures could enhance both the
community’s and facility’s ability to
effectively respond to emergencies
without necessarily requiring a facility
to maintain its own hazardous materials
response team and/or fire brigade,
unless the owner or operator, after
coordinating with local authorities,
decides this is the most effective
approach.
i. Changes to Emergency Response
Program Provisions
The proposed rulemaking contained
two substantive changes to the
emergency response program provisions
of § 68.95. The first change would have
modified the emergency response plan
provision in § 68.95(a)(1)(i) that requires
the plan to include procedures for
informing the public and local
emergency response agencies about
accidental releases, to also require these
procedures to inform appropriate
Federal and state emergency response
agencies about accidental releases. EPA
received no comments on this
provision, and therefore is finalizing it
as proposed.
The second change would have
modified § 68.95(a)(4). Under the
existing rule, this provision requires the
emergency response program to include
procedures to review and update the
emergency response plan to reflect
changes at the stationary source and
ensure employees are informed of
changes. The proposed change would
have required the owner or operator to
review and update the emergency
response plan annually, or more
frequently if necessary, to incorporate
recommendations and lessons learned
from emergency response exercises,
incident investigations, or other
available information.
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Some commenters stated that
requiring annual updates to the facility
emergency response plan is
unnecessary, and that EPA should allow
updates to be performed less frequently,
such as every three or five years, unless
changes occur. Others stated that the
proposed requirement was vague and
should be clarified. A few commenters,
including an industry trade association
and a private citizen, commented that
EPA’s proposed requirement to require
annual updates to emergency response
plans incorrectly assumes the owner or
operator will know when changes in
community emergency response
resources and capabilities occur. One
facility requested EPA clarify in the
final rule that facilities would not be
deemed noncompliant if changes in
local authorities’ response plans or
capabilities occur without notification
to the facility. A private citizen
suggested EPA add a requirement for
local response authorities to provide a
copy of the local community emergency
response plan to the facility.
The final rule has adopted a modified
version of the proposed emergency
response plan update provision. Under
the final rule, the owner or operator
must review and update the emergency
response plan as appropriate based on
changes at the source or new
information obtained from coordination
activities, emergency response
exercises, incident investigations, or
other available information, and ensure
that employees are informed of the
changes. EPA agreed with commenters
who stated that requiring annual
emergency response plan updates is
unnecessary. EPA is not finalizing a
requirement to update the emergency
response plan annually, because while
coordination activities will occur
annually, they may not always generate
information that necessitates changes to
the facility’s emergency response plan.
Other events that could trigger updates
to the emergency response plan, such as
incident investigations and field and
tabletop exercises, may also occur less
frequently than annually, and may or
may not produce information that could
affect the emergency response plan.
Therefore, EPA has decided to finalize
a more flexible update provision. Under
the final rule, the owner or operator is
required to update the emergency
response plan, but only when changes at
the source, or new information obtained
from coordination activities, exercises,
incident investigations, or other
information sources make it appropriate
to change the plan.
EPA disagrees with commenters who
stated the owner or operator will be
unaware of changes in community
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emergency response resources that
could affect the source’s emergency
response plan. EPA believes the annual
coordination provision should ensure
the owner or operator is kept up to date
on relevant changes in the community
emergency response plan. EPA agrees
with commenters that the owner or
operator should not be held responsible
for updating the facility emergency
response plan to reflect changes in the
local community emergency response
plan if local response officials do not
provide the necessary information.
However, the Agency is not requiring
local authorities to provide a complete
copy of the local community emergency
plan to the owner or operator. Local
authorities may provide it if they
choose, and in some cases the
community emergency response plan
may be publicly available information.
However, the local community
emergency response plan may also
contain a significant amount of
information that is not relevant to the
owner or operator, so local response
authorities may prefer to provide only
the information from the community
emergency response plan that relates to
the stationary source.
In the final rule, the Agency has also
included a requirement to ensure
employees are informed of any changes
to the emergency response plan. This
requirement was already in § 68.95(a)(4)
of the existing rule, but had
inadvertently been omitted from the
proposed rulemaking language that
revised this section. One commenter
noted this issue, and stated that workers
should continue to be involved in
reviewing the emergency response plan.
EPA agrees, and therefore has restored
this provision in the final rule.
Lastly, EPA is finalizing the proposal
to replace the term ‘‘local emergency
planning committee’’ with the acronym
‘‘LEPC.’’ EPA received no comments on
this issue.
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B. Facility Exercises
1. Summary of Proposed Rulemaking
In § 68.96 of the NPRM, EPA
proposed to require three types of
emergency response exercises under
Subpart E of the RMP rule—notification,
field, and tabletop exercises. Under
§ 68.96(a), EPA proposed to require all
stationary sources with any Program 2
or Program 3 process to conduct annual
notification exercises that would
include contacting the Federal, Tribal,
state, and local public emergency
response authorities and other external
responders that would respond to
accidental releases at the source. EPA
also proposed that these exercises be
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documented and written records
maintained for a period of five years.
Under § 68.96(b), EPA proposed that
responding stationary sources develop
and implement an exercise program that
includes field and tabletop exercises.
Under § 68.96(b)(1), field exercises
would have been required at least once
every five years, and within one year of
any accidental release meeting the
accident history reporting requirements
of § 68.42. Under § 68.96(b)(2), tabletop
exercises would have been required
annually, except during the calendar
year when a field exercise was
conducted. Also under these provisions,
when planning field and tabletop
exercises, EPA proposed to require the
owner or operator to coordinate with
local public emergency responders and
invite them to participate in exercises.
Lastly, under § 68.96(b)(3), EPA
proposed to require the owner or
operator to prepare an evaluation report
for both field and tabletop exercises,
within 90 days of the exercise. The
report would require a description of
the exercise scenario, names and
organizations of each participant, an
evaluation of the exercise results
including lessons learned,
recommendations for improvement or
revisions to the emergency response
exercise program and emergency
response program, and a schedule to
promptly address and resolve
recommendations. In the preamble to
the proposed rulemaking, EPA indicated
the report would also include an
evaluation of the adequacy of
coordination with local emergency
response authorities, and other external
responders, as appropriate.
2. Summary of Final Rule
EPA is finalizing the notification
exercise provisions of § 68.96(a) as
proposed but with modifications. Under
§ 68.96(b), the final rule requires
responding stationary sources to
develop and implement an exercise
program that includes both field and
tabletop exercises; however, EPA is
modifying the exercise frequency to
allow an owner or operator to establish
a schedule in coordination with local
officials, with minimum timeframes
prescribed in the rule. Exercises must
involve facility emergency response
personnel and, as appropriate,
emergency response contractors. When
planning emergency response field and
tabletop exercises, the owner or operator
must coordinate with local public
emergency response officials and invite
them to participate in the exercise.
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a. Field Exercises
Section 68.96(b)(1) requires the owner
or operator to conduct field exercises
involving a simulated accidental release
of a regulated substance. Under
§ 68.96(b)(1)(i), as part of the
coordination with local emergency
response officials required by § 68.93,
the owner or operator is required to
consult with these local officials to
establish an appropriate frequency for
field exercises. However, in all cases,
the owner or operator must conduct a
field exercise at least once every ten
years.
Section 68.96(b)(1)(ii) identifies the
scope of the field exercises including
tests of: Notification procedures;
procedures and measures for emergency
response actions (including evacuations
and medical treatment); and
communications systems. Field
exercises must also involve: Mobilizing
of facility emergency response
personnel, including contractors, as
appropriate; coordinating with local
emergency responders; deploying
emergency response equipment; and
any other action identified in the
emergency response program, as
appropriate.
b. Tabletop Exercises
Section 68.96(b)(2) requires the owner
or operator to conduct tabletop exercises
involving the simulated accidental
release of a regulated substance. Under
§ 68.96(b)(2)(i), as part of the
coordination with local emergency
response officials required by § 68.93,
the owner or operator is required to
consult with these officials to establish
an appropriate frequency for tabletop
exercises. However, in all cases, the
owner or operator must conduct a
tabletop exercise at least once every
three years.
Section 68.96(b)(2)(ii) requires
tabletop exercises to include
discussions of: Procedures to notify the
public and the appropriate Federal,
state, and local emergency response
agencies; procedures and measures for
emergency response including
evacuations and medical treatment;
identification of facility emergency
response personnel and/or contractors
and their responsibilities; coordination
with local emergency responders;
procedures for equipment deployment;
and any other action identified in the
emergency response plan, as
appropriate.
c. Documentation and Alternatives
EPA is finalizing the documentation
provisions of § 68.96(b)(3) as proposed.
The owner or operator must prepare an
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exercise evaluation report within 90
days of each field and tabletop exercise.
The final rule also adds § 68.96(c) to
describe alternative means of meeting
RMP exercise requirements. Under
§ 68.96(c)(1), the owner or operator may
satisfy the requirement to conduct
notification, field and/or tabletop
exercises through exercises conducted
to meet other Federal, state or local
exercise requirements, provided such
exercises meet the RMP exercise
requirements of § 68.96(a) and/or (b), as
appropriate.
Under § 68.96(c)(2), the owner or
operator may satisfy the requirement to
conduct notification, field and/or
tabletop exercises by responding to an
accidental release, provided the
response includes the actions indicated
in § 68.96(a) and/or (b), as appropriate.
When response to an accidental release
is used to meet field and/or tabletop
exercise requirements, the final rule
requires the owner or operator to
prepare an after-action report
comparable to the exercise evaluation
report required in § 68.96(b)(3), within
90 days of the incident.
3. Discussion of Comments and Basis for
Final Rule Provisions
Many commenters, including industry
trade associations, facilities, government
agencies, environmental advocates,
private citizens, and others supported
EPA’s proposal to incorporate
emergency response exercise
requirements into the RMP rule. Most
commenters supported EPA’s proposal
to require notification exercises. Many
commenters also supported
incorporating requirements for field and
tabletop exercises into the RMP rule, but
some of these commenters also
recommended various changes to the
proposed provisions. Other
commenters, including industry trade
associations, facilities, and others,
recommended eliminating field and/or
tabletop exercises. The approach
adopted in this rule increases the
flexibility for local responders and
stationary source owners and operators
to tailor their exercises to their
communities and to their resources.
Public comments on each proposed
requirement within the emergency
response exercise provisions of Subpart
E are discussed further in this preamble,
along with EPA’s decisions for the final
rule.
a. Notification Exercises
Almost all commenters that addressed
EPA’s proposed notification exercise
requirements supported those
requirements as proposed. Many of
these commenters stated notification
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systems must be tested regularly to
ensure they function successfully in the
event of an emergency. A few
commenters recommended changes to
the notification exercise requirement.
One commenter suggested notification
exercises should occur every five years
unless changes occur (e.g., management,
operation, or physical changes), in
which case they should occur within 60
days of the change. Another commenter
supported a requirement to confirm
emergency contact information but
opposed a requirement to send an actual
‘‘test’’ notification, stating this would be
an unnecessary burden on facilities and
responding organizations. A different
commenter requested EPA exempt
RCRA-permitted facilities from annual
notification exercise requirements,
where the RMP-regulated process is also
covered by a RCRA permit, stating the
proposed requirements are duplicative
of RCRA requirements.
EPA disagrees notification exercises
should occur every five years unless
changes occur, because the Agency
believes five years is too long of a gap
to confirm whether emergency
notification information is correct and
emergency notification systems function
properly. For example, EPA notes that
emergency contact information
provided in RMPs frequently changes,
particularly when facilities go several
years between RMP updates. For this
reason, in 2004 the Agency modified the
RMP submission requirements to
require emergency contact information
provided in RMPs to be corrected
within one month of any change in that
information. EPA also disagrees
management, operational, and physical
changes at the facility necessarily
represent appropriate triggers for
verification of emergency response
contact information. In some cases, such
changes may affect emergency
notification, but notification systems
and procedures may also be affected by
other changes, such as changes in the
community emergency response plan.
While EPA believes it would be
beneficial for the owner or operator to
update their emergency contact
information and confirm the
functionality of notification systems
whenever relevant changes occur, in
some cases changes that affect
emergency contact information and
notification systems may be infrequent,
and result in facility personnel and local
responders becoming unfamiliar with
stationary source emergency notification
procedures. EPA believes a requirement
for annual notification exercises will
ensure that emergency contact
information and notification systems
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remain relatively current, and also
provide regular training for facility
personnel and local responders.
EPA also disagrees that requiring an
actual test of the facility’s notification
system is unnecessary. Requiring annual
testing of notification systems should
prevent situations where emergency
notification systems are only found to
be ineffective when they are most
needed. Short of actually using the
emergency notification system during
an accidental release, performing a test
of the facility’s emergency notification
system is the most practical way to
evaluate whether or not the system is
functional.
EPA expects the notification exercise
will involve testing of on-site
notification equipment and procedures,
including contacting each entity listed
on the facility’s notification list to verify
the contact information and identify
that the facility is conducting a
notification exercise. Therefore, EPA
does not believe testing notification
mechanisms is unduly burdensome.
EPA also disagrees with exempting
RCRA-permitted facilities from the
notification exercise requirement.
However, in the final rule, EPA has
added § 68.96(c) to clarify that exercises
conducted to meet other Federal, state,
or local exercise requirements will also
satisfy the requirements of this rule,
provided such exercises meet all of the
applicable requirements of the RMP
exercise provision.
Due to the significant support for and
minimal opposition to the proposed
notification exercise requirements of
§ 68.96(a), EPA is finalizing those
requirements without modification.
Therefore, under the final rule, all
regulated sources with any Program 2 or
Program 3 process must conduct an
exercise of the source’s emergency
response notification mechanisms at
least once each calendar year. During
listening sessions conducted under
Executive Order 13650, members of the
public expressed significant concerns
about ineffective emergency notification
systems and procedures during
accidental release events at regulated
sources, and about receiving little or no
information on procedures for
evacuation and sheltering-in-place. In
most cases, community notification,
evacuation, and sheltering are managed
by local authorities after receiving an
emergency notification from the
regulated source. EPA encourages
owners and operators to work with local
authorities to perform joint
comprehensive testing of facility and
community notification systems where
possible, and to provide updated
information to local communities on
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evacuation and sheltering procedures.
In some cases, regulated facilities
provide direct notification to nearby
residents and other members of the
community when an accident has
occurred. These may include audible
and/or visual alarms and sirens, reverse
911 calling systems, or other direct
notification systems. Where such
systems are in place, annual notification
exercises should include tests of those
systems during the exercise. In either
case, EPA recommends regulated
sources and communities work together
after conducting notification exercises
to evaluate the effectiveness of
notification, evacuation, and sheltering
systems and procedures, and make
improvements to those systems and
procedures as appropriate, based on
lessons learned during exercises.
b. Field and Tabletop Exercises
EPA received numerous comments on
the proposed field and tabletop exercise
provisions. Most commenters, including
industry trade associations, facilities,
government agencies, environmental
advocates, and others provided general
support for including field and tabletop
exercise requirements in part 68,
although many also recommended
changes to the required frequency of
field and tabletop exercises, expressed
concerns regarding any requirement for
local public responders to be involved
in exercises, or recommended other
changes to the proposed requirements.
Several other commenters entirely
opposed adding field and tabletop
exercise requirements to the rule. In
general, these commenters stated that
field and tabletop exercises were unduly
burdensome on both facilities and local
responders, and exercises are
unnecessary because annual
coordination activities would be
sufficient to prepare facility employees
and local responders to respond to
accidental releases.
EPA disagrees with comments that
recommend completely eliminating
requirements for field and/or tabletop
exercises in the final rule. The Agency
views exercises as an important
component of an emergency response
program for responding stationary
sources, because it allows these sources
to implement their emergency response
plans, test their actual response
procedures and capabilities, identify
potential shortfalls, and take corrective
action. EPA also continues to believe
both field and tabletop exercises will
provide essential training for facility
personnel and local responders in
responding to accidental releases, and
will ultimately mitigate the effects of
such releases at RMP facilities.
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Therefore, in the final rule, EPA is
requiring all responding stationary
sources to perform field and tabletop
exercises. However, in the final rule
EPA has also modified some provisions
of § 68.96 in order to address public
comments. These changes are discussed
in more detail in the following sections.
c. Frequency of Exercises
The greatest number of comments on
the proposed field and tabletop exercise
provisions related to the required
frequency for exercises. While several
commenters supported EPA’s proposed
requirements for annual tabletop
exercises and field exercises every five
years, some commenters recommended
requiring more frequent field exercises,
while others recommended requiring
field and/or tabletop exercises less
frequently, and still others argued that
EPA should retain the requirement for
field and tabletop exercises but allow
owners and operators to have flexibility
in the scheduling of exercises.
Support for more frequent field
exercises. Commenters who argued for
more frequent field exercises included
non-governmental organizations,
government agencies, and others. These
commenters stated that EPA’s proposed
five-year frequency for field exercises
was insufficient. One commenter argued
a five-year timeframe for field exercises
does not conform to CAA section
112(r)(7)(B)(i), which states ‘‘the
Administrator shall promulgate
reasonable regulations and appropriate
guidance to provide, to the greatest
extent practicable, for the prevention
and detection of accidental releases of
regulated substances and for response to
such releases by the owners or operators
of the sources of such releases.’’ This
commenter also stated that more
frequent exercises are necessary so that
response personnel would gain more
experience. Several other commenters
who recommended more frequent
exercises noted that sources subject to
the New Jersey Toxic Catastrophe
Prevention Act (TCPA) regulations are
required to conduct annual field
exercises. Other commenters argued
more frequent field exercises are needed
due to the potential for personnel
turnover that results in the loss of
institutional knowledge and
collaborative relationships between
covered facility owners/operators and
community emergency responders.
EPA disagrees that CAA section
112(r)(7) requires EPA to establish a
requirement for more frequent exercises.
The statute itself in CAA section
112(r)(7)(B)(i) does not contain a
requirement for emergency response
exercises, therefore, nothing in the
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4661
statute mandates a frequency for such
exercises if the EPA decides some
exercises may be reasonable. The
requirement to conduct emergency
response exercises derives from EPA’s
authority to set ‘‘reasonable regulations’’
that include ‘‘procedures and measures
for emergency response after an
accidental release of a regulated
substance in order to protect human
health and the environment.’’ CAA
section 112(r)(7)(B)(ii) further requires
owners and operators to prepare and
implement a risk management plan that
includes, among other things, ‘‘a
response program providing for specific
actions to be taken in response to an
accidental release of a regulated
substance so as to protect human health
and the environment, including
procedures for informing the public and
local agencies responsible for
responding to accidental releases,
emergency health care, and employee
training measures.’’ This statutory
language provides the Administrator
with discretion to decide what
components of an emergency response
program are reasonable to include in
regulations.
EPA believes exercising emergency
response plans is a reasonable
requirement in order to ensure that
emergency response programs will work
well in the event of an accidental
release. However, EPA is cognizant of
the resources (e.g., staffing, cost,
expertise) that exercises demand both
from stationary sources and from local
responders. To ensure the
reasonableness of the exercise
requirement, EPA has provided
flexibility for stationary sources and
local emergency responders to set
schedules for such exercises. Given the
differences among communities and
stationary sources impacted by the
national Risk Management Program
rule, the reasonable minimum frequency
for exercises will vary by locale from
that which is appropriate under the NJ
TCPA requirements.
EPA disagrees with commenters who
recommended requiring field exercises
more frequently than every five years.
EPA notes that its own regulatory
impact analysis for the NPRM projected
the emergency response exercise
provisions to be the costliest provision
of the NPRM, and the Agency is
concerned that a requirement for even
more frequent field exercises could be
prohibitively expensive for some
facilities and local responders.
Regarding commenters’ concerns
about the potential that less frequent
exercises may result in response
personnel gaining less experience, and
for personnel turnover to result in the
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loss of institutional knowledge and
relationships between facility operators
and community emergency responders,
EPA shares such concerns, but must
balance those concerns with the
potentially higher burdens that more
frequent exercises could place on
facility response personnel and
community responders. Also, EPA
believes the annual emergency response
coordination requirements of § 68.93
will foster strong ongoing relationships
between facility personnel and local
responders, and prevent the loss of
institutional knowledge. Furthermore,
the timeframes EPA is establishing in
the final rule are minimum expectations
and we encourage owners and operators
to establish appropriate schedules for
exercises, in consultation with local
officials, considering factors such as
hazards, organizations (including
facility personnel training needs and
personnel turnover), budgets, resource
demands, regulations, or other factors.
Arguments for less frequent exercises.
Commenters who argued for less
frequent field and/or tabletop exercises
included industry associations,
government agencies, facilities, local
responders, private citizens, and others.
These commenters stated that requiring
field exercises every five years and
tabletop exercises every year would be
overly burdensome on facilities and
local responders. Some of these
commenters submitted data to EPA to
substantiate their burden estimates. One
commenter recommended reducing the
required exercise frequency because
holding exercises as frequently as
proposed by EPA would discourage
regular participation by facility
personnel and local responders. Several
commenters recommended the
frequency of field and tabletop exercises
be left to the discretion of the source
and/or local responders, so that the
exercise schedule could be tailored to
the individual circumstances of sources
and local communities. These
commenters also stated that exercises—
and particularly field exercises—can be
very costly for both sources and local
responders. They also indicated that
setting a single exercise frequency for all
sources does not account for the
differing situations faced by different
sources and communities. In some
cases, these commenters argued,
requiring too-frequent exercises could
potentially divert resources away from
other important safety activities. One
commenter representing an association
of state emergency planning officials
supported an exercise requirement, but
recommended the frequency for both
field and tabletop exercises be
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determined by collaboration between
the source and local responders during
the emergency response coordination
process.
EPA found these comments
compelling. EPA’s own projections in
the Regulatory Impact Analysis for the
proposed rulemaking indicated that
exercises would be the costliest
provision of the proposed rulemaking,
and in order to limit these costs, one
alternative considered in the NPRM was
to require only tabletop exercises.
Additionally, the Agency is sympathetic
to the concerns raised by emergency
response officials and others that
participation in exercises by local
responders can be burdensome,
particularly in smaller communities
with volunteer responders and fewer
response resources, as well as in
communities where multiple RMP
facilities are present—which would
place proportionally greater demands on
responders who desire to participate in
the RMP facility exercises held within
their jurisdiction. EPA is also mindful of
the concerns raised by small business
owners and their representatives both
during SBAR panel process and in
comments submitted to EPA, who
pointed out that exercises could
potentially place a relatively larger
burden on small businesses.
For these reasons, in the final rule
EPA has modified the provision for
frequency of both field and tabletop
exercises to allow sources and local
responders to work together to establish
an exercise frequency appropriate to
their situation. However, as EPA
continues to believe that both field and
tabletop exercises are an important
component of an emergency response
program, the Agency does not believe
any responding source should be
allowed to reach an agreement that
practically exempts the source from the
exercise program requirements. This
could happen if a source reached
agreement with local responders to hold
exercises extremely infrequently.
Therefore, the Agency is also
establishing a minimum required
exercise frequency of ten years for field
exercises, and three years for tabletop
exercises. The Agency believes even the
smallest sources will be able to hold
field exercises at least once each decade,
and in many cases EPA expects sources
will hold field exercises more
frequently. The Agency set the
frequency for tabletop exercises to be
more frequent than field exercises
because tabletop exercises require less
time and fewer resources to plan and
conduct than field exercises, and
therefore EPA believes sources will be
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able to perform tabletop exercises at
least every three years.
Under the final rule, owners and
operators are required to coordinate
with local responders to establish an
exercise frequency that works for both
organizations. In establishing the
exercise frequency, owners or operators
and local responders may account for
whatever factors they deem appropriate.
Owners or operators and local
authorities may also adjust exercise
frequencies as needed to account for
changes in hazards, organizations,
budgets, resource demands, regulations,
or other factors, provided that field
exercises occur at least every ten years,
and tabletop exercises occur at least
every three years. The agency notes that
some RMP facilities may be subject to a
more frequent schedule for exercises
under other (e.g., state or local)
regulations. In such cases, the owner or
operator should comply with the more
stringent exercise frequency
requirement. By doing so, they will
ensure that they also meet the required
exercise frequency for the RMP exercise
requirements.
d. Local Responder Participation in
Exercises and Exercise Planning
EPA proposed to require owners and
operators to coordinate with local
public emergency response officials
when planning emergency response
field and tabletop exercises, and invite
them to participate in exercises. While
most public comments on this issue
supported the idea that local response
officials should be involved in exercise
planning and execution, many
comments submitted by industry
associations, facilities, government
agencies, and others expressed concerns
that local responders could easily
become overburdened by any
requirement to participate in planning
or conducting exercises. These
commenters pointed out that in many
communities, local response
organizations may be staffed with
volunteers, or may have multiple RMP
facilities within their jurisdiction, such
that local response organizations could
be significantly impacted by a
requirement to participate in exercises.
These commenters agreed that local
responders should be invited to
participate in exercises, but
recommended that EPA not require
local authorities to participate in
planning or conducting exercises, and
not hold facilities accountable if local
response organizations decline to
participate. Comments submitted by
industry associations and facilities also
recommended EPA address the
possibility that exercises may
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sometimes need to be postponed if local
response organizations are unable to
participate due to actual emergencies or
lack of resources. These commenters
recommended that EPA allow
extensions of the required timeframe for
conducting the next exercise, or allow
the owner or operator to meet the
exercise requirement by conducting the
exercise as soon as possible without
participation by local responders, if
necessary.
In addition to coordinating with local
response authorities to establish an
exercise frequency, the final rule also
requires the owner or operator to
coordinate with local public emergency
response officials when planning field
and tabletop exercises, and to invite
local responders to participate in
exercises. EPA agrees with the many
commenters who stated that any
requirement for local responders to
participate in planning or conducting
exercises could in some cases
overburden local response organizations
or make it difficult for regulated
facilities to timely meet the exercise
requirements. EPA is aware of, and
various public comments have noted,
the fact that in the past some sources
have been unable to locate local
response organizations who are able or
willing to perform such coordination
activities. Therefore, while the final rule
requires the owner or operator to
coordinate with local public responders
to establish field and tabletop exercise
frequencies and plan exercises, and
invite local emergency responders to
participate in exercises, the final rule
does not require local responders to
participate in any of these activities.
In most cases, the LEPC, fire
department, or equivalent local
emergency response authority would be
the appropriate party for the owner or
operator to conduct exercise planning
and coordination. EPA believes these
local response authorities will usually
be willing to perform emergency
response coordination activities,
including exercise coordination
activities, with regulated sources. In
many cases, EPA expects that exercise
planning can be included as part of the
annual coordination meetings required
under § 68.93. In other cases, the owner
or operator and local responders may
choose to hold separate exercise
planning meetings. EPA also
understands that in some cases local
responders may elect to limit their
participation in exercise coordination
activities because of limitations on their
available time and resources. However,
if the owner or operator is unable to
identify a local emergency response
organization with which to coordinate
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field and tabletop exercise schedules
and plans and participate in exercises,
or the appropriate local response
organizations are unable or unwilling to
participate in these activities, then the
owner or operator may unilaterally
establish appropriate exercise
frequencies and plans, and if necessary
hold exercises without the participation
of local responders. In these cases, the
owner or operator must still ensure that
field exercises occur at least every ten
years, and tabletop exercises occur at
least every three years. Additionally, the
owner or operator should continue to
make ongoing efforts to locate
appropriate local public response
officials for purposes of emergency
response and exercise coordination and
participation.
As EPA believes the final rule
provides the owner or operator with
ample flexibility to establish and modify
exercise schedules, EPA sees no reason
to provide for additional extensions of
time for conducting exercises in the
event that local responders cannot
participate, or if for some other reason
the exercise must be rescheduled. EPA
recommends that owners and operators
and local response organizations take
such contingencies into account when
establishing exercise schedules, so there
is still time to complete the field or
tabletop exercise within the allotted
timeframe (i.e., at least every ten years
for field exercises and at least every
three years for tabletop exercises) in the
event the exercise must be postponed.
e. Exercise Scope
Some commenters recommended EPA
clarify the required scope of exercises.
One commenter indicated that if EPA
does require exercises, the Agency
should allow some variation in the
scope of exercises based on the needs
and resources of the community.
In the preamble to the proposed
rulemaking, EPA explained that field
exercises involve the actual
performance of emergency response
functions during a simulated accidental
release event. Field exercises involve
mobilization of firefighters and/or
hazardous materials response teams,
activation of an incident command
structure, deployment of response
equipment, evacuation or sheltering of
facility personnel as appropriate, and
notification and mobilization of law
enforcement, emergency medical, and
other response personnel as determined
by the scenario and the source’s
emergency response plan. Field
exercises include tests of:
• Procedures for informing the public
and the appropriate Federal, state, and
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4663
local emergency response agencies
about an accidental release;
• Procedures and measures for
emergency response after an accidental
release of a regulated substance
including evacuations and medical
treatment;
• Communications systems;
• Mobilization of facility emergency
response personnel, including
contractors as appropriate;
• Coordination with local emergency
responders;
• Equipment deployment, and
• Other actions identified in the
source’s emergency response plan, as
appropriate.
Tabletop exercises are discussionbased exercises without the actual
deployment of response equipment.
During tabletop exercises, responders
typically assemble in a meeting location
and simulate procedural and
communications steps for response to a
simulated accidental release, as
determined by the scenario and the
source’s emergency response plan.
Tabletop exercises include tests of:
• Procedures for informing the public
and the appropriate Federal, state, and
local emergency response agencies
about an accidental release;
• Procedures and measures for
emergency response after an accidental
release of a regulated substance
including evacuations and medical
treatment;
• Identification of facility emergency
response personnel and/or contractors
and their responsibilities;
• Coordination with local emergency
responders;
• Procedures for deploying
emergency response equipment, and
• Other actions identified in the
source’s emergency response plan, as
appropriate.
EPA believes these elements allow
ample flexibility for the owner and
operator, in consultation with local
emergency response officials, to choose
appropriate exercise scenarios.
Involving local response officials in
selecting exercise frequencies and in
planning exercises should ensure that
RMP facility exercises are consonant
with the needs and resources of
regulated facilities and local
communities. By involving local public
responders in the exercise scenario
itself, responders may also be able to
test or simulate important offsite
emergency response actions that are
usually managed by local public
emergency response officials, such as
community notification, public
evacuations, and sheltering in place,
and EPA encourages sources and local
response officials to design exercise
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scenarios where these functions are also
tested. Responding stationary sources
that rely on response contractors to
perform emergency response functions
during accidental releases should also
ensure that response contractors
participate in field and tabletop
exercises.
In preparing the exercise evaluation
report required under § 68.96(b)(3), the
owner or operator should evaluate all
aspects of the exercise, including, to the
extent possible, any offsite aspects of
the exercise such as community
notification, evacuation, and sheltering
in place. In many cases, this will require
the owner or operator to involve local
response officials in the exercise
evaluation.
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f. Post-Accident Exercises
In the NPRM, in addition to requiring
periodic field and tabletop exercises,
EPA proposed to require the owner or
operator to hold a field exercise within
one year of any accidental release
required to be reported under § 68.42.
Many commenters objected to this
requirement. These commenters stated
that this provision could potentially
overtax facility and local responders,
who would be required to deploy once
for the incident, and again for the
exercise following the incident.
EPA agrees with these comments, and
therefore has decided not to finalize the
requirement to conduct a field exercise
within one year of an accidental release.
g. Alternatives for Meeting RMP
Exercise Requirements
Several commenters indicated EPA
should allow sources to meet the
periodic field exercise requirements
through the actual deployment of
emergency response resources and
personnel during accidental release
events. Other commenters indicated that
many regulated facilities are already
subject to exercise requirements under
other Federal, state, or local regulations,
or through an industry code of practice,
and these exercises should suffice to
meet the exercise requirements of the
proposed rulemaking. Comments from
state regulatory agencies indicated that
one agency already requires more
frequent field exercises under state law,
and another state government agency is
considering imposing more frequent
exercise requirements.
EPA generally agrees with these
comments. The Agency does not want to
establish exercise requirements that
conflict with other Federal, state, or
local laws. Therefore, in the final rule,
EPA has added § 68.96(c) to describe
alternative means of meeting exercise
requirements. This section allows the
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owner or operator to meet requirements
for notification, field, and/or tabletop
exercises either through exercises
conducted to meet other Federal, state,
or local exercise requirements (or under
a facility’s industry code of practice or
another voluntary program) or by
responding to an actual accidental
release event, provided the exercise or
response includes the actions required
for exercises under § 68.96(a) and (b), as
appropriate.
h. Joint Exercises
Several commenters, including
industry associations and regulated
facilities, indicated that some
companies have formed mutual aid
associations among several neighboring
or nearby facilities so that participating
facilities can share response personnel
and resources in order to aid one
another in responding to accidental
release events at any member’s facility.
These commenters recommended that
in such situations, or situations where
there are clusters of regulated facilities
located close together, EPA should not
require each facility to conduct a field
exercise, but rather allow these facilities
to meet their periodic field exercise
obligation by conducting a single joint
exercise, where all participating
facilities perform simulated response
actions to an exercise scenario staged at
one member-facility’s site. These
commenters indicated that this
approach would reduce the exercise
demands on small and medium-sized
facilities, as well as local responders.
EPA agrees with these comments, and
encourages owners and operators of
neighboring RMP facilities to consider
planning and conducting joint exercises.
However, sources that participate in
joint exercises must ensure that their
participation meets all of the provisions
of § 68.96(a) and/or (b), as appropriate.
As commenters have noted, RMP
facilities participating in mutual aid
agreements with other nearby facilities
already coordinate response actions and
resources with those facilities, and EPA
believes conducting joint exercises
among these facilities will more
accurately simulate their behavior in the
event of an actual release event, and
further enhance the ability of these
facilities and surrounding communities
to effectively respond to accidental
releases. Even where such mutual aid
agreements are not currently in place,
EPA believes the owners and operators
of neighboring regulated facilities
should consider whether joint facility
exercises may have benefits for
participating facilities, local responders,
and surrounding communities. Such
benefits could include improved
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identification and sharing of response
resources, enhanced training for facility
personnel and local responders,
improvements in facility procedures
and practices resulting from information
sharing, and others. EPA also agrees that
joint exercises may be particularly
beneficial for small businesses. While
the Agency believes that even small
sources can design and conduct field
and tabletop exercises that are
appropriate to the size, hazards, and
capabilities of the source, joint exercises
involving multiple neighboring small
sources would allow these sources to
pool resources together in order to carry
out more extensive exercise scenarios
that could better simulate serious
accidental release events. In areas where
multiple RMP facilities are located close
together, joint exercises could also
reduce the overall burden of exercises
on local response organizations, who
might otherwise be asked to participate
in multiple separate exercises.
i. Exercise Documentation
While most commenters who
addressed the issue of exercise
documentation acknowledged the need
for exercise evaluation reports to be
prepared, some commenters expressed
concerns about specific aspects of the
proposed exercise documentation
requirements. Some commenters
objected to the proposed rulemaking’s
requirement to prepare the evaluation
report within 90 days, stating that
evaluation reports for large exercises
could take longer than 90 days to
prepare, and that EPA should allow
extensions of the required timeframe
where appropriate. Still other
commenters objected to the possibility
that exercise evaluation reports that
indicate deficiencies outside the control
of an owner or operator could
potentially be used by EPA in an
enforcement action against the owner or
operator. Other commenters stated EPA
should not require exercise reports to
include the names and associations of
exercise participants, because this
information could be difficult to obtain
and would risk the privacy of exercise
participants without any benefit.
EPA is finalizing the exercise
documentation requirements of
§ 68.96(b)(3) as proposed. EPA is also
requiring in § 68.96(c)(2),
documentation of a response to an
accidental release in order for the
response to be used to satisfy the RMP
field exercise requirements. The owner
or operator must prepare an after-action
report comparable to (and in lieu of) the
exercise evaluation report required in
§ 68.96(b)(3), within 90 days of the
incident, when the owner or operator
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uses the response to an accidental
release to meet their field or tabletop
exercise requirement. This provision is
necessary because documenting the
response to an accidental release may
differ from documenting the results of
an exercise. For example, instead of
documenting the ‘‘exercise scenario,’’
the owner or operator would document
the nature of the accidental release
prompting the response. Also, there may
be additional aspects of the response to
an accidental release that should be
documented, such as any injuries, first
aid and/or medical treatment that
occurred. To the extent possible, the
owner or operator should ensure that
additional items such as these are
documented in the after-action report,
as well as information equivalent or
comparable to that documented in an
exercise evaluation report.
EPA disagrees with commenters who
contend that 90 days is insufficient time
to develop an exercise evaluation report
(or after-action report), or that
extensions of time should be granted for
development of evaluation reports in
certain circumstances. Unlike incident
investigations, where report completion
may require extensive and timeconsuming evidence collection and
forensic analysis, the basic elements
required to be documented in an
exercise evaluation report should be
known relatively quickly after the
conclusion of the exercise.
Regarding commenters concerns
about the use of exercise evaluation
reports in enforcement actions—an
exercise report is like any other record
required to be developed under 40 CFR
part 68. Whether or not an exercise
evaluation report would be used in an
EPA enforcement action would depend
on the specific facts and circumstances
of the case.
EPA disagrees that exercise evaluation
reports should not contain the names
and associations of exercise
participants. Under the final rule, the
frequency of both field and tabletop
exercises is mainly left to the reasonable
judgement of the owner or operator and
local response officials. In some cases,
exercises may occur infrequently, and
EPA believes that maintaining a written
record including, among other things,
the identification and affiliation of
exercise participants will be useful in
planning future exercises.
VI. Information Availability
Requirements
EPA proposed requirements for
making information available to LEPCs
or emergency response officials, and the
public in order to ensure that
communities have the necessary
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chemical hazard information to protect
the health and safety of first responders
and residents. The following sections
provide an overview of the proposed
and final rule provisions, public
comments received, and EPA’s
responses.
A. Disclosure Requirements to LEPCs or
Emergency Response Officials
1. Summary of Proposed Rulemaking
EPA proposed that owners and
operators of all RMP-regulated facilities
provide certain information to LEPCs or
local emergency response officials upon
request. EPA stated that the facility
should make this information available
in a manner that is understandable and
avoids technical jargon, convey it
without revealing CBI or trade secret
information, and adequately explain any
findings, results, or analysis being
provided.
EPA proposed that the owner or
operator be required to develop the
following chemical hazard information
for all regulated processes and provide
it, upon request, to the LEPC or local
emergency response officials:
• Information on regulated
substances. Information related to the
names and quantities of regulated
substances held in a process;
• Accident history information. The
facility’s five-year accident history
information required to be reported
under § 68.42;
• Compliance audit reports.
Summaries of compliance audit reports
developed in accordance with §§ 68.58,
68.59, 68.79, or 68.80, as applicable;
• Incident investigation reports.
Summaries of incident investigation
reports developed in accordance with
§ 68.60(d) or § 68.81(d), as applicable;
• Inherently Safer Technologies (IST).
For each process in NAICS codes 322,
324, and 325, a summary of the IST or
ISD identified that the owner or
operator has implemented or plans to
implement;
• Exercises. Information on
emergency response exercises required
under § 68.96 including, at a minimum,
schedules for upcoming exercises,
reports for completed exercises, and
other related information.
2. Discussion of Comments and Basis for
Final Rule Provisions
Overall, commenters agreed that
providing communities, local planners,
and local first responders with
appropriate chemical hazard-related
information is critical to ensuring the
health and safety of the first responders
and local communities. Commenters
that supported the proposed
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4665
requirements provided general support
and offered no suggested changes other
than to expand the IST requirement to
apply to all facilities; require facilities to
submit IST analyses to the LEPC; and
make IST analyses available to the
public.
However, most commenters,
including professionals (e.g.,
consultants or technical/process safety
experts), state agencies, facilities, and
industry trade associations, did not
support the requirement for facilities to
submit specific chemical hazard-related
information to LEPCs and local
emergency response agencies, as the
appropriate mechanism to ensure that
local responders and planners have the
information they need to mitigate
chemical risks. Commenters provided
several reasons for their objections
including:
• A lack of data supporting the
Agency’s concern that LEPCs are not
receiving the information they need to
develop local emergency response
plans;
• Unnecessary redundancy with
existing requirements, such as data
reported under EPCRA;
• Data proposed is too broad and does
not provide useful information pertinent
to emergency response planning;
• The data may overwhelm LEPCs
with technical information and the
concern that most LEPCs lack the
expertise needed to use this information
to develop local emergency response
plans; and
• Security concerns regarding how
the information is maintained and
handled by the LEPC or emergency
response officials.
Of those commenters that did not
support the proposed requirements,
several stated that EPA provided no data
supporting the Agency’s concern that
some LEPCs were not receiving the
information they needed to develop
local emergency response plans. These
commenters pointed to EPA’s 2008
National Survey of Local Emergency
Planning Committees (LEPCs),110 which
did not reveal any concerns about RMP
facilities withholding information from
LEPCs. According to these commenters,
LEPCs indicated in the survey that they
were able to obtain RMP data from EPA,
the state, or RMP facilities and noted
their greatest obstacle was lack of
funding. In addition, commenters
pointed out that the Executive Order
13650 Working Group report, Actions to
Improve Chemical Facility Safety and
110 2008 Nationwide Survey of Local Emergency
Planning Committees (LEPCs). https://
www.epa.gov/epcra/nationwide-survey-localemergency-planning-committees.
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Security—A Shared Commitment, May
2014 111 contains no findings about
facilities ignoring LEPC requests for
information or that lack of information
provided to the LEPCs was an issue, but
rather the report stated that LEPCs had
concerns about managing all of the
information provided under various
laws and regulations, understanding
how each chemical is regulated, and
how to properly respond to an
emergency involving specific chemicals.
In addition, these commenters stated
that while some CSB
investigations 112 113 114 highlighted a
lack of emergency preparedness and
recommended strengthening local
infrastructures supporting LEPCs, they
did not find that facilities refused to
cooperate with the community or
withheld chemical information from
LEPCs.
Multiple commenters, including
professionals, state and local
government agencies, facilities, and
industry trade associations, also stated
that the information elements that EPA
proposed to require facilities to share
with LEPCs are already available to
them through the EPCRA or reported in
RMPs, which are also already available
to the LEPCs. Several commenters noted
that communication between LEPCs and
facilities is satisfactory via the EPCRA
process and stated that LEPCs were able
to obtain RMP data from EPA. One
commenter requested the EPA refocus
its efforts into collecting required data
from ‘‘outlier facilities who are not
providing required chemical hazard
information’’ rather than impose a
duplicative requirement for the creation
and distribution of data.
Many commenters also asserted that
the scope of information required by the
proposed provision was too broad.
These commenters argued that incident
111 Executive Order 13650 Actions to Improve
Chemical Facility Safety and Security—A Shared
Commitment, May 2014. https://www.osha.gov/
chemicalexecutiveorder/final_chemical_eo_status_
report.pdf.
112 CSB. January 2016. Final Investigation Report,
West Fertilizer Company Fire and Explosion, West,
TX, April 17, 2013. Report 2013–02–I–TX, pgs.
201–203, 242. https://csb.gov/west-fertilizerexplosion-and-fire-/.
113 CSB. January 2011. Investigation Report:
Pesticide Chemical Runaway Reaction Pressure
Vessel Explosion, Bayer CropScience, LP, Institute,
West Virginia, August 28, 2008. Report No. 2008–
08–I–WV, https://www.csb.gov/assets/1/19/Bayer_
Report_final.pdf.
114 CSB. July 10, 2007. CSB News Release: CSB
Chairman Merritt Describes the Lessons from Five
Years of Board Investigations to Senate Committee,
Urges Additional Resources and Clearer Authorities
for Federal Safety Efforts. https://www.csb.gov/csbchairman-merritt-describes-the-lessons-from-fiveyears-of-board-investigations-to-senate-committeeurges-additional-resources-and-clearer-authoritiesfor-federal-safety-efforts/.
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investigation summaries, compliance
audit summaries, and IST or ISD
implementation summaries would not
provide useful information for
emergency planning and that the
proposed information requirements
were unnecessarily detailed. Several of
these commenters also suggested that
the type and format of the information
should be determined by individual
LEPCs. Furthermore, commenters
expressed concern that the information
in these summaries would be too
technical and LEPC staff may not have
the expertise to understand the
information being submitted or
extrapolate information that may be
useful.
Multiple commenters raised concerns
regarding the security of sensitive
chemical and facility information that
would be shared with LEPCs under the
proposed requirements. These
commenters indicated that LEPCs
would be unable to keep the
information secure because they lack
procedures and resources to properly
vet those who would have access to the
information, and that the information
would be considered ‘‘public
information’’ once it is provided to the
LEPC. These commenters indicated that
there are multiple ways for the public to
access sensitive information from LEPCs
through information requests from the
public. Commenters also suggested that
these requirements to disclose
information to LEPCs interfere with the
Department of Homeland Security’s
(DHS) Chemical Facility Anti-Terrorism
Standards (CFATS). Commenters further
suggested that since much of this
information might reveal security
vulnerabilities at facilities, providing
this information to LEPCs increases the
risk of terrorism or criminal use of the
information which could cause harm to
first responders and the community.
EPA also received comments
regarding how the information should
be provided to LEPCs and the timeframe
for providing that information. Many
commenters suggested the information
should be provided through existing
systems in a format which is useful to
LEPCs or local emergency responders
for developing their local emergency
plans. Several states and a state
association suggested LEPCs and
emergency response officials should
determine what information is useful
and necessary to developing
preparedness and response plans. An
industry trade association suggested that
information should not be in an
electronic format but should be
communicated to LEPCs, local
emergency officers, neighbor groups,
and Community Advisory Panels at
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regular intervals. Two state agencies
commented that RMP information
should be incorporated into existing
management systems and that providing
information in a stand-alone single
document was of little value to
emergency planners. A few commenters
suggested that the format of the
information should be determined by
the individual LEPC. Finally, several
commenters proposed that the
information be relayed during the
annual coordination meeting between
LEPCs and facility personnel.
In response to these comments, EPA
maintains that it is very important to
ensure that LEPCs or local emergency
response officials have the chemical
information necessary for developing
local emergency response plans,
however, EPA believes it is unnecessary
to specify in the RMP rule the types or
format of information that LEPCs or
emergency response officials may
request. EPCRA section 303(d)(3)
already provides the necessary authority
to allow LEPCs to request information
needed to develop the local emergency
response plan. Additionally, EPCRA
requires facilities to provide Safety Data
Sheets (SDSs) and inventory
information to LEPCs to assist
emergency planners and responders.
Under EPCRA section 312(f), fire
departments have the authority to
inspect these facilities to better
understand the risk associated with
these chemicals and how to deal with
those risks in the local emergency
response plan.
As pointed out by the commenters,
the proposed requirements could be
perceived as limiting the flexibility of
LEPCs and emergency response officials
to collect the information they need to
develop a local emergency response
plan that addresses their community’s
specific chemical risks. Furthermore,
the proposed requirements would have
owners or operators preparing
information summaries on an annual
basis, regardless of whether the LEPC
requests the information, and EPA
agrees that this is overly burdensome for
facility owners and operators. This
could also result in reports being sent to
the LEPCs or emergency response
officials without the necessary context
to help officials to understand the
information contained within the
reports and utilize it for planning
purposes.
Without acknowledging any
inconsistency with CFATS or other
regulatory structure, EPA recognizes
both the security concerns that
commenters expressed and the
challenges associated with securing
arguably sensitive information.
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Therefore, EPA has decided not to
finalize § 68.205 of the proposed
rulemaking, and is instead adding
language to the emergency response
coordination provisions of § 68.93,
which requires the owner or operator to
provide ‘‘any other information that
local emergency planning and response
organizations identify as relevant to
local emergency planning.’’ (For more
information see section V.A. of this
preamble.) Under this structure,
assertions of Chemical-terrorism
Vulnerability Information (CVI) status
for certain information can be addressed
on a case-by-case basis by the stationary
source, the LEPC, DHS, and other
appropriate entities.
EPA agrees with commenters that this
approach will allow LEPCs and other
local emergency officials to obtain the
information they require to meet their
emergency response planning needs. It
will also allow local emergency
planners and response officials to ask
questions of facility personnel about the
risks associated with the chemical
hazards at the facility and about
appropriate mitigation and response
techniques to use in the event of a
chemical release. It further allows the
facility owner or operator and the LEPC
to identify information that may need to
be maintained securely and discuss
strategies to secure the information or to
provide only information that is
pertinent to emergency response
planning without revealing security
vulnerabilities.
The LEPC or local emergency
response officials may request
information such as accident histories,
portions of compliance audit reports
relevant to emergency response
planning, incident investigation reports,
records of notification exercises, field
and tabletop exercise evaluation reports,
or other information relevant to
community emergency planning. For
example, this may include requesting
information on changes made to the
facility that affect risk such as
incorporating safer alternatives.
Furthermore, EPA directs commenters
who indicated that the IST analyses
should apply to all facilities and be
submitted to the public to refer to
sections IV. C. and VI. B. in this
preamble.
B. Information Availability to the Public
1. Summary of Proposed Rulemaking
Under § 68.210(a), EPA proposed to
add a reference to 40 CFR part 1400,
which addresses the restrictions on
disclosing ‘‘offsite consequence
analysis’’ (OCA) information under the
CSISSFRRA.
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Under § 68.210(b), EPA proposed to
require the owner or operator of a
stationary source to distribute certain
chemical hazard information for all
regulated processes to the public in an
easily accessible manner, such as on a
company Web site. EPA proposed to
require the owner or operator to
distribute, as applicable:
• Names of regulated substances held
in a process;
• SDSs for all regulated substances at
the facility;
• The facility’s five-year accident
history required under § 68.42;
• Emergency responses program
information concerning the source’s
compliance with § 68.10(f)(3) or the
emergency response provisions of
subpart E, including:
Æ Whether the source is a responding
stationary source or a non-responding
stationary source;
Æ Name and phone number of local
emergency response organizations with
which the source last coordinated
emergency response efforts, pursuant to
§ 68.180; and
Æ For sources subject to § 68.95,
procedures for informing the public and
local emergency response agencies
about accidental releases.
• Information on emergency response
exercises required under § 68.96,
including schedules for upcoming
exercises, reports for completed
exercises as described in § 68.96(b)(3),
and any other related information; and
• LEPC contact information,
including LEPC name, phone number,
and Web site address as available.
EPA proposed to add § 68.210(c), to
require that the owner or operator
update and submit information required
under § 68.210(b) every calendar year,
including all applicable information
that was revised since the last update.
EPA also proposed to redesignate the
current § 68.210(b), which addresses the
non-disclosure of classified information
by the Department of Defense or other
Federal agencies or their contractors, as
§ 68.210(e). In new § 68.210(f), EPA
proposed to require that an owner or
operator asserting CBI provide a
sanitized version of the information
required under this section to the
public. Assertion of claims of CBI and
substantiation of CBI claims was
proposed to be in the same manner as
currently required in §§ 68.151 and
68.152 for information contained in the
RMP required under subpart G.
2. Summary of Final Rule
EPA is finalizing § 68.210(b) with
changes to address public comments.
Under the final rule, § 68.210(b) requires
the owner or operator to make certain
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4667
chemical hazard information for all
regulated processes at a stationary
source available to the public upon
request. The information that shall be
provided is the same as proposed,
except EPA is revising the exercise
information element. Under
§ 68.210(b)(5) of the final rule, upon
receiving a request for the information
from a member of the public, the owner
or operator is required to provide a list
of scheduled exercises required under
§ 68.96, rather than summary
information for those exercises, as
proposed.
Section 68.210(c) is now titled
‘‘Notification of availability of
information,’’ and it changes the manner
by which the facility informs the public
about what chemical hazard information
is available upon request and how the
public may obtain such information.
The owner or operator shall provide the
public with an ongoing notification of
the following: (1) The required
information elements in § 68.210(b)(1)
through (6) that is available to the
public upon request, (2) instructions for
requesting the information elements and
(3) where to access any other available
information on community emergency
preparedness.
Section 68.210(d) requires that the
owner or operator provide the requested
information listed under § 68.210(b) to
the public within 45 days of receiving
a request.
Finally, EPA is finalizing several
sections as proposed, including:
• § 68.210(a), RMP availability;
• § 68.210(f), which addresses the
non-disclosure of classified information
by the Department of Defense or other
Federal agencies or their contractors
(this was formerly proposed as
§ 68.210(e)); and
• § 68.210(g), which relates to CBI,
redesignated from § 68.210(f).
3. Discussion of Comments and Basis for
Final Rule Provisions
a. Legal Issues
An industry trade association and a
facility stated that legislation
subsequent to the CAA narrowed EPA’s
authority to mandate public disclosure
of RMP information. Relevant
legislation described by the commenters
includes (1) the 1999 CSISSFRRA, (2)
the Critical Infrastructure Information
Act (CIIA), (3) the Chemical Facilities
Anti-Terrorism Standards Act of 2007,
and (4) the Protecting and Securing
Chemical Facilities from Terrorist
Attacks Act of 2014.
Another industry trade association
commented that requiring private
companies to publish qualitative or
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quantitative environmental information
inappropriately seeks to delegate EPA’s
own duties to communicate with and
deal with public requests to the
regulated entity.
A few industry trade associations
argued that the proposed information
disclosure requirements are compelled
speech that may violate the first
amendment. An industry trade
association commented that EPA’s
proposal to require disclosure of RMP
information and chemical hazard
information raises constitutional issues,
as it amounts to compelled commercial
speech. The commenter described
compelled commercial speech as subject
to an intermediate-level of scrutiny, and
asserted that, unless EPA can
affirmatively prove that (1) its asserted
interest is substantial, (2) the speech
regulation directly and materially
advances that interest, and (3) the
regulation is narrowly tailored to that
interest, then the compelled commercial
speech will likely be found to be
unconstitutional.
The information disclosures required
by the final rule are fully consistent
with the statutes and regulatory
programs identified by the commenters
as enacted after the 1990 CAA
Amendments. CSISSFRRA specified
that portions of RMPs containing OCA
information, any electronic data base
created from those portions, and any
statewide or national ranking derived
from such information is subject to
restrictions on disclosure (CAA sections
112(r)(7)(H)(i)(III) and 112(r)(7)(H)(v)).
Regulations promulgated jointly by EPA
and the Department of Justice further
define OCA information in 40 CFR
1400.2(j). The final rule does not require
disclosure of release scenarios or
rankings based on such scenarios, nor
does it make available any information
based on such scenarios. The CIIA
restricts information ‘‘not customarily in
the public domain.’’ CFATS creates a
category of information, CVI, which
further restricts certain information
generated to implement CFATS (see 6
CFR 27.400). In promulgating CFATS,
DHS announced its intent to preserve
Federal release disclosure, emergency
planning, and accident prevention
statutes, including EPCRA and CAA
section 112(r) (72 FR 17714, April 9,
2007). In this final rule, EPA has not
promulgated the new mandatory
disclosure of STAA and incident
investigation information that we had
proposed, thereby eliminating the
tension between these after-enacted
programs and modernization of the risk
management program. The information
required to be disclosed by this rule
largely draws on information otherwise
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in the public domain and simplifies the
public’s access to it.
This final rule requires an owner or
operator of a stationary source to alert
the public, via any one of a wide variety
of methods, of how to access
information about the source that is
publicly available. Other statutes and
regulatory programs, or other provisions
of the risk management program, require
the stationary source to assemble the
information that the rule would make
available upon request (e.g., accident
history, SDSs, and aspects of the
emergency response program). The
burden of making this information
directly available from the source is
minimal. The public’s ability to
participate in emergency planning and
readiness is materially advanced by
being better informed about accident
history, types of chemicals present, and
how to interact with the stationary
source. EPA has been selective in
identifying what information a source
must make available; for example, we
have not required the facility to provide
an RMP to the public. Having the source
provide the information set out in
§ 68.210 directly to the public promotes
accident prevention by facilitating
public participation at the local level.
b. RMP Availability (§ 68.210(a))
EPA did not receive any comments on
this issue.
c. Chemical Hazard Information
(§ 68.210(b))
Comments on making information
available to the public. EPA received
multiple comments that supported the
proposed provisions. These comments
generally indicated that the revisions
would strengthen the community’s
‘‘right to know.’’ A mass mail campaign
joined by approximately 450
commenters provided general support
for the disclosure of information to the
public. EPA also received comments
stating that the RMP and accompanying
chemical hazard information would be
valuable to communities in order to
understand the risks involved.
Many commenters opposed the
proposed information provisions.
Multiple commenters, including state
agencies, facilities, and industry trade
associations, argued that the proposed
provisions for public disclosure of
information have the potential to create
a security risk, with several commenters
expressing opposition to the proposed
provisions because they appear to
conflict with CFATS or other existing
information security requirements. Two
diverse groups of commenters remarked
that OCA data should remain accessible
to the public only through Federal
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reading rooms, but an advocacy group
remarked that keeping information
solely in reading rooms would limit
access by the public. Some commenters
stated that the information requirement
was already available through EPCRA or
Freedom of Information Act (FOIA)
requests, while others stated that EPA
had not given enough reasoning for how
the increase in information disclosure to
the public would result in a safer
community in proportion to the burdens
imposed on facilities.
EPA continues to believe that
providing chemical hazard information
to the general public will allow people
that live or work near a regulated
facility to improve their awareness of
risks to the community and to be
prepared to protect themselves in the
event of an accidental release. EPA
believes that this information should be
more easily accessible to the public than
the existing approaches to access
information under EPCRA or through
FOIA requests. However, EPA
acknowledges the security concerns
raised by commenters and is committed
to ensuring a balance between making
information available to the public and
safeguarding that information.
Therefore, EPA is finalizing an approach
that requires facility owners and
operators to notify the public that
certain information is available upon
request. This allows community
members 115 an opportunity to request
chemical hazard information from a
facility, so they can take measures to
protect themselves in the event of an
accidental release, while allowing
facility owners and operators to identify
who is requesting the information. EPA
worked closely with Federal partners,
including DHS, to develop information
availability requirements that strike a
balance between security concerns and
the need for sharing chemical hazard
information with the public. EPA
believes that this approach is consistent
with existing requirements to secure
sensitive information under CSISSFRRA
and CFATS. Furthermore, EPA is
committed to safeguarding OCA
information in accordance with
requirements specified in CSISSFRRA,
which allows for any member of the
public to access paper copies of OCA
information for a limited number of
facilities. This OCA information
remains accessible to the public only in
Federal Reading Rooms.
EPA believes that the current
approach to notify the public that
information is available upon request
115 Community members can include a wide
variety of stakeholders that work or live near an
RMP-regulated facility.
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strikes an appropriate balance between
various concerns, including information
availability, community right-to-know,
minimizing facility burden, and
minimizing information security risks.
Scope of information to be shared.
Commenters provided suggestions on
the scope of information to be disclosed.
An advocacy group commented that
information on chemical hazards, safer
alternatives (such as information on
ISTs), incidents, inspections, and
training should all be made publically
available. Some commenters remarked
that the public should be given
information on the schedules and types
of emergency response drills performed;
how to adequately protect oneself
during a release; where to evacuate; how
the decision to evacuate will be made
and communicated; and how the allclear signal will be given. However,
several commenters objected to making
exercise reports available to the public.
These commenters stated that providing
the public with information about
potential weaknesses in a facility or
community field response could reveal
security vulnerabilities. A few other
commenters stated that only
information that could improve
community awareness of risks should be
made available to the public, such as
names of regulated substances held in a
process above threshold quantities,
names and phone numbers of local
emergency response organizations, and
LEPC contact information.
Some commenters recommended
making available to the public the same
information elements proposed for
disclosure to LEPCs (i.e. STAA/IST,
incident investigation reports and thirdparty compliance audits), while several
other commenters opposed these
suggestions. For example, a mass mail
campaign suggested that facilities
disclose STAA directly to the public.
However, one trade association opposed
publicly disclosing STAA, citing that
the information would be highly
technical and potentially confusing to
the general public and may involve the
disclosure of confidential, proprietary or
other sensitive information. The
association further argued that facilities
would be put in a position where they
must publicly defend IST evaluations
and decisions.
Some commenters stated that incident
investigation reports should be included
in the scope of information delivered to
the general public, while others said
that providing such reports would be
burdensome and confusing to the
public. Other commenters argued
specifically against making root cause
analyses available to the public
indicating that this greatly increases the
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likelihood that facilities will have to
respond to lawsuits. One commenter
expressed concern that disclosing root
cause analyses would discourage
facilities from performing meaningful
analyses.
A state agency commented that thirdparty compliance audit reports should
be made publicly available to assure the
public that appropriate investigation has
been done and appropriate steps are
being taken to avoid future incidents. A
group of commenters argued that
emergency contact information should
not be shared publicly online because it
will encourage unwanted telemarketing
and email spam and solicitations.
EPA agrees with commenters that
who suggested that only information
that could improve community
awareness of risks should be made
available to the public. EPA disagrees
with commenters that suggest making
additional information available to the
public, such as STAA reports, incident
investigation reports (with root cause
analyses), and third-party audit reports.
As some commenters indicated, much
of the information in these reports can
be technically complicated and
potentially confusing for the general
public. Furthermore, this information is
not always relevant to community
emergency preparedness and could
potentially reveal CBI or security
vulnerabilities. Therefore, the Agency is
finalizing the following chemical hazard
information elements to be made
available to the public, upon request:
• Names of regulated substances held
in a process;
• SDS for all regulated substances
located at the facility;
• Five-year accident history
information required to be reported
under § 68.42;
• The following summary
information concerning the source’s
compliance with § 68.10(f)(3) or the
emergency response provisions of
subpart E:
Æ Whether the source is a responding
stationary source or a non-responding
stationary source;
Æ Name and phone number of local
emergency response organizations with
which the owner or operator last
coordinated emergency response efforts,
pursuant to § 68.180; and
Æ For responding stationary sources
(i.e., those subject to § 68.95),
procedures for informing the public and
local emergency response agencies
about accidental releases;
• A list of scheduled exercises
required under § 68.96; and
• LEPC contact information,
including the LEPC name, phone
number, and Web address as available.
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EPA expects that making the
information available upon request will
minimize security vulnerabilities as
well as unwanted telemarketing and
email spam and solicitations.
EPA agrees with commenters that
members of the public do not
necessarily need access to exercise
evaluation reports. Therefore, to address
concerns that summary information of
facility exercise may be confusing to the
public and could reveal security
vulnerabilities, EPA is revising
§ 68.210(b)(5) to remove the requirement
to provide summary information about
exercises and only require a list of
scheduled exercises required under
§ 68.96. EPA believes that one benefit of
sharing exercise schedules is to avoid
unnecessary public alarm when
exercises are conducted. However, EPA
expects that facility owners and
operators will use good security
practices when revealing details about
upcoming exercises.
d. Notification of Availability of
Information (§ 68.210(c))
EPA proposed requiring the owner or
operator to make chemical hazard
information publicly available and
update the information every calendar
year. Many commenters supported the
use of a streamlined, one-stop Web
format for disseminating information to
the public. Several commenters opposed
posting information for the public on
facility Web sites due to security
concerns. Some commenters argued that
EPA should utilize existing online
public information resources (such as
the Agency’s Web site or available
RMP*Info or Enforcement and
Compliance History Online (ECHO) 116
databases) to share information, while a
few commenters concluded that
appropriate state level agencies should
be responsible for making information
available to the public.
Many other commenters remarked on
the variety of options to disseminate
information suggested by EPA,
including local libraries, government
buildings, or the Internet, and stated
that this fragmented approach would
not improve public access to
information. One commenter cited that
EPA should ensure availability of
information to those without Internet or
electronic media access, and another
commenter suggested that hard copies
should be made available for those
without access to online resources, in
addition to information published on an
EPA Web site. Another commenter
remarked that information should be
made available only after an email
116 https://echo.epa.gov/?redirect=echo.
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request is made directly to the facility.
An advocacy group commented that
information on accidental releases
should be reported, immediately, to the
public through the Internet, radio,
telephone, and television.
Commenters also provided
suggestions on the format of the
information. Some of these commenters
suggested that a one to two-page
summary of information would be
sufficient for the public.
EPA is committed to ensuring that
chemical hazard information is
available to the public in an easily
accessible manner; however, the Agency
acknowledges commenters’ security
concerns associated with providing
information to the public and the
additional burden that may fall on
owners or operators that do not have
Web sites or other means to publicly
and routinely post such information. In
response to these concerns, EPA is
requiring that owners and operators
notify the public that certain
information is available along with
instructions on how to request the
information. The facility owner or
operator must ensure that the
notification is ongoing through a
publicly accessible means, such as a
Web site or social media platform.
The facility owner or operator can
notify the public that information is
available in a variety of ways. For
example, the owner or operator could
make the notification of information
availability by using free or low cost
Internet platforms, file sharing services,
and social media tools that are designed
to be able to share information with the
public. As another option, the facility
could post hard copy notices at publicly
accessible locations, such as at a public
library, or a local government office. If
the facility has the means to handle
public visitors, it could choose to have
notices available at the facility’s public
visitor location. The facility could also
provide notices that information is
available to the public by email. EPA
encourages the facility owner or
operator coordinate information
distribution with the LEPC or local
emergency response officials to
determine the best way to reach public
stakeholders in their communities.
Facility owners and operators may also
want to consider outreach efforts that
would allow the public to provide input
on the best way to make this notification
available. The owner or operator shall
document whatever method and the
location of the notification in the RMP
pursuant to § 68.160(b)(21).
EPA believes that providing this
notification to the general public would
allow people that live or work near a
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regulated facility to gather the
information they need to improve their
awareness of risks to the community
and to prepare to protect themselves in
the event of an accidental release. The
notice shall specify what information is
available and provide instructions for
how to obtain the information. The
facility owner or operator shall also
identify where to access information on
community preparedness, if available,
including shelter-in-place and
evacuation procedures. The facility
should work with the LEPC and local
emergency responders to distribute and
convey relevant information on
appropriate shelter-in-place and
evacuation procedures.
e. Timeframe To Provide Information
Following a Request (§ 68.210(d))
One commenter expressed concern
that requiring public information to be
updated annually would be an
unnecessary burden on facilities. In
contrast, another state agency reasoned
that the public should not have to
request information, it should be readily
available. An advocacy group requested
that a version of the chemical hazard
information provided by the facility be
made on an annual basis.
While EPA agrees that requiring
facilities to annually update their
information could be unnecessarily
time-consuming, EPA encourages
facilities to update their chemical
hazard information as needed to ensure
that accurate information can be made
available to the requester within the
required timeframe. Therefore,
§ 68.210(d) requires that the facility
owner or operator provide the
information under § 68.210(b) to the
requester within 45 days of receiving a
request. EPA selected 45 days because
that timeframe is consistent with the
requirement for public provision of
facility chemical inventory information
(i.e., ‘‘Tier II information’’) under
§ 312(e)(3)(D) of EPCRA, which states,
‘‘a State emergency response
commission or local emergency
planning committee shall respond to a
request for Tier II information under
this paragraph no later than 45 days
after the date of receipt of the request.’’
f. Classified Information (§ 68.210(f))
EPA received no comments on this
issue.
g. CBI (§ 68.210(g))
Several commenters stated that the
public information disclosure
requirement would place CBI at risk,
and therefore EPA should eliminate this
requirement. Other commenters
requested that EPA clarify that CBI
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would still be protected from public
dissemination. Many commenters
requested that EPA require that certain
information in STAA reports either may
not be claimed as CBI or should require
up-front substantiation of
confidentiality claims. Some
commenters suggested that CBI claims
for STAA information include a
certification by the owner or operator or
a senior official. Other commenters
recommended that EPA prohibit STAA
reports from being claimed as CBI. Two
commenters stated that it may not be
practical or possible to provide the
public with a useful STAA document
after removing appropriate CBI.
EPA is finalizing § 68.210(f) relating
to CBI as proposed, but renumbered the
paragraph as § 68.210(g). EPA
acknowledges and shares industry’s
concerns pertaining to protection of CBI
information. By incorporating a CBI
provision in the information availability
section of the rule EPA is emphasizing
the facility owner or operator’s right to
protect CBI. EPA has also limited the
types of information to be disclosed to
eliminate matters likely to contain CBI
(e.g., names of regulated substances;
SDSs) as well as to include information
elements for which CBI cannot be
claimed (e.g. five-year accident history
information and emergency response
program information). Section 68.151
clearly identifies what information
cannot be claimed as CBI and § 68.152
identifies the procedure for how to
protect CBI. EPA believes that the RMP
rule adequately addresses CBI concerns.
Furthermore, EPA is not requiring
STAA reports to be submitted to LEPCs
or the public in the final rule and
therefore, no CBI concerns exist for
these reports.
An owner or operator of a stationary
source asserting that a chemical name is
CBI shall provide a generic category or
class name as a substitute. If an owner
or operator has already claimed CBI for
a portion of the RMP, then that claim
still applies for the disclosure elements
the information availability provisions
of the rule. The owner or operator
should provide a sanitized version as
described in the RMP*eSubmit User’s
Manual. This policy is consistent with
existing guidance and practices.117
117 For more information on CBI, see Chapter 9 of
the General Guidance on Risk Management
Programs for Chemical Accident Prevention (40
CFR part 68), March 2009. https://www.epa.gov/
sites/production/files/2013-11/documents/chap-09final.pdf.
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C. Public Meetings
1. Summary of Proposed Rulemaking
EPA proposed to require all facilities
to hold public meetings within 30 days
after any RMP reportable accident to
share information concerning the
accident with the public including:
When the accident occurred; the nature
of the accident; chemicals involved and
quantities released; on-site and offsite
impacts; notifications made to
emergency responders; weather
conditions (if known); initiating event
and contributing factors (if known); and
operational changes (if any) that have
resulted from the investigation of the
release. EPA also proposed that at this
public meeting, facilities would provide
other relevant chemical hazard
information such as the names and
SDSs for regulated substances at the
facility; accident history information for
the facility; information on the
emergency response and exercise
programs; and LEPC contact
information.
2. Summary of Final Rule
In the final rule, EPA is requiring all
facilities to hold a public meeting after
an RMP-reportable accident, but is
extending the timeframe for the public
meeting to 90 days in response to
comments. The public meeting
provision proposed as § 68.210(d) is
redesignated as § 68.210(e) in the final
rule. The owner or operator shall
document in the RMP whether a public
meeting has been held following an
RMP reportable accident, pursuant to
§ 68.160(b)(22).
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3. Discussion of Comments and Basis for
Final Rule Provisions
EPA received a wide range of
comments on the proposed public
meeting requirements—comments
generally in support of or against the
requirement for public meetings;
concerns about sufficient attendance or
availability of information at public
meetings; comments on the appropriate
timeframe for the meetings; and
comments on alternative options.
a. Attendance at Public Meetings
Many commenters opposed
requirements for public meetings. Some
commenters opposed based on their
experience that public meetings held
under CSISSFRRA were not well
attended. One commenter said the
public would not attend a meeting after
a minor incident, but a public meeting
for an event with major offsite impacts
should include a report summarizing
the incident. Some commenters
questioned the benefit of such a meeting
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if a facility is in compliance with
regulatory requirements.
Other commenters offered ideas for
improving or gauging public interest.
For example, one commenter suggested
that EPA establish minimum
requirements for sources to notify the
public of upcoming meetings but did
not offer suggestions for what those
requirements should be. Another
commenter suggested that polls could
be used to prescreen members of the
public who would like to attend or
participate in the public meeting, in
order to establish effective participation.
EPA recognizes concerns about
attendance at public meetings. When
the CSISSFRRA was enacted in 1999, it
required owners or operators of all
facilities regulated under the RMP rule
to hold a public meeting within 180
days of enactment.118 The purpose of
the public meeting was to discuss the
OCA information that was restricted
under other portions of CSISSFRRA.
Relatively few of these meetings were
hosted by facilities that had recently
suffered an RMP-reportable accident.
The Agency expects that after a
reportable accident occurs, attendance
at public meetings will be higher than
was the case at many public meetings
held under CSISSFRRA because of
interest generated by the accident itself
(e.g., an emergency response or media
reports). This public meeting
requirement applies only following an
RMP reportable accident, so this
provision has a much lower burden than
the CSISSFRRA public meeting
requirement because of the relatively
few number of RMP reportable
accidents that occur annually. CSB
highlighted in their comments that
public meetings held shortly after
accidents occur have the greatest level
of participation.
EPA supports commenters’
suggestions to find practical strategies to
increase attendance and encourages
public participation at public meetings;
however, we are not incorporating these
suggestions as mandatory requirements
in the final rule. Facilities have the
flexibility to encourage attendance at
meetings by means that are appropriate
and effective in their communities. This
could include methods suggested by
commenters, such as polling nearby
residents to gauge interest.
b. Applicability Criteria and Timeframe
Comments on applicability criteria.
One commenter requested clarification
118 Chemical Safety Information, Site Security
and Fuels Regulatory Relief Act, Public Law 106–
40, August 5, 1999. See https://www.gpo.gov/fdsys/
pkg/STATUTE-113/pdf/STATUTE-113-Pg207.pdf.
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on the meaning of ‘‘reportable accident’’
that would trigger a public meeting.
Another commenter remarked that
multiple meetings may be necessary in
certain circumstances, for instance if the
investigation report has not been
finalized. Commenters also suggested
that public meetings should be required
of all program level facilities while
others indicated that a ‘‘one-size-fitsall’’ approach was not appropriate.
Several commenters requested that
public meetings be required only when
an incident generated offsite impacts.
Finally, another commenter suggested
EPA require periodic public meetings
regardless of accident history.
The term ‘‘reportable accident’’ refers
to accidents required to be reported in
the five-year accident history required
under § 68.42 of the existing rule, which
include accidental releases from
covered processes that resulted in
deaths, injuries, or significant property
damage on site, or known offsite deaths,
injuries, evacuations, sheltering in
place, property damage, or
environmental damage. EPA agrees that
in some cases, multiple public meetings
may help to fully describe the
circumstances of an accident. While
EPA is requiring the owner or operator
to hold only one public meeting after an
RMP-reportable accident, the Agency
encourages owners and operators to
hold additional meetings if appropriate.
The final rule requires public meetings
for regulated sources, regardless of
program level, if the facility has an
RMP-reportable accident. The Agency
does not view the public meeting
requirement as a ‘‘one-size fits all’’
requirement. Sources have flexibility to
structure public meetings as appropriate
to their circumstances and the needs of
the surrounding community. EPA
recommends that facility owners and
operators engage in community
outreach to determine how best to
structure the public meetings. Involving
the public in advance of the meeting
will help to ensure public participation
in meetings. EPA considered requiring
public meetings only after accidents
with offsite impacts but decided to
apply the requirement to all RMPreportable accidents because even
though some RMP-reportable accidents
have only on-site impacts, those
accidents are often serious enough to
raise safety concerns within the
surrounding community.
Finally, EPA is not requiring periodic
public meetings, regardless of accident
history, in the final rule. EPA believes
that public interest in a meeting is
highest after an accident, and notes that
many commenters indicated that public
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meetings required by CSISSFRA were
not well attended.
Comments on timeframe. Several
commenters expressed support for the
proposed 30-day timeframe. Other
commenters said that a 30-day
timeframe would be too long, as the
greatest need for a public meeting
occurs within 2 weeks after an accident.
However, many commenters stated the
30-day timeframe for a public meeting is
too short, as a facility is unlikely to
complete an incident investigation in
that timeframe. Commenters warned
that incomplete information would not
be appropriate to share with the public
and could breed distrust between the
public and facilities over the lack of
complete data. Some commenters cited
the burden placed on facilities to
schedule and prepare for a meeting,
especially during an incident
investigation and other post-incident
actions. Commenters recommended
alternative timeframes for public
meetings after an accident including: 60
days, 90 days, 120 days, six months,
nine months, and 12 months or after the
investigation is completed. One
commenter suggested that EPA provide
an opportunity to extend the public
meeting timeframe with reasonable
justification. Another commenter
suggested that EPA allow the LEPC to
consult on or determine when to hold
the public meeting after an RMP
reportable accident.
EPA acknowledges concerns raised by
commenters about diverting facility
resources from post-accident
investigations, and the potential for a
facility to lack complete information
about an accident if the investigation
hasn’t yielded sufficient information to
share with the public within 30 days.
Therefore, EPA has revised the
timeframe in the final rule for the public
meeting to be held no later than 90 days
after an RMP reportable accident. EPA
expects that sources will either have
completed the incident investigation
required under § 68.60 or § 68.81 prior
to holding the public meeting, or will
have developed sufficient information
relevant to community members’
concerns to allow a productive meeting.
Even if the accident investigation is not
complete, a 90-day timeframe should
allow the owner or operator to share
appropriate information about the
accident with the local community. The
facility could discuss the progress of the
investigation so far and next steps
planned.
Some comments expressed the view
that attendance at a public meeting is
higher when the meeting takes place
very soon after an accident occurs. The
90-day timeframe in the final rule is a
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maximum timeframe, and EPA
encourages facilities to take into
consideration when public interest may
be highest when scheduling the public
meeting. EPA recognizes that in some
cases, such as for complex, protracted
investigations, the facility may need to
hold the public meeting prior to
completing the incident investigation.
In such cases, the owner or operator
should consider holding a second
public meeting after completing the
incident investigation, or sharing
information about results of the
investigation through another means,
such as a Web site, social media, with
the LEPC or local emergency response
officials, or distributing information
directly to people who attended the
public meeting and expressed interest in
the additional information.
EPA does not believe that it is
necessary to add a provision that would
allow an extension of the 90-day
timeframe with reasonable justification.
Such a provision would add complexity
to the requirement. Furthermore, EPA
believes that by extending the timeframe
to 90 days this allows sufficient time for
the facility to gather information to
share with the public after an accident.
EPA is not finalizing any
requirements for LEPCs or local
emergency response officials with
respect to post-accident public
meetings. EPA received many comments
that opposed increasing LEPC
responsibilities in the final rule, citing
resource limitations and significant
existing responsibilities. While a facility
should communicate closely with
LEPCs or local emergency response
officials after an RMP reportable
accident, and may combine public
meetings with LEPC meetings or other
events as long as those events/meetings
are available for public participation,
the facility bears the responsibility for
the public meeting. The final rule places
no additional burden on LEPCs or local
emergency response officials with
respect to requirements for postaccident public meeting.
c. Scope of Information Provided at
Public Meetings
Public commenters provided various
recommendations regarding how much
and what type of information should be
provided at public meetings. One
commenter asserted public meetings are
useless since the local media relay
information about incidents, such as
when and where the incident occurred
and emergency response information.
Another commenter said public
meetings after an accident would be
redundant, as the information required
to be shared would already be made
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available to the public for all reportable
accident investigations. A few
commenters said that completed STAAs
should be covered in public meetings.
One commenter stated that information
about the nature of chemical risks
within a community and emergency
response protocols during an accidental
release or another dangerous event
would be the best information to share
during a public meeting. Another
commenter requested clarification about
what information is required to be
shared at a public meeting.
EPA disagrees with commenters who
stated that public meetings are useless
or redundant to other sources of
information. EPA believes that public
meetings, particularly when held after
an accident, will often provide easier
access for community members to
appropriate facility chemical hazard
information, which can significantly
improve the community’s emergency
preparedness and understanding of how
the facility is addressing potential risks.
Public meetings also provide an
opportunity for the public to ask
questions or share their concerns with
appropriate facility staff and local
government officials in attendance.
Public meetings must address
information about the incident as well
as other relevant chemical hazard
information such as that described in
§ 68.210(b) (i.e., names of regulated
substances held in a process; SDSs;
accident history information; emergency
response program information; a list of
scheduled exercises and LEPC contact
information). The facility representative
should describe the risks that are
associated with the facility, and what
the facility is doing to protect the public
from those risks. In addition, the facility
personnel should relay information that
would assist the public to prepare for
accidental releases. It would be
extremely useful to have LEPC and local
emergency response officials participate
in the meeting to discuss the
community emergency response plan
and explain how the facility is
incorporated into that plan. This would
provide an opportunity for the facility
representative and local officials to
discuss the process for public
emergency notification procedures, for
sheltering in place or evacuating, and
where to obtain further updates on the
status of an emergency incident. The
discussion should also address how the
public can access community
emergency response plans and identify
what the community may expect to see
during a field exercise.
In the final rule, EPA maintains the
requirement for information in § 68.42
to be addressed at the public meeting.
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The facility will have the flexibility to
structure the public meeting to focus on
areas most relevant to a particular
accident, considering the interests of the
community. EPA is not requiring that
completed STAAs be included, in part
because this information is not pertinent
to community emergency response
planning and also in part because the
opportunity for the public to engage in
a completed STAA analysis, which may
contain CBI or trade secret information,
may compromise confidentiality and
create security vulnerabilities at the
facility.
d. Alternatives to Facility-Hosted Public
Meetings
One commenter argued that a facility
hosting a public meeting would be
redundant when LEPCs already hold
public meetings. EPA also received
comments that EPA regions or LEPCs
should host and facilitate a public
meeting instead of the facility, or that
facilities should be required to meet
with LEPCs or local emergency
responders instead of the public. Others
requested that LEPCs be able to decline
to facilitate a public meeting required by
this rule because of their already
substantial responsibilities, or that
public meetings should be held only at
the request of LEPCs or local emergency
response agencies regardless of whether
a regulated substance was involved, or
that they should be held only at the
request of the public. Commenters also
indicated that small businesses should
be allowed to post information that is
required to be disclosed, in lieu of a
public meeting.
EPA disagrees with the commenters.
LEPCs hold meetings with the public to
discuss issues related to community
planning. The public meetings required
by § 68.210(e) in the final rule are
intended to be a venue for facility
personnel to address questions and
concerns raised by the public following
an RMP reportable accident at a facility.
While communication between the
facility and the LEPC is essential, it
cannot replace communication between
knowledgeable facility staff and the
public. LEPCs are encouraged to
participate in public meetings, and may
collaborate with the owner or operator
to host the meeting in conjunction with
an LEPC meeting if appropriate.
However, LEPCs are not required to cohost or participate in public meetings.
Finally, EPA believes that small
businesses should also host public
meetings following an RMP reportable
accident to allow community members
an opportunity to talk with facility
personnel. EPA encourages small
businesses to find ways to reduce costs
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of public meetings such as by hosting
the meetings at inexpensive venues,
such as local schools, community
centers, or churches.
VII. Risk Management Plan
Streamlining, Clarifications, and RMP
Rule Technical Corrections
A stationary source subject to the
RMP rule is required to submit an RMP
in a method and format specified by the
EPA, pursuant to § 68.150(a). The CAA
and 40 CFR subpart G require that the
RMP indicate compliance with the
regulations at 40 CFR part 68 and also
include information regarding the
hazard assessment, prevention program,
and emergency response program. The
RMP also includes stationary source
registration information, such as name,
location and contact information. The
EPA may review RMPs for a variety of
reasons, including information
gathering, inspection preparation, errors
in submissions, and changes requiring a
correction or re-submission of the RMP.
The CAA requires that RMPs be made
available to states, local entities
responsible for planning or responding
to accidental releases at the source, the
CSB, and the public. As a result, the
information provided in an RMP is
intended to be easily understood, thus
encouraging the public, local entities,
and governmental agencies to interact
with stationary sources on issues related
to accident prevention and
preparedness.
EPA is deferring proposed revisions to
delete or revise data elements in the
current rule; however, EPA is adding
several RMP data elements in subpart G
based on the revised rule requirements
discussed in this document. This
includes data elements to address
compliance with:
• Third-party audit requirements,
• IST analysis requirements in the
PHA;
• Emergency response preparedness
requirements including information on
local coordination and emergency
response exercises; and
• Information sharing provisions.
By adding these data elements to the
RMP requirements in subpart G, EPA
will be able to evaluate a stationary
source’s compliance with these rule
requirements. EPA is also finalizing
technical corrections as proposed.
A. Revisions to § 68.160 (Registration)
EPA is adding the following RMP data
elements that relate to the information
sharing provisions discussed in this
document:
• § 68.160(b)(21) requires the method
of the communication and location of
the notification that chemical hazard-
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4673
related information is available to the
public, as set forth in § 68.210(c); and
• § 68.160(b)(22) requires the date of
most recent public meeting, as set forth
in § 68.210(e).
EPA revised § 68.160(b)(21) to clarify
that when identifying how a notification
is made, the owner or operator should
describe both the method of the
communication and the location. For
example, if the owner or operator is
modifying a Web site to identify that
information is available upon request,
then EPA expects that the owner or
operator will identify in the RMP that
the notification is being made through a
Web site and then provide the Web
address of the notification.
Alternatively, if the notification is made
via a printed notice, then the owner or
operator should identify that a printed
notice is available and explain how to
obtain the printed materials. EPA
received no comments on these
provisions.
B. Revisions to § 68.170 (Prevention
Program/Program 2)
EPA is revising:
• § 68.170(i) by adding a requirement
that the owner or operator identify
whether the most recent compliance
audit was a third-party audit, pursuant
to §§ 68.58 and 68.59; and
• § 68.170(j) by clarifying that the
date of the most recent incident
investigation be the completion date of
the investigation. This would be the
date on the final incident investigation
report.
EPA received no comments on these
provisions.
C. Revisions to § 68.175 (Prevention
Program/Program 3)
EPA is revising:
• § 68.175(e) by amending the
introductory sentence in paragraph (e)
to apply to information on the PHA or
PHA update and revalidation
information. EPA is moving the date of
completion of the most recent PHA or
update and the requirement to identify
the technique used to subparagraph
(e)(1). EPA is deleting the requirement
to identify the expected date of
completion of any changes resulting
from the PHA. Additional PHA
information moves to subparagraph
(e)(2) through (6) and a new requirement
to address inherently safer technology
or design measures implemented (if
any) and the technology category is in
subparagraph (e)(7). This is similar to
the proposed revisions but reorganized
to simplify the proposed subparagraph
(e)(2) and move to a new subparagraph
(e)(7);
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• § 68.175(k) by adding a requirement
that the owner or operator identify
whether the most recent compliance
audit was a third-party audit, pursuant
to §§ 68.79 and 68.80; and
• § 68.175(l) by clarifying that the
date of the most recent incident
investigation be the completion date of
the investigation. This would be the
date on the final incident investigation
report.
EPA received no comments on these
provisions.
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D. Revisions to § 68.180 (Emergency
Response Program)
Subpart G § 68.180 contains the
emergency response program data
elements that must be included in the
RMP. EPA proposed revisions to add
emergency response exercises and
revise local coordination provisions of
the rule in order to improve
coordination with local response
authorities and bolster emergency
response capabilities and preparedness
for accidental releases.
1. Summary of Proposed Rulemaking
• In § 68.180(a) EPA proposed to
delete the phrase ‘‘the following
information.’’ The text in subparagraphs
(a)(1) through (3) were reorganized and/
or replaced and EPA proposed to delete
subparagraphs (a)(4) through (6).
Æ In subparagraph (a)(1), EPA
proposed to require the RMP to identify
the name, organizational affiliation,
phone number, and email address of
local emergency planning and response
organizations with which the stationary
source last coordinated emergency
response efforts, pursuant to
§ 68.10(f)(3) or § 68.93.
Æ Subparagraph (a)(2) included
proposed requirements to identify
whether coordination with the local
emergency response organizations is
occurring at least annually, pursuant to
§ 68.93(a).
Æ Finally, in subparagraph (a)(3) EPA
proposed to require the RMP to identify
a list of Federal or state emergency plan
requirements to which the stationary
source is subject.
• In § 68.180(b), EPA proposed to
replace the current text with a
requirement to identify whether the
facility is a responding or nonresponding stationary source, pursuant
to § 68.90. EPA proposed subparagraph
(b)(1) to apply to non-responding
stationary sources and subparagraph
(b)(2) to apply to responding stationary
sources.
Æ Non-responding stationary sources.
In subparagraphs (b)(1)(i) through (iii)
the owner or operator would be required
to identify whether the owner or
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operator has confirmed that local
responders are capable of responding to
accidental releases at the source,
whether appropriate notification
mechanisms are in place, and whether
a notification exercise occurs at least
annually.
Æ Responding stationary sources. In
subparagraphs (b)(2)(i) through (v) the
owner or operator would be required to
identify whether the LEPC or local
response entity requested that the
stationary source be a responding
facility; whether the stationary source
complies with requirements in § 68.95;
whether a notification exercises occurs
at least annually, as required in
§ 68.96(a); whether a field exercise is
conducted every five years and after any
RMP reportable accident, pursuant to
§ 68.96(b)(1)(i); and whether a tabletop
exercise occurs at least annually, except
during the calendar year when a field
exercise is conducted, as required in
§ 68.96(b)(2)(i).
EPA proposed to delete § 68.180(c),
which required the owner or operator to
list other Federal or state emergency
plan requirements to which the
stationary source is subject.
2. Summary of Final Rule
EPA is completely revising and
reorganizing subpart G § 68.180 into the
following three parts: Requirements for
all stationary sources under paragraph
(a), requirements for non-responding
stationary sources under paragraph
(b)(1), and requirements for responding
stationary sources under paragraph
(b)(2). EPA believes that reorganizing
subpart G § 68.180 will clarify the
reporting requirements, reduce errors in
submitted RMPs, and improve
compliance with the RMP requirements.
The revisions to subpart G § 68.180 will
also improve EPA’s ability to evaluate a
facility’s compliance with the
Emergency Response Program
requirements.
EPA is amending and finalizing the
proposed revisions to require specific
information rather than attestations of
compliance. EPA is not finalizing the
proposed provisions that pertain to
LEPCs requesting a stationary source to
comply with emergency response
program requirements of § 68.95 so EPA
is eliminating those requirements under
§ 68.180.
EPA is finalizing § 68.180(a) as
proposed except that subparagraph
(a)(2) requires the RMP to identify the
date of the most recent coordination
with the local emergency response
organizations, pursuant to § 68.93(a)
(rather than attesting that coordination
occurs annually).
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EPA is finalizing § 68.180(b)
introductory paragraph as proposed. In
the final rule subparagraph (b)(1)
applies to non-responding stationary
sources and subparagraph (b)(2) applies
to responding stationary sources. EPA is
amending and finalizing the
subparagraph as follows:
• Non-responding stationary sources.
In subparagraphs (b)(1)(i) through (iii)
the owner or operator is required to
identify whether the stationary source is
included in the community emergency
response plan developed under EPCRA
(for stationary sources with any
regulated toxic substance); the date of
the most recent coordination with the
local fire department (for stationary
sources with only regulated flammable
substances); what notification
mechanisms are in place; and the date
of the most recent notification exercise.
• Responding stationary sources. In
subparagraphs (b)(2)(i) through (iv) the
owner or operator is required to identify
the date of the most recent review and
update of the emergency response plan
required in § 68.95(a)(4); the date of the
most recent notification, as required in
§ 68.96(a); the date of the most recent
field exercise, pursuant to
§ 68.96(b)(1)(i); and the date of the most
recent tabletop exercise, as required in
§ 68.96(b)(2)(i).
3. Discussion of Comments and Basis for
Final Rule Provisions
EPA received one comment indicating
that the revision to § 68.180 is unclear
and that the ‘data elements’ of the
proposal do not distinguish between
responding and non-responding
stationary sources.
EPA believes that the data elements
do distinguish between responding and
non-responding stationary sources. A
stationary source will be required to
identify whether they are ‘‘responding’’
or ‘‘non-responding’’ and responding
stationary sources and will answer
questions accordingly. EPA will revise
its online RMP submission system,
RMP*eSubmit, to include the additional
data elements, and expects that the
submission system will provide clarity
for stationary source owners and
operators on how to submit responses.
E. Technical Corrections
1. Revisions to § 68.10 (Applicability)
EPA is correcting a typographical
error in § 68.10(b)(2). Section 68.10(b)(2)
uses the term public receptor and
indicates that public receptor is defined
in § 68.30; however, the term public
receptor is defined in § 68.3, not § 68.30.
The revised rule language corrects this
typographical error. EPA received no
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comments and is finalizing this
provision as proposed.
2. Revisions to § 68.48 (Safety
Information)
EPA proposed to remove the word
‘‘material’’ from the term Material Safety
Data Sheet in § 68.48(a)(1) to conform
with OSHA’s revised terminology for
SDS.
Discussion of comments on safety
information provisions. A commenter
recommended that EPA’s revision to
§ 68.48 should not require facilities to
ensure that safety data sheets meet
OSHA’s hazard communication
standard requirements. This commenter
argued that operators are given their
safety data sheets by vendors and do not
have control over their content.
EPA disagrees with the commenter.
The current rule requires the owner or
operator to maintain Material Safety
Data Sheets (MSDS) that meets the
OSHA hazard communication standard
requirements of 29 CFR 1910.1200(g). In
2012, OSHA made changes to its Hazard
Communication Standard at 29 CFR
1910.1200 in order to align with the
U.N. Globally Harmonized System of
Classification and Labelling of
Chemicals (GHS), Revision 3 (77 FR
17574, March 26, 2012). One change
was in nomenclature from ‘‘Material
Safety Data Sheets’’ to ‘‘Safety Data
Sheets.’’ Consequently, OSHA revised
the name of the MSDS to Safety Data
Sheets (SDS) in the PSM standard at
1910.119(d)(1)(vii) (78 FR 9311,
February 8, 2013). Chemical producers
and users had to comply with SDS
requirements by June 1, 2015.119 EPA’s
technical correction is solely to be
consistent with the revised OSHA
requirements and EPA is finalizing this
amendment as proposed.
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3. Revisions to §§ 68.54 and 68.71
(Training)
The RMP rule requires initial and
refresher training for employees
operating a Program 2 or Program 3
covered process. Since the inception of
the rule, however, there has been
confusion on the types of employees
that are considered workers operating a
covered process. Although ‘‘employee’’
is not defined in § 68.3, EPA has
traditionally interpreted an employee to
be any worker that is involved in
operating a process, including
supervisors. This is consistent with the
OSHA definition of ‘‘employee’’ set
forth at 29 CFR 1910.2(d). EPA proposed
amendments to clarify that employees
119 OSHA Fact Sheet—Hazard Communication
Standard Final Rule. https://www.osha.gov/dsg/
hazcom/HCSFactsheet.html.
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‘‘involved in’’ operating a process are
subject to the training requirements of
the rule. EPA further proposed a
provision to clarify that the term
employee includes supervisors
responsible for directing process
operations. EPA is finalizing these
amendments as proposed.
Discussion of comments on training
provisions. Several commenters
suggested that the proposed revisions to
§ 68.54 are unclear. These commenters
indicated that EPA should provide
greater clarification regarding the length
of time employers should train their
employees, which employees need
training, and the distinction between
employees ‘‘operating’’ a process and
employees ‘‘involved in operating’’ a
process.
EPA directs readers to review the
Guidance for Facilities on Risk
Management Programs for Chemical
Accident Prevention (40 CFR part 68)
(or General Risk Management Program
Guidance), which clarifies expectations
for training requirements.120 The
guidance does not specify a specific
amount or type of training and allows
the owner or operator to develop a
training approach that is facility-specific
and tailored to the needs of the facility’s
employees. The revised language to
require training for employees
‘‘involved in’’ operating a process is
intended to include employees that
operate a process, as well as supervisors
of those employees, and other
employees that may occasionally be
involved in process operations, such as
process engineers and maintenance
technicians. For employees other than
operators and supervisors, EPA expects
that initial and refresher training will be
appropriate to the employee’s
responsibilities in operating the process.
If a supervisor is involved in decisionmaking for process operations, such as
making changes to operating
parameters, developing or approving
operating procedures, or conducting
emergency operations, then EPA expects
that the supervisor receives initial and
refresher training appropriate to the
supervisor’s responsibilities. In such
cases, the training of a supervisor might
not need to be as extensive as that of an
operator, but EPA expects that the
supervisor training will include process
operations for which the supervisor
might have decision-making authority.
120 General Guidance for Facilities on Risk
Management Programs for Chemical Accident
Prevention (40 CFR part 68), March 2009. https://
www.epa.gov/rmp/guidance-facilities-riskmanagement-programs-rmp.
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4. Revisions to § 68.65 (PSI)
EPA is revising § 68.65(a) in order to
remove irrelevant text regarding the
timeframe for initial development of PSI
and to more clearly demonstrate that
PSI must be kept up-to-date. EPA is
revising § 68.65(a) to remove the phrase
‘‘In accordance with the schedule set
forth in § 68.67’’ and is adding the
phrase: ‘‘and shall keep PSI up-to-date.’’
EPA expects that revising § 68.65(a) in
this manner will help Program 3
facilities to better comply with PSI
requirements and further clarifies the
requirement that PSI must be completed
prior to conducting a PHA.
Finally, in order to be consistent with
OSHA and the GHS, EPA is replacing
‘‘Material Safety Data Sheet’’ with
‘‘Safety Data Sheet’’ in the note to
§ 68.65(b). EPA received no comments
and is finalizing these revisions as
proposed.
5. Revisions to § 68.130—List of
Substances
EPA is revising Tables 1 and 4 in
§ 68.130 as follows:
Table 1 to § 68.130—List of Regulated
Toxic Substances and TQs for
Accidental Release Prevention. EPA is
correcting a typographical error in the
Chemical Abstracts Service (CAS)
number (no.) for allyl alcohol in Table
1 in § 68.130. The incorrect CAS no. of
107–18–61 for allyl alcohol is corrected
to 107–18–6.
Table 4 to § 68.130—List of Regulated
Flammable Substances and TQs for
Accidental Release Prevention. EPA is
correcting a typographical error to the
CAS no. for 1, 3-Butadiene, to read 106–
99–0, instead of 196–99–0, revising to
right justify the first CAS nos. column
and deleting the second CAS nos.
column because it is redundant. EPA
received no comments on these
provisions and is finalizing the
revisions as proposed.
6. Revisions to § 68.200 (Recordkeeping)
EPA is revising § 68.200 to clarify that
records must be maintained at the
stationary source. EPA received no
comments on this provision and is
finalizing the revision as proposed.
VIII. Compliance Dates
The initial Risk Management Program
rule applied 3 years after promulgation
of the rule on June 20, 1996, which is
consistent with the last sentence of CAA
section 112(r)(7)(B)(i). The statute does
not directly address when amendments
should become applicable. The
provisions of this action modify terms of
the existing rule, and, in some cases,
clarify existing requirements.
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A. Summary of Proposed Rulemaking
EPA proposed modifications to
§ 68.10 to establish compliance dates for
an owner operator to comply with the
revised rule provisions as follows:
• Require compliance with
emergency response coordination
activities within one year of an effective
date of a final rule;
• Provide up to three years for the
owner or operator of a non-responding
stationary source to develop an
emergency response program in
accordance with § 68.95 following an
LEPC or equivalent’s written request to
do so;
• Comply with new provisions (i.e.,
third-party compliance audits, root
cause analyses as part of incident
investigations, STAA, emergency
response exercises, and information
availability provisions), unless
otherwise stated, four years after the
effective date of the final rule; and
• Provide regulated sources one
additional year (i.e., five years after the
effective date of the final rule) to correct
or resubmit RMPs to reflect new and
revised data elements.
B. Summary of Final Rule
EPA is finalizing the compliance
dates as proposed, except that EPA is
deleting language requiring the owner or
operator of a non-responding stationary
source to develop an emergency
response program following an LEPC’s
written request to do so. Instead, the
final provides three years for the owner
or operator of a non-responding
stationary source to develop an
emergency response program in
accordance with § 68.95 when the
owner or operator determines that they
meet the applicability criteria for
responding stationary sources in
§ 68.90.
C. Discussion of Comments
Some commenters provided support
for one or more of the compliance dates;
however, many commenters were
concerned that the timeframes were too
long or in some cases too short.
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1. General Comments
One commenter argued that the
compliance dates should be set at one
to two years after the effective date of
the rule because the rule provisions are
procedural and do not involve capital
expenditures. A facility requested that
EPA clarify that annual compliance
dates and required reoccurring tasks
have flexible yearly due dates to allow
facilities to perform thorough
evaluations without the pressure of tight
yearly deadlines.
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EPA agrees with commenters that
annual compliance dates and required
reoccurring tasks should have flexible
yearly due dates. This will allow the
facility owner or operator and local
emergency response officials to
schedule coordination activities or
exercises based on availability of
personnel and minimize unnecessary
pressure to comply with a rigid
timeframe.
However, EPA disagrees that the
compliance dates for all provisions
should be shortened to one or two years.
EPA believes that additional time is
necessary for facility owners and
operators to understand the revised rule;
train facility personnel on the revised
provisions, learn new investigation
techniques, as appropriate; research
safer technologies; arrange for
emergency response resources and
response training; incorporate change
into their risk management programs;
and establish a strategy to notify the
public that certain information is
available upon request. Furthermore,
EPA intends to publish guidance for
certain provisions, such as STAA, root
cause analysis, and emergency response
exercises. Once these materials are
complete, owners and operators will
need time to familiarize themselves
with the new materials and incorporate
them into their risk management
programs.
2. Third-Party Compliance Audits
One commenter expressed concern
that the lack of qualified auditors would
result in compliance delays and the
three-year timeframe could result in an
excessive burden on facilities if there is
a limited availability of qualified
auditors. The commenter further cited
the inability to plan for a third-party
audit based on the applicability criteria
as a reason for the owner or operator to
be unable to comply within the
timeframe.
Other commenters urged for shorter
timeframes with one commenter
pointing out that this provision is
triggered by an accident and should
therefore be under an accelerated
compliance date. Two commenters
suggested a three-year compliance date,
with the one commenter arguing that
there already enough people to perform
third-party audits.
EPA disagrees with commenters and
is finalizing a four-year compliance date
for third-party audits. This means that
for any RMP reportable accident
occurring later than four years after the
effective date of the rule, the owner or
operator of a source must conduct a
third-party audit. The four-year
compliance timeframe will allow
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potential auditors enough time to
establish internal protocols and identify
personnel that meet the competency and
independence criteria necessary to serve
as a third-party auditor. These auditors
will also need time to advertise their
availability to conduct third-party
audits so facility owners and operators
can identify potential auditors before
there is a need to conduct a third-party
compliance audit.
3. Incident Investigations and Root
Cause Analysis
Many commenters argued that the
proposed four-year compliance date is
too long. Commenters offered
alternative timeframes such as 12
months, 18 months, and three years. A
local agency suggested a one-year
compliance date, arguing that many
complex facilities are already
conducting root cause analyses. One
commenter argued that provisions that
are triggered by an accident should be
required in an accelerated timeframe.
Other commenters argued that the
compliance date should be required as
soon as possible.
EPA disagrees with the commenters
and is finalizing a four-year compliance
date for incident investigations
involving root cause analyses. For any
incident that occurs four years after the
effective date of the final rule and
results in (e.g. an RMP reportable
accident) or could reasonably have
resulted in a catastrophic release, the
owner or operator must investigate the
incident and conduct a root cause
analysis. This will allow facility owners
and operators sufficient time to
establish training and program
development activities. EPA encourages
facility owner or operators that are
already conducting root cause analyses
to continue to do so for any incident
that resulted in (e.g. an RMP reportable
accident) or could reasonably have
resulted in a catastrophic release during
the compliance timeframe.
4. STAA
A local agency supported the fouryear compliance timeframe but
numerous commenters argued that the
proposed timeframe is too long. Many
commenters, including mass mail
campaigns joined by approximately
14,000 commenters and multiple
advocacy groups, requested that EPA
expedite compliance with STAA
requirements. A mass mail campaign
joined by approximately 300
commenters stated that the proposed
compliance period is unlawful and
arbitrarily long. The commenter argued
that EPA has no lawful legal basis to
extend the STAA compliance date
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beyond three years. Another commenter
suggested that EPA should consider
following the NJ model to implement
IST requirements and require an initial
review report within 120 days of the
rule’s effective date.
However, other commenters thought
the proposed timeframe was too short.
One commenter cited the complexity of
the IST/ISD analysis as a reason to
extend the compliance date into a
second PHA cycle to allow more time
for engineering studies and design.
Another commenter supported the U.S.
Small Business Administration (SBA)
recommendation to defer the STAA
requirement for three years for small
facilities so that EPA can gather
information on their experience and
assess how often safer alternatives were
identified and at what cost.
EPA disagrees with commenters and
is establishing a four-year compliance
date for STAA. EPA believes that in
many cases sources will prefer to
perform a full PHA update when
implementing the STAA requirements.
Sources subject to this provision are
among the largest and most complex
sources regulated under 40 CFR part 68,
and therefore PHAs and PHA updates at
these sources typically require a
significant level of effort. Since PHA
updates are normally done at five year
intervals, EPA believes it would be
appropriate to allow most sources to
adopt these provisions in their normal
PHA update cycle if they so choose.
Sources that performed their most
recent PHA update immediately prior to
this rule’s effective date will have up to
four years to perform their next PHA
update and adopt the STAA provisions.
Most sources could schedule their PHA
updates to incorporate the new STAA
provisions on their normal PHA update
schedule. EPA also intends to publish
guidance on STAA and once complete,
facility owners and operators will need
time to familiarize themselves with the
new materials and incorporate them
into their risk management programs.
EPA disagrees with the
recommendation to defer the STAA
requirement for three years for small
facilities in order to allow EPA to gather
information. STAA for a source is a sitespecific determination and would be
difficult to compare among facilities.
EPA believes it would be impractical to
gather/analyze information on STAA
implementation to determine the utility
of the provision for small facilities.
5. Emergency Response Coordination
EPA received comments supporting
the proposed one-year compliance date
for emergency response coordination
activities. One commenter requested
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clarification on how to calculate the
annual coordination activities,
recommending that it be based on a
calendar year.
EPA agrees with commenters and is
finalizing a one-year compliance date
for emergency response coordination
activities. EPA believes that a flexible
schedule is appropriate for scheduling
annual coordination and agrees with the
recommendation to base the
coordination on a calendar year
timeframe.
6. Emergency Response Program
One commenter suggested that EPA
should allow a minimum timeframe of
12 months for a non-responding facility
to transition to a responding facility.
The commenter further suggested
incorporating an extension request to
local agencies in the event of
compliance delays that fall outside the
owner/operator’s control (such as
budget constraints or inability to
procure response resources). Another
commenter expressed support for the
timeframe to develop an emergency
response program; however, expressed
concerns with the ongoing costs
associated with that requirement.
EPA is finalizing a three-year
compliance date for a facility owner or
operator to develop an emergency
response program once he or she
determines a need for a program. EPA
is not incorporating an extension
request to address compliance delays
that may fall outside the owner or
operator’s control. EPA notes that the
two provisions from § 68.90 of the
proposed rule that would have made the
owner or operator’s decision to develop
an emergency response program
contingent on the outcome of local
coordination activities, and required the
owner or operator to develop an
emergency response program upon
receiving a written request to do so from
the LEPC or local response authorities,
were not included in the final rule. EPA
believes that by making these changes,
the regulatory provisions that would
potentially have caused many sources to
convert from being non-responding
sources to responding sources have been
removed from the final rule. However,
as the emergency coordination
provisions of the final rule require
regulated sources to coordinate annually
with local responders and to document
coordination activities, EPA
acknowledges that it is possible that
these more frequent coordination
activities may still prompt some sources
to implement an emergency response
program (i.e., for a non-responding
source to become a responding source).
In such cases, EPA believes a three-year
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timeframe is appropriate to establish a
program that meets the requirements of
§ 68.95.
7. Facility Exercises
One commenter objected to the
proposed four-year compliance date for
emergency response exercises arguing
that exercises should be required within
one year of when coordination activities
must begin.
EPA disagrees with the commenter
and is finalizing a four-year compliance
date for conducting emergency response
exercises. This means that the owner or
operator has four years after the
effective date of this rule to conduct a
notification exercise, consult with local
emergency response officials to
establish a schedule for conducting
tabletop and field exercises, and
complete at least one tabletop or field
exercise. EPA believes that this
timeframe will allow owners and
operators to develop an exercise
program that is appropriate for their
facility, train personnel, and coordinate
with local emergency response officials.
EPA also expects to develop guidance
on emergency response exercises and
facility owners and operators will
require time to familiarize themselves
with the guidance.
8. Information Availability
A professional organization stated
that the proposed timeline for
information sharing should be
shortened to three years for information
that is shared with the public. The
commenter recommended that
information sharing with facility
workers should begin immediately after
the implementation of the rule. Another
commenter asserted that the proposed
rulemaking provisions and compliance
dates are inappropriate for the sharing
of information, arguing that provisions
triggered by an accident should be
required in an accelerated timeframe.
EPA disagrees with commenters and
is finalizing a four-year compliance date
for information availability provisions.
This means that four years after the
effective date of the rule, the facility
owner or operator must have
notifications in place to inform the
public that information specified in
§ 68.210(b) is available upon request.
For any RMP reportable accident
occurring later than four years after the
effective date of the rule, the owner or
operator of a source must hold a public
meeting within 90 days of the accident.
EPA believes that this timeframe is
sufficient to allow facility staff an
opportunity to determine the best
method for providing notifications to
the public and to assemble and format
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information to prepare to respond to
information requests.
9. Update and Resubmit RMP
EPA received no comments on the
proposed five-year compliance date for
owners or operators to update RMPs to
reflect the new and revised data
elements in subpart G of the rule. EPA
is finalizing a five-year compliance date
for this provision, as proposed. This
timeframe will allow owners and
operators an opportunity to begin to
comply with revised rule provisions
prior to certifying compliance in the
RMP. Additionally, the Agency will
revise its online RMP submission
system, RMP*eSubmit, to include the
additional data elements, and sources
will not be able to update RMPs with
new or revised data elements until the
submission system is ready. Also, once
it is ready, allowing an additional year
for sources to update RMPs will prevent
potential problems with thousands of
sources submitting updated RMPs on
the same day.
D. Compliance Date Examples
The following examples demonstrate
the compliance dates for the final rule
as described in Table 6: Final Rule
Provisions and Corresponding
Compliance Dates.
TABLE 6—FINAL RULE PROVISIONS AND CORRESPONDING COMPLIANCE DATES
Rule provision
Compliance date
Third-party audit .......................................................
Root cause analysis .................................................
STAA ........................................................................
Emergency response coordination activities ...........
Owner/operator determines that the facility is subject to the emergency response program requirements of § 68.95.
Emergency response exercises ...............................
Information sharing ..................................................
Update RMP .............................................................
Example 1: Provisions That Apply to a
Non-Responding Stationary Source
Source A (see Table 7) is a nonresponding stationary source with a
regulated process subject to Program 2
requirements. Source A’s owner
submitted the latest RMP update to EPA
on January 20, 2015 and completed its
latest compliance audit on August 11,
2017. The source is not in NAICS 322,
324, or 325, and therefore is not subject
to the STAA provisions. The source has
not had any RMP reportable accidents
since the effective date of the final rule.
TABLE 7—EXAMPLE 1, SOURCE A
Source A—Program 2, non-responding stationary
source
Date of last
RMP update
Last compliance
audit
January 20, 2015 ..
August 11, 2017 ...
Last
accident
N/A.
March
March
March
March
Within
Initiated after an RMP reportable accident?
15, 2021 .........................................
15, 2021 .........................................
15, 2021 .........................................
14, 2018 .........................................
three years of the determination ....
March 15, 2021 .........................................
March 15, 2021 .........................................
March 14, 2022 .........................................
In this example, the following
provisions apply:
• Annual emergency response
coordination activities in accordance
with § 68.93;
• Notification exercises (§ 68.96(a));
and
• Information availability provisions
(§ 68.210).
The owner or operator must
coordinate response needs with local
emergency planning and response
organizations as described in § 68.93
(i.e., to determine how the source is
addressed in the community emergency
response plan and to ensure that local
response organizations are aware of the
regulated substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility).
Coordination activities must occur
annually and be documented.
Yes.
Yes (also required after near misses).
No.
No.
No.
No.
Partially-public meeting within 90 days.
No (but previously existing correction requirements of § 68.195 still apply).
Source A is a non-responding facility,
and the owner or operator is required to
conduct annual notification exercises.
The owner or operator is also required
to provide ongoing public notification
that certain information is available to
the public upon request.
Finally, beginning five years after the
rule effective date, the owner or
operator must update the RMP to
include all revised data elements
specified in subpart G. In this case, the
owner or operator would update their
RMP no later than January 20, 2020 (the
source’s next scheduled five-year
update), and again by March 14, 2022
(the required resubmission date for the
final rule).
Table 8: Summary of provisions that
apply to a non-responding stationary
source summarizes the provisions that
apply to Source A.
TABLE 8—SUMMARY OF PROVISIONS THAT APPLY TO A NON-RESPONDING STATIONARY SOURCE
Additional information
When to complete *
Emergency response coordination activities.
Notification exercise .............
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Applicable provisions
Occurs annually ..............................................................
Complete coordination activities before March 14, 2018
and document coordination.
Complete first notification exercise by March 15, 2021.
Occurs annually ..............................................................
Information availability provisions
Information to the public ......
Update RMP ........................
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Ongoing. Includes notification that specifies the information that is available and provides instructions on
how to obtain, and links to community preparedness
information.
Owner’s next five-year resubmission date occurs prior
to effective date for provision, so owner must update
RMP twice.
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Complete first calendar year notification by March 15,
2021.
Update RMP on regular schedule (by January 20,
2020) and again to include new information by March
14, 2022.
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If the Source A’s owner or operator
determines that the facility is subject to
the emergency response program
requirements (i.e., the facility has toxic
substances and is not included in the
community emergency response plan or
the facility has flammable substances
and has not coordinated response
actions with the local fire department),
then he or she would have three years
from the determination date to develop
and implement an emergency response
plan, obtain equipment, and train
personnel in relevant procedures.
Once the owner has developed an
emergency response program, the source
is a responding facility and must also
comply with tabletop and field exercise
requirements for responding facilities.
Example 2A: Provisions That Apply to
a Responding Stationary Source
Source B (see Table 9) is a responding
stationary source with a process subject
to Program 3 requirements. Its latest
RMP update was submitted June 30,
2020. Its latest compliance audit was
performed on April 6, 2020. The source
is not in NAICS 322, 324, or 325, and
therefore is not subject to the STAA
provisions, and the source has not had
any RMP reportable accidents since the
effective date of a final rule.
TABLE 9—EXAMPLE 2A, SOURCE B
Source B—Program 3, responding stationary source
Date of last
RMP update
Last compliance
audit
Last
accident
June 30, 2020 .......
April 6, 2020 .........
N/A.
In this example, the following
provisions apply:
• Annual emergency response
coordination activities in accordance
with § 68.93;
• Emergency response exercises
(§ 68.96); and
• Information availability provisions
(§ 68.210).
The owner or operator must
coordinate response needs with local
emergency planning and response
organizations as described in § 68.93.
Coordination activities must occur
annually and be documented.
Additionally, since Source B is a
responding facility, the owner or
4679
operator is required to conduct annual
notification exercises and tabletop and
field exercises. The frequency of the
tabletop and field exercises will be
determined in consultation with local
emergency response officials, but at a
minimum, shall be every three years for
tabletop exercises and every ten years
for field exercises. EPA expects that
within four years of the effective date of
the final rule, that the owner or operator
will consult with local emergency
response officials to establish a schedule
for conducting at least one tabletop and/
or field exercise.
The owner or operator is also required
to provide ongoing public notification
that certain information is available the
public upon request.
Finally, by five years after the rule
effective date, the owner or operator
must update the RMP to include all
revised data elements specified in
subpart G. Table 10: Summary of
provisions that apply to Source B
summarizes the provisions that apply in
this example.
TABLE 10—SUMMARY OF PROVISIONS THAT APPLY TO SOURCE B
Applicable provisions
Additional information
When to complete *
Emergency response coordination activities.
Occurs annually ..............................................................
Complete coordination activities before March 14, 2018.
Emergency response exercises (§ 68.96)
Notification exercise .............
Field and tabletop exercises
Occurs annually ..............................................................
Tabletop exercise every three years, field exercise
once every ten years.
Complete first notification exercise by March 15, 2021.
Complete first tabletop or field exercise by March 15,
2021.
Information availability provisions
Information to the public ......
Update RMP ........................
Ongoing. Includes notification that specifies the information that is available, provides instructions on how
to obtain, and links to community preparedness information.
..........................................................................................
Example 2B: Additional Provisions That
Apply to a Responding Stationary
Following an RMP Reportable Accident.
See Table 11.
TABLE 11—EXAMPLE 2B, SOURCE B
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Source B—Program 3, responding stationary source
Date of last
RMP update
Last compliance
audit
Last
accident
June 30, 2020 ....
April 6, 2020 ......
July 5, 2021.
In this example, Source B has an
accidental release on July 5, 2021 that
meets the reporting requirements of
§ 68.42. As a result of the accident,
Source B’s owner is required to comply
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Complete first calendar year notification by March 15,
2021.
Update RMP to include new information by March 15,
2021.
with the following additional
provisions:
• Third-party audit provisions of
§ 68.80;
• Incident investigation and root
cause analysis requirements of § 68.81;
and
• Public meeting within 90 days of an
RMP reportable accident, pursuant to
§ 68.210(e).
Chronologically, the first provision
that applies is the requirement to host
a public meeting. Section 68.210(e)
requires the owner or operator to hold
a public meeting within 90 days after
the accident to inform the public about
the accident, including information
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required under § 68.42, and other
relevant information.
An incident investigation must be
initiated promptly, but no later than 48
hours following the incident. The
incident investigation provisions
require the owner or operator to
complete an incident investigation that
includes a root cause analysis and other
elements specified in § 68.81(d), and an
incident investigation report, within 12
months of the incident, unless the
implementing agency approves an
extension of time.
The third-party audit provisions
require the owner or operator to hire a
third-party auditor to perform a third-
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party compliance audit and complete an
audit report within 12 months of the
accident (unless the implementing
agency approves an extension). The
owner or operator must also complete
an audit findings response report within
90 days of receiving the audit report
from the third-party auditor. The owner
or operator must also provide the audit
findings response report, as well as a
schedule to address deficiencies
identified in the audit findings response
report and documentation of actions
taken to address deficiencies, to the
owner or operator’s audit committee of
the Board of Directors, or other
comparable committee or individual, if
applicable.
By five years after the rule effective
date, the owner or operator must update
the RMP to include all revised data
elements specified in subpart G and
§ 68.42. Finally, if the owner or
operator’s response to the incident
utilizes the facility’s emergency
response plan, tested the objectives of
an exercise as described in
§ 68.96(b)(1)(ii), and documents
response actions as described in
§ 68.96(b)(3), then the owner or operator
may use the response to satisfy the field
exercise requirements of the final rule.
Table 12 summarizes the additional
provisions that apply to Source B
following an RMP reportable accident
(in addition to complying with new
requirements triggered by an RMP
reportable accident, the owner or
operator must annually coordinate
response needs with local emergency
planning and response organizations,
document coordination activities, and
comply with the other information
disclosure provisions as previously
described).
TABLE 12—SUMMARY OF ADDITIONAL PROVISIONS THAT APPLY TO SOURCE B FOLLOWING AN RMP REPORTABLE
ACCIDENT
Applicable provisions following
an RMP reportable accident:
Compliance date
Additional information
Public meeting ............................
March 15, 2021
Incident investigations ................
March 15, 2021
Third-party audit ..........................
March 15, 2021
Field exercise ..............................
March 15, 2021
Accident history information in
RMP.
...........................
The accident occurred after the compliance
date for this provision, therefore, schedule a meeting within 90 days after the
RMP reportable accident.
The accident occurred after the compliance
date for this provision, therefore, initiate
within 48 hours, complete investigation
and root cause analysis within 12 months.
The accident occurred after the compliance
date for this provision, therefore, complete within 12 months of the RMP reportable accident.
May use the response to satisfy the field
exercise requirements of the rule when
all objectives of the exercise are tested
and the response is documented.
Correct RMP within 6 months of accident
(existing requirement).
Example 3: Compliance Date Example
for Sources Subject to STAA
Requirements
Source C (see Table 13) is a petroleum
refinery in NAICS 32411. Its latest RMP
update was submitted on March 31,
2018. Its latest PHA revalidation was
completed on March 7, 2017.
TABLE 13—EXAMPLE 3, SOURCE C
Source C—Program 3, NAICS 32411
Date of last
RMP update
Last PHA revalidation
March 31, 2018 .........
March 7, 2017.
Because the source is in NAICS
32411, it is subject to the STAA
provisions of § 68.67(c)(8). Therefore,
March 15, 2021, the owner or operator
must complete a PHA revalidation that
addresses safer technology and
alternative risk management measures,
and determine the practicability of the
ISTs and ISDs considered.
By March 14, 2018 the owner or
operator of Source C must comply with
the emergency response coordination
provisions, and by March 15, 2021, the
owner or operator must also comply
with other applicable rule provisions
including: Third-party audits; incident
investigations; emergency response
When to complete *
Hold public meeting by October 3, 2021.
Complete report by July 5, 2022.
Complete third-party audit by July 5, 2022
Complete findings response report within 90
days of completing audit.
Document the response within 90 days of
the incident (i.e., by October 3, 2021), if
using response to satisfy field exercise
requirements.
Correct RMP by January 5, 2022.
exercises; and information availability
(including public meetings).
By March 14, 2022, the owner or
operator of Source C must update the
RMP to include all revised data
elements specified in subpart G. Table
14: Compliance date example for
sources subject to STAA requirements,
summarizes the STAA provisions that
apply to Source C.
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TABLE 14—COMPLIANCE DATE EXAMPLE FOR SOURCES SUBJECT TO STAA REQUIREMENTS
Applicable provisions
Additional information
STAA ...............................................
Update RMP ....................................
Occurs every five years as part of PHA revalidation ............................
................................................................................................................
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When to complete *
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By March 15, 2021.
By March 14, 2022.
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IX. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is an economically
significant regulatory action that was
submitted to the Office of Management
and Budget (OMB) for review. Any
changes made in response to OMB
recommendations have been
documented in the docket. The EPA
prepared a Regulatory Impact Analysis
(RIA) of the potential costs and benefits
associated with this action. This RIA is
available in the docket and is
summarized here (Docket ID Number
EPA–HQ–OEM–2015–0725).
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1. Why EPA Is Considering This Action
In response to catastrophic chemical
facility incidents in the United States,
President Obama issued Executive
Order 13650, ‘‘Improving Chemical
Facility Safety and Security,’’ on August
1, 2013. The Executive Order establishes
the Chemical Facility Safety and
Security Working Group (Working
Group), co-chaired by the Secretary of
Homeland Security, the Administrator
of EPA, and the Secretary of Labor or
their designated representatives at the
Assistant Secretary level or higher, and
comprised of senior representatives of
other Federal departments, agencies,
and offices. The Executive Order
requires the Working Group to carry out
a number of tasks whose overall goal is
to prevent chemical accidents.
Section 6(a)(i) of Executive Order
13650 requires the Working Group to
develop options for improved chemical
facility safety and security that identify
‘‘improvements to existing risk
management practices through agency
programs, private sector initiatives,
Government guidance, outreach,
standards, and regulations.’’ Section 6(c)
of Executive Order 13650 requires the
Administrator of EPA to review the Risk
Management Program. As part of this
effort to solicit comments and
information from the public regarding
potential changes to EPA’s RMP
regulations (40 CFR part 68), on July 31,
2014, EPA published an RFI (79 FR
44604).
EPA believes that the RMP regulations
have been effective in preventing and
mitigating chemical accidents in the
United States; however, EPA believes
that revisions could further protect
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human health and the environment
from chemical hazards through
advancement of PSM based on lessons
learned. These revisions are a result of
a review of the existing Risk
Management Program and information
gathered from the comments on the
proposed rulemaking, SBAR panel,
public hearing, RFI, and Executive
Order listening sessions, and are
finalized under the statutory authority
provided by CAA section 112(r) as
amended (42 U.S.C. 7412(r)).
2. Description of Alternatives to the
Final Rule
EPA analyzed in the RIA the
requirements finalized in this action as
well as several alternatives for each.
a. Third-Party Audits (Program 2
§§ 68.58 and 68.59 and Program 3
§§ 68.79 and 68.80)
The existing rule requires Program 2
and Program 3 processes to conduct a
compliance audit at least once every
three years. The revised rule requires
facilities to contract with an
independent third-party, or assemble an
audit team led by an independent thirdparty, to conduct the next scheduled
compliance audit following an RMP
reportable accident or after an
implementing agency determines that
certain circumstances exist that suggest
a heightened risk for an accident. The
third-party would have to be someone
with whom the facility does not have an
existing or recent relationship and who
meets specific qualification criteria. The
low cost alternative applies only for
Program 2 and Program 3 processes after
an RMP reportable accident or at the
request of the implementing agency.
The medium cost alternative applies
every three years for all compliance
audits conducted for all Program 3
processes. The high cost alternative
applies every three years for all
compliance audits conducted for
Program 2 and Program 3 processes.
b. Incident Investigations/Root Cause
Analysis (§§ 68.60 and 68.81)
The rule requires facilities to conduct
a root cause analysis as part of an
incident investigation following an RMP
reportable accident or an incident that
could reasonably have resulted in an
RMP reportable accident (i.e., ‘‘near
miss’’). A root cause analysis is a formal
process to identify underlying reasons
for failures that lead to accidental
releases. These analyses usually require
someone trained in the technique. The
low cost alternative applies the
provision only to RMP reportable
accidents or near misses in Program 3
processes. The medium/high cost
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4681
alternative applies to RMP reportable
accidents or near misses involving
Program 2 and Program 3 processes.
c. STAA (§ 68.67)
Under the final rule, facilities in
NAICS codes 322 (paper
manufacturing), 324 (petroleum and
coal products manufacturing), and 325
(chemical manufacturing) with Program
3 processes are required to conduct a
STAA for each process as part of their
PHA, which occurs every five years. The
STAA includes two parts: The initial
analysis to identify alternatives, and a
practicability study to determine the
costs and assess the reasonableness of
implementing technology alternatives.
The final rule is the low cost alternative,
which applies to all facilities with
Program 3 processes in NAICS codes
322, 324, and 325. The medium cost
alternative applies the requirement to
all Program 3 processes. The high cost
alternative applies the requirement to
all Program 3 processes and require
facilities to implement practicable IST/
ISD.
d. Emergency Response Program
Coordination With Local Responders
(§§ 68.90, New 68.93, and 68.95)
Under the final rule, all facilities with
Program 2 or Program 3 processes are
required to coordinate with local
response agencies annually to determine
how the source is addressed in the
community emergency response plan
and to ensure that local response
organizations are aware of the regulated
substances at the source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the facility to
respond to an accidental release of a
regulated substance. The owner or
operator must document coordination
activities.
Alternatives to this provision are
similar to the finalized requirements.
One alternative that imposes the same
costs as the final rule option includes an
option for local officials to request that
a facility owner or operator comply with
the emergency response program
requirements of § 68.95. This would be
analogous to the requirements under the
Oil Pollution Prevention regulation (40
CFR part 112) where all facilities subject
to the FRP provisions at § 112.20 are
required to prepare and implement an
emergency response plan for oil
discharges into navigable waters or
adjoining shorelines.
e. Facility Exercises (§ 68.96)
Notification exercises. All facilities
with Program 2 or Program 3 processes
are required to conduct a notification
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exercise annually to ensure that the
contact list to be used in an emergency
is complete, accurate, and up-to-date.
Tabletop and field exercises. The rule
requires responding facilities to conduct
exercises of their emergency response
plans and invite local emergency
response officials to participate. Under
the low cost alternative, facilities would
conduct tabletop exercises every three
years. Under the final rule, which is the
medium cost alternative, facilities will
establish the frequency of exercises in
consultation with local emergency
response officials, but at a minimum,
full field exercises will be conducted at
least once every ten years and tabletop
exercises conducted at least once every
three years. Responding facilities that
have an RMP reportable accident, and
document the response activities in an
after-action report comparable to the
exercise evaluation reports may use that
response to satisfy the field exercise
requirements. Furthermore, owner and
operators of responding facilities that
conduct exercises to meet other Federal,
state or local exercise requirements may
satisfy the RMP exercise requirements
provided that the scope of the exercise
includes the objectives of an RMP
exercise. Under the high cost
alternative, facilities would conduct full
field exercises annually.
f. Information Availability (§ 68.210)
The rule requires all facilities to
provide certain basic chemical hazard
information to the public, upon request.
The owner or operator of the facility
shall provide ongoing notification of
availability of information elements on
a company Web site, social media
platforms, or through some other
publicly accessible means. The
information to be disclosed includes
names of regulated substances at the
facility; SDS; accident history
information; emergency response
program information; and LEPC or local
response agency contact information.
EPA proposed requirements for
facilities to provide certain information
to the LEPC, Tribal Emergency Planning
Committee (TEPC) or other local
emergency response agencies. However,
rather than prescribe information
elements that must be provided upon
request, EPA is requiring the owner or
operator of a stationary source to share
information that is relevant to
emergency response planning as part of
the coordination activities that occur
annually between facility
representatives and local emergency
response agencies.
Finally, the rule requires facilities to
hold a public meeting for the local
community within 90 days of an RMP
reportable accident. The medium cost
alternative would require Program 2 and
Program 3 facilities to hold a public
meeting at least once every five years
and within 90 days of an RMP
reportable accident. The high cost
alternative would require all facilities
(i.e., including Program 1 facilities) to
hold a public meeting at least once
every five years and immediately
following an RMP reportable accident.
3. Summary of Costs
Approximately 12,500 facilities have
filed current RMPs with EPA and are
potentially affected by the revised rule.
These facilities range from petroleum
refineries and large chemical
manufacturers to water and wastewater
treatment systems; chemical and
petroleum wholesalers and terminals;
food manufacturers, packing plants, and
other cold storage facilities with
ammonia refrigeration systems;
agricultural chemical distributors;
midstream gas plants; and a limited
number of other sources that use RMPregulated substances.
Table 15 presents the number of
facilities according to the latest RMP
reporting as of February 2015 by
industrial sector and chemical use.
TABLE 15—NUMBER OF AFFECTED FACILITIES BY SECTOR
Sector
Total
facilities
NAICS codes
Chemical uses
924
1,923
Use chlorine and other chemicals for treatment.
111, 112, 115, 42491
3,667
Chemical manufacturing ............................................
Chemical wholesalers ................................................
Food and beverage manufacturing ...........................
Oil and gas extraction ................................................
325
4246
311, 312
211
1,466
333
1,476
741
Other ..........................................................................
44, 45, 48, 54, 56, 61,
72
313, 326, 327, 33
248
Other manufacturing ..................................................
384
Other wholesale .........................................................
Paper manufacturing .................................................
423, 424
322
302
70
Petroleum and coal products manufacturing .............
324
156
Petroleum wholesalers ..............................................
4247
276
Utilities .......................................................................
221
445
Warehousing and storage .........................................
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Administration of environmental quality programs
(i.e., governments).
Agricultural chemical distributors/wholesalers ...........
493
1,056
Store ammonia for sale; some in NAICS 111 and
115 use ammonia as a refrigerant.
Manufacture, process, store.
Store for sale.
Use mostly ammonia as a refrigerant.
Intermediate processing (mostly regulated flammable substances and flammable mixtures).
Use chemicals for wastewater treatment, refrigeration, store chemicals for sale.
Use various chemicals in manufacturing process,
waste treatment.
Use (mostly ammonia as a refrigerant).
Use various chemicals in pulp and paper manufacturing.
Manufacture, process, store (mostly regulated flammable substances and flammable mixtures).
Store for sale (mostly regulated flammable substances and flammable mixtures).
Use chlorine (mostly for water treatment) and other
chemicals.
Use mostly ammonia as a refrigerant.
Total ....................................................................
....................................
12,542
Table 16 presents a summary of the
annualized costs estimated in the RIA.
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In total, EPA estimates annualized costs
of $131.2 million at a 3% discount rate
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TABLE 16—SUMMARY OF ANNUALIZED COSTS
[Millions, 2015 dollars]
Provision
3%
Third-party Audits ....................................................................................................................................................
Incident Investigation/Root Cause ...........................................................................................................................
STAA ........................................................................................................................................................................
Coordination .............................................................................................................................................................
Notification Exercises ..............................................................................................................................................
Facility Exercises .....................................................................................................................................................
Information Sharing (Public) ....................................................................................................................................
Public Meeting .........................................................................................................................................................
Rule Familiarization .................................................................................................................................................
Total Cost * ..............................................................................................................................................................
7%
$9.8
1.8
70.0
16.0
1.4
24.7
3.1
0.4
3.9
131.2
$9.8
1.8
70.0
16.0
1.4
24.7
3.1
0.4
4.6
131.8
* Totals may not sum due to rounding.
The largest average annual cost of the
final rule is the STAA costs ($70.0
million), followed by the exercise costs
($24.7 million), coordination ($16
million), and third-party audits ($9.8
million). The remaining provisions
impose average annual costs under $5
million each, including rule
familiarization ($3.9 to 4.6 million),
information sharing (public) ($3.1
million), incident investigation/root
cause analysis ($1.8 million),
notification exercises ($1.4 million), and
public meetings ($0.4 million).
The rule includes three prevention
program provisions—third-party audits,
root cause analysis, and STAA—
involving information collection and
analysis activities that can lead to a
wide range of outcomes, and therefore
costs, if and when the owner acts upon
the findings and/or recommendations
generated by the audit, investigation, or
analysis. Although resolving audit and
investigation findings is required under
the existing rule provisions, and the rule
does not require implementation of
practicable IST alternatives, EPA
believes it is possible that there may be
costs associated with resolving findings
from the third-party audit and root
cause analysis provisions that go
beyond the costs of the existing
provisions, and that some owners or
operators may have additional costs due
to voluntary implementation of IST.
EPA acknowledged the wide range of
outcomes from these provisions and the
significant uncertainties associated with
their costs, and requested information in
the proposed rulemaking on whether
these costs should accrue to the rule.
EPA did not receive any data from
commenters that illustrates the: Types
of costs that result from independent
audits (other than the cost of the audit)
that are different from self-audit costs;
the types of costs that result from root
cause investigations as compared to
non-root-cause investigations; and for
the STAA provisions, information to
project what changes facilities are likely
to voluntarily undertake (e.g., cost data
or studies for implementation of IST
changes).
4. Summary of Potential Benefits
EPA anticipates that implementation
of this rule will result in a reduction of
the frequency and magnitude of
damages from releases. Accidents and
releases from RMP facilities occur every
year, resulting in fires and explosions,
property damage, acute and chronic
exposures of workers and nearby
residents to hazardous materials, and
resultant damages to health. Although
we are unable to quantify what specific
damage reductions may occur as a result
of these revisions, we are able to present
data on the total damages that currently
occur at RMP facilities each year. The
data presented are based on a 10-year
baseline period, summarizing RMP
accident impacts and, when possible,
monetizing them. EPA expects that
some portion of future damages would
be prevented through implementation of
this rule. Table 17 presents a summary
of the quantified damages identified in
the analysis.
TABLE 17—SUMMARY OF QUANTIFIED DAMAGES
[Millions, 2015 dollars]
Unit value
10-Year total
Average/year
Average/accident
On-site
Fatalities ...........................................................................................
Injuries .............................................................................................
Property Damage .............................................................................
$8.6
0.05
............................
$497.8
105.2
2,054.9
$49.8
10.5
205.5
$0.33
0.69
1.4
On-site Total .............................................................................
............................
2,657.9
265.8
1.8
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Offsite
Fatalities ...........................................................................................
Hospitalizations ................................................................................
Medical Treatment ...........................................................................
Evacuations * ...................................................................................
Sheltering in Place * .........................................................................
Property Damage .............................................................................
8.6
0.4
0.001
0.0
0.0
............................
8.6
6.8
14.8
7.0
40.9
11.4
0.86
0.68
1.5
0.70
4.1
1.1
0.01
0.004
0.01
0.004
0.03
0.007
Offsite Total ..............................................................................
............................
89.5
8.9
0.06
Total ...................................................................................
............................
2,747.3
274.7
1.8
* The unit value for evacuations is less than two hundred dollars and for sheltering in place is less than one hundred dollars so when expressed in rounded millions the value represented in the table is zero.
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EPA monetized both on-site and
offsite damages. EPA estimated total
average annual on-site damages of
$265.8 million. The largest monetized
average annual on-site damage was onsite property damage, which resulted in
average annual damage of
approximately $205.5 million. The next
largest impact was on-site fatalities
($49.8 million) and injuries ($10.5
million).
EPA estimated total average annual
offsite damages of $8.9 million. The
largest monetized average annual offsite
damage was from sheltering in place
($4.1 million), followed by medical
treatment ($1.5 million), property
damage ($1.1 million), fatalities ($0.86
million), evacuations ($0.7 million), and
hospitalizations ($0.68 million).
In total, EPA estimated monetized
damages from RMP facility accidents of
$274.7 million per year. However, the
monetized impacts omit many
important categories of accident impacts
including lost productivity, the costs of
emergency response, transaction costs,
property value impacts in the
surrounding community (that overlap
with other benefit categories), and
environmental impacts. Also not
reflected in the 10-year baseline costs
are the impacts of non-RMP accidents at
RMP facilities and any potential impacts
of rare high consequence catastrophes.
A final omission is related to the
information provision. Reducing the
probability of chemical accidents and
the severity of their impacts, and
improving information disclosure by
chemical facilities, as the provisions
intend, would provide benefits to
potentially affected members of society.
Table 18 summarizes four broad
social benefit categories related to
accident prevention and mitigation
including prevention of RMP accidents,
mitigation of RMP accidents, prevention
and mitigation of non-RMP accidents at
RMP facilities, and prevention of major
catastrophes. The table explains each
and identifies ten associated specific
benefit categories, ranging from avoided
fatalities to avoided emergency response
costs. Table 18 also highlights and
explains the information disclosure
benefit category and identifies two
specific benefits associated with it:
Improved efficiency of property markets
and allocation of emergency resources.
TABLE 18—SUMMARY OF SOCIAL BENEFITS OF FINAL RULE PROVISIONS
Broad benefit category
Explanation
Accident Prevention ...........................................
Accident Mitigation .............................................
Non-RMP accident prevention and mitigation ...
Prevention of future RMP facility accidents .....
Mitigation of future RMP facility accidents .......
Prevention and mitigation of future non-RMP
accidents at RMP facilities.
Prevention of rare but extremely high consequence events.
Avoided Catastrophes ........................................
Information Disclosure .......................................
Specific benefit categories
Provision of information to the public ..............
•
•
•
•
•
•
•
•
•
•
•
•
Reduced Fatalities.
Reduced Injuries.
Reduced Property Damage.
Fewer People Sheltered in Place.
Fewer Evacuations.
Avoided Lost Productivity.
Avoided Emergency Response Costs.
Avoided Transaction Costs.
Avoided Property Value Impacts.*
Avoided Environmental Impacts.
Improved efficiency of property markets.
Improved emergency response resource allocation.
* These impacts partially overlap with several other categories such as reduced health and environmental impacts.
5. Discussion of Comments on
Estimated Costs and Benefits
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a. General Comments
EPA costs underestimated or based on
outdated information. Several
commenters stated that EPA’s cost
estimates in the RIA for the proposed
rulemaking were generally inaccurate
and underestimated the true costs that
facilities will face. Some commenters
indicated that EPA’s estimated labor
rates were based on outdated (2014)
information. Several commenters
representing industry trade associations
and regulated facilities expressed
specific concerns about the estimated
costs of each individual proposed
rulemaking element, as well as EPA’s
estimate of the costs of rule
familiarization. Some of these
commenters provided specific cost
information or estimates to support their
claims.
EPA considered this information and
made substantial adjustments to the cost
estimates for every rule provision,
including rule familiarization. In
addition to adjusting the cost estimate
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for the final rule to incorporate cost
information submitted by commenters,
EPA also adjusted the estimate to delete
costs associated with proposed
rulemaking provisions that were not
included in the final rule (e.g.,
Information availability to LEPCs), and
to account for structural changes
between proposed and final rule
provisions for certain rule elements
(e.g., the final rule requires emergency
field and tabletop exercises to be
conducted less frequently than EPA had
proposed). EPA also updated its
estimated labor rates to the most recent
(2015) values available from the Bureau
of Labor Statistics.
Benefit concerns. Several commenters
also addressed EPA’s assessment of
benefits in their public comment
submissions. While some commenters
indicated that the proposed
requirements would improve safety and
prevent chemical releases, other
commenters stated that the proposed
requirements would not provide any
benefits, or that the costs associated
with the rule would severely outweigh
any benefits. Other commenters
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indicated that EPA had failed to
quantify any benefits of the rule, making
a cost-benefit comparison impossible.
Other commenters stated that EPA
overestimated benefits or
inappropriately counted benefits that
actually accrue from OSHA’s PSM
standard as benefits of the proposed
rulemaking. One commenter also stated
that EPA’s benefit categories would be
offset by unstated additional costs,
including losses in reputation or brand
value, higher insurance premiums, and
difficulty hiring and retaining workers
that facilities may incur as a result of an
accident.
EPA disagrees that the proposed
rulemaking would not provide benefits
or that the costs of the rule would
necessarily outweigh its benefits. As
EPA explains in the RIA for the final
rule, the benefits of the final rule
include reductions in the number of
people killed, injured, and evacuated or
otherwise inconvenienced by sheltering
in place; reductions in the damage
caused to property on-site and offsite
including product, equipment, and
buildings; reductions in damages to the
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environment and ecosystems; and
reductions in resources diverted to
extinguish fires and clean up affected
areas. The final rule also provides other
benefits, such as increased public
information, which in addition to
helping to minimize the impacts of
accidents on the offsite public, may also
lead to more efficient property markets
in areas near RMP facilities.
EPA acknowledges that it is not
possible to estimate quantitative
benefits for the final rule. EPA has no
data to project the specific impact on
accidents made by each final rule
provision. The accidents themselves
have highly variable impacts that are
difficult to predict. However, it is clear
from the RMP accident data and other
available data that chemical accidents
can impose substantial costs on firms,
employees, emergency responders, the
community, and the broader economy.
Reducing the risk of such accidents and
the severity of the impacts when
accidents occur, and improving
information provision, as the final rule
intends, provides benefits to the
potentially affected members of society.
EPA disagrees that the final rule takes
credit for benefits that should accrue to
the OSHA PSM standard. None of the
provisions contained in the final rule
are duplicated in the OSHA PSM
standard. EPA also disagrees that
regulated facilities will suffer losses in
reputation or brand value, higher
insurance premiums, or have difficulty
hiring and retaining workers as a result
of the final rule. If, as EPA expects, the
final rule results in the prevention of
accidents, then it should have the
opposite of these effects, to the extent
they relate to chemical accidents.
b. Estimate of Rule Familiarization Costs
Several industry trade associations
stated that EPA’s estimate of the costs of
rule familiarization were too low. These
commenters stated that EPA’s estimate
only included time spent by
management level employees but
should be expanded to include the cost
of training all relevant facility
employees. Some of these commenters
recommended alternate approaches to
estimating the costs of rule
familiarization that included estimates
of time spent by additional labor
categories (e.g., attorneys, engineers,
production staff, etc.). One commenter
also recommended that EPA consider
adjusting its rule familiarization
estimate to better track with the estimate
used by the NJ DEP for revisions to the
NJ TCPA regulations.
EPA agrees with these comments, and
adjusted its rule familiarization estimate
accordingly, resulting in an increase of
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the estimated costs of rule
familiarization.
c. Third-Party Audit Costs
Many commenters including industry
trade associations and facilities stated
that EPA’s estimate of the costs of thirdparty audits was too low. Many
commenters also stated that third-party
auditor fees will be much higher than
EPA’s estimate, partially due to the low
availability of qualified auditors.
Several commenters submitted cost
information from external audits to
support their estimates.
EPA generally agrees with these
comments. Shortly after the proposed
rulemaking was published, EPA
received cost information relating to a
series of third-party audits conducted by
a facility as a result of an enforcement
action taken by EPA under CAA section
112(r). The average cost of these audits
was approximately double EPA’s
estimate in the proposed rulemaking,
and comparable to cost estimates
submitted by commenters. Therefore,
EPA adjusted its cost estimate for this
provision of the final rule accordingly,
resulting in the estimated costs of thirdparty audits under the final rule nearly
doubling. EPA notes that the third-party
audit provisions of the final rule also
relaxed, to some extent, the
independence and competency criteria
for third-party auditors. The Agency
believes that these changes will increase
the availability of qualified auditors,
and therefore make such audits less
costly than might otherwise have been
the case.
d. Incident Investigation/Root Cause
Costs
Several commenters stated that EPA’s
estimate of costs of incident
investigations and root cause analysis
was inaccurately low. Some of these
commenters suggested that the required
number of investigations will increase
significantly as a result of EPA’s
proposal to re-define the term
‘‘catastrophic release,’’ and that this
would cause the cost of this rule
element to increase substantially. Other
commenters stated that incident
investigations require more labor hours
than were accounted for in EPA’s cost
estimate, and that the Agency needs to
significantly raise its estimate in order
to account for these issues. Some of
these commenters submitted cost
information to support their estimates.
Although EPA disagrees that its
proposed changes to the definition of
‘‘catastrophic release’’ would have
increased the number of investigations
required under the rule, the Agency
elected not to finalize the proposed
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changes to that definition, so no
increase in incident investigation costs
will result from it. Regarding
commenters’ concerns that EPA had not
accounted for enough labor hours for
investigations in the RIA for the
proposed rulemaking, after considering
these comments, the Agency generally
agrees that its estimate was too low.
EPA incorporated the cost information
submitted by commenters into its
estimate for the final rule. EPA also
notes that unlike the estimate for the
proposed rulemaking, the final rule
economic estimate did not assume that
investigations of near misses would
require fewer labor hours than
investigations of actual release events.
This change also accounted for some of
the increase in the estimated cost of this
rule element. Overall, these changes
resulted in the estimated cost of this
rule element approximately doubling for
the final rule.
e. STAA Costs
STAA costs too low. EPA received
several comments stating that the
Agency’s estimate of costs for the
proposed STAA provisions was too low.
Most of these comments addressed both
EPA’s estimate of the cost of the initial
study of safer technology options, as
well as the Agency’s estimate of costs
for the required evaluation of the
practicability of IST considered during
the STAA.121 Some commenters
submitted alternate cost estimate
information for both the initial analysis
of options and the practicability study.
EPA notes that in general,
commenter’s cost estimates for the
initial analysis were higher than EPA’s
estimates, although not in every case.
EPA incorporated these estimates into
the RIA as appropriate—the Agency
assumed that cost estimates for the
STAA initial analysis submitted by
trade associations representing a
particular category of facilities (e.g.,
refineries, complex chemical
manufacturers, etc.) were the best
representation of estimated costs for
those categories of facilities, and
adjusted its own estimate accordingly.
In most cases, this cause the estimated
costs for the STAA initial analysis to
increase.
Practicability study costs. For the
practicability study, several commenters
stated that EPA’s estimate was far too
low, and indicated that EPA should
adopt an alternate approach that
estimated the cost of the practicability
study as a fixed fraction of the cost of
the project being considered.
121 EPA used the term ‘‘feasible’’ rather than
‘‘practicability’’ in the proposed rulemaking.
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After reviewing these comments, EPA
conducted additional research on this
subject which confirmed that these
commenters were generally correct on
this point. EPA therefore adjusted its
approach to estimating the costs of
practicability studies accordingly,
which resulted in a significant increase
for the cost of this provision. EPA’s
research on this topic and the resulting
cost estimation approach is explained in
detail in Appendix D to the RIA for the
final rule.
STAA implementation. EPA also
received several comments stating that
the Agency should assume that the
STAA provision will result in some
facilities implementing safer
technologies, and include the costs
associated with such implementation in
its economic estimate.
EPA disagrees with these comments.
While the Agency agrees that some
facilities may elect to implement IST,
the final rule does not require facilities
to do so. Therefore, the Agency believes
that implementation of IST will result
from the owner or operator’s own
judgement that it is beneficial for the
source, after considering all relevant
factors. The STAA required under this
rule may facilitate such decision
making, but does not require it.
f. Emergency Response Program
Coordination With Local Responders’
Costs
Emergency response program costs.
The Agency received several comments
relating to the proposed emergency
coordination provisions. Some of the
comments on this topic related to the
Agency’s projected estimate of the cost
for some sources to develop an
emergency response program, stating
that EPA’s estimate of these costs was
too low.
EPA is not finalizing the proposed
rulemaking provisions that it believes
would have resulted in many sources
developing emergency response
programs. Therefore, these ‘‘new
responder’’ costs were not included in
the RIA for the final rule.
Annual coordination burden. EPA
also received comments that stated its
estimate of burden for the annual
coordination provision, a modified form
of which is included in the final rule,
were too low. One commenter provided
emergency coordination cost
information for large complex facilities,
which was substantially higher than
EPA’s estimate for the category of
facilities.
EPA incorporated the emergency
coordination cost information into the
revised economic estimate in the RIA
for the final rule. EPA also revised its
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estimate for this element to account for
the fact that changes to the annual
coordination provision in the final rule,
as well as the Agency’s decision not to
finalize a portion of the information
availability provisions of the proposed
rulemaking, may result in greater
information exchange occurring during
annual coordination meetings than was
estimated under the proposed
rulemaking. Under the information
availability provisions of the proposed
rulemaking, the owner or operator
would have been required to annually
provide certain information to local
emergency responders. The final rule
does not include this provision;
however, the annual coordination
provisions in the final rule require the
owner or operator to provide local
response officials with information
relevant to emergency planning upon
request. The net effect of these changes
was to more than double the estimated
costs of the annual emergency response
coordination provision of the final rule.
g. Facility Exercise Costs
Several commenters disagreed with
EPA’s approach to estimating the costs
of emergency response exercises, and in
general, characterized EPA’s estimate as
too low. Two of these commenters
submitted alternate cost estimates for
this provision. However, the cost
estimate provided by one commenter
did not appear to apply to facilities
represented by the commenter’s
industry association. The information
submitted by the other commenter
appeared credible, but projected costs
for large complex facilities that were
lower than EPA’s estimate.
As a result of these comments EPA
determined that its NPRM cost estimate
for large complex facilities was inflated,
and lowered its estimate to better reflect
industry experience. The Agency also
notes that the final rule requires
emergency exercises to be conducted
less frequently than was proposed in the
NPRM. The net effect of the structural
changes to the final rule and EPA’s
adjustment of its cost estimation
approach resulting from public
comments was to substantially reduce
the estimated costs of this rule
provision.
h. Information Availability Costs
EPA received some comments stating
that EPA’s estimate of costs for the
proposed rulemaking’s information
availability provisions was too low.
These commenters indicated that EPA
underestimated the time required for
facilities to prepare information
required to be disclosed to the public,
and that EPA underestimated the cost of
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holding public meetings. One
commenter indicated that renting space
for a public meeting would cost as much
as $10,000 per day.
Based on these comments, EPA
increased its cost estimate for the public
information availability provision for
large complex facilities. EPA did not
change its cost estimate for public
meetings because commenter’s high
estimates of the costs of public meeting
space did not comport with EPA’s
research and prior experience with the
costs of public meetings.
B. Paperwork Reduction Act (PRA)
The information collection activities
in this rule have been submitted for
approval to the OMB under the PRA.
The Information Collection Request
(ICR) document that the EPA prepared
has been assigned EPA ICR number
2537.02 and OMB Control Number
2050–0216. You can find a copy of the
ICR in the docket for this rule, and it is
briefly summarized here.
This ICR amends a previously
approved ICR (1656.15), OMB Control
No. 2050–0144. That ICR covers the risk
management program rule, originally
promulgated on June 20, 1996; the
current rule, including previous
amendments, is codified as 40 CFR part
68. This ICR addresses the following
information requirements that are part
of the revised rule:
(1) Make certain information related
to the risk management program
available to the public, upon request;
(2) Hold a public meeting within 90days of an accident subject to reporting
under § 68.42 (i.e., an RMP reportable
accident);
(3) Hire a third-party to perform or
lead a compliance audit after an RMP
reportable accident or after an
implementing agency determines that
conditions at the stationary source
could lead to an accidental release of a
regulated substance or identifies
problems with the prior third-party
audit;
(4) Conduct and document a root
cause analysis after an RMP reportable
accident or a near miss;
(5) Conduct and document a STAA
for a subset of Program 3 facilities in
North American Industrial
Classification System (NAICS) codes
322 (paper manufacturing), 324
(petroleum and coal products
manufacturing), and 325 (chemical
manufacturing);
(6) Meet and coordinate with local
responders annually to exchange
emergency response planning
information;
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(7) Conduct an annual notification
drill to verify emergency contact
information; and
(8) Responding facilities conduct and
document emergency response exercises
including:
• A field exercise at least every ten
years, and
• A tabletop exercise at least every
three years.
EPA believes that the RMP regulations
have been effective in preventing and
mitigating chemical accidents in the
United States. However, EPA is revising
the rule to further protect human health
and the environment from chemical
hazards through advancement of PSM
based on lessons learned—resulting in
better coordination between facilities,
LEPC’s, and the public. State and local
authorities will use the information in
RMPs to modify and enhance their
community response plans. The
agencies implementing the RMP rule
will use RMPs to evaluate compliance
with part 68 and to identify sources for
inspection because they may pose
significant risks to the community.
Citizens may use the information to
assess and address chemical hazards in
their communities and to respond
appropriately in the event of a release of
a regulated substance. These revisions
are a result of a review of the existing
Risk Management Program and are
finalized under the statutory authority
provided by section 112(r) of the CAA
as amended (42 U.S.C. 7412(r)).
Some of the elements mandated in the
regulation for the RMP may require the
submittal of data viewed as proprietary,
trade secret, or confidential. As
described previously, EPA has adopted
procedures for sources to claim certain
information as confidential business
information. EPA encourages facilities
that have CBI claims to submit
substantiation with the RMP.
Respondents/affected entities:
Manufacturers, utilities, warehouses,
wholesalers, food processors, ammonia
retailers, and gas processors.
Respondent’s obligation to respond:
Mandatory (CAA sections 112(r)(7)(B)(i)
and (ii), CAA section 112(r)(7)(B)(iii),
114(c), CAA 114(a)(1)).
Estimated number of respondents:
14,280.
Frequency of response: On occasion.
Total estimated burden: 1,778,244
hours (per year). Burden is defined at 5
CFR 1320.3(b).
Total estimated cost: $130,578,842
(per year), includes $8,285,600
annualized capital or operation &
maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
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unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will
announce that approval in the Federal
Register and publish a technical
amendment to 40 CFR part 9 to display
the OMB control number for the
approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 and 609(b) of
the RFA the EPA prepared an initial
regulatory flexibility analysis (IRFA) for
the proposed rulemaking and convened
a Small Business Advocacy Review
(SBAR) Panel to obtain advice and
recommendations from small entity
representatives that potentially would
be subject to the rule’s requirements.
Summaries of the IRFA and Panel
recommendations are presented in the
proposed rulemaking at 81 FR 13637,
March 14, 2016.
As required by section 604 of the
RFA, the EPA prepared a final
regulatory flexibility analysis (FRFA) for
this action. The FRFA addresses the
issues raised by public comments on the
IRFA for the proposed rulemaking. The
complete FRFA is available for review
in the docket and is summarized here.
1. Statement of Need and Rule
Objectives
The purpose of this action is to
improve safety at facilities that use and
distribute hazardous chemicals. In
response to catastrophic chemical
facility incidents in the United States,
including the explosion that occurred at
the West Fertilizer facility in West,
Texas, on April 17, 2013 that killed 15
people (on May 11, 2016, ATF ruled
that the fire was intentionally set),122
President Obama issued Executive
Order 13650, ‘‘Improving Chemical
Facility Safety and Security,’’ on August
1, 2013. Section 6(a)(i) of Executive
Order 13650 requires that various
Federal agencies develop options for
improved chemical facility safety and
security, including modernizing
regulations. As a result, EPA is
finalizing revisions to the Risk
Management Program (40 CFR part
68).123
EPA believes that the RMP regulations
have been effective in preventing and
122 See ATF Announces $50,000 Reward in West,
Texas Fatality Fire, https://www.atf.gov/news/pr/
atf-announces-50000-reward-west-texas-fatalityfire.
123 For more information on the Executive Order
see https://www.whitehouse.gov/the-press-office/
2013/08/01/executive-order-improving-chemicalfacility-safety-and-security.
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mitigating chemical accidents in the
United States; however, EPA believes
that revisions could further protect
human health and the environment
from chemical hazards through the
advancement of process safety based on
lessons learned. These revisions are a
result of a review of the existing Risk
Management Program and information
gathered from the comments on the
proposed rulemaking, SBAR panel,
public hearing, RFI, and Executive
Order listening sessions, and are
finalized under the statutory authority
provided by CAA section 112(r) as
amended (42 U.S.C. 7412(r)). For more
information on the proposed
rulemaking, SBAR panel and outreach
efforts for this action, see the docket for
this rulemaking (Docket ID Number
EPA–HQ–OEM–2015–0725).
2. Significant Comments on the IRFA
a. General Comments
A Federal elected official, Federal
agency, facility, and multiple industry
trade associations commented that EPA
is not fulfilling its obligations under the
Regulatory Flexibility Act because the
Agency did not provide itself with
enough time to consider the comments
of either the SBAR panel report or the
SERs in the proposed rulemaking. Many
of these commenters asked that the
SBAR panel recommendations be
incorporated in the final rule.
A facility stated that the proposed
rulemaking will be burdensome to small
facilities. An association of government
agencies expressed concern that the
costs of a more prescriptive risk
management program will fall on small
communities. An industry trade
association and Federal agency claimed
that the proposed rulemaking imposes a
disproportionate burden on small
facilities and asserted that EPA should
eliminate impractical, unjustifiable, or
non-cost-effective requirements. Several
industry trade associations and a facility
commented that the proposed
rulemaking will result in more facilities
being required to become responders,
which will be costly and difficult for
small businesses.
Multiple facilities commented that
EPA should withdraw its proposed
rulemaking and coordinate more closely
with OSHA’s PSM rulemaking. An
industry trade association stated that
OSHA’s PSM program and EPA’s RMP
proposal is creating confusion for small
entities in the water sector. The
commenter asked that EPA update
guidance documents and delay further
development of RMP revisions until
OSHA’S PSM SBAR panel process is
complete.
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EPA disagrees that the Agency did not
fulfill its obligations under the
Regulatory Flexibility Act or that the
Agency did not consider the comments
of the SBAR panel and SERs in the
proposed or final rules. In many
locations throughout the proposed
rulemaking, EPA discussed SBAR panel
recommendations and requested public
comments on regulatory alternatives
recommended by the SBAR panel. EPA
also made numerous adjustments to the
final rule to incorporate regulatory
alternatives that were suggested by SERs
where those alternatives were also
supported by public comments and
were consistent with the Agency’s
policy goals. For example, EPA
incorporated SBAR panel
recommendations by relaxing the
competency and independence criteria
for third-party auditors; reducing the
frequency for conducting facility
exercises; and not finalizing the
proposed revision to the definition of
‘‘catastrophic release.’’
EPA also disagrees that the final rule
is disproportionately burdensome on
small entities. In fact, the costliest final
rule provisions—STAA and facility
exercises—affect relatively few small
entities. EPA minimized the effect of the
STAA provisions on small entities by
applying these requirements to a
narrowly-defined set of facilities in
three select industry sectors. EPA
minimized the impact of the exercise
requirements on small entities by
applying these requirements only to
responding facilities, which tend to
more often be large facilities. EPA also
removed language from the final rule
that would potentially have required
numerous small entities to become
responding facilities.
Regarding comments requesting that
EPA withdraw its rulemaking and
coordinate more closely with OSHA,
EPA notes that it did coordinate with
OSHA in the development of the
proposed and final rules, and that
OSHA has also completed a SBAR panel
as an initial step toward proposing
potential changes to the PSM standard,
which may include some changes that
are similar to those in this rule.
However, EPA does not believe it is
necessary for the Agency to conduct its
rulemaking on exactly the same timeline
as OSHA. The 1990 CAA Amendments
contained separate timelines for the
initial OSHA and EPA rulemakings and
has no provisions restricting timeframes
for either agency amending its rules.
b. Third-Party Audits
A facility and an industry trade
association stated that EPA’s assertion
that the proposed requirements for
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third-party audits will have ‘‘fairly low
impact on small businesses’’ is false and
the requirement should be withdrawn
entirely. Another industry trade
association commented that third-party
audits will be especially costly to small
facilities. An industry trade association
commented that the requirement for
third-party audits will lead to a lack of
auditor availability, a particularly
difficult problem for small businesses.
EPA disagrees that the final rule’s
third-party audit requirements have a
disproportionately high impact on small
businesses. EPA notes that the thirdparty audit provisions will only affect
facilities that experience an RMP
reportable accident. Over the last ten
years, RMP facilities reported
approximately 150 accidents per year,
and over 75% of these accidents
occurred at large businesses.124 Based
on comments expressed by SERS and
others, EPA also relaxed the final rule’s
independence criteria to allow the
owner or operator to use third-party
audit teams that include some nonindependent members, including
employees of the stationary source being
audited. Also, the final rule allows a
third-party audit team to include retired
employees of the facility being audited,
if their sole continuing financial
attachments to the owner or operator are
employer-financed or managed
retirement and/or health plans. The
audit team can also include other
persons who previously provided
consulting services as an employee or
contractor of the owner or operator,
provided those services were not
provided within the last two years
(whereas the proposed rulemaking
would have required a three-year
prohibition on previous employment).
EPA believes these changes will
increase the availability of auditors and
therefore make third-party audits more
cost-effective for small business owners.
c. Facility Exercises
Multiple state agencies, facilities and
a Federal agency commented that the
increase in mandatory field exercises for
Program 2 and Program 3 facilities
would adversely affect small RMP
facilities and small communities. An
industry trade association stated that the
proposed rulemaking for facility
coordination with local responders
should be more flexible based on the
size of the community and its existing
local response capabilities.
124 EPA, 2016. Regulatory Impact Analysis—
Accidental Release Prevention Requirements: Risk
Management Programs Under the Clean Air Act,
Section 112(r)(7). Exhibit 7–9.
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A consultant/engineer stated that
small utilities who lack a local
emergency agency with first responder
capabilities will have difficulty meeting
the proposed requirements. The
commenter requested that EPA exempt
small entities from the emergency
response program requirement and offer
increased assistance to LEPCs in small
communities.
A Federal agency stated that LEPC
concerns should be addressed in a
guidance document instead of a
rulemaking.
EPA notes that the final rule includes
significant changes to the exercise
requirements to address concerns
expressed by the SBAR panel,
individual SERs and other commenters.
First, the final rule allows owners and
operators to work with local response
officials to establish an exercise
schedule that works for both parties,
provided the owner or operator holds a
field exercise at least once every ten
years, and a tabletop exercise at least
once every three years. Second, the field
and tabletop exercise requirements only
apply to responding facilities, so nonresponding facilities, which include the
majority of small businesses regulated
under the RMP rule, are not required to
comply with them. Lastly, EPA did not
finalize proposed rulemaking provisions
that would have required many small
businesses to become responding
facilities.
d. Public Meetings and Information
Disclosure
A Federal agency stated that the
public meeting requirement should
include small business flexibility,
allowing small business to post the
required information to be disclosed
instead of organizing a public meeting.
While EPA did not implement the
recommendation to allow small
businesses to post required information
in lieu of holding a public meeting, EPA
notes that the public meeting
requirement, like the third-party audit
requirement, only applies to facilities
after an RMP-reportable accident, which
minimizes its impact on small
businesses. Also, EPA revised the public
meeting requirements to extend the
timeframe within which the meeting
must be held (from 30 to 90 days after
an RMP reportable accident).
3. SBA Office of Advocacy Comments
and EPA Response
The SBA Office of Advocacy
comments urged EPA to consider small
business concerns and provide
flexibility to reduce the impact of the
proposed rulemaking on small
businesses. The following sections
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describe SBA recommendations and
how EPA has revised the rule to provide
additional flexibility that benefits small
businesses.
a. Third-Party Audits
Duplicative of existing requirements.
SBA suggested that third-party audits
are too burdensome for small businesses
and should be eliminated or reduced
significantly in scope. SBA argued that
the requirements are duplicative of the
existing requirements for self-audits and
incident investigations and suggested
that EPA waive the requirements if an
implementing agency conducts an
inspection as a result of a reportable
release or facility noncompliance.
EPA disagrees that third-party audits
are duplicative of existing requirements.
Following an accident, incident
investigations often reveal that facilities
have deficiencies in some prevention
program requirements related to that
process. Incident investigations
generally only evaluate the affected
process, and do not necessarily address
all covered processes at a facility, or
even all prevention program elements
for the affected process. However,
compliance audits entail a systematic
evaluation of the full prevention
program for all covered processes, and
EPA expects that third-party audits
should identify deficiencies in any other
covered processes at such facilities.
Additionally, EPA does not agree that
third-party audits should be waived if
EPA conducts an inspection. Thirdparty audits do not constitute
enforcement, nor do they substitute for
inspections by implementing agencies.
The audits are designed primarily to
benefit owners or operators by assisting
them to identify both actual
noncompliance as well as operational or
equipment deficiencies, previously
unidentified risk factors, and accident
release and/or regulatory
noncompliance precursor conditions
which, if uncorrected, could lead to
releases and/or enforcement actions.
Proactively addressing deficiencies, risk
factors, and precursor conditions to
accidental releases and regulatory
noncompliance will provide financial,
regulatory, and environmental benefits
for facility owners and operators,
including small businesses, and
communities.
Finally, EPA has reasonably targeted
third-party audit requirements at
facilities that have had RMP reportable
incidents that may demonstrate
weaknesses in prior self-assessments
and at facilities of heightened concern
for implementing agencies. Most small
businesses do not have RMP reportable
releases and the implementing agency
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criterion focuses on conditions with the
potential to lead to accidental releases,
rather than authorizing implementing
agencies to require third-party audits
under a potentially wide range of
circumstances, including minor
noncompliance. Therefore, EPA does
not expect that this provision will be
burdensome for small facilities.
Applicability. SBA recommended that
EPA limit the requirement to Program 3
facilities with major accidents with
offsite impacts.
EPA disagrees with this approach.
EPA based applicability of third-party
audits on whether a source had an RMP
reportable accident or whether
conditions exist that could lead to an
accidental release. EPA believes that
these criteria are potential indicators for
noncompliance with prevention
program requirements and therefore
warrant an evaluation by a third-party.
Auditor qualifications. SBA expressed
concerns with the auditor qualifications
in the proposed rulemaking arguing that
it would be difficult to find auditors
with no financial connection to the
facility (such as retirees). SBA
recommended that EPA allow small
businesses with less than 250
employees to submit a waiver request of
the independence criteria based on
limited availability of independent
auditors. SBA also expressed concern
over the PE criterion for third-party
auditors and recommended that EPA
consider other accreditations125 to
satisfy the competency criterion for
third-party auditors. SBA recommended
EPA consider other criteria in place of
the PE criterion to allow additional
flexibility such as years of experience,
number of audits conducted at a specific
facility type, and active involvement in
developing industry standards.
In order to address concerns about the
availability of auditors, EPA modified
the third-party auditor qualification
criteria in the final rule to enable more
firms and individuals to qualify as
third-party auditors or third-party audit
team leaders. The most significant
modification to the third-party auditor
qualification criteria is that only
employees of the independent thirdparty audit firm must meet the
independence criteria of § 68.59(c)(2)
and/or § 68.80(c)(2). For third-party
audit teams, the team leader must meet
both the competency and independence
125 SERs suggested other accreditations including:
degreed chemists, degreed chemical engineers,
Certified Safety Professionals (CSP), Certified
Industrial Hygienists (CIH), Certified Fire Protection
Specialists (CFPS), Certified Hazardous Materials
Managers (CHMM), Certified Professional
Environmental Auditors (CPEA) or Certified Process
Safety Auditors (CPSA).
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criteria of § 68.59(c) and/or § 68.80(c)
and all other employees of the thirdparty auditor firm that participate on the
team need only meet the independence
criteria. Third-party audit teams may
also include other personnel, such as
consultants or facility employees and
these personnel are not subject to the
third-party qualification criteria of the
final rule.
EPA also revised the timeframe
within which third-party auditors
cannot provide business or consulting
services to two years. EPA added
language indicating that if a third-partyfirm employs personnel who have
provided business or consulting services
to the facility within the prescribed
timeframe (i.e. within two years of the
audit) then the third-party audit firm
must ensure that these personnel do not
participate on the audit team.
Additionally, EPA clarified in
regulatory language the circumstances
in which a retired employee may
participate in a third-party audit and
deleted the PE requirement from the
final rule. Viewed as a whole, these
changes serve to increase the types of
personnel who may potentially serve as
independent third-party auditors.
Therefore, EPA believes it will be
unnecessary for facility owners or
operators to petition for a relaxation of
auditor qualifications.
b. Incident Investigations and Root
Cause Analysis
SBA recommended that EPA limit the
scope of this requirement to apply only
to reportable releases in order to reduce
the burden on small businesses. SBA
further recommended that EPA retain
the existing definition of ‘‘catastrophic
release.’’
EPA is finalizing the scope of the
incident investigation requirement to
apply to an incident that resulted in a
catastrophic release or could reasonably
have resulted in a catastrophic release
(i.e. a near miss). However, EPA is not
finalizing the proposed definition for
catastrophic release and is instead
maintaining the existing definition. In
the final rule, EPA is clarifying what we
mean by near miss to address
uncertainty about the term.
c. STAA
SBA recommended mandating an IST
analysis only at the design stage of new
processes. Alternatively, to reduce the
burden for small entities, SBA
recommended delaying the provision
for small firms (with less than 250
employees) until three years after the
rule’s compliance date for larger firms
in order to allow EPA a chance to
review the utility of the provision. SBA
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also recommended that EPA exclude
processes that are governed by
specifications established by a
government agency or by a customer
through a contractual relationship.
EPA is finalizing the STAA provision
as proposed. EPA disagrees that STAA
analyses should only be required during
the initial design phase of a facility.
While the greatest potential
opportunities for using IST occur early
in process design and development,
many IST options may still be
practicable after the initial design phase.
Furthermore, STAA involves more than
just IST. Safer technology alternatives
also include passive measures, active
measures, and procedural measures, and
these measures can be modified and
improved after the initial design of a
facility. EPA notes that many RMPregulated facilities were originally
constructed decades ago, yet major
enhancements have been reported in
some plants that have been operating for
many years.126 CCPS explains that
inherently safer strategies can be
evaluated throughout the lifecycle of a
process, including operations,
maintenance and modification, and EPA
agrees with this approach.
EPA also disagrees with the
suggestion to exempt certain groups
(such as batch toll manufacturers) from
the STAA requirement. Safer technology
alternatives include many options
beyond chemical substitution or
minimization. Therefore, even where a
contractual relationship or regulation
requires a regulated batch toll
manufacturing facility to use a
particular regulated substance in
specified quantities, owners and
operators of batch toll manufacturing
facilities may still consider other
potential safer alternatives, such as
passive, active, or procedural measures.
Also, the final rule does not require
regulated sources to implement IST or
ISD considered, so there is no conflict
between this final rule and other
regulations that may apply to RMPregulated facilities subject to STAA
requirements. For example, an owner or
operator would be in compliance with
this rule if he or she determines that a
chemical substitution is not practicable
if the substitution is prohibited by
another regulation.
Finally, EPA is not delaying
compliance dates for small businesses to
allow time for evaluating the provision
at large facilities. STAA for a source is
a site-specific determination and would
126 CCPS. 2009. Inherently Safer Chemical
Processes: A Life Cycle Approach, 2nd ed.,
American Institute of Chemical Engineers, CCPS
New York, Wiley, p. 25.
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be difficult to compare among facilities.
EPA believes it would be impractical to
gather/analyze information on STAA
implementation to determine the utility
of the provision for small facilities.
d. Emergency Response Program
Coordination With Local Responders
SBA recommended that EPA adopt
compliance flexibility for small
businesses by limiting their
responsibility to making good faith
efforts to coordinate with local
responders. SBA further suggested that
EPA remove the provision to allow
LEPCs to require sources to develop
emergency response programs. SBA also
suggested that EPA provide guidance to
local responders, rather than expand
existing regulations, and focus on
implementing and enforcing emergency
planning requirements for LEPCs.
Finally, SBA recommended providing
guidance on expectations for
coordination between a facility and
local responders as well as clarifying a
facility’s obligations for preparing an
emergency response program.
EPA is not finalizing the provision
that would have required the source to
develop an emergency response
program following a written request
from the LEPCs or local response
authorities. Furthermore, the final rule
clarifies requirements for coordination
activities between facility personnel and
local responders. EPA understands
some communities do not have
functional LEPCs, but has accounted for
this possibility by requiring
coordination to be with ‘‘local
emergency planning and response
organizations.’’ This term is intended to
encompass all manner of local public
emergency planning and response
organizations. In many cases this will be
the LEPC, but in other cases it may be
a local emergency management agency,
a local fire department, or another local
response organization. These non-LEPC
planning entities can use this provision
to obtain necessary planning
information even when they lack the
authority granted LEPCs under EPCRA
303(d)(3). Regardless of whether or not
their community has an active LEPC,
EPA expects owners and operators of
regulated sources to make good faith
efforts to carry out the coordination
activities required in the final rule. If
local emergency planning and response
organizations decline to participate in
coordination activities, or the owner or
operator cannot identify any appropriate
local emergency planning and response
organization with which to coordinate,
the owner or operator should document
their coordination efforts, and continue
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to attempt to perform coordination
activities at least annually.
The rule also clarifies requirements
for facilities that must develop an
emergency response program in
accordance with § 68.95. Responding
facilities must comply with all of the
provisions of § 68.95, which include
developing an emergency response plan,
developing procedures for the use,
inspection, and testing of emergency
response equipment, conducting
training for employees in relevant
procedures, and updating the
emergency response plan to reflect
changes at the source. Any facility that
plans to use its employees to take
response actions beyond those specified
in its emergency action plan under 29
CFR 1910.38 as a result of an accidental
release at the source—which could
include, for example, donning
emergency air breathing apparatus in
order to enter an area where a toxic gas
leak has occurred with the intention of
stopping or controlling the release—
would be expected to have obtained
appropriate equipment and training,
and to address these activities in its
emergency response program, even if
the facility is also relying on local
responders to supplement its own
response, or to manage offsite response
actions such as evacuations and
sheltering-in-place.
e. Exercises
SBA recommends requiring small
businesses to only conduct tabletop
exercises and eliminate the field
exercises requirement of the proposed
rulemaking.
EPA is requiring that responding
facilities conduct both tabletop and field
exercises; however, we have revised the
frequency to reduce the burden on all
facilities. The rule requires the owner or
operator to conduct both tabletop and
field exercises involving a simulated
accidental release of a regulated
substance. As part of the coordination
with local emergency response officials
required by § 68.93, the owner or
operator is required to consult with
these local officials to establish an
appropriate frequency for tabletop and
field exercises. However, in all cases,
the owner or operator must conduct a
field exercise at least once every ten
years and a tabletop exercises at least
once every three years. Additionally,
EPA encourages several nearby or
adjacent facilities to conduct joint
exercises, and this may prompt small
facilities to pool their response
resources, thereby reducing the exercise
and emergency response burden on each
facility.
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f. Information Availability
Availability of information for LEPCs.
SBA suggests that EPA require a onepage summary of information relevant
for emergency response to an accident at
the facility. SBA also expressed concern
with the recordkeeping requirement of
the proposed provision and suggested
that EPA require the information be
provided within a reasonable time
period after receiving a request to allow
the facility time to develop the
information.
EPA maintains that it is very
important to ensure that LEPCs or local
emergency response officials have the
chemical information necessary for
developing local emergency response
plans, however, EPA believes it is
unnecessary to specify in the RMP rule
the types or format of information that
LEPCs or emergency response officials
may request. Therefore, EPA has
eliminated this provision in the final
rule. EPCRA section 303(d)(3) already
provides the necessary authority to
allow LEPCs to request information
needed to develop the local emergency
response plan. Additionally, EPCRA
requires facilities to provide SDSs and
inventory information to LEPCs to assist
emergency planners and responders.
Under EPCRA section 312(f), fire
departments have the authority to
inspect these facilities to better
understand the risk associated with
these chemicals and how to deal with
those risk in the local emergency
response plan.
EPA added language to the emergency
response coordination provisions of
§ 68.93, which requires the owner or
operator to provide ‘‘any other
information that local emergency
planning and response organizations
identify as relevant to local emergency
planning.’’ This approach will allow
LEPCs and other local emergency
officials to obtain the information they
require to meet their emergency
response planning needs. It will also
allow local emergency planners and
response officials to ask questions of
facility personnel about the risks
associated with the chemical hazards at
the facility and about appropriate
mitigation and response techniques to
use in the event of a chemical release.
Availability of information for the
public. SBA recommends that EPA
improve public awareness of existing
sources of information through its own
Web site or other public forums rather
than requiring small businesses to
repackage existing information.
Alternatively, SBA suggests requiring
facilities to indicate where this
information can be obtained.
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The final rule requires the owner or
operator to make certain chemical
hazard information for all regulated
processes at a stationary source
available to the public upon request.
The facility must provide ongoing
notification to the public about what
chemical hazard information is
available upon request, how the public
may obtain such information, and where
to access any other available
information on community emergency
preparedness. The facility owner or
operator must provide information to
the requester within 45 days of
receiving a request.
Public meetings. SBA recommends
allowing small businesses to post
information that would be disclosed at
a public meeting rather than require
them to host meetings. Furthermore,
SBA suggests that EPA should provide
a longer time period for holding a public
meeting to allow the owner or operator
more time to gather information and
adequately prepare for the meeting.
In the final rule, EPA is requiring all
facilities to hold a public meeting after
an RMP-reportable accident, but is
extending the timeframe for the public
meeting to 90 days in response to
comments. EPA believes that small
businesses should host public meetings
following an RMP reportable accident to
allow community members an
opportunity to talk with facility
personnel. EPA encourages small
businesses to find ways to reduce costs
of public meetings such as by hosting
the meetings at inexpensive venues,
such as local schools, community
centers, or churches.
4. Estimate of the Number of Small
Entities to Which the Final Rule Applies
The RMP rule affects a broad range of
sectors (296 separate NAICS codes are
listed in RMP filings; 240 of these are
associated with small entities). The
RMP data include facility and parent
company name, as well as the number
of full time equivalents (FTE) for the
facility and the NAICS codes. To
develop an estimate of the number of
small entities, the analysis required a
series of reviews of the data to identify
the large entities and the small entities
that were part of small firms owning
multiple facilities. For more information
on the analysis to estimate the number
of small entities, see section 7.2 of the
RIA.
5. Projected Reporting, Recordkeeping
and Other Compliance Requirements of
the Final Rule
Under the final rule, all facilities are
required to make certain information
available to the public upon request.
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Program 2 and Program 3 facilities are
also required to provide information
upon request to local response officials
during annual coordination meetings.
Program 1 facilities will likely not have
to spend more than an hour per year on
this disclosure because the information
disclosed to the public is information
every facility should have readily
available and because the additional
information that will be provided, upon
request, to local responders relates to
provisions that do not apply to Program
1 facilities. Therefore, the FRFA has not
considered Program 1 small facilities in
the analysis of impacts.
Program 2 and Program 3 facilities
will incur the same costs for the other
provisions except for the STAA. Each
facility will be required to update
information to be disclosed annually,
coordinate with the local responders,
and conduct a notification drill
annually. If the facility is a responder,
it will have to hold exercises every three
to ten years, including at least one full
field exercise every ten years. Program
3 facilities in NAICS codes 322, 324,
and 325 will have to conduct an STAA
as part their PHA every five years.
If a facility has an accident, it will
incur costs to hold a public meeting
within 90 days of an RMP reportable
accident. The facility will also incur
costs for obtaining an independent
third-party to conduct their next
scheduled compliance audit and to
conduct a root cause analysis as part of
the incident investigation. In the event
of a near miss, facilities will also be
required to conduct a root cause
investigation. Section 7.3.1 of the RIA
describes the costs of the final rule for
small entities.
6. Steps Taken To Minimize Economic
Impact to Small Entities
The RIA analyzed the proposed new
requirements and revisions to existing
requirements as well as several
alternatives for each. In most cases, EPA
chose regulatory alternatives that had
reduced impacts on small businesses
relative to other alternatives that EPA
considered. In this section, we discuss
each final rule provision and explain
how the provision minimizes impacts
on small businesses and which of the
SBAR Panel recommendations were
implemented.
a. Third-Party Audits (Program 2
§§ 68.58 and 68.59 and Program 3
§§ 68.79 and 68.80)
EPA is finalizing a requirement for the
owner or operator to engage a thirdparty auditor to conduct a compliance
audit when required by an
implementing agency due to conditions
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at the stationary source that could lead
to an accidental release of a regulated
substance or following an RMP
reportable accident. Limiting the
applicability of this provision to sources
that have had RMP reportable accidents
minimizes its impact to the overall
universe of RMP facilities, and
particularly to small businesses. As
indicated in Exhibit 5–18 of the RIA, the
estimated cost of the high option ($196
million annualized) is nearly 20 times
higher than the estimated costs of the
preferred option ($9.9 million
annualized). Furthermore, a majority of
the costs for the option would likely be
borne by large businesses as historically,
most RMP accidents have occurred at
facilities that do not meet SBA small
business criteria. Table 19 shows the
number of accidents from 2004—2013
that occurred at small and large
facilities.
TABLE 19—PERCENTAGE OF ACCIDENTS AT SMALL AND LARGE RMP FACILITIES, 2004–2013
Program 1
Program 2
Program 3
Sector
Total
Small
Large
Small
Large
Small
Large
NAICS 325—Chemical Manufacturing ..............................................
NAICS 311, 312—Food/Beverage Manufacturers ............................
NAICS 322—Paper Manufacturing ....................................................
NAICS 331, 332, 333, 334, 336, 339—Other Manufacturing ...........
NAICS 11, 12, 15, 42491—Agricultural Chemical Distributors .........
NAICS 4246, 4247—Chemical/petroleum wholesale ........................
NAICS 4244, 4245—Other wholesale ...............................................
NAICS 493—Warehouse ...................................................................
NAICS 324—Petroleum and Coal Products Manufacturing ..............
NAICS 22131, 22132—Water/POTW ................................................
NAICS 211—Oil/Gas exploration .......................................................
Other ..................................................................................................
0
0
0
0
0
0
0
0
2
0
4
3
6
0
0
0
0
2
0
1
6
0
4
7
1
2
0
4
0
0
0
0
0
14
1
7
5
0
0
0
0
0
0
0
0
20
0
4
53
58
9
12
91
7
7
18
15
17
10
7
465
210
37
27
65
29
13
53
146
24
34
17
530
270
46
43
156
38
20
72
169
75
53
45
Total ...................................................................................................
9
26
29
29
304
1,120
1,517
While the third-party audit provision
should have a fairly low impact on
small businesses, the SBAR Panel made
additional recommendations to further
minimize the impacts of this provision
on small businesses, which EPA
considered for this final rule. Of the
suggested recommendations, EPA
revised the provision to require that
only a third-party leading the audit team
must meet the independence and
competency criteria of the rule, and also
by allowing that a retired employee of
the source can participate in the audit.
EPA also did not finalize the
competency criterion that required a PE
to participate in the audit.
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b. Incident Investigation/Root Cause
Analysis (§§ 68.60 and 68.81)
In the final rule, EPA is requiring a
root cause investigation for any P2 or P3
reportable accident or near miss.
Although the Agency chose the higher
cost option, this provision is estimated
to be one of the least costly provisions
of the final rule. In fact, the costs for
both options considered were nearly
indistinguishable—as indicated in
Exhibit 5–18 of the RIA, both the low
and preferred options are estimated to
cost approximately $1.8 million
annually. Therefore, EPA believes that
the additional safety benefit of requiring
owners and operators of Program 2
processes to also conduct root cause
analyses after incidents and near misses
is warranted. Of the suggested SBAR
recommendations, EPA clarified that
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near miss investigations are not
intended to cover minor accidents or
minor near misses that could not
reasonably have resulted in a
catastrophic release. EPA also chose not
to finalize the proposed definition of
‘‘catastrophic release,’’ which some
SERs had indicated could increase the
number of investigations required.
c. STAA (§ 68.67)
For STAA, EPA is finalizing the least
costly option. The final rule, which
applies the STAA requirement to P3
processes in NAICS 322 (paper
manufacturing), 324 (petroleum and
coal products manufacturing), and 325
(chemical manufacturing), costs $80.0
million annually and is approximately
$40 million less costly than the medium
option ($120.4 million annually), which
would have applied the requirement to
all P3 processes, and likely far less
costly than the high option, which
would require implementation of
practicable safer alternatives for all P3
processes. Although the SBAR panel
provided recommendations, EPA
finalized this provision as proposed,
and estimates that it will affect
relatively few small businesses given
the narrow focus of the provision’s
applicability.
d. Emergency Response Program
Coordination With Local Responders
(§§ 68.90, 68.93, and 68.95)
The final rule requires all facilities
with P2 or P3 processes to coordinate
with local response agencies annually
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and document coordination activities.
This provision does not have
alternatives, but the SBAR panel did
provide recommendations on
streamlining the provision. In response
to these and other recommendations,
EPA modified the extent of required
coordination, removed the requirement
for the outcome of coordination to
dictate whether a source must
implement an emergency response
program, and eliminated the ability for
LEPCs to mandate sources’ response
capabilities.
e. Facility Exercises (§ 68.96)
Notification Exercises. The final rule
requires all facilities with P2 or P3
processes to annually conduct an
emergency notification exercise to
ensure that their emergency contact list
is complete, accurate, and up-to-date.
This provision is expected to be one of
the least costly rule provisions at $1.4
million annually (only the public
meetings provision is estimated to cost
less). Therefore, EPA did not consider
any alternatives to reduce the impact of
this provision on small businesses, nor
did the SBAR panel make any such
recommendations.
Tabletop and Field Exercises. The
final rule requires responding facilities
to conduct a full field exercise at least
once every ten years and tabletop
exercises triennially. As this provision
only affects responding facilities, which
tend to more often be large facilities (see
Exhibit 3–7 in the RIA), EPA has
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implemented a rule that mitigates the
impact on small entities. EPA also
considered a low option that would
only require triennial tabletop exercises.
This option would have saved
approximately $8 million annually. EPA
did not implement the low option
because the Agency believes that
periodic field exercises are an important
component of a comprehensive
emergency response program. In
response to SBAR panel
recommendations, EPA reduced the
required frequency of exercises to
minimize the impact of this provision
on small businesses.
f. Information Availability (§ 68.210)
Under the final rule requirements, all
facilities are required to make certain
chemical hazard information available
to the public, upon request. The owner
or operator must provide an ongoing
notification to the public that such
information is available as well as
instructions on how to request the
information. Facilities are also required
to hold public meetings within 90 days
of any RMP reportable accident.
Although EPA has not identified
specific alternatives to minimize the
impact of the information disclosure
provisions on small businesses, the
Agency believes that in general, smaller
facilities will bear lower costs to comply
with these provisions.
In response to the SBAR
recommendations, EPA eliminated the
proposed provision that would have had
required specific information to be
disclosed to LEPCs and extended the
timeline for public meetings from 30
days to 90 days after an RMP reportable
accident. In addition, information to be
provided to the public is only required
to be disclosed to the public upon
request.
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7. Small Business Compliance Guides
EPA is preparing a Small Entity
Compliance Guide to help small entities
comply with this rule. EPA expects that
this guide will be made available on the
EPA Web site prior to March 15, 2021,
when facilities will have to comply with
new and revised data elements for the
final rule.
D. Unfunded Mandates Reform Act
(UMRA)
This action contains a Federal
mandate under UMRA, 2 U.S.C. 1531–
1538, that may result in expenditures of
$100 million or more for state, local,
and tribal governments, in the aggregate,
or the private sector in any one year.
Accordingly, the EPA has prepared a
written statement required under
section 202 of UMRA. The statement is
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included in the docket for this action
and briefly summarized here.
Over the 16 years of implementing the
RMP program and, most recently
through Executive Order 13650 listening
sessions, webinars, consultations, and a
public hearing, EPA has engaged states
and local communities to discuss
chemical safety issues. In the nine
Executive Order 13650 Improving
Chemical Facility Safety and Security
listening sessions and webinars, held
between November 2013 and January
2014, states and local communities
identified lack of chemical facility
participation and coordination in local
emergency contingency planning as a
key barrier to successful local
community preparedness. Additionally,
EPA has had consultations with states
and local communities through
participation in the National
Association of SARA Title III Program
Officials (NASTTPO) annual meetings
to discuss key issues related to chemical
facility and local community
coordination and what areas of the RMP
regulations need to be modernized to
facilitate this coordination and improve
local emergency preparedness and
prevention. Key priority options
discussed with NASTTPO states and
local communities included: improving
emergency response coordination
between RMP facilities and LEPCs/first
responder and requiring emergency
response exercises of the RMP facility
plan to involve LEPCs, first responders
and emergency response personnel.
This action may significantly or
uniquely affect small governments. The
EPA consulted with small governments
concerning the regulatory requirements
that might significantly or uniquely
affect them. Through the July 31, 2014,
RFI (79 FR 44604), EPA sought feedback
from governmental entities while
formulating the proposed revisions in
this action. Additionally, EPA
participated in ongoing consultations
with affected SERs (including small
governmental entities) through the
SBAR panel. EPA convened an SBAR
panel in accordance with the
requirements of the RFA, as amended by
the Small Business Regulatory
Enforcement Fairness Act (SBREFA).
Finally, EPA hosted a public hearing on
March 29, 2016 to provide interested
parties the opportunity to present data,
views or arguments concerning the rule.
Discussion of comments. EPA
received comments concerning
unfunded mandates. Several
commenters, including state agencies
and a professional organization, said
that the proposed rulemaking adds to
the unfunded mandate for LEPCs, which
were never provided with any source of
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4693
Federal funding. A few state agencies
said that the proposed field exercises in
particular will be a significant unfunded
cost for LEPCs that choose to
participate. A state agency, an industry
trade association, and an association of
government agencies commented that
these additional costs will adversely
affect smaller RMP facilities and smaller
communities with municipal-owned
RMP facilities. The industry trade
association also suggested that EPA
should consult with these municipal
governments on the impact these
proposed requirements will have on
their operating budgets. A professional
organization stated that very few LEPCs
are able to support themselves with fees
or other taxes on regulated facilities.
EPA disagrees that this final rule adds
to the burden to LEPCs and local
emergency response organizations. EPA
believes that the amendments to the
local coordination requirements clarifies
existing requirements. LEPCs are
required to develop community
emergency response plans and the
revisions to the RMP rule are intended
to ensure that facility representatives
coordinate with LEPC and local
emergency response officials in
developing those plans. Furthermore,
EPA provided flexibility in the final rule
to allow LEPC and local emergency
response officials to participate as their
schedules allow. LEPC and local
emergency response officials are
encouraged, but not required, to
participate in facility exercises.
EPA agrees that the final rule will
bear costs for small facilities and small
governments; however, EPA has built
flexibility into the rule provisions to
allow facility owners and operators to
tailor their risk management programs
to their facility specific circumstances.
Third-party compliance audits, and
public meetings apply only following an
RMP reportable accident, root cause
analysis applies only after a catastrophic
release (e.g. an RMP-reportable
accident) or after an incident that could
reasonably have resulted in a
catastrophic release. STAA analyses are
limited to specific NAICS codes, and
exercises apply only to responding
facilities. EPA has further revised
information availability requirement to
be provided only upon request by a
member of the public. These provisions
should minimize costs of the final rule
for small facilities.
E. Executive Order 13132: Federalism
This action does not have Federalism
implications. The EPA believes,
however, that these regulatory revisions
may be of significant interest to local
governments. Consistent with the EPA’s
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policy to promote communications
between the EPA and state and local
governments, and to better understand
the concerns of local governments, EPA
sought feedback through the July 31,
2014, RFI (79 FR 44604), through the
SBREFA process, and a public hearing
on March 29, 2016. EPA also hosted a
conference call with governmental
entities on May 4, 2016. A copy of the
presentation and notes from the meeting
are available in the docket for this
action.127
EPA received comments pertaining to
Federalism implications for this action.
An industry trade association asserted
that EPA’s proposal to allow local
authorities to request that the owner or
operator assume emergency response
obligations, which the commenter
argues divorces these organizations from
their Federal, state, and/or local legal
obligations, raises Federalism issues by
undermining the fundamental mission
of those entities and state delegations of
more (or less) authority to local
emergency response organizations.
Similarly, other industry trade
associations commented that EPA’s
proposed delegation of authority to
LEPCs to designate facilities as
responding stationary sources raises
significant separation of powers and
federalism concerns. As the basis for
this argument, the commenters relied
primarily on the Supreme Court
decisions in Printz v. United States (521
U.S. 898 (1997)) and New York v.
United States (505 U.S. 144 (1992)), in
which the court held that Federal
agencies cannot ‘‘commandeer’’ local
governments to implement Federal
regulatory programs.
A few commenters, including an
associations of government agencies and
an industry trade association,
commented that the Agency had missed
a valuable opportunity to engage local
governments prior to the rule’s
publication, which the commenter
described as counter to EPA’s internal
‘‘Guidance on Executive Order 13132:
Federalism’’ (Nov. 2008) that specifies
that States and local governments must
be consulted on rules if they impose
substantial compliance costs, preempt
state or local laws, and/or have
substantial direct effects on state and
local governments. Because the
commenter does not believe that EPA
has adequately engaged local
government agencies, an association of
government agencies requested that EPA
delay advancing the proposed
rulemaking and perform a local
government impact analysis and
127 https://www.regulations.gov/
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consultation with the nation’s cities,
counties, and mayors before finalizing
the rule.
EPA is finalizing requirements for the
stationary source owner or operator to
coordinate annually with local
emergency planning and response
officials to ensure that the stationary
source is included in the community
emergency response plan (for toxic
substances) and/or to coordinate
response activities with local emergency
responders (for flammable substances).
However, after considering concerns
raised by commenters related to
providing LEPCs with the authority to
require a stationary source to develop an
emergency response program in
accordance with § 68.95, EPA has
eliminated this provision from the final
rule. EPA did not intend this provision
to undermine the fundamental mission
of response agencies nor as a delegation
of Federal authority. EPA expects that
some stationary source owners or
operators will self-identify a need to
develop an emergency response
program if the result of local
coordination indicates that the
stationary source is not included in the
community emergency response plan
(e.g., when an LEPC is inactive and
there is no community emergency
response plan or the existing plan is
outdated).
EPA disagrees with comments that
suggest that EPA did not engage local
governments prior to the rule’s
publication. EPA followed the agency’s
internal guidance on Executive Order
13132 when determining whether to
initiate consultation with state and local
governments. Furthermore, through
Executive Order 13650 listening
sessions, webinars, consultations, and a
public hearing, EPA has engaged states
and local communities to discuss
chemical safety issues. Additionally,
EPA has consulted with states and local
communities through participation in
the NASTTPO annual meetings to
discuss key issues related to chemical
facility and local community
coordination and what areas of the RMP
regulations need to be modernized to
facilitate this coordination and improve
local emergency preparedness and
prevention.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action has tribal implications.
However, it will neither impose
substantial direct compliance costs on
federally recognized tribal governments,
nor preempt tribal law. There are
approximately 260 RMP facilities
located on tribal lands. Tribes could be
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impacted by the final rule either as an
owner or operator of an RMP-regulated
facility or as a Tribal government when
the Tribal government conducts
emergency response or emergency
preparedness activities under EPCRA.
The EPA consulted with tribal
officials under the EPA Policy on
Consultation and Coordination with
Indian Tribes early in the process of
developing this regulation to permit
them to have meaningful and timely
input into its development. EPA hosted
a public hearing on March 29, 2016 that
was open to all interested parties and
hosted a total of two conference calls for
interested tribal representatives on April
20, 2016 and April 26, 2016. A summary
of each conference call is available in
the docket for this action.128 EPA did
not receive any written comments from
tribal representatives.
As required by section 7(a), the EPA’s
Tribal Consultation Official has certified
that the requirements of the executive
order have been met in a meaningful
and timely manner. A copy of the
certification is included in the docket
for this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 because the EPA does not
believe the environmental health risks
or safety risks addressed by this action
present a disproportionate risk to
children. The EPA believes that the
proposed revisions to the Risk
Management Program regulations would
further protect human health, including
the health of children, through
advancement of process safety. EPA did
not receive any comments associated
with this issue.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a ‘‘significant
energy action’’ because it is not likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
This action is not anticipated to have
notable impacts on emissions, costs or
energy supply decisions for the affected
electric utility industry. EPA did not
receive any comments associated with
this issue.
I. National Technology Transfer and
Advancement Act (NTTAA)
This action involves technical
standards. The EPA is requiring thirdparty auditors to be experienced with
applicable RAGAGEP, which include
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Voluntary Consensus Standards as well
as other measures, for regulated
processes being audited. Numerous
different standards apply to processes
regulated under the final rule and their
application will vary depending on the
particular process and chemicals
involved. EPA is not listing all the
various codes, standards and practices
that would apply to the wide variety of
chemical processes covered by this rule
as doing so would be impracticable,
given that this rule affects sectors across
many industries and listing the
applicable RAGAGEP measures would
require the EPA to update that list every
time there was a change in the industry
standards or best practices. The final
rule requires third-party auditors to be
familiar with standards applicable to
processes they audit, and to obtain their
own copies of applicable standards
where needed. Auditors must be
knowledgeable of applicable consensus
standards because the accident
prevention program provisions of the
existing rule (subparts C and D) require
owners or operators to comply with
RAGAGEP. Therefore, auditors must be
knowledgeable of those practices in
order to perform an effective audit. EPA
did not receive any comments
associated with this issue.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes the human health or
environmental risk addressed by this
action will not have potential
disproportionately high and adverse
human health or environmental effects
on minority, low income, or indigenous
populations. The results of this
evaluation are included in the RIA,
located in the docket. EPA received
multiple comments relating to
environmental justice concerns.
Discussion of comments on access to
information. Several groups stated that
communities need better transparency
and access to information on hazards
and investigations, training on response
plans, and access to inspection and
incident reports. A few advocacy groups
commented that the rule should include
specific elements to address
disproportionate impacts. A few
advocacy groups said that EPA should
create a centralized database available
through a Web site and local community
centers and libraries that provides this
information. A facility commented that
a Web site is a poor method to
communicate information to individuals
in poor or rural communities that may
not have access to computers or the
Internet. The commenter also said that
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LEPCs already hold public meetings to
discuss emergency plans.
A couple advocacy groups stated that
the RMP rule fails to ensure that at-risk
communities near RMP facilities have
the information they need to participate
effectively in engagement with facilities.
The groups also argued that the rule
does not improve access to summaries
of incident investigation reports, safety
audits, and STAA, among other things,
which are essential to ensuring fair
treatment. Further, the groups
commented that at-risk communities are
not given access to information on
prevention opportunities, and are not
invited to participate in prevention
analysis and planning. Another
advocacy group said that the RMP rule
should facilitate partnerships and
interactions between facilities, local
governments, and the community. A
different group said that EPA should
require a community meeting within 30
days of an incident, require publication
of response and evacuation plans for
affected areas, and establish an appeals
process for communities to report when
information and engagement
opportunities are not provided as
required, among other proposals.
EPA agrees with commenters that
have requested better access to chemical
hazard information at facilities in their
communities and improved public
transparency. EPA is finalizing a
requirement for facility owners and
operators to share information with the
public that will assist neighboring
communities to understand the hazards
in their communities. Facility owners
and operators must notify the public
that specific information is available
and provide instructions on how to
request that information as well as how
to access evacuation and shelter-inplace procedures for the community.
Additionally, following an RMP
reportable accident, facility owner and
operators are required to host a public
meeting within 90 days to communicate
information about the accident. This
allows sufficient time for facilities to
gather information about the incident to
share with the public. EPA believes that
these provisions provides the public
with more information that they can use
to protect themselves and their families
in the event of an accidental release at
an RMP-regulated facility.
EPA has included other elements in
the final rule that are intended to
address disproportionate impacts of a
release to surrounding communities. For
example, EPA is requiring paper
manufacturing, petroleum and coal
products manufacturing, and chemical
manufacturing facilities with Program 3
processes to analyze safer technologies
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4695
for each process in order to consider
ways to reduce and remove hazards.
EPA is also encouraging better
coordination between local emergency
response organizations and facility
representatives annually and during
facility exercises which will lead to
more effective community emergency
response plans and mitigate the impacts
of an accidental release to the
surrounding community. EPA
encourages facility representatives to
attend LEPC meetings along with the
public to facilitate partnerships among
these representatives.
EPA disagrees with commenters that
suggest creating a centralized database
available through a Web site and local
community centers and libraries to
provide this information. Establishing
such a centralized database would be
costly, difficult to maintain, information
would quickly become outdated, and a
centralized database could create
security vulnerabilities. See section VI.B
of this preamble for more information
on information availability to the
public.
EPA recognizes that some community
residents want to participate in
prevention planning and have access to
incident investigation reports, safety
audits, and STAA. However,
community input can be effective in
other ways that relate to community
planning. EPA encourages community
residents to become active in their
LEPCs who are already working to
reduce hazards for local communities.
Providing access to facility reports
outside of existing community planning
activities could result in duplicative
work and increased burden for
communities, emergency responders,
and facility staff.
Furthermore, developing a risk
management program involves process
hazards analyses and hierarchies of
controls developed by trained
professionals. Investigation reports,
safety audits and STAA are often
complicated and contain technical
jargon, which can be difficult to
understand without the proper training.
Information in these reports can also
reveal security vulnerabilities which
may put communities in greater danger
of terrorism if released.
Discussion of comments on
meaningful involvement. A few
commenters, including advocacy
groups, said that the only meaningful
involvement EPA has facilitated
included collecting input to shape the
proposed rulemaking. The commenters
said that there is no analysis in the rule
on whether or how the rule would
facilitate meaningful involvement by at-
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risk or environmental justice (EJ)
communities.
EPA believes there were numerous
opportunities for the public to provide
meaningful input on this final rule. This
final rule was developed following
extensive public feedback through
Executive Order 13650 listening
sessions, public comments on the RFI
and the proposed rulemaking, and the
public hearing held on March 29, 2016.
EPA has incorporated requirements in
the final rule to prevent accidental
releases, mitigate the impacts of releases
that do occur, and share chemical
hazard information with the public.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and
the EPA will submit a rule report to
each House of the Congress and to the
Comptroller General of the United
States. This action is a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 68
Environmental protection,
Administrative practice and procedure,
Air pollution control, Chemicals,
Hazardous substances,
Intergovernmental relations, Reporting
and recordkeeping requirements.
Dated: December 21, 2016.
Gina McCarthy,
Administrator.
For the reasons set out in the
preamble, title 40, chapter I, part 68, of
the Code of Federal Regulations is
amended as follows:
PART 68—CHEMICAL ACCIDENT
PREVENTION PROVISIONS
1. The authority citation for part 68
continues to read as follows:
■
Authority: 42 U.S.C. 7412(r), 7601(a)(1),
7661–7661f.
2. Amend § 68.3 by adding in
alphabetical order the definitions
‘‘Active measures’’, ‘‘CBI’’, ‘‘Inherently
safer technology or design’’, ‘‘LEPC’’,
‘‘Passive measures’’, ‘‘Practicability’’,
‘‘Procedural measures’’, ‘‘Root cause’’,
and ‘‘Third-party audit’’ to read as
follows:
■
§ 68.3
Definitions.
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*
*
*
*
Active measures mean risk
management measures or engineering
controls that rely on mechanical, or
other energy input to detect and
respond to process deviations. Examples
of active measures include alarms,
safety instrumented systems, and
detection hardware (such as
hydrocarbon sensors).
*
*
*
*
*
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CBI means confidential business
information.
*
*
*
*
*
Inherently safer technology or design
means risk management measures that
minimize the use of regulated
substances, substitute less hazardous
substances, moderate the use of
regulated substances, or simplify
covered processes in order to make
accidental releases less likely, or the
impacts of such releases less severe.
*
*
*
*
*
LEPC means local emergency
planning committee as established
under 42 U.S.C. 11001(c).
*
*
*
*
*
Passive measures mean risk
management measures that use design
features that reduce either the frequency
or consequence of the hazard without
human, mechanical, or other energy
input. Examples of passive measures
include pressure vessel designs, dikes,
berms, and blast walls.
*
*
*
*
*
Practicability means the capability of
being successfully accomplished within
a reasonable time, accounting for
economic, environmental, legal, social,
and technological factors.
Environmental factors would include
consideration of potential transferred
risks for new risk reduction measures.
Procedural measures mean risk
management measures such as policies,
operating procedures, training,
administrative controls, and emergency
response actions to prevent or minimize
incidents.
*
*
*
*
*
Root cause means a fundamental,
underlying, system-related reason why
an incident occurred.
*
*
*
*
*
Third-party audit means a compliance
audit conducted pursuant to the
requirements of § 68.59 and/or § 68.80,
performed or led by an entity
(individual or firm) meeting the
competency and independence
described in § 68.59(c) or § 68.80(c).
*
*
*
*
*
■ 3. Amend § 68.10 by:
■ a. Revising paragraph (a);
■ b. Redesignating paragraphs (b)
through (f) as paragraphs (f) through (j);
■ c. Adding new paragraphs (b) through
(e); and
■ d. Revising the newly designated
paragraph (f)(2).
The revisions and additions read as
follow:
§ 68.10
Applicability.
(a) Except as provided in paragraphs
(b) through (e) of this section, an owner
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or operator of a stationary source that
has more than a threshold quantity of a
regulated substance in a process, as
determined under § 68.115, shall
comply with the requirements of this
part no later than the latest of the
following dates:
(1) June 21, 1999;
(2) Three years after the date on
which a regulated substance is first
listed under § 68.130;
(3) The date on which a regulated
substance is first present above a
threshold quantity in a process; or
(4) For any revisions to this part, the
effective date of the final rule that
revises this part.
(b) By March 14, 2018 the owner or
operator of a stationary source shall
comply with the emergency response
coordination activities in § 68.93.
(c) Within three years of when the
owner or operator determines that the
stationary source is subject to the
emergency response program
requirements of § 68.95, pursuant to
§ 68.90(a), the owner or operator must
develop and implement an emergency
response program in accordance with
§ 68.95.
(d) By March 15, 2021, the owner or
operator shall comply with the
following provisions promulgated on
January 13, 2017:
(1) Third-party audit provisions in
§§ 68.58(f), 68.58(g), 68.58(h), 68.59,
68.79(f), 68.79(g), 68.79(h), and 68.80;
(2) Incident investigation root cause
analysis provisions in §§ 68.60(d)(7) and
68.81(d)(7);
(3) Safer technology and alternatives
analysis provisions in § 68.67(c)(8);
(4) Emergency response exercise
provisions of § 68.96, and;
(5) Availability of information
provisions in § 68.210(b) through (e).
(e) By March 14, 2022, the owner or
operator shall comply with the risk
management plan provisions of subpart
G of this part promulgated on January
13, 2017.
(f) * * *
(2) The distance to a toxic or
flammable endpoint for a worst-case
release assessment conducted under
subpart B and § 68.25 is less than the
distance to any public receptor, as
defined in § 68.3; and
*
*
*
*
*
■ 4. Amend § 68.12 by:
■ a. Revising paragraphs (c)(4) and (5),
and adding paragraph (c)(6); and
■ b. Revising paragraphs (d)(4) and (5),
and adding paragraph (d)(6).
The revisions and additions read as
follows:
§ 68.12
*
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General requirements.
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(c) * * *
(4) Coordinate response actions with
local emergency planning and response
agencies as provided in § 68.93;
(5) Develop and implement an
emergency response program, and
conduct exercises, as provided in
§§ 68.90 to 68.96; and
(6) Submit as part of the RMP the data
on prevention program elements for
Program 2 processes as provided in
§ 68.170.
(d) * * *
(4) Coordinate response actions with
local emergency planning and response
agencies as provided in § 68.93;
(5) Develop and implement an
emergency response program, and
conduct exercises, as provided in
§§ 68.90 to 68.96; and
(6) Submit as part of the RMP the data
on prevention program elements for
Program 3 processes as provided in
§ 68.175.
■ 5. Amend § 68.48 by revising
paragraph (a)(1) to read as follows:
§ 68.48
Safety information.
(a) * * *
(1) Safety Data Sheets (SDS) that meet
the requirements of 29 CFR
1910.1200(g);
*
*
*
*
*
■ 6. Amend § 68.50 by revising
paragraph (a)(2) to read as follows:
§ 68.50
Hazard review.
(a) * * *
(2) Opportunities for equipment
malfunctions or human errors that could
cause an accidental release, including
findings from incident investigations;
*
*
*
*
*
■ 7. Amend § 68.54 by revising
paragraphs (a), (b), and (d); and adding
paragraph (e) to read as follows:
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§ 68.54
Training.
(a) The owner or operator shall ensure
that each employee presently involved
in operating a process, and each
employee newly assigned to a covered
process have been trained or tested
competent in the operating procedures
provided in § 68.52 that pertain to their
duties. For those employees already
operating a process on June 21, 1999,
the owner or operator may certify in
writing that the employee has the
required knowledge, skills, and abilities
to safely carry out the duties and
responsibilities as provided in the
operating procedures.
(b) Refresher training. Refresher
training shall be provided at least every
three years, and more often if necessary,
to each employee involved in operating
a process to ensure that the employee
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understands and adheres to the current
operating procedures of the process. The
owner or operator, in consultation with
the employees operating the process,
shall determine the appropriate
frequency of refresher training.
*
*
*
*
*
(d) The owner or operator shall ensure
that employees involved in operating a
process are trained in any updated or
new procedures prior to startup of a
process after a major change.
(e) For the purposes of this section,
the term employee also includes
supervisors responsible for directing
process operations.
■ 8. Amend § 68.58 by revising
paragraph (a) and adding paragraphs (f)
through (h) to read as follows:
§ 68.58
Compliance audits.
(a) The owner or operator shall certify
that they have evaluated compliance
with the provisions of this subpart for
each covered process, at least every
three years to verify that the procedures
and practices developed under the rule
are adequate and are being followed.
When required as set forth in paragraph
(f) of this section, the compliance audit
shall be a third-party audit.
*
*
*
*
*
(f) Third-party audit applicability.
The next required compliance audit
shall be a third-party audit when one of
the following conditions apply:
(1) An accidental release meeting the
criteria in § 68.42(a) from a covered
process at a stationary source has
occurred; or
(2) An implementing agency requires
a third-party audit due to conditions at
the stationary source that could lead to
an accidental release of a regulated
substance, or when a previous thirdparty audit failed to meet the
competency or independence criteria of
§ 68.59(c).
(g) Implementing agency notification
and appeals. (1) If an implementing
agency makes a preliminary
determination that a third-party audit is
necessary pursuant to paragraph (f)(2) of
this section, the implementing agency
will provide written notice to the owner
or operator that describes the basis for
this determination.
(2) Within 30 days of receipt of such
written notice, the owner or operator
may provide information and data to,
and may consult with, the
implementing agency on the
determination. Thereafter, the
implementing agency will provide a
final determination to the owner or
operator.
(3) If the final determination requires
a third-party audit, the owner or
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4697
operator shall comply with the
requirements of § 68.59, pursuant to the
schedule in paragraph (h) of this
section.
(4) Appeals. The owner or operator
may appeal a final determination made
by an implementing agency under
paragraph (g)(2) of this section within
30 days of receipt of the final
determination. The appeal shall be
made to the EPA Regional
Administrator, or for determinations
made by other implementing agencies,
the administrator or director of such
implementing agency. The appeal shall
contain a clear and concise statement of
the issues, facts in the case, and any
relevant additional information. In
reviewing the appeal, the implementing
agency may request additional
information from the owner or operator.
The implementing agency will provide
a written, final decision on the appeal
to the owner or operator.
(h) Schedule for conducting a thirdparty audit. The audit and audit report
shall be completed as follows, unless a
different timeframe is specified by the
implementing agency:
(1) For third-party audits required
pursuant to paragraph (f)(1) of this
section, within 12 months of the release;
or
(2) For third-party audits required
pursuant to paragraph (f)(2) of this
section, within 12 months of the date of
the final determination pursuant to
paragraph (g)(3) of this section.
However, if the final determination is
appealed pursuant to paragraph (g)(4) of
this section, within 12 months of the
date of the final decision on the appeal.
■ 9. Section 68.59 is added to subpart C
to read as follows:
§ 68.59
Third-party audits.
(a) Applicability. The owner or
operator shall engage a third-party to
conduct an audit that evaluates
compliance with the provisions of this
subpart in accordance with the
requirements of this section when either
criterion of § 68.58(f) is met.
(b) Third-party auditors and auditing
teams. The owner or operator shall
either:
(1) Engage a third-party auditor
meeting all of the competency and
independence criteria in paragraph (c)
of this section; or
(2) Assemble an auditing team, led by
a third-party auditor meeting all of the
competency and independence criteria
in paragraph (c) of this section. The
team may include:
(i) Other employees of the third-party
auditor firm meeting the independence
criteria of paragraph (c)(2) of this
section; and
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(ii) Other personnel not employed by
the third-party auditor firm, including
facility personnel.
(c) Third-party auditor qualifications.
The owner or operator shall determine
and document that the third-party
auditor(s) meet the following
competency and independence
requirements:
(1) Competency requirements. The
third-party auditor(s) shall be:
(i) Knowledgeable with the
requirements of this part;
(ii) Experienced with the stationary
source type and processes being audited
and applicable recognized and generally
accepted good engineering practices;
and
(iii) Trained and/or certified in proper
auditing techniques.
(2) Independence requirements. The
third-party auditor(s) shall:
(i) Act impartially when performing
all activities under this section;
(ii) Receive no financial benefit from
the outcome of the audit, apart from
payment for auditing services. For
purposes of this paragraph, retired
employees who otherwise satisfy the
third-party auditor independence
criteria in this section may qualify as
independent if their sole continuing
financial attachments to the owner or
operator are employer-financed or
managed retirement and/or health
plans;
(iii) Not have conducted past
research, development, design,
construction services, or consulting for
the owner or operator within the last
two years. For purposes of this
requirement, consulting does not
include performing or participating in
third-party audits pursuant to § 68.59 or
§ 68.80. An audit firm with personnel
who, before working for the auditor,
conducted research, development,
design, construction, or consulting
services for the owner or operator
within the last two years as an employee
or contractor may meet the requirements
of this subsection by ensuring such
personnel do not participate in the
audit, or manage or advise the audit
team concerning the audit;
(iv) Not provide other business or
consulting services to the owner or
operator, including advice or assistance
to implement the findings or
recommendations in an audit report, for
a period of at least two years following
submission of the final audit report;
(v) Ensure that all third-party
personnel involved in the audit sign and
date a conflict of interest statement
documenting that they meet the
independence criteria of this paragraph;
and
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(vi) Ensure that all third-party
personnel involved in the audit do not
accept future employment with the
owner or operator of the stationary
source for a period of at least two years
following submission of the final audit
report. For purposes of this requirement,
employment does not include
performing or participating in thirdparty audits pursuant to § 68.59 or
§ 68.80.
(3) The auditor shall have written
policies and procedures to ensure that
all personnel comply with the
competency and independence
requirements of this section.
(d) Third-party auditor
responsibilities. The owner or operator
shall ensure that the third-party auditor:
(1) Manages the audit and participates
in audit initiation, design,
implementation, and reporting;
(2) Determines appropriate roles and
responsibilities for the audit team
members based on the qualifications of
each team member;
(3) Prepares the audit report and
where there is a team, documents the
full audit team’s views in the final audit
report;
(4) Certifies the final audit report and
its contents as meeting the requirements
of this section; and
(5) Provides a copy of the audit report
to the owner or operator.
(e) Audit report. The audit report
shall:
(1) Identify all persons participating
on the audit team, including names,
titles, employers and/or affiliations, and
summaries of qualifications. For thirdparty auditors, include information
demonstrating that the competency
requirements in paragraph (c)(1) of this
section are met;
(2) Describe or incorporate by
reference the policies and procedures
required under paragraph (c)(3) of this
section;
(3) Document the auditor’s evaluation,
for each covered process, of the owner
or operator’s compliance with the
provisions of this subpart to determine
whether the procedures and practices
developed by the owner or operator
under this rule are adequate and being
followed;
(4) Document the findings of the
audit, including any identified
compliance or performance deficiencies;
(5) Summarize any significant
revisions (if any) between draft and final
versions of the report; and
(6) Include the following certification,
signed and dated by the third-party
auditor or third-party audit team
member leading the audit:
I certify that this RMP compliance audit
report was prepared under my direction or
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supervision in accordance with a system
designed to assure that qualified personnel
properly gather and evaluate the information
upon which the audit is based. I further
certify that the audit was conducted and this
report was prepared pursuant to the
requirements of subpart C of 40 CFR part 68
and all other applicable auditing,
competency, independence, impartiality, and
conflict of interest standards and protocols.
Based on my personal knowledge and
experience, and inquiry of personnel
involved in the audit, the information
submitted herein is true, accurate, and
complete.
(f) Third-party audit findings—(1)
Findings response report. As soon as
possible, but no later than 90 days after
receiving the final audit report, the
owner or operator shall determine an
appropriate response to each of the
findings in the audit report, and develop
a findings response report that includes:
(i) A copy of the final audit report;
(ii) An appropriate response to each of
the audit report findings;
(iii) A schedule for promptly
addressing deficiencies; and
(iv) A certification, signed and dated
by a senior corporate officer, or an
official in an equivalent position, of the
owner or operator of the stationary
source, stating:
I certify under penalty of law that I have
engaged a third-party to perform or lead an
audit team to conduct a third-party audit in
accordance with the requirements of 40 CFR
68.59 and that the attached RMP compliance
audit report was received, reviewed, and
responded to under my direction or
supervision by qualified personnel. I further
certify that appropriate responses to the
findings have been identified and
deficiencies were corrected, or are being
corrected, consistent with the requirements
of subpart C of 40 CFR part 68, as
documented herein. Based on my personal
knowledge and experience, or inquiry of
personnel involved in evaluating the report
findings and determining appropriate
responses to the findings, the information
submitted herein is true, accurate, and
complete. I am aware that there are
significant penalties for making false material
statements, representations, or certifications,
including the possibility of fines and
imprisonment for knowing violations.
(2) Schedule implementation. The
owner or operator shall implement the
schedule to address deficiencies
identified in the audit findings response
report in paragraph (f)(1)(iii) of this
section and document the action taken
to address each deficiency, along with
the date completed.
(3) Submission to Board of Directors.
The owner or operator shall
immediately provide a copy of each
document required under paragraphs
(f)(1) and (2) of this section, when
completed, to the owner or operator’s
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audit committee of the Board of
Directors, or other comparable
committee or individual, if applicable.
(g) Recordkeeping. The owner or
operator shall retain at the stationary
source, the two most recent final thirdparty audit reports, related findings
response reports, documentation of
actions taken to address deficiencies,
and related records. This requirement
does not apply to any document that is
more than five years old.
■ 10. Amend § 68.60 by:
■ a. Revising paragraph (a);
■ b. Redesignating paragraphs (c)
through (f) as paragraphs (d) through (g);
■ c. Adding a new paragraph (c); and
■ d. Revising the newly designated
paragraphs (d) and (g).
The revisions and additions read as
follows:
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§ 68.60
Incident investigation.
(a) The owner or operator shall
investigate each incident that:
(1) Resulted in a catastrophic release
(including when the affected process is
decommissioned or destroyed
following, or as the result of, an
incident); or
(2) Could reasonably have resulted in
a catastrophic release (i.e., was a near
miss).
*
*
*
*
*
(c) An incident investigation team
shall be established and consist of at
least one person knowledgeable in the
process involved and other persons with
appropriate knowledge and experience
to thoroughly investigate and analyze
the incident.
(d) A report shall be prepared at the
conclusion of the investigation. The
report shall be completed within 12
months of the incident, unless the
implementing agency approves, in
writing, an extension of time. The report
shall include:
(1) Date, time, and location of
incident;
(2) Date investigation began;
(3) A description of the incident, in
chronological order, providing all
relevant facts;
(4) The name and amount of the
regulated substance involved in the
release (e.g., fire, explosion, toxic gas
loss of containment) or near miss and
the duration of the event;
(5) The consequences, if any, of the
incident including, but not limited to:
injuries, fatalities, the number of people
evacuated, the number of people
sheltered in place, and the impact on
the environment;
(6) Emergency response actions taken;
(7) The factors that contributed to the
incident including the initiating event,
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direct and indirect contributing factors,
and root causes. Root causes shall be
determined by conducting an analysis
for each incident using a recognized
method; and
(8) Any recommendations resulting
from the investigation and a schedule
for addressing them.
*
*
*
*
*
(g) Incident investigation reports shall
be retained for five years.
■ 11. Amend § 68.65 by revising the first
sentence of paragraph (a) and the note
to paragraph (b) to read as follows:
§ 68.65
Process safety information.
(a) The owner or operator shall
complete a compilation of written
process safety information before
conducting any process hazard analysis
required by the rule, and shall keep
process safety information up-to-date. *
**
(b) * * *
Note to paragraph (b): Safety Data Sheets
(SDS) meeting the requirements of 29 CFR
1910.1200(g) may be used to comply with
this requirement to the extent they contain
the information required by paragraph (b) of
this section.
*
*
*
*
*
12. Amend § 68.67 by:
a. Revising paragraph (c)(2);
b. Amending paragraph (c)(6) by
removing the word ‘‘and;’’
■ c. Amending paragraph (c)(7) by
removing the period at the end of the
paragraph and adding ‘‘; and’’ in its
place; and
■ d. Adding paragraph (c)(8).
The revisions and additions read as
follows:
■
■
■
§ 68.67
Process hazard analysis.
*
*
*
*
*
(c) * * *
(2) The findings from all incident
investigations required under § 68.81, as
well as any other potential failure
scenarios;
*
*
*
*
*
(8) For processes in NAICS 322, 324,
and 325, safer technology and
alternative risk management measures
applicable to eliminating or reducing
risk from process hazards.
(i) The owner or operator shall
consider, in the following order of
preference inherently safer technology
or design, passive measures, active
measures, and procedural measures. A
combination of risk management
measures may be used to achieve the
desired risk reduction.
(ii) The owner or operator shall
determine the practicability of the
inherently safer technologies and
designs considered.
*
*
*
*
*
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4699
13. Amend § 68.71 by adding
paragraph (d) to read as follows:
■
§ 68.71
Training.
*
*
*
*
*
(d) For the purposes of this section,
the term employee also includes
supervisors with process operational
responsibilities.
■ 14. Amend § 68.79 by revising
paragraph (a) and adding paragraphs (f)
through (h) to read as follows:
§ 68.79
Compliance audits.
(a) The owner or operator shall certify
that they have evaluated compliance
with the provisions of this subpart for
each covered process, at least every
three years to verify that the procedures
and practices developed under the rule
are adequate and are being followed.
When required as set forth in paragraph
(f) of this section, the compliance audit
shall be a third-party audit.
*
*
*
*
*
(f) Third-party audit applicability.
The next required compliance audit
shall be a third-party audit when one of
the following conditions apply:
(1) An accidental release meeting the
criteria in § 68.42(a) from a covered
process at a stationary source has
occurred; or
(2) An implementing agency requires
a third-party audit due to conditions at
the stationary source that could lead to
an accidental release of a regulated
substance, or when a previous thirdparty audit failed to meet the
competency or independence criteria of
§ 68.80(c).
(g) Implementing agency notification
and appeals. (1) If an implementing
agency makes a preliminary
determination that a third-party audit is
necessary pursuant to paragraph (f)(2) of
this section, the implementing agency
will provide written notice to the owner
or operator that describes the basis for
this determination.
(2) Within 30 days of receipt of such
written notice, the owner or operator
may provide information and data to,
and may consult with, the
implementing agency on the
determination. Thereafter, the
implementing agency will provide a
final determination to the owner or
operator.
(3) If the final determination requires
a third-party audit, the owner or
operator shall comply with the
requirements of § 68.80, pursuant to the
schedule in paragraph (h) of this
section.
(4) Appeals. The owner or operator
may appeal a final determination made
by an implementing agency under
paragraph (g)(2) of this section within
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30 days of receipt of the final
determination. The appeal shall be
made to the EPA Regional
Administrator, or for determinations
made by other implementing agencies,
the administrator or director of such
implementing agency. The appeal shall
contain a clear and concise statement of
the issues, facts in the case, and any
relevant additional information. In
reviewing the appeal, the implementing
agency may request additional
information from the owner or operator.
The implementing agency will provide
a written, final decision on the appeal
to the owner or operator.
(h) Schedule for conducting a thirdparty audit. The audit and audit report
shall be completed as follows, unless a
different timeframe is specified by the
implementing agency:
(1) For third-party audits required
pursuant to paragraph (f)(1) of this
section, within 12 months of the release;
or
(2) For third-party audits required
pursuant to paragraph (f)(2) of this
section, within 12 months of the date of
the final determination pursuant to
paragraph (g)(3) of this section.
However, if the final determination is
appealed pursuant to paragraph (g)(4) of
this section, within 12 months of the
date of the final decision on the appeal.
■ 15. Section 68.80 is added to subpart
D to read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 68.80
Third-party audits.
(a) Applicability. The owner or
operator shall engage a third-party to
conduct an audit that evaluates
compliance with the provisions of this
subpart in accordance with the
requirements of this section when either
criterion of § 68.79(f) is met.
(b) Third-party auditors and auditing
teams. The owner or operator shall
either:
(1) Engage a third-party auditor
meeting all of the competency and
independence criteria in paragraph (c)
of this section; or
(2) Assemble an auditing team, led by
a third-party auditor meeting all of the
competency and independence criteria
in paragraph (c) of this section. The
team may include:
(i) Other employees of the third-party
auditor firm meeting the independence
criteria of paragraph (c)(2) of this
section; and
(ii) Other personnel not employed by
the third-party auditor firm, including
facility personnel.
(c) Third-party auditor qualifications.
The owner or operator shall determine
and document that the third-party
auditor(s) meet the following
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competency and independence
requirements:
(1) Competency requirements. The
third-party auditor(s) shall be:
(i) Knowledgeable with the
requirements of this part;
(ii) Experienced with the stationary
source type and processes being audited
and applicable recognized and generally
accepted good engineering practices;
and
(iii) Trained or certified in proper
auditing techniques.
(2) Independence requirements. The
third-party auditor(s) shall:
(i) Act impartially when performing
all activities under this section;
(ii) Receive no financial benefit from
the outcome of the audit, apart from
payment for auditing services. For
purposes of this paragraph, retired
employees who otherwise satisfy the
third-party auditor independence
criteria in this section may qualify as
independent if their sole continuing
financial attachments to the owner or
operator are employer-financed or
managed retirement and/or health
plans;
(iii) Not have conducted past
research, development, design,
construction services, or consulting for
the owner or operator within the last
two years. For purposes of this
requirement, consulting does not
include performing or participating in
third-party audits pursuant to § 68.59 or
§ 68.80. An audit firm with personnel
who, before working for the auditor,
conducted research, development,
design, construction, or consulting
services for the owner or operator
within the last two years as an employee
or contractor may meet the requirements
of this subsection by ensuring such
personnel do not participate in the
audit, or manage or advise the audit
team concerning the audit;
(iv) Not provide other business or
consulting services to the owner or
operator, including advice or assistance
to implement the findings or
recommendations in an audit report, for
a period of at least two years following
submission of the final audit report;
(v) Ensure that all third-party
personnel involved in the audit sign and
date a conflict of interest statement
documenting that they meet the
independence criteria of this paragraph;
and
(vi) Ensure that all third-party
personnel involved in the audit do not
accept future employment with the
owner or operator of the stationary
source for a period of at least two years
following submission of the final audit
report. For purposes of this requirement,
employment does not include
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performing or participating in thirdparty audits pursuant to § 68.59 or
§ 68.80.
(3) The auditor shall have written
policies and procedures to ensure that
all personnel comply with the
competency and independence
requirements of this section.
(d) Third-party auditor
responsibilities. The owner or operator
shall ensure that the third-party auditor:
(1) Manages the audit and participates
in audit initiation, design,
implementation, and reporting;
(2) Determines appropriate roles and
responsibilities for the audit team
members based on the qualifications of
each team member;
(3) Prepares the audit report and
where there is a team, documents the
full audit team’s views in the final audit
report;
(4) Certifies the final audit report and
its contents as meeting the requirements
of this section; and
(5) Provides a copy of the audit report
to the owner or operator.
(e) Audit report. The audit report
shall:
(1) Identify all persons participating
on the audit team, including names,
titles, employers and/or affiliations, and
summaries of qualifications. For thirdparty auditors, include information
demonstrating that the competency
requirements in paragraph (c)(1) of this
section are met;
(2) Describe or incorporate by
reference the policies and procedures
required under paragraph (c)(3) of this
section;
(3) Document the auditor’s evaluation,
for each covered process, of the owner
or operator’s compliance with the
provisions of this subpart to determine
whether the procedures and practices
developed by the owner or operator
under this rule are adequate and being
followed;
(4) Document the findings of the
audit, including any identified
compliance or performance deficiencies;
(5) Summarize any significant
revisions (if any) between draft and final
versions of the report; and
(6) Include the following certification,
signed and dated by the third-party
auditor or third-party audit team
member leading the audit:
I certify that this RMP compliance audit
report was prepared under my direction or
supervision in accordance with a system
designed to assure that qualified personnel
properly gather and evaluate the information
upon which the audit is based. I further
certify that the audit was conducted and this
report was prepared pursuant to the
requirements of subpart D of 40 CFR part 68
and all other applicable auditing,
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competency, independence, impartiality, and
conflict of interest standards and protocols.
Based on my personal knowledge and
experience, and inquiry of personnel
involved in the audit, the information
submitted herein is true, accurate, and
complete.
(f) Third-party audit findings—(1)
Findings response report. As soon as
possible, but no later than 90 days after
receiving the final audit report, the
owner or operator shall determine an
appropriate response to each of the
findings in the audit report, and develop
a findings response report that includes:
(i) A copy of the final audit report;
(ii) An appropriate response to each of
the audit report findings;
(iii) A schedule for promptly
addressing deficiencies; and
(iv) A certification, signed and dated
by a senior corporate officer, or an
official in an equivalent position, of the
owner or operator of the stationary
source, stating:
asabaliauskas on DSK3SPTVN1PROD with RULES
I certify under penalty of law that I have
engaged a third-party to perform or lead an
audit team to conduct a third-party audit in
accordance with the requirements of 40 CFR
68.80 and that the attached RMP compliance
audit report was received, reviewed, and
responded to under my direction or
supervision by qualified personnel. I further
certify that appropriate responses to the
findings have been identified and
deficiencies were corrected, or are being
corrected, consistent with the requirements
of subpart D of 40 CFR part 68, as
documented herein. Based on my personal
knowledge and experience, or inquiry of
personnel involved in evaluating the report
findings and determining appropriate
responses to the findings, the information
submitted herein is true, accurate, and
complete. I am aware that there are
significant penalties for making false material
statements, representations, or certifications,
including the possibility of fines and
imprisonment for knowing violations.
(2) Schedule implementation. The
owner or operator shall implement the
schedule to address deficiencies
identified in the audit findings response
report in paragraph (f)(1)(iii) of this
section and document the action taken
to address each deficiency, along with
the date completed.
(3) Submission to Board of Directors.
The owner or operator shall
immediately provide a copy of each
document required under paragraphs
(f)(1) and (2) of this section, when
completed, to the owner or operator’s
audit committee of the Board of
Directors, or other comparable
committee or individual, if applicable.
(g) Recordkeeping. The owner or
operator shall retain at the stationary
source the two most recent final thirdparty audit reports, related findings
response reports, documentation of
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20:28 Jan 12, 2017
Jkt 241001
actions taken to address deficiencies,
and related records.
■ 16. Amend § 68.81 by revising
paragraphs (a), (d) introductory text,
(d)(1), (d)(3) through (5), and adding
paragraphs (d)(6) through (8) to read as
follows:
§ 68.81
Incident investigation.
(a) The owner or operator shall
investigate each incident that:
(1) Resulted in a catastrophic release
(including when the affected process is
decommissioned or destroyed
following, or as the result of, an
incident); or
(2) Could reasonably have resulted in
a catastrophic release (i.e., was a near
miss).
*
*
*
*
*
(d) A report shall be prepared at the
conclusion of the investigation. The
report shall be completed within 12
months of the incident, unless the
implementing agency approves, in
writing, an extension of time. The report
shall include:
(1) Date, time, and location of
incident;
*
*
*
*
*
(3) A description of the incident, in
chronological order, providing all
relevant facts;
(4) The name and amount of the
regulated substance involved in the
release (e.g., fire, explosion, toxic gas
loss of containment) or near miss and
the duration of the event;
(5) The consequences, if any, of the
incident including, but not limited to:
injuries, fatalities, the number of people
evacuated, the number of people
sheltered in place, and the impact on
the environment;
(6) Emergency response actions taken;
(7) The factors that contributed to the
incident including the initiating event,
direct and indirect contributing factors,
and root causes. Root causes shall be
determined by conducting an analysis
for each incident using a recognized
method; and
(8) Any recommendations resulting
from the investigation and a schedule
for addressing them.
*
*
*
*
*
■ 17. Revise § 68.90 to read as follows:
§ 68.90
Applicability.
(a) Responding stationary source.
Except as provided in paragraph (b) of
this section, the owner or operator of a
stationary source with Program 2 and
Program 3 processes shall comply with
the requirements of §§ 68.93, 68.95, and
68.96.
(b) Non-responding stationary source.
The owner or operator of a stationary
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4701
source whose employees will not
respond to accidental releases of
regulated substances need not comply
with § 68.95 of this part provided that:
(1) For stationary sources with any
regulated toxic substance held in a
process above the threshold quantity,
the stationary source is included in the
community emergency response plan
developed under 42 U.S.C. 11003;
(2) For stationary sources with only
regulated flammable substances held in
a process above the threshold quantity,
the owner or operator has coordinated
response actions with the local fire
department;
(3) Appropriate mechanisms are in
place to notify emergency responders
when there is a need for a response;
(4) The owner or operator performs
the annual emergency response
coordination activities required under
§ 68.93; and
(5) The owner or operator performs
the annual notification exercises
required under § 68.96(a).
■ 18. Section 68.93 is added to subpart
E to read as follows:
§ 68.93 Emergency response coordination
activities.
The owner or operator of a stationary
source shall coordinate response needs
with local emergency planning and
response organizations to determine
how the stationary source is addressed
in the community emergency response
plan and to ensure that local response
organizations are aware of the regulated
substances at the stationary source, their
quantities, the risks presented by
covered processes, and the resources
and capabilities at the stationary source
to respond to an accidental release of a
regulated substance.
(a) Coordination shall occur at least
annually, and more frequently if
necessary, to address changes: At the
stationary source; in the stationary
source’s emergency response and/or
emergency action plan; and/or in the
community emergency response plan.
(b) Coordination shall include
providing to the local emergency
planning and response organizations:
The stationary source’s emergency
response plan if one exists; emergency
action plan; updated emergency contact
information; and any other information
that local emergency planning and
response organizations identify as
relevant to local emergency response
planning. For responding stationary
sources, coordination shall also include
consulting with local emergency
response officials to establish
appropriate schedules and plans for
field and tabletop exercises required
under § 68.96(b). The owner or operator
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shall request an opportunity to meet
with the local emergency planning
committee (or equivalent) and/or local
fire department as appropriate to review
and discuss these materials.
(c) The owner or operator shall
document coordination with local
authorities, including: The names of
individuals involved and their contact
information (phone number, email
address, and organizational affiliations);
dates of coordination activities; and
nature of coordination activities.
■ 19. Amend § 68.95 by:
■ a. Revising paragraph (a)(1)(i);
■ b. Adding a sentence to the end of
paragraph (a)(4); and
■ c. Revising paragraph (c).
The revisions and addition read as
follows:
68.95
Emergency response program.
(a) * * *
(1) * * *
(i) Procedures for informing the
public and the appropriate Federal,
state, and local emergency response
agencies about accidental releases;
*
*
*
*
*
(4) * * * The owner or operator shall
review and update the plan as
appropriate based on changes at the
stationary source or new information
obtained from coordination activities,
emergency response exercises, incident
investigations, or other available
information, and ensure that employees
are informed of the changes.
*
*
*
*
*
(c) The emergency response plan
developed under paragraph (a)(1) of this
section shall be coordinated with the
community emergency response plan
developed under 42 U.S.C. 11003. Upon
request of the LEPC or emergency
response officials, the owner or operator
shall promptly provide to the local
emergency response officials
information necessary for developing
and implementing the community
emergency response plan.
■ 20. Section 68.96 is added to subpart
E to read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 68.96
Emergency response exercises.
(a) Notification exercises. At least
once each calendar year, the owner or
operator of a stationary source with any
Program 2 or Program 3 process shall
conduct an exercise of the stationary
source’s emergency response
notification mechanisms required under
§ 68.90(a)(2) or § 68.95(a)(1)(i), as
appropriate. Owners or operators of
responding stationary sources may
perform the notification exercise as part
of the tabletop and field exercises
VerDate Sep<11>2014
20:28 Jan 12, 2017
Jkt 241001
required in paragraph (b) of this section.
The owner/operator shall maintain a
written record of each notification
exercise conducted over the last five
years.
(b) Emergency response exercise
program. The owner or operator of a
stationary source subject to the
requirements of § 68.95 shall develop
and implement an exercise program for
its emergency response program,
including the plan required under
§ 68.95(a)(1). Exercises shall involve
facility emergency response personnel
and, as appropriate, emergency response
contractors. When planning emergency
response field and tabletop exercises,
the owner or operator shall coordinate
with local public emergency response
officials and invite them to participate
in the exercise. The emergency response
exercise program shall include:
(1) Emergency response field
exercises. The owner or operator shall
conduct field exercises involving the
simulated accidental release of a
regulated substance (i.e., toxic substance
release or release of a regulated
flammable substance involving a fire
and/or explosion).
(i) Frequency. As part of coordination
with local emergency response officials
required by § 68.93, the owner or
operator shall consult with these
officials to establish an appropriate
frequency for field exercises, but at a
minimum, shall conduct a field exercise
at least once every ten years.
(ii) Scope. Field exercises shall
include: Tests of procedures to notify
the public and the appropriate Federal,
state, and local emergency response
agencies about an accidental release;
tests of procedures and measures for
emergency response actions including
evacuations and medical treatment; tests
of communications systems;
mobilization of facility emergency
response personnel, including
contractors, as appropriate; coordination
with local emergency responders;
emergency response equipment
deployment; and any other action
identified in the emergency response
program, as appropriate.
(2) Tabletop exercises. The owner or
operator shall conduct a tabletop
exercise involving the simulated
accidental release of a regulated
substance.
(i) Frequency. As part of coordination
with local emergency response officials
required by § 68.93, the owner or
operator shall consult with these
officials to establish an appropriate
frequency for tabletop exercises, but at
a minimum, shall conduct a field
exercise at least once every three years.
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(ii) Scope. The exercise shall include
discussions of: Procedures to notify the
public and the appropriate Federal,
state, and local emergency response
agencies; procedures and measures for
emergency response including
evacuations and medical treatment;
identification of facility emergency
response personnel and/or contractors
and their responsibilities; coordination
with local emergency responders;
procedures for emergency response
equipment deployment; and any other
action identified in the emergency
response plan, as appropriate.
(3) Documentation. The owner/
operator shall prepare an evaluation
report within 90 days of each exercise.
The report shall include: A description
of the exercise scenario; names and
organizations of each participant; an
evaluation of the exercise results
including lessons learned;
recommendations for improvement or
revisions to the emergency response
exercise program and emergency
response program, and a schedule to
promptly address and resolve
recommendations.
(c) Alternative means of meeting
exercise requirements. The owner or
operator may satisfy the requirement to
conduct notification, field and/or
tabletop exercises through:
(1) Exercises conducted to meet other
Federal, state or local exercise
requirements, provided the exercise
meets the requirements of paragraphs (a)
and/or (b) of this section, as appropriate.
(2) Response to an accidental release,
provided the response includes the
actions indicated in paragraphs (a) and/
or (b) of this section, as appropriate.
When used to meet field and/or tabletop
exercise requirements, the owner or
operator shall prepare an after-action
report comparable to the exercise
evaluation report required in paragraph
(b)(3) of this section, within 90 days of
the incident.
21. Amend § 68.130 by:
a. In Table 1, ‘‘List of Regulated Toxic
Substances and Threshold Quantities
for Accidental Release Prevention’’,
under second column entitled ‘‘CAS
No.’’, removing the number ‘‘107–18–
61’’ adding ‘‘107–18–6’’ in its place; and
■ b. Revising Table 4, ‘‘List of Regulated
Flammable Substances and Threshold
Quantities for Accidental Release
Prevention’’.
The revisions read as follows:
■
■
§ 68.130
*
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List of substances.
*
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TABLE 4 TO § 68.130—LIST OF REGULATED FLAMMABLE SUBSTANCES 1 AND THRESHOLD QUANTITIES FOR ACCIDENTAL
RELEASE PREVENTION
[CAS Number Order—63 Substances]
Threshold quantity
(lbs)
Chemical name
60–29–7 ..........................................
74–82–8 ..........................................
74–84–0 ..........................................
74–85–1 ..........................................
74–86–2 ..........................................
74–89–5 ..........................................
74–98–6 ..........................................
74–99–7 ..........................................
75–00–3 ..........................................
75–01–4 ..........................................
75–02–5 ..........................................
75–04–7 ..........................................
75–07–0 ..........................................
75–08–1 ..........................................
75–19–4 ..........................................
75–28–5 ..........................................
75–29–6 ..........................................
75–31–0 ..........................................
75–35–4 ..........................................
75–37–6 ..........................................
75–38–7 ..........................................
75–50–3 ..........................................
75–76–3 ..........................................
78–78–4 ..........................................
78–79–5 ..........................................
79–38–9 ..........................................
106–97–8 ........................................
106–98–9 ........................................
106–99–0 ........................................
107–00–6 ........................................
107–01–7 ........................................
107–25–5 ........................................
107–31–3 ........................................
109–66–0 ........................................
109–67–1 ........................................
109–92–2 ........................................
109–95–5 ........................................
115–07–1 ........................................
115–10–6 ........................................
115–11–7 ........................................
116–14–3 ........................................
124–40–3 ........................................
460–19–5 ........................................
463–49–0 ........................................
463–58–1 ........................................
463–82–1 ........................................
504–60–9 ........................................
557–98–2 ........................................
563–45–1 ........................................
563–46–2 ........................................
590–18–1 ........................................
590–21–6 ........................................
598–73–2 ........................................
624–64–6 ........................................
627–20–3 ........................................
646–04–8 ........................................
689–97–4 ........................................
1333–74–0 ......................................
4109–96–0 ......................................
7791–21–1 ......................................
7803–62–5 ......................................
10025–78–2 ....................................
25167–67–3 ....................................
asabaliauskas on DSK3SPTVN1PROD with RULES
CAS No.
Ethyl ether [Ethane, 1,1′-oxybis-] .........................................................
Methane ................................................................................................
Ethane ...................................................................................................
Ethylene [Ethene] .................................................................................
Acetylene [Ethyne] ................................................................................
Methylamine [Methanamine] .................................................................
Propane ................................................................................................
Propyne [1-Propyne] .............................................................................
Ethyl chloride [Ethane, chloro-] ............................................................
Vinyl chloride [Ethene, chloro-] .............................................................
Vinyl fluoride [Ethene, fluoro-] ..............................................................
Ethylamine [Ethanamine] ......................................................................
Acetaldehyde ........................................................................................
Ethyl mercaptan [Ethanethiol] ...............................................................
Cyclopropane ........................................................................................
Isobutane [Propane, 2-methyl] .............................................................
Isopropyl chloride [Propane, 2-chloro-] ................................................
Isopropylamine [2-Propanamine] ..........................................................
Vinylidene chloride [Ethene, 1,1-dichloro-] ...........................................
Difluoroethane [Ethane, 1,1-difluoro-] ...................................................
Vinylidene fluoride [Ethene, 1,1-difluoro-] ............................................
Trimethylamine [Methanamine, N, N-dimethyl-] ...................................
Tetramethylsilane [Silane, tetramethyl-] ...............................................
Isopentane [Butane, 2-methyl-] ............................................................
Isoprene [1,3,-Butadiene, 2-methyl-] ....................................................
Trifluorochloroethylene [Ethene, chlorotrifluoro-] ..................................
Butane ...................................................................................................
1-Butene ...............................................................................................
1,3-Butadiene ........................................................................................
Ethyl acetylene [1-Butyne] ....................................................................
2-Butene ...............................................................................................
Vinyl methyl ether [Ethene, methoxy-] .................................................
Methyl formate [Formic acid, methyl ester] ..........................................
Pentane .................................................................................................
1-Pentene .............................................................................................
Vinyl ethyl ether [Ethene, ethoxy-] .......................................................
Ethyl nitrite [Nitrous acid, ethyl ester] ...................................................
Propylene [1-Propene] ..........................................................................
Methyl ether [Methane, oxybis-] ...........................................................
2-Methylpropene [1-Propene, 2-methyl-] ..............................................
Tetrafluoroethylene [Ethene, tetrafluoro-] .............................................
Dimethylamine [Methanamine, N-methyl-] ...........................................
Cyanogen [Ethanedinitrile] ....................................................................
Propadiene [1,2-Propadiene] ................................................................
Carbon oxysulfide [Carbon oxide sulfide (COS)] .................................
2,2-Dimethylpropane [Propane, 2,2-dimethyl-] .....................................
1,3-Pentadiene ......................................................................................
2-Chloropropylene [1-Propene, 2-chloro-] ............................................
3-Methyl-1-butene .................................................................................
2-Methyl-1-butene .................................................................................
2-Butene-cis ..........................................................................................
1-Chloropropylene [1-Propene, 1-chloro-] ............................................
Bromotrifluorethylene [Ethene, bromotrifluoro-] ....................................
2-Butene-trans [2-Butene, (E)] .............................................................
2-Pentene, (Z)- .....................................................................................
2-Pentene, (E)- .....................................................................................
Vinyl acetylene [1-Buten-3-yne] ............................................................
Hydrogen ..............................................................................................
Dichlorosilane [Silane, dichloro-] ..........................................................
Chlorine monoxide [Chlorine oxide] .....................................................
Silane ....................................................................................................
Trichlorosilane [Silane, trichloro-] .........................................................
Butene ...................................................................................................
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
10,000
Basis for
listing
g
f
f
f
f
f
f
f
f
a, f
f
f
g
g
f
f
g
g
g
f
f
f
g
g
g
f
f
f
f
f
f
f
g
g
g
g
f
f
f
f
f
f
f
f
f
f
f
g
f
g
f
g
f
f
g
g
f
f
f
f
f
g
f
1 A flammable substance when used as a fuel or held for sale as a fuel at a retail facility is excluded from all provisions of this part (see
§ 68.126).
Note: Basis for Listing:
a Mandated for listing by Congress.
f Flammable gas.
g Volatile flammable liquid.
22. Amend § 68.160 by adding
paragraphs (b)(21) and (22) to read as
follows:
■
VerDate Sep<11>2014
20:28 Jan 12, 2017
Jkt 241001
§ 68.160
*
Registration.
*
*
(b) * * *
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*
Fmt 4701
*
Sfmt 4700
(21) Method of communication and
location of the notification that
chemical hazard information is
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available to the public, pursuant to
§ 68.210(c); and
(22) Whether a public meeting has
been held following an RMP reportable
accident, pursuant to § 68.210(e).
■ 23. Amend § 68.170 by revising
paragraphs (i) and (j) to read as follows:
§ 68.170
Prevention program/Program 2.
*
*
*
*
*
(i) The date of the most recent
compliance audit, the expected date of
completion of any changes resulting
from the compliance audit, and identify
whether the most recent compliance
audit was a third-party audit, pursuant
to §§ 68.58 and 68.59.
(j) The completion date of the most
recent incident investigation and the
expected date of completion of any
changes resulting from the investigation.
*
*
*
*
*
■ 24. Amend § 68.175 by:
■ a. Revising the introductory text of
paragraph (e), and paragraphs (e)(1), (5),
and (6);
■ b. Adding paragraph (e)(7); and
■ c. Revising paragraphs (k) and (l).
The revisions and addition read as
follows:
§ 68.175
Prevention program/Program 3.
asabaliauskas on DSK3SPTVN1PROD with RULES
*
*
*
*
*
(e) The most recent process hazard
analysis (PHA) or PHA update and
revalidation information, pursuant to
§ 68.67, including:
(1) The date of completion of the most
recent PHA or update and the technique
used;
*
*
*
*
*
(5) Monitoring and detection systems
in use;
(6) Changes since the last PHA; and
(7) Inherently safer technology or
design measures implemented since the
last PHA, if any, and the technology
category (substitution, minimization,
simplification and/or moderation).
*
*
*
*
*
(k) The date of the most recent
compliance audit, the expected date of
completion of any changes resulting
from the compliance audit, and identify
whether the most recent compliance
audit was a third-party audit, pursuant
to §§ 68.79 and 68.80.
(l) The completion date of the most
recent incident investigation and the
expected date of completion of any
changes resulting from the investigation.
*
*
*
*
*
■ 25. Revise § 68.180 to read as follows:
§ 68.180 Emergency response program
and exercises.
(a) The owner or operator shall
provide in the RMP:
VerDate Sep<11>2014
20:28 Jan 12, 2017
Jkt 241001
(1) Name, organizational affiliation,
phone number, and email address of
local emergency planning and response
organizations with which the stationary
source last coordinated emergency
response efforts, pursuant to
§ 68.10(f)(3) or § 68.93;
(2) The date of the most recent
coordination with the local emergency
response organizations, pursuant to
§ 68.93 and
(3) A list of Federal or state
emergency plan requirements to which
the stationary source is subject.
(b) The owner or operator shall
identify in the RMP whether the facility
is a responding stationary source or a
non-responding stationary source,
pursuant to § 68.90.
(1) For non-responding stationary
sources, the owner or operator shall
identify:
(i) For stationary sources with any
regulated toxic substance held in a
process above the threshold quantity,
whether the stationary source is
included in the community emergency
response plan developed under 42
U.S.C. 11003, pursuant to § 68.90(b)(1);
(ii) For stationary sources with only
regulated flammable substances held in
a process above the threshold quantity,
the date of the most recent coordination
with the local fire department, pursuant
to § 68.90(b)(2);
(iii) What mechanisms are in place to
notify the public and emergency
responders when there is a need for
emergency response; and
(iv) The date of the most recent
notification exercise, as required in
§ 68.96(a).
(2) For responding stationary sources,
the owner or operator shall identify:
(i) The date of the most recent review
and update of the emergency response
plan, pursuant to § 68.95(a)(4);
(ii) The date of the most recent
notification exercise, as required in
§ 68.96(a);
(iii) The date of the most recent field
exercise, as required in § 68.96(b)(1);
and
(iv) The date of the most recent
tabletop exercise, as required in
§ 68.96(b)(2).
■ 26. Amend § 68.190 by adding a
sentence at the end of paragraph (c) to
read as follows:
§ 68.190
Updates.
*
*
*
*
*
(c) * * * Prior to de-registration the
owner or operator shall meet applicable
reporting and incident investigation
requirements in accordance with
§§ 68.42, 68.60, and/or 68.81.
*
*
*
*
*
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Frm 00112
Fmt 4701
Sfmt 4700
■
27. Revise § 68.200 to read as follows:
§ 68.200
Recordkeeping.
The owner or operator shall maintain
records supporting the implementation
of this part at the stationary source for
five years, unless otherwise provided in
subpart D of this part.
■ 28. Revise § 68.210 to read as follows:
§ 68.210
public.
Availability of information to the
(a) RMP availability. The RMP
required under subpart G of this part
shall be available to the public under 42
U.S.C. 7414(c) and 40 CFR part 1400.
(b) Chemical hazard information. The
owner or operator of a stationary source
shall provide, upon request by any
member of the public, the following
chemical hazard information for all
regulated processes, as applicable:
(1) Regulated substances information.
Names of regulated substances held in
a process;
(2) Safety data sheets (SDS). SDSs for
all regulated substances located at the
facility;
(3) Accident history information.
Provide the five-year accident history
information required to be reported
under § 68.42;
(4) Emergency response program. The
following summary information
concerning the stationary source’s
compliance with § 68.10(f)(3) or the
emergency response provisions of
subpart E:
(i) Whether the stationary source is a
responding stationary source or a nonresponding stationary source;
(ii) Name and phone number of local
emergency response organizations with
which the owner or operator last
coordinated emergency response efforts,
pursuant to § 68.180; and
(iii) For stationary sources subject to
§ 68.95, procedures for informing the
public and local emergency response
agencies about accidental releases;
(5) Exercises. A list of scheduled
exercises required under § 68.96; and
(6) LEPC contact information. Include
LEPC name, phone number, and web
address as available.
(c) Notification of availability of
information. The owner or operator
shall provide ongoing notification on a
company Web site, social media
platforms, or through other publicly
accessible means that:
(1) Information specified in paragraph
(b) of this section is available to the
public upon request. The notification
shall:
(i) Specify the information elements,
identified in paragraph (b) of this
section, that can be requested; and
(ii) Provide instructions for how to
request the information (e.g. email,
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asabaliauskas on DSK3SPTVN1PROD with RULES
mailing address, and/or telephone or
Web site request);
(2) Identify where to access
information on community
preparedness, if available, including
shelter-in-place and evacuation
procedures.
(d) Timeframe to provide requested
information. The owner or operator
shall provide the requested information
under paragraph (b) of this section
within 45 days of receiving a request
from any member of the public.
(e) Public meetings. The owner or
operator of a stationary source shall
hold a public meeting to provide
information required under § 68.42 as
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20:28 Jan 12, 2017
Jkt 241001
well as other relevant chemical hazard
information, such as that described in
paragraph (b) of this section, no later
than 90 days after any accident subject
to reporting under § 68.42.
(f) Classified information. The
disclosure of information classified by
the Department of Defense or other
Federal agencies or contractors of such
agencies shall be controlled by
applicable laws, regulations, or
executive orders concerning the release
of classified information.
(g) CBI. An owner or operator
asserting CBI for information required
under this section shall provide a
sanitized version to the public.
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Fmt 4701
Sfmt 9990
4705
Assertion of claims of CBI and
substantiation of CBI claims shall be in
the same manner as required in
§§ 68.151 and 68.152 for information
contained in the RMP required under
subpart G of this part. As provided
under § 68.151(b)(3), an owner or
operator of a stationary source may not
claim five-year accident history
information as CBI. As provided in
§ 68.151(c)(2), an owner or operator of a
stationary source asserting that a
chemical name is CBI shall provide a
generic category or class name as a
substitute.
[FR Doc. 2016–31426 Filed 1–12–17; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Pages 4594-4705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31426]
[[Page 4593]]
Vol. 82
Friday,
No. 9
January 13, 2017
Part IV
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 68
Accidental Release Prevention Requirements: Risk Management Programs
Under the Clean Air Act; Final Rule
Federal Register / Vol. 82 , No. 9 / Friday, January 13, 2017 / Rules
and Regulations
[[Page 4594]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 68
[EPA-HQ-OEM-2015-0725; FRL-9954-46-OLEM]
RIN 2050-AG82
Accidental Release Prevention Requirements: Risk Management
Programs Under the Clean Air Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA), in response to
Executive Order 13650, is amending its Risk Management Program
regulations. The revisions contain several changes to the accident
prevention program requirements including an additional analysis of
safer technology and alternatives as part of the process hazard
analysis for some Program 3 processes, third-party audits and incident
investigation root cause analysis for Program 2 and Program 3
processes; enhancements to the emergency preparedness requirements;
increased public availability of chemical hazard information; and
several other changes to certain regulatory definitions and data
elements submitted in risk management plans. These amendments seek to
improve chemical process safety, assist local emergency authorities in
planning for and responding to accidents, and improve public awareness
of chemical hazards at regulated sources.
DATES: This final rule is effective on March 14, 2017.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OEM-2015-0725. All documents in the docket are
listed on the https://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: James Belke, United States
Environmental Protection Agency, Office of Land and Emergency
Management, 1200 Pennsylvania Ave. NW., (Mail Code 5104A), Washington,
DC 20460; telephone number: (202) 564-8023; email address:
belke.jim@epa.gov, or: Kathy Franklin, United States Environmental
Protection Agency, Office of Land and Emergency Management, 1200
Pennsylvania Ave. NW., (Mail Code 5104A), Washington, DC, 20460;
telephone number: (202) 564-7987; email address:
franklin.kathy@epa.gov.
Electronic copies of this document and related news releases are
available on EPA's Web site at https://www.epa.gov/rmp. Copies of this
final rule are also available at https://www.regulations.gov.
SUPPLEMENTARY INFORMATION: The contents of this preamble are:
I. General Information
A. Executive Summary
B. Does this action apply to me?
II. Background
A. Events Leading to This Action
B. Overview of EPA's Risk Management Program Regulations
III. Additional Information
A. Agency's Authority for Taking This Action
B. List of Regulated Substances
IV. Prevention Program Requirements
A. Incident Investigation and Accident History Requirements
B. Third-Party Audits
C. Safer Technology and Alternatives Analysis (STAA)
D. Stationary Source Location and Emergency Shutdown
V. Emergency Response Preparedness Requirements
A. Emergency Response Program Coordination With Local Responders
B. Facility Exercises
VI. Information Availability Requirements
A. Disclosure Requirements to LEPCs or Emergency Response
Officials
B. Information Availability to the Public
C. Public Meetings
VII. Risk Management Plan Streamlining, Clarifications, and RMP Rule
Technical Corrections
A. Revisions to Sec. 68.160 (Registration)
B. Revisions to Sec. 68.170 (Prevention Program/Program 2)
C. Revisions to Sec. 68.175 (Prevention Program/Program 3)
D. Revisions to Sec. 68.180 (Emergency Response Program)
E. Technical Corrections
VIII. Compliance Dates
A. Summary of Proposed Rulemaking
B. Summary of Final Rule
C. Discussion of Comments
D. Compliance Date Examples
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act (NTTAA)
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act (CRA)
I. General Information
A. Executive Summary
1. Purpose of the Regulatory Action
The purpose of this action is to improve safety at facilities that
use and distribute hazardous chemicals. In response to catastrophic
chemical facility incidents in the United States, including the
explosion that occurred at the West Fertilizer facility in West, Texas,
on April 17, 2013 that killed 15 people (on May 11, 2016, ATF ruled
that the fire was intentionally set.) \1\ President Obama issued
Executive Order 13650, ``Improving Chemical Facility Safety and
Security,'' on August 1, 2013.\2\
---------------------------------------------------------------------------
\1\ See ATF Announces $50,000 Reward in West, Texas Fatality
Fire, https://www.atf.gov/news/pr/atf-announces-50000-reward-west-texas-fatality-fire.
\2\ For more information on the Executive Order see https://www.whitehouse.gov/the-press-office/2013/08/01/executive-order-improving-chemical-facility-safety-and-security.
---------------------------------------------------------------------------
Section 6(a)(i) of Executive Order 13650 requires that various
Federal agencies develop options for improved chemical facility safety
and security that identify ``improvements to existing risk management
practices through agency programs, private sector initiatives,
Government guidance, outreach, standards, and regulations.'' One
existing agency program is the Risk Management Program implemented by
EPA under section 112(r) of the Clean Air Act (CAA) (42 U.S.C.
7412(r)). Section 6(c) of Executive Order 13650 requires the
Administrator of EPA to review the chemical hazards covered by the Risk
Management Program and expand, implement and enforce the Risk
Management Program to address any additional hazards.
EPA proposed changes to its Risk Management Program regulations (40
CFR part 68) on March 14, 2016 (81 FR 13637) after publishing a
``Request for Information'' notice or ``RFI'' that solicited comments
and information from the public regarding potential changes to the Risk
Management
[[Page 4595]]
Program regulations (July 31, 2014, 79 FR 44604). While developing the
proposed rulemaking, EPA convened a Small Business Advocacy Review
(SBAR) panel to receive input from Small Entity Representatives (SERs).
EPA also hosted a public hearing on March 29, 2016 to provide
interested parties the opportunity to present data, views or arguments
concerning the proposed action.
The Risk Management Program regulations have been effective in
preventing and mitigating chemical accidents in the United States.
However, EPA believes that revisions could further protect human health
and the environment from chemical hazards through advancement of
process safety management based on lessons learned.
2. Summary of the Major Provisions of the Regulatory Action
This action amends EPA's Risk Management Program regulations at 40
CFR part 68. These regulations apply to stationary sources (also
referred to as ``facilities'') that hold specific ``regulated
substances'' in excess of threshold quantities. These facilities are
required to assess their potential release impacts, undertake steps to
prevent releases, plan for emergency response to releases, and
summarize this information in a risk management plan (RMP) submitted to
EPA. The release prevention steps vary depending on the type of
process, but progressively gain granularity and rigor over three
program levels (i.e., Program 1, Program 2, and Program 3).
The major provisions of this rule include several changes to the
accident prevention program requirements, as well as enhancements to
the emergency response requirements, and improvements to the public
availability of chemical hazard information. Each of these revisions is
introduced in the following paragraphs of this section and described in
greater detail in sections IV through VI, later in this preamble.
Certain revised provisions would apply to a subset of the processes
based on program levels described in 40 CFR part 68 (or in one case, to
a subset of processes within a program level). A full description of
these program levels is provided in section II of this preamble.
a. Accident Prevention Program Revisions
This action includes three changes to the accident prevention
program requirements. First, the rule requires all facilities with
Program 2 or 3 processes to conduct a root cause analysis as part of an
incident investigation of a catastrophic release or an incident that
could have reasonably resulted in a catastrophic release (i.e., a near-
miss). This provision is intended to reduce the number of chemical
accidents by requiring facilities to identify the underlying causes of
an incident so that they may be addressed. Identifying the root causes,
rather than isolating and correcting solely the immediate cause of the
incident, will help prevent similar incidents at other locations, and
will yield the maximum benefit or lessons learned from the incident
investigation.
Second, the rule requires regulated facilities with Program 2 or 3
processes to contract with an independent third-party, or assemble an
audit team led by an independent third-party, to perform a compliance
audit after the facility has an RMP reportable accident. Compliance
audits are required under the existing rule, but are allowed to be
self-audits (i.e., performed by the owner or operator of the regulated
facility). This provision is intended to reduce the risk of future
accidents by requiring an objective auditing process to determine
whether the owner or operator of the facility is effectively complying
with the accident prevention procedures and practices required under 40
CFR part 68.
The third revision to the prevention program adds an element to the
process hazard analysis (PHA), which is updated every five years.
Specifically, owners or operators of facilities with Program 3
regulated processes in North American Industrial Classification System
(NAICS) codes 322 (paper manufacturing), 324 (petroleum and coal
products manufacturing), and 325 (chemical manufacturing) are required
to conduct a safer technology and alternatives analysis (STAA) as part
of their PHA, and to evaluate the practicability of any inherently
safer technology (IST) identified. The current PHA requirements include
consideration of active, passive, and procedural measures to control
hazards. These revisions support the analysis of those measures and
adds consideration of IST alternatives. The provision is intended to
reduce the risk of serious accidental releases by requiring facilities
in these sectors to conduct a careful examination of potentially safer
technology and designs that they could implement in lieu of, or in
addition to, their current technologies.
b. Emergency Response Enhancements
This action also enhances the rule's emergency response
requirements. Owners or operators of all facilities with Program 2 or 3
processes are required to coordinate with the local emergency response
agencies at least once a year to determine how the source is addressed
in the community emergency response plan and to ensure that local
response organizations are aware of the regulated substances at the
source, their quantities, the risks presented by covered processes, and
the resources and capabilities at the facility to respond to an
accidental release of a regulated substance.
Additionally, all facilities with Program 2 or 3 processes are
required to conduct notification exercises annually to ensure that
their emergency contact information is accurate and complete. This
provision is intended to reduce the impact of accidents by ensuring
that appropriate mechanisms and processes are in place to notify local
responders when an accident occurs. One of the factors that can
contribute to the severity of chemical accidents is a lack of effective
coordination between a facility and local emergency responders.
Increasing such coordination and establishing appropriate emergency
response procedures can help reduce the effects of accidents.
This action also requires that all facilities subject to the
emergency response program requirements of subpart E of the rule (or
``responding facilities'') conduct field exercises and tabletop
exercises. The frequency of these exercises shall be established in
consultation with local emergency response officials, but at a minimum,
full field exercises will be conducted at least once every ten years
and tabletop exercises conducted at least once every three years.
Responding facilities that have an RMP reportable accident, and
document the response activities in an after-action report comparable
to the exercise evaluation reports may use that response to satisfy the
field exercise requirements. Furthermore, owner and operators of
responding facilities that conduct exercises to meet other Federal,
state or local exercise requirements may satisfy the RMP exercise
requirements provided that the scope of the exercise includes the
objectives of an RMP exercise. The purpose of this provision is to
reduce the impact of accidents by ensuring that emergency response
personnel understand their roles in the event of an incident, that
local responders are familiar with the hazards at a facility, and that
the emergency response plan is up-to-date. Improved coordination with
emergency response personnel will better prepare responders to respond
effectively to an incident and take steps to notify the community of
appropriate actions, such as shelter-in-place or evacuation.
[[Page 4596]]
c. Enhanced Availability of Information
This action includes various enhancements to the public
availability of chemical hazard information. The rule requires all
facilities to provide certain basic information to the public, upon
request. The owner or operator of the facility shall provide ongoing
notification of availability of information elements on a company Web
site, social media platforms, or through some other publicly accessible
means. The rule also requires all facilities to hold a public meeting
for the local community within 90 days of an RMP reportable accident.
This provision will ensure that first responders and members of the
community have easier access to appropriate facility chemical hazard
information, which can significantly improve emergency preparedness and
their understanding of how the facility is addressing potential risks.
EPA proposed requirements for facilities to provide certain
information to the Local Emergency Planning Committee (LEPC), Tribal
Emergency Planning Committee (TEPC)\3\ or other local emergency
response agencies. However, rather than prescribe information elements
that must be provided upon request, EPA is requiring the owner or
operator of a stationary source to share information that is relevant
to emergency response planning as part of the coordination activities
that occur annually between facility representatives and local
emergency response agencies.
---------------------------------------------------------------------------
\3\ Note for the purposes of this document the term TEPC can be
substituted for LEPC, as appropriate.
---------------------------------------------------------------------------
In addition to the major provisions described previously in this
section, this action discusses comments received on other aspects of
the proposed action including revisions to the list of regulated
substances, location of stationary sources (related to their proximity
to public receptors), requirements for emergency shutdown systems,
compliance dates, technical corrections and revisions to the RMP
requirements.
3. Costs and Benefits
a. Summary of Potential Costs
Approximately 12,500 facilities have filed current RMPs with EPA
and are potentially affected by the revised rule. These facilities
range from petroleum refineries and large chemical manufacturers to
water and wastewater treatment systems; chemical and petroleum
wholesalers and terminals; food manufacturers, packing plants, and
other cold storage facilities with ammonia refrigeration systems;
agricultural chemical distributors; midstream gas plants; and a limited
number of other sources, including Federal installations that use RMP-
regulated substances.
Table 1 presents the number of facilities according to the latest
RMP reporting as of February 2015 by industrial sector and chemical
use.
Table 1--Number of Affected Facilities by Sector
----------------------------------------------------------------------------------------------------------------
Total
Sector NAICS codes facilities Chemical uses
----------------------------------------------------------------------------------------------------------------
Administration of environmental 924...................... 1,923 Use chlorine and other
quality programs (i.e., governments). chemicals for treatment.
Agricultural chemical distributors/ 111, 112, 115, 42491..... 3,667 Store ammonia for sale; some
wholesalers. in NAICS 111 and 115 use
ammonia as a refrigerant.
Chemical manufacturing................ 325...................... 1,466 Manufacture, process, store.
Chemical wholesalers.................. 4246..................... 333 Store for sale.
Food and beverage manufacturing....... 311, 312................. 1,476 Use--mostly ammonia as a
refrigerant.
Oil and gas extraction................ 211...................... 741 Intermediate processing
(mostly regulated flammable
substances and flammable
mixtures).
Other................................. 44, 45, 48, 54, 56, 61, 247 Use chemicals for wastewater
72. treatment, refrigeration,
store chemicals for sale.
Other manufacturing................... 313, 326, 327, 33........ 384 Use various chemicals in
manufacturing process, waste
treatment.
Other wholesale....................... 423, 424................. 302 Use (mostly ammonia as a
refrigerant).
Paper manufacturing................... 322...................... 70 Use various chemicals in pulp
and paper manufacturing.
Petroleum and coal products 324...................... 156 Manufacture, process, store
manufacturing. (mostly regulated flammable
substances and flammable
mixtures).
Petroleum wholesalers................. 4247..................... 276 Store for sale (mostly
regulated flammable
substances and flammable
mixtures).
Utilities............................. 221...................... 445 Use chlorine (mostly for
water treatment) and other
chemicals.
Warehousing and storage............... 493...................... 1,056 Use mostly ammonia as a
refrigerant.
----------------
Total............................. ......................... 12,542 .............................
----------------------------------------------------------------------------------------------------------------
Table 2 presents a summary of the annualized costs estimated in the
regulatory impact analysis.\4\ In total, EPA estimates annualized costs
of $131.2 million at a 3% discount rate and $131.8 million at a 7%
discount rate.
---------------------------------------------------------------------------
\4\ A full description of costs and benefits for this final rule
can be found in the Regulatory Impact Analysis--Accidental Release
Prevention Requirements: Risk Management Programs Under the Clean
Air Act, Section 112(r)(7). This document is available in the docket
for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
[[Page 4597]]
Table 2--Summary of Annualized Costs
[Millions, 2015 dollars]
------------------------------------------------------------------------
Provision 3 (percent) 7 (percent)
------------------------------------------------------------------------
Third-party Audits...................... $9.8 $9.8
Incident Investigation/Root Cause....... 1.8 1.8
STAA.................................... 70.0 70.0
Coordination............................ 16.0 16.0
Notification Exercises.................. 1.4 1.4
Facility Exercises...................... 24.7 24.7
Information Sharing with the Public..... 3.1 3.1
Public Meeting.......................... 0.4 0.4
Rule Familiarization.................... 3.9 4.6
-------------------------------
Total Cost *........................ 131.2 131.8
------------------------------------------------------------------------
* Totals may not sum due to rounding.
The largest average annual cost of the final rule is the STAA costs
($70.0 million), followed by the exercise costs ($24.7 million),
coordination ($16 million), and third-party audits ($9.8 million). The
remaining provisions impose average annual costs under $5 million each,
including rule familiarization ($3.9-4.6 million), information sharing
with the public ($3.1 million), incident investigation/root cause
analysis ($1.8 million), notification exercises ($1.4 million), and
public meetings ($0.4 million).
b. Summary of Potential Benefits
EPA anticipates that promulgation and implementation of this rule
would result in a reduction of the frequency and magnitude of damages
from releases. Accidents and releases from RMP facilities occur every
year, causing fires and explosions; damage to property; acute and
chronic exposures of workers and nearby residents to hazardous
materials; and resulting in serious injuries and death. Although we are
unable to quantify what specific reductions may occur as a result of
these revisions, we are able to present data on the total damages that
currently occur at RMP facilities each year. The data presented is
based on a 10-year baseline period, summarizing RMP accident impacts
and, when possible, monetizing them. EPA expects that some portion of
future damages would be prevented through implementation of this final
rule. Table 3 presents a summary of the quantified damages identified
in the analysis.
Table 3--Summary of Quantified Damages
[Millions, 2015 dollars]
----------------------------------------------------------------------------------------------------------------
Unit value 10-year total Average/year Average/accident
----------------------------------------------------------------------------------------------------------------
On-site
----------------------------------------------------------------------------------------------------------------
Fatalities.............................. $8.6 $497.8 $49.8 $0.33
Injuries................................ 0.05 105.2 10.5 0.69
Property Damage......................... ................ 2,054.9 205.5 1.4
-----------------------------------------------------------------------
On-site Total....................... ................ 2,657.9 265.8 1.8
----------------------------------------------------------------------------------------------------------------
Offsite
----------------------------------------------------------------------------------------------------------------
Fatalities.............................. 8.6 8.6 0.86 0.01
Hospitalizations........................ 0.4 6.8 0.68 0.004
Medical Treatment....................... 0.001 14.8 1.5 0.01
Evacuations *........................... 0.0 7.0 0.70 0.004
Sheltering in Place *................... 0.0 40.9 4.1 0.03
Property Damage......................... ................ 11.4 1.1 0.007
-----------------------------------------------------------------------
Offsite Total....................... ................ 89.5 8.9 0.06
-----------------------------------------------------------------------
Total........................... ................ 2,747.3 274.7 1.8
----------------------------------------------------------------------------------------------------------------
* The unit value for evacuations is less than two hundred dollars and for sheltering in place is less than one
hundred dollars so when expressed in rounded millions the value represented in the table is zero.
EPA monetized both on-site and offsite damages. EPA estimated total
average annual on-site damages of $265.8 million. The largest monetized
average annual on-site damage was on-site property damage, which
resulted in average annual damage of approximately $205.5 million. The
next largest impact was on-site fatalities ($49.8 million) and injuries
($10.5 million).
EPA estimated total average annual offsite damages of $8.9 million.
The largest monetized average annual offsite damage was from sheltering
in place ($4.1 million), followed by medical treatment ($1.5 million),
property damage ($1.1 million), fatalities ($0.86 million), evacuations
($0.7 million), and hospitalizations ($0.68 million).
In total, EPA estimated monetized damages from RMP facility
accidents of $274.7 million per year. The 10-year RMP baseline suggests
that considering
[[Page 4598]]
only the monetized impacts of RMP accidents would mean that the rule's
costs may outweigh the portion of avoided impacts from improved
prevention and mitigation that were monetized. The annualized cost of
the final rule (approximately $142 million annually) is approximately
52% of the average annual monetized costs in the 10-year baseline.
However, the monetized impacts omit many important categories of
accident impacts including lost productivity, the costs of emergency
response, transaction costs, property value impacts in the surrounding
community (that overlap with other benefit categories), and
environmental impacts. Also not reflected in the 10-year baseline costs
are the impacts of non-RMP accidents at RMP facilities and any
potential impacts of rare high consequence catastrophes. A final
omission is related to the information provision. Reducing the
probability of chemical accidents and the severity of their impacts,
and improving information disclosure by chemical facilities, as the
provisions intend, would provide benefits to potentially affected
members of society.
Table 4 summarizes four broad social benefit categories related to
accident prevention and mitigation including prevention of RMP
accidents, mitigation of RMP accidents, prevention and mitigation of
non-RMP accidents at RMP facilities, and prevention of major
catastrophes. The table explains each and identifies ten associated
specific benefit categories, ranging from avoided fatalities to avoided
emergency response costs. Table 4 also highlights and explains the
information disclosure benefit category and identifies two specific
benefits associated with it: Improved efficiency of property markets
and allocation of emergency resources.
When considering the rule's likely benefits that are due to
avoiding some portion of the monetized accident impacts, as well as the
additional non-monetized benefits described previously, EPA believes
the costs of the rule are reasonable in comparison to its benefits.
Table 4--Summary of Social Benefits of Final Rule Provisions
------------------------------------------------------------------------
Specific benefit
Broad benefit category Explanation categories
------------------------------------------------------------------------
Accident Prevention............. Prevention of Reduced
future RMP Fatalities.
facility
accidents.
Accident Mitigation............. Mitigation of Reduced
future RMP Injuries.
facility
accidents.
Non-RMP accident prevention and Prevention and Reduced
mitigation. mitigation of Property Damage.
future non-RMP Fewer
accidents at RMP People Sheltered
facilities. in Place.
Avoided Catastrophes............ Prevention of rare Fewer
but extremely Evacuations.
high consequence Avoided
events. Lost
Productivity.
Avoided
Emergency
Response Costs.
Avoided
Transaction
Costs.
Avoided
Property Value
Impacts.*
Avoided
Environmental
Impacts.
Information Disclosure.......... Provision of Improved
information to efficiency of
the public. property markets.
Improved
emergency
response resource
allocation.
------------------------------------------------------------------------
* These impacts partially overlap with several other categories such as
reduced health and environmental impacts.
B. Does this action apply to me?
This rule applies to those facilities (referred to as ``stationary
sources'' under the CAA) that are subject to the chemical accident
prevention requirements at 40 CFR part 68. This includes stationary
sources holding more than a threshold quantity (TQ) of a regulated
substance in a process. Table 5 provides industrial sectors and the
associated NAICS codes for entities potentially affected by this
action. The Agency's goal is to provide a guide for readers to consider
regarding entities that potentially could be affected by this action.
However, this action may affect other entities not listed in this
table. If you have questions regarding the applicability of this action
to a particular entity, consult the person(s) listed in the
introductory section of this action under the heading entitled FOR
FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------
\5\ For descriptions of NAICS codes, see https://www.census.gov/cgi-bin/sssd/naics/naicsrch.
Table 5--Industrial Sectors and Associated NAICS Codes for Entities
Potentially Affected by This Action
------------------------------------------------------------------------
Sector NAICS code
------------------------------------------------------------------------
Administration of Environmental Quality 924.
Programs.
Agricultural Chemical Distributors:
Crop Production........................ 111.
Animal Production and Aquaculture...... 112.
Support Activities for Agriculture and 115.
Forestry Farm.
Supplies Merchant Wholesalers.......... 42491.
Chemical Manufacturing..................... 325.
Chemical and Allied Products Merchant 4246.
Wholesalers.
Food Manufacturing......................... 311.
Beverage Manufacturing..................... 3121.
Oil and Gas Extraction..................... 211.
Other \5\.................................. 44, 45, 48, 54, 56, 61, 72.
Other manufacturing........................ 313, 326, 327, 33.
Other Wholesale:
Merchant Wholesalers, Durable Goods.... 423.
Merchant Wholesalers, Nondurable Goods. 424.
[[Page 4599]]
Paper Manufacturing........................ 322.
Petroleum and Coal Products Manufacturing.. 324.
Petroleum and Petroleum Products Merchant 4247.
Wholesalers.
Utilities.................................. 221.
Warehousing and Storage.................... 493.
------------------------------------------------------------------------
II. Background
A. Events Leading to This Action
Recent catastrophic chemical facility incidents in the United
States prompted President Obama to issue Executive Order 13650,
``Improving Chemical Facility Safety and Security,'' on August 1,
2013.\6\ The purpose of the Executive Order is to enhance the safety
and security of chemical facilities and reduce risks associated with
hazardous chemicals to owners and operators, workers, and communities.
The Executive Order establishes the Chemical Facility Safety and
Security Working Group (``Working Group''), co-chaired by the Secretary
of Homeland Security, the Administrator of EPA, and the Secretary of
Labor or their designated representatives at the Assistant Secretary
level or higher, and composed of senior representatives of other
Federal departments, agencies, and offices. The Executive Order
requires the Working Group to carry out a number of tasks whose overall
aim is to prevent chemical accidents. In addition to the tragedy at the
West Fertilizer facility in West, Texas, on April 17, 2013,\7\ a number
of other incidents have demonstrated a significant risk to the safety
of American workers and communities. On March 23, 2005, explosions at
the BP Refinery in Texas City, Texas, killed 15 people and injured more
than 170 people.\8\ On April 2, 2010, an explosion and fire at the
Tesoro Refinery in Anacortes, Washington, killed seven people.\9\ On
August 6, 2012, at the Chevron Refinery in Richmond, California, a fire
involving flammable fluids endangered 19 Chevron employees and created
a large plume of highly hazardous chemicals that traveled across the
Richmond, California, area.\10\ Nearly 15,000 residents sought medical
treatment due to the release. On June 13, 2013, a fire and explosion at
Williams Olefins in Geismar, Louisiana, killed two people and injured
many more.\11\
---------------------------------------------------------------------------
\6\ For more information on the Executive Order see https://www.whitehouse.gov/the-press-office/2013/08/01/executive-order-improving-chemical-facility-safety-and-security.
\7\ CSB. January 2016. Final Investigation Report, West
Fertilizer Company Fire and Explosion, West, TX, April 17, 2013.
REPORT 2013-02-I-TX. https://www.csb.gov/west-fertilizer-explosion-and-fire-/. On May 11, 2016, ATF ruled that the fire was
intentionally set. See ATF Announces $50,000 Reward in West, Texas
Fatality Fire, https://www.atf.gov/news/pr/atf-announces-50000-reward-west-texas-fatality-fire.
\8\ U.S. Chemical Safety and Hazard Investigation Board (CSB).
March 2007. Investigation Report: Refinery Explosion and Fire, BP,
Texas City, Texas, March 23, 2005. Report No. 2005-04-I-TX. https://www.csb.gov/assets/1/19/CSBFinalReportBP.pdf.
\9\ CSB. May 2014. Investigation Report: Catastrophic Rupture of
Heat Exchanger, Tesoro Anacortes Refinery, Anacortes, Washington,
April 2, 2010. Report No. 2010-08-I-WA. https://www.csb.gov/assets/1/7/Tesoro_Anacortes_2014-May-01.pdf.
\10\ CSB. January 2014. Regulatory Report: Chevron Richmond
Refinery Pipe Rupture and Fire, Chevron Richmond Refinery #4 Crude
Unit, Richmond, California, August 6, 2012. Report No. 2012-03-I-CA.
https://www.csb.gov/assets/1/19/CSB_Chevron_Richmond_Refinery_Regulatory_Report.pdf.
\11\ CSB. October 2016. Case Study: Williams Geismar Olefins
Plant Reboiler Rupture and Fire, Geismar, Louisiana. Incident Date:
June 13, 2013, No. 2013-03-I-LA. US Chemical Safety and Hazard
Investigation Board, Washington, DC https://www.csb.gov/williams-olefins-plant-explosion-and-fire-/.
---------------------------------------------------------------------------
Section 6 of the Executive Order is entitled ``Policy, Regulation,
and Standards Modernization.'' This section, among other things,
requires certain Federal agencies to consider possible changes to
existing chemical safety and security regulations. To solicit comments
and information from the public regarding potential changes to EPA's
Risk Management Program regulations (40 CFR part 68), on July 31, 2014,
EPA published an RFI (79 FR 44604). Information collected through the
RFI informed the proposed rulemaking that was published on March 14,
2016 (81 FR 13637).
EPA received a total of 61,716 public comments on the proposed
rulemaking. Several public comments were the result of various mass
mail campaigns and contained numerous copies of letters or petition
signatures. Approximately 61,467 letters and signatures were contained
in these several comments. The remaining comments include 235
submissions with unique content, 10 duplicate submissions, and 4 non-
germane submissions. In addition to these public submissions, EPA also
received 8 written comments and had 22 members of the public provide
verbal comments at a public hearing on March 29, 2016. Discussion of
public comments can be found in topics included in this final rule and
in the Response to Comments document,\12\ available in the docket for
this rulemaking.
---------------------------------------------------------------------------
\12\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
---------------------------------------------------------------------------
B. Overview of EPA's Risk Management Program Regulations
Both EPA's 40 CFR part 68 RMP regulation \13\ and Occupational
Safety and Health Administration's (OSHA) 29 CFR 1910.119 Process
Safety Management (PSM) standard were authorized in the CAA Amendments
of 1990. This was in response to a number of catastrophic chemical
accidents occurring worldwide that had resulted in public and worker
fatalities and injuries, environmental damage, and other community
impacts. OSHA published the PSM standard in 1992 (57 FR 6356, February
24, 1992), as required by section 304 of the 1990 CAAA, using its
authority under 29 U.S.C. 653.
---------------------------------------------------------------------------
\13\ 40 CFR part 68 is titled, ``Chemical Accident Prevention
Provisions,'' but is more commonly known as the ``RMP regulation,''
the ``RMP rule,'' or the ``Risk Management Program.'' This document
uses all three terms to refer to 40 CFR part 68. The term ``RMP''
refers to the document required to be submitted under subpart F of
40 CFR part 68, the Risk Management Plan. See https://www.epa.gov/rmp for more information on the Risk Management Program.
---------------------------------------------------------------------------
The 1990 CAA Amendments added accidental release provisions under
section 112(r). The statute required EPA to develop a list of at least
100 regulated substances for accident prevention and related thresholds
(CAA section 112(r)(3) through (5)), and authorized EPA to issue
accident prevention regulations (CAA section 112(r)(7)(A)). The statute
also required EPA to develop ``reasonable regulations'' requiring
facilities with over a TQ of a regulated substance to undertake
accident prevention steps and submit a ``risk management plan'' to
various local, state, and Federal planning entities (CAA section
112(r)(7)(B)).
[[Page 4600]]
EPA published the RMP regulation in two stages. The Agency
published the list of regulated substances and TQs in 1994 (59 FR 4478,
January 31, 1994) (the ``list rule'') \14\ and published the RMP final
regulation, containing risk management requirements for covered
sources, in 1996 (61 FR 31668, June 20, 1996) (the ``RMP
rule'').15 16 Both the OSHA PSM standard and the EPA RMP
rule aim to prevent or minimize the consequences of accidental chemical
releases through implementation of management program elements that
integrate technologies, procedures, and management practices. In
addition to requiring implementation of management program elements,
the RMP rule requires covered sources to submit (to EPA) a document
summarizing the source's risk management program--called a Risk
Management Plan (or RMP). The RMP rule required covered sources to
comply with its requirements and submit initial RMPs to EPA by June 21,
1999. Each RMP must be revised and updated at least once every five
years from the date the plan was initially submitted.
---------------------------------------------------------------------------
\14\ Documents and information related to development of the
list rule can be found in the EPA docket for the rulemaking, docket
number A-91-74.
\15\ Documents and information related to development of the RMP
rule can be found in EPA docket number A-91-73.
\16\ 40 CFR part 68 applies to owners and operators of
stationary sources that have more than a TQ of a regulated substance
within a process. The regulations do not apply to chemical hazards
other than listed substances held above a TQ within a regulated
process.
---------------------------------------------------------------------------
EPA later revised the list rule and the RMP rule. EPA modified the
regulated list of substances by exempting solutions with less than 37%
concentrations of hydrochloric acid (62 FR 45130, August 25, 1997). EPA
also deleted the category of Department of Transportation Division 1.1
explosives, and exempted flammable substances in gasoline used as fuel
and in naturally occurring hydrocarbon mixtures prior to initial
processing (63 FR 640, January 6, 1998).
EPA subsequently modified the RMP rule five times. First, in 1999,
EPA revised the facility identification data and contact information
reported in the RMP (64 FR 964, January 6, 1999). Next, EPA revised
assumptions for the worst case scenario analysis for flammable
substances and clarified what the Agency means by chemical storage not
incidental to transportation (64 FR 28696, May 26, 1999). After the
Chemical Safety Information, Site Security and Fuels Regulatory Relief
Act (CSISSFRRA) was enacted on August 5, 1999, EPA excluded regulated
flammable substances when used as a fuel or held for sale as a fuel at
a retail facility (65 FR 13243, March 13, 2000). Later, EPA restricted
access to offsite consequence analysis (OCA) data for the public and
government officials to minimize the security risks associated with
posting the information on the Internet (65 FR 48108, August 4, 2000).
Finally, EPA revised the RMP executive summary to remove a requirement
to describe the OCA; revised reporting deadlines for RMP reportable
accidents and emergency contact changes; and made other minor revisions
to RMP facility contact information (69 FR 18819, April 8, 2004).
The RMP rule establishes three ``program levels'' for regulated
processes:
Program 1 applies to processes that would not affect the public in
the case of a worst-case release and that have had no accidents with
specific offsite consequences within the past five years. Program 1
imposes limited hazard assessment requirements, requires coordination
with local response agencies, and requires submission of an RMP.
Program 2 applies to processes not eligible for Program 1 or
subject to Program 3, and imposes streamlined prevention program
requirements, including safety information, hazard review, operating
procedures, training, maintenance, compliance audits, and incident
investigation elements. Program 2 also imposes additional hazard
assessment, management, and emergency response requirements.
Program 3 applies to processes not eligible for Program 1 and
either subject to OSHA's PSM standard under Federal or state OSHA
programs or classified in one of ten specified industry sectors
identified by their 2002 NAICS codes listed at Sec. 68.10(d)(1). These
industries were selected because they had a higher frequency of the
most serious accidents as compared to other industry sectors. The ten
NAICS codes and the industries they represent are 32211 (pulp mills),
32411 (petroleum refineries), 32511 (petrochemical manufacturing),
325181 (alkalies and chlorine manufacturing), 325188 (all other basic
inorganic chemical manufacturing), 325192 (cyclic crude and
intermediate manufacturing), 325199 (all other basic chemical
manufacturing), 325211 (plastics material and resin manufacturing),
325311 (nitrogenous fertilizer manufacturing), or 32532 (pesticide and
other agricultural chemicals manufacturing).\17\ Program 3 imposes
elements nearly identical to those in OSHA's PSM standard as the
accident prevention program. The Program 3 prevention program includes
requirements relating to process safety information (PSI), PHA,
operating procedures, training, mechanical integrity, management of
change (MOC), pre-startup review, compliance audits, incident
investigations, employee participation, hot work permits, and
contractors. Program 3 also imposes the same hazard assessment,
management, and emergency response requirements that are required for
Program 2.
---------------------------------------------------------------------------
\17\ NAICS codes 325181 and 325188 are now combined and
represented as revised NAICS code 325180 in the 2012 and 2017 code
versions (other basic inorganic chemical manufacturing). NAICS code
325192 is now revised NAICS code 325194 (cyclic crude, intermediate,
and gum and wood chemical manufacturing) in the 2012 and 2017 code
versions.
---------------------------------------------------------------------------
The RMP rule has been effective in preventing and mitigating
chemical accidents in the United States and protecting human health and
the environment from chemical hazards. However, major incidents, such
as the West, Texas explosion,\18\ highlight the importance of reviewing
and evaluating current practices and regulatory requirements, and
applying lessons learned from other incident investigations to advance
process safety where needed.
---------------------------------------------------------------------------
\18\ CSB. January 2016. Final Investigation Report, West
Fertilizer Company Fire and Explosion, West, TX, April 17, 2013.
REPORT 2013-02-I-TX. https://www.csb.gov/west-fertilizer-explosion-and-fire-/.
---------------------------------------------------------------------------
III. Additional Information
A. Agency's Authority for Taking This Action
The statutory authority for this action is provided by section
112(r) of the CAA as amended (42 U.S.C. 7412(r)). Each of the portions
of the Risk Management Program rule we are amending in this document
are based on EPA's rulemaking authority under section 112(r)(7) of the
CAA (42 U.S.C. 7412(r)(7)). A more detailed discussion of the
underlying statutory authority for the current requirements of the Risk
Management Program rule appears in the action that proposed the Risk
Management Program (58 FR 54190, 54191-93, October 20, 1993). The
prevention program provisions discussed in this preamble (auditing,
incident investigation, and safer technologies alternatives analysis)
address the ``prevention and detection of accidental releases.'' The
emergency coordination and exercises provisions in this rule modify
existing provisions that provide for ``response to such release by the
owners or operators of the sources of such releases'' (CAA section
112(r)(7)(B)(i)). This paragraph in the
[[Page 4601]]
statute calls for EPA's regulations to recognize differences in ``size,
operations, processes, class and categories of sources.'' In this
document, we maintain the distinctions in prevention program levels and
in response actions authorized by this provision. The information
disclosure provisions discussed in this document generally assist in
the development of ``procedures and measures for emergency response
after an accidental release of a regulated substance in order to
protect human health and the environment.'' This information disclosure
ensures the emergency plans for impacts on the community are based on
more relevant and accurate information than would otherwise be
available and ensures that the public can become an informed
participant in such emergency planning.
Various commenters suggested that particular provisions of the
proposed rulemaking were not consistent with CAA section 112(r) or
other relevant statutes. We address these comments in each relevant
section of the preamble and in the Response to Comments document,\19\
available in the docket for this rulemaking. Some commenters also
suggested that EPA has not complied with the requirements in CAA
section 112(r)(7)(D) for the Administrator to ``consult with the
Secretary of Labor and the Secretary of Transportation'' and
``coordinate any requirements under this paragraph with any
requirements established for comparable purposes by the Occupational
Safety and Health Administration or the Department of Transportation.''
---------------------------------------------------------------------------
\19\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
---------------------------------------------------------------------------
EPA disagrees with these comments. Under section 6 of Executive
Order 13650, ``Improving Chemical Facility Safety and Security,'' the
Executive Order Working Group, chaired by EPA, OSHA, and Department of
Homeland Security (DHS), was tasked with enhancing safety at chemical
facilities by identifying key improvements to existing risk management
practices through guidance, policies, procedures, outreach, and
regulations. As part of this task, the Working Group conducted
extensive interagency coordination, and solicited public comment on
potential options for improving chemical facility safety. EPA's
coordination efforts included discussions with numerous Federal
agencies, including OSHA and the Department of Transportation (DOT), on
potential changes to the Risk Management Program rule. As EPA explained
in the preamble to the proposed rulemaking, the OSHA PSM standard and
EPA RMP regulation are closely aligned in content, policy
interpretations, Agency guidance, and enforcement. Since the inception
of these regulations, EPA and OSHA have coordinated closely on their
implementation in order to minimize regulatory burden and avoid
conflicting requirements for regulated facilities. This coordination
has continued throughout the development of this rule and on OSHA's
initial steps toward proposing potential changes to the PSM standard.
EPA's coordination with DOT was less extensive because nothing in this
rule changes its basic applicability provisions, which apply the rule
only to stationary sources, and exclude transportation. However, EPA
continues to coordinate with DOT through ongoing Executive Order
activities, which includes updates on RMP regulatory development, and
this coordination is sufficient to meet EPA's obligations under CAA
section 112(r)(7)(D). As with OSHA, EPA has a long history of close
coordination with DOT on implementation of the RMP, particularly where
potential transportation-related issues arise, and the Agency fully
intends for such coordination to continue.
B. List of Regulated Substances
As part of its work under Executive Order 13650, the Working Group
solicited public comment on potential changes to the list of regulated
substances for the Risk Management Program, including what actions to
take to address ammonium nitrate (AN). EPA did not propose revisions to
the list of regulated substances. Instead, EPA explained the actions
other agencies in the Executive Order Working Group are considering to
address AN and indicated that EPA will coordinate any potential changes
to the list of substances in 40 CFR part 68 with the actions of these
other agencies. EPA received several comments related to revising the
list of regulated substances and whether to expand the list to include
AN.
1. Discussion of Comments on the List of Regulated Substances
A couple of commenters expressed support for expanding the scope of
regulated substances under the RMP rule. One private citizen stated
that EPA should broaden the range of chemicals covered under RMP and
account for effects on vulnerable populations including children and
the elderly. A professional organization asserted that EPA should
update the list of regulated substances and require facilities to
``evaluate the risk of a reactive chemical accident and take
appropriate measures, even if the chemicals in question are not on the
list.''
However, multiple commenters supported EPA's decision not to revise
the list of regulated substances in this action. These commenters
opposed adding toxic or flammable substances to the list of regulated
substances in a separate action. One industry commenter opposed the
addition of combustible dust to the list, arguing that it is already
regulated under OSHA and constitutes a low risk to the public.
EPA will consider these comments when determining whether to
propose revisions to the list of substances.
2. Discussion of Comments on AN
Many commenters supported regulating AN in the RMP rule. Several
commenters requested that EPA consider the danger to the public from
AN, and other reactive chemicals, in its rulemaking. A state agency
further asked EPA to ensure that calculations for the OCA consider the
unique explosive characteristics of fertilizer grade ammonium nitrate
(FGAN) and develop specific RMP guidance for regulated FGAN facilities.
One commenter supported adding AN to the list of regulated substances
but requested unique requirements for AN formulated as an explosive or
blasting agent and FGAN. Another commenter claimed that EPA failed to
address Executive Order 13650 by failing to address AN in the proposed
rulemaking.
However, EPA also received comments opposed to adding AN to the
list of regulated substances. One commenter stated that EPA didn't have
authority to regulate FGAN under the CAA and urged the Agency against
including FGAN under the RMP regulations. Another commenter supported
EPA's decision not to change current threshold quantities and toxic
endpoints.
An industry trade association requested EPA's support and
recognition of its voluntary private sector comprehensive inspection
and assessment organization and FGAN guidelines for fertilizer retail
facilities.
EPA acknowledges that there is both support and opposition to
regulating AN and will consider these comments when determining whether
to take further action on this issue. In the interim, EPA encourages
fertilizer retailers to review and use existing guidance. OSHA compiles
several resources on their Fertilizer Industry Guidance on Storage and
Use of Ammonium Nitrate Web
[[Page 4602]]
page at https://www.osha.gov/dep/fertilizer_industry/.
EPA disagrees with the commenter that indicated that EPA failed to
address Executive Order 13650 when we chose not to propose to list AN
in the list of regulated substances for the RMP regulations. In the
proposed rulemaking, EPA explained that other agencies, including OSHA
and DHS, are considering modifications to their regulations, and EPA
will coordinate any potential changes to the list of substances in 40
CFR part 68 with the actions of these other agencies.
IV. Prevention Program Requirements
A. Incident Investigation and Accident History Requirements
1. Summary of Proposed Rulemaking
a. Definitions, Sec. 68.3
EPA proposed to revise the definition of ``catastrophic release''
in Sec. 68.3 to include impact categories identical to the description
of accidental releases required to be reported under the accident
history reporting requirements in Sec. 68.42. The proposed definition,
in Sec. 68.3, would replace the phrase ``that presents imminent and
substantial endangerment to public health and the environment'' with
impacts categories including impacts that resulted in:
On-site: Deaths, injuries, or significant property damage;
or
Offsite: Known deaths, injuries, evacuations, sheltering
in place, property damage, or environmental damage.
EPA proposed to define ``root cause'' in Sec. 68.3 to mean a
fundamental, underlying, system-related reason why an incident occurred
that identifies a correctable failure(s) in management systems.
b. Incident Investigation Sections, Sec. Sec. 68.60 and 68.81
EPA proposed a number of revisions to the incident investigation
provisions. EPA proposed to revise Sec. 68.60, which is applicable to
Program 2 processes, and Sec. 68.81, which is applicable to Program 3
processes, by revising paragraph (a) to add subparagraphs (a)(1) and
(a)(2) to better clarify the scope of incidents that must be
investigated. Proposed subparagraph (a)(1) applied to an incident that
resulted in a catastrophic release and clarifies that the owner or
operator must investigate the incident even if the process involving
the regulated substance is destroyed or decommissioned. Proposed
subparagraph (a)(2) applied to a near-miss, which is an incident that
could reasonably have resulted in a catastrophic release. EPA also
proposed removing the phrase ``of a regulated substance'' from
paragraph (a) because it is duplicative. The definition of
``catastrophic release'' refers to releases of regulated substances.
EPA also proposed to add a new paragraph (c) to Sec. 68.60
requiring that an incident investigation team be established and
consist of at least one person knowledgeable in the process involved
and other persons with appropriate knowledge and experience to
thoroughly investigate and analyze the incident. This is similar to the
existing requirement in Sec. 68.81(c) for Program 3 processes. EPA
proposed that current Sec. 68.60(c) through (f) would become Sec.
68.60(d) through (g).
EPA proposed to revise the redesignated paragraph (d) in Sec.
68.60 and current paragraph (d) in Sec. 68.81 to revise the incident
investigation report requirements. EPA proposed to change the word
``summary'' to ``report'' and require facility owners or operators to
complete incident investigation reports within 12 months unless the
implementing agency approves, in writing, an extension of time.
In addition, EPA proposed to amend and add new subparagraphs in the
redesignated paragraph (d) in Sec. 68.60 and current paragraph (d) in
Sec. 68.81 requiring additional elements in an incident investigation
report. Specifically, EPA proposed to:
Revise paragraph (d)(1) to require the time and location
of the incident in the investigation report;
Revise paragraph (d)(3) to specify that the description of
the incident be in chronological order and provide all relevant facts;
Add paragraph (d)(4) to require that the investigation
report include the name and amount of the regulated substance involved
in the release or near miss and the duration of the event;
Add paragraph (d)(5) to require a description of the
consequences, if any, of the incident;
Add paragraph (d)(6) to require a description of emergency
response actions taken;
Renumber current paragraph (d)(4) to (d)(7) and require
additional criteria related to the factors contributing to the
incident, including the initiating event, direct and indirect
contributing factors, and root causes. EPA also proposed to add
language to paragraph (d)(7) to require that root causes be determined
through the use of a recognized method.
Renumber the current paragraph (d)(5) to (d)(8) and add
language to require a schedule for addressing recommendations resulting
from the investigation to be included in the investigation report.
Finally, in the redesignated Sec. 68.60(g), EPA proposed to add
the word incident before investigation and change ``summaries'' to
``reports'' for consistency.
c. Accident History, Sec. 68.42
EPA also proposed to amend the five-year accident history section
to require reporting of categories of root causes identified in the
root cause analysis proposed to be required in Sec. Sec. 68.60(d)(7)
and 68.81(d)(7).
d. Hazard Review, Sec. 68.50
For the Hazard review section, EPA proposed to amend subparagraph
(a)(2) by adding a phrase at the end to require the owner or operator
to consider findings from incident investigations.
e. Process Hazard Analysis (PHA), Sec. 68.67
In the PHA section, EPA proposed to add subparagraph (c)(2) to
require the owner or operator to address findings from incident
investigations, as well as any other potential failure scenarios (e.g.,
incidents that occurred at other similar facilities and or processes,
failure mechanisms discovered in literature or from other sources of
information).
f. Updates, Sec. 68.190
In the Updates section, EPA proposed to amend paragraph (c) to
require the owner or operator to report any accidents covered by Sec.
68.42 and conduct incident investigations required under Sec. 68.60
and/or Sec. 68.81 prior to de-registering a process or stationary
source that is no longer subject to the RMP rule.
2. Summary of Final Rule
EPA is not finalizing the proposed definition for catastrophic
release and is instead maintaining the existing definition.
Additionally, EPA is finalizing a modified version of the proposed
definition of the term ``root cause.'' In the final definition EPA
deleted the phrase ``that identifies a correctable failure(s) in
management systems.''
EPA is not finalizing the proposed revisions to the five-year
accident history section in the final rule.
EPA is finalizing the following provisions as proposed:
Hazard review section, Sec. 68.50;
Incident investigation section Sec. Sec. 68.60 and 68.81;
Process hazard analysis (PHA) section, Sec. 68.67, to add
subparagraph (c)(2).
[[Page 4603]]
Updates section, Sec. 68.190.
3. Discussion of Comments and Basis for Final Rule Provisions
EPA's rationale for modifying the accident investigation provisions
to explicitly require root cause analysis for investigations of
catastrophic releases and near miss events and to have the findings of
these investigations integrated into the PHA remains generally the same
as in the proposed rulemaking. In the discussion that follows and in
the Response to Comment document, we explain the modifications to our
approach and the basis for these modifications.\20\ The most
significant change in approach is to retain the catastrophic release
definition. As became apparent in the comments, our view that having a
common definition of reportable accidental release and catastrophic
release would simplify and clarify compliance was outweighed by the
potential burden of inadvertently expanding the number of investigated
accidental releases. We continue to require investigations of near
misses, but have provided additional guidance as to what we intend by
the term. Other changes from the proposal are similarly intended to
clarify terms used in the rule. Identification of root cause categories
in accident history reporting has been eliminated because identifying
root cause categories only provides limited information for
understanding the root cause which is best attained by reviewing the
complete incident investigation report. Implementing agencies and/or
local emergency planners may still obtain the investigation report
through direct contact with the facility. The changes we adopt in this
final rule strike a balance between ensuring facilities and planners
learn about the causes of catastrophic releases and near misses while
also better targeting the reporting to minimize burden.
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\20\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
---------------------------------------------------------------------------
a. Definitions
Catastrophic release. Although EPA received some support for the
proposed definition of ``catastrophic release,'' many commenters were
opposed to the revision. Many commenters, including government
agencies, industry trade associations, and facilities, argued that
EPA's proposed definition of ``catastrophic release'' (1) expands its
scope, rather than clarifying it, (2) is redundant of OSHA's authority
to regulate workplace safety by including on-site damage or injuries,
and (3) exceeds the CAA authority to regulate only ambient air beyond a
facility's property.
EPA also received some comments identifying other concerns with the
proposed change to the definition of ``catastrophic release.'' Some
commenters, including a few facilities, said that the proposed
definition is too vague, and some commenters noted that terms such as
``injuries,'' ``significant property damage,'' ``environmental
damage,'' and ``major'' are not defined. A facility and a private
citizen commented that the wording of the definition implies that a
``catastrophic release'' could include a fire, regardless of whether an
actual release of regulated material occurs due to the fire, and also
implies that releases involving on-site environmental damage would not
be considered catastrophic.
Many commenters, including a state government agency, facilities,
and industry trade associations, argued that EPA's proposed definition
of ``catastrophic release'' would regulate workplace safety concerns
that are outside EPA's authority to regulate under the CAA. Commenters
asserted that EPA has authority to address through regulation and
enforcement offsite impacts of facility releases, not on-site impacts.
A facility asserted that the proposed definition inappropriately
expands the scope of EPA's reach into workplace safety by requiring
investigations of releases that would also include impacts to on-site
workers or property. An industry trade association stated that the
definition ignores Congress's express prohibition against EPA
``exercising statutory authority to prescribe or enforce standards or
regulations affecting occupational safety and health.'' This commenter
further argued that on-site injuries should be excluded from the
proposed definition because OSHA already has jurisdiction in this area
and because these often do not pose any risk to public health or the
environment.
A facility stated that the proposed revision directly contradicts
EPA's long-held interpretation that the references in section
112(r)(2)(A) to ``ambient'' air limit the Agency's authority to
activities with offsite consequences. The commenter asserted that in
the proposed rulemaking the EPA does not acknowledge the contradiction
from its previous position or explain what new statutory authority
exists or why it now has the authority to regulate workplace incidents.
Due to the large number of comments opposing the proposed revision
to the definition of ``catastrophic release,'' EPA has decided not to
finalize the proposed language. EPA believed that providing a
consistent trigger for accident investigations and reportable accidents
under the accident history requirements of Sec. 68.42 would simplify
compliance for the regulated community. EPA acknowledges that the
proposed revision may have inadvertently expanded the definition and
therefore the type of accident that could trigger an investigation.
Some reportable incidents under the accident history provision may not
pose an imminent and substantial threat to public health and the
environment (see 40 CFR 68.3 (Catastrophic release)). Due to EPA's
decision to retain the existing ``catastrophic release'' definition and
not go forward with the proposed revision, the authority issues raised
in comments are moot. However, contrary to one commenter's claim, it
has never been EPA's position that the references in section 112(r) to
``ambient'' air limit the Agency's authority to regulate only
activities with offsite consequences. On the contrary, it has been the
Agency's longstanding position that incidents that primarily or even
exclusively impact on-site receptors are potentially relevant to
protection of the public and the environment from the risks of an
accidental release. As EPA explained in the Response to Comments
document for the original RMP rule, certain on-site accident impacts
are relevant because they ``may reflect safety practices at the
source'' and because ``accidental releases from covered processes which
resulted in deaths, injuries, or significant property damage on-site,
involve failures of sufficient magnitude that they have the potential
to affect offsite areas.'' \21\
---------------------------------------------------------------------------
\21\ EPA, Risk Management Plan Rule: Summary and Response to
Comments, Excerpt from Volume 1: Table of Contents, Introduction,
and Sections 3, 16 and 17. May 24, 1996, pp 3-11 and 17-4. Document
No. EPA-HQ-OEM-2015-0725-0153, https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0153.
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For similar reasons, requiring investigation of accidents with on-
site impacts is not redundant to OSHA's authority when such accidents
have the potential to affect offsite areas.
Root cause. Many commenters opposed the proposed definition of
``root cause.'' These commenters, which included industry trade
associations, facilities, and a private citizen, said that EPA should
revise the definition of ``root cause'' to remove ``system-related''
and ``management system,'' reasoning that not all incidents are due to
system failures. One commenter also stated that the definition assumes
that there is only
[[Page 4604]]
one root cause and that the failure is correctable, when there can be
many causes and the investigators may not be able to determine what is
``correctable.'' An association of government agencies agreed that the
investigation should identify all root causes of failure, regardless of
whether they are deemed correctable or related to the management
system. An industry trade association stated that EPA should not define
``root cause'' and instead should defer to facilities to rely on
standard definitions from independent safety organizations. Another
industry trade association also argued that EPA does not need to define
``root cause'' because current incident investigator requirements,
which call for the investigator to uncover ``the factors that
contributed to the incident,'' are sufficient. Other industry trade
associations commented that it is very misleading and may lead to
incorrect enforcement proceedings to require a facility to identify a
management system failure as a root cause of incidents whose true root
cause is a design deficiency, equipment failure, or misuse of
equipment.
EPA agrees with some of the comments, and is finalizing the
proposed definition of ``root cause'' with modifications. EPA deleted
the language regarding identifying correctable failure(s) in management
systems. In response to the comment that the definition assumes that
there is only one root cause, EPA agrees that there are often multiple
root causes. The final rule defines ``root cause'' in the singular, but
does not preclude the possibility of more than one root cause. EPA
agrees with the comments that support investigations identifying all
root causes, and the Agency notes that the root cause requirements in
the final rule require the owner or operator to identify ``root
causes.''
b. Accident History Reporting
Some government agencies, an industry trade association, and a
professional association agreed that the RMP accident history should
include the root causes of incidents. However, other commenters,
including industry trade associations and a facility, stated that the
existing reporting requirements in Sec. 68.42 are sufficient, and that
requiring root cause reporting in the five-year accident history is an
additional burden that is not offset by improved performance.
Although EPA believes there could be some benefit to identifying
root cause categories within a facility's accident history, in most
cases, the Agency believes the incident investigation report must be
reviewed in order to fully understand root causes attributed to that
incident. Implementing agency officials can obtain investigation
reports during inspections or by using the Agency's information
gathering authorities when needed. Therefore, EPA did not finalize the
proposed requirement.
c. Changes to Hazard Review (Sec. 68.50) and Process Hazard Analysis
(PHA) (Sec. 68.67) Requirements
Hazard review and PHA. Some commenters, including several
government agencies, a professional organization, and an industry trade
association, supported the requirement to include incident
investigation findings in the hazard review. Other commenters opposed
the requirement. Some of these commenters stated that the OSHA PSM
standard already requires PHAs to address previous incidents, and EPA's
changes are therefore unnecessary. One industry trade association
commented that, as written, the proposal would require facilities to
include all findings from all investigations for the facility's entire
history.
Another commenter argued that incident investigation findings
should not be required for PHAs because PHA teams typically use
established techniques and requiring the ``findings from incident
investigations'' to be included would not be a good fit for these types
of assessments.
EPA disagrees with commenters and is finalizing these requirements
as proposed, so that findings from incident investigations are
considered when hazard reviews are conducted. EPA notes that the basic
purpose of a hazard review is to identify what process equipment
malfunctions or human errors could potentially lead to accidental
releases, and then to identify what safeguards are needed in order to
prevent such malfunctions and errors from occurring. An obvious source
of information about such malfunctions and errors is information gained
from investigating incidents that have previously occurred within the
covered process. For this reason, the Program 3 analog to the hazard
review, the PHA, already requires the owner or operator to identify any
previous incidents that had a likely potential for catastrophic
consequences when conducting the PHA.
EPA therefore not only disagrees with the commenter who stated that
including findings from incident investigations within the PHA ``would
not be a good fit'' for the PHA (as the existing rule already contains
this requirement), but also believes that this requirement should be
incorporated into the hazard review. EPA also disagrees that widely-
used PHA (or hazard review) techniques preclude consideration of prior
incidents--all PHA and hazard review techniques that EPA is aware of
are easily adapted to allow consideration of prior incident scenarios.
The commenter provided the example of the Hazard and Operability Study
(HAZOP) PHA technique as an example of a technique for PHAs that is
widely accepted but does not consider prior incidents. EPA disagrees
that the HAZOP may not be adapted to consider prior incident causes. In
fact, this PHA technique, which EPA acknowledges is widely used, is
specifically intended to identify process deviations that can lead to
undesirable consequences, as well as the causes and consequences of
such deviations, and safeguards necessary to protect against the
deviation from occurring. Incident scenarios are a key source of
knowledge for conducting this technique. According to the Center for
Chemical Process Safety (CCPS) ``Guidelines for Hazard Evaluation
Procedures--Second Edition with Worked Examples'' (AIChE/CCPS, 1992, pp
143) ``the knowledge-based HAZOP Analysis study can help ensure that
the company's practices, and therefore its experience, have indeed been
incorporated in the design.'' The CCPS Guidelines also provide a
specific example of how incident information can be incorporated into
the HAZOP:
As a more specific example, consider the discharge from a
centrifugal pump. The guide-word HAZOP approach would apply the
guide word ``Reverse'' to identify the need for a check valve. The
knowledge-based HAZOP approach might also identify the need for a
check valve because an actual problem was experienced with reverse
flow . . . [emphasis added].
In response to the comment regarding the requirements of OSHA PSM, EPA
notes that this final rule requirement is applicable to Program 2
covered processes, which are not subject to the OSHA PSM standard.
Other potential failure scenarios. Some commenters opposed
including ``other potential failure scenarios'' in the process hazards
analysis (PHA). A state agency and an industry trade association stated
that it is unclear what ``any other potential failure scenarios''
means. The state agency also said that facilities may not have access
to or knowledge of issues at similar facilities. A facility said that
EPA should provide a clearinghouse of ``potential failure scenarios''
so that facilities will have access to them. An industry trade
association commented that a literature
[[Page 4605]]
review would not provide much information and would be costly to
conduct.
In response, as stated in the preamble to the proposed rulemaking,
other potential failure scenarios can include incidents that occurred
at other similar facilities and or processes, failure mechanisms
discovered in literature, or from other sources of information. EPA
believes that it is appropriate to research information about other
potential scenarios and consider these scenarios when conducting a
(PHA). Regarding the comment to provide a clearinghouse of scenarios,
given the variety of processes and stationary sources, and ongoing
changes to technologies, it would be difficult to establish a one-stop
resource that would identify all potential failure scenarios for all
processes covered under the rule. However, EPA believes that owners and
operators are in the best position to obtain incident information
relevant to their own covered processes. In most cases, industry trade
associations will be a useful source for this information. Such
information is also commonly available in trade journals, at industry
conferences, in industry newsletters, in the Chemical Safety Board's
accident investigation reports, in reference publications (e.g., Lees'
Loss Prevention in the Process Industries \22\), and through other
professional networks. EPA therefore believes that information about
other potential failure scenarios that are potentially relevant to a
covered process should not be costly for the owner or operator to
conduct and will benefit both the regulated stationary sources and its
surrounding community.
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\22\ Lees, Frank P. 2012. Loss Prevention in the Process
Industries, Fourth Edition. Butterworth-Heinemann. https://www.sciencedirect.com/science/book/9780123971890.
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Regarding the comment that this provision will require the owner or
operator to review findings from all incident investigations for the
facility's entire history--EPA agrees that the owner or operator should
review all available incident information, but notes that the rule does
not require the owner or operator to retain incident investigation
reports for more than five years. However, if the owner or operator has
access to incident information beyond that period, they should
incorporate it into their hazard review as appropriate.
d. Destroyed or Decommissioned Processes
EPA received various comments regarding the proposed rulemaking's
requirement for investigation of incidents that resulted in destruction
or decommissioning of a process. Several commenters, including local
agencies, facilities, an advocacy group, and an association of
government agencies, expressed support for the requirement that an
incident investigation with a root cause analysis be performed for
incidents involving processes units that were destroyed or will be
decommissioned. A local agency and a facility explained that this
information could improve safety for other processes at the same
facility or at other facilities.
EPA also received comments opposing incident investigations for
destroyed or decommissioned processes. A facility and industry trade
associations commented that there is no benefit to requiring
investigations in cases where a process is decommissioned or destroyed.
EPA also received comments in opposition to registration
requirements for decommissioned processes. A facility and an industry
trade association said that there is no incremental safety benefit to
requiring a destroyed or decommissioned unit to remain registered under
RMP until after the incident investigation is complete. The commenters
argued that this requirement imposes additional paperwork burdens
without any additional safety benefit.
EPA is finalizing this requirement as proposed. The Agency agrees
with the commenters who support this requirement because it will ensure
that when incidents occur, particularly incidents so severe that the
owner or operator elects to decommission the process involved or where
the process is destroyed in the incident, lessons are learned as a
result, both for the benefit of the owner/operator, and potentially for
other stationary sources with similar processes.
In response to the comments opposed to the registration
requirements for decommissioned processes, EPA believes that the
additional paperwork burden regarding such requirements is minimal, as
the processes would have already been registered in the source's most
recent RMP. New accident history information may be added to the RMP
without performing a full update. Following that correction, if the
affected process has been decommissioned or destroyed, and if the
source has multiple covered processes, the owner or operator would
update their RMP to reflect the loss of the affected process (this
would be required whether or not the incident was investigated). If the
affected process was the only process at the source, after completing
the investigation and correcting the existing RMP, the owner or
operator would submit a deregistration notice for the source to EPA.
Deregistration is already required by Sec. 68.190(c) when a source is
no longer subject to Part 68. Therefore, from a paperwork standpoint,
the primary effect of this change would be the timing of when
deregistration occurs. EPA believes the potential benefits of the
knowledge gained from the incident investigation warrant this delay in
deregistering a source.
e. Near Misses
In the proposed rulemaking, EPA did not propose a definition for
the term ``near miss,'' although EPA did include the term in proposed
revisions to Sec. Sec. 68.60 and 68.81, paragraph (a)(2), in the
phrase: ``Could reasonably have resulted in a catastrophic release
(i.e., was a near miss).'' EPA also sought public comment on whether to
include a formal definition for the term. EPA received comments both
supporting and opposing a definition of ``near miss.''
Requests to define ``near miss.'' Several commenters, including
government agencies, industry trade associations, facilities, and an
advocacy group, recommended defining ``near miss'' to reduce vagueness,
uncertainty around which incidents require investigation, and the
reliance on owners and operators to define the term. A local agency and
an industry trade association suggested providing examples of near
misses in guidance. A local agency said that EPA should clarify whether
a release is considered a ``near miss'' if it was a controlled release.
Other commenters, including a state agency and an industry trade
association, opposed a regulatory definition of the term, stating that
facilities should be permitted to determine what qualifies as a ``near
miss'' that requires investigation. A state agency also said that EPA
should not define ``near miss'' because it would be challenging to
provide a definition that is suitable for all industry sectors. An
industry trade association stated that the rule raises constitutional
due process concerns because the rule lacks specificity to define the
``near miss'' standard and fails to provide adequate notice to the
regulated community as to what the RMP rule will require.
EPA is finalizing the language in paragraph (a)(2) of Sec. Sec.
68.60 and 68.81 as proposed, and has elected not to finalize a
regulatory definition of ``near miss'' to identify incidents that
require investigation. The criteria for determining incidents that
require investigation will continue to include events that ``could
reasonably have resulted in a catastrophic release.''
[[Page 4606]]
Under the final rule, this criterion, rather than a definition of
``near miss,'' applies to determine which incidents require
investigation. However, the rule makes clear that a ``near miss'' is an
example of an event that ``could reasonably have resulted in a
catastrophic release.'' EPA agrees with commenters who said it would be
difficult to address in a single definition the various types of
incidents that may occur in RMP-regulated sectors that should be
considered near misses, and therefore be investigated. Instead,
facility owners or operators will need to decide which incidents
``could reasonably have resulted in a catastrophic release.'' This may
be based on the seriousness of the incident, the process(es) involved,
and the specific conditions and circumstances involved. In the 1996
Response to Comments on the original rule, EPA acknowledged that the
range of incidents that reasonably could have resulted in a
catastrophic release is very broad and cannot be specifically
defined.\23\ EPA decided to leave it up to the owner or operator to
determine whether an incident could reasonably have resulted in a
catastrophic release and to investigate such incidents.
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\23\ [thinsp]EPA. May 24, 1996. Risk Management Plan Rule,
Summary and Response to Comments. Volume 1, p. 16-4. Docket No. A-
91-73, Document No. IX-C-1.
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EPA understands from the comments that there was some uncertainty
about the term near miss. EPA's experiences with RMP facility
inspections and incident investigations show there have been incidents
that were not investigated, even though under slightly different
circumstances, the incident could have resulted in a catastrophic
release. While most of these events did not result in deaths, injuries,
adverse health or environmental effects, or sheltering-in-place, the
Agency believes that in some cases, if circumstances had been slightly
different, a catastrophic release could reasonably have occurred.
As described in the preamble to the proposed rulemaking, and as
noted by one commenter, there is a CCPS definition of ``near miss.''
CCPS defines a ``near miss'' as an event in which an accident causing
injury, death, property damage, or environmental impact, could have
plausibly resulted if circumstances had been slightly different.
For example, a runaway reaction that is brought under control by
operators is a near miss that may need to be investigated to determine
why the problem occurred, even if it does not directly involve a
covered process both because it may have led to a release from a nearby
covered process or because it may indicate a safety management failure
that applies to a covered process at the facility. Similarly, fires and
explosions near or within a covered process, any unanticipated release
of a regulated substance, and some process upsets could potentially
lead to a catastrophic release.
CCPS's ``Process Safety Leading and Lagging Metrics--You Don't
Improve What You Don't Measure'' explains that a near miss has three
essential elements.\24\ These include:
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\24\ CCPS. January 2011. Process Safety Leading and Lagging
Metrics--You Don't Improve What You Don't Measure, p. 36. CCPS,
American Institute of Chemical Engineers, New York, NY. John Wiley
and Sons. https://www.aiche.org/sites/default/files/docs/pages/CCPS_ProcessSafety_Lagging_2011_2-24.pdf.
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An event occurs, or a potentially unsafe situation is
discovered;
The event or unsafe situation had reasonable potential to
escalate; and
The potential escalation would have led to adverse
impacts.
The CCPS document and the CCPS ``Guidelines for Investigating
Chemical Process Incidents'' contain many examples of near misses,
which can be an actual event or discovery of a potentially unsafe
situation.\25\ Examples of incidents that should be investigated
include some process upsets, such as: excursions of process parameters
beyond pre-established critical control limits; activation of layers of
protection such as relief valves, interlocks, rupture discs, blowdown
systems, halon systems, vapor release alarms, and fixed vapor spray
systems; and activation of emergency shutdowns.
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\25\ CCPS. March 2003. Guidelines for Investigating Chemical
Process Incidents, 2nd ed., p. 68.
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Near misses should also include any incidents at nearby processes
or equipment outside of a regulated process if the incident had the
potential to cause a catastrophic release from a nearby regulated
process. An example would be a transformer explosion that could have
impacted nearby regulated process equipment causing it to lose
containment of a regulated substance. Near misses could also include
process upsets such as activation of relief valves, interlocks,
blowdown systems, or rupture disks.
The intent is not to include every minor incident or leak, but
focus on serious incidents that could reasonably have resulted in a
catastrophic release, although EPA acknowledges this will require
subjective judgment. EPA will update existing RMP guidance to reflect
the revised RMP requirements and will provide guidance to identify what
types of incidents could be considered near misses.
The concept of ``near miss'' has a meaning in industry and in the
chemical engineering profession. In this preamble and in guidance, EPA
has explained the concept and has identified sources that explain the
term, and EPA believes that this satisfies any due process concerns
raised by commenters related to the definition of this term. These
sources put the regulated community on notice of EPA's expectations
under the rule and thus also address the due process concerns raised by
commenters regarding notice to the regulated community as to what the
RMP rule will require. EPA expects that by expanding the root cause
analysis requirement to near misses that could have resulted in a
catastrophic incident, some stationary sources will be able to take
corrective actions before another similar, but catastrophic incident
occurs in the future. For example, as discussed in the March 14, 2016
RMP proposed rulemaking (81 FR 13637), incidents at Tosco Refinery,
Georgia Pacific, Shell Olefins, Morton International, BP Texas City
Refinery and Millard Refrigerated Services all involved near-misses or
less serious incidents involving the same cause as the later
catastrophic release.
Industry suggestions for clarifying near misses. A few industry
trade associations commented that the examples of near misses that EPA
provided in the NPRM, such as excursions of process parameters and
activation of protections devices such as relief valves, should not be
considered ``near misses.'' The commenters said that many of these
examples are safeguards that are designed to be used to prevent
catastrophic releases. An industry trade association also proposed a
definition of ``near miss'' that would be limited only to scenarios
where the final safeguard or layer of protection is activated, such
that a release would have occurred if not for that control.
In response to these comments, EPA agrees that not all excursions
of process parameters outside control levels or all instances of
protective device activation should necessarily be considered to be
near misses. EPA expects that activation of protective devices should
be investigated when the failure of such devices could have reasonably
resulted in a catastrophic release. However, EPA does not agree that
near miss investigations should only include situations that resulted
in activation of a final safeguard or layer of protection. This may be
appropriate in some cases, but in others, multiple layers of protection
may quickly fail. EPA
[[Page 4607]]
believes that owners and operators must use reasonable judgement to
decide which incidents, if they had occurred under slightly different
circumstances, could reasonably have resulted in a catastrophic
release, and investigate those incidents.
f. Investigation Timeframe
EPA received many comments in support of a shorter investigation
timeframe. Many commenters, including a local agency and a professional
association, stated that 12 months is too long to complete most
investigations, and some commenters said that the timeframe should be
shortened to five or six months. Some commenters also stated there
should be a shorter timeframe, but with the ability to request an
extension.
Other commenters, including state and local agencies and industry
trade associations, said that EPA should allow for 12 months to
complete an investigation and also allow extensions for especially
large or complex incidents. Some commenters also recommended requiring
interim reports. An industry trade association asked EPA to clarify
that the 12-month period is only for completing the investigation
report, not for implementing the recommendations in the report.
Other commenters, including facilities and industry trade
associations, said that EPA should not impose any deadline for
completing incident investigations. A few commenters, including a
facility and industry trade associations, commented that an arbitrary
deadline does not account for the complexity of the incident, the types
of process units involved, or the need to retain outside consultants or
experts to complete the investigation.
After considering these comments, EPA has decided to finalize the
requirement to complete incident investigations within twelve months as
proposed. EPA believes that this timeframe will provide a reasonable
amount of time to conduct most investigations, while also ensuring that
investigation findings are available relatively quickly in order to
assist in preventing future incidents. For very complex incident
investigations that cannot be completed within 12 months, EPA is
allowing an extension of time if the implementing agency approves such
an extension, in writing. EPA encourages owners and operators to
complete incident investigations as soon as practicable, and believes
that 12 months is typically long enough to complete even complex
incident investigations. However, EPA provided flexibility for
facilities to request more time to complete investigations when they
consult with their implementing agency and receive written approval for
an extension.
g. Incident Investigation Team
Some commenters, including a Federal agency, local government
agencies, an association of government agencies, and an industry trade
association, supported the proposed requirements under Sec. 68.60(c)
for the owner or operator of a Program 2 process to establish an
incident investigation team consisting of at least one person
knowledgeable in the process involved and other persons with
appropriate knowledge and experience to thoroughly investigate and
analyze the incident. Other commenters opposed these requirements. A
facility commented that the incident investigation team requirements
are unnecessary because they are already covered by the OSHA PSM
standard. A private citizen commented that the requirement assumes that
all investigations will be conducted by a team, when it is possible for
a competent individual to perform all aspects of the investigation if
given access and support by the facility owner or operator. The
commenter also stated that although the proposed rulemaking provides
significant information on who may perform a third-party audit, it does
not specify the qualifications of persons who may perform
investigations and certify investigation reports.
EPA is finalizing the Program 2 incident investigation
requirements, as proposed. The Agency agrees with the commenters who
support requiring at least one person on the investigation team to be
knowledgeable in the process involved and other persons with
appropriate knowledge and experience in incident investigation
techniques, as EPA believes these provisions are necessary to ensure
that facilities thoroughly investigate and analyze incidents and their
root causes.
EPA disagrees that these incident investigation team requirements
are already covered by the OSHA PSM standard. The requirements for
Program 3 processes in the current rule already include a provision for
incident investigation teams; however, the incident investigation team
requirements in this rule apply to Program 2 processes, which by
definition are not covered by the OSHA PSM standard. EPA agrees that
the requirement assumes that all investigations will be conducted by a
team. EPA believes that all incident investigations, whether conducted
on Program 2 or Program 3 processes, should involve a team of at least
two people, particularly given the requirement under the final rule for
investigations to include analysis of root causes. However, beyond the
requirements specified in the final rule (i.e., to establish an
investigation team consisting of at least one person knowledgeable in
the process involved and other persons with appropriate knowledge and
experience to thoroughly investigate and analyze the incident), the
Agency does not believe it is necessary to specify additional
qualification criteria for incident investigation team members.
h. Root Causes
Support for root cause requirements. Many commenters, including
government agencies, advocacy groups, a facility, and others, expressed
support for the requirements to determine root causes through the use
of a recognized method and to include information on root causes in
investigation reports. The commenters supported these provisions as a
way to prevent future incidents. Most of these commenters also
expressed support for applying the root cause analysis requirement to
both catastrophic release incidents and to incidents that could
reasonably have resulted in a catastrophic release (i.e. near misses).
These commenters stated that conducting root cause analysis on near
misses would allow the owner or operator to identify and make
corrective actions before a catastrophic incident occurs. Some
commenters also supported EPA's proposal to allow the use of any
recognized method to complete a root cause analysis.
EPA agrees with these comments and believes that requiring root
cause analyses for catastrophic releases and near misses, and including
root cause information in incident investigation reports is vital for
understanding the nature of these events. EPA is finalizing, as
proposed, the requirements that root causes must be determined through
the use of a recognized method and that information on root causes must
be included in investigation reports. As previously noted, however, the
final rule includes a modified version of the proposed definition of
the term ``root cause.'' The phrase ``that identifies a correctable
failure(s) in management systems'' from the proposed definition has
been deleted.
Opposition for root cause requirements. EPA also received many
comments opposing the proposed root cause analysis requirements. Some
commenters, including industry trade associations and Federal agencies,
said
[[Page 4608]]
that requiring the owner or operator to conduct a root cause analysis
versus other investigation methods is unnecessary. Some of these
commenters also argued that root cause analysis assumes that there is
an underlying management or system-related cause behind every incident,
which may not be the case and which EPA has failed to prove. An
industry trade association and a facility stated that EPA should not
require facilities to select from a predetermined list of root causes
so as to avoid forcing them to fit their findings into a category that
may not be appropriate.
Regarding these comments, EPA agrees that root cause analysis may
result in identifying causes that are not always an underlying
management or system-related cause, but still believes that the
analysis is necessary to understand why the accident occurred so that
the causes can be addressed. Therefore, we have modified the definition
of ``root cause'' to remove the phrase ``that typically identifies a
correctable failure(s) in management systems'' in order to remove the
implication that all incidents involve correctable management system
failures. EPA also notes that the final rule does not require
facilities to select from a predetermined list of root causes or force
them to fit their findings into an inappropriate category.
Many commenters argued that EPA should not require root cause
analyses for near misses. A Federal agency, industry trade
associations, and some facilities stated that EPA should not require
root cause analyses for near misses because the requirement would
increase compliance burdens and costs on facilities and take attention
away from other safety activities. A few industry trade associations
also argued that the quality of safety reviews will be diluted by
applying the requirement to low-consequence, high-frequency events. One
industry trade association stated that requiring a root cause analysis
for near misses creates a false equivalency between near misses and
actual catastrophic releases.
While EPA acknowledges that requiring root cause analyses for near
misses may impose some additional burden on facilities, the Agency
disagrees that the burden is unwarranted or that it will take attention
away from other safety activities. The Agency notes that catastrophic
release near miss events are infrequent events, and therefore do not
typically divert attention from other safety activities. However, EPA
believes that investigation of such incidents, when they occur, should
be a high priority safety activity for regulated stationary sources,
because these investigations can lead to the correction of problems
which could ultimately prevent much more serious and costly
catastrophic release incidents.
EPA also disagrees that the final rule applies the root cause
investigation requirement to low-consequence, high-frequency events.
The final rule requires root cause investigations only for incidents
that resulted in, or could reasonably have resulted in, a catastrophic
release. Such incidents are unusual. Based on accident history
information reported to EPA, most regulated sources have never
experienced a catastrophic release incident, and the Agency also
believes that near misses will also be relatively rare events. The
final rule does not presume any ``equivalency'' between near misses and
actual catastrophic releases. The Agency notes that actual catastrophic
releases may be more difficult to investigate if the incident requires
extensive cleanup, damage assessment, evidence collection, etc.--
activities that are unlikely to be necessary for near miss events.
However, lessons learned from catastrophic releases and near misses
should both benefit the source and its surrounding community, whether
or not such events are viewed as equivalent.
Root cause requirements for Program 2 facilities. Some commenters
opposed requiring root cause analyses for Program 2 processes. An
industry trade association said that since most incidents happen at
facilities with Program 3 facilities, it is unnecessary to expand this
requirement to Program 2 facilities. Another industry trade association
said root cause analyses should only be required at Program 3
facilities because the methodology is most appropriate for complex
incidents.
While it is true that most RMP-reportable incidents occur at
Program 3 processes, EPA decided that there was little justification
for limiting the root cause requirements to only Program 3 processes,
because some serious accidents also occur at Program 2 processes. Also,
the Agency notes that some of the accidents at Program 2 processes
occur at publicly owned water and wastewater treatment facilities that
are not in Program 3 only because they are not located in a state with
an OSHA-approved State Plan. Unlike state and local government
employees at facilities in states with OSHA-approved State Plans, state
and local government employees at facilities in states under Federal
OSHA authority are not covered by the OSHA PSM standard. This results
in regulated processes at these sources being placed in Program 2, even
though the processes generally pose the same risk as similar processes
at publicly owned water or wastewater treatment processes that are
located at sources in OSHA State Plan states.
Incident investigation methodology. One commenter argued that EPA
does not have authority to specify a specific incident investigation
and analysis methodology and should remove all references to or
requirement for any named investigation or analysis method from its
proposed rulemakings. The commenter cited various provisions of the CAA
and the language within the Memorandum of Understanding between CSB and
EPA and asserted that CSB is the lead entity for accident
investigations and has the authority to specify a named investigation
method. Other commenters, including a state agency and facilities, said
that EPA has not provided examples of how to determine what is a
recognized method or which consensus bodies are to be used to determine
recognized methods.
EPA disagrees with these comments. While the final rule does not
require use of a specific incident investigation or analysis method
(the final rule allows the owner or operator to determine root causes
using ``a recognized method''), nothing in the CAA precludes EPA from
requiring sources to conduct incident investigations. Contrary to the
commenter's suggestion, the legislative history specifically
contemplates EPA requiring accident investigations (see Senate Report
at 242-43 \26\). The Agency notes that the existing RMP rule already
contains such a requirement applicable to Program 2 and Program 3
processes. Like other risk management provisions, CAA section
112(r)(7)(B)(i) requires investigation requirements to be reasonable,
but nothing in the statute otherwise limits EPA from requiring the
investigation to address the issue of the underlying root cause of the
accident.
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\26\ Senate Committee on Environment and Public Works, Clean Air
Act Amendments of 1989, Senate Report No. 228, 101st Congress, 1st
Session (1989)--``Senate Report''.
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Nothing in this final rule interferes with the ability of the CSB
to conduct its accident investigations. The incident investigation
provision we adopt is designed to have the facility learn from its
accidents and near misses in order to identify ways to improve the
facility's prevention program. The root cause investigations in this
rule serve a distinct purpose from the oversight purposes of the CSB.
EPA also disagrees that we should specify recognized investigation
methods or point to specific governing
[[Page 4609]]
bodies for such methods. Investigation methods evolve over time, and
new methods may be developed, so any list promulgated by EPA in this
rule may soon be obsolete. The Agency took a similar approach in the
PHA requirements for the existing rule, where it listed several
potential methods, but also included the option to use an appropriate
equivalent methodology. EPA recommends that owners and operators
consult available literature on root cause investigation. For example,
CCPS has published Guidelines for Investigating Chemical Process
Incidents, which provides extensive guidance on incident
investigations, near miss identification, root cause analysis, and
other related topics.\27\
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\27\ CCPS 2003. Center for Chemical Process Safety, Guidelines
for Investigating Chemical Process Incidents, 2nd Edition, NY:
AIChE.
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i. Other Incident Investigation Report Requirements
A few commenters, including a Federal agency, expressed support for
the proposal to require additional information to be included in
incident investigation reports. Several other commenters expressed
opposition to various proposed incident investigation report
requirements. A facility said that EPA's proposed changes are
unnecessary because each of the proposed items is already required
under the OSHA PSM standard. Some industry trade associations opposed
requiring facilities to include the results of the root cause analysis
in the incident investigation report, saying this could increase the
likelihood of lawsuits against the facility if those reports are made
public, or could result in the release of confidential business
information.
EPA believes that providing the additional required information is
vital for understanding the nature of the incident and should be
included in the incident investigation report. Some facility owners or
operators may already voluntarily include root cause information and
other elements required under this rule (e.g., time and location of
incident, name and amount of substance involved in the release, etc.)
in incident investigation reports prepared to comply with the RMP rule.
However, Sec. Sec. 68.60 and 68.81 are being revised to require this
information to ensure clarity and consistency among reports. While the
OSHA PSM standard contains the same incident investigation reporting
requirements as the existing RMP rule for Program 3 processes, prior to
this rule, neither regulation required reporting of root cause
information nor the other report elements required in this rule. EPA
disagrees with the conjecture that there may be an increased
possibility of lawsuits is a good reason not to include root causes and
other factual incident information in incident investigation reports.
We note that the current rule requires a report that discusses factors
contributing to the incident and recommendations resulting from the
investigation, so to the extent that litigants would seek to use
reports to establish cause or preventability of an incident, the
litigation risk is there already. To the extent that the root cause
discussion contains CBI, the existing rule provides methods for
asserting CBI claims. Identifying root causes can prevent future
incidents, thereby reducing accidental release impacts.
B. Third-Party Audits
EPA proposed to require owners or operators of certain RMP
facilities to perform third-party audits, in order to prevent accidents
and ensure compliance with part 68 requirements. The third-party audits
are similar to the compliance audits already required by Sec. Sec.
68.58 and 68.79, but EPA expects that independent compliance audits
will assist stationary sources to come fully into compliance with the
applicable prevention program requirements. The details of these
requirements are described further.
1. Summary of Proposed Rulemaking
a. Definitions
EPA proposed to define ``third-party audit'' in Sec. 68.3 as a
compliance audit conducted pursuant to the requirements of Sec. 68.59
and/or Sec. 68.80, by an entity (individual or firm) meeting the
competency, independence and impartiality criteria in those sections.
b. Compliance Audit Requirements Under Sec. Sec. 68.58 and 68.79
EPA proposed changes to Sec. Sec. 68.58 and 68.79 to require
third-party compliance audits for both Program 2 and Program 3
processes, under certain conditions and to clarify existing
requirements for compliance audits. EPA proposed to edit Sec. Sec.
68.58(a) and 68.79(a) to add the language ``for each covered process''
to clarify that all compliance audits, self and third-party, shall
address compliance with the provisions of Subpart C or D for each
covered process. EPA also added a sentence at the end of the paragraph
to reference when a compliance audit must be a third-party audit.
EPA also proposed to add paragraphs (f) through (h) in Sec. Sec.
68.58 and 68.79. Paragraph (f) identified third-party audit
applicability. EPA proposed that the next required compliance audit for
an RMP facility would be a third-party audit when one of the following
conditions apply:
An accidental release, meeting the criteria in Sec.
68.42(a), from a covered process has occurred; or
An implementing agency requires a third-party audit based
on noncompliance with the requirements of this subpart, including when
a previous third-party audit failed to meet the competency,
independence, or impartiality criteria of Sec. 68.59(b) or Sec.
68.80(b).
Proposed paragraph (g) described the procedure when an implementing
agency requires a third-party audit and proposed an internal appeals
process. EPA proposed to require an implementing agency to provide
written notice to the facility owner or operator stating the reasons
for the implementing agency's preliminary determination that a third-
party audit is necessary. The owner or operator would have an
opportunity to respond by providing information to, and consulting
with, the implementing agency. The implementing agency would then
provide a final determination to the owner or operator. If the final
determination requires a third-party audit, the owner or operator would
have an opportunity to appeal the final determination. EPA proposed
that the implementing agency would provide a written, final decision on
the appeal to the owner or operator after considering the appeal.
Proposed paragraph (h) described the schedule for completing third-
party audits. The proposed language required the audit and associated
report to be completed, and submitted to the implementing agency within
12 months of when any third-party audit is required or within three
years of completion of the previous compliance audit, whichever is
sooner. The provision also allowed an implementing agency to specify a
different schedule.
c. Third-Party Compliance Audit Requirements in Sec. Sec. 68.59 and
68.80
EPA proposed new Sec. Sec. 68.59 and 68.80, which included
requirements for both third-party compliance audits and third-party
auditors. In paragraph (a), EPA proposed that owners or operators
engage a third-party auditor to evaluate compliance with the provisions
of subpart C or D (as applicable) when the applicability criteria of
Sec. 68.58(f) or Sec. 68.79(f) are met.
[[Page 4610]]
Auditor qualifications. In paragraph (b), EPA proposed third-party
auditor qualifications and required facility owners and operators to
document that the third-party auditor or audit team meets competency
and independence criteria of the rule. Specifically, EPA proposed that
facility owners or operators determine and document that the third-
party auditors meet the competency criteria in paragraph (b)(1) and the
independence criteria in paragraph (b)(2).
EPA proposed competency criteria for auditors, requiring third-
party auditors to be:
Knowledgeable with the requirements of part 68;
Experienced with the facility type and processes being
audited and the applicable recognized and generally accepted good
engineering practices (RAGAGEP);
Trained or certified in proper auditing techniques; and
A licensed Professional Engineer (PE) or include a
licensed PE on the audit.
EPA also proposed independence and impartiality criteria that would
apply to the third-party auditor or auditing team, and to each audit
team member, individually. Specifically, the criteria would have
required the auditor/audit team to:
Act impartially when performing all activities under this
section;
Receive no financial benefit from the outcome of the
audit, apart from payment for the auditing services;
Not have conducted past research, development, design,
construction services, or consulting for the owner or operator within
the last 3 years. For purposes of this requirement, consulting does not
include performing or participating in third-party audits pursuant to
Sec. 68.59 or Sec. 68.80;
Not provide other business or consulting services to the
owner or operator, including advice or assistance to implement the
findings or recommendations in an audit report, for a period of at
least 3 years following submission of the final audit report;
Ensure that all personnel involved in the audit sign and
date the conflict of interest statement in Sec. 68.59(d)(8); and
Ensure that all personnel involved in the audit do not
accept future employment with the owner or operator of the stationary
source for a period of at least 3 years following submission of the
final audit report. For purposes of this requirement, employment does
not include performing or participating in third-party audits pursuant
to Sec. 68.59 or Sec. 68.80.
In addition, in paragraph (b)(3), the proposed rulemaking required
the auditor to have written policies and procedures to ensure that all
personnel comply with the applicable competency, independence, and
impartiality requirements.
Audit report. EPA proposed requirements for the audit report in
paragraph (c). In paragraph (c)(1) EPA specified the scope and content
of these reports, including a statement to be signed by the third-party
auditor certifying that the third-party audit was performed in
accordance with the requirements of subpart C or D, as applicable. EPA
also proposed to require that the final third-party audit reports
identify any adjustments made by the third-party auditor to any draft
third-party audit reports provided to the owners or operators for their
review or comment.
Proposed paragraph (c)(2) included requirements for third-party
auditors to retain reports and records. Proposed paragraph (c)(3)
required the audit report to be submitted to the implementing agency at
the same time, or before, it is provided it to the owner or operator.
Proposed paragraph (c)(4) provided that the audit report and related
records could not be claimed as attorney-client communications or as
attorney work products, even if written for or reviewed by legal staff.
Third-party audit findings. EPA proposed in paragraph (d)(1), to
require owners or operators, as soon as possible, but no later than 90
days after receiving the final audit report, to determine an
appropriate response to each of the findings in the audit report, and
develop and provide to the implementing agency a findings response
report. EPA proposed that the findings response report would include:
A copy of the final audit report;
An appropriate response to each of the audit report
findings;
A schedule for promptly addressing deficiencies; and
A statement, signed and dated by a senior corporate
officer, certifying that appropriate responses to the findings in the
audit report have been identified and deficiencies were corrected, or
are being corrected, consistent with the requirements of subpart C or D
of 40 CFR part 68.
EPA proposed in paragraph (d)(2), to require the owner or operator
to implement the schedule to address deficiencies identified in the
audit findings response report, and document the action taken to
address each deficiency, along with the date completed.
Proposed paragraph (d)(3) required the owner or operator to provide
a copy of documents required under paragraphs (d)(1) and (d)(2) to the
owner or operator's audit committee of the Board of Directors, or other
comparable committee, if one exists.
Recordkeeping. Finally, EPA proposed recordkeeping requirements for
the owner or operator in paragraph (e). The proposal would have
required the owner or operator to retain records at the stationary
source, including: The two most recent third-party audit reports,
related findings response reports, documentation of actions taken to
address deficiencies, and related records; and copies of all draft
third-party audit reports. Those sections would further have required
the owner or operator to provide draft third-party audit reports, or
other documents, to the implementing agency upon request. EPA proposed
that requirements would not apply to any documents that are more than
five years old.
2. Summary of Final Rule
Regulated entities must engage a third-party to conduct an
independent compliance audit when they (1) have an RMP reportable
accident or (2) have been notified by an implementing agency of a
determination of either conditions that could lead to an accidental
release or problems with a prior third-party audit.
EPA is finalizing the proposed requirements for third-party
auditors with modifications that include:
Revising the applicability criteria for third-party audits
required by implementing agencies from noncompliance to conditions that
could lead to an accidental release;
Providing for a third-party audit team, led by an
independent third-party, which may now include a wide variety of
additional, non-independent personnel, including facility employees and
other personnel;
Eliminating the competency criterion that the auditor be a
PE;
Revising the third-party auditor independence criteria to
increase the number and diversity of qualified and available auditors;
and
Removing the requirement that either or both draft and
final audit reports be submitted to implementing agencies.
EPA believes these changes address many of the most significant public
comments EPA received on the proposed third-party audit requirements.
[[Page 4611]]
a. Definitions
In the final rule, EPA revised the definition of ``third-party
audit'' to reflect the changes in Sec. Sec. 68.59 and 68.80, which,
when applicable, require that an owner or operator must either engage a
third-party auditor or assemble an auditing team led by a third-party
auditor. EPA also deleted the reference to impartiality, because
impartiality is a criterion under the independence criteria in
Sec. Sec. 68.59(c)(2) and 68.80(c)(2) and there is no need to
highlight this term individually.
b. Compliance Audit Requirements Under Sec. Sec. 68.58 and 68.79
EPA is finalizing paragraph (a) as proposed. This includes
clarifying language ``for each covered process'' added to Sec. Sec.
68.58(a) and 68.79(a).
EPA is finalizing the applicability requirements set forth in
Sec. Sec. 68.58(f)(1) and 68.79(f)(1) as proposed but modifies the
criterion in Sec. Sec. 68.58(f)(2) and 68.79(f)(2) to apply when an
implementing agency requires a third-party audit due to conditions at
the stationary source that could lead to an accidental release of a
regulated substance, or when a previous third-party audit failed to
meet the competency or independence criteria of Sec. 68.59(c).
EPA is also finalizing the implementing agency notifications and
appeals process in paragraph (g), as proposed. However, the final rule
language includes minor editorial revisions. The language of
subparagraph (g)(1) requires the implementing agency to provide written
notice to the owner or operator that describes the basis for the
determination. The language of Sec. Sec. 68.58(g)(3) and 68.79(g)(3)
was modified to delete the unnecessary phrase ``of this section.''
EPA has modified and clarified the schedule for completing a third-
party audit in paragraph (h) as follows:
EPA deleted the language requiring the auditor to submit
the audit report to the implementing agency.
The final rule requires a third-party audit to be
completed within 12 months, unless a different timeframe is specified
by the implementing agency. However, EPA made changes to simplify and
clarify the schedule requirements.
[cir] Subparagraph (h)(1) requires a third-party audit to be
completed within 12 months of an RMP reportable accident.
[cir] Subparagraph (h)(2) requires a third-party audit to be
completed within 12 months of the date of the implementing agency's
final determination, or if appealed, within 12 months of the date of
the final decision on the appeal.
c. Third-Party Compliance Audit Requirements in Sec. Sec. 68.59 and
68.80
EPA is finalizing paragraph (a) as proposed but modified the
language slightly to clarify that the owner or operator shall engage a
third-party to conduct an audit to evaluate compliance with subpart C
or D as applicable.
Third-party auditors and auditing teams. In the final rule, EPA
added paragraph (b) to provide options for assembling a third-party
auditor or an audit team. In addition to engaging a fully independent
third-party auditing firm, owners or operators may assemble auditing
teams that include competent and independent third-party auditor team
leaders and other qualifying, non-independent personnel. The owner or
operator shall either:
Engage a third-party auditor meeting all of the competency
and independence criteria of the rule (subparagraph (b)(1)); or
Assemble an auditing team, led by a third-party auditor
meeting all of the competency and independence criteria. The team may
include:
[cir] Other employees of the third-party auditor firm meeting the
independence criteria of the rule; and
[cir] Other personnel not employed by the third-party auditor firm
(subparagraph (b)(2)).\28\
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\28\ ``Other personnel'' may be facility personnel, personnel
from any other facilities owned or controlled by the owner or
operator, and/or any non-independent second or third-party
consultants or contractors the owners or operators choose to include
on the auditing teams they assemble under subparagraph (b)(2). In
addition, the auditing teams may include other employees of the
third-party auditor firm who meet the independence criteria of
subparagraph (c)(2). Such personnel need not individually meet the
final rule's third-party auditor competency criteria as long as the
independent third-party audit team leader, pursuant to his/her
evaluation of audit team member competencies under subparagraph
(d)(2), determines that the full audit team includes all of the
competencies required to successfully complete the audit pursuant to
the requirements in the final rule.
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Auditor qualifications. The final rule retains the third-party
auditor qualification requirements in paragraph (b) of the proposed
rulemaking but redesignated as paragraph (c). The qualification
requirements set forth in this paragraph apply only to the third-party
auditors. The third-party auditor qualifications are clarified and
modified as described further in this preamble.
In the final rule, EPA simplified the introductory paragraph to
indicate that the owner or operator shall determine and document that
the third-party auditor(s) meets the competency and independence
requirements set forth in the subparagraphs.
Subparagraph (c)(1) identifies competency criteria that apply to
third-party auditors.\29\ EPA is finalizing the competency criteria as
proposed, except to delete the requirement for a licensed PE to conduct
the audit or participate on the audit team.
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\29\ The competency criteria do not apply to other personnel,
not employed by the third-party auditor firm, that participate on
the auditing team (e.g., facility personnel).
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Subparagraph (c)(2) identifies independence criteria that apply to
third-party auditors. EPA is amending and finalizing the proposed
independence criteria as follows:
EPA is deleting the phrase ``and impartiality'' from the
title because the impartiality requirement is listed as one of several
criteria, and it is unnecessary to highlight the term separately.
EPA clarified that retired employees qualify as third-
party auditors when financial attachments are limited to retirement
and/or health plans.
EPA revised the timeframe that limits third-party auditors
past and future research, development, design, construction services,
or consulting services to two years. EPA further clarified that if the
firm employs personnel that did conduct these services within the
prescribed timeframe, then these personnel may not participate in the
audit.
The final rule requires third-party audit personnel to
sign and date a conflict of interest statement documenting that they
meet the independence criteria.
The limitation regarding future employment with the owner
or operator has been modified to apply to only third-party personnel
involved in the audit and the timeframe decreased to two years.
EPA is finalizing subparagraph (c)(3), as proposed, to require
auditors to have written policies and procedures to ensure that all
personnel comply with the qualification criteria--except to delete the
word impartiality from the criteria description.
Third-party auditor responsibilities. EPA is adding requirements
for the owner or operator to provide certain responsibilities to the
third-party auditor.\30\ Paragraph (d) requires the
[[Page 4612]]
owner or operator to ensure that the third-party auditor:
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\30\ EPA is finalizing auditor responsibilities to ensure that
third-party auditors maintain certain responsibilities when audit
teams are comprised of both third-party auditor personnel and other
personnel. EPA did not propose roles and responsibilities for
independent third-party auditors because, in the proposed approach,
independent third-party auditors were responsible for conducting all
auditing activities.
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Manages the audit and participates in audit initiation,
design, implementation, and reporting;
Determines appropriate roles and responsibilities for the
audit team members based on the qualifications of each team member;
Prepares the audit report and where there is a team,
documents the full audit team's views in the final audit report;
Certifies the final audit report and its contents as
meeting the requirements of the rule; and
Provides a copy of the audit report to the facility owner
or operator.
Audit report. EPA is redesignating and finalizing audit report
requirements under paragraph (e) of the final rule with modifications.
EPA reorganized and added one report requirement to the proposed
subparagraphs (c)(1)(i) to (c)(1)(v). These are subparagraphs (e)(1) to
(e)(6) in the final rule.
EPA also amended the audit report provisions in the final rule to
simplify the applicable provisions and simplify the requirements for
preparing and handling the third-party audit reports:
Subparagraph (e)(1) requires the report to identify all
persons participating on the audit team, including their employers and/
or affiliations. The report must also document that third-party
auditors meet the competency criteria of the rule; \31\
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\31\ Note-only third-party auditors must meet the competency
criteria of the rule-does not apply to other personnel on an audit
team.
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EPA added an additional requirement under subparagraph
(e)(2) for the auditor to describe in the report, or incorporate by
reference, policies and procedures to ensure all third-party personnel
comply with the competency and independence criteria of the rule;
Proposed subparagraphs (c)(ii) and (c)(iii) are finalized
as proposed and redesignated as (e)(3) and (e)(4). The report must
document the auditor's compliance evaluation for each covered process
and document the findings of the audit, including any identified
deficiencies;
Subparagraph (e)(5) requires the report to summarize any
significant revisions between draft and final versions of the report;
Subparagraph (e)(6) requires the auditor or audit team
leader to sign and date a certification. The certification is finalized
as proposed except to remove the last sentence that acknowledges
penalties for submitting false information;
EPA deleted the provision that required the auditor to
maintain copies of all reports and records; \32\
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\32\ EPA retains its authority under Section 114 of the CAA to
require regulated entities to make such records available to the
Agency, as appropriate, upon request or during inspections. EPA is
finalizing recordkeeping requirements under paragraph (g) of the
final rule.
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EPA deleted the provision that required the auditor to
submit the report to the implementing agency at the same time as it
would be provided to the owner or operator; and
EPA deleted the provision limiting attorney-client
privilege.
Third-party audit findings. EPA is finalizing requirements for the
owner or operator to prepare a findings response report; develop a
schedule to address deficiencies; and submit the findings response
report and schedule to the Board of Directors. These requirements are
redesignated to paragraph (f) of the final rule with the following
modifications to the findings response report:
EPA deleted the proposed requirement to submit the
findings response report to the implementing agency; and
EPA amended the owner/operator certification in the
findings response report to add a sentence indicating that the owner or
operator has engaged a third-party to perform or lead an audit team to
conduct a third-party audit in accordance with the requirements of 40
CFR 68.80. EPA also modified the final sentence of the certification to
clarify that submitting false information includes making false
material statements, representations, or certifications.\33\
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\33\ This change was made to track the language of Section
113(c)(2)(A) of the CAA which makes it illegal for regulated
entities to ``make any false material statement, representation, or
certification.''
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EPA is finalizing requirements in subparagraph (f)(2) to develop a
schedule to address deficiencies as proposed, except to modify the
title of the provision to schedule implementation and correct citations
to redesignated paragraphs.
EPA is also finalizing the requirement in subparagraph (f)(3) to
submit the findings response report and implementation schedule to the
board of directors as proposed with minor modifications to update
citations to redesignated paragraphs, and capitalize Board of Directors
in the title. In addition, the end of the last sentence was changed to
reference a comparable committee, or individual, if applicable.
Recordkeeping. EPA is finalizing the recordkeeping requirements as
proposed in paragraph (d) with the following modifications:
The paragraph has been redesignated as paragraph (g) in
the final rule;
EPA eliminated the proposed subparagraphs and moved the
language of proposed subparagraph (e)(1) into the main paragraph with
edits to clarify that the owner or operator shall retain at the
stationary source the two most recent final third-party audit reports;
EPA eliminated the proposed requirement for owners or
operators to retain copies of all draft third-party audit reports
(subparagraph (e)(2) of the proposed rulemaking); and
EPA amended the recordkeeping provision for Program 3
processes in Sec. 68.80(e) to delete the sentence that applied the
recordkeeping provisions to any documents that were five-years old or
less. This revision is consistent with current recordkeeping compliance
audits under Sec. 68.79(e) and corrects an error in the proposed
rulemaking text.
3. Discussion of Comments and Basis for Final Rule Provisions
Several comments supported the proposed third-party audit
requirements, including one stating that the commenter found that
internal audits often fail to identify systemic process safety
deficiencies. However, many commenters opposed the proposed third-party
compliance audit provisions, including some who expressed general
opposition, reasoning that existing requirements and mechanisms are
working. Some comments argued that the costs outweigh the benefits
associated with this provision or that audits by internal resources are
more cost-effective and less disruptive, while still providing adequate
assessment and encouraging compliance.
EPA has retained a third-party audit requirement in the final rule.
We continue to rely on the rationale expressed in the proposed
rulemaking. However, in the final rule, we have modified the
requirements for the audit team to expand the potential membership
while still retaining the critical role of the independent auditor in
the review of the compliance program. In the discussion that follows
and in the Response to Comment document, we explain the modifications
to our approach and the basis for these modifications.\34\ While the
RMP rule does not prohibit accidental releases, an accidental release
can be an indication of a prevention program that both needs
[[Page 4613]]
improvement and that may benefit from an audit by someone independent
from the source's historic program and the management of the source.
The requirements finalized in this rule are not based on a wide finding
that the original compliance audit requirement of the RMP rule does not
have value; instead, we promulgate this requirement to target a
subgroup that have had indications of potential problems not detected
and addressed by the traditional audit structure.
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\34\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
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EPA believes it is appropriate to require a subset of RMP-regulated
facilities to engage competent and independent third-party auditors
following an RMP-reportable accident or identification of conditions at
the stationary source that could lead to an accidental release of a
regulated substance. The purpose of the third-party audit is to assist
the owners and operators in determining whether facility procedures and
practices to comply with subparts C and/or D of the RMP rule (i.e., the
prevention program requirements) are adequate and being followed. Thus,
EPA is finalizing requirements for third-party audits when required
under Sec. 68.58 and/or Sec. 68.79, to require that owners and
operators ensure that third-party auditors meet qualification criteria,
audits are conducted and documented, and findings are addressed
pursuant to the requirements of Sec. 68.59 and/or Sec. 68.80, as
applicable. EPA notes that under part 68, sources with any Program 2
and/or Program 3 processes are already required to conduct compliance
audits every three years. This rule does not change the requirement
that RMP facilities regularly conduct RMP compliance audits but
provides only that, in specific situations, those audits be performed
by a third-party or a team led by a third-party, pursuant to the
schedule in Sec. 68.58(h) and/or Sec. 68.79(h) of the rule.
EPA considered, but did not adopt, changes to the final rule that
would establish additional processes or programs under which EPA or
other regulatory agencies must first approve or credential third-party
auditors before owners or operators can engage them. Nor did EPA modify
the rule to establish or reference additional independent auditor
accreditation programs or auditor accreditation oversight committees or
otherwise require potential third-party auditors to be accredited by an
independent auditing or accreditation body before owners or operators
may engage the auditors under this rule. For some programs, external
accreditation of third-party auditors adds additional rigor to the
process of ensuring the competence and independence of the auditors but
such external accreditation can be time-consuming and add financial
costs. EPA believes that the level of effort and resources necessary to
establish these programs would cause unnecessary delays in implementing
third-party compliance audit requirements and are not warranted for the
small universe of facilities that may be subject to these requirements.
Comments on significant issues relating to third-party audits are
summarized and discussed further in this preamble. The following also
discusses EPA's basis for the third-party audit provisions adopted in
this final rule.
a. Third-Party Auditing Constitutional Law and Agency Authority Issues
EPA's enforcement authority. Several commenters stated that EPA
should rely on its existing enforcement authority, including the
ability to require third-party audits in particular enforcement
proceedings, rather than requiring third-party audits more generally.
Another encouraged EPA to focus on enforcing existing audit
requirements. Similarly, another recommended that EPA address
facilities deemed to be incapable of performing objective self-auditing
through EPA's enforcement authorities. One commenter argued that the
proposed third-party audit requirements violate the U.S. Constitution's
Fifth Amendment Due Process Clause because the proposal seeks to
outsource EPA's inspectional duties to a third-party and force facility
owners or operators to accept and implement the third-party's findings
without processes to protect the due process rights of those subject to
the audits. A few commenters stated that the proposed third-party
auditing provisions are an unlawful and unconstitutional circumvention
of Congressional appropriations limits on EPA's enforcement budget.
Specifically, the commenters argued that the Anti-Deficiency Act
prohibits EPA from augmenting its enforcement budget by mandating that
third parties oversee the RMP program.
EPA disagrees with the commenters. Third-party audits do not
constitute enforcement, nor do they substitute for inspections by
implementing agencies, and as such, EPA believes that they do not
violate either the Due Process Clause of the Fifth Amendment, or the
Anti-Deficiency Act. In addition, as discussed further in this
preamble, EPA believes that there is no violation of the Due Process
Clause of the Fifth Amendment regarding implementation of third-party
audit findings.
The third-party audits required in this final rule are compliance
audits, similar to the current self-audit requirements, only conducted
by a team led by a third-party auditor. The Senate Environment and
Public Works Committee identified program audits ``by company personnel
. . . or outside consultants'' as an element of prevention program
rules within the range of authorities provided EPA. See Senate Report
at 243.\35\ The findings of a third-party audit are intended to
identify noncompliance that was not discovered by facility personnel
during self-audits, and are not intended primarily to bring such
findings to the attention of government regulators. In fact, the audits
are designed primarily to benefit owners or operators by assisting them
to identify both actual noncompliance as well as operational or
equipment deficiencies, previously unidentified risk factors, and
accident release and/or regulatory noncompliance precursor conditions
which, if uncorrected, could lead to releases and/or enforcement
actions. Proactively addressing deficiencies, risk factors, and
precursor conditions to accidental releases and regulatory
noncompliance will provide financial, regulatory, and environmental
benefits for facility owners and operators and communities. EPA has
reasonably targeted third-party audit requirements at facilities that
have had RMP reportable incidents that may demonstrate weaknesses in
prior self-assessments and at facilities of heightened concern for
implementing agencies.
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\35\ Senate Committee on Environment and Public Works, Clean Air
Act Amendments of 1989, Senate Report No. 228, 101st Congress, 1st
Session 211 (1989)--``Senate Report.''
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Furthermore, third-party compliance audits in no way constitute
regulatory inspections of, or enforcement at, RMP-regulated facilities.
This rule is clear that third-party auditors' or third-party audit
teams' findings are not, in and of themselves, determinations of
regulatory violations. Nor are the audit reports or related
documentation required to be automatically submitted to implementing
agencies. EPA believes there is no violation of the Due Process Clause
of the Fifth Amendment regarding implementation of third-party audit
findings. Owners or operators must address all third-party audit
findings, the rule provides that addressing the audit findings may
include, where appropriate, determining that some specific findings
were based on incorrect factual assumptions or were otherwise
inappropriate to implement. Thus, as described further
[[Page 4614]]
in this preamble, the owner or operator of a stationary sources may
determine an appropriate response to the findings in the audit report,
and are not required to accept findings when they can justifiably
decline to adopt them, and EPA believes that determining appropriate
responses, and addressing of deficiencies, risk factors, and precursor
conditions to accidental releases and regulatory noncompliance pursuant
to the third-party audit regulatory requirements, do not constitute
violations of the Due Process Clause of the Fifth Amendment.
Finally, nothing in this rule relieves the EPA of any of its
responsibilities under the CAA or implies that EPA will not continue to
use its enforcement authorities under the CAA or devote resources to
monitoring and enforcing this rule. The third-party auditing regulatory
requirements simply ensure that regulated entities will, in a
carefully-defined subset of circumstances, take reasonable measures to
assess and ensure their own compliance.
Security and CBI concerns. A few commenters expressed security
concerns associated with third-party compliance audits. One commenter
was concerned with ensuring proper treatment of confidential
information by third-party auditors, and asserted that the proposed
rulemaking does not address whether or not a facility will be able to
limit the release of sensitive information once a third-party auditor
is involved. Another comment was received stating that facility and
process security are concerns for the commercial explosives industry,
and recommended that EPA eliminate the third-party audit requirements.
This commenter reasoned that internal staff at explosives sites would
have undergone mandatory background checks but third-party auditors
wouldn't necessarily be subject to the same security screening. A few
commenters stated that attempts to find auditors with appropriate
security clearances would further limit the pool of available qualified
auditors. One commenter asserted that the third-party compliance audit
requirements create legal concerns given that the third parties would
be privy to potential CBI or information that should be protected under
attorney-client privilege.
EPA acknowledges commenters concerns; however, facility owners or
operators routinely obtain and review the internal policies,
procedures, and qualifications of a wide range of consultants and
contractors before engaging them in order to assess their
qualifications to perform consulting or contractual services. EPA is
confident owners and operators will be able to ensure that third-party
auditor personnel meet applicable security criteria.
Regarding concerns that the third-party compliance audit
requirements create legal concerns given that the third-parties would
be privy to potential CBI, the contracts or other agreements between
owner/operators and third-party auditors can address how any potential
confidential business information is handled by the third-party.
With regard to information that arguably should be protected under
evidentiary privileges, EPA's view is that the third-party audit
reports and related records under this rule, like other documents
prepared pursuant to part 68 requirements, such as process safety
information, PHAs, operating procedures and others, are not documents
produced in anticipation of litigation. With respect to the attorney-
client communication privilege specifically, the third-party auditor is
arms-length and independent of the stationary source being audited. The
auditor lacks an attorney-client relationship with counsel for the
audited entity. Therefore, in EPA's view, neither the audit report nor
the records related to the audit report provided by the third-party
auditor are attorney-client privileged (including documents originally
prepared with assistance or under the direction of the audited source's
attorney). Nevertheless, EPA recognizes that the ultimate decision
maker on questions of evidentiary privileges are the courts. Therefore,
this rule does not contain a specific regulatory provision prohibiting
assertion of these privileges.
b. Requirement To Conduct Compliance Audit for Each Covered Process
EPA received several comments regarding the clarification in
Sec. Sec. 68.58(a) and 68.79(a) of the proposed rulemaking that all
RMP audits must address ``each covered process'' at a facility. Some
commenters opposed this clarification. A few commenters indicated that
this would be a change, and asserted that EPA has endorsed guidance
from the CCPS allowing facilities with a large number of covered
processes to audit a representative sample of processes.
One commenter argued that it was punitive for an accidental release
from one process to automatically trigger a third-party audit
requirement for all covered processes. A few commenters stated that
requiring that all RMP-covered processes at the facility be audited
regardless of what process triggered the requirement to perform the
third-party audit would result in duplication of efforts with little
benefit where processes at multi-process facilities are on different
auditing schedules and third-parties are required to audit processes
that were recently audited and not related to the incident that
triggered the third-party audit. One commenter stated that requiring
audits of processes that are not part of an incident would tie-up plant
resources for longer than needed, which was particularly notable to the
commenter because these processes would very likely still be operating
after the incident and at the time of the audit.
Finally, commenters asserted that it is unfair and more burdensome
to require larger facilities with multiple processes to audit each
covered process, arguing that they would essentially be auditing all
the time, where small facilities with one or two processes would have a
lesser auditing burden.
EPA disagrees with commenters that believe it is punitive or
redundant to require an audit of all RMP-covered processes at the
facility, including those not involved in an RMP-reportable accident.
Under existing rules, each facility compliance audit must address each
covered process at least every three years. The third-party audit
required under this rule simply replaces the next scheduled self-
compliance audit, which must address each covered process.
EPA has consistently maintained that, at least every three years,
owners or operators must, under the RMP rule, certify that they have
evaluated compliance with the prevention program requirements for each
covered process. ''In EPA's General Risk Management Guidance, issued in
2004 and updated in 2009, in Chapter 6, ``Prevention Program (Program
2)'' Section 6.7 ``Compliance Audits (Sec. 68.58)'', under the heading
``What Do I Need to Do?'' it states ``At least every three years, you
must certify that you have evaluated compliance with the prevention
program requirements for each covered process'' [emphasis added]. In
addition, Chapter 7 of this guidance, ``Prevention Program (Program
3)'' Section 7.9 ``Compliance Audits (Sec. 68.79),'' states ``You must
conduct an audit of the process to evaluate compliance with the
prevention program requirements at least once every three years.''
While EPA does list the 1993 edition of CCPS Guidelines for Auditing
Process Safety Management Systems as a reference source within this
guidance, EPA disagrees that the CCPS guidelines endorse allowing large
facilities to audit a representative sample of covered processes.
[[Page 4615]]
EPA has also clearly stated its position within the Notice of
Proposed Rulemaking preamble for the initial RMP regulation, and in the
Response to Comments for that rule. In response to a question
concerning whether facilities could stagger compliance audits where
there are multiple processes at a facility, EPA stated, in the Response
to Comments document, that a source ``may choose to audit different
processes on different schedules (if) over each three-year period, all
covered processes are audited.'' \36\ Furthermore, while OSHA's
original PSM compliance audit guidelines may have allowed for auditing
a sample of processes, the current guidelines are consistent with EPA's
General Risk Management Guidance. See OSHA's ``Appendix C to Sec.
1910.119--Compliance Guidelines and Recommendations for Process Safety
Management (Nonmandatory).'' EPA's decision to retain, in Sec. Sec.
68.59(e)(3) and 68.80(e)(3) of the final rule, the requirements for the
third-party audit reports to document the auditor's evaluation, for
each covered process, of the owner or operator's compliance with the
prevention program provisions is thus consistent with both the initial
RMP rule and EPA's longstanding interpretation of the scope of the
rule.
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\36\ EPA. May 24, 1996. Risk Management Plan Rule, Summary and
Response to Comments. Volume 1, p. 15-2. Docket No. A-91-73,
Document No. IX-C-1.
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EPA also disagrees with commenters' burden argument for larger
companies and facilities with a larger number of processes. These
larger facilities typically also have more personnel and resources,
where smaller facilities with fewer processes may have fewer employees,
so the burden of auditing is proportionate for these facilities.
Furthermore, larger facilities with more processes, in general, are
likely to have more potential opportunities for accidental releases due
to their size, complexity, and scale of operations. Therefore, it is
appropriate for such facilities' auditing responsibilities to be
commensurate to their size, complexity, and scale of operations.
c. Third-Party Audit Applicability
Some commenters generally supported the proposed applicability
requirements. However, many commenters opposed the requirements,
requesting that EPA narrow, limit, or eliminate these requirements.
RMP-reportable accident criterion. A commenter encouraged EPA to
develop a narrower range of circumstances that can trigger a third-
party audit to ensure they will not become an overwhelming compliance
function, and detract from the performance-based aspects of RMP. Other
commenters recommended limiting the requirements to: Releases that
result in offsite impacts, such as offsite deaths, serious injuries, or
significant environmental contamination; Program 3 facilities;
facilities with multiple releases or multiple major accidents; or
incidents that result in significant impacts to workers, or to the
community. Another commenter stated that third-party audits should not
be required automatically, but should only be required if the facility
has experienced an accidental release that meets the criteria in Sec.
68.42(a) and EPA makes the determination that there is good cause for
the audit, in light of the particular circumstances and facts
surrounding the release in question. One commenter stated that the
accidental release trigger was not an effective way to improve public
safety and urged EPA to adopt a more proactive and targeted approach.
EPA disagrees with commenters that third-party compliance audits
will become an overwhelming compliance function. EPA has limited
applicability of third-party audits to circumstances in which an RMP
reportable accident has occurred or where conditions exist at the
source that could lead to a release. In responding to the previous
comments, it is necessary to provide context for how infrequently
third-party auditing will, in practice, be necessary under the final
rule, both in absolute numbers of such audits and their number relative
to the full universe of RMP-regulated stationary sources already
subject to the RMP rule's self-auditing requirements.
Currently, there are approximately 12,000 stationary sources with
Program 2 and/or Program 3 processes. The final rule requires third-
party compliance audits only under the following two conditions:
If there has been an RMP reportable accident (i.e., an
accidental release from an RMP facility meeting the five-year accident
history criteria as described in Sec. 68.42(a)); or
If an implementing agency makes a determination that a
third-party audit at an RMP facility is necessary, based on conditions
``that could lead to an accidental release of a regulated substance''
or a prior third-party audit at the facility.
EPA does not expect these criteria to impact a large percentage of
stationary sources with Program 2 and/or Program 3 processes. For
example, comparing the number of facilities which in past years have
had an RMP reportable accident (averages approximately 150/year), with
the number of current stationary sources with Program 2 and/or Program
3 processes, would represent less than 2% of stationary sources subject
to this requirement, due to an accident, on an annual basis. For more
information on the number of RMP reportable accidents over a ten-year
period see section IX.A of this preamble.
EPA also disagrees with suggestions to limit the applicability of
third-party compliance audits to releases with offsite impacts, deaths,
injuries, or significant environmental impacts. The purpose of the
third-party audit is to help reduce the risk of future accidents by
requiring an independent and objective audit to determine whether the
owner or operator of the facility is effectively meeting the prevention
program requirements of the RMP rule. Stationary sources that have had
accidents and/or substantial noncompliance with Risk Management Program
requirements may pose a greater risk to the surrounding communities.
EPA agrees that releases with offsite impacts, deaths, injuries, or
significant environmental impacts are potential indicators of
noncompliance with RMP prevention program requirements. But so are
accidental releases that involve significant property damage on-site,
or known offsite evacuations, sheltering in place, property damage, or
environmental damage of any degree.
The existing self-audit requirements under Sec. Sec. 68.58 and
68.79 incorporate a proactive evaluation of prevention program
requirements for Program 2 and Program 3 processes. However, when a
facility has an accidental release or noncompliance that could lead to
an accidental release of a regulated substance, EPA has determined that
further self-auditing may be insufficient to prevent accidents and
ensure safe operation. Therefore, we believe it is appropriate to
require such stationary sources to undergo third-party auditing to
better assist owners and operators and implementing agencies to
determine whether the procedures and practices developed by the owner
and/or operator under subparts C and/or D of the RMP rule (i.e., the
prevention program requirements) are adequate and being followed. EPA
believes this approach will improve public safety overall by preventing
future accidents at the source.
Overlap between incident investigations and third-party audits.
Many commenters recommended that EPA focus on incident investigations
after accidental releases rather than third-party audits. Some
commenters reasoned that incident investigations are
[[Page 4616]]
the activities that are most likely to mitigate both the severity of
future incidents and the potential for recurrence. Some commenters
stated that third-party audits should not be required when an incident
investigation is also required because both of these activities require
substantial internal resources and the incident investigation is more
responsive to health and safety concerns. Some commenters also stated
that requiring a facility to conduct the third-party audit after an
accidental release has the potential to dilute resources from the
facility's efforts to complete a comprehensive incident investigation
and implement associated improvements. One commenter suggested that an
incident investigation be required immediately after a catastrophic
release but not a third-party audit, and that EPA could then require
the stationary source's next three-year compliance audit (after the
completion of the incident investigation) to have some degree of
independence to assess the effectiveness of the changes made in
response to the incident investigation.
EPA disagrees with commenters. Following an accident, incident
investigations often reveal that facilities have deficiencies in some
prevention program requirements related to that process. Incident
investigations generally only evaluate the affected process, and do not
necessarily address all covered processes at a facility, or even all
prevention program elements for the affected process. However,
compliance audits entail a systematic evaluation of the full prevention
program for all covered processes, and EPA expects that third-party
audits should identify deficiencies in any other covered processes at
such facilities.
EPA believes that conducting the third-party compliance audits
immediately after an accidental release is necessary to identify and
correct existing noncompliance at prevention program facilities that
could lead to future releases. EPA acknowledges that conducting third-
party audits at the same time as incident investigations may impact the
availability of facility resources for these activities. However, this
is not a sufficient argument to delay the independent audit. Facilities
may hire personnel from different firms to conduct the two activities
or, for some facilities with knowledgeable internal staff to conduct
investigations, they may only need to hire the third-party.
Although we agree with the commenter that suggested that compliance
audits assess the effectiveness of changes made in response to an
incident investigation, we disagree that this assessment must be made
by a third-party. The owner or operator will resume the three-year
schedule to conduct self-compliance audits after the third-party audit
and, at that time, the facility owner or operator may consider the
findings of the incident investigation and the third-party compliance
audit when assessing compliance with prevention program requirements.
Implementing agency criterion. Many commenters argued that the
third-party audit trigger associated with implementing agency findings
of noncompliance should either be eliminated or significantly revised.
Commenters expressed concerns with allowing an implementing agency to
require a third-party audit based on a noncompliance determination.
Commenters were also concerned about the potential for inconsistent or
arbitrary decisions by implementing agencies, and a few commenters were
concerned about the potential for abuse of this mechanism by
implementing agencies. One commenter expressed due process concerns
related to the triggers for third-party compliance audits, stating that
the proposed rulemaking fails to provide the regulated facility an
opportunity to contest implementing agency allegations of
noncompliance. Commenters also requested clarification on whether an
implementing agency could require a third-party compliance audit
following a site inspection by the implementing agency.
In response to comments, EPA has revised the third-party audit
applicability criterion by requiring the implementing agency to base a
determination on conditions at the stationary source that could lead to
an accidental release of a regulated substance, rather than on
noncompliance. An implementing agency may determine that a third-party
audit is necessary following inspections, audits, or facility visits,
if conditions are observed at the stationary source that could lead to
an accidental release of a regulated substance. The implementing agency
may choose to take other action following an inspection, as
appropriate.
Conditions at a stationary source that could lead to an accidental
release may include, but are not be limited to, significant
deficiencies with process equipment containing regulated substances,
such as unaddressed deterioration, rust, corrosion, inadequate support,
and/or other lack of maintenance that could lead to an accidental
release. The presence of small ``pinhole'' releases, that do not meet
the criteria in Sec. 68.42(a) for RMP-regulated accidental releases,
could also constitute conditions that could lead to a larger accidental
release of a regulated substance. The occurrence of several prior
accidental releases that did not meet the reporting criteria in Sec.
68.42(a) at or from a facility could also constitute conditions which
could lead to potentially more severe accidental releases. These
releases may be a potential indicator that an owner or operator is not
complying with RMP prevention program requirements and would benefit
from a third-party audit to prevent future accidental releases.
EPA believes that having the implementing agency evaluate whether
conditions exist that could lead to an accidental release better
addresses the types of situations where a third-party audit would be
most effective and will minimize the potential for inconsistent or
arbitrary decisions made by implementing agencies. EPA also believes
that the revised criterion is responsive to commenters' requests to
narrow the applicability of these requirements. The criterion focuses
on conditions with the potential to lead to accidental releases, rather
than authorizing implementing agencies to require third-party audits
under a potentially wide range of circumstances, including minor
noncompliance.
In the final rule, a facility owner or operator has an opportunity
to challenge the underlying findings when an implementing agency
requires a third-party audit. Sections 68.58(g) and 68.79(g) describe
the notification and appeals process. The implementing agency must
provide written notice to the facility owner or operator that describes
the basis for the implementing agency's determination. Within 30 days,
the owner or operator may consult with, and provide information and
data to the implementing agency on the preliminary determination. The
implementing agency will then consider this information and provide a
final determination to the owner or operator. EPA believes this appeal
process provides due process to the owner or operator and is sufficient
to eliminate any potential inconsistent use or abuse of authority.
Previous third-party audit criterion. A few commenters suggested
deleting the failure of a previous third-party audit to meet the
competency, independence, or impartiality criteria as a criterion for
potentially requiring a subsequent third-party audit. These commenters
reasoned that EPA has not shown that the auditor criteria will
necessarily lead to better outcomes. A commenter questioned whether it
was reasonable for EPA to declare a previous audit that was otherwise
conducted in good faith, to be null and void, arguing that stationary
[[Page 4617]]
sources could find it burdensome and difficult to track auditor
qualification criteria.
EPA disagrees with commenters' assertions that stationary sources
will find it burdensome or difficult to apply the third-party auditor
competency and independence criteria in this rule to identify qualified
third-party auditors. See sections IV.B.3.i and IV.B.3.j of this
preamble for a discussion of auditor qualifications in the final rule
as well as an explanation for why EPA believes that independent
auditors can provide a fresh perspective on compliance audits that will
enable an owner or operator to improve the source's risk management
program.
If the implementing agency has concerns about a previous third-
party audit, which involved an auditor that failed to meet the
qualification criteria for competency and independence, and the agency
is concerned about the quality and/or adequacy of the audit and/or its
findings, then the implementing agency may choose to require that
another third-party audit be conducted. The final rule establishes a
procedure for owners or operators to challenge the regulators'
determinations.
Regarding the comment concerning auditor criteria leading to better
outcomes, this issue was addressed in the preamble to the proposed
rulemaking, and is also discussed extensively in section IV.B.3.h of
this preamble.
Alternative criteria suggestions. EPA received a comment
recommending that EPA require third-party compliance audits for all
Program 2 and Program 3 facilities every three years, reasoning that
this alternative option is a more preventative measure than the
proposed applicability.
A few commenters, including a state government agency, suggested
that EPA consider limiting the requirement to perform third-party
audits to specific NAICs codes. Some of these commenters further
recommended that certain types of facilities be excluded from the
requirement, including water and wastewater treatment facilities and
retail anhydrous ammonia facilities. A local government agency
commented that EPA should consider limiting the requirement to perform
third-party audits to the petroleum manufacturing, chemical
manufacturing, and paper manufacturing industries only.
As part of the SBAR panel process for the proposed rulemaking, SERs
suggested that EPA consider excluding or exempting small businesses
from the rule's third-party auditing requirements or providing small
businesses with special flexibility to use less-than-fully-independent
third-party auditors such as retired facility employees not otherwise
meeting all of the proposed rulemaking's independence criteria. The
SERs noted that the requirements in the proposed rulemaking for every
member of the third-party auditing team to individually meet all of the
proposed rulemaking's competency and independence criteria would be
especially costly and burdensome to small businesses.
EPA disagrees with the suggestion to require all facilities with
Program 2 and/or Program 3 processes conduct third-party compliance
audits every three years, because the Agency believes that this would
impose a very large economic burden on the regulated industry. EPA is
also concerned that there may not be a sufficient number of independent
auditors available to perform third-party audits at the frequency that
this approach would demand.
Upon review of these comments in the context of EPA's overall
approach to this rule, EPA has determined that it is unnecessary to add
an exceptions or exemptions process for third-party auditor competency
and independence to the final RMP rule, or to exempt small facilities
or facilities within select industry sectors from the third-party
auditing requirements. First, EPA expects that the current approach to
require third-party audits following an RMP reportable accident, or
based upon an implementing agency's determination, will impact
approximately 150 facilities per year. In the Initial Regulatory
Flexibility Assessment (IRFA) \37\ for the proposed rulemaking, EPA
determined that relatively few small businesses have reportable
accidents and therefore this provision will typically not apply to
small facilities. Therefore, it is unnecessary to exempt small
facilities or revise the auditor qualifications for small facilities.
---------------------------------------------------------------------------
\37\ The IRFA can be found in Chapter 7 of the Regulatory Impact
Analysis for Proposed Revisions to the Accidental Release Prevention
Requirements: Risk Management Programs Under the Clean Air Act,
Section 112(r)(7). This document is available in the docket for this
rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------
Additionally, EPA believes that the revised third-party auditor
qualifications in this final rule will make it easier for owners and
operators to find suitable third-party auditors and third-party audit
team leaders to comply with the third-party audit provisions, making it
unnecessary to add additional exceptions or an exception process to the
final rule. EPA agrees with commenters' requests to provide additional
flexibility to allow retired facility employees to conduct a third-
party audit and has revised the auditor qualification criteria to
address this request (see section IV.B.3.j of this preamble for more
information).
Finally, EPA disagrees with commenters that request EPA exclude
facilities within specific sectors from third-party applicability. EPA
based applicability of third-party audits on whether a source had an
RMP reportable accident or whether conditions exist that could lead to
an accidental release. EPA believes that these criteria are potential
indicators for noncompliance with prevention program requirements and
therefore warrant an evaluation by a third-party. If a specific
industry sector does not typically have accidental releases, then this
provision will not likely apply. Furthermore, EPA modified the third-
party auditor qualification criteria to make it simpler for all
businesses, small, medium, and large and in all sectors, to find
qualified third-party auditors. Therefore, it is unnecessary to exclude
or limit third-party audit applicability to specific industry sectors.
d. Implementing Agency Notification and Appeals
A few commenters asserted that the appeals process associated with
third-party compliance audits is insufficient. One commenter stated
that the proposed appeals process does not preclude the excessive or
baseless use of the claim by agency staff nor detail the quality or
quantity of information that a facility could present to overcome an
agency's determination and the requirement to perform a third-party
audit. Commenters also recommended adding an additional independent
party to the appeals process. One commenter stated that EPA should
clearly provide for judicial review of decisions on appeals by
including regulatory language specifying that EPA's decision
``constitutes final agency action for purposes of judicial review.''
Another commenter stated that EPA should make the deadline for appeals
at least 60 days and should expressly provide for extensions.
EPA disagrees with the comments requesting an independent party be
added to the appeals process. This approach would create unacceptable
delays while the implementing agency and the facility identifies an
appropriate third-party. EPA believes the appeals process set out in
the final rule provides sufficient opportunities for the owner or
operator to challenge an implementing agency's determination.
[[Page 4618]]
Sections 68.58(g) and 68.79(g) describe the notification and
appeals process for when an implementing agency requires a third-party
audit. The implementing agency must provide written notice to the
facility owner or operator that describes the basis for the
implementing agency's determination. Within 30 days, the owner or
operator may consult with, and provide information and data to, the
implementing agency on the preliminary determination. The implementing
agency will then consider this information and provide a final
determination to the owner or operator. Then there is an appeals
process, in which the owner or operator may appeal the final
determination to the EPA Regional Administrator, or for determinations
made by other implementing agencies, the administrator or director of
such implementing agency.
It is important to note that the final determination regarding the
applicability of these provisions is not an enforcement determination.
It is a notification regarding the applicability of an existing
regulatory requirement, a requirement that does not apply to all
stationary sources, all the time, but when an agency determines that it
would apply, the owner or operator is notified, given an opportunity to
consult, and appeal further within the agency. Part 68 already includes
final agency determinations regarding regulatory requirements in
Section 68.220, and the process set out in this final rule for appeals
of third-party audit determinations is similar.
In response to comments about the short time frames, EPA has
determined that the 30-day timeframe to submit an appeal, which follows
an initial 30-day time period for the owner or operator to provide
information and data to, and consult with, the implementing agency, is
adequate and will ensure timely consideration of the information
presented. EPA believes there is sufficient time built into the initial
notification and consultation process, and the subsequent appeals
process, particularly considering that the provisions apply to third-
party audits required due to accidents or conditions at the facility
that could lead to an accidental release of a regulated substance, and
taking into account the need, in these circumstances, to take prompt
action to identify and correct deficiencies.
e. Schedule for Conducting a Third-Party Audit
One commenter supported the proposed 12-month timeframe to complete
a third-party audit. However, a few commenters opposed the proposed
schedule. One commenter said that it would not be reasonable or
appropriate to require completion of an audit report within twelve
months by default. Some comments suggested modifying the rule to allow
extensions of time to conduct third-party audits. Some comments sought
clarification concerning the timing of a third-party audit. One
commenter stated that the proposal seems to include inconsistent
requirements for the required timing of third-party audits. Another
commenter stated that, although it seems that EPA intended to require
the third-party audit to be completed within 12 months of a triggering
event, the deadline would be even sooner if the next scheduled
triennial compliance audit is fewer than 12 months away. A few
commenters encouraged EPA to clarify that conducting a third-party
audit would count as the scheduled compliance audit and reset the clock
on the three-year compliance audit schedule.
In response to comments, EPA has revised the regulatory text to
clarify that the schedule for conducting a third-party audit, unless a
different timeframe is specified by the implementing agency, is within
12 months of an RMP reportable accident or within 12 months of the date
of the implementing agency's final determination. If the final
determination is appealed, the third-party audit is required within 12
months of the date of the final decision on the appeal. EPA believes
that the 12-month timeframe in the final rule provides sufficient time
for owners or operators to complete a third-party audit while avoiding
unnecessary delays in identifying and addressing noncompliance.
Additionally, the final rule allows the implementing agency to specify
a different timeframe for conducting third-party audits. This allows
flexibility for an implementing agency to grant an extension, or to
specify a shorter timeframe, to complete the audit, as appropriate. For
example, an implementing agency may grant an extension if a source can
demonstrate that it has had difficulty finding a qualified third-party
auditor to conduct or lead the audit team, or that the audit will
require extra time due to the complexity or number of processes, due to
extensive damage to the facility following an incident, or due to
resource constraints. Alternatively, the implementing agency may
specify a shorter timeframe to complete the audit after considering the
severity of the release or determining that unsafe conditions exist at
the source.
EPA acknowledges that in some cases, the default result of these
timeframes may be that a gap of greater than three years may occur
between completion of the previous compliance audit and a subsequent
third-party audit (e.g., if an accident triggering a third-party audit
occurs shortly before the facility's next regular compliance audit is
due). In these cases, the owner or operator will still have 12 months
to complete the third-party audit unless a different timeframe is
specified by the implementing agency. Finally, stationary sources are
required to audit compliance at least every three years, and a third-
party compliance audit counts toward meeting this recurring requirement
for purposes of determining the timing of the stationary source's next
compliance audit.
f. Process by Which Owners or Operators Select Third-Party Auditors
In the preamble to the proposed rulemaking, EPA sought comment on
potential alternative approaches to determining auditor competency and
independence, such as requiring third-party auditors to be accredited
by EPA or an independent auditing or accreditation body or board. EPA
received a range of public comments on this issue. Commenters disagreed
about whether facility owners and operators should be responsible for
determining and documenting third-party auditor qualifications for
competence and independence. A few commenters, including local agencies
and industry trade associations, supported having the facility, rather
than a regulatory agency, determine their third-party auditors'
qualifications. Another industry trade association agreed that auditor
competency should be determined and documented by individual owners and
operators but asserted that it should be the auditors' responsibility
to determine whether they qualify as independent. Other commenters,
however, including a state agency, facilities, and industry trade
associations, asserted that it is burdensome to the owners and
operators to require them to self-select qualified auditors that they
determined to be competent and independent. One commenter stated that a
facility cannot easily obtain and review a third-party auditing firm's
internal policies and procedures each time it engages a third-party
auditor. Two commenters further questioned whether facility owners and
operators would be sufficiently able to assess a third-party's
qualifications to perform the required audits.
A few commenters expressed support for establishing an
accreditation program for auditing firms while others
[[Page 4619]]
stated that determinations of third-party auditor competency and
independence are more properly performed by regulatory agencies. A
state agency suggested, as an alternative, establishing an auditor
oversight committee to include representatives from the facility, local
agencies, and the community. Another state agency commented that an
oversight committee would be needed to ensure that the process is truly
independent if the auditor is hired by the owner or operator and not by
the implementing agency. One commenter suggested that EPA approve
third-party auditors based on technical and other qualifications and
provide a list of those determined to be acceptable to industry. Some
local agencies suggested that the implementing agency should approve or
assist the facility in selecting a third-party auditor. One local
agency stated that existing accreditation from a recognized auditing
body should be allowed but not be the only prerequisite for being
qualified to conduct a third-party audit. An advocacy group suggested
that if an auditor failed to identify a crucial hazard that could have
prevented a catastrophic event, the auditor should lose its
accreditation until it corrects the problems that led to the failure.
EPA has considered these comments and believes that establishing an
accreditation program for third-party auditors would add time and costs
to the process of third-party auditor selection and engagement.
Therefore, in this final rule EPA has elected, instead, to focus on
streamlining the auditor competency and independence criteria. Owners
and operators are responsible for determining and documenting that the
third-party auditors are qualified pursuant to the rule's competency
and independence criteria. EPA believes this approach is consistent
with commenters' requests that the process for engaging the auditors
should be straightforward and allow for reasonable judgement of the
owner or operator in selecting third-party auditors. Owners and
operators routinely obtain and review the internal policies,
procedures, and qualifications of a wide range of consultants and
contractors before engaging them in order to assess their
qualifications to perform consulting or contractual services. EPA is
confident that owners and operators will be able to assess third-party
auditor qualifications in a similar manner.
g. Auditors and Audit Team Structure
In the preamble to the proposed rulemaking, EPA invited comment on
how to determine the roles and responsibilities for third-party
auditors and how to structure third-party audit teams. Many commenters,
including a Federal government agency, a state government agency,
facilities, and industry associations, stated that facilities should
have the flexibility to utilize internal staff who are much more
familiar with the facility and covered processes than outside
consultants. A facility commented that in the past it has used third-
party auditors and determined that the facility's existing internal
audit process provided an audit of equal or greater value than that of
the third-party. Industry trade associations also asserted that the use
of facility staff was more effective than third-party auditors because
crucial time is not lost in learning about the facility. Another
industry trade association stated that, in addition to identifying
deficiencies, the most effective audits identify opportunities for
improvement, which the commenter asserted is why audits that are
conducted by or overseen by corporate staff or staff from other
facilities within a company with similar processes can be more
effective than strictly third-party audits. A professional association
stated that companies must determine their own policies, procedures,
and programs for performing audits. Similarly, an industry trade
association stated that owners and operators should be allowed to
choose whether in-house personnel or a third-party auditor conduct the
compliance audit, as long as the organization can demonstrate that the
auditor is qualified.
Industry trade associations commented that EPA's proposed approach
may have unintended consequences on the effectiveness of audits by
setting up an adversarial relationship between the regulated facility
and the third-party auditor and creating a scenario that discourages
the free flow of information between the facility and the auditor.
Furthermore, an industry trade association commented that this
fundamental change to the RMP audit program will likely cause companies
to separate RMP and PSM audits. The commenter argued that such a change
would demonstrate that EPA had failed in this rulemaking to satisfy its
statutory obligation to develop a coordinated approach with OSHA. An
individual commenter recommended the Institute of Nuclear Power
Operations evaluation team model, which is a hybrid of a self-audit and
a third-party audit by well qualified individuals. An industry trade
association suggested setting up an industry sharing option (similar to
the Occupational Safety and Health Administration's Voluntary
Protection Program, which uses qualified personnel from other regulated
facilities or company employees from a different plant to perform
audits at facilities being evaluated under the program) in lieu of
third-party auditing firms.
A Federal government agency recommended that third-party auditors
be required to consult with facility employees and their
representatives when conducting audits, reasoning that this requirement
would be consistent with the language in the CAA at 29 U.S.C. 651 et
seq. and EPA guidance on worker participation during EPA audits and
inspections. And although opposed to the proposed requirement for
third-party audits, an industry trade association asserted that there
can be value in having/adding a third-party individual on or in
coordination with a self-audit team, reasoning that the addition of the
third-party auditor contributes to the development of the internal
experts and expertise.
In response to commenters' suggestions to allow more flexibility on
the composition of the audit team, EPA is finalizing an approach that
allows owners or operators to meet their third-party auditing
obligations either by:
Engaging third-party auditors meeting all applicable
competency and independence criteria, as originally proposed, or
By assembling an auditing team which is led by a third-
party auditor but may include other audit team members. The audit team
may be comprised of:
[cir] A team leader--this must be an employee of the third-party
auditor firm who meets all of the competency and independence criteria
of the rule;
[cir] Other employees of the third-party auditor firm--these
personnel must meet the independence criteria of the rule; and
[cir] Other personnel not employed by the third-party auditor firm
(e.g. facility personnel or employees of another consulting firm with
specialized expertise). These personnel are not required to meet the
competency and/or independence criteria of the rule.
EPA agrees with commenters who suggest that allowing facility
personnel and other knowledgeable but non-independent contractors and
consultants to participate in the audit would improve the audit teams'
performance and outcomes. This change addresses, among other things,
the commenters' concerns that requiring the audit team and all of its
individual members to meet the full independence criteria would exclude
too many potential team members with critical sector or facility-
specific experience.
[[Page 4620]]
This approach allows qualified personnel from other regulated
facilities or company employees to participate in the audit and enables
facility personnel to provide input during the compliance audit.
Although some commenters suggested that facility's existing
internal audit process provided an audit of equal or greater value than
that of a third-party, EPA believes that an independent, third-party
perspective can provide insight on the facility's risk management
program that may not otherwise be identified during an internal
compliance audit. EPA further disagrees that this change to the RMP
audit program will cause companies to separate RMP and PSM audits. EPA
believes that the flexible approach for assembling a third-party audit
that includes both independent and facility personnel will allow
facilities to continue to conduct RMP and PSM audits simultaneously, as
appropriate.
h. Auditor Qualifications and Responsibilities
General comments on qualification criteria. Many commenters stated
that the requirements in the proposed rulemaking for every member of
the third-party auditing team to individually meet all of the proposed
rulemaking's competency and independence criteria will severely reduce
the number of qualified auditors available and raise the costs of
auditing for facilities. One facility argued that the auditor
qualification requirements are arbitrary and should be withdrawn.
Specifically, the commenter described the findings from the EPA-Wharton
pilot study and concluded that this study undermines EPA's assertion in
the proposal that rigid qualifications are necessary for a successful
RMP third-party audit program. A professional association recommended
that EPA require companies to develop, implement, and maintain
effective policies, procedures, and programs for performing RMP audits.
Such policies, procedures, and programs could themselves establish
basic third-party auditor competency and independence criteria.
EPA agrees with commenters that the proposed qualification criteria
could limit availability of qualified auditors and raise costs of
audits. Therefore, EPA is finalizing an approach that allows owners or
operators to comply with third-party auditing requirements either by
engaging third-party auditors that meet all applicable competency and
independence criteria, as originally proposed; or by assembling an
auditing team, led by a third-party auditor, that includes other
personnel (e.g., consultants or facility employees).
EPA disagrees with commenters who argue that auditor qualifications
are unnecessary for a successful third-party audit program. EPA's goal,
in proposing criteria for auditor qualifications, was to ensure clarity
and objectivity as to the minimum expected standards third-party
auditors must meet for competency and independence. Since EPA is not
finalizing requirements for third-party auditors to be qualified or
accredited by an outside independent accreditation board, nor to meet
competency and independence criteria in external consensus standards or
protocols, the final rule must necessarily specify third-party auditor
competency and independence criteria. Such criteria are necessary to
ensure that owners and operators are able to successfully identify and
engage fully qualified, competent and independent third-party auditors.
Consensus standards. EPA did not propose that consensus standards
apply to third-party audits or auditors. However, in the preamble to
the proposed rulemaking, EPA sought comment regarding potentially
relevant and applicable consensus standards and protocols that might
apply to the third-party auditors or audits that could be incorporated
into the rule. Some commenters recommended that EPA use existing
guidelines and standards including the CCPS ``Guidelines for Auditing
Process Safety Management Systems'' and National Fire Protection
Association codes and standards. One commenter stated that establishing
protocols for auditing would assist in ensuring that a third-party
audit is being performed to some type of recognized standard. However,
the commenter stated that it is not aware of the establishment of such
a standard at this time and noted that EPA might be required to work
with a standard setting organization to develop the standard, if such a
standard was to be provided to facilities and auditors. One commenter
stated that the International Code Council (ICC) administers exams for
building, fire, plumbing, and many other trade inspectors. An industry
trade association commented that it opposed a requirement that
consensus standards and protocols be incorporated into compliance
audits and asserted that such a requirement was not within the scope of
Executive Order 13650.
A few commenters, including a local government agency, noted that
consensus standards may result in the bar for acceptable procedures
being set low. Although noting that consensus standards could offer
some minimum criteria to follow, a commenter stated that applying
consensus standards to third-party compliance audits could be
problematic because they are the lowest high-bar industry has agreed
to, which runs the risk of lowering the bar for select companies or the
consultants hired to perform the audit.
EPA acknowledges that consensus standards and protocols are
referenced in a range of Federal and state regulations and can play
useful roles in third-party verification programs. California's
Underground Storage Tank program is an example of a program that relies
on consensus standards in which designated operators are required to
pass an exam administered by the ICC in order to be certified to
conduct audits.\38\ However, EPA has determined that reference to such
standards and protocols is unnecessary for third-party compliance
audits conducted under this rule because the final rule identifies
qualification criteria for competency and independence for third-party
auditors and third-party auditor team leaders.
---------------------------------------------------------------------------
\38\ See, e.g., CA UST Regulations (CCR, Title 23, Division 3,
Chapter 16), Amended and Effective July 1, 2012) at Sec. 2715
(Certification, Licensing, and Training Requirements for Underground
Storage Tank Owners, Operators, Installers, Service Technicians, and
Inspectors). https://www.swrcb.ca.gov/ust/regulatory/docs/title23_d3_c16.pdf
---------------------------------------------------------------------------
EPA is also finalizing third-party auditor responsibilities in
Sec. Sec. 68.59(d) and 68.80(d). This provides the third-party auditor
with minimum expectations for conducting the compliance audit. The
owner or operator shall ensure that the third-party auditor:
Manages the audit and participates in audit activities
including: Initiation, design, implementation, and reporting;
Determines appropriate roles and responsibilities for the
audit team members;
Prepares the audit report and ensures all audit team
members' views are reflected in the final audit report;
Certifies the final audit report and its contents as
meeting the requirements of the rule and
Provides a copy of the audit report to the facility owner
or operator.
Third-party auditors must evaluate the audit team members'
qualifications to determine appropriate audit roles and
responsibilities in order to produce audit outcomes and final audit
reports meeting the applicable rule requirements. This approach
recognizes that audit team members may have varying levels of knowledge
and experience with the RMP rule requirements, the stationary source
being audited, the applicable or relevant
[[Page 4621]]
engineering practices, and proper auditing techniques. EPA believes it
is appropriate for the third-party auditor to be responsible for these
determinations and that this approach allows the owners or operators
and the third-party audit team leader to successfully collaborate to
assemble an effective auditing team.
i. Third-Party Auditor Competency Criteria
Almost all of the public comments on the proposed third-party
auditor competency criteria focused on the requirement for the auditor
to be a licensed Professional Engineer (PE) or include a licensed PE on
the audit team. PE organizations supported the proposed requirement
arguing that many facilities that would require third-party audits are
designed, constructed, and maintained by PEs, who are subject to
professional ethical standards that require objectivity. Some of these
commenters described the supply of PEs as being sufficient to meet the
demand for the third-party auditors under the approach in the proposed
RMP rule.
However, a large number of commenters opposed the proposed PE
competency criterion. Many commenters stated that they saw no value in
requiring a PE because PEs do not specifically have process safety or
auditing skills. Several commenters questioned whether there are a
sufficient number of PEs with appropriate experience to meet the need
for RMP audits. As an industry trade association observed, even though
the number of PEs may be large, there may be an insufficient number of
PEs that have third-party audits as an area of expertise. A facility
asserted that every PE cannot practice in every state, and if a PE is
part of the audit team, he or she must be licensed in the state
affected by the RMP incident.
As part of the feedback for the SBAR Panel for the proposed
rulemaking, SERs suggested that EPA consider allowing other qualified,
credentialed personnel besides PEs to qualify as third-party auditors.
Such other personnel could, SERs suggested, be degreed chemists,
degreed chemical engineers, Certified Safety Professionals (CSP),
Certified Industrial Hygienists (CIH), Certified Fire Protection
Specialists (CFPS), Certified Hazardous Materials Managers (CHMM),
Certified Professional Environmental Auditors (CPEA) or Certified
Process Safety Auditors (CPSA). SERs indicated that these credentials
also include ethical obligations to provide sound independent advice.
Many other commenters also suggested that professionals with process
safety management experience who have other credentials subject to
ethical standards should also be allowed to give facilities a larger
choice for their third-party auditors. Another facility and an industry
trade association commented argued that the owner or operator is in the
best position to assess who is qualified to perform the audit. Two
commenters characterized the EPA-Wharton Pilot Study on Third-Party
Audits \39\ as suggesting that relevant industry and process specific
experience, training, and regulatory knowledge are the essential
qualifications of RMP auditors and that the PE requirement should be
withdrawn.
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\39\ EPA conducted a pilot study with the Wharton School of the
University of Pennsylvania on the efficacy of voluntary third-party
RMP audits. For relevant reports from this pilot, see R. Barrish, R.
Antoff, & J. Brabson, Dep't of Natural Resources & Env. Control,
Third Party Audit Pilot Project in the State of Delaware, Final
Report (June 6, 2000) https://opim.wharton.upenn.edu/risk/library/2000_RAB,RA,JB_3rdPartyAudit_Delaware.pdf and EPA Region 3, Third-
Party Pilot Project in the Commonwealth of Pennsylvania, Final
Report (February 2001).
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EPA agrees with commenters that stated it is unnecessary for third-
party auditors to be PEs and that a variety of qualified personnel can
potentially be effective third-party auditors or third-party audit team
leaders. Consequently, EPA deleted the PE requirement from the final
rule. EPA believes it is sufficient for the third-party auditor or
third-party audit team leader to be:
Knowledgeable with the requirements of the RMP rule;
Experienced with the stationary source type and processes
being audited and applicable recognized and generally accepted good
engineering practices; and
Trained or certified in proper auditing techniques.
Third-party auditors can meet the requirement to be knowledgeable
with the RMP rule requirements, and the requirement to be experienced
with the stationary source type and processes being audited and
applicable recognized and generally accepted good engineering practices
through a variety of ways, including prior experience and training.
Third-party auditors can meet the requirement to be trained or
certified in proper auditing techniques by completing courses in
environmental or safety auditing, obtaining certifications from
recognized professional bodies, or having prior process safety auditing
experience.
EPA has also established third-party auditor responsibilities in
Sec. Sec. 68.59(d) and 68.80(d). If the third-party auditor believes
that a necessary skill or expertise is lacking in the auditing team,
the owner or operator and third-party auditor are responsible for
augmenting the audit team with the additional team members needed to
supply the missing skill or expertise. For example, an owner or
operator may choose to designate an employee competent in using an
infrared camera to participate on a third-party auditing team. Such an
audit team member would be acceptable, even though the individual does
not meet the independence criteria and lacks specific knowledge of the
stationary source type and processes being audited, as long as the
third-party audit team leader evaluates the employee's qualifications
to perform the specific role the employee will perform in the audit.
The same standard would also apply to the participation of any other
personnel the owner or operator might choose to include when assembling
the third-party audit team.
j. Third-Party Auditor Independence Criteria
A few commenters, including a Federal and two local government
agencies, supported the proposed provisions for ensuring auditor
independence. Some local government agencies agreed that the proposed
requirement for auditors to have written policies and procedures to
ensure that personnel comply with the proposed competency,
independence, and impartiality requirements is appropriate. Several
commenters, however, warned that the independence criteria would be
difficult to monitor and enforce. Conversely, many commenters opposed
the third-party auditor independence criteria, arguing that the
criteria are too restricted and will limit the availability of third-
party auditors and the quality of the audits.
Availability of third-party auditors. Some commenters warned that
the proposed auditor independence criteria would have the unintended
consequence of reducing the quality of the audits and/or the
availability of sufficiently qualified auditors. A few commenters
suggested that the lack of ability for employees to participate on the
audit team could lead to an adversarial relationship, inhibiting the
impartial fact-finding an audit is supposed to facilitate. Some
commenters stated that the independence criteria would, in practice,
discourage open and productive auditor-source dialog, that auditor
unfamiliarity with the audited facilities could turn the audits into
``check-the-box'' exercises, and that new and unfamiliar auditors will
feel
[[Page 4622]]
pressure to be ``trigger happy'' on finding deficiencies. An industry
trade association suggested that facilities should be allowed to
petition for a relaxation of these requirements if auditors cannot be
identified.
As part of the SBAR Panel process, some SERs raised concerns about
the extent of the independence criteria and suggested this would limit
the availability of qualified auditors. Specifically, these SERs were
concerned that the independence criteria would rule out, as third-party
auditors, all of the members of any auditing firm employing any
personnel who previously worked for or otherwise engaged in consulting
services with the owner or operator. This was deemed problematic
because, in the SERs' experience, many, if not most, otherwise
qualifying audit firms hire retired personnel specifically because the
personnel have sector, company, and/or facility-specific experience
with firms subject to the RMP rule. Numerous other commenters observed
that consulting firms perform a wide variety of work for RMP facilities
of which only a fraction is auditing but the new restrictions could
cause those firms to exit the auditing market rather than risk losing
their other business lines.
In order to address concerns about the availability of auditors,
EPA modified the third-party auditor independence criteria in the final
rule to enable more firms and individuals to qualify as third-party
auditors or third-party audit team leaders. The final rule
modifications provide additional flexibility while still ensuring that
audit teams are managed and operated independently to produce the types
of enhanced audit outcomes commonly associated with independent
auditors per the literature and evidence described in the preamble to
the proposed rulemaking and in this document.
EPA made many significant changes to the third-party independence
criteria. The most significant modification to the third-party audit
requirements is that only employees of the independent third-party
audit firm must meet the independence criteria of Sec. 68.59(c)(2)
and/or Sec. 68.80(c)(2). For third-party audit teams, the team leader
must meet both the competency and independence criteria of Sec.
68.59(c) and/or Sec. 68.80(c) and all other employees of the third-
party auditor firm that participate on the team need only meet the
independence criteria. Third-party audit teams may also include other
personnel, such as consultants or facility employees and these
personnel are not subject to the third-party qualification criteria of
the final rule.
EPA also revised the timeframe within which third-party auditors
cannot provide business or consulting services to two years. EPA also
added language indicating that if a third-party-firm employs personnel
who have provided business or consulting services to the facility
within the prescribed timeframe (i.e. within two years of the audit)
then the third-party audit firm must ensure that these personnel do not
participate on the audit team. Additionally, EPA clarified in
regulatory language the circumstances in which a retired employee may
participate in a third-party audit. Viewed as a whole, these changes
serve to increase the types of personnel who may potentially serve as
independent third-party auditors. Therefore, EPA believes it will be
unnecessary for facility owners or operators to petition for a
relaxation of auditor qualifications.
Criteria limiting past and future business or consulting services
and future employment. A large number of commenters specifically
opposed the proposed independence provisions, particularly the
requirement that an auditor cannot have provided other consulting
services to the owner or operator in the prior three years and cannot
accept future employment for three years following submission of the
final audit report. Some commenters stated that third-party auditing is
entirely unnecessary for RMP facilities because there is no evidence to
believe that internal auditors working for, or employed by, facility
owners or operators would deliberately fail to conduct honest and
complete audits because of their prior, current, or future financial or
employment ties to the owners or operators. Many commenters stated that
to disqualify auditors who have performed certain services for the
owner or operator of a facility within the past three years would
disqualify those auditors who are most familiar with a source's
operations, and facilities would be forced to select auditors who are
unfamiliar with the facility and its processes. Many commenters
emphasized that audit teams should include personnel with direct,
personal familiarity with the facility (including facility employees)
to ensure effective RMP compliance audits. Commenters stated that this
could be of concern particularly for plants with complex engineered
processes requiring site-specific expertise.
In response to these comments, in the final rule EPA has modified
the three-year prohibition on auditors providing prior consulting
services to (other than auditing services) or subsequently being
employed by the owner or operator to a two-year prohibition. This
prohibition applies only to employees of the third-party auditor firm.
Owners or operators can assemble a third-party audit team led by a
third-party auditor that meets both the competency and independence
criteria of the final rule. The third-party audit team can also include
other non-independent personnel such as current or former employees of
the facility or other persons with prior site-specific experience. This
revision, itself, will enable a much broader and more diverse set of
auditors to serve on the audit teams, including knowledgeable facility
personnel, other personnel employed at different facilities owned by
the regulated company, and a variety of second or third-party personnel
such as consultants and contractors. Only employees of the third-party
auditor firm leading the audit team are subject to the independence
criteria of the final rule and only the individual leading the third-
party audit team is subject to both the competency and independence
criteria of the final rule.
Retired employees. Commenters and SERs supported allowing company
retirees to participate on audit teams.
EPA agrees with commenters. EPA modified the final rule to clearly
identify that retired employees who otherwise satisfy the third-party
auditor independence criteria may still qualify as independent if their
sole continuing financial attachments to the owner or operator are
employer-financed or managed retirement and/or health plans. This
revision clarifies that owners or operators can hire retired employees
with specialized knowledge or experience with the source type or
facility to participate in third-party audits.
Effectiveness of self-audits. Three trade associations stated that
EPA failed to adequately demonstrate through statistical or other
analyses that the RMP rule's self-auditing requirement was deficient or
that independent auditor certification is necessary. Some commenters
stated that the proposed third-party auditing requirements and criteria
are unnecessary because the record does not demonstrate widespread RMP
self-auditing-related fraud. One association referenced the CSB's
report on the Texas City refinery accident as suggesting that
management's failure to implement prior self-audit recommendations is
of greater concern than self-audit inadequacy, per se.
While third-party auditing is useful for minimizing the potential
for fraudulent behavior or reporting, EPA believes that helping to
prevent or
[[Page 4623]]
minimize fraud is but one positive independent third-party auditing
outcome. In fact, the third-party auditing requirements are intended to
improve auditing practices and outcomes by also correcting biases shown
by the literature to be associated with self-auditing. These biases are
compelling precisely because they are not the hallmark solely of
fraudulent firms but are exhibited commonly by entities with no overt
or covert malicious intent to be inaccurate or unfair in their auditing
or reporting.\40\
---------------------------------------------------------------------------
\40\ See, e.g.: (1) Short, Jodi L., and Michael W. Toffel, The
Integrity of Private Third-party Compliance Monitoring, Harvard
Kennedy School Regulatory Policy Program Working Paper, No. RPP-
2015-20, November 2015. (Revised December 2015) https://www.hbs.edu/faculty/Pages/item.aspx?num=50186; (2) Lesley K. McAllister,
Regulation by Third-Party Verification, 53 B.C. L. Rev. 1 (2012).
https://lawdigitalcommons.bc.edu/cgi/viewcontent.cgi?article=3182&context=bclr; (3) Esther Duflo et al.,
Truth-Telling by Third-Party Auditors and the Response of Polluting
Firms: Experimental Evidence From India, 128 Q.J. Econ. 1499, 1499
(2013) https://qje.oxfordjournals.org/content/128/4/1499.abstract.
---------------------------------------------------------------------------
EPA's recent experience demonstrates that in some cases self-
auditing is deficient. In the preamble to the proposed rulemaking, EPA
referenced enforcement settlements requiring third-party auditing of
settlement agreement implementation and compliance at facilities
handling CAA section 112(r) chemicals. One such settlement is the
administrative order on consent issued by Region 1, in 2015, to Mann
Distribution LLC and 3134 Post Road LLC (Respondents) to address
Resource Conservation and Recovery Act (RCRA) and CAA section 112(r)(1)
(the ``general duty clause'') violations found during an April 4, 2013
inspection at a chemical distribution facility in Warwick, Rhode
Island. Like the Risk Management Program requirements, section
112(r)(1) of the CAA addresses safe operation and prevention of
accidental releases. Unsafe conditions found during the inspection
included, among other things, failure to have a fire suppression
system, failure to inspect a fire alarm, co-location of incompatible
chemicals, and many RCRA generator violations. The facility also had a
prior history of noncompliance. The order required Respondents to,
among other things, implement an independent third-party inspection
program. The Respondents agreed to the program because they wanted to
maximize the benefits of implementing the administrative order on
consent by accelerating the improvement of the culture of compliance
and safety at the facility.
Since the proposed rulemaking was published, EPA has received and
reviewed the Mann independent third-party inspection team's audit
reports. These reports state that the third-party team found several
compliance and safety issues the facility owner and operator had not
independently found or corrected. The suite of audits uncovered and
tracked the correction of these deficiencies. EPA has also received
feedback from a facility representative and its third-party auditor
about the program. All of the involved parties--EPA, facility
representative, and the third-party auditor--agreed that the new and
independent third-party auditing required pursuant to the enforcement
order was beneficial for both correcting specific deficiencies and
improving a culture of compliance. The suite of four third-party
inspections improved the company's hazardous materials management plan,
plan implementation, and emergency response program. As of March 2016,
corrections to issues identified by the third-party auditors produced
results including safer storage of chemicals that are oxidizers,
improved integrity testing and maintenance of chemical storage tanks;
better emergency egress, training, and coordination with the fire
department; and improvements in container storage (such as better
labeling and more aisle space). After a year of audits, the audit team
leader provided some constructive suggestions about how EPA could
modify third-party audit requirements in the future. For example, she
felt that one of the order's auditor independence criterion (a five-
year ban on future work with the company) was excessive as such a
requirement, in light of New England's contracting manufacturing/
industrial market, might serve as a disincentive to the participation
as third-party auditors by highly qualified professionals and firms.
Also, although this order did not require that the audit team include a
PE, the auditor said she was aware that EPA was considering requiring
PEs for future audits and believed that such a requirement would be
unnecessary because good practice suggests that team make-up and
qualifications should be determined on a case-by-case basis.
EPA agrees with the commenters stating that auditors with facility-
specific experience can contribute insights that independent auditors
lacking such experience would be unlikely to contribute. EPA addressed
this comment in the final rule by, among other things, modifying the
final rule to allow owners or operators to include non-independent
employees, contractors, or consultants with facility-specific
experience on the third-party auditing teams.
EPA continues, however, to believe that the ``fresh eyes'' and
perspectives that third-parties contribute to audit teams support the
approach in this rule to third-party auditing for the small subset of
RMP facilities that have RMP reportable accidents or conditions at
their stationary sources that could lead to an accidental release of a
regulated substance. In this context, EPA has assessed available
empirical research suggesting why independent auditors lacking prior
facility-specific experience can actually produce better audit outcomes
than personnel with prior site-specific experience. This research
suggests independent personnel can audit the facilities they monitor
with ``fresh eyes'' and thus be more likely to identify issues of
concern. While the research that follows primarily involves government
inspectors, EPA believes that the findings correlate to designing
effective third-party auditing programs.
One such study concerns the relationship of inspector experience
and product recalls in the medical device industry.\41\ The study's
authors explain:
---------------------------------------------------------------------------
\41\ Ball, George and Siemsen, Enno and Shah, Rachna; Inspector
Experience and Product Recalls in the Medical Device Industry (June
2, 2014). Available at https://ssrn.com/abstract=2445022, https://dx.doi.org/10.2139/ssrn.2445022, or https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2445022.
Plant inspections enable supply chain partners to manage quality
risk in global supply chains. However, surprisingly little research
examines the behavioral aspects of inspectors' work. Drawing on
insights from the experience, learning, and complacency literatures,
we examine the how well plant inspection outcomes predict future
recalls and analyze the effect of inspector experience on both the
information content of plant inspections as well as the prevalence
of product recalls. Using secondary data spanning a 7-year period in
the medical device industry and a recurrent event Cox Proportional
Hazard model, our results show that inspection outcomes contain
information and hence predict future product recalls, and that this
relationship is moderated by inspector experience. . . . [T]he
hazard of recalls at a plant increases if the same inspector
continues to inspect the plant, independent of the inspection
outcome. Recall hazard increases by 48% the second time an inspector
visits a plant, and 63% by the third visit. These results indicate
the need to rotate inspectors among plants and have important
---------------------------------------------------------------------------
implications for managers, regulatory agencies, and theory.
The authors' views on the drivers for these outcomes are
informative. Although significant literature exists indicating that
sending the same auditor or inspector to repeatedly inspect a facility
can lead to familiarity, that
[[Page 4624]]
weakens an auditor's independence and compromises audit outcomes,\42\
these were not the above study's primary findings. Rather, the authors
found that the worsening inspection outcomes over time were likely
primarily due to inspector complacency. In the authors' words,
---------------------------------------------------------------------------
\42\ See, e.g., Abigail Brown, The Economics of Auditor Capture,
Edmond J. Safra Center for Ethics, Harvard University (Nov. 8, 2011)
at https://abigailbrown.files.wordpress.com/2009/08/auditor-capture-111108.pdf (``[T]here does not need to be an explicit exchange of
bribes to sustain a collusive equilibrium, suggesting that social
norms and psychological biases reinforce rational action and allow
profitable collusion to occur with little conscious intent.'' Id. at
Abstract).
The stale, routine nature of the job, and the familiarity which
comes from repeat visits to a site, can lead to complacency and
lower the information contained in an inspection, even when the
investigator has no clear incentive to `go easier' on an inspection
---------------------------------------------------------------------------
site.
These complacency effects ``may outweigh the benefits [such repeat
visits have on inspector] learning.'' Another analysis of 426,831
unannounced inspections by state government inspectors from July 2003
through March 2010 found that new inspectors tend to have ``fresher
eyes'' in their first visit to a restaurant, reporting 12.7-17.5% more
violations than the second visit of a repeat inspector, and that this
effect is more pronounced when the previous inspector had a longer
relationship with the restaurant.\43\
---------------------------------------------------------------------------
\43\ Ginger Zhe Jin & Jungmin Lee, A Tale of Repetition: Lessons
from Florida Restaurant Inspections, National Bureau of Eco.
Research Working Paper No. 20596 (Oct. 2014). https://www.nber.org/papers/w20596.
---------------------------------------------------------------------------
Findings such as these, and the policy implications that flow from
such studies, address human behavioral and psychological influences
that appear to be common to inspection and auditing regimes. Thus,
although not expressly required by this rule, EPA encourages owners or
operators, when assembling both third-party audit teams and conducting
self-audits under the RMP rule, to include on their teams a mix of
personnel previously familiar, and unfamiliar, with the specific
facilities they are tasked with auditing.
Finally, EPA agrees with commenters that it is critical that
facility owners and operators implement corrective actions to address
findings from compliance audits. Therefore, the final rule requires the
owner or operator to certify in the findings response report that
deficiencies are being corrected. As an additional measure to ensure
accountability, EPA is also requiring a copy of the findings response
report and schedule to implement deficiencies to be submitted to the
auditing committee of the Board of Directors or other comparable
committee or individual, if applicable.
Validity of examples of third-party audits. Commenters sought to
criticize the many examples of third-party auditing provided by EPA in
the preamble to the proposed rulemaking, including mandatory and
voluntary programs by regulators and industry trade associations, on
the grounds that these other regulations and programs operate in a
different context from that of the RMP rule (i.e., that the literature
and empirical data on the effectiveness of third-party auditing cited
by EPA do not specifically address regulatory compliance auditing at
RMP facilities). These commenters stated that most or all of EPA's
examples of other Federal, state, and voluntary or industry independent
auditing do not relate to RMP rule compliance, and therefore limit the
transferability of these programs' design features and outcomes to the
RMP context. The associations further stated that there is no evidence
showing:
A systemic problem with RMP facilities' self-audits or
that employees or contractors act unethically or are biased;
A lack of auditor independence creates bias leading to
accidents;
Third-party audits would have successfully prevented past
accidental releases; or
The root causes of a significant number of past accidents
at RMP facilities were deficient self-audits.
EPA disagrees with commenters. Because RMP facilities were not
previously required to have third-party compliance audits,
statistically valid outcome data specifically on RMP rule third-party
auditing does not currently exist. As EPA has described, however, there
is a considerable and growing body of literature and empirical data on
the effectiveness of third-party auditing, generally. These literature
and data occur in many contexts that involve a diverse set of statutes
and voluntary standards. In fact, some of these contexts are similar to
RMP auditing.
In the preamble to the proposed rulemaking, EPA presented many
examples of Federal and state agencies and trade association third-
party verification programs. Like the RMP rule, some of those programs
are expressly described by their managers as designed to improve
regulatory compliance, prevent or reduce risks, or improve safety at
the same or similar facility types and operations as are regulated by
the RMP rule. These programs reflect industry recognition that third-
party auditing does, in fact, produce better outcomes relative to self-
auditing in a variety of settings. Such programs include: \44\
---------------------------------------------------------------------------
\44\ EPA has not formally evaluated these programs and standards
or their outcomes. This discussion is not a formal Agency review or
endorsement.
---------------------------------------------------------------------------
Responsible Care. This program is described by ACC as
identifying, and acting to address potential hazards and risks
associated with their products, processes, distribution and other
operations.\45\ Responsible Care's Guiding Principles include
``mak[ing] continual progress toward a goal of no accidents, injuries
or harm to human health and the environment from products and
operations and openly report health, safety, environmental and security
performance.'' \46\ The Responsible Care management system process
includes mandatory certification, by auditors described by ACC as
accredited and independent, to ensure the program participants have a
structure and system in place to measure, manage and verify
performance.\47\ The Responsible Care Web site provides, ``A key part
of the Responsible Care Management System process is mandatory
certification by an independent, accredited auditor.'' \48\
---------------------------------------------------------------------------
\45\ ACC. 2012. Responsible Care Product Safety Code. https://responsiblecare.americanchemistry.com/Product-Safety-Code/.
\46\ ACC Responsible Care Guiding Principles. https://responsiblecare.americanchemistry.com/ResponsibleCare/Responsible-Care-Program-Elements/Guiding-Principles/.
\47\ Certification must be renewed every three years, and
companies can choose one of two certification options. RCMS[supreg]
certification is intended to verify that a company has implemented
the Responsible Care Management System. RC14001[supreg]
certification combines Responsible Care and ISO 14001 certification.
See https://responsiblecare.americanchemistry.com/Responsible-Care-Program-Elements/Management-System-and-Certification and https://responsiblecare.americanchemistry.com/Responsible-Care-Program-Elements/Process-Safety-Code/Responsible-Care-Process-Safety-Code-PDF.pdf.
\48\ ACC Responsible Care Management System. https://responsiblecare.americanchemistry.com/Management-System-and-Certification/.
---------------------------------------------------------------------------
The API Process Safety Site Assessment Program (PSSAP).
According to API, the PSSAP ``is focused on higher risk activities in
petroleum refining and petrochemical facilities. This program primarily
involves the assessment of a site's process safety systems by
independent and credible third-party teams of industry-qualified
process safety expert assessors.'' \49\ Using industry-developed
protocols, API describes the process safety site assessments as
evaluating the quality of written programs and effectiveness of field
implementation for the following process safety areas that
[[Page 4625]]
will be evaluated: Process Safety Leadership; MOC; Mechanical Integrity
(focused on fixed equipment); Safe Work Practices; Operating Practices;
Facility Siting; Process Safety Hazards; and HF Alkylation/RP 751.\50\
---------------------------------------------------------------------------
\49\ API. 2015. PSSAP. https://www.api.org/~/media/Files/
Certification/PSSAP/PSSAP-Brochure.pdf?la=en.
\50\ API. 2015. PSSAP. https://www.api.org/certification-programs/process-safety-site-assessment-programs.
---------------------------------------------------------------------------
Center for Offshore Safety (COS). This strategy for
promoting safety and protection of the environment includes third-party
auditing and certification of the COS member company's SEMS and
accreditation of the organizations (Audit Service Providers) providing
the audit services. The Center serves the U.S. offshore oil and gas
industry with the purpose of adopting standards of excellence to ensure
continuous improvement in safety and offshore operational integrity.
The third-party audits are intended to ensure that COS member companies
are implementing and maintaining Safety and Environmental Management
Systems (SEMS) throughout their deepwater operations.\51\ COS states
expressly that ``the highest level of safety for offshore drilling,
completions, and operations [is promoted through] independent third-
party auditing and certification.'' \52\
---------------------------------------------------------------------------
\51\ COS. 2013. See https://www.centerforoffshoresafety.org/auditInfo.html.
\52\ COS. 2015. See https://www.centerforoffshoresafety.org/About.
---------------------------------------------------------------------------
ChemStewards[supreg]. ChemStewards is a SOCMA program
intended to promote continuous performance improvement in batch
chemical manufacturing. The program offers a three-tiered approach to
participation. Each tier includes a third-party verified management
system.\53\ On its Web site, SOCMA describes the environmental benefits
of the program as including improving environmental performance,
decrease releases and waste disposal costs, and positioning members to
meet current and future compliance requirements.\54\ The associated
training materials explain the on-site audit elements of the third-
party verification program.\55\
---------------------------------------------------------------------------
\53\ SOCMA. 2015. See https://www.socma.com/ChemStewards/.
\54\ SOCMA, 2016. See Benefits of Implementing
ChemStewards[supreg]. https://www.socma.com/chemstewards/about/benefits.
\55\ SOCMA. See https://www.socma.com/Portals/0/Files/ChemStewards/ChemStewards_101_Training.pdf.
---------------------------------------------------------------------------
Additionally, the supporting literature and data described by EPA
in the proposed rulemaking preamble remain relevant to RMP compliance
auditing, notwithstanding the varied contexts they describe, because
such literature addresses cross-cutting human biases and behaviors,
common to all auditor and audit types, that can be addressed or
corrected through independent third-party auditing.\56\ EPA thus finds
that the state of the science, evidence, and data on the effectiveness
of independent third-party auditing programs supports requiring
independent third-party audits for RMP facilities with accidental
releases or conditions that could lead to an accidental release of a
regulated substance.
---------------------------------------------------------------------------
\56\ See, esp.: (1) Short, Jodi L., and Michael W. Toffel, The
Integrity of Private Third-party Compliance Monitoring, Harvard
Kennedy School Regulatory Policy Program Working Paper, No. RPP-
2015-20, November 2015. (Revised December 2015) https://www.hbs.edu/faculty/Pages/item.aspx?num=50186; (2) Lesley K. McAllister,
Regulation by Third-Party Verification, 53 B.C. L. Rev. 1 (2012).
https://lawdigitalcommons.bc.edu/cgi/viewcontent.cgi?article=3182&context=bclr; (3) Esther Duflo et al.,
Truth-Telling by Third-Party Auditors and the Response of Polluting
Firms: Experimental Evidence From India, 128 Q.J. Econ. 1499, 1499
(2013) https://qje.oxfordjournals.org/content/128/4/1499.abstract.
---------------------------------------------------------------------------
k. Third-Party Audit Report
Draft reports. EPA received numerous comments regarding the
proposed third-party audit reporting requirements. While no commenters
objected to the requirement to prepare an audit report, most commenters
opposed the proposed requirements to submit draft and final reports to
the implementing agency. Many commenters felt that a requirement to
submit draft reports before they have been vetted by internal
operations and management teams could have the unintended consequence
of incomplete or inaccurate information being distributed. Some of the
commenters added that the owner or operator should be able to ensure
that the audit report does not contain confidential business
information. Finally, some commenters stated that the proposed
requirement to document all changes made by the owner or operator to
audit report drafts would chill communications and information exchange
during audits.
EPA agrees with commenters. The final rule requires the third-party
auditor to prepare an audit report and provide it to the owner or
operator, but does not require that the draft or final reports be
submitted to the implementing agency. However, the third-party auditor
must summarize in the audit report any significant revisions between
draft and final versions of the report.
Submitting reports to the implementing agency. Many commenters,
including industry trade associations and facilities, objected to the
proposed requirement that third parties submit their reports to the
implementing agency at the same time, or before, the reports are sent
to the source. These commenters felt that this would prevent facilities
from being allowed to correct factual errors or present evidence that
the auditors either missed or were not aware of, which could markedly
change the audit's recommendations. Some commenters who opposed
distribution of audit reports to the implementing agency warned of the
potential release of confidential business information.
EPA agrees with commenters and deleted provisions that require the
third-party auditor to submit audit reports to the implementing agency.
Attorney-client communications. EPA received several comments
regarding the proposed limitation on claiming the audit report and
related records as attorney-client communications or attorney work
products. One commenter agreed with EPA that the audit report should
not be protected from disclosure under the attorney-client privilege.
Many commenters opposed EPA's proposal to prohibit companies from
asserting attorney-client privilege and attorney work product privilege
over third-party audits and related documents. The commenters argued
that EPA lacked authority to do this and that these privileges are
essential for purposes of legal representation. One commenter stated
that attorney-client privilege is a long-established common-law rule of
evidence, and asserted that any attempt to abrogate it across the board
is likely a violation of the Sixth Amendment. Similarly, another
commenter stated that the proposed limitations on attorney-client
privilege seem contrary to due process and legal rights that should be
afforded the owner or operators of the facility.
It remains EPA's position, as stated in the preamble to the
proposed rulemaking, that with respect to the attorney work product
privilege, the audit report and related records are produced to
document compliance. Audit reports and related records are similar to
other documents prepared pursuant to RMP rule requirements (e.g.,
process safety information, PHAs, operating procedures) and are not
produced in anticipation of litigation. They are analogous to work or
management practice records that show a regulated operation was
performed. With respect to the attorney-client communication privilege,
the third-party auditor is arms-length and independent of the
stationary source being audited. The auditor lacks an attorney-client
relationship with counsel for the audited entity. Therefore, in EPA's
view, neither the audit report nor the records related to the audit
report provided to the third-
[[Page 4626]]
party auditor, including documents originally prepared with assistance
or under the direction of the audited source's attorney, should be
considered attorney-client privileged. Nevertheless, EPA recognizes
that the ultimate decision makers on questions of evidentiary
privileges are the courts. Therefore, this rule does not contain a
specific regulatory provision prohibiting assertion of these
privileges.
l. Findings Response Report, Timeframe, and Response to Audit Findings
EPA received several comments relating to the proposed requirement
for the owner or operator to develop a findings response report within
90 days of receiving the final audit report, and to provide the report
to the implementing agency and the owner or operator's audit committee
of the Board of Directors. EPA also received comments opposing various
aspects of the proposed requirements for findings response reports.
Timeframe. Some commenters supported these proposed requirements.
One commenter urged EPA to shorten the required reporting from 90 days
to 30 days, arguing that deficiencies in compliance indicate a risk of
a catastrophic release that could harm the facility, its employees, and
the community. The commenter reasoned that 30 days is enough time to
review the audit report and develop a schedule to address deficiencies.
Other commenters objected to the proposed timeframe for preparing
and submitting the findings response report, stating that 90 days
provides for an insufficient timeframe for preparing the report. A few
commenters recommended a six-month timeframe. One commenter asserted
that EPA has not demonstrated that a 90-day period to develop a
findings response report is achievable. As an alternative to extending
the timeframe for all facilities, a few commenters urged EPA to
consider allowing facilities to obtain extensions as needed to
adequately address the concerns raised by third-party auditors.
EPA is finalizing the requirement that the owner or operator
prepare a findings response report as soon as possible, but no later
than 90 days after receiving the final audit report as proposed. EPA
believes this timeframe is appropriate for the owner or operator to
consider the findings of the audit report and determine a response to
each of the audit's findings. This approach allows the owner or
operator an opportunity to establish a schedule to implement corrective
actions that can extend beyond the 90-day period for developing the
findings response report and balances the need to promptly respond to
the audit findings. EPA notes that, in many instances, an owner or
operator may receive prior information about the audit's findings
before receiving a final audit report, particularly when the third-
party audit team includes facility personnel. This will give the owner
or operator additional time to consider its responses.
Submitting findings response report to implementing agency. Some
commenters opposed the proposed requirement to submit a findings
response report to the implementing agency. One such commenter stated
that EPA has not demonstrated a need for universal submission of an
action plan to respond to audit findings and schedule. Commenters also
expressed legal concerns about the findings response report. These
commenters raised concerns about not being able to dispute purported
violations or deficiencies identified by third-party auditors. Some
commenters asserted that refusing to afford companies the opportunity
to dispute audit findings raises fundamental due process concerns.
EPA agrees with the commenters and has eliminated the requirement
to submit findings response reports to the implementing agency in the
final rule. The audit report, findings response report and related
records must be retained at the stationary source in accordance with
the recordkeeping requirements in Sec. Sec. 68.59(g) and 68.80(g).
Eliminating the requirement to submit the findings response report
to the implementing agency also responds to commenters legal concerns.
The owner or operator can determine an appropriate response to each of
the audit report findings. This is similar to existing self-compliance
audit requirements for the owner or operator to promptly determine and
document an appropriate response to each of the findings of the
compliance audit.
In addition, there is no need for a process to dispute findings as
the relevant requirement in the final rule for each of the findings in
the audit report is to determine an appropriate response. In
determining an appropriate response, owners or operators may follow
EPA's existing guidance for addressing PHA team findings and
recommendations, which is based on OSHA's 29 CFR 1910.119, Process
Safety Management of Highly Hazardous Chemicals--Compliance Guidelines
and Enforcement Procedures for resolving such findings.\57\ Under these
guidelines, EPA considers an owner or operator to have resolved a
finding or deficiency when the owner or operator either has adopted or
implemented the associated recommendations or has justifiably declined
to do so. An owner or operator can justifiably decline to adopt a
recommendation where the owner or operator can document, in writing and
based upon adequate evidence, that one or more of the following
conditions is true:
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\57\ See page 7-7 of EPA's General Guidance on Risk Management
Programs for Chemical Accident Prevention (40 CFR part 68), EPA-550-
B-04-001, April 2004 https://www.epa.gov/rmp/guidance-facilities-risk-management-programs-rmp; and replacement pages B-21 and B-22 of
OSHA 29 CFR 1910.119, Process Safety Management of Highly Hazardous
Chemicals--Compliance Guidelines and Enforcement Procedures CPL 2-
2.45A CH-1, September 13, 1994 https://www.osha.gov/OshDoc/Directive_pdf/CPL02-02-045_CH-1_20150901.pdf.
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The analysis upon which the recommendation is based
contains material factual errors;
The recommendation is unnecessary to protect public health
and safety or the health and safety of the owner or operator's
employees, or the employees of contractors;
An alternative measure would provide a sufficient level of
protection; or
The recommendation is infeasible.
Where a recommendation is rejected, the owner or operator must
communicate this to the audit team and expeditiously resolve any
subsequent recommendations of the team. Provided that the owner or
operator addresses the audit report's findings by implementing the
findings or by justifiably declining to do so, the owner or operator
complies with the requirement. If an implementing agency concludes that
a justification is inadequate and brings an enforcement action
regarding this requirement, then the owner or operator may dispute the
enforcement action through the normal adjudication process.
m. Owner or Operator Certification to Findings Response Report
Certification burden. EPA received comments regarding the
certification to the findings response report. A few commenters opposed
the proposed certification requirement. Some commenters argued that the
certification requirement increases the regulated community's burden,
but provides no corresponding benefit. Other comments urged EPA to
incorporate the ``reasonable inquiry'' concept from Title V compliance
certifications into the proposed certification framework. These
commenters described the ``reasonable
[[Page 4627]]
inquiry'' concept as requiring certification based on ``information and
belief formed after reasonable inquiry.'' The commenters argued that
this was necessary because a senior official signing a certification
could not be expected to have or obtain personal knowledge of all the
facts potentially relevant to the findings response report. Similarly,
a facility encouraged EPA to coordinate the certification statement in
this rule with the certification statement that is already required
under CAA Title V. One commenter stated that EPA's rules regarding
self-audits impose a less stringent certification requirement, and
recommended that a less stringent standard may be appropriate here,
too, if the third-party compliance audit provisions are finalized.
In this rule, EPA is requiring a senior corporate officer, or an
official in an equivalent position, to certify in the findings response
report that:
He or she engaged a third-party to perform or lead an
audit team to conduct a third-party audit in accordance with the
requirements of 40 CFR 68.59 or 68.80,
The attached RMP compliance audit report was received,
reviewed, and responded to under the senior officer's direction or
supervision by qualified personnel, and
Appropriate responses to the findings have been identified
and deficiencies were corrected, or are being corrected, consistent
with the requirements of subparts C or D of 40 CFR part 68.
EPA believes these requirements and the associated certification
are consistent with equivalent certification requirements in many EPA
regulations, including in the CAA Title V regulations (40 CFR
70.5(d).\58\)
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\58\ ``(d) Any application form, report, or compliance
certification submitted pursuant to these regulations shall contain
certification by a responsible official of truth, accuracy, and
completeness. This certification and any other certification
required under this part shall state that, based on information and
belief formed after reasonable inquiry, the statements and
information in the document are true, accurate, and complete.''
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EPA agrees that senior corporate officials do not necessarily have
high levels of technical expertise; however, these officials and
entities include key managers responsible for establishing internal
corporate accountability and overseeing corporate prioritization,
budgeting, and operations. Indeed, the Security and Exchange Commission
(SEC) requires other specified documents to be provided to such
individuals, committees, and boards for similar reasons.\59\ Finally,
EPA believes that the certification will minimize corporate failures to
properly address and implement compliance audit findings and
recommendations. Adopting a less stringent standard would not be
appropriate. EPA expects that the senior corporate official
certification of the audit findings will improve facility and public
confidence that third-party audit report findings and recommendations
are promptly and properly addressed.
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\59\ Under Section 3(a)(58) of the Exchange Act as added by
Section 205 of the Sarbanes-Oxley Act, the term audit committee is
defined as ``[a] committee (or equivalent body) established by and
amongst the board of directors of an issuer for the purpose of
overseeing the accounting and financial reporting processes of the
issuer and audits of the financial statements of the issuer'' (if no
such committee exists with respect to an issuer, the entire board of
directors of the issuer). See Securities and Exchange Commission, 17
CFR 240.10A-3--Listing standards relating to audit committees (68 FR
18818, April 16, 2003, as amended at 70 FR 1620, January 7, 2005; 73
FR 973, January 4, 2008).
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Senior corporate officer or equivalent official. Comments were
received requesting clarification of the terms ``senior corporate
officer, or official in an equivalent position.'' Some commenters
recommended that EPA incorporate the ``responsible official''
definition from the CAA's Title V operating permit program for major
stationary sources which allows for certification by corporate
leadership or a ``duly authorized representative'' appointed by
corporate officials.
One commenter stated that the certification requirement risks
infringing on the senior corporate official's Fifth Amendment privilege
against self-incrimination. The commenter stated that the Supreme Court
has held that the privilege protects against compulsory disclosures to
the government when those disclosures have ``the direct and
unmistakable consequences of incriminating'' the disclosing party, and
concluded that the proposed certification requirement may compel
precisely those sorts of disclosures. The commenter went on to state
that the certification necessarily admits the existence of
``deficiencies'' which can only be interpreted as violations of the CAA
and which could certainly be a significant link in a chain of evidence
tending to establish guilt in a criminal case. One commenter also
argued that the certification requirement raises First Amendment
concerns by compelling speech that does not serve a sufficient
government interest to avoid running afoul of the right to free speech
because it is unclear what government interest the certification
advances and the relevant section of the rule is not narrowly tailored
to that interest.
EPA disagrees with this recommendation to allow delegation of the
certification to a duly authorized representative. The certification
indicates that the compliance audit report was received, reviewed, and
responded to under the senior corporate officer's direction or
supervision by qualified personnel. Similar to the requirement to
submit the findings response report to the audit committees of the
Board of Directors, a senior corporate official ensures accountability
and overseeing corporate prioritization, budgeting, and operations.
Furthermore, the language of the certification cites the actions
that are taken by the owner or operator pursuant to these requirements,
and includes, among other things, a statement that based on personnel
knowledge and experience, or inquiry of personnel involved in
evaluating the report findings and or inquiry of personnel involved in
evaluating the report findings and determining appropriate responses to
the findings, the information submitted herein is true, accurate, and
complete. This language is equivalent to the language in certifications
that support submissions under Title V of the CAA. EPA continues to
believe that it is important for a senior corporate official, or an
official in an equivalent position, sign such a certification, ensuring
that the owner or operator is aware of the findings and responses, and
will be correcting the deficiencies, pursuant to these requirements.
For smaller entities without corporate officials, the official in an
equivalent position for purposes of this requirement may include the
owner or operator, or designated representatives of the owner or
operator, including facility manager, operations manager, or another
official at or above that level. Regarding comments concerning self-
incrimination in connection with the certification requirement, the
certification does not contain an acknowledgement of a violation. It
merely describes the actions taken by the owner or operator pursuant to
the third-party audit requirements, and states that the information
submitted is true, accurate, and complete. The certification and report
are not required to be automatically submitted to the implementing
agency.
n. Schedule Implementation
EPA received comments supporting the proposed requirement for
owners and operators to ``promptly'' address deficiencies noted in
audit reports. A few commenters stated that there should be no specific
timeframe for addressing deficiencies identified during a third-
[[Page 4628]]
party audit, reasoning that there will be a wide variety of possible
site-specific actions that an owner or operator may take to address
audit findings. Another commenter believed it was appropriate to
require ``prompt'' correction of deficiencies, but encouraged EPA to
provide guidelines on what would be considered ``prompt'' action.
Some commenters recommended specific timeframes for addressing
deficiencies. One commenter recommended that deficiencies be corrected
``promptly'' and no later than six months absent a written extension
from EPA. A few commenters recommended that facilities be required to
promptly implement corrective actions and that deficiencies be
addressed within 18 months. However, some of these commenters stated
that facilities should be given the opportunity to request an
extension, if needed, from the implementing agency. Another commenter
recommended that facilities be given 24 months to correct deficiencies
after the facility has identified an appropriate response, with the
deficiencies presenting the highest risk of injury being addressed
first.
One commenter recommended that EPA allow stationary sources to
develop a reasonable schedule for correcting audit findings that would
be based on the types of audit findings and the resulting efforts to
implement them appropriately, rather than at a pace that may impede
sound and sustainable implementation processes. One commenter stated
that the proposal does not account for the likelihood that plans and
schedules for addressing deficiencies may need to change. To account
for needed changes, the commenter recommended that EPA should clarify
that the details of the schedule are not binding.
EPA disagrees with commenters that suggested incorporating a
prescribed schedule for addressing findings in the final rule and we
are finalizing the schedule implementation provision of Sec. Sec.
68.59(f)(2) and 68.80(f)(2) as proposed. The owner or operator's third-
party audit findings response report must include ``a schedule for
promptly addressing deficiencies'' but does not prescribe a specific
timeframe or due dates by which the deficiencies must be addressed.
Thus, under the final rule, the owner or operator must exercise best
judgement to determine how, and when, to prioritize and address
actions, consistent with the normal definition of ``promptly'' as
meaning quickly, without delay.\60\ EPA finds that this approach best
provides the flexibility owners or operators will need to address a
potentially very wide range of deficiencies and other findings noted in
third-party audit reports. This allows the facility owner or operator
to develop a reasonable schedule for correcting audit findings that
would be based on the types of audit findings and the resulting efforts
to implement them appropriately.
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\60\ See definition of ``promptly,'' Cambridge English
Dictionary, at https://dictionary.cambridge.org/us/dictionary/english/promptly.
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EPA also disagrees with commenters' suggestions to request a
schedule extension from the implementing agency. The implementing
agency will not receive a copy of the final audit report or findings
response report and therefore it is inappropriate to request an
extension to address deficiencies identified in the findings response
report. In the event that a schedule must change due to unforeseen
circumstances, EPA recommends that the owner or operator document the
reasons for the change and update the schedule to reflect revised
dates.
o. Submitting Reports to the Board of Directors
EPA received comments both supporting and opposing the proposed
requirement to submit the audit report to the audit committee of the
Board of Directors. Those in support reasoned that it will make the
Board of Directors aware of the deficiencies, and noted that the
requirement will allow the Board of Directors the opportunity to
properly budget for corrective actions.
Several commenters, including facilities and industry trade
associations, opposed the proposed requirement to submit the audit
report to the Board of Directors, arguing that it is generally
unnecessary or inappropriate to do so. These commenters stated that the
requirement would unduly constrain facilities that may have other
processes to involve facility leadership in responding to findings from
third-party audits. Similarly, an industry trade association reasoned
that this requirement subverts company policy established under the
rule's management provisions and that the program would be most
effective if each company is allowed to determine the most appropriate
chain of command and reporting. The commenter also warned that such a
requirement could set a precedent for other regulatory programs, which
could result in Boards of Directors receiving a deluge of technical
information that they do not have time to address and that they are in
no position to interpret.
One commenter recommended that EPA provide definitions for Board of
Directors and audit committee to avoid ambiguity. The commenter also
recommended that EPA specify a timeframe for this report to be
submitted to the Board's audit committee. Furthermore, the commenter
urged EPA to address how this requirement would be documented as
completed or what documentation would be required to demonstrate that
the owner or operator does not have an audit committee or comparable
committee.
Boards of Directors and their audit committees play an important
role in establishing internal corporate accountability and overseeing
corporate prioritization, budgeting, and operations. EPA believes that
providing the audit committee of the Board of Directors with third-
party audit findings will ensure the committees and their Boards of
Directors are aware of any deficiencies and have the opportunity to
properly budget for any required corrective actions in a timely manner.
EPA expects that this approach will improve facility and public
confidence that third-party audit report findings and recommendations
are promptly and properly addressed.
Therefore, the final rule requires the owner or operator to
immediately, upon its completion, provide to the audit committee of the
Board of Directors, or other comparable committee or individual, if
applicable a copy of the:
Findings response report; and
Implementation schedule to address deficiencies identified
in the audit findings response report.
EPA does not agree that we should define ``Board of Directors'' and
``audit committee.'' Facility owners or operators should consider their
corporate structure to determine if there is, in fact, a committee or
individual that may serve to oversee auditing and compliance oversight.
The closing clause in Sec. Sec. 68.59(e)(3) and 68.80(e)(3), ``if
applicable,'' replaces the corresponding language in the proposed
rulemaking, ``if one exists.'' ``If applicable,'' in this context, is
intended to clarify that owners or operators not otherwise required by
law to have an audit committee of the Board of Directors or that have
not, otherwise, established or designated a comparable committee or
individual, are not subject to the requirements in Sec. Sec.
68.59(e)(3) and 68.80(e)(3).
Finally, in response to concerns about demonstrating compliance
with this requirement, EPA recommends that the facility document how
the owner or
[[Page 4629]]
operator complied with this requirement and maintain that documentation
with the findings response report. This may include identifying who
received a copy of the report and the date it was provided. If there is
no audit committee of the Board of Directors or a comparable committee
or individual, then the owner or operator should consider documenting
that no committee or individual exists.
p. Third-Party Audit Recordkeeping
Some commenters supported the proposed third-party audit
recordkeeping requirements. However, some commenters opposed the
requirement to retain copies of the draft audit report. A few
commenters opposed the requirement that records be retained at the
stationary source.
EPA agrees with commenters that opposed maintaining draft audit
reports. Therefore, EPA is not finalizing the proposed requirement in
Sec. Sec. 68.59(e)(2) and 68.80(e)(2) for owners or operators to
retain copies of all draft third-party audit reports. The final rule
requires that the owner or operator retain as records certain documents
at the stationary source, including the two most recent final third-
party audit reports, related findings response reports, documentation
of actions taken to address deficiencies, and related records. The
final audit report must include a summary of any significant revisions
between draft (if any) and final versions of the report.
The final rule also requires the owner or operator to retain
records at the stationary source in order to ensure that records are
readily available to stationary source staff to review and utilize and
for implementing agency inspectors to access during site inspections.
These documents may be retained electronically as long as they are
immediately and easily accessible to the owner or operator and the
owner or operator retains the signed original documents, where
appropriate.
q. Other Comments
One commenter encouraged EPA to correct what it described as a
grammatical error within Sec. Sec. 68.58(a) and 68.79(a).
Specifically, the commenter urged EPA to correct the plural reference
to the owner or operator by changing the word ``they'' to ``it'' to
make it clear that only one of the entities needs to conduct an audit.
EPA is not making this recommended revision. Both the owner and
operator are responsible to evaluate compliance with the prevention
program requirements of the rule and we do not believe that this
language has been confusing. However, to clarify, we do agree that as
long as the audit is performed, only one of the entities needs to have
conducted the audit.
C. Safer Technology and Alternatives Analysis (STAA)
1. Summary of Proposed Rulemaking
EPA proposed to modify the PHA provisions in Sec. 68.67 by adding
paragraph (c)(8) to require certain industry sectors to conduct a safer
technology and alternatives analysis (STAA) and to evaluate the
feasibility of any inherently safer technology (IST) identified. EPA
proposed to limit the requirement to owners or operators of facilities
with Program 3 regulated processes in North American Industrial
Classification System (NAICS) codes 322 (paper manufacturing), 324
(petroleum and coal products manufacturing), and 325 (chemical
manufacturing).
In the proposed rulemaking, EPA specified that the STAA would
consider, in the following order of preference:
IST or inherently safer design (ISD),
Passive measures,
Active measures, and
Procedural measures.
EPA further indicated that the owner or operator would be able to
evaluate a combination of these risk management measures to reduce risk
at the process.
EPA also proposed to add several definitions that relate to an STAA
in Sec. 68.3. EPA proposed active measures to mean risk management
measures or engineering controls that rely on mechanical, or other
energy input to detect and respond to process deviations. Some examples
of active measures included alarms, safety instrumented systems, and
detection hardware (such as hydrocarbon sensors).
EPA proposed feasible to mean capable of being successfully
accomplished within a reasonable time, accounting for economic,
environmental, legal, social, and technological factors. EPA further
clarified in the definition that environmental factors would include
consideration of potential transferred risks for new risk reduction
measures.
For inherently safer technology or design, the proposed definition
meant risk management measures that:
Minimize the use of regulated substances,
Substitute less hazardous substances,
Moderate the use of regulated substances, or
Simplify covered processes in order to make accidental
releases less likely or the impacts of such releases less severe.
The proposed definition of ``passive measures'' meant risk management
measures that use design features that reduce the hazard without human,
mechanical, or other energy input. EPA provided examples of passive
measures that included pressure vessel designs, dikes, berms, and blast
walls.
Finally, EPA proposed procedural measures to mean risk management
measures such as policies, operating procedures, training,
administrative controls, and emergency response actions to prevent or
minimize incidents. EPA sought comment on these proposed revisions.
2. Summary of Final Rule
After review and consideration of public comments, EPA is
finalizing the STAA provision in Sec. 68.67(c)(8), and related
definitions in Sec. 68.3, as proposed, with the following
modifications:
EPA is substituting the term ``practicability'' for
``feasibility'' in proposed Sec. 68.67(c)(8)(ii) of the PHA
requirements;
EPA is substituting the term ``practicability'' for
``feasible'' in the definition in Sec. 68.3 and substituting the
phrase ``the capability'' for ``capable,'' while retaining the
remaining definition as proposed; and
EPA is revising the definition of ``passive measures'' by
clarifying that these measures not only reduce a hazard but reduce the
frequency or consequence of a hazard.
Significant comments on the proposed STAA provisions and related
definitions are discussed in section IV.C.3 of this preamble.
3. Discussion of Comments and Basis for Final Rule Provisions
Many commenters from environmental advocacy groups and some state
agencies expressed support for the proposal to require an STAA to
improve process safety. However, some believed that implementation of
feasible safer alternatives, particularly IST, should be required and
that STAA requirements should apply to a greater universe of facilities
and not just those in the chemical manufacturing, petroleum refining
and paper manufacturing industries. Many commenters, mostly from
industry, requested that EPA remove IST and design requirements from
the rule entirely for a variety of reasons, or requested significant
clarifications to applicability if the STAA provision is finalized.
[[Page 4630]]
As noted previously, except for substituting the term
``practicable'' for ``feasible'' and some other definition changes, EPA
is finalizing the STAA provisions as proposed. We continue to rely on
the rationale expressed in the proposed rulemaking. In the discussion
that follows and in the Response to Comment document, we explain our
consideration of the comments and our analysis and response.\61\
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\61\ 2016. EPA Response to Comments on the 2016 Proposed
Rulemaking Amending EPA's Risk Management Program Regulations. This
document is available in the docket for this rulemaking.
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We recognize there may be multiple, rational approaches to STAA. We
determined that it was reasonable to require STAA for sectors that have
had a high per facility incidence of reportable accidental releases and
where the complexity and variety of methods of chemical handling
demonstrate the potential for process safety revisions. We do this in
part to balance potential accidental release rate reduction and cost.
There are some sectors, such as water treatment, with known ISTs that
we do not require to evaluate or implement ISTs under this rule. In the
water treatment sector in particular, the sector's lower accidental
release rates do not demonstrate that requiring thousands of facilities
to conduct STAA would result in a significant drop in accidental
releases.\62\ In contrast, even if some of the sectors we have
identified for the STAA requirement already may have voluntarily
undertaken an STAA approach (at least at new facilities), accidental
release rates remain higher for these industries, technologies advance
over time, and ensuring a minimum level of application of the STAA
approach limits the disincentives for sector members to be leaders in
adoption of safer technologies. We do not mandate the adoption of any
IST found to be practicable in part because we recognize that a passive
measure or other approach on the STAA hierarchy may also be effective
at risk reduction; we continue to leave the adoption of particular
accident prevention approaches to owners' and operators' reasonable
judgment. We discuss other factors that have led us to select
particular industries for STAA and particular requirements in our STAA
approach in response to particular comments.
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\62\ An intentionally-caused release through the criminal act of
a third-party would be an accidental release because the emission
would be unanticipated from the perspective of the owner or operator
of the stationary source. Where the location of a water treatment
source could expose large populations to regulated substances, we
believe it is appropriate for such sources to work with local
emergency planners and homeland security officials to reduce the
risk. Nevertheless, such isolated cases do not justify a mandate
across the industry in place of a case-specific review.
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a. Legal Issues
Various commenters raised potential legal issues or challenges
regarding the STAA requirements based on CAA authority, Congressional
intent, deficient analysis or substantiation, vagueness of
requirements, and jurisdiction.
Several industry associations and individual companies commented
that EPA lacked the legal authority to require assessment of STAA in
general and IST/ISD in particular. One argued that the authority for
RMPs rests in subparagraph (B) of CAA section 112(r)(7), while the
authority for design and equipment changes rests in subparagraph (A).
Several argued that EPA did not adequately explain its change of
position from the one adopted in the 1996 final RMP rule, which did not
require the assessment or implementation of IST. In light of EPA's
position that the 1996 final RMP rule and EPA's program implementation
provided incentives to adopt IST, some argued that requiring STAA
analysis without requiring implementation of changes would offer no new
benefit to public health and safety; these commenters suggested that
IST had been informally used already for decades where it was feasible.
Another commenter said the STAA requirement could effectively ban
certain chemicals without the authority to do so. Others noted that IST
consideration would lead to increased liability issues for facilities
because, even if a source was not required to implement IST by rule,
should an accident happen, plaintiffs could cite the failure to adopt
the IST in a court case. A commenter criticized the requirement as too
amorphous to be meaningfully implemented and enforced in a non-
arbitrary manner. Other commenters said IST is more properly within the
authority of OSHA, that EPA's record did not reveal consultations and
coordination with OSHA as required by CAA section 112(r)(7)(D), and
that subsequent to the enactment of the 1990 CAA Amendments, Congress
had denied both EPA and DHS the authority to require IST when it
rejected bills requiring or authorizing IST.
In contrast to the comments discussed previously, a coalition of
environmental, labor, community and other public groups, as well as a
mass mail campaign, commented that EPA must adopt STAA in its final
rule not only for NAICS codes we proposed but for all facilities where
STAA is feasible. In the commenters' view, the proposed amendments are
inconsistent with the statute's prevention objectives and its
preference for measures that completely eliminate potential hazards
because only certain sectors are required to undertake STAA while
others only have requirements imposed after accidental releases.
Additionally, the commenters argue that the authority to ``make
distinctions'' among classes of facilities in CAA section 112(r)(7)(A)
and to ``recognize differences'' among types of sources in CAA section
112(r)(7)(B) does not include the authority to exempt entire sectors
from STAA; even if the statute gave such authority, EPA failed to
explain how it is relying on that authority. Finally, the commenters
contended EPA's action was arbitrary and capricious by failing to
account for the significant value STAA could provide to facilities,
workers, and communities by not only removing hazards but by saving
money through removing potential liability and sometimes improving
industrial efficiency.
EPA disagrees with the comments that the CAA does not authorize the
STAA provisions of this final rule. Both subparagraphs (A) and (B) of
CAA section 112(r)(7) authorize STAA and IST in particular. EPA cited
all of paragraph (7) as authority for ``[e]ach of the portions of the
Risk Management Program rule we propose to modify.'' 81 FR 13646, March
14, 2016.\63\ The authority section for 40 CFR part 68 references CAA
section 112(r) and is not limited to particular paragraphs and
subparagraphs. The proposed rulemaking also noted that subparagraph (A)
had been invoked in the rulemaking petition on IST. Therefore, EPA
provided sufficient notice that we contemplated action under any
authority under CAA section 112(r)(7). Nevertheless, we also view that
our authority to require STAA assessments or an IST review is
consistent with subparagraph (B). Under subparagraph (B), EPA has broad
authority to develop ``reasonable regulations . . . for the prevention
of accidental releases.''
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\63\ We note that our more extensive discussion of authority for
the RMP rule provided in the 1993 proposal focused on CAA
112(r)(7)(B)(i) and (ii), 58 FR 54191-93 (October 20, 1993), which
the proposal for the Modernization rule referenced for additional
authority discussion.
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Further support for IST can be found in both the Conference Report
accompanying the 1990 CAA Amendments and the Senate Report explaining
the provisions of the Senate bill that closely mirrors enacted
provisions. In discussing the ``Hazard Assessments'' required by
section
[[Page 4631]]
112(r)(7)(B), the Conference Report specifies that such assessments
``shall include . . . a review of the efficacy of various release
prevention and control measures, including process changes or
substitution of materials.'' \64\ Conference Report at 340-41. The STAA
analysis is such a review.\65\ The Senate Report identifies as
``release prevention measures'' many of the techniques that are now
known as IST--substitution of less hazardous materials, reduction in
the severity of the conditions of processing and complexity of the
process, and decreasing volumes of chemicals in storage.\66\ Senate
Report at 242. That subsequent Congresses did not enact additional
legislation on IST is irrelevant to what was enacted and intended at
the time of enactment.
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\64\ H. Rep. 101-952, Clean Air Act Amendments of 1990
Conference Report to Accompany S. 1630, 101st Cong., 2d Session,
340-41. October 26, 1990.
\65\ EPA chose to incorporate into the prevention program
provisions several of the hazard assessment elements mentioned in
the conference report and to limit the hazard assessment portions of
40 CFR subpart B to the offsite consequence analysis and accident
history in order to better conform the RMP rule to the format of the
PSM rule. 58 FR 54194 (October 20, 1993).
\66\ Clean Air Act Amendments of 1989, Report of the Committee
on Environment and Public Works, U.S. Senate together with
Additional and Minority Views to Accompany S. 1630. S. Report No.
101-228. 101st Congress, 1st Session, p. 242, December 20, 1989.
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The proposed rulemaking, 81 FR 13646, March 14, 2016, provided an
extensive discussion of developments concerning IST since the 1996
final RMP rule. As we explained, EPA adopted a rule in 1996 that
provided incentives for IST without a specific mandate to either
conduct studies of IST or implement IST measures. From 1996 on, EPA has
recognized that good PHA techniques will often identify opportunities
to make new and existing processes and operation inherently safer.
However, in the 1996 rule and thereafter, we also recognized that IST
is not the only way to prevent accidents, and that sometimes IST can be
impractical, especially for existing sources.
The STAA approach we adopt in this action places IST in a hierarchy
that allows for sources to choose non-IST approaches to accident
prevention, such as passive mitigation, active mitigation, and
administrative controls. While the EPA did not, in 1996, expressly
require facilities to analyze and implement IST specifically, this rule
places IST in a set of options to be studied. EPA relies on sources
making rational decisions once presented with STAA studies and
selecting prevention approaches that optimize the cost of the measures
taken and costs avoided (e.g., liability, operational efficiency,
image). Such an approach is similar to the approach to energy
assessments recently taken in the major source and area source boiler
rules under CAA section 112(d) and affirmed in U.S. Sugar Corp v.
EPA.\67\
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\67\ United States Sugar Corp. v. EPA, 830 F.3d 579 (D.C. Cir.
2016).
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We acknowledge that many sources have conducted STAA analyses
already. For these sources, the cost of implementing the new STAA
requirement should be lessened. The requirement we promulgate in this
rule captures those slower in considering IST in high accident
industries rather than harms leaders. There are no specific chemicals
banned by this final rule. While we recognize that companies have moved
away from certain processes, such as those that involve the storage of
large quantities of methyl isocyanate, in order to make facilities
safer, we leave process design decisions to the reasonable judgment of
owners and operators under this action.
EPA disagrees with the comments concerning IST being more properly
within the authority of OSHA. It is plain from the history of the 1990
Amendments that both agencies were given authority to prevent
accidents, and that Congress contemplated EPA adopting some IST
measures as appropriate. Furthermore, EPA has a history of prior
coordination with OSHA to define and promote STAA when developing the
EPA and OSHA, Chemical Safety Alert: Safer Technology and Alternatives
(EPA 550-F-15-003; June 2015).\68\
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\68\ https://www.epa.gov/sites/production/files/2015-06/documents/alert_safer_tech_alts.pdf.
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Not only for STAA, but also for other provisions of this final
rule, the record adequately reflects EPA's coordination and
consultation with Department of Labor (DOL)/OSHA and DOT. As an initial
matter, both DOL and DOT were part of the Working Group under Executive
Order 13650. That order and report of the Working Group reflect
consultation and direction regarding the development of the this final
rule. Second, we note that EPA's decision to not consider the
regulation of AN at this time explicitly is based on an effort to
coordinate any potential regulatory requirements for this substance
with actions contemplated by other agencies, including OSHA. Third,
while the content of interagency deliberations are not for the record
for judicial review under CAA section 307(d), multiple agencies have an
opportunity to review a draft rule under Executive Order 12866
Regulatory Planning and Review. Finally, OSHA had representatives
attend the SBAR panel which discussed the development of the proposed
rulemaking. All of this is a matter of public record in the docket for
this rulemaking.
Consistent with the structure of the RMP rule, EPA has placed IST
among the methods a facility may choose to adopt to prevent accidents.
Commenters who argue that we have failed to require accident prevention
by not mandating the adoption of IST measures for all facilities
wherever feasible fail to acknowledge that non-IST methods for
preventing accidents may be reasonable in some circumstances. To the
extent that these regulations are imposed under subparagraph (B), these
regulations have an overriding requirement to be reasonable. While it
is true that similar quantities of chemicals under the same conditions
present similar hazards regardless of sector, various sectors present
different likelihood of release. Some sectors handle chemicals
differently under conditions that are more likely to lead to severe
releases. The record reflects that the likelihood of severe accidents
is greater in the sectors that must conduct STAA analysis under this
final rule. Thus, it is reasonable to have different requirements for
these sectors than for others. Independent of whether any new IST/ISD
is adopted, there is a cost to conducting an STAA analysis. EPA has
reasonably limited STAA analysis requirements to sectors that we view
as most likely to likely to have more frequent, severe releases that
are most likely to be benefit from STAA review. Inherent in our
approach is distinguishing among classes and types of facilities. We
expect that the adoption of STAA analysis requirements in this final
rule will advance IST not only in the sectors targeted by the rule, but
also more generally as experience is gained and opportunities for
technology transfer are developed.
b. Applicability
Limiting applicability of STAA provisions. While some commenters
supported EPA's proposal to limit applicability of STAA provisions to
the petroleum refining, chemical manufacturing, and paper manufacturing
sectors, other commenters objected to this aspect of the proposal. Many
commenters, including a mass mail campaign joined by approximately 300
commenters, expressed concern that the proposed rulemaking arbitrarily
determined which industries have feasible and worthwhile alternatives,
and which communities and facilities would benefit from STAAs. These
commenters
[[Page 4632]]
asserted that limiting the requirement to certain industry sectors
would exempt other sectors that pose a significant threat to the
public. Commenters argue that focusing on accident rate to target
sectors for STAA was not a credible way to forecast and prevent rare
catastrophic events that tend to fall out of existing patterns.
Some commenters urged EPA to apply the STAA requirement to all
sources, or all Program 3 sources. Other commenters, including another
mass mail campaign joined by approximately 17,250 commenters,
recommended that EPA require assessment and implementation of STAA for
industries where safer alternatives are feasible or well demonstrated,
such as water supply, wastewater treatment, power generation, food and
beverage manufacturing, and others. Several other commenters indicated
that EPA should apply the STAA provisions to facilities with the
largest worst case scenario populations, or to the 2,000 high-risk
facilities cited in EPA's 2017-2019 National Enforcement Initiative
(NEI). A few commenters suggested that EPA implement a pilot program
requiring IST implementation for a subset of sectors considered
extremely high risk, such as wastewater or drinking water treatment
plants, bleach plants, refineries using hydrogen fluoride and for those
facilities among the 2,000 high-risk facilities cited in the EPA's NEI
2017-2019 proposal. A few commenters believe that the proposed STAA
requirements have failed to address the disproportionate health and
safety threats in communities of color and low-income communities, and
want the STAA provisions to apply to all RMP facilities.
In this rule, EPA is finalizing the STAA provisions as proposed,
which limits applicability of the STAA requirements to Program 3
processes in the petroleum refining, chemical manufacturing, and paper
manufacturing sectors. EPA does not believe that the final provisions
have been limited arbitrarily, or that the Agency's decision to limit
applicability of the STAA provisions to the petroleum refining,
chemical manufacturing, and paper manufacturing sectors implies that
other sectors do not have viable safer technology alternatives. In the
proposed rulemaking, EPA acknowledged that most RMP-regulated sectors
could identify safer technologies and alternatives. However, the Agency
proposed to limit the applicability of the STAA provisions to
facilities in complex manufacturing sectors with high accident rates.
EPA took this approach in order to target these provisions to the
industrial sectors with the potential to achieve the greatest safety
improvements through consideration of safer technology alternatives.
EPA explained that sources involved in complex manufacturing operations
have the greatest range of opportunities to identify and implement
safer technology, particularly in the area of inherent safety, because
these sources generally produce, transform, and consume large
quantities of regulated substances under sometimes extreme process
conditions and using a wide range of complex technologies. Therefore,
such sources can often consider the full range of inherent safety
options, including minimization, substitution, moderation, and
simplification, as well as passive, active, and procedural measures.
Further, EPA noted that RMP facilities in the three selected sectors
have been responsible for a relatively large number of accidents,
deaths, and injuries, and the most costly property damage.\69\
Facilities in these sectors also have significantly higher accidents
rates as compared to other sectors.\70\ EPA agrees that there is no way
to forecast rare catastrophic events; however, we believe it is
appropriate to target sectors that have had a large number of accidents
and have the greatest opportunity to identify safer technologies.
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\69\ For more information, see Chapter 6 of the Regulatory
Impact Analysis--Accidental Release Prevention Requirements: Risk
Management Programs Under the Clean Air Act, Section 112(r)(7). This
document is available in the docket for this rulemaking (Docket ID
Number EPA-HQ-OEM-2015-0725).
\70\ For more information, see EPA, January 27, 2016. Technical
Background Document for Notice of Proposed Rulemaking: Risk
Management Programs under the Clean Air Act, Section 112(r)(7). This
document is available in the docket for this rulemaking (Docket ID
Number EPA-HQ-OEM-2015-0725).
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While EPA does not believe it is necessary to require all sources,
all Program 3 sources, or all sources in industry sectors where
feasible safer technology alternatives have been identified to perform
an STAA, the Agency encourages such sources to consider performing an
STAA, and to determine practicability of IST or ISD considered, even if
they are not subject to the STAA provisions of the final rule.
EPA does not agree that only sources with large worst-case scenario
populations, or only sources on EPA's high risk facility list should be
required to comply with the STAA provisions. EPA believes it is not
appropriate to apply the STAA provisions only to sources with specified
worst case scenario populations for several reasons. First, EPA's OCA
requirements allow regulated facilities to use any commercially or
publicly available air dispersion modeling techniques, provided the
techniques account for the modeling conditions specified in the rule
and are recognized by industry as applicable as part of current
practices. This flexibility can result in two similar facilities
obtaining significantly different endpoint distances (and vulnerable
zone populations) simply through choosing different modeling
techniques. By linking the STAA requirement to the worst case scenario,
EPA could inadvertently cause some facilities to recalculate their OCA
using a different modeling approach, simply to avoid the STAA
requirement, and without actually implementing process changes that
might reduce the facility's worst case scenario. Second, linking the
STAA requirement to large worst case scenario populations would
effectively bias the applicability of the requirement to facilities in
densely populated areas, and potentially exempt equally hazardous
facilities in or near less densely populated communities. Third, this
application of the STAA requirement would disregard the criteria that
EPA has used in the proposed rulemaking--accident history and facility
complexity, which EPA believes provide a stronger rationale for
limiting the applicability of the requirement. In addition, EPA
believes that targeting the STAA requirements to the larger and more
complex processes will benefit minority communities, who are located
closer to larger facilities with more complex chemical processes and
who bear a larger portion of risk from chemical accidents. Lastly,
distribution of worst-case scenario population information is
restricted under the CAA, and this would effectively prohibit the
public from knowing which facilities are required to perform an STAA.
For similar reasons, EPA does not agree with commenters'
suggestions to develop a pilot program to apply to a subset of high
risk facilities or to apply the STAA requirement to facilities on EPA's
high risk facility list. This list is generated, in part, using worst
case scenario population information (chemical quantities and accident
history are also considered, although sector accident frequency is
not), and therefore the list may not be publicized by EPA.
Apply to facilities using different incident rate methodology.
Several commenters objected to EPA's methodology for selecting
industrial sectors subject to STAA requirements using an incident rate
based on the
[[Page 4633]]
number of RMP-reportable accidents per facility in the industry sector.
These commenters expressed concern that the proposal to require STAAs
from only three NAICS codes is based on an incorrect approach to, and
interpretation of, incident rates. An industry trade association
commented that looking at the number of accidents per facility does not
allow for direct comparisons as it does not account for the relative
number of employees at a facility. This commenter argued that EPA
should recalculate this value using the number of accidents per hours
worked or the number of accidents per full time worker, and reasoned
that such a calculation would be more consistent with the incident rate
calculations conducted by the Occupational Safety and Health
Administration (OSHA) and the Bureau of Labor Statistics (BLS). Another
industry trade association remarked that EPA's methodology ignores not
only the size of the facility but also the quantity of chemicals and
the number of covered process units at a given facility. According to
this commenter, upon normalizing the petroleum refining sector's
accident rate to account for the number of process units and the
diversity of facilities being compared, the accident rate for this
sector is lower than for most other sectors. The commenter also
expressed concern that EPA's proposal to subject this sector to the
STAA requirement ignores the industry's significant recent safety
improvements that EPA itself has noted in the NPRM, and that industries
such as poultry processing have higher incident rates than petroleum
refining or chemical manufacturing, even though these industries are
not subject to the STAA requirement.
A trade association representing the paper manufacturing industry
urged EPA to remove the STAA requirement for that sector. The industry
trade association stated that paper manufacturing should not be
considered a ``complex'' manufacturing process, and cited EPA's
Technical Background Document \71\ which, according to the commenter,
does not categorize paper manufacturing facilities as ``complex.''
Additionally, the commenter remarked that the paper manufacturing
industry has a much lower level incident risk than other sectors based
on injuries offsite, and stated that of the roughly 15,000 offsite
injuries mentioned by EPA, the paper manufacturing industry was
responsible for only two. Citing Exhibit 6-4 of EPA's Regulatory Impact
Analysis for the proposed rulemaking, the commenter asserted that the
entire U.S. paper manufacturing sector has been responsible for the
fewest offsite injuries out of any industrial sector over the ten-year
study period. This commenter concluded that implementing the
requirement for the paper industry would not enhance public safety, and
that the industry has made significant strides to increase safety
procedures in recent years.
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\71\ EPA. January 27, 2016. Technical Background Document for
Notice of Proposed Rulemaking: Risk Management Programs under the
Clean Air Act, Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
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Another commenter stated that EPA's use of routine incident rates
in selecting industry sectors to conduct STAAs was faulty because
frequent smaller incidents cannot be used to reliably predict
infrequent catastrophic events.
EPA acknowledges that there were other possible methods of
selecting industry sectors that would be subject to STAA requirements.
All of the methods offered by commenters--normalizing accident rates by
FTE, number of process units, chemical quantities, etc.--were
considered but ultimately rejected by the Agency. EPA does not believe
normalizing accident rates by FTE or chemical quantity is appropriate
because prior research has shown that the interaction between these
factors and incident rates is complex, and that none of these
variables, by itself, is a suitable proxy for the relative risk of a
catastrophic chemical release incident at a facility.\72\ Likewise,
selecting industry sectors for applicability of the rule's STAA
provisions using an approach similar to that used for OSHA personal
injury statistics (e.g., OSHA lost workday injury and illness rates)
would not identify sectors with higher chemical process risks. These
OSHA rate data generally scale directly with the number of employees
because most of the incidents measured in these metrics involve single-
person injuries (e.g., overexertion, sprains and strains, slips, trips,
falls, injuries due to contact with objects and equipment, etc.).\73\
In other words, facilities with more employees are more likely to
suffer higher amounts of these ``lost workday'' injuries, but not
necessarily higher numbers of chemical release incidents.
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\72\ Elliott, M.R., Kleindorfer, P.R., and Lowe, R.A., The Role
of Hazardousness and Regulatory Practice in the Accidental Release
of Chemicals at U.S. Industrial Facilities, Risk Analysis, Vol. 23,
No. 5, 2003.
\73\ See, e.g., ``Nonfatal Occupational Injuries and Illnesses
Requiring Days Away from Work, 2014,'' U.S. Department of Labor,
Bureau of Labor Statistics, November 19, 2015. Available at https://www.bls.gov/news.release/osh2.nr0.htm.
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Furthermore, EPA chose not to normalize accident rates by the
number of process units for two reasons. First, regulated sources have
significant discretion in determining covered process boundaries--some
petroleum refineries and large chemical manufacturing facilities
containing numerous unit process operations have chosen to consider
their entire plant as a single covered process, while other similar
plants have divided their stationary source into dozens of different
covered processes. Therefore, normalizing accident rates by the number
of processes could result in a less accurate reflection of a sector's
historical accident propensity. More importantly, even if a higher
accident rate at a large facility is due, in part, to the facility
having more covered processes, that fact does not reduce its risk to
the surrounding community. For the community, it is the frequency of
accidents at its neighbor that matters, not the rate per process. In
fact, the relatively higher likelihood of accidental releases at such
sources further warrants their consideration, and potential
application, of safer alternative technologies.
EPA disagrees that its approach ignores recent safety improvements
on the part of the petroleum refining sector. The Agency views the
application of safer technology alternatives as an approach to hazard
control that can be applied throughout the life-cycle of a facility. A
facility's recent implementation of a safer technology alternative does
not foreclose consideration of additional safer technologies in the
future. Facilities that have already implemented safer technology
alternatives should document their implementation in their next PHA,
determine whether there is additional information that should be
considered in their STAA, and continue to consider additional safer
alternatives during subsequent PHA re-validation cycles.
EPA agrees that the poultry processing sector, when that sector is
considered separately from other food and beverage industry sectors,
has a slightly higher RMP facility incident rate than the petroleum
refining sector. However, EPA did not include the poultry processing
sector under the final rule STAA provision because the poultry
processing sector, by itself, does not delineate a meaningful
technological subgrouping of RMP facilities. Poultry processing
facilities are just one of many different types of food and beverage
manufacturing and processing facilities covered under the RMP
regulation. The common technology among these facilities that results
in their coverage under the RMP
[[Page 4634]]
regulation is ammonia refrigeration. While EPA is aware that some RMP
facilities in the poultry processing sector have had serious chemical
accidents, the Agency does not believe that these accidents are usually
related to the fact that these facilities process poultry. Rather, they
generally relate to the design, maintenance, or operation of the
ammonia refrigeration system at the facility, and are similar to the
causes of accidents involving ammonia refrigeration systems at other
types of food and beverage processing facilities. Therefore, when
considering the accident rates of RMP-covered poultry processing
facilities, EPA believes the proper approach is to combine RMP
facilities in this sector with RMP facilities in all other sectors in
the food and beverage industry, as indicated in the RIA for the final
rule.\74\ When this is done, the accident frequency for the food and
beverage manufacturing sector is significantly lower than the accident
frequency for the petroleum refining sector.
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\74\ Regulatory Impact Analysis--Accidental Release Prevention
Requirements: Risk Management Programs Under the Clean Air Act,
Section 112(r)(7). This document is available in the docket for this
rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------
EPA disagrees with the commenter that argued the paper
manufacturing sector should be exempt from the STAA provision of the
final rule because the sector has had fewer accidents with offsite
injuries, or because the sector was not characterized as ``complex'' by
EPA's economic analysis. While it is true that the paper manufacturing
sector has had fewer accidents with offsite injuries than other
sectors, this is partly due to the relatively small number of RMP
facilities (70) in the paper manufacturing sector. Additionally, the
great majority of the offsite injuries reported by RMP facilities
resulted from a single accident at the Chevron Richmond refinery,
therefore it is inappropriate to compare offsite injuries from the
paper manufacturing sector to the total of all offsite injuries that
occurred during the ten-year period analyzed.\75\
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\75\ According to the CSB, ``approximately 15,000 people from
the surrounding communities sought medical treatment at nearby
medical facilities for ailments including breathing problems, chest
pain, shortness of breath, sore throat, and headaches. Approximately
20 of these people were admitted to local hospitals as inpatients
for treatment.'' CSB, January 2015, Final Investigation Report:
Chevron Richmond Refinery Pipe Rupture and Fire, Chevron Richmond
Refinery #4 Crude Unit, Richmond, California, August 6, 2012, Report
No. 2012-03-I-CA, https://www.csb.gov/assets/1/16/Chevron_Final_Investigation_Report_2015-01-28.pdf.
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More importantly, offsite injury is only one of several types of
accident consequences that require reporting under the RMP rule. Other
reportable consequences include deaths, injuries, and significant
property damage on-site, and known offsite deaths, evacuations,
sheltering-in-place, property damage and environmental damage. When all
RMP-reportable accident consequences for a sector are considered, and
normalized by the number of sources in the sector, the paper
manufacturing sector has the second highest accident rate among all
sectors regulated under the RMP rule. EPA believes this approach is a
better gauge of the historical accident propensity for a sector than
considering only accidents with offsite injuries.
While it is also true that EPA did not characterize the paper
manufacturing sector as ``complex'' in the Technical Background
Document \76\ and for estimating the costs of most rule provisions
within the RIA, it did do so for purposes of the STAA provision, and
arguably could have done so for all rule provisions. Paper
manufacturing facilities, and particularly large integrated pulp and
paper mills, are clearly more complex than most other RMP facilities,
which only involve chemical storage (e.g., agricultural ammonia
distribution facilities) or simple chemical processes (e.g., water
treatment). The main purpose for EPA's broad characterization of
certain sectors as ``complex'' and all others as ``simple'' for certain
rule provisions within the RIA was because the Agency judged that the
cost of implementing those rule provisions would vary primarily by the
complexity of the processes involved, and that a rough two-tier
division of regulated sources (e.g., simple vs. complex) would suffice
to establish cost estimates for those rule provisions. However, EPA did
not use this two-tier division for purposes of estimating the costs of
the rule's STAA provision. For the STAA provision, EPA included paper
manufacturing as a sector that involves ``complex manufacturing
operations.'' EPA chose to apply the STAA requirement to sources
involved in complex manufacturing operations because these sources have
the greatest range of opportunities to identify and implement safer
technology, particularly in the area of inherent safety. These sources
generally produce, transform, and consume large quantities of regulated
substances under sometimes extreme process conditions and using a wide
range of complex technologies. For more information, see the preamble
discussion in the proposed rulemaking at 81 FR 13688, March 14, 2016.
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\76\ EPA. January 27, 2016. Technical Background Document for
Notice of Proposed Rulemaking: Risk Management Programs under the
Clean Air Act, Section 112(r)(7). This document is available in the
docket for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
---------------------------------------------------------------------------
EPA disagrees that the agency used ``routine'' incident rates to
select industry sectors covered by the STAA provision. Accidents
meeting EPA reporting criteria include accidental releases from covered
processes that result in deaths, injuries, and significant property
damage on-site, and known offsite deaths, injuries, evacuations,
sheltering-in-place, property damage and environmental damage. EPA
believe that such accidents generally either resulted in, or could
reasonably have resulted in, a catastrophic release of a regulated
substance, and are therefore an appropriate criterion to consider when
identifying industrial sectors that may benefit public safety the most
by analyzing safer alternative technologies.
Eliminate or exempt batch toll chemical manufacturers. In the
context of exempting batch toll processors from the STAA provision,
some commenters recommended that processes governed by government
agency specifications or through a contractual relationship with a
customer should not be subject to the STAA provision because in these
cases, the customer specifies the manufacturing process. According to
one commenter, the customer is subject to regulation, often from the
FDA or EPA. An industry trade association requested that EPA explicitly
state in the body of the regulation that the STAA requirement would not
apply to processes in whole or in part specified by a government agency
or through any contractual obligation.
EPA disagrees with the suggestion to exempt batch toll
manufacturers from the STAA requirement. Safer technology alternatives
include many options beyond chemical substitution. For example, IST
could involve minimization of stored raw material chemicals, making
process changes that make it less likely to release the chemical
(moderation), or reducing complexity in the process in order to make
accidents less likely (simplification). Therefore, even where a
contractual relationship or regulation requires a regulated batch toll
manufacturing facility to use a particular regulated substance in
specified quantities, owners and operators of batch toll manufacturing
facilities should still consider other potential IST measures besides
chemical substitution. The facility must also consider potential safer
alternatives beyond IST, such as passive measures instead of or in
combination with active
[[Page 4635]]
measures, or active measures instead of procedural measures. Toll
manufacturers may use RMP chemicals for purposes in addition to making
a formulated product, such as for cleaning equipment, wastewater
treatment or refrigeration, for which chemical substitution may not be
prohibited by regulation or contractual relationship. Also, the final
rule does not require regulated sources to implement IST or ISD
considered, so there is no conflict between this final rule and other
regulations that may apply to RMP-regulated facilities subject to STAA
requirements. For example, an owner or operator would be in compliance
with the STAA requirement to consider potential chemical substitution
as part of the analysis if he or she determines that a chemical
substitution is not practicable because the substitution is prohibited
by another regulation The owner or operator would still need to
consider other types of IST (minimization, moderation, or
simplification), and passive, active, and procedural measures in the
analysis.
Applicability to water treatment facilities. Some commenters,
including professionals and a mass mail campaign joined by
approximately 300 commenters, urged that water supply and wastewater
treatment facilities should be subject to the proposed STAA provision.
A number of commenters expressed concern about threats posed by water
and wastewater facilities and related operations. Several commenters
asserted that technologically and economically feasible alternatives
are available for water supply and wastewater treatment facilities, and
suggested that exploring the implementation of these alternatives would
be beneficial for the safety of workers, personnel, and communities
associated with the facilities. One commenter stated that the costs for
water facilities to convert to safer alternatives are feasible, and
remarked that it is possible to adopt IST without disrupting
operations.
Alternatively, a few industry trade associations and government
organizations stated that STAA should not be applied to water
facilities citing that any STAA requirement would be repetitive and
counterproductive and that drinking water utilities already have to
consider a variety of public health and safety factors under the Safe
Drinking Water Act (SDWA).
EPA disagrees with commenters who suggest subjecting water and
wastewater treatment facilities to STAA requirements. EPA's approach to
applying the STAA requirement was to identify industry sectors with the
greatest accident frequency at RMP-regulated facilities within the
sector, and with the greatest opportunity to apply STAA risk management
measures. While EPA agrees that water supply and wastewater treatment
facilities often have feasible alternatives available, according to RMP
accident history data, the sector is among the least accident-prone
sectors covered under the risk management program. Therefore, the final
rule does not apply the STAA requirement to the water and wastewater
treatment sector. EPA acknowledges that drinking water utilities
already may have considered alternative technologies for their
disinfection process while addressing safety and health considerations,
risk tradeoffs and compliance with the SDWA.
Limit applicability to major process changes or after accidents. A
few commenters want EPA to consider having a requirement similar to
that required by Contra Costa County for facilities to conduct an STAA
whenever major process changes are proposed and in the aftermath of
accidents, when there are often significant opportunities for making
process improvements as equipment is rebuilt or repaired. One commenter
noted that the CCHS program requires an ISS analysis during the design
of new processes, for PHA recommendations, or for major changes
resulting from incident investigation recommendations, root cause
analysis or MOC review that could reasonably result in a major chemical
accident or release. This commenter noted that California's proposed
refinery regulations are following the same requirements as the CCHS
program. Other commenters recommended that instead of requiring STAA
analyses at least every five years in conjunction with the a PHA
revalidation, EPA should require the analysis only after accidents.
Another commenter recommended modifying the wording in section
68.67(c)(8) to limit the provisions to new processes or major
modifications to existing processes. The commenter also remarked that
stationary sources' management of change (MOC) programs should be
updated to account for process changes and allow for reassessment of
the IST analysis. The commenter concluded that this will ensure that
existing IST components are not removed, replaced, or changed without
revalidating the IST feasibility criteria.
EPA disagrees that the STAA requirement should be triggered only by
a major process change. While the Agency acknowledges that a major
process change could be an opportune time to evaluate safer technology
alternatives, the Agency is concerned that requiring STAA reviews only
after major process changes could result in some processes rarely or
never being evaluated for safer technology alternatives. This could
occur if few or no major changes occurred during the life of the
process. Also, limiting the STAA to only major process changes could
create a disincentive to upgrading processes if facilities chose not to
make improvements to avoid having to perform an STAA. EPA is also
concerned that there is no common definition or understanding of the
term ``major process change'' that could easily be applied to the wide
range of processes affected by the STAA requirement. Therefore, while
EPA agrees that integrating STAA reviews into a facility's MOC program
(and other prevention programs) may often be beneficial, the Agency
believes it is appropriate to incorporate the STAA provision into the
PHA section of Sec. 68.67, rather than the MOC section of Sec. 68.75.
Nevertheless, EPA encourages owners and operator to also consider safer
technology alternatives whenever major process changes are planned.
EPA is revising the PHA requirements in Sec. 68.67 to require that
the PHA address findings from incident investigations as well as any
other potential failure scenarios. Other potential failure scenarios
may include those introduced from major process changes or new designs
or those discovered as a result of an accident investigation. Thus, EPA
believes that the PHA with its requirement to encompass IST review as
part of the PHA process, would cover the same process changes whether
they result from an incident investigation, MOC action or other process
change.
Finally, EPA disagrees that the STAA requirement should be
triggered only by accidental releases. Although the Agency agrees that
accidental releases may indeed signal to the owner or operator that
safer technology alternatives should be considered, the Agency prefers
that owners and operators evaluate safer technologies before accidents
occur, with the aim of ultimately preventing such accidents. Also,
similar to the Agency's objection to requiring STAA reviews only after
major process changes, requiring an STAA only after an accident would
mean that many processes subject to this provision may never undergo an
STAA.
Limit applicability of STAA requirements to the design phase of a
process. Several commenters, including
[[Page 4636]]
industry trade associations suggested that EPA should not require STAAs
for existing facilities or processes. Numerous commenters, including
facilities, industry trade associations, local agencies, and a Federal
agency, stated that an STAA is more appropriate during the design phase
of a new process or facility, or during significant modifications. Some
commenters, including a local agency, encouraged EPA to require STAAs
to consider the highest level of hazard control (referring to the
``hierarchy of controls'') that is feasible during the design phase or
whenever a facility makes a change. Another commenter stated that
adding a new regulatory requirement, particularly for existing
operations, is unnecessary to address inherently safer design, and that
safer technology reviews should not be part of a PHA.
In contrast, other commenters urged that safer technologies
analyses are an ongoing need and should not be limited to new
facilities. A state agency and an individual urged that IST should be
performed for all new projects, processes, or stationary sources
throughout various phases of a project's life cycle. According to the
commenter, performing a separate IST analysis for the entire existing
process approximately every five years allows evaluators to see the big
picture rather than just the minute details associated with a typical
PHA process.
EPA disagrees that STAA analyses should only be required during the
initial design phase of a facility. While the greatest potential
opportunities for using IST occur early in process design and
development, many IST options may still be practicable after the
initial design phase. Furthermore, STAA involves more than just IST.
Safer technology alternatives also include passive measures, active
measures, and procedural measures, and these measures can be modified
and improved after the initial design of a facility. EPA notes that
many RMP-regulated facilities were originally constructed decades ago,
yet major enhancements have been reported in some plants that have been
operating for many years.\77\ CCPS explains that inherently safer
strategies can be evaluated throughout the lifecycle of a process,
including operations, maintenance and modification, and EPA agrees with
this approach.
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\77\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley, p. 25.
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Lastly, EPA disagrees that the PHA is not an appropriate risk
management program element in which to integrate the STAA. EPA believes
that safer technologies can and should be evaluated during the full
life-cycle of a covered process, and the PHA is the fundamental and
recurring risk management program element concerned with overall
analysis and control of process hazards. By integrating the STAA with
the PHA, every process subject to the provision will undergo an STAA,
every five years. EPA believes that five-year revalidation will give
the owner or operator the opportunity to identify new risk reduction
strategies, as well as revisit strategies that were previously
evaluated to determine whether they are now practicable.
Owners and operators of new construction facilities that will be
subject to the RMP rule should consider performing the STAA portion of
their initial PHA well enough in advance of facility construction so
that the full range of inherently safer designs is considered, and
include this evaluation in the initial PHA for the process.
c. Definitions
Feasible definition. Many commenters, including a facility, several
trade associations and an environmental advocacy group, remarked that
EPA did not sufficiently explain any of the five factors (``economic,
environmental, legal, social and technological'') for facilities to
consider in the proposed definition of ``feasible,'' and asserted that
the examples provided by EPA are unhelpful and vague. The commenters
argue that the proposed rulemaking does not provide sufficient guidance
on the feasibility component of the STAA review. As such, the
commenters conclude that these factors are so expansive and vague that
they do not provide any clear guidance as to how feasibility of IST
should be determined, and therefore have no place in the RMP rule.
According to one commenter, even if the five measures are properly
defined, they do not address the full range of issues in the
operational life of a project rather than just the processing phase.
A mass mail campaign joined by approximately 300 commenters warned
that ``accounting for'' these factors could be used as an excuse to
avoid necessary implementation measures.
An industry trade association said that it does not want EPA to
elaborate further on the proposed STAA requirement. One commenter
stated that it would be very subjective and difficult to prescribe in
regulations what is ``feasible'' for a facility and that any ``one-size
fits all'' approach to process safety would limit employers' ability to
react to real facts on the ground. In regards to incorporating ISTs
into safety programs, the commenter asserted that only facility
operators know whether IST is appropriate given the complexities of
their unique operating environments, and no one program will work for
all facilities.
EPA believes that the same tools and methods that facilities
currently use for their PHA can be used to identify and measure hazards
and risks of any safer alternative options. Further explanation of the
economic, environmental, legal, social and technological factors
included in the ``practicability'' definition of this final rule can be
found in NJDEP's Guidance for Toxic Catastrophe Prevention Act (TCPA)-
Inherently Safer Technology (IST) Review, Attachment 1 Feasibility
guidance.\78\
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\78\ https://www.nj.gov/dep/enforcement/tcpa/downloads/IST_guidance.pdf.
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EPA did not define the various factors, such as ``economic'' or
``social'' used in the proposed definition of ``feasible'' or in the
revised term ``practicability.'' The examples in the proposed
rulemaking preamble are taken from the guidelines provided by CCPS, and
are not exclusive of other situations. EPA believes that the definition
of ``practicability'' in the final rule provides sufficient flexibility
for the owner or operator to determine whether an IST or ISD considered
could be successfully accomplished. EPA does not believe that we should
further define ``economic or social factors'' in the rule because
further specificity of these terms would likely be too prescriptive and
would not encompass all the possible conditions and outcomes that might
be encountered when determining the practicability of an IST or ISD
considered in the STAA. EPA expects that facility owners and operators
will use their expertise and make reasonable judgements when
considering the appropriate meaning of economic or social factors so
that any decisions regarding possible implementation of IST is not
driven towards changes that would cause unintended adverse
consequences.
Finally, EPA disagrees with commenters' assertion that accounting
for the factors in the definition of ``practicability'' could be used
as an excuse to avoid necessary implementation measures. EPA is not
requiring IST or ISD implementation in the final rule and, therefore,
further clarifying the practicability definition will not impact IST or
ISD implementation.
[[Page 4637]]
Consistency of feasible definition with other programs. A commenter
encouraged EPA to incorporate the definition of ``feasibility''
provided in the Contra Costa County Safety Program Guidance Document.
Another commenter stated that the proposed definition of
``feasibility'' is consistent with California's proposed California
Accidental Release Prevention (CalARP) regulations and the Contra Costa
County and the City of Richmond's Industrial Safety Ordinances.
However, a state agency, commented that there is an inconsistency with
CalARP's definition of ``feasible'' in that the proposed EPA definition
omits the terms ``health'' and ``safety,'' and the commenter encouraged
EPA to add these terms to the list of factors to consider in a
determination of feasibility.
EPA based the feasible definition on the CCHS definition of
``feasible'' but modified the definition to add language acknowledging
that environmental factors include a consideration of the potential to
transfer risks or introduce new risks to a process or source. The
practicability definition in the final rule maintains this language.
EPA disagrees with the suggestion to add the terms ``health'' and
``safety'' to the definition. The primary reason for EPA to consider
ISTs in a STAA is to reduce risks to health and safety of the public by
mitigating the frequency and severity of accidental releases. EPA
believes this is adequately addressed in the definition of ``inherently
safer technology or design'' of this final rule and including these
factors in the definition of ``practicability'' would be redundant.
Suggested revisions to feasible definition. One commenter argued
that the term ``within a reasonable time'' in the definition of
``feasible'' could allow facilities to avoid implementation, and urged
EPA to exclude a time based factor from the final definition. This
commenter also argued that EPA should not make any level of cost, no
matter how minimal, an excuse to not implement any IST measures, but
rather should recognize that IST measures should be implemented unless
doing so would cause an extremely serious adverse economic effect, such
as a facility shutdown. A facility noted that the proposed feasibility
analysis does not allow sufficient time to complete the necessary work
and recommended that the timeframe be determined on a case by case
basis. A state agency commented that the feasibility of an IST must
consider factors such as timeliness of implementation and costs. This
commenter expressed concern that the definition of ``feasible'' would
allow for the implementation of IST options that may not be
economically justifiable compared to other equally protective options.
Some commenters recommended deleting the explanation of
environmental factors in the feasible definition. These commenters
warned that this language is too specific in comparison with the
general terms included in the definition. One commenter expressed
concern that the language shows an industry bias and suggested using
the following alternative definition: ``Feasible means capable of being
successfully accomplished within a reasonable time, accounting for
economic, environmental, legal, social, and technological factors
weighed against the immediate and long-term benefits to safety and
health. A claim of infeasibility shall not be based solely on evidence
of reduced profits.''
EPA disagrees with the commenters. Cost is a consideration when
determining whether a risk management measure can be successfully
accomplished and because EPA is not requiring implementation of any
IST, we see no reason to exclude this factor from a practicability
determination. EPA also disagrees with the suggestion to limit
consideration of reduced profits when assessing a risk management
measure because the Agency believes that cost is a valid consideration
for practicability. Identifying an amount of an allowable cost for an
IST is not something that can be prescribed in the regulation because
cost decisions are highly dependent on the economics involving a
particular process, facility and industry.
EPA also disagrees that incorporating consideration of a reasonable
timeframe will allow facilities to avoid implementation. EPA is not
requiring IST implementation and we acknowledge that there may exist
practical limits on whether some projects or process designs can be
done to enhance safety. If a risk management measure cannot be
accomplished within a reasonable time, then the facility should ensure
that other safeguards are in place to prevent accidents instead of
relying on the uncertainty of completing a long-term project that is
dependent on future conditions such as process design, operating
budgets, etc.
Finally, as other commenters have noted, some ISTs involving
chemical substitution or significant process redesign can result in new
hazards or risks being introduced, and these should be considered when
deciding the practicability of an IST. Thus, EPA is retaining the
explanation of environmental factors in the practicability definition
in this final rule.
Definition should be stronger than OSHA definition of ``feasible.''
One commenter urged EPA to adopt a definition that is stronger than or
at least as protective of health and safety as the OSHA definition of
``feasible'' to provide an appropriate minimum level of protection
under CAA--42 U.S.C. 7412(r)(7) that EPA should not go below. The
commenter states that under the OSHA standard, a protective measure is
technologically feasible if, using existing technology or technology
that is reasonably expected to be developed, a typical facility could
achieve the standard in most operations most of the time. Additionally,
the protective measure is economically feasible if its costs do not
threaten the existence or competitive structure of an industry. The
commenter contends that OSHA's definition has been interpreted by
courts to mean that the mere expense of a measure, alone, cannot trump
the implementation of safety measures that are ``capable of being
done.'' The commenter believes that EPA should not set a weaker
definition that would make it less likely that IST or other prevention
measures would be implemented under Sec. 7412(r) than under OSHA's
definition. Doing so would be both inconsistent with the objectives of
Sec. 7412(r) to protect the public and with the existing framework
facilities follow under OSHA requirements, could lead to confusion for
facilities and in the courts, and result in an overall reduction in
safety measures.
EPA disagrees with the commenter and believes the approach in the
final rule to consider the practicability of IST or ISD considered is
consistent with the intent of CAA and will not lead to an overall
reduction in safety measures. The current rule already requires the PHA
to consider active, passive and procedural risk management measures in
Sec. 68.67; however, the requirements do not prescribe exactly which
type or exactly what engineering and administrative controls must be
implemented. The regulations allow facilities to use their specific
knowledge and expertise of the process to meet the PHA requirement to
``identify, evaluate and control the hazard'' [emphasis added]. EPA is
finalizing a requirement for certain sectors to conduct a STAA that
also considers IST in the hierarchy of controls. However, requiring
facilities to implement IST instead of using passive, active or
procedural safeguards can involve extensive and very expensive changes
to a facility's
[[Page 4638]]
process, depending on the IST, especially if it involves substitution
of alternative chemicals and/or major process redesign. EPA believes
that a practicability consideration should address whether an IST or
ISD can be accomplished technologically, is economically possible, does
not result in an increase in hazards or other risks that cannot be
controlled, or cannot be successfully accomplished because of other
considerations. Therefore, EPA disagrees that the practicability
definition should be stronger than (or even similar to) OSHA's
interpretation of feasible.
Harmonize feasible definition with OSHA. A facility noted that the
proposed definition of ``feasible'' in Sec. 68.3 could cause the
potential for confusion because the proposed rulemaking preamble states
that OSHA has indicated that it would be unable to adopt the term
feasible, as defined in this notice, under its PSM standard if OSHA
considers similar revisions involving IST. This is an illustration of
the need to harmonize the requirements of EPA RMP requirements with
that of OSHA PSM.
A few commenters, including facilities and industry associations,
urged harmonization with OSHA's definition of ``feasibility'' and
requirements. A facility and an industry trade association warned of
the confusion that could ensue if ``feasibility'' is defined
inconsistently between EPA and OSHA, and encouraged EPA to use the term
``practicability'' instead. Similarly, an industry trade association
urged EPA to use the term ``practical'' in place of ``feasible.'' The
industry trade association argued that what is deemed feasible is often
not practical for a number of reasons, and asserted that any decision
to alter a technology involves a complex variety of factors such as
operating costs, associated risk, energy consumption and greenhouse gas
emissions. The commenter concluded that only facility owners should
ultimately be able to define what is feasible or practical for their
facility. In contrast, a state agency encouraged use of the term
``feasible'' rather than ``practical.'' An industry trade association
asserted that neither term should be the basis for the analysis.
EPA agrees with commenters and is revising the rule to replace the
term ``feasible'' with ``practicability.'' EPA proposed to use the term
``feasibility'' as part of the STAA analysis as it is already widely
used in the technical literature discussing IST. However, because OSHA
is considering similar revisions to its PSM standard involving IST and
in order to eliminate the potential for confusion of different meanings
of the term ``feasible,'' \79\ EPA has decided to use the term
``practicability'' while retaining the same definition and meaning used
for ``feasible'' in the proposed rulemaking.
---------------------------------------------------------------------------
\79\ 81 FR 13667, March 14, 2016.
---------------------------------------------------------------------------
Hierarchy of controls. A commenter noted that California's proposed
regulations for refineries and EPA's proposed regulations would require
that the facility look for inherently safer means to reduce the
hazards, but if there is not a means to reduce the hazard, the facility
would go through a hierarchy of prevention methods and select the
highest level of prevention. This commenter and another requested that
EPA use the term ``Hierarchy of Control,'' which is a term that is
already understood, instead of adding a brand new term.
EPA does not use the term hierarchy of control (nor substitutes a
new term for it) but instead explicitly explains the concept in the
regulation by stating that the owner or operator shall consider risk
management measures in the following order of preference:
Inherently safer technology or design,
Passive measures,
Active measures, and
Procedural measures.
EPA believes this is consistent with proposed CalARP regulations
\80\ for Hierarchy for Hazard Control Analysis, which require
refineries to eliminate hazards using first order inherent safety
measures; to reduce any remaining hazards using second order inherent
safety measures; and to address any remaining risks in the following
sequence and priority by using passive safeguards, active safeguards,
and procedural safeguards.
---------------------------------------------------------------------------
\80\ Draft California Accidental Release Prevention Program
(ARP) Regulations, California Governor's Office of Emergency
Services. July 5, 2016, p. 83 https://www.caloes.ca.gov/FireRescueSite/Documents/CalARP%20Proposed%20Regs%202016.pdf.
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Passive measures. A commenter recommended revising the definition
of ``passive measures'' to ``mean risk reduction measures designed to
reduce the probability or the consequences of an accidental regulated
chemical release without human intervention'' to better reflect that
EPA probably meant ``reducing the hazard'' as an aspect of risk
management. The commenter views ``hazard'' as the inherent capacity of
a substance to cause an adverse effect, while ``risk'' is the
probability that an adverse effect will occur, if one uses OSHA's
definition of the terms. In addition, the commenter said that the
definition of ``other energy inputs'' needs revision, and suggested
replacing the phrase ``energy inputs'' with ``human intervention'' to
meet the intent of the definition. This commenter expressed concern
that the word ``other'' in the phrase ``other energy input''
mischaracterizes pressure vessel designs, dikes, etc. as energy inputs.
This commenter also suggested that passive ``design features'' could
include mechanical or energy intervention measures and the commenter
cited examples such as automatic fire suppression systems and automatic
vapor ignition.
EPA agrees with the commenter's suggestion to revise the definition
of ``passive measures'' to address the frequency and consequence of the
hazard. EPA based the proposed definition of ``passive measures'' on
the definition used by CCPS, which defined ``passive'' as ``minimizing
the hazard through process and equipment design features that reduce
either the frequency or consequence of the hazard without the active
functioning of any device, i.e., providing a dike wall around a storage
tank of flammable liquids.'' \81\ Thus the intent of the CCPS
definition appears to be on aspects of both hazard and risk reduction.
EPA is modifying the ``passive measures'' definition in the final rule
to clarify that passive measures reduce the frequency or consequence of
the hazard.
---------------------------------------------------------------------------
\81\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed., p. 10. https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0253.
---------------------------------------------------------------------------
EPA disagrees that the word ``other'' in ``other energy inputs''
characterizes pressure vessel designs and dikes as energy inputs and
also disagrees that passive design features would include automatic
fire suppression systems or automatic vapor ignition (in which a flare
is ignited). These types of measures would most likely be considered to
be active measures. CCPS, in their Guidelines for Hazard Evaluation
Procedures,\82\ cites a fire protection system as an active safeguard
because a fusible link or other engineered device must function to
successfully trip the system.
---------------------------------------------------------------------------
\82\ CCPS. 2008, Guidelines for Hazard Evaluation Procedures.
3rd ed., p. 234. https://www.aiche.org/ccps/publications/books/guidelines-hazard-evaluation-procedures-3rd-edition.
---------------------------------------------------------------------------
IST/ISD. A number of commenters, requested clarification on the
definition of IST, ISD or Inherently Safer Measures. A few wanted
clarification as to what would qualify as ``safer'' in this context.
One labor union expressed general support for the proposed definition
of IST. One commenter asked
[[Page 4639]]
EPA to ensure that there is a distinction between IST and less
effective controls and management methods. This commenter argued that
chemical substitution and process changes are the most effective
methods to protect workers and the public from incidents and that these
``inherently'' safer options should be distinguished from less
effective controls and management methods. The commenter cited lesser
effective controls from the NJDEP IST compliance, such as safer
extremely hazardous substance risk location, protection of storage
vessels from weather conditions, changes in truck traffic patterns,
addition of EHS leak detectors, use of closed circuit television
systems, labeling of valves and equipment, revising procedures,
installing a simulation training station, and adding light towers for
EHS leak alarms. The commenter requested that EPA develop a precise
definition for IST and Inherently Safer Design (ISD).
EPA disagrees with the commenters' suggestions to provide a
distinction between IST and other controls and management methods. EPA
believes that determining effective risk management strategies for a
facility is a site-specific determination and EPA encourages any
improvement that will could lead to inherently safer conditions.
Therefore, EPA is finalizing the definition of IST/ISD as proposed.
EPA based its definition of inherently safer technologies (IST) or
design (ISD) on the four inherently safer strategies as explained in
the Inherently Safer Chemical Processes: A Life Cycle Approach by
CCPS.\83\ These four types of strategies have been widely recognized by
the industry and best encompass the concepts and principles of applying
inherent safety, which focuses on eliminating or reducing the hazards
associated with a set of conditions.
---------------------------------------------------------------------------
\83\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed., https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0253.
---------------------------------------------------------------------------
As the 2010 CCPS Final Report: Definition for Inherently Safer
Technology (IST) in Production, Transportation, Storage and Use \84\
states:
---------------------------------------------------------------------------
\84\ CCPS. July 2010. Final Report: Definition for Inherently
Safer Technology in Production, Transportation, Storage, and Use,
https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0274.
IST (Inherently Safer Technology), also known as Inherently
Safer Design (ISD), permanently eliminates or reduces hazards to
avoid or reduce the consequences of incidents. IST is a philosophy,
applied to the design and operation life cycle, including
manufacture, transport, storage, use, and disposal. IST is an
iterative process that considers such options, including eliminating
a hazard, reducing a hazard, substituting a less hazardous material,
using less hazardous process conditions, and designing a process to
reduce the potential for, or consequences of, human error, equipment
---------------------------------------------------------------------------
failure, or intentional harm. [emphasis added]
The CCPS guidance is organized by these four strategies and
provides many examples of each type of strategy. NJDEP also uses
descriptions of the four strategies to identify available IST
alternatives in their inherently safer technology review
requirements.\85\ Although some NJ facilities may have reported some
controls that others might not strictly view as IST, EPA does not
believe that IST should be limited only to chemical substitution and
process changes. Some changes such as better labeling of equipment are
cited as examples of process simplification in CCPS' IST Checklist.
Changes involving transportation of chemicals and storage location are
also cited in the checklist because inherent safety can involve
reduction of hazard, and does not require complete elimination of a
hazard.
---------------------------------------------------------------------------
\85\ NJDEP TCPA. March 29, 2012. NJ Title 7, Chapter 31 TCPA
Program Consolidated Rule Document, https://www.nj.gov/dep/rules/rules/njac7_31.pdf.
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d. General Comments on STAA Requirements
Suggestions for minimal elements for STAA methodology. An
environmental advocacy group noted that in the proposed rulemaking, EPA
states that owners and operators may use ``any available methodology or
guidance'' to conduct their STAA, but urged EPA to define the minimum
basic elements that owners or operators must include in their STAA. The
commenter believed the STAA should include an analysis of the
technical, economic, legal/regulatory, social, and hazards implications
of each major technology option, and noted that the sample
methodologies and guidance listed in the proposed rulemaking may not
include all of these elements. The commenter urged EPA to require the
economic analysis to include potential liabilities, costs, avoided
costs, and savings associated with each major STAA option evaluated.
EPA does not believe it should specify factors other than those
already present in the PHA and STAA requirements, including the
definition of ``practicability.'' EPA believes that various resources
and guidance exist (as well as existing PHA methodologies, such as
HAZOP, What-If? Method, or checklists or a combination of these as
discussed in Chapter 8 of CCPS' book, Inherently Safer Chemical
Processes: A Life Cycle Approach \86\) that can assist facilities in
understanding how IST can reduce hazards and risk and in determining
practicability of IST or ISD considered in the STAA. Facilities can
follow, for example, guidance for IS Review Documentation found in
CCPS's Inherently Safer Chemical Processes, which suggests documenting
the summary of the approach used for the IS review (i.e., methodology,
checklist, etc.), names and qualifications of the review team, IS
alternatives considered, as well as those already implemented or
included in the design, results of each consideration including those
not considered and why, documentation of feasibility and rationale for
rejection of IS opportunities.
---------------------------------------------------------------------------
\86\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley.
---------------------------------------------------------------------------
While some facilities may choose to conduct an economic analysis of
potential liabilities, costs, avoided costs, and savings associated
with each major STAA option evaluated, EPA is only requiring facilities
to determine whether IST is practicable and document this
determination. It may not be always be possible to estimate avoided
costs and savings for a particular IST.
STAA is not a suitable replacement for other prevention program
measures. An association of governments expressed concern that analyses
will not prevent accidents because human factors such as operational
bias towards production rather than safety, failures to manage changes,
failures to provide adequate training for employees and failures to
follow standards cannot be eliminated by a safer technology analysis.
The association warned that the analysis could be used as a substitute
for appropriate emergency preparedness and accident prevention
programs. The commenter also believed that adoption of safer technology
without a holistic review of risk transfers might be dangerous.
EPA does not believe or intend that a safer technology analysis as
part of the exiting PHA would negate the need or requirements for
facilities to follow other RMP rule provisions, such as training,
managing change, and following RAGAGEP. Rather this analysis is
designed to supplement or enhance the ways that hazards or risks of an
accidental release can be eliminated or reduced by possibly more
rigorous risk reduction measures.
[[Page 4640]]
Facilities can evaluate the feasibility of potential safer technologies
and this evaluation can and should take into account any known
transfers of risk, as well as other considerations. For this reason,
EPA is not prescribing that facilities adopt any particular safer
alternative and is allowing any decision on implementation of IST to be
made based upon a facility's judgement using accepted hazard analysis
and their knowledge of their processes, hazards, risks and methods to
control hazards. EPA does not believe the analysis could be used as a
substitute for appropriate emergency preparedness and accident
prevention programs--existing requirements in these areas are still in
place and this final rule also provides more emphasis on emergency
coordination and response (for more information see section V of this
preamble).
STAA guidance, regulatory incentives and voluntary partnership
programs. An industry trade association suggested the establishment of
a working group to develop decision framework and guidance materials
for STAAs. The commenter remarked that creation of a working group
would be more effective than mandating RMP facilities to conduct STAAs
with insufficient guidance. A commenter recommended that the working
group should consider existing voluntary programs that include a safer
alternatives assessment, and should consider the possibility of
establishing a public-private partnership. The commenter further
explained that the working group should explore how EPA could leverage
these programs by providing regulatory incentives to those who
participate in and fulfill the requirements of the voluntary programs.
The commenter also suggested that a partnership could be created based
on the core principles adopted by industry (i.e., stewardship) programs
and the lessons learned from existing and past voluntary partnership
programs. The commenter stated that such a program could provide
technical assistance and tools to help create awareness and instill a
quality culture of safety and security. The commenter provided a white
paper with more detailed discussion on the potential purposes,
components, incentives and requirements for a voluntary partnership
program to improve chemical safety and security.
EPA appreciates the commenters' suggestions for developing
guidance, regulatory incentives and partnership programs for STAAs. EPA
is finalizing a regulatory provision requiring Program 3 industry
sectors in NAICS codes 322, 324, and 325 to conduct an STAA as part of
the PHA and determine the practicability of IST or ISD considered. EPA
disagrees that STAA should be limited to a voluntary partnership
program; however, EPA will further consider the merits of a potential
voluntary partnership program with industry to engage in improved
process safety practices.
EPA believes the STAA requirements are flexible and allow the use
of industry expertise to best decide which safer technologies and
alternatives to consider, and to determine the practicability of IST or
ISD considered in the STAA. EPA will develop guidance for complying
with RMP PHA and STAA requirements before sources must comply with the
STAA provision required in this action. A draft of this guidance will
be available for public comment.
Making STAA information available to LEPCs. A facility is concerned
that the proposed requirement to share information pertaining to
inherently safer technology or design with the local LEPC would require
specific detailed information that the LEPC may not consider relevant.
While the facility expressed willingness to share appropriate
information with the LEPC, the facility does not believe the LEPC would
be interested in the minute details of the changes in process units. An
industry trade association stated that not requiring implementation
while requiring facilities to provide LEPCs the date of implementation
or planned implementation could cause confusion.
EPA agrees that providing LEPCs with detailed information regarding
process changes involving IST or ISD may not always be relevant or
necessary to community emergency preparedness or can be confusing. The
final rule eliminates the proposed requirements under Sec. 68.205 to
provide information to the LEPC, upon request (including IST
information). For more information about how the final rule addresses
sharing information with LEPCs or emergency response officials, see
section VI.A. of this preamble.
e. Including STAA as a PHA Requirement
Appropriateness of PHA techniques or process for STAA. A few local
agencies expressed support for STAA measures being used as a method of
addressing PHA recommendations. Commenters, including a local agency,
encouraged the review of the STAA at least every five years.
However, several commenters opposed including STAA in the PHA. Two
trade associations commented that requiring PHA teams to evaluate the
feasibility of IST has the potential to undermine the effectiveness of
the PHA process. The commenters argued that regulating IST is
infeasible because there is no simple answer when it comes to managing
risk. The same two trade associations and one facility asserted that a
PHA review of an existing process considers the adequacy of the
existing controls for that process while an IST review is entirely
different. The commenters believe an IST review involves a comparison
to a different technology and an operation-specific and site-specific
evaluation based on engineering judgment, in which many variables are
considered that include hazards, the location of the facility,
surrounding populations, exposures, technical feasibility and economic
feasibility. A state agency and an industry trade association warned
that requiring STAA during the PHA would be inappropriate because the
structure of a PHA does not facilitate such an analysis.
A facility expressed concern that none of the PHA methodologies
described in the NPRM require this type of comparison, arguing that
IST/ISD methodologies are similar, but not identical, to PHA analysis
techniques. The facility stated that it would be wrong to assume that
STAA can be directly incorporated into existing PHA methodologies. A
trade association commented that in order to have PHA team members
perform a comparative analysis on alternatives, the PHA team would be
required to compile relevant process safety information for the
alternatives in order to perform the IST analysis.
One commenter believes that IST needs to be evaluated outside of
the PHA process because the node-to-node hazard and operability study
(HAZOP) approach is minutely focused, does not look at the bigger
picture and reduces the impact of IST to localized risk reduction
measures rather than making the whole process inherently safer. The
commenter stated that a separate IST analysis for the entire existing
process is needed and could be performed every five years but
separately from the PHA since different team participants (such as
technical experts) are usually needed.
One trade association and a facility believed that IST analyses are
not practical to conduct as part of a PHA for a defined process with
defined chemicals. The commenters claimed that to consider a
substitute, a facility operator would need to design the new process
before being able to conduct the analysis. Some facility commenters
reasoned that design and hazard reviews for new facilities can take
place years
[[Page 4641]]
before any PHA. An industry trade agency suggested that EPA should
include appropriate lead-time and grandfathering provisions so as not
to disrupt projects already in the design or construction phase.
Finally, an industry trade association asserted that IST decisions are
very complex and should not be determined by any government agency, and
recommended that EPA delete the proposed STAA provisions.
EPA believes that IST analysis can be incorporated in the existing
RMP PHAs by using PHA techniques such as HAZOP, What-If? Method, or
checklists or a combination of these as discussed in Chapter 8 of CCPS'
book, Inherently Safer Chemical Processes: A Life Cycle Approach.\87\
These techniques themselves are not requirements, but tools available
to help the facility owner or operator to identify, evaluate and
control the hazards involved in the process.
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\87\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley.
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While developing the original RMP rule, EPA noted some commenters
strongly opposed any requirement for safer technology analyses because
PHA teams regularly suggest viable, effective (and inherently safer)
alternatives for risk reduction. In the preamble to the original RMP
rule, EPA agreed with these commenters, indicating that ``application
of good PHA techniques often reveals opportunities for continuous
improvement of existing processes and operations without a separate
analysis of alternatives.'' \88\ While these comments in 1996 led us to
not require STAA in the original rule, further developments in STAA,
and EPA's own experience with implementation of the rule, now indicate
that a specific mandate to conduct STAA reviews as part of the PHA will
encourage facilities who were performing PHAs that were of lower
quality but legally compliant with the old rule, to perform better
PHAs.
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\88\ See 61 FR 31699, June 20, 1996.
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Therefore, EPA disagrees with commenters that argue it is not
appropriate to include an STAA in the PHA. In fact, the RMP PHA
requirements include other aspects of an analysis that is typically
associated with process design. For example, the PHA must also address
stationary source siting issues which involve the location and
proximity of the source to local population and their numbers.
Nevertheless, EPA agrees that for situations where an IST would
involve a new process that is entirely different from the current
process, the process design would have to exist or be developed, and
process safety information be compiled, to conduct a PHA for this new
process. EPA does not expect facility owners or operators to research
and create new process designs or conduct research into all
possibilities for the use of new chemicals. Instead, the STAA should
focus on the known and existing substitute processes and chemicals that
have been demonstrated to be in use commercially.
If a facility is considering a chemical substitution or process
change that involves a significant redesign of their process, such
efforts involved with redesign and its evaluation may need to be
undertaken as part of a practicability study.\89\ The definition of
``practicability'' allows for consideration of technological factors,
which could include whether the potential safer alternative can be
designed and operated to meet the process functions needed. However,
not all IST involves substituting a chemical or an entirely new process
and there are other types of other IST measures (minimization,
moderation or simplification) that can be considered to address various
points within the current process where hazards and risks exist.
Furthermore, the final rule does not require the facility to implement
IST measures.
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\89\ EPA modified the final rule to replace the term
``feasible'' defined in Sec. 68.3 with ``practicability.'' When
evaluating the practicability of an IST, the facility owner or
operator would determine whether the IST is capable of being
successfully accomplished within a reasonable time, accounting for
economic, environmental (including consideration of potential
transferred risks for new risk reduction measures), legal, social,
and technological factors.
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Facilities may, if desired, conduct a separate IST analysis of each
covered process, outside of the PHA, if desired, as long as it is done
in same timeframe as the PHA and the results are documented. If a
facility does not have staff capable to identify and evaluate
alternatives, the facility owner or operator may require outside
assistance from engineering firms or consultants.
The RMP PHA requirements require the facility owner or operator to
identify risk management measures that eliminate or reduce the risks
from the process hazards. If the facility has already performed such
IST analysis in the past, then the owner or operator should consider
these analyses when updating or revalidating their PHAs and determine
whether there is new information that should be considered as part of
conducting the current STAA.
Involvement and training of employees and team members. An industry
trade association expressed concern about the potential experience
limitations of the PHA team. The commenter stated that team members may
lack the expertise required to assess all alternative technologies, and
said that in the case of inadequate experience the STAA should be
considered within the management of change element of the RMP and the
facility's ongoing risk assessment analysis. Two trade associations
commented that a PHA and an IST analysis serve two entirely different
engineering functions and the teams that conduct these reviews are
staffed differently. The two associations further commented that small
facilities do not have staff design engineers to conduct an IST review,
which means the facility would be required to absorb the cost of
retaining them even though there is no requirement that their findings
be implemented.
One Federal agency commented that throughout the SBAR panel
process, SERs noted that this analysis would require additional
staffing such as design engineers, in addition to the chemical and
mechanical engineers already staffed for PHA analyses. The SERs added
that most small facilities do not have design engineers on staff and as
a result, would need to incur additional expenses to retain them.
Another commenter stated that conducting a full IST/ISD review
based on yet-unproven technologies typically is an extremely complex
endeavor (particularly for a chemical production process), and would
require very different PHA teams that could adequately assess IST/ISD
(e.g., to adequately study how the hypothetical use of new IST/ISD
might create additional, unanticipated hazards throughout a process).
Another commenter suggested that the PHA/hazard review team should
be properly educated in inherent safety analysis. A professional
organization encouraged the participation of workers in the STAA
process, but urged that these employees must have proper training and
education to participate. Some commenters recommended engaging workers
in the alternatives and feasibility assessment process and making sure
they have the ability to report anonymously and hold whistleblower
authority. One commenter urged EPA to explicitly state that union
representatives and workers can participate fully in the STAA.
EPA believes that limiting the applicability of the STAA
requirement to only those facilities in Program 3 in the petroleum and
coal products manufacturing (NAICS code 324), chemical manufacturing
(NAICS code
[[Page 4642]]
325) and paper manufacturing (NAICS codes 322) minimizes the burden of
the requirement for many small businesses. Of those approximately 1,557
facilities that are subject to the STAA requirements, approximately 40%
of them are owned by small entities, however, about 86% of these small
entity-owned facilities have 20 or more full-time equivalent
employees.\90\ EPA agrees that team members conducting an STAA should
be properly trained and knowledgeable on how to conduct the analysis.
The facility owner or operator is responsible for ensuring that
facility personnel have the proper training to conduct STAAs or hire
consultants with the appropriate qualifications. EPA expects that some
facilities in NAICS codes 322, 324, and 325 will have staff qualified
to conduct the analysis. If the facility owner or operator determines
that two different teams should conduct the PHA and STAA, then they may
choose to conduct a separate STAA of each entire process, outside of
the PHA as long as it is done in same timeframe as the PHA and the
results are documented.
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\90\ Regulatory Impact Analysis, Accidental Release Prevention
Requirements: Risk Management Programs Under the Clean Air Act,
Section 112(r)(7), using data from Exhibit 7-3 and 7-5.
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As discussed in the RIA, the technical practicability assessment
considers the extent of process redesign, its engineering implications,
and possible costs. EPA estimates that most facilities except the large
facilities in NAICS codes 322, 324, and 325 will seek help from
consultants (i.e., engineering firms) to conduct STAA and determine the
practicability of IST/ISD considered. However, EPA does not expect
facilities to spend resources evaluating hypothetical untested
alternatives that they believe are not proven within their industry.
Finally, the final rule provides facility owners or operators the
flexibility to use facility personnel with expertise and experience
with facility processes and their industry to conduct STAAs and
determine the practicability of IST/ISD considered. However, EPA does
not believe the RMP rule is the appropriate mechanism to address worker
rights or whistleblower protections.
Overlap or conflict with PHA analysis. A few industry trade
associations and a facility expressed concern that an IST analysis
would detract from the goal and focus of the PHA process to identify
hazards to be addressed and to identify opportunities for continuous
improvement of operations. For example, one commenter was concerned
that in an effort to ensure compliance with new safer alternative
technology analysis regulations, PHA teams may be distracted from
identifying and addressing the hazards of existing processes by
spending too much time assessing potential alternative technologies
with which they have no experience. Two commenters elaborated, stating
that requiring IST or ISD ``consideration'' based on a laundry-list of
``factors'' would substantially increase the already extensive time
that is required to complete a PHA, and favor subjective reviews over
objective reviews of actual safety problems and the most direct and
timely techniques required to resolve them.
EPA disagrees with the commenters. The RMP PHA requirements are not
only to identify hazards but also to incorporate measures to reduce or
mitigate those hazards. Under Sec. 68.67(a), the rule requires the
owner or operator to identify, evaluate and control the hazards
involved in the process. Several commenters acknowledge that some
companies already evaluate ``safer alternatives'' during their PHAs
when it is efficient to consider fundamental process changes. EPA
disagrees that consideration of additional inherently safer measures
necessarily precludes addressing hazards and applying other risk
reduction measures in the hierarchy of controls. If facility owners or
operators are concerned that an IST assessment could preclude other
aspects of the PHA, they may choose to conduct the STAA separately from
the PHA, as long as it is performed on the same timeframe and
documented.
IST already incorporated as part of PHA or otherwise considered.
Another industry trade association remarked that STAA requirements are
already a component of the PHA and concluded that costs of the new
requirement would be redundant, but that these costs are incommensurate
with the much lower risks faced by facilities in their industry. One
trade association disagrees with requiring STAA as part of the PHA
because currently approved PHA methodologies already provide for
successful risk mitigation (reducing risks to personnel and the
environment to `acceptable' levels), including the consideration of
inherently safer design technologies by the PHA team where appropriate.
A commenter noted that some companies already evaluate ``safer
alternatives'' during their PHAs when it is efficient to consider
fundamental process changes. However, they consider available, proven
technologies, not ``potentially'' safer technology that may be noted in
literature, but not yet in use anywhere within their industry. Another
industry trade association remarked on the importance of process safety
information for alternatives and its availability to the PHA team. A
process safety organization commented that they believe the existing
provisions to conduct a PHA automatically includes the team to consider
safer alternatives as appropriate and applicable. An industry trade
association said that many of the activities being reported as IST in
NJDEP's IST Implementation Summary, were activities that already occur
as a matter of course in most facilities.
A facility and multiple industry trade associations remarked that
other programs such as the Department of Homeland Security's Chemical
Facility Anti-Terrorism Standards (CFATS) already provide incentives
for facilities to promote safe practices, and implement safer
alternatives and designs. Several commenters urged EPA to avoid
burdensome requirements that overlap with the CFATS program at
additional cost without added benefit. An industry trade association
noted that CFATS allows facilities to move to a lower risk tier or out
of the program if risk profiles are reduced and vulnerabilities are
minimized, resulting in roughly 3,000 facilities that have changed
processes or inventories in ways that have enabled them to be excluded
from the program. This commenter notes that DHS's risk performance-
based approach does not mandate solutions, recognizes the unique
situation of each facility, and embraces a public-private sector effort
for implementation of safer measures. The commenter further indicated
that mandating the adoption of government-selected ISTs would be unduly
burdensome, particularly for smaller chemical facilities, and could
hinder their overall efforts at improving security.
While EPA recognizes that some facilities may already consider ISTs
as part of a PHA, whether as part of a voluntary program or through
other incentives, EPA believes that all facilities in NAICS 322, 324,
and 325 industry sectors should consider IST to ensure that they are
considering all the options to operate their facility safer. EPA
expects that these regulatory requirements will raise industry
awareness of IST possibilities and will reduce risk. EPA is not
mandating implementation or adoption of any particular IST and will
rely on facility expertise to reduce the hazard and mitigate risk
without causing undesirable consequences such as reducing product
quality or transferring risk to some other point in the supply chain.
[[Page 4643]]
Furthermore, EPA disagrees with commenters that asserted that the
STAA requirements will overlap with other regulatory requirements and
result in an increased burden with no corresponding benefit. In its
2007 Interim Rule for CFATS,\91\ DHS stated that Section 550 of the
Homeland Security Appropriations Act of 2007 prohibited the Department
from disapproving a site security plan ``based on the presence or
absence of a particular security measure,'' including ISTs.\92\ DHS
noted that, even so, covered chemical facilities are certainly free to
consider IST options, and their use may reduce risk and regulatory
burdens. Therefore, because DHS does not require IST or the assessment
of IST, EPA does not believe there is an ``overlap'' in requirements.
Furthermore, DHS requirements address site security measures, and not
measures designed to reduce accidental releases.
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\91\ See 72 FR 17718, April 9, 2007, https://www.gpo.gov/fdsys/pkg/FR-2007-04-09/pdf/E7-6363.pdf.
\92\ Section 550 has since been replaced by the Protecting and
Securing Chemical Facilities from Terrorist Attacks Act of 2014,
Public Law 113-254. However, the prohibition on DHS disapproving a
security plan based on the presence or absence of a particular
security measure remains. See 6 U.S.C. 622(c)(1)(B).
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Potential for risk tradeoff or risk transfer. Some commenters,
including an association of government agencies and an industry trade
association, encouraged a holistic review of IST to avoid or minimize
risk transfers. A few commenters stated that, for example, a facility
adopting a safer technology may increase transportation requirements of
hazardous materials and increase risks of incidents outside of the
facility, including necessitating more exotic emergency response
equipment or preparation. One commenter noted that minimization
frequently involves the decrease of on-site storage and could result in
the potential for additional shutdowns and startups due to insufficient
raw materials. The same commenter further indicated that substitution
of a purportedly safer alternative may introduce environmental or
safety risks that are not realized until much later.
In contrast, an advocacy group urged EPA to consider that the
commenters citing risk transfer are often industry funded and, in the
opinion of the commenter, overlook risk transfer that is caused by
actions of the facilities themselves. A process safety organization
stated that EPA should not require an STAA as part of a new prevention
program, as part of the existing PHA/hazard review, or as a requirement
under CAA section 112(r) because the definition of ``inherently safer
alternatives'' has always been very debatable and use of these
alternatives may not result in the overall reduction of the total
quantitative risk of the facility. The organization expressed concerns
that a verbatim statement of consideration and/or implementation of
inherent safer options has the potential for unintended outcomes, such
as risk transfer, risk accumulation, increased opportunities for
terrorism, and other undesirable tradeoffs. This commenter recommended
that EPA should not require the IST analysis because few technologies
would be inherently safer with respect to all hazards, there may not be
a clear implementation path for all situations, and facilities would
have to address multiple tradeoffs in the decision making process. The
commenter warned that improper implementation of a ``safer''
alternative may have negative consequences. Some commenters note that
an absolute safer alternative is highly dependent on the hazard, the
process, the technology and the facility. For every process there could
be different type of alternative chemical use.
EPA recognizes the risk transfer concerns raised by the commenters.
However, EPA believes that the final rule allows the owner or operator
to consider the potential for quantitative risk reduction, risk
transfers and tradeoffs when determining whether it is practicable to
implement ISTs or ISDs considered. EPA agrees that some technologies
may not be inherently safer with respect to all hazards, may not be
implementable for all situations and may involve multiple tradeoffs in
the decision making process. IST is a relative concept dependent on the
hazard, the technology, and the facility. Therefore, EPA is requiring
facilities to only consider IST as a possibility for addressing hazards
rather than requiring ISTs be implemented. The final rule gives the
facility owner or operator the flexibility to assess IST as well as
passive, active, and procedural measures to reduce risk associated with
a process and to determine the practicability of any IST considered
based on various factors (including those involving risk transference).
Current PHA requirements and other risk reduction measures already
adequate address risks. Several facilities and industry trade
associations urged that existing requirements and principles, such as
PHA and Layer of Protection Analysis (LOPA), are sufficient for
determining if proper safeguards are in place in existing process
units. Industry trade associations said that LOPA or similar risk-based
analyses are more easily implemented and cost effective than IST, and
stated that risk-based analyses also minimize risk shifting. A state
agency urged EPA to require a LOPA but to ensure that it is clearly
separated from the STAA.
Some facilities and an industry trade association remarked that
industry has proven capable of reducing hazards from current operations
by using active, passive, or procedural measures. A facility and an
industry trade association asked why the proposed rulemaking is not
specifically focused on STAAs for new or potential processes when,
according to the commenters, nothing indicates that IST evaluations
have become more beneficial or less expensive for existing process
units since the 1996 RMP rule.
A facility asserted that current regulations that require
compliance with RAGAGEP already ensure that appropriate controls are
implemented in equipment and processes. One commenter expressed
concerns that the STAA evaluation will become a paperwork exercise that
will not result in any increase to safety. This commenter suggests that
EPA require a review of safer technology or IST only when the PHA
results show that a technology or design scenario does not meet the
company's appropriate risk tolerance/reduction requirements.
EPA believes that where feasible, reducing or eliminating hazards
through change in materials, chemistry, or process variables is
preferable to adding layers of safety to a process. While layers of
passive, active or procedural controls will reduce the risk, they will
do nothing to reduce the nature of the hazard itself. Failure of
control devices or human error can result in an accidental release.
However, an inherent safer strategy seeks to preferentially remove the
hazard at the source, as opposed to accepting the hazard and attempting
to mitigate the effects.\93\ In addition to eliminating or reducing a
hazard, IST can also minimize the impact of a release or terminate the
accident sequence before there are major impacts on people, property or
the environment.
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\93\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed. American Institute of Chemical Engineers,
Center for Chemical Process Safety. pp. 10-11.
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EPA agrees with other commenters who have indicated that the PHA
can and should consider IST as hazard reduction or risk management
measures where feasible and appropriate. Opportunities for the
application of the
[[Page 4644]]
inherently safer strategy of simplification can be evaluated for each
safety device or procedure during a PHA as well as in review of
mechanical integrity program practices and procedures. CCPS provides
examples for this.\94\ Although we agree that the general principles of
PHA combined with LOPA may at times be appropriate to address the risk
of an accidental release, EPA believes that facility owners or
operators should consider IST first in the hierarchy of risk reduction
measures to reduce and/or control the hazards of a process.
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\94\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed. American Institute of Chemical Engineers,
Center for Chemical Process Safety. pp. 112-113.
---------------------------------------------------------------------------
Consideration of untested and unproven technologies. One commenter
was concerned that any potential IST considered should not have to
include untested and unproven technologies. An industry trade
association urged that technology takes time to mature and become
acceptable and safe for widespread use. Concerns were that facilities
might be encouraged to substitute novel and untested controls for
existing controls and layers of protection that are in place at
existing processes to control and manage risks, detracting from actual
safety performance. One commenter was concerned that operators should
not be required to update or replace technology on a year-in, year-out
basis simply because new technologies are introduced into the
marketplace. One commenter stated that any alternative considered
should be easy to be applied and should have been properly tested.
EPA agrees that a facility owner or operator may conclude that IST
measures that have not been tested or used commercially should not be
considered. It may be difficult to evaluate the practicability of
hypothetical technologies or those that are still undergoing research
and testing.
f. General Opposition to STAA
Benefits and cost of STAA not adequately explained or justified.
Commenters warned that analysis of existing facilities and processes is
unlikely to provide significant insights or opportunities for safety
improvement, but may be very costly. A facility and a number of trade
associations asserted that IST analysis would not meaningfully increase
safety. Stating that safer technology would have been adopted if it
made business sense to do so, a facility remarked that the STAA
requirement is unnecessary.
An industry trade association and a facility expressed concern that
the process of retrofitting existing facilities would be expensive and
could result in facilities shutting down. Several commenters agreed
with EPA conclusions made in the 1996 RMP rule regarding an IST
analysis mandate where the agency stated, ``EPA does not believe that a
requirement that sources conduct searches or analyses of alternative
processing technologies for new or existing processes will produce
additional benefits beyond those accruing to the rule already.'' The
commenters, including a facility and industry trade associations,
warned that EPA changed its position on whether or not a mandatory IST
analysis leads to any incremental benefits, without any clear rebuttal,
analysis, explanation, or substantiation of benefits from the STAA and
urged EPA to withdraw the STAA mandate from the proposed rulemaking. An
industry trade association, agreeing with EPA's 1996 assessment,
remarked that the new conclusion was made without regard for the nature
of the reported accidents or any scientific support. Many commenters
stated that requiring STAAs would create a burden for industries that
would not produce any significant benefits if the existing process has
already had risks addressed by a PHA. A few commenters asserted that,
for most facilities, an IST analysis would likely produce limited
options that would not justify the cost and effort of the exercise
itself.
Two industry trade associations contend that there is no data to
suggest that requiring an STAA analysis provides any measurable benefit
or reduces the frequency or severity of incidents or any empirical
studies showing that STAA effectively improves process safety. They
believe that the analysis of the New Jersey data for facilities
conducting IST analysis since 2008, shows no decrease in reportable
accidents and that revising the RMP rule will likely have a negligible
effect at great cost to covered facilities. Commenters asked whether or
not EPA's analysis of the IST programs implemented by New Jersey and
Contra Costa County has yielded any concrete data demonstrating that
the programs have successfully reduced hazardous safety risks over
voluntary adoption. One commenter urged EPA to withdraw the proposed
IST requirement until EPA has conducted such an analysis.
Several trade associations commented that the regulatory burden of
requiring costly IST reviews tends to stifle innovation. The commenters
asserted that for those companies already looking to improve safety by
implementing IST options, a formal IST review would add costs to a
process by forcing them to document the activities they are already
performing. They further indicated that small operations might not have
the manpower or expertise to do this and lack the resources to hire it
out cost effectively. The same commenters further stated that for
companies that do not implement IST options, the IST review becomes a
``paper exercise'' where they document why it is ``infeasible'' to
implement these options. Another commenter argued that if EPA only
intends for an analysis to be conducted and not for the technologies to
be implemented, then the proposal should be withdrawn on the basis that
it provides no benefit to the public.
One trade association commented that there is no value in having a
facility perform an IST assessment if one was already performed earlier
in the lifecycle of the process or to repeat the same STAA every five
years on the same process. The association asserts that nothing new
will be learned from doing so.
According to a facility and some industry trade associations, the
claim in the proposed rulemaking preamble that voluntary adoption of
IST is becoming more prevalent indicates that the incremental benefits
of mandatory adoption are decreasing, which the commenters remarked
would be in line with the 1996 decision not to require IST analysis.
EPA believes that the STAA should identify potential process
changes including IST that, if implemented, would result in owners or
operators using less hazardous substances, minimizing the amount of
regulated substances present in a process, moderating process
conditions, reducing process complexity, or implementing passive,
active, or procedural changes to make processes safer. Such changes
help prevent accidents by either eliminating the possibility of an
accidental release entirely, by making a process more fault-tolerant,
such that a minor process upset or equipment malfunction does not
result in a serious accidental release, and by reducing the severity of
releases that do occur. The STAA provision does not actually require
the owner or operator to implement any changes, so facilities will only
incur additional costs beyond the analysis when the benefits of the
change make adoption of the change reasonable for the facility.
IST is widely recognized as a concept or principle that can be used
in process safety management along with other types of hazard reduction
measures to eliminate or reduce the frequency and/or impact of
accidents. As recognized in
[[Page 4645]]
process safety technical literature, the benefit of using practicable
IST as the first choice for accident prevention is more likely
permanent risk reduction. Some trade associations agree that individual
companies often consider inherently safer approaches or safer
alternatives as a matter of course. In fact, one of the key elements
under ACC's Responsible Care, Process Safety Code \95\ requires ACC
member companies to consider inherently safer approaches as one of many
risk reduction measures when conducting a process safety risk
assessment.
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\95\ ACC. 2016. Responsible Care Process Safety Code https://responsiblecare.americanchemistry.com/Responsible-Care-Program-Elements/Process-Safety-Code/Responsible-Care-Process-Safety-Code-PDF.pdf.
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Since 1996, EPA has seen that advances in ISTs and safer
alternatives are becoming more widely available and are being adopted
by some companies. Voluntary implementation of some ISTs has been
identified through surveys and studies and potential opportunities have
been identified through EPA enforcement cases and CSB incident
investigations.\96\ The Contra Costa County Health Services (CCHS) and
New Jersey Department of Environmental Protection (NJDEP) IST
regulations requirements to consider IST have resulted in some
facilities adopting IST measures.\97\ The concept of IST is more widely
understood and accepted within the chemical process industry than it
was 20 years ago. Innovations and research in chemical process safety
have evolved and continue to evolve. Industries change and update their
processes over time for a variety of reasons and when possible, EPA
believes that opportunities to improve chemical process safety using
all available means--not only passive, active, and procedural
measures--should also be considered.
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\96\ For more information, see the preamble of the proposed
rulemaking at 81 FR 13663-13665, March 14, 2016.
\97\ For more information, see the preamble of the proposed
rulemaking at 81 FR 13665-13666, March 14, 2016.
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EPA disagrees that increasing voluntary adoption of IST means that
incremental benefits of mandatory adoption are decreasing. Benefits
derived by those implementing IST do not negate any potential benefits
from those who have not. As stated in the 1996 rule, ``EPA encourages
sources to continue to examine and adopt viable alternative processing
technologies, system safeguards, or process modifications to make new
and existing processes and operations inherently safer.'' \98\ For
those facilities who have not considered adopting any IST or have only
done so in limited fashion, EPA believes that there is value in
requiring facilities with extremely hazardous substances to evaluate
whether they can improve risk management of current hazards through
potential implementation of ISTs or risk management measures that are
more robust and reliable than ones currently in use at the facility.
For those facilities who have already considered IST, EPA believe
facilities should re-evaluate whether any improvements in hazard or
risk reduction can be made and we believe the five-year re-validation
timeframe of the PHA is an appropriate time period for such re-
evaluation.
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\98\ See 61 FR 31700, June 20, 1996.
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EPA did not perform any further analysis of the NJDEP or Contra
Costa County IST data. The main purpose of providing these reports was
to demonstrate that regulations involving IST in these two
jurisdictions resulted in implementation of IST at some of their
facilities and to explain what types of IST were implemented. NJDEP's
2010 IST Implementation Summary report \99\ on IST reports submitted by
NJ facilities since August 2008 is available in the docket and
discusses 143 additional IST measures reported to have been implemented
or scheduled to be implemented by 41 of the 85 facilities submitting
reports. CCHS and Richmond CA annual performance review and evaluation
reports on the Industrial Safety Ordinance include a summary of
Inherently Safer Systems (ISS) results from their nine total
facilities, as well as the actual ISS data reported by each facility.
Three of these reports are in the docket for this rulemaking.\100\
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\99\ https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0143.
\100\ https://www.regulations.gov/document?D=VEPA-HQ-OEM-2015-0725-0147, https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0148, and https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0149.
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Because the requirements involve prevention of accidents before
they occur, it is difficult to provide a quantitative assessment that
the requirement would reduce a certain number of accidents. The
assertion of increase in the number of NJ accidents reported cannot be
explained as a result of implementation or non-implementation of IST
because there are other factors involved. For example, the number of NJ
facilities reporting over the years varies, which can affect the number
of reportable accidents and not all NJ facilities may have implemented
IST. In principle, because of the ``inherentness'' of any actual IST
changes, there should be a hazard and risk reduction for a particular
RMP chemical, because IST eliminates or minimizes the opportunities for
a chemical release in a more rigorous fashion than relying on a device
or human intervention. EPA recognizes that IST will not eliminate all
hazard or risk and that reliance of other risk reduction measures will
probably still be needed for other points in a process.
Contra Costa County commented that it has seen improvements at
existing facilities with existing processes subject to its ISS
requirements.\101\ The county indicated that facilities have eliminated
unnecessary vessels, shortened piping and replaced chemicals with less
toxic chemicals. CCHS has seen that by considering ISS, facilities have
looked at the highest level of risk reduction such as using passive
means (such as a change in metallurgy) instead of relying on
administrative means (such as increased piping inspections).
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\101\ https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0450.
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As some commenters indicated, some facilities have been evaluating
IST as a best practice for decades and, in most cases, have already
taken steps to implement beneficial technologies where it is
practicable and cost-effective to do so. In those situations, where IST
was previously evaluated but not implemented, facilities should review
the analysis to determine if new information is available that would
affect the analysis. The facility should document the STAA and
practicability of IST and ISD considered.
Inconsistent STAA implementation. A facility remarked that the lack
of clarity and consensus about the methodology, definitions or
standards for STAA would contribute to burden and could lead to
inconsistent implementation of STAA across companies.
EPA does not expect to see ``one-size-fits-all'' implementation of
STAA by sources. The STAA requirements are not prescriptive in nature,
but more similar to a performance-based standard (like other provisions
of the RMP regulations) that give facilities the flexibility and allow
facility owners and operators to exercise reasonable judgement to
determine what technology or risk reduction measures work best for
their particular chemical use, process or facility. However, in an
effort to ensure a consistent understanding of EPA's expectations for
conducting an STAA and determining practicability of IST and IST
considered, the rule defines several terms related to the STAA, such as
practicability, inherently safer technology or design, passives
measures, active measures and
[[Page 4646]]
procedural measures. EPA has also cited various references and
technical sources of information that explain the concepts and
principles of STAA and provided examples.\102\
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\102\ CCPS. 2009, Inherently Safer Chemical Processes: A Life
Cycle Approach. 2nd ed., https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0253; CCPS. July 2010. Final Report: Definition for
Inherently Safer Technology in Production, Transportation, Storage,
and Use, https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0274; Contra Costa Hazardous Materials Program. June 15, 2011.
Industrial Safety Ordinance Guidance Document, Attachment C--
Inherently Safer Systems Checklist. Contra Costa County Health
Services, Martinez, CA, https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0146; NJDEP. January 15, 2015. Guidance for Toxic
Catastrophe Prevention Act (TCPA), Inherently Safer Technology
(IST), https://www.regulations.gov/document?D=EPA-HQ-OEM-2015-0725-0142.
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Impact to agribusinesses. One commenter stated that the proposed
mandate for regulated facilities to consider STAA as a part of the PHA,
and to evaluate the feasibility of IST, will fail to generate tangible
RMP outcomes in the fertilizer industry or with other ag-industry RMP
regulated chemicals, beyond what the current PHA requirements and
procedural measures can accomplish in controlling hazards. The
commenter further asserted that the administrative and recordkeeping
burden associated with this portion of the proposed rulemaking will
undoubtedly increase costs on the agribusiness industry at a time when
margins across the industry are thin to non-existent. The same
commenter indicated that these requirements will cause many small
agricultural fertilizer retail facilities to close.
EPA is not requiring agricultural fertilizer retail facilities to
perform STAA and thus there should be no burden to this particular
industry as a result of the STAA provision. The STAA requirement in the
PHA will only apply to Program 3 facilities in chemical manufacturing
(NAICS code 324), petroleum and coal products manufacturing (NAICS code
325) and paper manufacturing (NAICS code 322).
Feasibility costs. One trade association stated that the cost of
determining feasibility was wholly underestimated by EPA because
feasibility study costs can be quite large depending upon the type of
project, but still be only a fraction of the cost of what it would take
to implement any projects determined to be feasible. The commenter
noted that a typical project consists of conceptual level design,
feasibility level design, and then engineering and implementation. The
association member's experience with hundreds of projects is that the
cost of a conceptual level design is about 1% of the total project cost
and the cost of a feasibility level design is 1% to 2% of the total
project cost.
EPA acknowledges that for some industries, evaluation of chemical
substitution and process redesign will involve a greater level of
effort and resources to consider the practicability of such changes.
EPA has revised the cost estimates in the RIA to reflect the greater
effort involved in conducting such practicability studies.
g. Model STAA Provisions After Other Regulatory Programs
Several commenters suggested that the STAA requirement align with
similar requirements by CCHS and NJDEP. Some of these comments are
addressed under other STAA topic headings, as appropriate. Other
specific comments are discussed further in this preamble.
Establish qualifications for IST review team. One commenter
recommended expanding on the NJDEP requirement which specifies that an
IST review team should be ``a team of qualified experts, convened by
the owner or operator, whose members shall have expertise in
environmental health and safety, chemistry, design and engineering,
process controls and instrumentation, maintenance, production and
operations, and chemical process safety.'' This commenter also wanted
EPA to require the names, qualification, and experience of team members
to be stated in the review report and to explicitly specify that
workers and union representatives can fully participate in the STAA.
Another commenter noted that the proposed STAA requirement does not
require employee participation and stated that employees have deep
experience and knowledge of the processes and are best equipped to
determine inherently safer technology or design, but cautioned that
workers must have adequate education and training to participate in
STAAs.
EPA notes that Sec. 68.67 requires the PHA to be performed by a
team with expertise in engineering and process operations, and the team
shall include at least one employee who has experience and knowledge
specific to the process being evaluated. Also, one member of the team
must be knowledgeable in the specific process hazard analysis
methodology being used. These same qualifications apply to team members
involved in conducting the STAA. EPA believes most PHA reports already
include the names and qualifications of team members in the report, and
we do not believe it is necessary to prescribe a regulatory requirement
to address this issue. EPA already requires Program 3 facilities to
consult with their employees and their representatives on the conduct
and development of process hazard analysis and on the development of
other elements of process safety management, and EPA believes it would
be inappropriate to incorporate additional provisions related to worker
participation in the PHA requirements of Sec. 68.67.
Establishing goals. A Federal agency recommended incorporating a
goal setting requirement similar to that of CCC's ISO, expressing
concern that a lack of goal setting requirements could allow regulatory
requirements to be satisfied even if analyses fail to identify or
control major hazards. The commenter explains that there is no RMP
requirement to reduce risks to ``as low as reasonably practicable,'' or
``ALARP'', while CCHS ISO requires facilities to select and implement
ISS to the greatest extent feasible and as soon as administratively
practicable.
EPA disagrees with commenters. EPA did base some components of the
STAA requirement on NJDEP and CCHS regulations (see discussion in
section in IV.C.3.c Definitions of this preamble). Also see further
discussion in section in IV.C.3.k of this preamble regarding
documentation of feasibility. NJDEP and CCHS require a separate
Inherently Safer Technology review or Inherently Safer Systems Analysis
(ISSA), but NJ requires IST updates (covering both new and existing
processes) on the same schedule as the PHA. CCHS requires an ISSA for
existing and new processes every five years, but the analysis can be
done as part of a PHA. CCHS also requires that an ISSA for any major
changes (which could be result of accident investigation). EPA is
requiring that the five-year PHA revalidation address the findings from
all incident investigations required under section 68.81, as well as
any other potential failure scenarios.
EPA did not propose to require any implementation of any IST. EPA
proposed to require facilities to determine the feasibility of IST
options, but the final rule allows flexibility for facility owners or
operators to decide whether to implement an IST in order to allow them
to balance the appropriateness of the technology for their process,
costs, risk transfer and other requirements that would have to be met
along with possible integration with the use of existing risk reduction
measures in place. In the final rule, EPA also replaced the term
``feasibility'' with ``practicability.''
[[Page 4647]]
Requiring risk reduction to be ``as low as reasonably practicable
(ALARP)'' is a standard that can be seen as stricter than the ``to the
greatest extent feasible'' requirement set by CCHS and could require
implementation of risk reduction measures ``except where they are ruled
out because they involve grossly disproportionate sacrifices.'' \103\
EPA does not believe that adopting a requirement that facilities reduce
risks to ``ALARP'' is advisable for the RMP program because there are
no set standards to define what level of risk is reasonably practicable
for the variety of chemicals, processes, and hazards involved.
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\103\ https://www.hse.gov.uk/risk/theory/alarpglance.htm.
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h. Feasibility
Insufficient guidance and clarity for methodology for comparing
risks. A facility, a local agency, and industry trade associations,
among others, remarked that IST cannot be meaningfully and consistently
implemented because there is no consensus in science or among the
industry on its definition, how to implement it, or how to measure its
effect. Stating that the concept of IST is vague, an industry trade
association said that multiple factors are taken into account when
making a determination of feasibility, including materials used for
equipment.
One commenter stated that the feasibility factors in the proposed
STAA provision also provide no guidance on how to measure or balance
risks or hazards. This commenter notes that there is no simple way to
measure whether one process is safer than another or when a process is
``safe enough'' as discussed in the July 2010 DHS report by CCPS. The
commenter indicated that the proposed rulemaking does not address a
multitude of critical questions: What does the PHA team measure? Does
the team evaluate reduction in particular hazards or in overall risk?
Is that reduction measured quantitatively or qualitatively? Who or what
is the required beneficiary of that reduction--the employees, the
adjacent community, the environment? What level of risk is tolerable?
If EPA requires STAA analysis under the final RMP rule, it will
necessarily need to become involved in measuring, evaluating, and
determining the tolerable level of risk. It is unlikely that EPA has
the expertise or bandwidth to take this on.
EPA based its definition of IST upon CCPS' descriptions of
inherently safer strategies and its definition of ``practicability''
upon CCHS' definition of ``feasible'' in their Industrial Safety
Ordinance. EPA has existing requirements under Sec. 68.67 for
facilities to evaluate and control hazards in the process and to
establish a system to address the PHA's team findings and
recommendations. Management response to hazard evaluation studies and
recommended options involve risk management considerations that are
developed based on a facility's risk tolerance criteria. EPA has not
prescribed how facilities define or manage risk, whether it involves
conforming to minimum standards such as codes or tries to reduce risk
to as low as reasonably practical or whether it uses risk matrices or
assesses qualitative or quantitative risk. EPA expects only that
facilities consider IST as one of the types of risk management measures
employed. Much of the structure of the RMP rule requires owners and
operators to collect information and relies on them to make reasonable
judgments in light of that information. The requirement here is no
different. EPA only requires the analysis. There is no mandate to
implement IST under this rule. For further information, EPA recommends
consulting Chapter 9--Hazard Identification and Risk Analysis in the
2007 CCPS Guidelines for Risk Based Process Safety.\104\
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\104\ CCPS. 2007. Guidelines for Risk Based Process Safety.
American Institute of Chemical Engineers, CCPS, NY, Wiley. Chapter
9--Hazard Identification and Risk Analysis.
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Efforts involved for determining feasibility. One commenter
asserted that EPA has failed to consider the substantial complexity of
the activities it is proposing to require, and the significant burden
that will be placed on facilities with multiple or complex RMP
regulated processes. The commenter cited issues involved with many
chemical manufacturing processes that involve multiple optimizations of
complicated reactions and integration of many processes with each
other. The commenter cited as an example, the efforts involved by the
National Academy of Sciences (NAS) to identify and evaluate the many
individual alternative paths to methyl isocyanate (MIC) production for
potential safer operations.\105\ The commenter stated that each
alternative then had implications for the facility, the customer, the
surrounding community and numerous other factors that needed to be
identified, considered and weighed carefully. The commenter further
explained that these factors included the costs of the chemicals, labor
and energy requirements, new capital expenditures, quality of the
product and revenues expected from its production, environmental
impacts anticipated from the process, regulatory constraints,
environmental policy and regulations and influence of local community
on company decision making. The commenter indicated that many of these
characteristics involve a substantial degree of uncertainty. The
commenter also stated that the framework for decision-making discussed
by NAS is akin to the proposed EPA requirement to perform a feasibility
analysis for all ISTs considered. The commenter concluded that under
the EPA proposal, complex chemical manufacturing RMP facilities would
be required to go through this analysis multiple times for each and
every regulated process.
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\105\ National Research Council of the National Academy of
Sciences, The Use and Storage of Methyl Isocyanate (MIC) at Bayer
CropScience, 2012. https://www.nap.edu/catalog/13385/the-use-and-storage-of-methyl-isocyanate-mic-at-bayer-cropscience.
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EPA believes a practicability determination for any considered IST
or ISD is necessary to ensure the facility owner or operator seriously
considers whether IST or ISD modifications could further reduce risks
and prevent accidents at the facility. EPA expects that facilities will
only evaluate chemical substitutes that have already been shown to be
commercially viable and does not expect facility owners or operators to
expend a major effort on hypothetical or untested chemical substitutes
or uses.
Insufficient time to complete a feasibility analysis. One commenter
stated that when evaluating IST, a facility owner may at times be able
to reject an alternative based on determining a single basis of
infeasibility. The commenter asserted that if there is no known
rationale for infeasibility, a facility may need to conduct lengthy and
costly engineering studies, which would require a unit revamp on an
existing process unit. The commenter further stated that under such
circumstances, feasibility or practicality must consider unit
congestion and constructability in addition to all of the issues
associated with a new process. The commenter indicated that this need
to perform detailed engineering study/design, in many cases, is
indicative of impracticability. The commenter concluded that the
proposed rulemaking allows four years after the rule become final for
each PHA to consider IST/ISD alternatives for covered processes and, in
the event the EPA decides to include this requirement in the final
rule, facility owners should be allowed a second PHA cycle, following
the four-
[[Page 4648]]
year applicability, where the determination of feasibility or
practicality requires engineering studies and design. Another commenter
stated that the feasibility analysis outlined in the proposed
regulation is ill-defined and doesn't allow sufficient time for the
work to be properly completed.
EPA allows that where a practicability evaluation is complex and
resource intensive and may not be completed within the four-year
compliance timeframe from the final rule or within the five years
between PHA reviews, a facility should document during their PHA review
that the IST is under consideration and that the practicability of
implementing the technology is unknown and still undergoing evaluation.
Practicability decisions made by facilities or outside parties. An
environmental advocacy group argued that, if decisions are left up to
facilities themselves, the economic interests of the facilities will
outweigh considerations of public health. The advocacy group concluded
that an independent body should be tasked with reviewing facilities'
IST/ISD evaluations to determine whether or not such technologies are
feasible and to prevent facility self-regulation. One local agency
asserted that stationary sources rather than a regulatory body should
determine the feasibility of ISD and document their decision.
EPA disagrees that practicability decisions should be made by
outside parties. These decisions are based on site-specific
circumstances that a third-party may not have the experience to
evaluate. EPA believes it would not be practical for many reasons
including: The delay that may result in finding a third-party to assess
practicability; the variety of factors that must be considered in
establishing a basis for choosing an outside party (e.g. there may not
be enough qualified third-parties with the expertise and resources to
evaluate the various options and processes for the number of facilities
subject to this provision); and the need to protect CBI and sensitive
information that could reveal security vulnerabilities.
Feasible definition does not take into account removal of existing
safeguards. One commenter stated that the proposed definition for
feasible precludes any reasonable basis for replacing existing controls
and safeguards that have already been identified and implemented to
address the risks. This commenter believes that since all the
engineering and administrative controls necessary to address risk have
already been identified and implemented in an operating plant, it is
not appropriate to require a repeated analysis of alternatives that
that are not feasible for an operating plant.
EPA disagrees with the commenter. The definition of
``practicability'' in the final rule is not intended to be used to
judge the reasonableness or effectiveness of existing risk reduction
measures, but whether new IST measures could be implemented. The STAA
requirements allow a combination of risk measures to be used to achieve
the desired risk reduction; therefore, they do not necessarily preclude
the use of existing controls and safeguards.
Feasibility factors go beyond scope of a PHA. One commenter
asserted that requiring consideration of the five factors mentioned in
the proposed definition of ``feasibility'' goes beyond the scope of a
PHA.
EPA disagrees. While the PHA identifies the hazards, the RMP PHA
requirements require the facility to identify the risk management
measures applicable to eliminating or reducing the risks from the
process hazards. EPA believes that it is appropriate for a facility to
consider the five feasibility (now practicability) factors (``economic,
environmental, legal, social and technological'') for evaluating the
appropriateness of implementing for potential IST measures because some
IST can involve significant costs or involve impacts that go beyond the
facility.
Feasibility does not take into account full supply chain. An
industry trade organization and a facility warned that the proposed
definition of ``feasible'' does not sufficiently consider costs and
benefits and fails to take into account the full supply chain.
Facilities pressured to take these measures, such as reducing
inventories of products, would prevent companies from meeting
customers' needs. For example, downstream users may not even be able to
receive an alternative product.
EPA disagrees that the practicability determination does not allow
facilities to take into account costs and benefits and the effect on
the full supply chain. The STAA requirements do not require any
implementation of any particular IST. EPA expects that facility owners
or operators will seriously consider the merits and consequences of
ISTs for their facilities and use their expertise and judgement to
ensure safety while not severely affecting the economic viability of
their businesses. Facilities can consider the effects in their supply
chain (downstream and upstream) when evaluating potential IST options.
i. IST Implementation
Several industry trade associations and a facility expressed
support for EPA's decision not to require implementation of feasible
safer alternatives and noted that the best approach would be to allow
operators to decide which measures, methods, or IST components would be
feasible at their facilities. An industry trade organization requested
that EPA include language stating that ``the scope of the STAA for a
regulated process will be based on the expert judgment of owners and
operators'' because only the facility is uniquely qualified to
determine what types of changes are feasible and practical. The
commenter cited an example where reducing the volume of chlorine
dioxide on-site at a paper mill may not be practical because a minimum
amount is needed to ensure that production of pulp and paper can
continue when operation of the chlorine dioxide generator is
momentarily disrupted due to maintenance or other issues. The commenter
also cited another example in which eliminating the use of chlorine
dioxide for bleaching may not provide the necessary characteristics of
the finished product.
Many commenters, including multiple mass mail campaigns joined by
approximately 24,610 commenters and advocacy groups, urged that upon
identifying alternatives in an analysis, facilities should be required
to switch to the safest cost-effective chemicals and technologies
available. Among other reasons, one commenter cited the need to
implement feasible alternatives because the NAS report on the Bayer
CropScience accident stated that feasible alternatives should be
attempted before moving on to specification of risk management
equipment and procedures.\106\ This commenter notes that existing
safeguards used have not prevented accidents from occurring and that
CAA section 7412(r)(7)(B)(i), directs that regulations and guidance
under this provision must ``provide, to the greatest extent
practicable, for the prevention and detection of accidental releases of
regulated substances and for response to such releases.'' [Emphasis
added] In addition, this commenter states that not requiring
implementation of IST also creates a competitive disadvantage for those
facilities that do so voluntarily, as compared to other facilities who
will avoid taking available preventative safety measures to maximize
short-term profits. This commenter wants EPA to
[[Page 4649]]
require a timeframe for implementation of IST for those facilities who
plan to implement IST as this will prevent accidents from happening
sooner. A commenter urged that required implementation of feasible
alternatives would reduce the risks associated with a catastrophic
release, including from terrorist attacks, and would be important for
protection of public health.
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\106\ National Research Council, The Use and Storage of Methyl
Isocyanate (MIC) at Bayer CropScience, at 4-53 (2012).
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One commenter wanted IST to be implemented wherever feasible
because IST is likely to be more effective and less costly in the long
run than other safeguards, noting that the existing rule requires that
facilities implement the recommendations from a conventional PHA. This
commenter also stated that EPA should model its implementation
requirements on California's Contra Costa County Industrial Safety
Ordinance, which directs companies to ``select and implement each
inherently safer system identified to the greatest extent feasible and
as soon as administratively practicable'' or consider California's
Department of Industrial Relations current proposed requirements for
refineries which directs each facility to ``implement all
recommendations'' from inherent safety analyses, unless the facility
can demonstrate that a recommendation is factually flawed or infeasible
on grounds other than cost alone.
An industry trade association said that in their industry,
operations are diverse and are constantly evolving, making it difficult
to implement IST. A few industry trade associations warned that
substitution is not a legitimate option for their industries, for
manufacturing of agricultural products or in fragrance industry, for
example. Stating that active ingredients in fragrances are extremely
specific and non-fungible, an industry association commented that any
substitution of fragrance ingredients should be done at the point of
design to minimize the threat to fragrance businesses. The commenter
requested that EPA provide a clear statement acknowledging the
infeasibility of substitution in the fragrance industry. Some
commenters stated that the analysis would be of no benefit for their
facility because a Federal permit requires it to use certain processes.
EPA agrees that the facility is in the best position to decide what
safeguards or risk reduction measure can be employed to eliminate or
reduce process hazards. Facilities must consider safeguards, in the
following order of preference: IST, passive, active or procedural
measures; however, the rule does not automatically require the facility
to implement the measures preferentially in that order. EPA recognizes
that for any particular hazard point, any one of the four types of
safeguards may not exist or may not be practicable for a variety of
reasons. EPA also recognizes that facilities may wish to employ more
than one safeguard.
The purpose of the STAA requirement is to ensure that facilities
consider the available options and for them to find the best method for
the facility to address accidental releases. The hierarchy of control
methods in an STAA analysis--IST/ISD, passive, active, administrative--
is consistent with the language of CAA section 112(r)(7)(B)(i) in that
it systematically provides for the identification of practicable
control methods while also recognizing that the regulation must be
reasonable. This approach is consistent with the current PHA
requirements which provide flexibility for the owner or operator to
decide which safeguards are appropriate to prevent accidental releases.
We expect STAA analyses to lead to new control approaches at sources
where management finds such approaches to be reasonable and
practicable.
EPA is not requiring implementation of IST at any facility because
we believe that only the facility has the expertise and resources to
determine whether implementation of any IST or ISD should be
undertaken, taking into account that many factors must be considered
when substituting a chemical or modifying a process, including cost,
risk transfers, technological hurdles, etc. Facilities that choose to
adopt the use of IST or ISD can eliminate or reduce hazards by using
different materials and/or process conditions, which would make
accidental releases less likely, or the impacts of such releases less
severe. The results of the practicability determination must be
documented as part of the current PHA requirements in Sec. 68.67(e),
which requires the owner or operator to document actions to be taken
and resolution of recommendations.
Also EPA does not believe we should establish a required timeframe
for any planned implementation of IST. Planning, design, equipment
modification and cost to implement IST can vary tremendously depending
on the technology and scope of the project and could only be best
determined by the facility involved in such implementation.
EPA acknowledges that chemical substitution or whole design
processes may be not practicable for some processes for a variety of
reasons and that facilities should document these reasons for any
particular IST that were considered by the facility for purposes of
complying with the STAA requirements.
j. Security and Risk
Terrorism. A commenter cited an increased risk of global and
domestic terrorism as a reason to broaden the applicability of STAA
requirements to cover transportation and storage of liquid chlorine.
Another commenter stated that the existing RMP provisions already
require the PHA team to consider safer alternatives, and warned that
explicitly stating consideration or implementation of IST can expose
facilities to risks, such as increased opportunity for terrorism, risk
transfer, and risk accumulation. The commenter remarked that chemicals
handled are highly dependent on the processes employed, so it would be
difficult or impossible to identify an absolute safer alternative. The
commenter concluded that facilities should asses the total risk reduced
by implementation and stated that any alternative considered should be
easily applied and properly tested.
EPA acknowledges that transportation and storage of liquid chlorine
can pose risks, not only from accidental releases, but from
intentionally caused releases. However, EPA is limiting the scope of
applicability of the STAA requirements in order to balance the
regulatory and administrative burdens of assessing IST against the
accident rate and possible opportunities to employ IST because of
process complexity for various industries. EPA believes that the
industries subject to the STAA provisions are also more likely than
others to have the expertise and resources to properly assess and
implement IST.
In response to the commenter's concern that explicitly stating
consideration or implementation of IST can expose facilities to risks,
EPA believes that the STAA provisions in the final rule provide enough
flexibility for owners and operators to consider a hierarchy of risk
management measures to minimize the hazard of a process without
prescribing an approach that could compromise facility security or
transfer or increase risks. The STAA requirement does not require IST
implementation but instead allows the facility owner or operator to
determine whether an IST considered would achieve a reduction in risk,
specific to the hazard being addressed. More specifically, the STAA
requirement allows for a combination of risk management measures to be
used to achieve the desired risk reduction. This
[[Page 4650]]
flexibility acknowledges that there is not always an absolute safer
alternative to a chemical, which is highly dependent on the process or
application and the chemical involved. EPA is also requiring the
facility to evaluate the practicability of any IST or ISD considered to
account for economic, environmental, legal, social, and technological
factors. Environmental factors would include consideration of potential
transferred risks for new risk reduction measures. This allows
facilities to carefully consider whether an IST could create new risks
or security concerns, including those involving terrorism.
Security concerns related to STAA documentation. An industry trade
association urged that if (or when) IST becomes applicable to a certain
process, methods should be available for additional review. For
example, the commenter said that documentation of safer technology
information should be considered from a homeland security and critical
infrastructure perspective.
EPA agrees that documentation that could reveal vulnerabilities at
an RMP-regulated facility must be secured. Therefore, although EPA is
requiring facility owners and operators to document STAA and
practicability determinations, EPA is not requiring this information to
be submitted to implementing agencies, LEPCs or local emergency
response officials. These entities have the ability to request
documentation, at which point representatives of the facility and the
requesting agency can discuss the security concern and involve security
agencies as appropriate.
k. STAA Documentation
Extent of STAA documentation. Some commenters urged EPA to require
sufficient, detailed documentation of feasibility and alternatives
considered. One commenter asserted that requiring sufficient
documentation of alternatives would facilitate the incorporation of
safer design principles into the PHA and would enhance the integrity of
the process and encouraged a more extensive documentation of
feasibility similar to the program in Contra Costa County, California.
An advocacy group suggested that entities should be required to
document economic benefits as well and quantify specific economic
benefits of adopting safer options, such as reduced liability and
insurance costs, public benefits such as savings to municipalities for
reduced emergency response, and savings to workers and affected
residents for medical care, property damage, etc.
An industry trade association asserted that any requirement for
entities to determine or document feasibility would be beyond EPA's
authority and would be inappropriate because it does not provide
sufficient detail of what would be required in a ``determination'' or
information about how the determination was considered. An industry
trade association expressed general opposition to a documentation
requirement. A state agency requested clarification as to what type of
documentation would be required in order to demonstrate compliance.
EPA is not specifying any particular form of documentation for STAA
given the potential complexity of analysis, variety of risk reduction
measures involved and the factors that may be considered for
feasibility and/or implementation. Facilities should retain any
reports, analysis, findings and recommendations used to comply with the
STAA requirements for the life of the process as is required by Sec.
68.67(g). For IST/ISD measures considered, facilities should document
the analysis and methodology used to evaluate or consider IST, its
feasibility and the recommendations of the review team. Facilities may
follow, for example, guidance for IS Review Documentation found in
CCPS's Inherently Safer Chemical Processes, which suggests documenting
the summary of the approach used for the IS review (i.e., methodology,
checklist, etc), names and qualifications of the review team, IS
alternatives considered, as well as those already implemented or
included in the design, results of each consideration including those
not considered and why, documentation of feasibility and rationale for
rejection of IS opportunities. Facilities must provide in their RMP,
any inherently safer technology or design measures implemented since
the last PHA, if any, and the technology category (substitution,
minimization, simplification and/or moderation) (Sec. 68.175(e)(7)).
CBI. A facility contended that changes in process technology
involving IST or ISD could be considered CBI, have a substantial impact
on the strategic competitive nature of their operation and necessitates
provisions to ensure that CBI claims can be asserted for IST or ISD
implementation. An environmental advocacy group stated that facilities
should have the ability to withhold CBI based on existing standards
when they submit their STAA to EPA.
EPA is not requiring the STAA or its documentation within the PHA
to be automatically submitted to EPA nor to anyone else, but such
analysis or documentation must be kept as records under the
recordkeeping requirements of Sec. 68.200 and be available for
inspection or review by EPA. Owners or operators may assert claims of
CBI for information requested by EPA following the procedures in
Sec. Sec. 68.151 and 68.152 if the information meets the criteria set
forth in 40 CFR 2.301.
l. Availability and/or Submission of STAA Documentation
Many commenters, including multiple mass mail campaigns joined by
approximately 22,260 commenters, a Federal agency, and advocacy groups,
stated that RMP facilities should be required to submit their STAA
information to EPA. An environmental advocacy group suggested that the
collection of STAAs is vital for the establishment of a clearinghouse
of safer technology and alternatives and that EPA should certify STAAs
for accuracy and completeness. One commenter suggested that by
requiring the submission of STAAs to EPA, the Agency will enhance the
quality of STAA assessments and feasibility analysis. This commenter
also believed STAA submission would better inform enforcement under the
CAA's General Duty Clause by providing the Agency with world class
knowledge of feasible safer alternatives and effects taken under the
EPA's 2017-2019 NEI approved on February 18, 2016.
Two local agencies stated that STAA information should be retained
on-site at the facility for inspection or be submitted upon request to
be reviewed by EPA and implementing agencies. One commenter said that
information on IST should be maintained at the stationary source.
In contrast, other commenters, including multiple industry trade
associations, remarked that EPA should not require RMP-regulated
facilities to submit STAA information to EPA. Some industry trade
associations argued that EPA or any other implementing agency will
likely lack the required knowledge, resources, or expertise to evaluate
an STAA or feasibility determination. An industry trade association
asserted that EPA should have no role in analyzing or approving the
plans. An industry association argued that any requirement for approval
of STAAs by EPA would be too similar to a permitting program and would
thus be against Congress' intent as per CAA section 112(r)(7)(F).
Some commenters suggested that the submitted STAA information
should be included in the RMP National Database and facilities be
allowed to withhold CBI based on current RMP CBI
[[Page 4651]]
protections and facility-specific, element-specific, up-front
substantiation of security claims. A professional organization
encouraged EPA to use the STAA summary information provided in the RMPs
to gather helpful data and incorporate lessons learned. One commenter
reasoned that collection of STAA data is necessary for EPA and other
regulatory agencies to carry out their regulatory responsibilities.
Another commenter asserted that incorporating summary STAA information
into RMPs will facilitate knowledge of successful practices as well as
knowledge of barriers.
Two commenters suggested that EPA collect information from
facilities that change program levels within RMP or deregister entirely
in order to collect valuable lessons learned for future use about IST
preventive measures and reducing on-site quantities. One commenter
expressed concern that the current deregistration reason codes are not
sufficient to allow EPA to collect basic information about lessons
learned from deregistered facilities and suggested adding a code
representing ``implemented IST/ISO'' paired with a field to indicate
the nature of the change.
Some commenters wanted more detailed information about STAA to be
provided in the RMP. Suggested additional information included:
Descriptions of the alternatives evaluated; description of each option
chosen for implementation and timeline; reasons for not implementing
IST such as (1) cost; (2) technical feasibility; (3) conflicts with
other regulatory requirements or good practices; (4) other hazards; (5)
other (indicate reason) or by listing one of the factors included in
the definition of ``feasible:'' time, economic, environmental, legal,
social, or technological; and an attestation and checklist
demonstrating a comprehensive accounting of potential benefits,
savings, and avoided costs associated with each major option.
One commenter recommended that an independent body be in place to
carefully review the facilities' IST/ISD evaluations to assist in
determining whether or not such technologies are feasible and to
prevent facilities from self-regulating.
Some commenters wanted STAA and documentation to be made publicly
available, and allowed with reasonable protections, for genuine CBI and
trade secrets. An advocacy group recommended allowing public comment
and response on facilities' STAAs. A few commenters wanted STAA
summaries to be available to at-risk communities and the public both
online and offline, including at public meetings required at Sec.
68.210.
Reasons given by commenters for providing public availability of
STAA included:
To hold companies accountable and facilitate significant
process safety changes with appropriate public discussion and oversight
from other stakeholders;
To ensure right-to-know and transparency for affected
workers and communities;
To provide comments on the STAA and get implementing
agency response;
To have facilities that have adopted IST receive public
credit for their positive steps; and
To ensure opportunities for at-risk communities to engage
with facilities about alternatives and prevention plans.
EPA is not requiring automatic submission of STAA information or
documentation to EPA or requiring that it be made available to the
public. EPA acknowledges there is much public interest in having STAA
and documentation available to them, but STAA will be part of a PHA
which can be a lengthy (e.g., the sectors subject to STAA requirements
have multiple processes and some PHAs are hundreds of pages)
technically complex document that could contain not only CBI, but
sensitive security information involving process or equipment
vulnerabilities. Some commenters' suggested solution of having
facilities sanitize submitted documents and provide upfront
justification of CBI claims would entail a significant level of burden
upon industry and EPA. It would not be practical or good use of
resources to have thousands of documents submitted to EPA, to any other
body or with the RMP submission. EPA can inspect documents on-site or
request their submission from facilities as needed.
EPA believes that primary utility of STAA information for the
public is whether or not facilities are implementing IST and the nature
of that change. EPA is requiring that basic information on IST being
implemented be provided in the RMP submission in accordance with Sec.
68.175(e)(7). Facilities must provide in their RMP any inherently safer
technology or design measures implemented since the last PHA, if any,
and the technology category (substitution, minimization, simplification
and/or moderation). In the event of a public meeting held after an
accident, EPA encourages facilities to provide information about any
IST or other safer technology alternatives that the facility is using
or could be using and suggests that the public use this forum to
inquire about ISTs implemented at the facility.
EPA is not adopting an approval process for STAA analyses, either
by an independent board, by the implementing agency, or by any
emergency planning entity. We recognize nothing in the statute
prohibits the adoption of an approval process. The language of CAA
section 112(r)(7)(F) is directed towards the need for an operating
permit under Title V of the CAA and therefore has no bearing on whether
the underlying substantive rule may establish an approval process. In
CAA section 112(r)(7)(B)(iii), the statute specifically requires EPA's
rules to establish a system that provides for review and, if necessary
revision of RMPs (see 40 CFR 68.220). Nevertheless, the approach we
adopt in this final rule, which requires the owner or operator to
conduct a STAA review and document its review in general and its
reasoning for not adopting practicable IST/ISD, is consistent with the
overall approach of the RMP rule to rely on the development and
assessment of information to lead owners and operators to adopt
reasonable measures to prevent accidents.
m. Clearinghouse
Some commenters, including a Federal agency, a state agency,
environmental advocacy groups, and a local agency, supported the
establishment of a publicly available online clearinghouse providing
information about the feasibility and efficacy of safer substances and
processes. A Federal agency commented that such a database would also
be a useful resource for insurers, chemical process vendors, emergency
responders, academic researchers, and other government agencies, such
as OSHA.
One commenter remarked that such a clearinghouse should be
dedicated to the topic of safer technology and alternatives and should
be managed by either EPA, another Federal agency, or an independent
third-party rather than industry-funded academics or institutions. One
commenter suggested that a clearinghouse could be developed by EPA or a
third-party such as CCPS or Texas A&M's Mary Kay O'Connor Process
Safety Center.
A few industry trade associations remarked that the creation of a
clearinghouse would be redundant with some resources already publicly
available. For example, one trade association asserted that it has
effectively created its own clearinghouse through the publication and
maintenance of its own publicly available publications, semi-annual
[[Page 4652]]
conferences, and regular member exchange forums. Additionally, this
organization stated that it hosts a technology symposium every other
year, where members can learn about new technologies, both from members
sharing their experiences and directly from vendors and consultants.
Another trade association suggested that the searchable database of all
patents and patent applications available from the US Patent and
Trademark Office can be used as a clearing house for safer technology
and that information on unpatented technologies is readily available
through the internet and other means.
Another industry trade association warned that a government
clearinghouse would not reduce chemical accidents because each chemical
process is highly complex and unique and it would be difficult to find
value in a massive database of technologies. A commenter warned that
any clearinghouse would be required to have many ground rules so as to
clarify what factors were at play in the IST decision. The commenter
expressed concern that the clearinghouse could be harmful or not useful
if the information was selective in detail because an IST selected by a
stationary source may be narrow in scope for a specific set of risks to
be avoided or mitigated. The commenter also stated that it is possible
companies would provide information lacking enough detail to be useful.
Another commenter cautioned that one type of technology, system or
design that works for one facility or process may not work for another
facility or process, due to differing processes and other conditions.
EPA is not finalizing a provision to establish a clearinghouse in
this rule. EPA will further consider the comments and suggestions on
establishing a safer technologies and alternatives information
clearinghouse should we pursue an effort to develop and establish such
a clearinghouse in the future. Currently, industry and other
stakeholders can share chemical safety and security best practices,
including those involving safer technologies and alternatives, at the
Executive Order 13650 best practices Web site.\107\ EPA encourages
stakeholders to review information shared through this forum and to
submit best practices on safer alternatives or other best practices
that serve to improve chemical safety and security.
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\107\ https://www.osha.gov/chemicalexecutiveorder/LLIS/.
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D. Stationary Source Location and Emergency Shutdown
EPA discussed the importance of location of stationary sources and
their emergency shutdown capabilities in the preamble of the proposed
rulemaking. However, EPA did not propose any provisions related to
these issues.
1. Discussion of Comments on Stationary Source Location
The location of stationary sources, and the location and
configuration of regulated processes and equipment within a source, can
significantly affect the severity of an accidental release. The
location of the stationary source in relation to public and
environmental receptors may exacerbate the impacts of an accidental
release, such as blast overpressures or concentrations of toxic gases,
or conversely may allow such effects to dissipate prior to reaching
receptors. EPA requested comments on whether to consider stationary
source location requirements for future rulemakings, including the
scope of such requirements, or whether the Agency should publish
guidance. EPA received multiple comments on this issue.
Commenters indicated that EPA should use stricter standards for
calculating blast radius areas for new and existing facilities to
ensure that communities, schools, and hospitals are outside of the
blast impact. One commenter stated that EPA should use information
availability requirements to better inform and protect local
communities from accidents. A Federal agency and state/local agency
requested that EPA consider the stationary source location issue in
future rulemakings. A professional organization requested that EPA
consider a 2014 Fire Protection Research Foundation report in future
requirements for stationary source location.
Several commenters argued that facilities should be located where
no damage could occur to people and homes, asserting that the proposed
rulemaking does not go far enough to ensure public safety. Some of
these commenters specifically mentioned the Rancho LPG facility in San
Pedro, California, and asked that EPA review the siting of this
facility due to the danger it poses to the surrounding community.
A local agency and an advocacy group asked that EPA consider IST or
risk reduction methodologies and the importance of buffer zones in
siting of new stationary sources. Multiple state and local agencies and
an association of government agencies requested new guidance and tools
for localities to clarify additional requirements for stationary source
location. One commenter stated that EPA should consider reverse 911
calls to public receptors in setting requirements.
However, numerous commenters opposed adding provisions to address
stationary source location issues in the proposed rulemaking, citing
OSHA's PSM regulations and the lack of authority in the CAA. One
commenter stated that EPA should not propose any additional
requirements on the location of stationary sources. Multiple comments
indicated that states and localities, not EPA, should regulate the
siting of facilities.
EPA will consider these comments when determining whether to
develop guidance or propose stationary source location requirements in
a future action.
2. Discussion of Comments on Emergency Shutdown
The RMP regulation requires owners and operators of stationary
sources to develop and implement written operating procedures for the
safe and timely emergency shutdown of Program 2 and Program 3
processes, to ensure operator training for these procedures, and for
maintaining the mechanical integrity of emergency shutdown systems.
However, the regulation does not explicitly require that all covered
processes must include emergency shutdown systems.
EPA requested comment on whether emergency shutdown system
requirements should be considered for future rulemakings, including the
scope of such requirements, or whether the Agency should publish
guidance.
Many commenters supported additional regulations and/or guidance on
emergency shutdown systems regulations and/or guidance. Local agencies
stated that EPA should issue regulations or guidance requiring that all
processes be built such that they can be placed in a safe state during
an emergency. Another local agency recommended that EPA publish
guidance on emergency shutdown systems to assist regulated entities in
evaluating various alternatives, but argued that including emergency
shutdown systems in a future rulemaking would be infeasible for
existing locations. One commenter stated that EPA should consider
reverse 911 calls to public receptors in setting requirements. A state/
local agency expressed support for emergency shutdown systems
requirements in a future rulemaking, to include operating procedures
and annual testing.
[[Page 4653]]
However, several commenters argued that EPA should not propose any
additional requirements--regulations or guidance--on emergency shutdown
systems. These commenters asserted that existing regulation and
facility practices address emergency shutdown issues. One commenter
supported EPA's decision to forgo an emergency shutdown system
requirement, arguing that exclusion is consistent with RMP's
performance-based nature, but opposed EPA's suggestion to issue a
guidance document. Another commenter opposed a ``one-size-fits-all''
rule or guidance for emergency shutdown systems and argued that EPA
should propose specific regulatory text in a future rulemaking should
it decide to regulate emergency shutdown.
EPA will consider these comments when determining whether to
develop guidance or propose emergency shutdown system requirements in a
future action.
V. Emergency Response Preparedness Requirements
A. Emergency Response Program Coordination With Local Responders
1. Summary of Proposed Rulemaking
EPA proposed to require owners or operators of ``responding'' and
``non-responding'' stationary sources to coordinate response needs with
local emergency planning and response organizations to ensure that
resources and capabilities are in place to respond to an accidental
release of a regulated substance. Responding stationary sources also
would be required to comply with the emergency response program
provisions of Sec. 68.95 when the outcome of coordination activities
demonstrated that local public emergency response capabilities were not
adequate to appropriately respond to an accidental release at the
stationary source, or when the LEPC or equivalent requested in writing
that the owner or operator comply with the requirements of Sec. 68.95.
``Non-responding'' stationary sources need not have complied with Sec.
68.95 provided that the coordination activities indicated that adequate
local public emergency response capabilities are available to
appropriately respond to accidental releases at the source, appropriate
mechanisms are in place to notify emergency responders when there is a
need for a response, and the LEPC or equivalent has not requested in
writing that the owner or operator comply with the requirements of
Sec. 68.95.
The proposed coordination provisions would have required
coordination to occur at least annually, and more frequently if
necessary to address changes at the source, in the source's emergency
action plan, in local authorities' response resources and capabilities,
or in the local community emergency response plan. The owner or
operator would also have been required to document coordination
activities, including the names of individuals involved and their
contact information, dates of coordination activities, and the nature
of coordination activities. The proposed coordination provisions of
Sec. 68.93 also would have required sources with regulated toxic
substances to coordinate response actions with the LEPC or equivalent,
and sources with only regulated flammable substances to coordinate with
the local fire department. This language is similar to the language in
Sec. 68.90(b)(1) and (2) of the original rule, which requires that
sources with toxic substances held above threshold quantities be
included in the community emergency response plan developed under
EPCRA, and sources with only regulated flammable substances held above
threshold quantities coordinate response actions with the local fire
department.
The proposed rulemaking retained all emergency response program
provisions from Sec. 68.95 of the original rule, and made two
additions. The first was to modify Sec. 68.95(a)(1)(i) to require that
release notification procedures included procedures to notify Federal
and state emergency response agencies, in addition to the existing
rule's requirement to notify the public and local emergency response
agencies. The second addition was to modify Sec. 68.95(a)(4) to
require the owner or operator to review and update the emergency
response program annually, or more frequently if necessary, to
incorporate recommendations and lessons learned from emergency response
exercises, incident investigations, or other available information. The
proposed rulemaking also would have replaced the phrase ``local
emergency planning committee'' with the acronym ``LEPC.''
2. Summary of Final Rule
In this rule, EPA has retained the proposed term ``Responding
stationary source'' as a heading for Sec. 68.90(a) and ``Non-
responding stationary source'' as a heading for Sec. 68.90(b), as an
indication of whether or not a facility is required to comply with the
emergency response program provisions of Sec. 68.95. Section 68.90(a)
is otherwise unchanged from the existing rule, as are Sec.
68.90(b)(1), (2), and (3). EPA is also adopting as proposed paragraphs
Sec. 68.90(b)(4) and (5), which require the owner or operator of a
non-responding stationary source to perform the annual coordination
activities required under Sec. 68.93, and the emergency notification
exercises required under Sec. 68.96(a), respectively.
The final rule adopts as proposed Sec. 68.93, but with some
changes, which are discussed in the following sections. Section 68.93
requires the owner or operator to coordinate response needs with local
emergency planning and response organizations to determine how the
source is addressed in the community emergency response plan and to
ensure that local response organizations are aware of the regulated
substances at the source, their quantities, the risks presented by
covered processes, and the resources and capabilities at the facility
to respond to an accidental release of a regulated substance.
Section 68.93(a) requires coordination to occur at least annually,
and more frequently if necessary, to address changes at the source, in
the source's emergency response and/or emergency action plans, and/or
in the local community emergency response plan.
Section 68.93(b) requires coordination to include providing to the
local emergency planning and response organizations, the facility's
emergency response plan if one exists, emergency action plan, updated
emergency contact information, and any other information that local
emergency response planning and response organizations identify as
relevant to local emergency planning. For responding stationary
sources, Sec. 68.93(b) also requires coordination to include
consulting with local emergency response officials to establish
appropriate schedules and plans for field and tabletop exercises
required under Sec. 68.96(b). Lastly, Sec. 68.93(b) require the owner
or operator to request an opportunity to meet with the LEPC (or
equivalent) and/or local fire department as appropriate to review and
discuss these materials.
Section 68.93(c) adopts as proposed the coordination documentation
provisions without revision. Under Sec. 68.93(c), the owner or
operator is required to document coordination with local authorities,
including the names of individuals involved in coordination and their
contact information, dates of coordination activities, and the nature
of coordination activities.
EPA is finalizing several modifications to Sec. 68.95. EPA has
adopted the proposed addition to Sec. 68.95(a)(1)(i), which requires
that release notification procedures include procedures to notify
Federal and state emergency response agencies, in addition to public
and local emergency
[[Page 4654]]
response agencies. The final rule also adopts as proposed revisions to
Sec. 68.95(a)(4), with some modifications. The final rule requires the
owner or operator to review and update the emergency response plan as
appropriate based on changes at the source or new information obtained
from coordination activities, emergency response exercises, incident
investigations, or other available information, and ensure that
employees are informed of the changes.
3. Discussion of Comments and Basis for Final Rule Provisions
Many commenters, including industry trade associations, advocacy
groups, professional organizations, facilities, Federal and state
agencies, and others supported EPA's efforts to increase emergency
response program coordination between facilities and local responders.
Other commenters including industry trade associations and regulated
facilities stated the proposal would potentially duplicate other
Federal or state requirements or voluntary efforts, or suggested that
EPA should increase enforcement efforts rather than impose additional
requirements in certain areas.
Although ATF ruled that the fire at West Fertilizer in West, Texas
was intentionally set,\108\ the incident highlighted the need for
better coordination between facility staff and local emergency
responders. The approach EPA adopts in the final rule retains the
proposed rulemaking's promotion of coordination between facilities and
responders while recognizing the concerns of many of the commenters
about LEPCs and owners and operators making determinations about the
abilities and roles of owners and operators as well as LEPCs. We
preserve local flexibility under our approach. Public comments on each
proposed provision to the emergency response coordination and emergency
response program provisions of Subpart E are discussed further in this
preamble, along with EPA's responses and decisions for the final rule.
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\108\ See ATF Announces $50,000 Reward in West, Texas Fatality
Fire, https://www.atf.gov/news/pr/atf-announces-50000-reward-west-texas-fatality-fire.
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a. Designation of ``Responding'' and ``Non-Responding'' Stationary
Sources
Some commenters objected to EPA's proposal to designate all sources
as either responding or non-responding sources. These commenters
pointed out these discrete categories do not accurately represent the
realities of emergency response, which can include many different
degrees of involvement by facilities and local communities in planning,
preparing for and responding to accidental release events. One
commenter stated that all facilities, regardless of whether they are
responding or non-responding facilities, should have a partnership with
the LEPC or local emergency responders. Another commenter stated that
even facilities with full on-site emergency response capability would
likely rely on local public responders to order and manage shelter-in-
place actions or evacuations. Another commenter stated that all
facilities are responsible for and must be prepared to deal with the
regulated substances they handle and there should be no such thing as a
``non-responding'' stationary source, but this does not mean every
facility needs a technician-level hazmat response team. This commenter
stated that every facility must be able to immediately notify emergency
response agencies when a release having the potential to impact the
public occurs, take actions to protect the lives of employees and the
public, minimize or contain the release, and coordinate with local
response agencies who respond to the release.
EPA agrees there is a wide spectrum of planning, preparedness, and
response arrangements available to facilities and local communities,
and the two categories of ``responding'' and ``non-responding''
facilities do not fully capture this continuum. EPA also acknowledges
there is some overlap between the obligations of non-responding and
responding facilities. For example, both non-responding and responding
facilities must have mechanisms or procedures in place to notify
emergency responders about accidental releases, and both types of
sources must coordinate emergency response activities with local
responders (and under the final rule, these coordination activities
must occur annually and be documented, as further described further in
this preamble). Because the outcome of coordination activities may
result in different types of response arrangements involving regulated
facilities and communities, EPA understands that a facility's
designation as ``responding'' or ``non-responding'' does not, by
itself, explain all facets of emergency preparedness and response for
the facility.
These designations are still useful, however, because
``responding'' facilities must meet certain requirements that ``non-
responding'' facilities are not required to meet. Responding facilities
must comply with all of the provisions of Sec. 68.95, which include
developing an emergency response plan, developing procedures for the
use, inspection, and testing of emergency response equipment,
conducting training for employees in relevant procedures, and updating
the emergency response plan to reflect changes at the source. Any
facility that plans to use its employees to take response actions
beyond those specified in its emergency action plan under 29 CFR
1910.38 as a result of an accidental release at the source--which could
include, for example, donning emergency air breathing apparatus in
order to enter an area where a toxic gas leak has occurred with the
intention of stopping or controlling the release--would be expected to
have obtained appropriate equipment and training, and to address these
activities in its emergency response program, even if the facility is
also relying on local responders to supplement its own response, or to
manage offsite response actions such as evacuations and sheltering-in-
place. Therefore, in the final rule, EPA has retained the proposed
terms ``Responding stationary source'' as a heading for Sec. 68.90(a)
and ``Non-responding stationary source'' as a heading for Sec.
68.90(b), as an indication of whether or not a facility is required to
comply with the emergency response program provisions of Sec. 68.95.
b. Evaluating Resources and Capabilities of Local Responders
The proposed rulemaking would have made the owner or operator's
decision to develop an emergency response program contingent on the
outcome of local coordination activities. Under the NPRM, in order to
be a non-responding facility, the owner or operator would have been
required not only to coordinate with local responders and have
appropriate notification mechanisms in place, but also to confirm that
adequate local public emergency response capabilities are available to
appropriately respond to any accidental release of the regulated
substances at the stationary source.
EPA received numerous comments objecting to this provision. Many
commenters, including industry trade associations, government agencies,
an association of government agencies, facilities, and other
commenters, expressed concern over ambiguity in the terms ``adequate''
response capabilities and ``appropriate'' response. One commenter noted
that unless they are notified by the LEPC or fire department,
facilities will not know when a change in community response
capabilities or resources occurs. Another commenter pointed out there
is no accepted standard for community emergency
[[Page 4655]]
response capability applicable nationwide, and that response resources
and capabilities can only be evaluated in the context of the overall
community's response plan.
EPA has not adopted this provision in the final rule. While EPA
believes it is important for regulated facilities and local responders
to share information on response resources and capabilities, the Agency
acknowledges the capabilities and resources of local response
organizations are subject to numerous influences, including other
potential demands within the community for local response resources,
local government organization and budgets, Federal, state, and local
regulations, and others. Few if any of these factors are within the
purview of the owners and operators of individual regulated facilities,
and therefore in many cases, owners and operators will not be in a
position to judge the adequacy of local response capabilities and
resources.
c. Developing an Emergency Response Program Upon Receiving a Written
Request From the LEPC
The NPRM would also have required the owner or operator to develop
an emergency response program in accordance with Sec. 68.95 upon
receiving a written request to do so from the LEPC or local response
authorities. Numerous commenters objected to this provision. These
commenters indicated that the provision would allow or incentivize
LEPCs to absolve themselves of their emergency response obligations
under EPCRA, even if this may not be in the best interest of the
overall emergency response. Several commenters stated that allowing
local authorities to ``opt out'' of their responsibilities would
undermine the mission of those authorities, and that relying on
facilities to fulfill emergency response obligations if an LEPC ``opts
out'' may not be within these facilities' authority or capability.
Several commenters also expressed concern that EPA's proposal did not
include criteria LEPCs must meet before requesting a facility become a
responding facility. One commenter representing an association of state
government response commissions stated that this provision would cause
the vast majority of LEPCs to request facilities become responding
facilities.
EPA disagrees the proposed provision would have absolved local
responders of their responsibilities under EPCRA or allowed them to
disregard their other response obligations. The proposed provisions
would have had no effect on local authorities' community emergency
planning responsibilities under EPCRA. Also, even in situations where
regulated sources maintain full emergency response capabilities, local
responders would still be responsible for managing the aspects of the
response external to the source, such as community evacuations and
sheltering-in-place. Nevertheless, EPA has decided not to finalize this
provision because of the objections raised by commenters, and because
it would have allowed local governments to place emergency response
program obligations on the owners or operators of regulated facilities
without requisite knowledge of the facility's operations, business
practices, financial condition, and other relevant factors. Also,
commenters pointed out that many facilities--particularly small
businesses--would as a practical matter simply be unable to manage all
of their own response needs, which could include maintaining a full
hazardous materials response team, as well as firefighting
capabilities. In the preamble to the original rule, EPA acknowledged
that small businesses would often be unable to manage these duties.
d. Emergency Response Coordination Activities
Many commenters, including industry trade associations, advocacy
groups, facilities, government agencies, professional organizations,
and others supported EPA's proposed requirements for improved emergency
response coordination between facilities and local responders. Several
commenters recommended EPA clarify what is meant by ``coordination.''
Some commenters opposed EPA's proposed coordination requirements on the
basis that these activities were already required under other
regulations, or were being carried out voluntarily. Other commenters
expressed concerns about an historical lack of participation by LEPCs
in emergency response coordination activities, or that the proposed
coordination provisions would place increased burdens on local
responders.
In the final rule, EPA has adopted as proposed the emergency
response coordination provisions of Sec. 68.93, with some changes. One
significant change relates to the modified applicability provisions
discussed previously. In addition to removing the two provisions from
Sec. 68.90 of the final rule that would have made the owner or
operator's decision to develop an emergency response program contingent
on the outcome of local coordination activities, and required the owner
or operator to develop an emergency response program upon receiving a
written request to do so from the LEPC or local response authorities,
EPA has also removed the proposed language in Sec. 68.93 that placed
the focus of coordination on ensuring response resources and
capabilities are in place. This language has been replaced with
language that places the focus of coordination on sharing information
related to emergency planning.
EPA has also clarified what coordination activities are required.
In the final rule, under Sec. 68.93 the owner or operator is required
to provide local authorities with information about the regulated
substances at the source, their quantities, the risks presented by
covered processes, and the resources and capabilities at the facility
to respond to an accidental release of a regulated substance. Section
68.93(a) requires coordination to occur at least annually, and under
Sec. 68.93(b), the owner or operator is also required to provide the
facility's emergency response plan if one exists, the emergency action
plan required under 29 CFR 1910.38, updated emergency contact
information, and any other information local emergency planning and
response organizations identify as relevant to local emergency
planning. EPA notes that under 29 CFR 1910.38(b), OSHA requires
emergency action plans to be kept in writing, unless an employer has 10
or fewer employees, in which case they may communicate the plan orally
to employees. Under the final rule, if the owner or operator has a
written emergency action plan, that written plan should be provided to
local authorities, but if the plan is an oral plan, the owner or
operator may also communicate the plan orally to local authorities.
In requiring ``any other information that local emergency planning
and response organizations identify as relevant to local emergency
planning,'' EPA is encouraging local emergency officials to consider
what other facility information may aid them in preparing for
emergencies at the source beyond those specific elements identified in
Sec. 68.93 and Sec. 68.93(b), and request such information from the
owner or operator when conducting annual coordination activities. Such
information could include accident histories, portions of incident
investigation reports relevant to emergency response, incident after-
action reports, records of notification exercises, field and tabletop
exercise evaluation reports, etc. The owner or operator is required to
provide any information requested by local emergency planning and
response organizations, to the extent the information is relevant to
local emergency planning.
[[Page 4656]]
EPA disagrees with commenters who suggested not adopting the
proposed emergency response coordination requirements on the basis that
they are already required under other regulations, or are being carried
out voluntarily. While it is true that in some cases, other Federal or
state regulations contain emergency response coordination provisions
similar to those in the final rule, many regulated sources are not
subject to other regulations with requirements comparable to those in
the final rule. Also, in locations without functional LEPCs, other
local response authorities may be carrying out local emergency planning
functions, and these organizations may be unable to rely on authorities
granted to LEPCs under EPCRA to obtain needed information. Where
regulated sources are already subject to other Federal or state
emergency response coordination requirements comparable to those in the
final rule, compliance with those regulations may be used to
demonstrate compliance with the final rule, to the extent the
activities meet the specific requirements of the rule. Similarly, while
EPA agrees that some facilities may already voluntarily carry out the
coordination activities required under the final rule, not all
regulated facilities do so. Facilities that already carry out these
activities voluntarily may also use them to demonstrate compliance with
the final rule to the extent the activities meet the specific
requirements of the rule.
EPA understands some communities do not have functional LEPCs, but
has accounted for this possibility by requiring coordination to be with
``local emergency planning and response organizations.'' This term is
intended to encompass all manner of local public emergency planning and
response organizations. In many cases this will be the LEPC, but in
other cases it may be a local emergency management agency, a local fire
department, or another local response organization (or, if appropriate,
multiple organizations). These non-LEPC planning entities can use this
provision to obtain necessary planning information even when they lack
the authority granted LEPCs under EPCRA 303(d)(3). Regardless of
whether or not their community has an active LEPC, EPA expects owners
and operators of regulated sources to make good faith efforts to carry
out the coordination activities required in the final rule. If local
emergency planning and response organizations decline to participate in
coordination activities, or the owner or operator cannot identify any
appropriate local emergency planning and response organization with
which to coordinate, the owner or operator should document their
coordination efforts, and continue to attempt to perform coordination
activities at least annually.
EPA is also aware that increasing regulated facilities' emergency
response coordination obligations will often place increased demands on
local emergency planning and response organizations through increased
coordination requests made by the owners or operators of regulated
sources located in their communities. This is an unavoidable
consequence of increasing the owner or operator's emergency response
coordination obligations. However, the final rule's emergency response
coordination requirements are intended to be a straightforward
information exchange for both regulated sources and local response
organizations, and therefore should not be highly burdensome for either
party. Also, the regulatory requirements for coordination have been
placed on the owner or operator, rather than local emergency planning
and response organizations. Therefore, local response organizations are
not obligated to participate in the coordination activities specified
in the final rule. In our estimate of the burden of the rule, we have
conservatively projected an estimate of the cost of coordination on
local responders. EPA expects in most cases, local responders will
participate in these coordination activities because it is in their
best interest to have up-to-date information about the risks posed by
regulated stationary sources in their community and sources' emergency
response plans.
e. Frequency of Emergency Response Ccoordination Activities
Many commenters, including state or local agencies and industry
trade associations, expressed support for EPA's proposal to require
annual emergency response coordination activities between owners and
operators and local emergency response officials. Commenters noted such
ongoing coordination could help clarify roles and responsibilities and
refresh contacts. Some commenters expressed concerns that annual
coordination may be difficult or impractical if a source is remote or
if local authorities refuse to participate. One commenter suggested
that coordination activities should occur on a regular basis at an
appropriate frequency determined by the facility and when there is a
significant change to the source's emergency plan.
EPA has decided to finalize as proposed the requirement at Sec.
68.93(a) for coordination to occur at least annually and more
frequently if necessary. EPA agrees with the majority of commenters
that believe that regular ongoing coordination is useful to address
changes at the source and in the local community emergency plan. EPA
believes most sources are located close enough to local responders to
make annual coordination activities practical. Where necessary, owners
and operators and local authorities may conduct coordination activities
remotely (e.g., using conference calls, webinars, email, etc.). EPA
does not agree the frequency of coordination should be left completely
up to the source. Sources and local response organizations may choose
to coordinate more frequently than annually, but the Agency believes
annual emergency coordination between regulated sources and local
responders is necessary to the development and maintenance of effective
response plans,\109\ and unlikely to impose an undue burden on any
source.
---------------------------------------------------------------------------
\109\ See preamble discussion in proposed rulemaking, 81 FR
13671, March 14, 2016.
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f. Annual Coordination Meetings
In the proposed rulemaking, EPA did not specifically propose to
require that the owner or operator ``meet with'' local authorities to
conduct annual coordination. However, in the preamble to the proposal,
EPA did indicate that as part of the coordination, the owner or
operator and the local response authorities should ``work together'' to
determine who will respond if an incident occurs, and what would be an
appropriate response. Additionally, in the information availability
section of the preamble to the proposed rulemaking, EPA requested
comment on whether the Agency should require owners and operators to
meet with LEPCs and emergency responders. Several commenters
recommended EPA clarify that coordination activities should include
regular meetings between the owner or operator and local authorities.
These commenters noted that such regular meetings would provide
opportunities for both parties to exchange, update, and discuss
information relating to emergency response planning. One commenter
noted that annual meetings would allow the owner or operator to
communicate potentially security-sensitive information needed for
emergency preparedness and response. A few commenters noted that while
they were in favor of coordination meetings, the owner or operator
should not be held to a requirement for such meetings in situations
where local authorities are
[[Page 4657]]
unable or unwilling to participate. Another commenter stated that
coordination meetings should occur, but the frequency of such meetings
should be left up to the owner or operator and local authorities to
decide.
In Sec. 68.93(b) of the final rule, as part of the required annual
coordination activities, EPA is requiring the owner or operator to
request an opportunity to meet with the local emergency planning
committee (or equivalent) and/or local fire department. The purpose of
the annual coordination meeting is to allow the owner or operator to
update and discuss the information being provided to local authorities,
and to allow local authorities to provide the owner or operator with
updated information on how the source is addressed in the community
emergency response plan. The annual coordination meeting will also
provide an opportunity for local authorities to request any other
information that may be relevant to local emergency planning, and for
the owner or operator to provide this information. In the final rule,
EPA has worded the meeting requirement to only require the owner or
operator to request such a meeting, so that the owner or operator would
not be required to hold a meeting if local authorities are unable or
unwilling to participate. The forum for coordination meetings is left
up to the reasonable judgement of the owner or operator and local
response authorities. They may choose to hold a meeting specifically
for this purpose, or combine the coordination meeting with another
appropriate meeting, such as a regularly scheduled LEPC meeting, if
both parties agree to the arrangement. Where necessary, owners and
operators and local authorities may hold meetings remotely (e.g., via
conference call or webinar).
g. Coordination of Exercise Frequencies and Plans
In Sec. 68.96(b) of the final rule the owner or operator of a
responding stationary source is required, as part of their emergency
response coordination activities, to consult with local emergency
response officials to establish appropriate frequencies and plans for
tabletop and field exercises. This provision was added because numerous
commenters, including industry associations, facilities, government
agencies, and others, objected to the potentially high burden
associated with conducting field exercises every five years and
tabletop exercises every year. An association of government agencies
noted that requiring field exercises every five years and tabletop
exercises every year would place substantial burdens on LEPCs and
response agencies, particularly as these organizations are often
composed of volunteers. This commenter recommended that the frequency
and scope of field and tabletop exercises be determined as part of the
coordination process. EPA adopted a modified form of this provision
(which is discussed further in the following preamble section on
Emergency Response Exercises) in the final rule, and therefore added
language to Sec. 68.93 (b) to also require that for responding
stationary sources, coordination must include consulting with local
emergency response officials to establish appropriate schedules and
plans for field and tabletop exercises.
EPA understands there may be cases where local emergency response
agencies are unable or unwilling to coordinate with a regulated
stationary source on exercise frequencies and plans, or to participate
in exercises. In such cases, the owner or operator may establish
appropriate exercise frequencies and plans on their own, provided they
meet the minimum requirements set forth in Sec. 68.96. Also, the owner
or operator should revisit their exercise schedules and plans at the
next annual coordination opportunity with local response officials, so
that these officials are given an opportunity for input on exercise
schedules and plans, even if they remain unable to participate in the
exercises.
h. Documentation of Coordination Activities
Many commenters, including state and local agencies and industry
trade associations, expressed support for EPA's proposal to require
documentation of coordination activities. Several commenters requested
EPA clarify how facilities should document coordination activities when
local responders are not available or responsive to a facility's
attempts to coordinate. Some commenters suggested that EPA require
facilities make a reasonable attempt to make arrangements to coordinate
with local responders and document any failure to complete such
arrangements. One commenter suggested facilities should be required to
seek a written or electronic acknowledgement from local responders of
coordination efforts, or, if unavailable, document any efforts made to
coordinate. A few commenters expressed opposition to the requirement
for documentation of coordination. One indicated that such
documentation could ``serve as a basis for mutual accusations or
second-guessing between first responders and the RMP-regulated facility
in the aftermath of an emergency.'' Another indicated that fire
departments in California have found CalARP requirements to document
emergency coordination to be a large burden. A third commenter stated
that if facilities are included in the community response plan, this
should be all the documentation needed to demonstrate coordination.
EPA has decided to finalize the requirement at Sec. 68.93(c) for
coordination to be documented, as proposed (the final rule reverses the
order that the coordination and documentation provisions appear in the
regulatory text). The final rule does not specifically require the
owner or operator to seek acknowledgement from local responders of
coordination efforts. The owner or operator may seek such
acknowledgement if desired, but local authorities are not required to
provide it. EPA believes the required documentation elements, which
include the names of individuals involved in coordination activities
and their contact information, the dates of coordination activities,
and the nature of coordination activities, should clearly demonstrate
whether local responders were involved in coordination, without
requiring any other specific acknowledgement from local responders. EPA
agrees with commenters that suggested the owner or operator should
document any unsuccessful attempts to coordinate with local response
organizations. The final rule does not specifically require the owner
or operator to document unsuccessful coordination attempts, but EPA
believes it will be in the owner or operator's best interest to do so,
and allow the owner or operator to demonstrate their good faith efforts
to conduct coordination activities in the event an implementing agency
requests this information.
EPA does not agree with commenters' objections to documentation of
coordination activities. If response to an emergency goes badly,
documentation of prior coordination is more likely to clarify
deficiencies than obscure or exacerbate them. The objection that
documentation could cause a large burden on fire departments is not
applicable to this provision, as the requirement for documentation in
this rule is placed on the owner or operator rather than local
responders, and in any case, the Agency does not view the documentation
requirement as highly burdensome. Most of the documents the final rule
requires the owner or operator to provide to local authorities are
either already required to exist (i.e., emergency response plan and
emergency action plan), or should require minimal effort
[[Page 4658]]
to produce (i.e., updated emergency contact information, names and
contact information of individuals involved in coordination activities,
dates of coordination activities, and the nature of coordination
activities). EPA views these documentation requirements as
straightforward and minimally burdensome.
During coordination meetings, EPA encourages owners and operators
to provide local emergency response officials with additional
documentation relating to emergency planning if those officials request
it. The annual coordination provisions require the owner or operator to
ensure local response organizations are aware of the regulated
substances at the source, their quantities, the risks presented by
covered processes, and the resources and capabilities at the facility
to respond to an accidental release of a regulated substance. The final
rule also requires the owner or operator to provide any other
information local emergency planning and response organizations
identify as relevant to local emergency planning. In most cases, the
Agency believes the most efficient way for the owner or operator to
provide such information is to not only discuss it during annual
coordination meetings, but also to provide appropriate documentation to
local authorities.
Lastly, EPA does not agree that a facility's inclusion in the
community response plan is sufficient documentation to demonstrate
annual coordination. EPA notes that community emergency response plans
are not prepared or maintained by stationary sources, and that EPCRA
does not require community emergency plans to be updated annually.
Without regular emergency response coordination activities involving
local authorities, the owner or operator could remain unaware of
important changes in the community emergency plan, and local responders
could remain unaware of changes at the source that could potentially
affect the response to an accidental release.
EPA believes there is a wide range of potential outcomes from
emergency response coordination activities, but the primary purpose of
such coordination should be the regular sharing of information between
the owner or operator and local response authorities. Both the owner or
operator and local responders should benefit from this exchange by
becoming more aware of each organization's response capabilities,
resources, and procedures. Based on these increased coordination
activities, both regulated sources and local response organizations
will be better able to adapt their response plans and procedures to
updated information. This information exchange could also prompt some
facilities to enhance their existing response capabilities, and even to
develop a full emergency response program where none previously
existed. Conversely, such increased coordination could result in local
authorities, in consultation with an owner or operator, deciding that
local public responders are better positioned to respond to releases of
regulated substances at the source than the facility itself.
Additionally, coordination could lead to development of mutual aid
agreements with neighboring facilities, arrangements with response
contractors, or other means to improve community and/or facility
response plans, procedures, and resources. Such measures could enhance
both the community's and facility's ability to effectively respond to
emergencies without necessarily requiring a facility to maintain its
own hazardous materials response team and/or fire brigade, unless the
owner or operator, after coordinating with local authorities, decides
this is the most effective approach.
i. Changes to Emergency Response Program Provisions
The proposed rulemaking contained two substantive changes to the
emergency response program provisions of Sec. 68.95. The first change
would have modified the emergency response plan provision in Sec.
68.95(a)(1)(i) that requires the plan to include procedures for
informing the public and local emergency response agencies about
accidental releases, to also require these procedures to inform
appropriate Federal and state emergency response agencies about
accidental releases. EPA received no comments on this provision, and
therefore is finalizing it as proposed.
The second change would have modified Sec. 68.95(a)(4). Under the
existing rule, this provision requires the emergency response program
to include procedures to review and update the emergency response plan
to reflect changes at the stationary source and ensure employees are
informed of changes. The proposed change would have required the owner
or operator to review and update the emergency response plan annually,
or more frequently if necessary, to incorporate recommendations and
lessons learned from emergency response exercises, incident
investigations, or other available information.
Some commenters stated that requiring annual updates to the
facility emergency response plan is unnecessary, and that EPA should
allow updates to be performed less frequently, such as every three or
five years, unless changes occur. Others stated that the proposed
requirement was vague and should be clarified. A few commenters,
including an industry trade association and a private citizen,
commented that EPA's proposed requirement to require annual updates to
emergency response plans incorrectly assumes the owner or operator will
know when changes in community emergency response resources and
capabilities occur. One facility requested EPA clarify in the final
rule that facilities would not be deemed noncompliant if changes in
local authorities' response plans or capabilities occur without
notification to the facility. A private citizen suggested EPA add a
requirement for local response authorities to provide a copy of the
local community emergency response plan to the facility.
The final rule has adopted a modified version of the proposed
emergency response plan update provision. Under the final rule, the
owner or operator must review and update the emergency response plan as
appropriate based on changes at the source or new information obtained
from coordination activities, emergency response exercises, incident
investigations, or other available information, and ensure that
employees are informed of the changes. EPA agreed with commenters who
stated that requiring annual emergency response plan updates is
unnecessary. EPA is not finalizing a requirement to update the
emergency response plan annually, because while coordination activities
will occur annually, they may not always generate information that
necessitates changes to the facility's emergency response plan. Other
events that could trigger updates to the emergency response plan, such
as incident investigations and field and tabletop exercises, may also
occur less frequently than annually, and may or may not produce
information that could affect the emergency response plan. Therefore,
EPA has decided to finalize a more flexible update provision. Under the
final rule, the owner or operator is required to update the emergency
response plan, but only when changes at the source, or new information
obtained from coordination activities, exercises, incident
investigations, or other information sources make it appropriate to
change the plan.
EPA disagrees with commenters who stated the owner or operator will
be unaware of changes in community
[[Page 4659]]
emergency response resources that could affect the source's emergency
response plan. EPA believes the annual coordination provision should
ensure the owner or operator is kept up to date on relevant changes in
the community emergency response plan. EPA agrees with commenters that
the owner or operator should not be held responsible for updating the
facility emergency response plan to reflect changes in the local
community emergency response plan if local response officials do not
provide the necessary information. However, the Agency is not requiring
local authorities to provide a complete copy of the local community
emergency plan to the owner or operator. Local authorities may provide
it if they choose, and in some cases the community emergency response
plan may be publicly available information. However, the local
community emergency response plan may also contain a significant amount
of information that is not relevant to the owner or operator, so local
response authorities may prefer to provide only the information from
the community emergency response plan that relates to the stationary
source.
In the final rule, the Agency has also included a requirement to
ensure employees are informed of any changes to the emergency response
plan. This requirement was already in Sec. 68.95(a)(4) of the existing
rule, but had inadvertently been omitted from the proposed rulemaking
language that revised this section. One commenter noted this issue, and
stated that workers should continue to be involved in reviewing the
emergency response plan. EPA agrees, and therefore has restored this
provision in the final rule.
Lastly, EPA is finalizing the proposal to replace the term ``local
emergency planning committee'' with the acronym ``LEPC.'' EPA received
no comments on this issue.
B. Facility Exercises
1. Summary of Proposed Rulemaking
In Sec. 68.96 of the NPRM, EPA proposed to require three types of
emergency response exercises under Subpart E of the RMP rule--
notification, field, and tabletop exercises. Under Sec. 68.96(a), EPA
proposed to require all stationary sources with any Program 2 or
Program 3 process to conduct annual notification exercises that would
include contacting the Federal, Tribal, state, and local public
emergency response authorities and other external responders that would
respond to accidental releases at the source. EPA also proposed that
these exercises be documented and written records maintained for a
period of five years.
Under Sec. 68.96(b), EPA proposed that responding stationary
sources develop and implement an exercise program that includes field
and tabletop exercises. Under Sec. 68.96(b)(1), field exercises would
have been required at least once every five years, and within one year
of any accidental release meeting the accident history reporting
requirements of Sec. 68.42. Under Sec. 68.96(b)(2), tabletop
exercises would have been required annually, except during the calendar
year when a field exercise was conducted. Also under these provisions,
when planning field and tabletop exercises, EPA proposed to require the
owner or operator to coordinate with local public emergency responders
and invite them to participate in exercises.
Lastly, under Sec. 68.96(b)(3), EPA proposed to require the owner
or operator to prepare an evaluation report for both field and tabletop
exercises, within 90 days of the exercise. The report would require a
description of the exercise scenario, names and organizations of each
participant, an evaluation of the exercise results including lessons
learned, recommendations for improvement or revisions to the emergency
response exercise program and emergency response program, and a
schedule to promptly address and resolve recommendations. In the
preamble to the proposed rulemaking, EPA indicated the report would
also include an evaluation of the adequacy of coordination with local
emergency response authorities, and other external responders, as
appropriate.
2. Summary of Final Rule
EPA is finalizing the notification exercise provisions of Sec.
68.96(a) as proposed but with modifications. Under Sec. 68.96(b), the
final rule requires responding stationary sources to develop and
implement an exercise program that includes both field and tabletop
exercises; however, EPA is modifying the exercise frequency to allow an
owner or operator to establish a schedule in coordination with local
officials, with minimum timeframes prescribed in the rule. Exercises
must involve facility emergency response personnel and, as appropriate,
emergency response contractors. When planning emergency response field
and tabletop exercises, the owner or operator must coordinate with
local public emergency response officials and invite them to
participate in the exercise.
a. Field Exercises
Section 68.96(b)(1) requires the owner or operator to conduct field
exercises involving a simulated accidental release of a regulated
substance. Under Sec. 68.96(b)(1)(i), as part of the coordination with
local emergency response officials required by Sec. 68.93, the owner
or operator is required to consult with these local officials to
establish an appropriate frequency for field exercises. However, in all
cases, the owner or operator must conduct a field exercise at least
once every ten years.
Section 68.96(b)(1)(ii) identifies the scope of the field exercises
including tests of: Notification procedures; procedures and measures
for emergency response actions (including evacuations and medical
treatment); and communications systems. Field exercises must also
involve: Mobilizing of facility emergency response personnel, including
contractors, as appropriate; coordinating with local emergency
responders; deploying emergency response equipment; and any other
action identified in the emergency response program, as appropriate.
b. Tabletop Exercises
Section 68.96(b)(2) requires the owner or operator to conduct
tabletop exercises involving the simulated accidental release of a
regulated substance. Under Sec. 68.96(b)(2)(i), as part of the
coordination with local emergency response officials required by Sec.
68.93, the owner or operator is required to consult with these
officials to establish an appropriate frequency for tabletop exercises.
However, in all cases, the owner or operator must conduct a tabletop
exercise at least once every three years.
Section 68.96(b)(2)(ii) requires tabletop exercises to include
discussions of: Procedures to notify the public and the appropriate
Federal, state, and local emergency response agencies; procedures and
measures for emergency response including evacuations and medical
treatment; identification of facility emergency response personnel and/
or contractors and their responsibilities; coordination with local
emergency responders; procedures for equipment deployment; and any
other action identified in the emergency response plan, as appropriate.
c. Documentation and Alternatives
EPA is finalizing the documentation provisions of Sec. 68.96(b)(3)
as proposed. The owner or operator must prepare an
[[Page 4660]]
exercise evaluation report within 90 days of each field and tabletop
exercise.
The final rule also adds Sec. 68.96(c) to describe alternative
means of meeting RMP exercise requirements. Under Sec. 68.96(c)(1),
the owner or operator may satisfy the requirement to conduct
notification, field and/or tabletop exercises through exercises
conducted to meet other Federal, state or local exercise requirements,
provided such exercises meet the RMP exercise requirements of Sec.
68.96(a) and/or (b), as appropriate.
Under Sec. 68.96(c)(2), the owner or operator may satisfy the
requirement to conduct notification, field and/or tabletop exercises by
responding to an accidental release, provided the response includes the
actions indicated in Sec. 68.96(a) and/or (b), as appropriate. When
response to an accidental release is used to meet field and/or tabletop
exercise requirements, the final rule requires the owner or operator to
prepare an after-action report comparable to the exercise evaluation
report required in Sec. 68.96(b)(3), within 90 days of the incident.
3. Discussion of Comments and Basis for Final Rule Provisions
Many commenters, including industry trade associations, facilities,
government agencies, environmental advocates, private citizens, and
others supported EPA's proposal to incorporate emergency response
exercise requirements into the RMP rule. Most commenters supported
EPA's proposal to require notification exercises. Many commenters also
supported incorporating requirements for field and tabletop exercises
into the RMP rule, but some of these commenters also recommended
various changes to the proposed provisions. Other commenters, including
industry trade associations, facilities, and others, recommended
eliminating field and/or tabletop exercises. The approach adopted in
this rule increases the flexibility for local responders and stationary
source owners and operators to tailor their exercises to their
communities and to their resources. Public comments on each proposed
requirement within the emergency response exercise provisions of
Subpart E are discussed further in this preamble, along with EPA's
decisions for the final rule.
a. Notification Exercises
Almost all commenters that addressed EPA's proposed notification
exercise requirements supported those requirements as proposed. Many of
these commenters stated notification systems must be tested regularly
to ensure they function successfully in the event of an emergency. A
few commenters recommended changes to the notification exercise
requirement. One commenter suggested notification exercises should
occur every five years unless changes occur (e.g., management,
operation, or physical changes), in which case they should occur within
60 days of the change. Another commenter supported a requirement to
confirm emergency contact information but opposed a requirement to send
an actual ``test'' notification, stating this would be an unnecessary
burden on facilities and responding organizations. A different
commenter requested EPA exempt RCRA-permitted facilities from annual
notification exercise requirements, where the RMP-regulated process is
also covered by a RCRA permit, stating the proposed requirements are
duplicative of RCRA requirements.
EPA disagrees notification exercises should occur every five years
unless changes occur, because the Agency believes five years is too
long of a gap to confirm whether emergency notification information is
correct and emergency notification systems function properly. For
example, EPA notes that emergency contact information provided in RMPs
frequently changes, particularly when facilities go several years
between RMP updates. For this reason, in 2004 the Agency modified the
RMP submission requirements to require emergency contact information
provided in RMPs to be corrected within one month of any change in that
information. EPA also disagrees management, operational, and physical
changes at the facility necessarily represent appropriate triggers for
verification of emergency response contact information. In some cases,
such changes may affect emergency notification, but notification
systems and procedures may also be affected by other changes, such as
changes in the community emergency response plan. While EPA believes it
would be beneficial for the owner or operator to update their emergency
contact information and confirm the functionality of notification
systems whenever relevant changes occur, in some cases changes that
affect emergency contact information and notification systems may be
infrequent, and result in facility personnel and local responders
becoming unfamiliar with stationary source emergency notification
procedures. EPA believes a requirement for annual notification
exercises will ensure that emergency contact information and
notification systems remain relatively current, and also provide
regular training for facility personnel and local responders.
EPA also disagrees that requiring an actual test of the facility's
notification system is unnecessary. Requiring annual testing of
notification systems should prevent situations where emergency
notification systems are only found to be ineffective when they are
most needed. Short of actually using the emergency notification system
during an accidental release, performing a test of the facility's
emergency notification system is the most practical way to evaluate
whether or not the system is functional.
EPA expects the notification exercise will involve testing of on-
site notification equipment and procedures, including contacting each
entity listed on the facility's notification list to verify the contact
information and identify that the facility is conducting a notification
exercise. Therefore, EPA does not believe testing notification
mechanisms is unduly burdensome. EPA also disagrees with exempting
RCRA-permitted facilities from the notification exercise requirement.
However, in the final rule, EPA has added Sec. 68.96(c) to clarify
that exercises conducted to meet other Federal, state, or local
exercise requirements will also satisfy the requirements of this rule,
provided such exercises meet all of the applicable requirements of the
RMP exercise provision.
Due to the significant support for and minimal opposition to the
proposed notification exercise requirements of Sec. 68.96(a), EPA is
finalizing those requirements without modification. Therefore, under
the final rule, all regulated sources with any Program 2 or Program 3
process must conduct an exercise of the source's emergency response
notification mechanisms at least once each calendar year. During
listening sessions conducted under Executive Order 13650, members of
the public expressed significant concerns about ineffective emergency
notification systems and procedures during accidental release events at
regulated sources, and about receiving little or no information on
procedures for evacuation and sheltering-in-place. In most cases,
community notification, evacuation, and sheltering are managed by local
authorities after receiving an emergency notification from the
regulated source. EPA encourages owners and operators to work with
local authorities to perform joint comprehensive testing of facility
and community notification systems where possible, and to provide
updated information to local communities on
[[Page 4661]]
evacuation and sheltering procedures. In some cases, regulated
facilities provide direct notification to nearby residents and other
members of the community when an accident has occurred. These may
include audible and/or visual alarms and sirens, reverse 911 calling
systems, or other direct notification systems. Where such systems are
in place, annual notification exercises should include tests of those
systems during the exercise. In either case, EPA recommends regulated
sources and communities work together after conducting notification
exercises to evaluate the effectiveness of notification, evacuation,
and sheltering systems and procedures, and make improvements to those
systems and procedures as appropriate, based on lessons learned during
exercises.
b. Field and Tabletop Exercises
EPA received numerous comments on the proposed field and tabletop
exercise provisions. Most commenters, including industry trade
associations, facilities, government agencies, environmental advocates,
and others provided general support for including field and tabletop
exercise requirements in part 68, although many also recommended
changes to the required frequency of field and tabletop exercises,
expressed concerns regarding any requirement for local public
responders to be involved in exercises, or recommended other changes to
the proposed requirements. Several other commenters entirely opposed
adding field and tabletop exercise requirements to the rule. In
general, these commenters stated that field and tabletop exercises were
unduly burdensome on both facilities and local responders, and
exercises are unnecessary because annual coordination activities would
be sufficient to prepare facility employees and local responders to
respond to accidental releases.
EPA disagrees with comments that recommend completely eliminating
requirements for field and/or tabletop exercises in the final rule. The
Agency views exercises as an important component of an emergency
response program for responding stationary sources, because it allows
these sources to implement their emergency response plans, test their
actual response procedures and capabilities, identify potential
shortfalls, and take corrective action. EPA also continues to believe
both field and tabletop exercises will provide essential training for
facility personnel and local responders in responding to accidental
releases, and will ultimately mitigate the effects of such releases at
RMP facilities. Therefore, in the final rule, EPA is requiring all
responding stationary sources to perform field and tabletop exercises.
However, in the final rule EPA has also modified some provisions of
Sec. 68.96 in order to address public comments. These changes are
discussed in more detail in the following sections.
c. Frequency of Exercises
The greatest number of comments on the proposed field and tabletop
exercise provisions related to the required frequency for exercises.
While several commenters supported EPA's proposed requirements for
annual tabletop exercises and field exercises every five years, some
commenters recommended requiring more frequent field exercises, while
others recommended requiring field and/or tabletop exercises less
frequently, and still others argued that EPA should retain the
requirement for field and tabletop exercises but allow owners and
operators to have flexibility in the scheduling of exercises.
Support for more frequent field exercises. Commenters who argued
for more frequent field exercises included non-governmental
organizations, government agencies, and others. These commenters stated
that EPA's proposed five-year frequency for field exercises was
insufficient. One commenter argued a five-year timeframe for field
exercises does not conform to CAA section 112(r)(7)(B)(i), which states
``the Administrator shall promulgate reasonable regulations and
appropriate guidance to provide, to the greatest extent practicable,
for the prevention and detection of accidental releases of regulated
substances and for response to such releases by the owners or operators
of the sources of such releases.'' This commenter also stated that more
frequent exercises are necessary so that response personnel would gain
more experience. Several other commenters who recommended more frequent
exercises noted that sources subject to the New Jersey Toxic
Catastrophe Prevention Act (TCPA) regulations are required to conduct
annual field exercises. Other commenters argued more frequent field
exercises are needed due to the potential for personnel turnover that
results in the loss of institutional knowledge and collaborative
relationships between covered facility owners/operators and community
emergency responders.
EPA disagrees that CAA section 112(r)(7) requires EPA to establish
a requirement for more frequent exercises. The statute itself in CAA
section 112(r)(7)(B)(i) does not contain a requirement for emergency
response exercises, therefore, nothing in the statute mandates a
frequency for such exercises if the EPA decides some exercises may be
reasonable. The requirement to conduct emergency response exercises
derives from EPA's authority to set ``reasonable regulations'' that
include ``procedures and measures for emergency response after an
accidental release of a regulated substance in order to protect human
health and the environment.'' CAA section 112(r)(7)(B)(ii) further
requires owners and operators to prepare and implement a risk
management plan that includes, among other things, ``a response program
providing for specific actions to be taken in response to an accidental
release of a regulated substance so as to protect human health and the
environment, including procedures for informing the public and local
agencies responsible for responding to accidental releases, emergency
health care, and employee training measures.'' This statutory language
provides the Administrator with discretion to decide what components of
an emergency response program are reasonable to include in regulations.
EPA believes exercising emergency response plans is a reasonable
requirement in order to ensure that emergency response programs will
work well in the event of an accidental release. However, EPA is
cognizant of the resources (e.g., staffing, cost, expertise) that
exercises demand both from stationary sources and from local
responders. To ensure the reasonableness of the exercise requirement,
EPA has provided flexibility for stationary sources and local emergency
responders to set schedules for such exercises. Given the differences
among communities and stationary sources impacted by the national Risk
Management Program rule, the reasonable minimum frequency for exercises
will vary by locale from that which is appropriate under the NJ TCPA
requirements.
EPA disagrees with commenters who recommended requiring field
exercises more frequently than every five years. EPA notes that its own
regulatory impact analysis for the NPRM projected the emergency
response exercise provisions to be the costliest provision of the NPRM,
and the Agency is concerned that a requirement for even more frequent
field exercises could be prohibitively expensive for some facilities
and local responders.
Regarding commenters' concerns about the potential that less
frequent exercises may result in response personnel gaining less
experience, and for personnel turnover to result in the
[[Page 4662]]
loss of institutional knowledge and relationships between facility
operators and community emergency responders, EPA shares such concerns,
but must balance those concerns with the potentially higher burdens
that more frequent exercises could place on facility response personnel
and community responders. Also, EPA believes the annual emergency
response coordination requirements of Sec. 68.93 will foster strong
ongoing relationships between facility personnel and local responders,
and prevent the loss of institutional knowledge. Furthermore, the
timeframes EPA is establishing in the final rule are minimum
expectations and we encourage owners and operators to establish
appropriate schedules for exercises, in consultation with local
officials, considering factors such as hazards, organizations
(including facility personnel training needs and personnel turnover),
budgets, resource demands, regulations, or other factors.
Arguments for less frequent exercises. Commenters who argued for
less frequent field and/or tabletop exercises included industry
associations, government agencies, facilities, local responders,
private citizens, and others. These commenters stated that requiring
field exercises every five years and tabletop exercises every year
would be overly burdensome on facilities and local responders. Some of
these commenters submitted data to EPA to substantiate their burden
estimates. One commenter recommended reducing the required exercise
frequency because holding exercises as frequently as proposed by EPA
would discourage regular participation by facility personnel and local
responders. Several commenters recommended the frequency of field and
tabletop exercises be left to the discretion of the source and/or local
responders, so that the exercise schedule could be tailored to the
individual circumstances of sources and local communities. These
commenters also stated that exercises--and particularly field
exercises--can be very costly for both sources and local responders.
They also indicated that setting a single exercise frequency for all
sources does not account for the differing situations faced by
different sources and communities. In some cases, these commenters
argued, requiring too-frequent exercises could potentially divert
resources away from other important safety activities. One commenter
representing an association of state emergency planning officials
supported an exercise requirement, but recommended the frequency for
both field and tabletop exercises be determined by collaboration
between the source and local responders during the emergency response
coordination process.
EPA found these comments compelling. EPA's own projections in the
Regulatory Impact Analysis for the proposed rulemaking indicated that
exercises would be the costliest provision of the proposed rulemaking,
and in order to limit these costs, one alternative considered in the
NPRM was to require only tabletop exercises. Additionally, the Agency
is sympathetic to the concerns raised by emergency response officials
and others that participation in exercises by local responders can be
burdensome, particularly in smaller communities with volunteer
responders and fewer response resources, as well as in communities
where multiple RMP facilities are present--which would place
proportionally greater demands on responders who desire to participate
in the RMP facility exercises held within their jurisdiction. EPA is
also mindful of the concerns raised by small business owners and their
representatives both during SBAR panel process and in comments
submitted to EPA, who pointed out that exercises could potentially
place a relatively larger burden on small businesses.
For these reasons, in the final rule EPA has modified the provision
for frequency of both field and tabletop exercises to allow sources and
local responders to work together to establish an exercise frequency
appropriate to their situation. However, as EPA continues to believe
that both field and tabletop exercises are an important component of an
emergency response program, the Agency does not believe any responding
source should be allowed to reach an agreement that practically exempts
the source from the exercise program requirements. This could happen if
a source reached agreement with local responders to hold exercises
extremely infrequently. Therefore, the Agency is also establishing a
minimum required exercise frequency of ten years for field exercises,
and three years for tabletop exercises. The Agency believes even the
smallest sources will be able to hold field exercises at least once
each decade, and in many cases EPA expects sources will hold field
exercises more frequently. The Agency set the frequency for tabletop
exercises to be more frequent than field exercises because tabletop
exercises require less time and fewer resources to plan and conduct
than field exercises, and therefore EPA believes sources will be able
to perform tabletop exercises at least every three years.
Under the final rule, owners and operators are required to
coordinate with local responders to establish an exercise frequency
that works for both organizations. In establishing the exercise
frequency, owners or operators and local responders may account for
whatever factors they deem appropriate. Owners or operators and local
authorities may also adjust exercise frequencies as needed to account
for changes in hazards, organizations, budgets, resource demands,
regulations, or other factors, provided that field exercises occur at
least every ten years, and tabletop exercises occur at least every
three years. The agency notes that some RMP facilities may be subject
to a more frequent schedule for exercises under other (e.g., state or
local) regulations. In such cases, the owner or operator should comply
with the more stringent exercise frequency requirement. By doing so,
they will ensure that they also meet the required exercise frequency
for the RMP exercise requirements.
d. Local Responder Participation in Exercises and Exercise Planning
EPA proposed to require owners and operators to coordinate with
local public emergency response officials when planning emergency
response field and tabletop exercises, and invite them to participate
in exercises. While most public comments on this issue supported the
idea that local response officials should be involved in exercise
planning and execution, many comments submitted by industry
associations, facilities, government agencies, and others expressed
concerns that local responders could easily become overburdened by any
requirement to participate in planning or conducting exercises. These
commenters pointed out that in many communities, local response
organizations may be staffed with volunteers, or may have multiple RMP
facilities within their jurisdiction, such that local response
organizations could be significantly impacted by a requirement to
participate in exercises. These commenters agreed that local responders
should be invited to participate in exercises, but recommended that EPA
not require local authorities to participate in planning or conducting
exercises, and not hold facilities accountable if local response
organizations decline to participate. Comments submitted by industry
associations and facilities also recommended EPA address the
possibility that exercises may
[[Page 4663]]
sometimes need to be postponed if local response organizations are
unable to participate due to actual emergencies or lack of resources.
These commenters recommended that EPA allow extensions of the required
timeframe for conducting the next exercise, or allow the owner or
operator to meet the exercise requirement by conducting the exercise as
soon as possible without participation by local responders, if
necessary.
In addition to coordinating with local response authorities to
establish an exercise frequency, the final rule also requires the owner
or operator to coordinate with local public emergency response
officials when planning field and tabletop exercises, and to invite
local responders to participate in exercises. EPA agrees with the many
commenters who stated that any requirement for local responders to
participate in planning or conducting exercises could in some cases
overburden local response organizations or make it difficult for
regulated facilities to timely meet the exercise requirements. EPA is
aware of, and various public comments have noted, the fact that in the
past some sources have been unable to locate local response
organizations who are able or willing to perform such coordination
activities. Therefore, while the final rule requires the owner or
operator to coordinate with local public responders to establish field
and tabletop exercise frequencies and plan exercises, and invite local
emergency responders to participate in exercises, the final rule does
not require local responders to participate in any of these activities.
In most cases, the LEPC, fire department, or equivalent local
emergency response authority would be the appropriate party for the
owner or operator to conduct exercise planning and coordination. EPA
believes these local response authorities will usually be willing to
perform emergency response coordination activities, including exercise
coordination activities, with regulated sources. In many cases, EPA
expects that exercise planning can be included as part of the annual
coordination meetings required under Sec. 68.93. In other cases, the
owner or operator and local responders may choose to hold separate
exercise planning meetings. EPA also understands that in some cases
local responders may elect to limit their participation in exercise
coordination activities because of limitations on their available time
and resources. However, if the owner or operator is unable to identify
a local emergency response organization with which to coordinate field
and tabletop exercise schedules and plans and participate in exercises,
or the appropriate local response organizations are unable or unwilling
to participate in these activities, then the owner or operator may
unilaterally establish appropriate exercise frequencies and plans, and
if necessary hold exercises without the participation of local
responders. In these cases, the owner or operator must still ensure
that field exercises occur at least every ten years, and tabletop
exercises occur at least every three years. Additionally, the owner or
operator should continue to make ongoing efforts to locate appropriate
local public response officials for purposes of emergency response and
exercise coordination and participation.
As EPA believes the final rule provides the owner or operator with
ample flexibility to establish and modify exercise schedules, EPA sees
no reason to provide for additional extensions of time for conducting
exercises in the event that local responders cannot participate, or if
for some other reason the exercise must be rescheduled. EPA recommends
that owners and operators and local response organizations take such
contingencies into account when establishing exercise schedules, so
there is still time to complete the field or tabletop exercise within
the allotted timeframe (i.e., at least every ten years for field
exercises and at least every three years for tabletop exercises) in the
event the exercise must be postponed.
e. Exercise Scope
Some commenters recommended EPA clarify the required scope of
exercises. One commenter indicated that if EPA does require exercises,
the Agency should allow some variation in the scope of exercises based
on the needs and resources of the community.
In the preamble to the proposed rulemaking, EPA explained that
field exercises involve the actual performance of emergency response
functions during a simulated accidental release event. Field exercises
involve mobilization of firefighters and/or hazardous materials
response teams, activation of an incident command structure, deployment
of response equipment, evacuation or sheltering of facility personnel
as appropriate, and notification and mobilization of law enforcement,
emergency medical, and other response personnel as determined by the
scenario and the source's emergency response plan. Field exercises
include tests of:
Procedures for informing the public and the appropriate
Federal, state, and local emergency response agencies about an
accidental release;
Procedures and measures for emergency response after an
accidental release of a regulated substance including evacuations and
medical treatment;
Communications systems;
Mobilization of facility emergency response personnel,
including contractors as appropriate;
Coordination with local emergency responders;
Equipment deployment, and
Other actions identified in the source's emergency
response plan, as appropriate.
Tabletop exercises are discussion-based exercises without the
actual deployment of response equipment. During tabletop exercises,
responders typically assemble in a meeting location and simulate
procedural and communications steps for response to a simulated
accidental release, as determined by the scenario and the source's
emergency response plan. Tabletop exercises include tests of:
Procedures for informing the public and the appropriate
Federal, state, and local emergency response agencies about an
accidental release;
Procedures and measures for emergency response after an
accidental release of a regulated substance including evacuations and
medical treatment;
Identification of facility emergency response personnel
and/or contractors and their responsibilities;
Coordination with local emergency responders;
Procedures for deploying emergency response equipment, and
Other actions identified in the source's emergency
response plan, as appropriate.
EPA believes these elements allow ample flexibility for the owner
and operator, in consultation with local emergency response officials,
to choose appropriate exercise scenarios. Involving local response
officials in selecting exercise frequencies and in planning exercises
should ensure that RMP facility exercises are consonant with the needs
and resources of regulated facilities and local communities. By
involving local public responders in the exercise scenario itself,
responders may also be able to test or simulate important offsite
emergency response actions that are usually managed by local public
emergency response officials, such as community notification, public
evacuations, and sheltering in place, and EPA encourages sources and
local response officials to design exercise
[[Page 4664]]
scenarios where these functions are also tested. Responding stationary
sources that rely on response contractors to perform emergency response
functions during accidental releases should also ensure that response
contractors participate in field and tabletop exercises.
In preparing the exercise evaluation report required under Sec.
68.96(b)(3), the owner or operator should evaluate all aspects of the
exercise, including, to the extent possible, any offsite aspects of the
exercise such as community notification, evacuation, and sheltering in
place. In many cases, this will require the owner or operator to
involve local response officials in the exercise evaluation.
f. Post-Accident Exercises
In the NPRM, in addition to requiring periodic field and tabletop
exercises, EPA proposed to require the owner or operator to hold a
field exercise within one year of any accidental release required to be
reported under Sec. 68.42. Many commenters objected to this
requirement. These commenters stated that this provision could
potentially overtax facility and local responders, who would be
required to deploy once for the incident, and again for the exercise
following the incident.
EPA agrees with these comments, and therefore has decided not to
finalize the requirement to conduct a field exercise within one year of
an accidental release.
g. Alternatives for Meeting RMP Exercise Requirements
Several commenters indicated EPA should allow sources to meet the
periodic field exercise requirements through the actual deployment of
emergency response resources and personnel during accidental release
events. Other commenters indicated that many regulated facilities are
already subject to exercise requirements under other Federal, state, or
local regulations, or through an industry code of practice, and these
exercises should suffice to meet the exercise requirements of the
proposed rulemaking. Comments from state regulatory agencies indicated
that one agency already requires more frequent field exercises under
state law, and another state government agency is considering imposing
more frequent exercise requirements.
EPA generally agrees with these comments. The Agency does not want
to establish exercise requirements that conflict with other Federal,
state, or local laws. Therefore, in the final rule, EPA has added Sec.
68.96(c) to describe alternative means of meeting exercise
requirements. This section allows the owner or operator to meet
requirements for notification, field, and/or tabletop exercises either
through exercises conducted to meet other Federal, state, or local
exercise requirements (or under a facility's industry code of practice
or another voluntary program) or by responding to an actual accidental
release event, provided the exercise or response includes the actions
required for exercises under Sec. 68.96(a) and (b), as appropriate.
h. Joint Exercises
Several commenters, including industry associations and regulated
facilities, indicated that some companies have formed mutual aid
associations among several neighboring or nearby facilities so that
participating facilities can share response personnel and resources in
order to aid one another in responding to accidental release events at
any member's facility. These commenters recommended that in such
situations, or situations where there are clusters of regulated
facilities located close together, EPA should not require each facility
to conduct a field exercise, but rather allow these facilities to meet
their periodic field exercise obligation by conducting a single joint
exercise, where all participating facilities perform simulated response
actions to an exercise scenario staged at one member-facility's site.
These commenters indicated that this approach would reduce the exercise
demands on small and medium-sized facilities, as well as local
responders.
EPA agrees with these comments, and encourages owners and operators
of neighboring RMP facilities to consider planning and conducting joint
exercises. However, sources that participate in joint exercises must
ensure that their participation meets all of the provisions of Sec.
68.96(a) and/or (b), as appropriate. As commenters have noted, RMP
facilities participating in mutual aid agreements with other nearby
facilities already coordinate response actions and resources with those
facilities, and EPA believes conducting joint exercises among these
facilities will more accurately simulate their behavior in the event of
an actual release event, and further enhance the ability of these
facilities and surrounding communities to effectively respond to
accidental releases. Even where such mutual aid agreements are not
currently in place, EPA believes the owners and operators of
neighboring regulated facilities should consider whether joint facility
exercises may have benefits for participating facilities, local
responders, and surrounding communities. Such benefits could include
improved identification and sharing of response resources, enhanced
training for facility personnel and local responders, improvements in
facility procedures and practices resulting from information sharing,
and others. EPA also agrees that joint exercises may be particularly
beneficial for small businesses. While the Agency believes that even
small sources can design and conduct field and tabletop exercises that
are appropriate to the size, hazards, and capabilities of the source,
joint exercises involving multiple neighboring small sources would
allow these sources to pool resources together in order to carry out
more extensive exercise scenarios that could better simulate serious
accidental release events. In areas where multiple RMP facilities are
located close together, joint exercises could also reduce the overall
burden of exercises on local response organizations, who might
otherwise be asked to participate in multiple separate exercises.
i. Exercise Documentation
While most commenters who addressed the issue of exercise
documentation acknowledged the need for exercise evaluation reports to
be prepared, some commenters expressed concerns about specific aspects
of the proposed exercise documentation requirements. Some commenters
objected to the proposed rulemaking's requirement to prepare the
evaluation report within 90 days, stating that evaluation reports for
large exercises could take longer than 90 days to prepare, and that EPA
should allow extensions of the required timeframe where appropriate.
Still other commenters objected to the possibility that exercise
evaluation reports that indicate deficiencies outside the control of an
owner or operator could potentially be used by EPA in an enforcement
action against the owner or operator. Other commenters stated EPA
should not require exercise reports to include the names and
associations of exercise participants, because this information could
be difficult to obtain and would risk the privacy of exercise
participants without any benefit.
EPA is finalizing the exercise documentation requirements of Sec.
68.96(b)(3) as proposed. EPA is also requiring in Sec. 68.96(c)(2),
documentation of a response to an accidental release in order for the
response to be used to satisfy the RMP field exercise requirements. The
owner or operator must prepare an after-action report comparable to
(and in lieu of) the exercise evaluation report required in Sec.
68.96(b)(3), within 90 days of the incident, when the owner or operator
[[Page 4665]]
uses the response to an accidental release to meet their field or
tabletop exercise requirement. This provision is necessary because
documenting the response to an accidental release may differ from
documenting the results of an exercise. For example, instead of
documenting the ``exercise scenario,'' the owner or operator would
document the nature of the accidental release prompting the response.
Also, there may be additional aspects of the response to an accidental
release that should be documented, such as any injuries, first aid and/
or medical treatment that occurred. To the extent possible, the owner
or operator should ensure that additional items such as these are
documented in the after-action report, as well as information
equivalent or comparable to that documented in an exercise evaluation
report.
EPA disagrees with commenters who contend that 90 days is
insufficient time to develop an exercise evaluation report (or after-
action report), or that extensions of time should be granted for
development of evaluation reports in certain circumstances. Unlike
incident investigations, where report completion may require extensive
and time-consuming evidence collection and forensic analysis, the basic
elements required to be documented in an exercise evaluation report
should be known relatively quickly after the conclusion of the
exercise.
Regarding commenters concerns about the use of exercise evaluation
reports in enforcement actions--an exercise report is like any other
record required to be developed under 40 CFR part 68. Whether or not an
exercise evaluation report would be used in an EPA enforcement action
would depend on the specific facts and circumstances of the case.
EPA disagrees that exercise evaluation reports should not contain
the names and associations of exercise participants. Under the final
rule, the frequency of both field and tabletop exercises is mainly left
to the reasonable judgement of the owner or operator and local response
officials. In some cases, exercises may occur infrequently, and EPA
believes that maintaining a written record including, among other
things, the identification and affiliation of exercise participants
will be useful in planning future exercises.
VI. Information Availability Requirements
EPA proposed requirements for making information available to LEPCs
or emergency response officials, and the public in order to ensure that
communities have the necessary chemical hazard information to protect
the health and safety of first responders and residents. The following
sections provide an overview of the proposed and final rule provisions,
public comments received, and EPA's responses.
A. Disclosure Requirements to LEPCs or Emergency Response Officials
1. Summary of Proposed Rulemaking
EPA proposed that owners and operators of all RMP-regulated
facilities provide certain information to LEPCs or local emergency
response officials upon request. EPA stated that the facility should
make this information available in a manner that is understandable and
avoids technical jargon, convey it without revealing CBI or trade
secret information, and adequately explain any findings, results, or
analysis being provided.
EPA proposed that the owner or operator be required to develop the
following chemical hazard information for all regulated processes and
provide it, upon request, to the LEPC or local emergency response
officials:
Information on regulated substances. Information related
to the names and quantities of regulated substances held in a process;
Accident history information. The facility's five-year
accident history information required to be reported under Sec. 68.42;
Compliance audit reports. Summaries of compliance audit
reports developed in accordance with Sec. Sec. [thinsp]68.58, 68.59,
68.79, or 68.80, as applicable;
Incident investigation reports. Summaries of incident
investigation reports developed in accordance with Sec.
[thinsp]68.60(d) or Sec. [thinsp]68.81(d), as applicable;
Inherently Safer Technologies (IST). For each process in
NAICS codes 322, 324, and 325, a summary of the IST or ISD identified
that the owner or operator has implemented or plans to implement;
Exercises. Information on emergency response exercises
required under Sec. 68.96 including, at a minimum, schedules for
upcoming exercises, reports for completed exercises, and other related
information.
2. Discussion of Comments and Basis for Final Rule Provisions
Overall, commenters agreed that providing communities, local
planners, and local first responders with appropriate chemical hazard-
related information is critical to ensuring the health and safety of
the first responders and local communities. Commenters that supported
the proposed requirements provided general support and offered no
suggested changes other than to expand the IST requirement to apply to
all facilities; require facilities to submit IST analyses to the LEPC;
and make IST analyses available to the public.
However, most commenters, including professionals (e.g.,
consultants or technical/process safety experts), state agencies,
facilities, and industry trade associations, did not support the
requirement for facilities to submit specific chemical hazard-related
information to LEPCs and local emergency response agencies, as the
appropriate mechanism to ensure that local responders and planners have
the information they need to mitigate chemical risks. Commenters
provided several reasons for their objections including:
A lack of data supporting the Agency's concern that LEPCs
are not receiving the information they need to develop local emergency
response plans;
Unnecessary redundancy with existing requirements, such as
data reported under EPCRA;
Data proposed is too broad and does not provide useful
information pertinent to emergency response planning;
The data may overwhelm LEPCs with technical information
and the concern that most LEPCs lack the expertise needed to use this
information to develop local emergency response plans; and
Security concerns regarding how the information is
maintained and handled by the LEPC or emergency response officials.
Of those commenters that did not support the proposed requirements,
several stated that EPA provided no data supporting the Agency's
concern that some LEPCs were not receiving the information they needed
to develop local emergency response plans. These commenters pointed to
EPA's 2008 National Survey of Local Emergency Planning Committees
(LEPCs),\110\ which did not reveal any concerns about RMP facilities
withholding information from LEPCs. According to these commenters,
LEPCs indicated in the survey that they were able to obtain RMP data
from EPA, the state, or RMP facilities and noted their greatest
obstacle was lack of funding. In addition, commenters pointed out that
the Executive Order 13650 Working Group report, Actions to Improve
Chemical Facility Safety and
[[Page 4666]]
Security--A Shared Commitment, May 2014 \111\ contains no findings
about facilities ignoring LEPC requests for information or that lack of
information provided to the LEPCs was an issue, but rather the report
stated that LEPCs had concerns about managing all of the information
provided under various laws and regulations, understanding how each
chemical is regulated, and how to properly respond to an emergency
involving specific chemicals. In addition, these commenters stated that
while some CSB investigations 112 113 114 highlighted a lack
of emergency preparedness and recommended strengthening local
infrastructures supporting LEPCs, they did not find that facilities
refused to cooperate with the community or withheld chemical
information from LEPCs.
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\110\ 2008 Nationwide Survey of Local Emergency Planning
Committees (LEPCs). https://www.epa.gov/epcra/nationwide-survey-local-emergency-planning-committees.
\111\ Executive Order 13650 Actions to Improve Chemical Facility
Safety and Security--A Shared Commitment, May 2014. https://www.osha.gov/chemicalexecutiveorder/final_chemical_eo_status_report.pdf.
\112\ CSB. January 2016. Final Investigation Report, West
Fertilizer Company Fire and Explosion, West, TX, April 17, 2013.
Report 2013-02-I-TX, pgs. 201-203, 242. https://csb.gov/west-fertilizer-explosion-and-fire-/.
\113\ CSB. January 2011. Investigation Report: Pesticide
Chemical Runaway Reaction Pressure Vessel Explosion, Bayer
CropScience, LP, Institute, West Virginia, August 28, 2008. Report
No. 2008-08-I-WV, https://www.csb.gov/assets/1/19/Bayer_Report_final.pdf.
\114\ CSB. July 10, 2007. CSB News Release: CSB Chairman Merritt
Describes the Lessons from Five Years of Board Investigations to
Senate Committee, Urges Additional Resources and Clearer Authorities
for Federal Safety Efforts. https://www.csb.gov/csb-chairman-merritt-describes-the-lessons-from-five-years-of-board-investigations-to-senate-committee-urges-additional-resources-and-clearer-authorities-for-federal-safety-efforts/.
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Multiple commenters, including professionals, state and local
government agencies, facilities, and industry trade associations, also
stated that the information elements that EPA proposed to require
facilities to share with LEPCs are already available to them through
the EPCRA or reported in RMPs, which are also already available to the
LEPCs. Several commenters noted that communication between LEPCs and
facilities is satisfactory via the EPCRA process and stated that LEPCs
were able to obtain RMP data from EPA. One commenter requested the EPA
refocus its efforts into collecting required data from ``outlier
facilities who are not providing required chemical hazard information''
rather than impose a duplicative requirement for the creation and
distribution of data.
Many commenters also asserted that the scope of information
required by the proposed provision was too broad. These commenters
argued that incident investigation summaries, compliance audit
summaries, and IST or ISD implementation summaries would not provide
useful information for emergency planning and that the proposed
information requirements were unnecessarily detailed. Several of these
commenters also suggested that the type and format of the information
should be determined by individual LEPCs. Furthermore, commenters
expressed concern that the information in these summaries would be too
technical and LEPC staff may not have the expertise to understand the
information being submitted or extrapolate information that may be
useful.
Multiple commenters raised concerns regarding the security of
sensitive chemical and facility information that would be shared with
LEPCs under the proposed requirements. These commenters indicated that
LEPCs would be unable to keep the information secure because they lack
procedures and resources to properly vet those who would have access to
the information, and that the information would be considered ``public
information'' once it is provided to the LEPC. These commenters
indicated that there are multiple ways for the public to access
sensitive information from LEPCs through information requests from the
public. Commenters also suggested that these requirements to disclose
information to LEPCs interfere with the Department of Homeland
Security's (DHS) Chemical Facility Anti-Terrorism Standards (CFATS).
Commenters further suggested that since much of this information might
reveal security vulnerabilities at facilities, providing this
information to LEPCs increases the risk of terrorism or criminal use of
the information which could cause harm to first responders and the
community.
EPA also received comments regarding how the information should be
provided to LEPCs and the timeframe for providing that information.
Many commenters suggested the information should be provided through
existing systems in a format which is useful to LEPCs or local
emergency responders for developing their local emergency plans.
Several states and a state association suggested LEPCs and emergency
response officials should determine what information is useful and
necessary to developing preparedness and response plans. An industry
trade association suggested that information should not be in an
electronic format but should be communicated to LEPCs, local emergency
officers, neighbor groups, and Community Advisory Panels at regular
intervals. Two state agencies commented that RMP information should be
incorporated into existing management systems and that providing
information in a stand-alone single document was of little value to
emergency planners. A few commenters suggested that the format of the
information should be determined by the individual LEPC. Finally,
several commenters proposed that the information be relayed during the
annual coordination meeting between LEPCs and facility personnel.
In response to these comments, EPA maintains that it is very
important to ensure that LEPCs or local emergency response officials
have the chemical information necessary for developing local emergency
response plans, however, EPA believes it is unnecessary to specify in
the RMP rule the types or format of information that LEPCs or emergency
response officials may request. EPCRA section 303(d)(3) already
provides the necessary authority to allow LEPCs to request information
needed to develop the local emergency response plan. Additionally,
EPCRA requires facilities to provide Safety Data Sheets (SDSs) and
inventory information to LEPCs to assist emergency planners and
responders. Under EPCRA section 312(f), fire departments have the
authority to inspect these facilities to better understand the risk
associated with these chemicals and how to deal with those risks in the
local emergency response plan.
As pointed out by the commenters, the proposed requirements could
be perceived as limiting the flexibility of LEPCs and emergency
response officials to collect the information they need to develop a
local emergency response plan that addresses their community's specific
chemical risks. Furthermore, the proposed requirements would have
owners or operators preparing information summaries on an annual basis,
regardless of whether the LEPC requests the information, and EPA agrees
that this is overly burdensome for facility owners and operators. This
could also result in reports being sent to the LEPCs or emergency
response officials without the necessary context to help officials to
understand the information contained within the reports and utilize it
for planning purposes.
Without acknowledging any inconsistency with CFATS or other
regulatory structure, EPA recognizes both the security concerns that
commenters expressed and the challenges associated with securing
arguably sensitive information.
[[Page 4667]]
Therefore, EPA has decided not to finalize Sec. 68.205 of the proposed
rulemaking, and is instead adding language to the emergency response
coordination provisions of Sec. 68.93, which requires the owner or
operator to provide ``any other information that local emergency
planning and response organizations identify as relevant to local
emergency planning.'' (For more information see section V.A. of this
preamble.) Under this structure, assertions of Chemical-terrorism
Vulnerability Information (CVI) status for certain information can be
addressed on a case-by-case basis by the stationary source, the LEPC,
DHS, and other appropriate entities.
EPA agrees with commenters that this approach will allow LEPCs and
other local emergency officials to obtain the information they require
to meet their emergency response planning needs. It will also allow
local emergency planners and response officials to ask questions of
facility personnel about the risks associated with the chemical hazards
at the facility and about appropriate mitigation and response
techniques to use in the event of a chemical release. It further allows
the facility owner or operator and the LEPC to identify information
that may need to be maintained securely and discuss strategies to
secure the information or to provide only information that is pertinent
to emergency response planning without revealing security
vulnerabilities.
The LEPC or local emergency response officials may request
information such as accident histories, portions of compliance audit
reports relevant to emergency response planning, incident investigation
reports, records of notification exercises, field and tabletop exercise
evaluation reports, or other information relevant to community
emergency planning. For example, this may include requesting
information on changes made to the facility that affect risk such as
incorporating safer alternatives. Furthermore, EPA directs commenters
who indicated that the IST analyses should apply to all facilities and
be submitted to the public to refer to sections IV. C. and VI. B. in
this preamble.
B. Information Availability to the Public
1. Summary of Proposed Rulemaking
Under Sec. 68.210(a), EPA proposed to add a reference to 40 CFR
part 1400, which addresses the restrictions on disclosing ``offsite
consequence analysis'' (OCA) information under the CSISSFRRA.
Under Sec. 68.210(b), EPA proposed to require the owner or
operator of a stationary source to distribute certain chemical hazard
information for all regulated processes to the public in an easily
accessible manner, such as on a company Web site. EPA proposed to
require the owner or operator to distribute, as applicable:
Names of regulated substances held in a process;
SDSs for all regulated substances at the facility;
The facility's five-year accident history required under
Sec. 68.42;
Emergency responses program information concerning the
source's compliance with Sec. 68.10(f)(3) or the emergency response
provisions of subpart E, including:
[cir] Whether the source is a responding stationary source or a
non-responding stationary source;
[cir] Name and phone number of local emergency response
organizations with which the source last coordinated emergency response
efforts, pursuant to Sec. 68.180; and
[cir] For sources subject to Sec. 68.95, procedures for informing
the public and local emergency response agencies about accidental
releases.
Information on emergency response exercises required under
Sec. 68.96, including schedules for upcoming exercises, reports for
completed exercises as described in Sec. 68.96(b)(3), and any other
related information; and
LEPC contact information, including LEPC name, phone
number, and Web site address as available.
EPA proposed to add Sec. 68.210(c), to require that the owner or
operator update and submit information required under Sec. 68.210(b)
every calendar year, including all applicable information that was
revised since the last update.
EPA also proposed to redesignate the current Sec. 68.210(b), which
addresses the non-disclosure of classified information by the
Department of Defense or other Federal agencies or their contractors,
as Sec. 68.210(e). In new Sec. 68.210(f), EPA proposed to require
that an owner or operator asserting CBI provide a sanitized version of
the information required under this section to the public. Assertion of
claims of CBI and substantiation of CBI claims was proposed to be in
the same manner as currently required in Sec. Sec. 68.151 and 68.152
for information contained in the RMP required under subpart G.
2. Summary of Final Rule
EPA is finalizing Sec. 68.210(b) with changes to address public
comments. Under the final rule, Sec. 68.210(b) requires the owner or
operator to make certain chemical hazard information for all regulated
processes at a stationary source available to the public upon request.
The information that shall be provided is the same as proposed, except
EPA is revising the exercise information element. Under Sec.
68.210(b)(5) of the final rule, upon receiving a request for the
information from a member of the public, the owner or operator is
required to provide a list of scheduled exercises required under Sec.
68.96, rather than summary information for those exercises, as
proposed.
Section 68.210(c) is now titled ``Notification of availability of
information,'' and it changes the manner by which the facility informs
the public about what chemical hazard information is available upon
request and how the public may obtain such information. The owner or
operator shall provide the public with an ongoing notification of the
following: (1) The required information elements in Sec. 68.210(b)(1)
through (6) that is available to the public upon request, (2)
instructions for requesting the information elements and (3) where to
access any other available information on community emergency
preparedness.
Section 68.210(d) requires that the owner or operator provide the
requested information listed under Sec. 68.210(b) to the public within
45 days of receiving a request.
Finally, EPA is finalizing several sections as proposed, including:
Sec. 68.210(a), RMP availability;
Sec. 68.210(f), which addresses the non-disclosure of
classified information by the Department of Defense or other Federal
agencies or their contractors (this was formerly proposed as Sec.
68.210(e)); and
Sec. 68.210(g), which relates to CBI, redesignated from
Sec. 68.210(f).
3. Discussion of Comments and Basis for Final Rule Provisions
a. Legal Issues
An industry trade association and a facility stated that
legislation subsequent to the CAA narrowed EPA's authority to mandate
public disclosure of RMP information. Relevant legislation described by
the commenters includes (1) the 1999 CSISSFRRA, (2) the Critical
Infrastructure Information Act (CIIA), (3) the Chemical Facilities
Anti-Terrorism Standards Act of 2007, and (4) the Protecting and
Securing Chemical Facilities from Terrorist Attacks Act of 2014.
Another industry trade association commented that requiring private
companies to publish qualitative or
[[Page 4668]]
quantitative environmental information inappropriately seeks to
delegate EPA's own duties to communicate with and deal with public
requests to the regulated entity.
A few industry trade associations argued that the proposed
information disclosure requirements are compelled speech that may
violate the first amendment. An industry trade association commented
that EPA's proposal to require disclosure of RMP information and
chemical hazard information raises constitutional issues, as it amounts
to compelled commercial speech. The commenter described compelled
commercial speech as subject to an intermediate-level of scrutiny, and
asserted that, unless EPA can affirmatively prove that (1) its asserted
interest is substantial, (2) the speech regulation directly and
materially advances that interest, and (3) the regulation is narrowly
tailored to that interest, then the compelled commercial speech will
likely be found to be unconstitutional.
The information disclosures required by the final rule are fully
consistent with the statutes and regulatory programs identified by the
commenters as enacted after the 1990 CAA Amendments. CSISSFRRA
specified that portions of RMPs containing OCA information, any
electronic data base created from those portions, and any statewide or
national ranking derived from such information is subject to
restrictions on disclosure (CAA sections 112(r)(7)(H)(i)(III) and
112(r)(7)(H)(v)). Regulations promulgated jointly by EPA and the
Department of Justice further define OCA information in 40 CFR
1400.2(j). The final rule does not require disclosure of release
scenarios or rankings based on such scenarios, nor does it make
available any information based on such scenarios. The CIIA restricts
information ``not customarily in the public domain.'' CFATS creates a
category of information, CVI, which further restricts certain
information generated to implement CFATS (see 6 CFR 27.400). In
promulgating CFATS, DHS announced its intent to preserve Federal
release disclosure, emergency planning, and accident prevention
statutes, including EPCRA and CAA section 112(r) (72 FR 17714, April 9,
2007). In this final rule, EPA has not promulgated the new mandatory
disclosure of STAA and incident investigation information that we had
proposed, thereby eliminating the tension between these after-enacted
programs and modernization of the risk management program. The
information required to be disclosed by this rule largely draws on
information otherwise in the public domain and simplifies the public's
access to it.
This final rule requires an owner or operator of a stationary
source to alert the public, via any one of a wide variety of methods,
of how to access information about the source that is publicly
available. Other statutes and regulatory programs, or other provisions
of the risk management program, require the stationary source to
assemble the information that the rule would make available upon
request (e.g., accident history, SDSs, and aspects of the emergency
response program). The burden of making this information directly
available from the source is minimal. The public's ability to
participate in emergency planning and readiness is materially advanced
by being better informed about accident history, types of chemicals
present, and how to interact with the stationary source. EPA has been
selective in identifying what information a source must make available;
for example, we have not required the facility to provide an RMP to the
public. Having the source provide the information set out in Sec.
68.210 directly to the public promotes accident prevention by
facilitating public participation at the local level.
b. RMP Availability (Sec. 68.210(a))
EPA did not receive any comments on this issue.
c. Chemical Hazard Information (Sec. 68.210(b))
Comments on making information available to the public. EPA
received multiple comments that supported the proposed provisions.
These comments generally indicated that the revisions would strengthen
the community's ``right to know.'' A mass mail campaign joined by
approximately 450 commenters provided general support for the
disclosure of information to the public. EPA also received comments
stating that the RMP and accompanying chemical hazard information would
be valuable to communities in order to understand the risks involved.
Many commenters opposed the proposed information provisions.
Multiple commenters, including state agencies, facilities, and industry
trade associations, argued that the proposed provisions for public
disclosure of information have the potential to create a security risk,
with several commenters expressing opposition to the proposed
provisions because they appear to conflict with CFATS or other existing
information security requirements. Two diverse groups of commenters
remarked that OCA data should remain accessible to the public only
through Federal reading rooms, but an advocacy group remarked that
keeping information solely in reading rooms would limit access by the
public. Some commenters stated that the information requirement was
already available through EPCRA or Freedom of Information Act (FOIA)
requests, while others stated that EPA had not given enough reasoning
for how the increase in information disclosure to the public would
result in a safer community in proportion to the burdens imposed on
facilities.
EPA continues to believe that providing chemical hazard information
to the general public will allow people that live or work near a
regulated facility to improve their awareness of risks to the community
and to be prepared to protect themselves in the event of an accidental
release. EPA believes that this information should be more easily
accessible to the public than the existing approaches to access
information under EPCRA or through FOIA requests. However, EPA
acknowledges the security concerns raised by commenters and is
committed to ensuring a balance between making information available to
the public and safeguarding that information. Therefore, EPA is
finalizing an approach that requires facility owners and operators to
notify the public that certain information is available upon request.
This allows community members \115\ an opportunity to request chemical
hazard information from a facility, so they can take measures to
protect themselves in the event of an accidental release, while
allowing facility owners and operators to identify who is requesting
the information. EPA worked closely with Federal partners, including
DHS, to develop information availability requirements that strike a
balance between security concerns and the need for sharing chemical
hazard information with the public. EPA believes that this approach is
consistent with existing requirements to secure sensitive information
under CSISSFRRA and CFATS. Furthermore, EPA is committed to
safeguarding OCA information in accordance with requirements specified
in CSISSFRRA, which allows for any member of the public to access paper
copies of OCA information for a limited number of facilities. This OCA
information remains accessible to the public only in Federal Reading
Rooms.
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\115\ Community members can include a wide variety of
stakeholders that work or live near an RMP-regulated facility.
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EPA believes that the current approach to notify the public that
information is available upon request
[[Page 4669]]
strikes an appropriate balance between various concerns, including
information availability, community right-to-know, minimizing facility
burden, and minimizing information security risks.
Scope of information to be shared. Commenters provided suggestions
on the scope of information to be disclosed. An advocacy group
commented that information on chemical hazards, safer alternatives
(such as information on ISTs), incidents, inspections, and training
should all be made publically available. Some commenters remarked that
the public should be given information on the schedules and types of
emergency response drills performed; how to adequately protect oneself
during a release; where to evacuate; how the decision to evacuate will
be made and communicated; and how the all-clear signal will be given.
However, several commenters objected to making exercise reports
available to the public. These commenters stated that providing the
public with information about potential weaknesses in a facility or
community field response could reveal security vulnerabilities. A few
other commenters stated that only information that could improve
community awareness of risks should be made available to the public,
such as names of regulated substances held in a process above threshold
quantities, names and phone numbers of local emergency response
organizations, and LEPC contact information.
Some commenters recommended making available to the public the same
information elements proposed for disclosure to LEPCs (i.e. STAA/IST,
incident investigation reports and third-party compliance audits),
while several other commenters opposed these suggestions. For example,
a mass mail campaign suggested that facilities disclose STAA directly
to the public. However, one trade association opposed publicly
disclosing STAA, citing that the information would be highly technical
and potentially confusing to the general public and may involve the
disclosure of confidential, proprietary or other sensitive information.
The association further argued that facilities would be put in a
position where they must publicly defend IST evaluations and decisions.
Some commenters stated that incident investigation reports should
be included in the scope of information delivered to the general
public, while others said that providing such reports would be
burdensome and confusing to the public. Other commenters argued
specifically against making root cause analyses available to the public
indicating that this greatly increases the likelihood that facilities
will have to respond to lawsuits. One commenter expressed concern that
disclosing root cause analyses would discourage facilities from
performing meaningful analyses.
A state agency commented that third-party compliance audit reports
should be made publicly available to assure the public that appropriate
investigation has been done and appropriate steps are being taken to
avoid future incidents. A group of commenters argued that emergency
contact information should not be shared publicly online because it
will encourage unwanted telemarketing and email spam and solicitations.
EPA agrees with commenters that who suggested that only information
that could improve community awareness of risks should be made
available to the public. EPA disagrees with commenters that suggest
making additional information available to the public, such as STAA
reports, incident investigation reports (with root cause analyses), and
third-party audit reports. As some commenters indicated, much of the
information in these reports can be technically complicated and
potentially confusing for the general public. Furthermore, this
information is not always relevant to community emergency preparedness
and could potentially reveal CBI or security vulnerabilities.
Therefore, the Agency is finalizing the following chemical hazard
information elements to be made available to the public, upon request:
Names of regulated substances held in a process;
SDS for all regulated substances located at the facility;
Five-year accident history information required to be
reported under Sec. 68.42;
The following summary information concerning the source's
compliance with Sec. 68.10(f)(3) or the emergency response provisions
of subpart E:
[cir] Whether the source is a responding stationary source or a
non-responding stationary source;
[cir] Name and phone number of local emergency response
organizations with which the owner or operator last coordinated
emergency response efforts, pursuant to Sec. 68.180; and
[cir] For responding stationary sources (i.e., those subject to
Sec. 68.95), procedures for informing the public and local emergency
response agencies about accidental releases;
A list of scheduled exercises required under Sec. 68.96;
and
LEPC contact information, including the LEPC name, phone
number, and Web address as available.
EPA expects that making the information available upon request will
minimize security vulnerabilities as well as unwanted telemarketing and
email spam and solicitations.
EPA agrees with commenters that members of the public do not
necessarily need access to exercise evaluation reports. Therefore, to
address concerns that summary information of facility exercise may be
confusing to the public and could reveal security vulnerabilities, EPA
is revising Sec. 68.210(b)(5) to remove the requirement to provide
summary information about exercises and only require a list of
scheduled exercises required under Sec. 68.96. EPA believes that one
benefit of sharing exercise schedules is to avoid unnecessary public
alarm when exercises are conducted. However, EPA expects that facility
owners and operators will use good security practices when revealing
details about upcoming exercises.
d. Notification of Availability of Information (Sec. 68.210(c))
EPA proposed requiring the owner or operator to make chemical
hazard information publicly available and update the information every
calendar year. Many commenters supported the use of a streamlined, one-
stop Web format for disseminating information to the public. Several
commenters opposed posting information for the public on facility Web
sites due to security concerns. Some commenters argued that EPA should
utilize existing online public information resources (such as the
Agency's Web site or available RMP*Info or Enforcement and Compliance
History Online (ECHO) \116\ databases) to share information, while a
few commenters concluded that appropriate state level agencies should
be responsible for making information available to the public.
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\116\ https://echo.epa.gov/?redirect=echo.
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Many other commenters remarked on the variety of options to
disseminate information suggested by EPA, including local libraries,
government buildings, or the Internet, and stated that this fragmented
approach would not improve public access to information. One commenter
cited that EPA should ensure availability of information to those
without Internet or electronic media access, and another commenter
suggested that hard copies should be made available for those without
access to online resources, in addition to information published on an
EPA Web site. Another commenter remarked that information should be
made available only after an email
[[Page 4670]]
request is made directly to the facility. An advocacy group commented
that information on accidental releases should be reported,
immediately, to the public through the Internet, radio, telephone, and
television.
Commenters also provided suggestions on the format of the
information. Some of these commenters suggested that a one to two-page
summary of information would be sufficient for the public.
EPA is committed to ensuring that chemical hazard information is
available to the public in an easily accessible manner; however, the
Agency acknowledges commenters' security concerns associated with
providing information to the public and the additional burden that may
fall on owners or operators that do not have Web sites or other means
to publicly and routinely post such information. In response to these
concerns, EPA is requiring that owners and operators notify the public
that certain information is available along with instructions on how to
request the information. The facility owner or operator must ensure
that the notification is ongoing through a publicly accessible means,
such as a Web site or social media platform.
The facility owner or operator can notify the public that
information is available in a variety of ways. For example, the owner
or operator could make the notification of information availability by
using free or low cost Internet platforms, file sharing services, and
social media tools that are designed to be able to share information
with the public. As another option, the facility could post hard copy
notices at publicly accessible locations, such as at a public library,
or a local government office. If the facility has the means to handle
public visitors, it could choose to have notices available at the
facility's public visitor location. The facility could also provide
notices that information is available to the public by email. EPA
encourages the facility owner or operator coordinate information
distribution with the LEPC or local emergency response officials to
determine the best way to reach public stakeholders in their
communities. Facility owners and operators may also want to consider
outreach efforts that would allow the public to provide input on the
best way to make this notification available. The owner or operator
shall document whatever method and the location of the notification in
the RMP pursuant to Sec. 68.160(b)(21).
EPA believes that providing this notification to the general public
would allow people that live or work near a regulated facility to
gather the information they need to improve their awareness of risks to
the community and to prepare to protect themselves in the event of an
accidental release. The notice shall specify what information is
available and provide instructions for how to obtain the information.
The facility owner or operator shall also identify where to access
information on community preparedness, if available, including shelter-
in-place and evacuation procedures. The facility should work with the
LEPC and local emergency responders to distribute and convey relevant
information on appropriate shelter-in-place and evacuation procedures.
e. Timeframe To Provide Information Following a Request (Sec.
68.210(d))
One commenter expressed concern that requiring public information
to be updated annually would be an unnecessary burden on facilities. In
contrast, another state agency reasoned that the public should not have
to request information, it should be readily available. An advocacy
group requested that a version of the chemical hazard information
provided by the facility be made on an annual basis.
While EPA agrees that requiring facilities to annually update their
information could be unnecessarily time-consuming, EPA encourages
facilities to update their chemical hazard information as needed to
ensure that accurate information can be made available to the requester
within the required timeframe. Therefore, Sec. 68.210(d) requires that
the facility owner or operator provide the information under Sec.
68.210(b) to the requester within 45 days of receiving a request. EPA
selected 45 days because that timeframe is consistent with the
requirement for public provision of facility chemical inventory
information (i.e., ``Tier II information'') under Sec. 312(e)(3)(D) of
EPCRA, which states, ``a State emergency response commission or local
emergency planning committee shall respond to a request for Tier II
information under this paragraph no later than 45 days after the date
of receipt of the request.''
f. Classified Information (Sec. 68.210(f))
EPA received no comments on this issue.
g. CBI (Sec. 68.210(g))
Several commenters stated that the public information disclosure
requirement would place CBI at risk, and therefore EPA should eliminate
this requirement. Other commenters requested that EPA clarify that CBI
would still be protected from public dissemination. Many commenters
requested that EPA require that certain information in STAA reports
either may not be claimed as CBI or should require up-front
substantiation of confidentiality claims. Some commenters suggested
that CBI claims for STAA information include a certification by the
owner or operator or a senior official. Other commenters recommended
that EPA prohibit STAA reports from being claimed as CBI. Two
commenters stated that it may not be practical or possible to provide
the public with a useful STAA document after removing appropriate CBI.
EPA is finalizing Sec. 68.210(f) relating to CBI as proposed, but
renumbered the paragraph as Sec. 68.210(g). EPA acknowledges and
shares industry's concerns pertaining to protection of CBI information.
By incorporating a CBI provision in the information availability
section of the rule EPA is emphasizing the facility owner or operator's
right to protect CBI. EPA has also limited the types of information to
be disclosed to eliminate matters likely to contain CBI (e.g., names of
regulated substances; SDSs) as well as to include information elements
for which CBI cannot be claimed (e.g. five-year accident history
information and emergency response program information). Section 68.151
clearly identifies what information cannot be claimed as CBI and Sec.
68.152 identifies the procedure for how to protect CBI. EPA believes
that the RMP rule adequately addresses CBI concerns. Furthermore, EPA
is not requiring STAA reports to be submitted to LEPCs or the public in
the final rule and therefore, no CBI concerns exist for these reports.
An owner or operator of a stationary source asserting that a
chemical name is CBI shall provide a generic category or class name as
a substitute. If an owner or operator has already claimed CBI for a
portion of the RMP, then that claim still applies for the disclosure
elements the information availability provisions of the rule. The owner
or operator should provide a sanitized version as described in the
RMP*eSubmit User's Manual. This policy is consistent with existing
guidance and practices.\117\
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\117\ For more information on CBI, see Chapter 9 of the General
Guidance on Risk Management Programs for Chemical Accident
Prevention (40 CFR part 68), March 2009. https://www.epa.gov/sites/production/files/2013-11/documents/chap-09-final.pdf.
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[[Page 4671]]
C. Public Meetings
1. Summary of Proposed Rulemaking
EPA proposed to require all facilities to hold public meetings
within 30 days after any RMP reportable accident to share information
concerning the accident with the public including: When the accident
occurred; the nature of the accident; chemicals involved and quantities
released; on-site and offsite impacts; notifications made to emergency
responders; weather conditions (if known); initiating event and
contributing factors (if known); and operational changes (if any) that
have resulted from the investigation of the release. EPA also proposed
that at this public meeting, facilities would provide other relevant
chemical hazard information such as the names and SDSs for regulated
substances at the facility; accident history information for the
facility; information on the emergency response and exercise programs;
and LEPC contact information.
2. Summary of Final Rule
In the final rule, EPA is requiring all facilities to hold a public
meeting after an RMP-reportable accident, but is extending the
timeframe for the public meeting to 90 days in response to comments.
The public meeting provision proposed as Sec. 68.210(d) is
redesignated as Sec. 68.210(e) in the final rule. The owner or
operator shall document in the RMP whether a public meeting has been
held following an RMP reportable accident, pursuant to Sec.
68.160(b)(22).
3. Discussion of Comments and Basis for Final Rule Provisions
EPA received a wide range of comments on the proposed public
meeting requirements--comments generally in support of or against the
requirement for public meetings; concerns about sufficient attendance
or availability of information at public meetings; comments on the
appropriate timeframe for the meetings; and comments on alternative
options.
a. Attendance at Public Meetings
Many commenters opposed requirements for public meetings. Some
commenters opposed based on their experience that public meetings held
under CSISSFRRA were not well attended. One commenter said the public
would not attend a meeting after a minor incident, but a public meeting
for an event with major offsite impacts should include a report
summarizing the incident. Some commenters questioned the benefit of
such a meeting if a facility is in compliance with regulatory
requirements.
Other commenters offered ideas for improving or gauging public
interest. For example, one commenter suggested that EPA establish
minimum requirements for sources to notify the public of upcoming
meetings but did not offer suggestions for what those requirements
should be. Another commenter suggested that polls could be used to
prescreen members of the public who would like to attend or participate
in the public meeting, in order to establish effective participation.
EPA recognizes concerns about attendance at public meetings. When
the CSISSFRRA was enacted in 1999, it required owners or operators of
all facilities regulated under the RMP rule to hold a public meeting
within 180 days of enactment.\118\ The purpose of the public meeting
was to discuss the OCA information that was restricted under other
portions of CSISSFRRA. Relatively few of these meetings were hosted by
facilities that had recently suffered an RMP-reportable accident. The
Agency expects that after a reportable accident occurs, attendance at
public meetings will be higher than was the case at many public
meetings held under CSISSFRRA because of interest generated by the
accident itself (e.g., an emergency response or media reports). This
public meeting requirement applies only following an RMP reportable
accident, so this provision has a much lower burden than the CSISSFRRA
public meeting requirement because of the relatively few number of RMP
reportable accidents that occur annually. CSB highlighted in their
comments that public meetings held shortly after accidents occur have
the greatest level of participation.
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\118\ Chemical Safety Information, Site Security and Fuels
Regulatory Relief Act, Public Law 106-40, August 5, 1999. See https://www.gpo.gov/fdsys/pkg/STATUTE-113/pdf/STATUTE-113-Pg207.pdf.
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EPA supports commenters' suggestions to find practical strategies
to increase attendance and encourages public participation at public
meetings; however, we are not incorporating these suggestions as
mandatory requirements in the final rule. Facilities have the
flexibility to encourage attendance at meetings by means that are
appropriate and effective in their communities. This could include
methods suggested by commenters, such as polling nearby residents to
gauge interest.
b. Applicability Criteria and Timeframe
Comments on applicability criteria. One commenter requested
clarification on the meaning of ``reportable accident'' that would
trigger a public meeting. Another commenter remarked that multiple
meetings may be necessary in certain circumstances, for instance if the
investigation report has not been finalized. Commenters also suggested
that public meetings should be required of all program level facilities
while others indicated that a ``one-size-fits-all'' approach was not
appropriate. Several commenters requested that public meetings be
required only when an incident generated offsite impacts. Finally,
another commenter suggested EPA require periodic public meetings
regardless of accident history.
The term ``reportable accident'' refers to accidents required to be
reported in the five-year accident history required under Sec. 68.42
of the existing rule, which include accidental releases from covered
processes that resulted in deaths, injuries, or significant property
damage on site, or known offsite deaths, injuries, evacuations,
sheltering in place, property damage, or environmental damage. EPA
agrees that in some cases, multiple public meetings may help to fully
describe the circumstances of an accident. While EPA is requiring the
owner or operator to hold only one public meeting after an RMP-
reportable accident, the Agency encourages owners and operators to hold
additional meetings if appropriate. The final rule requires public
meetings for regulated sources, regardless of program level, if the
facility has an RMP-reportable accident. The Agency does not view the
public meeting requirement as a ``one-size fits all'' requirement.
Sources have flexibility to structure public meetings as appropriate to
their circumstances and the needs of the surrounding community. EPA
recommends that facility owners and operators engage in community
outreach to determine how best to structure the public meetings.
Involving the public in advance of the meeting will help to ensure
public participation in meetings. EPA considered requiring public
meetings only after accidents with offsite impacts but decided to apply
the requirement to all RMP-reportable accidents because even though
some RMP-reportable accidents have only on-site impacts, those
accidents are often serious enough to raise safety concerns within the
surrounding community.
Finally, EPA is not requiring periodic public meetings, regardless
of accident history, in the final rule. EPA believes that public
interest in a meeting is highest after an accident, and notes that many
commenters indicated that public
[[Page 4672]]
meetings required by CSISSFRA were not well attended.
Comments on timeframe. Several commenters expressed support for the
proposed 30-day timeframe. Other commenters said that a 30-day
timeframe would be too long, as the greatest need for a public meeting
occurs within 2 weeks after an accident. However, many commenters
stated the 30-day timeframe for a public meeting is too short, as a
facility is unlikely to complete an incident investigation in that
timeframe. Commenters warned that incomplete information would not be
appropriate to share with the public and could breed distrust between
the public and facilities over the lack of complete data. Some
commenters cited the burden placed on facilities to schedule and
prepare for a meeting, especially during an incident investigation and
other post-incident actions. Commenters recommended alternative
timeframes for public meetings after an accident including: 60 days, 90
days, 120 days, six months, nine months, and 12 months or after the
investigation is completed. One commenter suggested that EPA provide an
opportunity to extend the public meeting timeframe with reasonable
justification. Another commenter suggested that EPA allow the LEPC to
consult on or determine when to hold the public meeting after an RMP
reportable accident.
EPA acknowledges concerns raised by commenters about diverting
facility resources from post-accident investigations, and the potential
for a facility to lack complete information about an accident if the
investigation hasn't yielded sufficient information to share with the
public within 30 days. Therefore, EPA has revised the timeframe in the
final rule for the public meeting to be held no later than 90 days
after an RMP reportable accident. EPA expects that sources will either
have completed the incident investigation required under Sec. 68.60 or
Sec. 68.81 prior to holding the public meeting, or will have developed
sufficient information relevant to community members' concerns to allow
a productive meeting. Even if the accident investigation is not
complete, a 90-day timeframe should allow the owner or operator to
share appropriate information about the accident with the local
community. The facility could discuss the progress of the investigation
so far and next steps planned.
Some comments expressed the view that attendance at a public
meeting is higher when the meeting takes place very soon after an
accident occurs. The 90-day timeframe in the final rule is a maximum
timeframe, and EPA encourages facilities to take into consideration
when public interest may be highest when scheduling the public meeting.
EPA recognizes that in some cases, such as for complex, protracted
investigations, the facility may need to hold the public meeting prior
to completing the incident investigation. In such cases, the owner or
operator should consider holding a second public meeting after
completing the incident investigation, or sharing information about
results of the investigation through another means, such as a Web site,
social media, with the LEPC or local emergency response officials, or
distributing information directly to people who attended the public
meeting and expressed interest in the additional information.
EPA does not believe that it is necessary to add a provision that
would allow an extension of the 90-day timeframe with reasonable
justification. Such a provision would add complexity to the
requirement. Furthermore, EPA believes that by extending the timeframe
to 90 days this allows sufficient time for the facility to gather
information to share with the public after an accident.
EPA is not finalizing any requirements for LEPCs or local emergency
response officials with respect to post-accident public meetings. EPA
received many comments that opposed increasing LEPC responsibilities in
the final rule, citing resource limitations and significant existing
responsibilities. While a facility should communicate closely with
LEPCs or local emergency response officials after an RMP reportable
accident, and may combine public meetings with LEPC meetings or other
events as long as those events/meetings are available for public
participation, the facility bears the responsibility for the public
meeting. The final rule places no additional burden on LEPCs or local
emergency response officials with respect to requirements for post-
accident public meeting.
c. Scope of Information Provided at Public Meetings
Public commenters provided various recommendations regarding how
much and what type of information should be provided at public
meetings. One commenter asserted public meetings are useless since the
local media relay information about incidents, such as when and where
the incident occurred and emergency response information. Another
commenter said public meetings after an accident would be redundant, as
the information required to be shared would already be made available
to the public for all reportable accident investigations. A few
commenters said that completed STAAs should be covered in public
meetings. One commenter stated that information about the nature of
chemical risks within a community and emergency response protocols
during an accidental release or another dangerous event would be the
best information to share during a public meeting. Another commenter
requested clarification about what information is required to be shared
at a public meeting.
EPA disagrees with commenters who stated that public meetings are
useless or redundant to other sources of information. EPA believes that
public meetings, particularly when held after an accident, will often
provide easier access for community members to appropriate facility
chemical hazard information, which can significantly improve the
community's emergency preparedness and understanding of how the
facility is addressing potential risks. Public meetings also provide an
opportunity for the public to ask questions or share their concerns
with appropriate facility staff and local government officials in
attendance.
Public meetings must address information about the incident as well
as other relevant chemical hazard information such as that described in
Sec. 68.210(b) (i.e., names of regulated substances held in a process;
SDSs; accident history information; emergency response program
information; a list of scheduled exercises and LEPC contact
information). The facility representative should describe the risks
that are associated with the facility, and what the facility is doing
to protect the public from those risks. In addition, the facility
personnel should relay information that would assist the public to
prepare for accidental releases. It would be extremely useful to have
LEPC and local emergency response officials participate in the meeting
to discuss the community emergency response plan and explain how the
facility is incorporated into that plan. This would provide an
opportunity for the facility representative and local officials to
discuss the process for public emergency notification procedures, for
sheltering in place or evacuating, and where to obtain further updates
on the status of an emergency incident. The discussion should also
address how the public can access community emergency response plans
and identify what the community may expect to see during a field
exercise.
In the final rule, EPA maintains the requirement for information in
Sec. 68.42 to be addressed at the public meeting.
[[Page 4673]]
The facility will have the flexibility to structure the public meeting
to focus on areas most relevant to a particular accident, considering
the interests of the community. EPA is not requiring that completed
STAAs be included, in part because this information is not pertinent to
community emergency response planning and also in part because the
opportunity for the public to engage in a completed STAA analysis,
which may contain CBI or trade secret information, may compromise
confidentiality and create security vulnerabilities at the facility.
d. Alternatives to Facility-Hosted Public Meetings
One commenter argued that a facility hosting a public meeting would
be redundant when LEPCs already hold public meetings. EPA also received
comments that EPA regions or LEPCs should host and facilitate a public
meeting instead of the facility, or that facilities should be required
to meet with LEPCs or local emergency responders instead of the public.
Others requested that LEPCs be able to decline to facilitate a public
meeting required by this rule because of their already substantial
responsibilities, or that public meetings should be held only at the
request of LEPCs or local emergency response agencies regardless of
whether a regulated substance was involved, or that they should be held
only at the request of the public. Commenters also indicated that small
businesses should be allowed to post information that is required to be
disclosed, in lieu of a public meeting.
EPA disagrees with the commenters. LEPCs hold meetings with the
public to discuss issues related to community planning. The public
meetings required by Sec. 68.210(e) in the final rule are intended to
be a venue for facility personnel to address questions and concerns
raised by the public following an RMP reportable accident at a
facility. While communication between the facility and the LEPC is
essential, it cannot replace communication between knowledgeable
facility staff and the public. LEPCs are encouraged to participate in
public meetings, and may collaborate with the owner or operator to host
the meeting in conjunction with an LEPC meeting if appropriate.
However, LEPCs are not required to co-host or participate in public
meetings.
Finally, EPA believes that small businesses should also host public
meetings following an RMP reportable accident to allow community
members an opportunity to talk with facility personnel. EPA encourages
small businesses to find ways to reduce costs of public meetings such
as by hosting the meetings at inexpensive venues, such as local
schools, community centers, or churches.
VII. Risk Management Plan Streamlining, Clarifications, and RMP Rule
Technical Corrections
A stationary source subject to the RMP rule is required to submit
an RMP in a method and format specified by the EPA, pursuant to Sec.
68.150(a). The CAA and 40 CFR subpart G require that the RMP indicate
compliance with the regulations at 40 CFR part 68 and also include
information regarding the hazard assessment, prevention program, and
emergency response program. The RMP also includes stationary source
registration information, such as name, location and contact
information. The EPA may review RMPs for a variety of reasons,
including information gathering, inspection preparation, errors in
submissions, and changes requiring a correction or re-submission of the
RMP. The CAA requires that RMPs be made available to states, local
entities responsible for planning or responding to accidental releases
at the source, the CSB, and the public. As a result, the information
provided in an RMP is intended to be easily understood, thus
encouraging the public, local entities, and governmental agencies to
interact with stationary sources on issues related to accident
prevention and preparedness.
EPA is deferring proposed revisions to delete or revise data
elements in the current rule; however, EPA is adding several RMP data
elements in subpart G based on the revised rule requirements discussed
in this document. This includes data elements to address compliance
with:
Third-party audit requirements,
IST analysis requirements in the PHA;
Emergency response preparedness requirements including
information on local coordination and emergency response exercises; and
Information sharing provisions.
By adding these data elements to the RMP requirements in subpart G,
EPA will be able to evaluate a stationary source's compliance with
these rule requirements. EPA is also finalizing technical corrections
as proposed.
A. Revisions to Sec. 68.160 (Registration)
EPA is adding the following RMP data elements that relate to the
information sharing provisions discussed in this document:
Sec. 68.160(b)(21) requires the method of the
communication and location of the notification that chemical hazard-
related information is available to the public, as set forth in Sec.
68.210(c); and
Sec. 68.160(b)(22) requires the date of most recent
public meeting, as set forth in Sec. 68.210(e).
EPA revised Sec. 68.160(b)(21) to clarify that when identifying
how a notification is made, the owner or operator should describe both
the method of the communication and the location. For example, if the
owner or operator is modifying a Web site to identify that information
is available upon request, then EPA expects that the owner or operator
will identify in the RMP that the notification is being made through a
Web site and then provide the Web address of the notification.
Alternatively, if the notification is made via a printed notice, then
the owner or operator should identify that a printed notice is
available and explain how to obtain the printed materials. EPA received
no comments on these provisions.
B. Revisions to Sec. 68.170 (Prevention Program/Program 2)
EPA is revising:
Sec. 68.170(i) by adding a requirement that the owner or
operator identify whether the most recent compliance audit was a third-
party audit, pursuant to Sec. Sec. 68.58 and 68.59; and
Sec. 68.170(j) by clarifying that the date of the most
recent incident investigation be the completion date of the
investigation. This would be the date on the final incident
investigation report.
EPA received no comments on these provisions.
C. Revisions to Sec. 68.175 (Prevention Program/Program 3)
EPA is revising:
Sec. 68.175(e) by amending the introductory sentence in
paragraph (e) to apply to information on the PHA or PHA update and
revalidation information. EPA is moving the date of completion of the
most recent PHA or update and the requirement to identify the technique
used to subparagraph (e)(1). EPA is deleting the requirement to
identify the expected date of completion of any changes resulting from
the PHA. Additional PHA information moves to subparagraph (e)(2)
through (6) and a new requirement to address inherently safer
technology or design measures implemented (if any) and the technology
category is in subparagraph (e)(7). This is similar to the proposed
revisions but reorganized to simplify the proposed subparagraph (e)(2)
and move to a new subparagraph (e)(7);
[[Page 4674]]
Sec. 68.175(k) by adding a requirement that the owner or
operator identify whether the most recent compliance audit was a third-
party audit, pursuant to Sec. Sec. 68.79 and 68.80; and
Sec. 68.175(l) by clarifying that the date of the most
recent incident investigation be the completion date of the
investigation. This would be the date on the final incident
investigation report.
EPA received no comments on these provisions.
D. Revisions to Sec. 68.180 (Emergency Response Program)
Subpart G Sec. 68.180 contains the emergency response program data
elements that must be included in the RMP. EPA proposed revisions to
add emergency response exercises and revise local coordination
provisions of the rule in order to improve coordination with local
response authorities and bolster emergency response capabilities and
preparedness for accidental releases.
1. Summary of Proposed Rulemaking
In Sec. [thinsp]68.180(a) EPA proposed to delete the
phrase ``the following information.'' The text in subparagraphs (a)(1)
through (3) were reorganized and/or replaced and EPA proposed to delete
subparagraphs (a)(4) through (6).
[cir] In subparagraph (a)(1), EPA proposed to require the RMP to
identify the name, organizational affiliation, phone number, and email
address of local emergency planning and response organizations with
which the stationary source last coordinated emergency response
efforts, pursuant to Sec. [thinsp]68.10(f)(3) or Sec. [thinsp]68.93.
[cir] Subparagraph (a)(2) included proposed requirements to
identify whether coordination with the local emergency response
organizations is occurring at least annually, pursuant to Sec.
[thinsp]68.93(a).
[cir] Finally, in subparagraph (a)(3) EPA proposed to require the
RMP to identify a list of Federal or state emergency plan requirements
to which the stationary source is subject.
In Sec. [thinsp]68.180(b), EPA proposed to replace the
current text with a requirement to identify whether the facility is a
responding or non-responding stationary source, pursuant to Sec.
[thinsp]68.90. EPA proposed subparagraph (b)(1) to apply to non-
responding stationary sources and subparagraph (b)(2) to apply to
responding stationary sources.
[cir] Non-responding stationary sources. In subparagraphs (b)(1)(i)
through (iii) the owner or operator would be required to identify
whether the owner or operator has confirmed that local responders are
capable of responding to accidental releases at the source, whether
appropriate notification mechanisms are in place, and whether a
notification exercise occurs at least annually.
[cir] Responding stationary sources. In subparagraphs (b)(2)(i)
through (v) the owner or operator would be required to identify whether
the LEPC or local response entity requested that the stationary source
be a responding facility; whether the stationary source complies with
requirements in Sec. [thinsp]68.95; whether a notification exercises
occurs at least annually, as required in Sec. [thinsp]68.96(a);
whether a field exercise is conducted every five years and after any
RMP reportable accident, pursuant to Sec. [thinsp]68.96(b)(1)(i); and
whether a tabletop exercise occurs at least annually, except during the
calendar year when a field exercise is conducted, as required in Sec.
[thinsp]68.96(b)(2)(i).
EPA proposed to delete Sec. [thinsp]68.180(c), which required the
owner or operator to list other Federal or state emergency plan
requirements to which the stationary source is subject.
2. Summary of Final Rule
EPA is completely revising and reorganizing subpart G Sec. 68.180
into the following three parts: Requirements for all stationary sources
under paragraph (a), requirements for non-responding stationary sources
under paragraph (b)(1), and requirements for responding stationary
sources under paragraph (b)(2). EPA believes that reorganizing subpart
G Sec. 68.180 will clarify the reporting requirements, reduce errors
in submitted RMPs, and improve compliance with the RMP requirements.
The revisions to subpart G Sec. 68.180 will also improve EPA's ability
to evaluate a facility's compliance with the Emergency Response Program
requirements.
EPA is amending and finalizing the proposed revisions to require
specific information rather than attestations of compliance. EPA is not
finalizing the proposed provisions that pertain to LEPCs requesting a
stationary source to comply with emergency response program
requirements of Sec. 68.95 so EPA is eliminating those requirements
under Sec. 68.180.
EPA is finalizing Sec. 68.180(a) as proposed except that
subparagraph (a)(2) requires the RMP to identify the date of the most
recent coordination with the local emergency response organizations,
pursuant to Sec. 68.93(a) (rather than attesting that coordination
occurs annually).
EPA is finalizing Sec. 68.180(b) introductory paragraph as
proposed. In the final rule subparagraph (b)(1) applies to non-
responding stationary sources and subparagraph (b)(2) applies to
responding stationary sources. EPA is amending and finalizing the
subparagraph as follows:
Non-responding stationary sources. In subparagraphs
(b)(1)(i) through (iii) the owner or operator is required to identify
whether the stationary source is included in the community emergency
response plan developed under EPCRA (for stationary sources with any
regulated toxic substance); the date of the most recent coordination
with the local fire department (for stationary sources with only
regulated flammable substances); what notification mechanisms are in
place; and the date of the most recent notification exercise.
Responding stationary sources. In subparagraphs (b)(2)(i)
through (iv) the owner or operator is required to identify the date of
the most recent review and update of the emergency response plan
required in Sec. 68.95(a)(4); the date of the most recent
notification, as required in Sec. 68.96(a); the date of the most
recent field exercise, pursuant to Sec. 68.96(b)(1)(i); and the date
of the most recent tabletop exercise, as required in Sec.
68.96(b)(2)(i).
3. Discussion of Comments and Basis for Final Rule Provisions
EPA received one comment indicating that the revision to Sec.
68.180 is unclear and that the `data elements' of the proposal do not
distinguish between responding and non-responding stationary sources.
EPA believes that the data elements do distinguish between
responding and non-responding stationary sources. A stationary source
will be required to identify whether they are ``responding'' or ``non-
responding'' and responding stationary sources and will answer
questions accordingly. EPA will revise its online RMP submission
system, RMP*eSubmit, to include the additional data elements, and
expects that the submission system will provide clarity for stationary
source owners and operators on how to submit responses.
E. Technical Corrections
1. Revisions to Sec. 68.10 (Applicability)
EPA is correcting a typographical error in Sec. 68.10(b)(2).
Section 68.10(b)(2) uses the term public receptor and indicates that
public receptor is defined in Sec. 68.30; however, the term public
receptor is defined in Sec. 68.3, not Sec. 68.30. The revised rule
language corrects this typographical error. EPA received no
[[Page 4675]]
comments and is finalizing this provision as proposed.
2. Revisions to Sec. 68.48 (Safety Information)
EPA proposed to remove the word ``material'' from the term Material
Safety Data Sheet in Sec. 68.48(a)(1) to conform with OSHA's revised
terminology for SDS.
Discussion of comments on safety information provisions. A
commenter recommended that EPA's revision to Sec. 68.48 should not
require facilities to ensure that safety data sheets meet OSHA's hazard
communication standard requirements. This commenter argued that
operators are given their safety data sheets by vendors and do not have
control over their content.
EPA disagrees with the commenter. The current rule requires the
owner or operator to maintain Material Safety Data Sheets (MSDS) that
meets the OSHA hazard communication standard requirements of 29 CFR
1910.1200(g). In 2012, OSHA made changes to its Hazard Communication
Standard at 29 CFR 1910.1200 in order to align with the U.N. Globally
Harmonized System of Classification and Labelling of Chemicals (GHS),
Revision 3 (77 FR 17574, March 26, 2012). One change was in
nomenclature from ``Material Safety Data Sheets'' to ``Safety Data
Sheets.'' Consequently, OSHA revised the name of the MSDS to Safety
Data Sheets (SDS) in the PSM standard at 1910.119(d)(1)(vii) (78 FR
9311, February 8, 2013). Chemical producers and users had to comply
with SDS requirements by June 1, 2015.\119\ EPA's technical correction
is solely to be consistent with the revised OSHA requirements and EPA
is finalizing this amendment as proposed.
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\119\ OSHA Fact Sheet--Hazard Communication Standard Final Rule.
https://www.osha.gov/dsg/hazcom/HCSFactsheet.html.
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3. Revisions to Sec. Sec. 68.54 and 68.71 (Training)
The RMP rule requires initial and refresher training for employees
operating a Program 2 or Program 3 covered process. Since the inception
of the rule, however, there has been confusion on the types of
employees that are considered workers operating a covered process.
Although ``employee'' is not defined in Sec. 68.3, EPA has
traditionally interpreted an employee to be any worker that is involved
in operating a process, including supervisors. This is consistent with
the OSHA definition of ``employee'' set forth at 29 CFR 1910.2(d). EPA
proposed amendments to clarify that employees ``involved in'' operating
a process are subject to the training requirements of the rule. EPA
further proposed a provision to clarify that the term employee includes
supervisors responsible for directing process operations. EPA is
finalizing these amendments as proposed.
Discussion of comments on training provisions. Several commenters
suggested that the proposed revisions to Sec. 68.54 are unclear. These
commenters indicated that EPA should provide greater clarification
regarding the length of time employers should train their employees,
which employees need training, and the distinction between employees
``operating'' a process and employees ``involved in operating'' a
process.
EPA directs readers to review the Guidance for Facilities on Risk
Management Programs for Chemical Accident Prevention (40 CFR part 68)
(or General Risk Management Program Guidance), which clarifies
expectations for training requirements.\120\ The guidance does not
specify a specific amount or type of training and allows the owner or
operator to develop a training approach that is facility-specific and
tailored to the needs of the facility's employees. The revised language
to require training for employees ``involved in'' operating a process
is intended to include employees that operate a process, as well as
supervisors of those employees, and other employees that may
occasionally be involved in process operations, such as process
engineers and maintenance technicians. For employees other than
operators and supervisors, EPA expects that initial and refresher
training will be appropriate to the employee's responsibilities in
operating the process.
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\120\ General Guidance for Facilities on Risk Management
Programs for Chemical Accident Prevention (40 CFR part 68), March
2009. https://www.epa.gov/rmp/guidance-facilities-risk-management-programs-rmp.
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If a supervisor is involved in decision-making for process
operations, such as making changes to operating parameters, developing
or approving operating procedures, or conducting emergency operations,
then EPA expects that the supervisor receives initial and refresher
training appropriate to the supervisor's responsibilities. In such
cases, the training of a supervisor might not need to be as extensive
as that of an operator, but EPA expects that the supervisor training
will include process operations for which the supervisor might have
decision-making authority.
4. Revisions to Sec. 68.65 (PSI)
EPA is revising Sec. 68.65(a) in order to remove irrelevant text
regarding the timeframe for initial development of PSI and to more
clearly demonstrate that PSI must be kept up-to-date. EPA is revising
Sec. 68.65(a) to remove the phrase ``In accordance with the schedule
set forth in Sec. 68.67'' and is adding the phrase: ``and shall keep
PSI up-to-date.'' EPA expects that revising Sec. 68.65(a) in this
manner will help Program 3 facilities to better comply with PSI
requirements and further clarifies the requirement that PSI must be
completed prior to conducting a PHA.
Finally, in order to be consistent with OSHA and the GHS, EPA is
replacing ``Material Safety Data Sheet'' with ``Safety Data Sheet'' in
the note to Sec. 68.65(b). EPA received no comments and is finalizing
these revisions as proposed.
5. Revisions to Sec. 68.130--List of Substances
EPA is revising Tables 1 and 4 in Sec. 68.130 as follows:
Table 1 to Sec. 68.130--List of Regulated Toxic Substances and TQs
for Accidental Release Prevention. EPA is correcting a typographical
error in the Chemical Abstracts Service (CAS) number (no.) for allyl
alcohol in Table 1 in Sec. 68.130. The incorrect CAS no. of 107-18-61
for allyl alcohol is corrected to 107-18-6.
Table 4 to Sec. 68.130--List of Regulated Flammable Substances and
TQs for Accidental Release Prevention. EPA is correcting a
typographical error to the CAS no. for 1, 3-Butadiene, to read 106-99-
0, instead of 196-99-0, revising to right justify the first CAS nos.
column and deleting the second CAS nos. column because it is redundant.
EPA received no comments on these provisions and is finalizing the
revisions as proposed.
6. Revisions to Sec. 68.200 (Recordkeeping)
EPA is revising Sec. 68.200 to clarify that records must be
maintained at the stationary source. EPA received no comments on this
provision and is finalizing the revision as proposed.
VIII. Compliance Dates
The initial Risk Management Program rule applied 3 years after
promulgation of the rule on June 20, 1996, which is consistent with the
last sentence of CAA section 112(r)(7)(B)(i). The statute does not
directly address when amendments should become applicable. The
provisions of this action modify terms of the existing rule, and, in
some cases, clarify existing requirements.
[[Page 4676]]
A. Summary of Proposed Rulemaking
EPA proposed modifications to Sec. 68.10 to establish compliance
dates for an owner operator to comply with the revised rule provisions
as follows:
Require compliance with emergency response coordination
activities within one year of an effective date of a final rule;
Provide up to three years for the owner or operator of a
non-responding stationary source to develop an emergency response
program in accordance with Sec. 68.95 following an LEPC or
equivalent's written request to do so;
Comply with new provisions (i.e., third-party compliance
audits, root cause analyses as part of incident investigations, STAA,
emergency response exercises, and information availability provisions),
unless otherwise stated, four years after the effective date of the
final rule; and
Provide regulated sources one additional year (i.e., five
years after the effective date of the final rule) to correct or
resubmit RMPs to reflect new and revised data elements.
B. Summary of Final Rule
EPA is finalizing the compliance dates as proposed, except that EPA
is deleting language requiring the owner or operator of a non-
responding stationary source to develop an emergency response program
following an LEPC's written request to do so. Instead, the final
provides three years for the owner or operator of a non-responding
stationary source to develop an emergency response program in
accordance with Sec. 68.95 when the owner or operator determines that
they meet the applicability criteria for responding stationary sources
in Sec. 68.90.
C. Discussion of Comments
Some commenters provided support for one or more of the compliance
dates; however, many commenters were concerned that the timeframes were
too long or in some cases too short.
1. General Comments
One commenter argued that the compliance dates should be set at one
to two years after the effective date of the rule because the rule
provisions are procedural and do not involve capital expenditures. A
facility requested that EPA clarify that annual compliance dates and
required reoccurring tasks have flexible yearly due dates to allow
facilities to perform thorough evaluations without the pressure of
tight yearly deadlines.
EPA agrees with commenters that annual compliance dates and
required reoccurring tasks should have flexible yearly due dates. This
will allow the facility owner or operator and local emergency response
officials to schedule coordination activities or exercises based on
availability of personnel and minimize unnecessary pressure to comply
with a rigid timeframe.
However, EPA disagrees that the compliance dates for all provisions
should be shortened to one or two years. EPA believes that additional
time is necessary for facility owners and operators to understand the
revised rule; train facility personnel on the revised provisions, learn
new investigation techniques, as appropriate; research safer
technologies; arrange for emergency response resources and response
training; incorporate change into their risk management programs; and
establish a strategy to notify the public that certain information is
available upon request. Furthermore, EPA intends to publish guidance
for certain provisions, such as STAA, root cause analysis, and
emergency response exercises. Once these materials are complete, owners
and operators will need time to familiarize themselves with the new
materials and incorporate them into their risk management programs.
2. Third-Party Compliance Audits
One commenter expressed concern that the lack of qualified auditors
would result in compliance delays and the three-year timeframe could
result in an excessive burden on facilities if there is a limited
availability of qualified auditors. The commenter further cited the
inability to plan for a third-party audit based on the applicability
criteria as a reason for the owner or operator to be unable to comply
within the timeframe.
Other commenters urged for shorter timeframes with one commenter
pointing out that this provision is triggered by an accident and should
therefore be under an accelerated compliance date. Two commenters
suggested a three-year compliance date, with the one commenter arguing
that there already enough people to perform third-party audits.
EPA disagrees with commenters and is finalizing a four-year
compliance date for third-party audits. This means that for any RMP
reportable accident occurring later than four years after the effective
date of the rule, the owner or operator of a source must conduct a
third-party audit. The four-year compliance timeframe will allow
potential auditors enough time to establish internal protocols and
identify personnel that meet the competency and independence criteria
necessary to serve as a third-party auditor. These auditors will also
need time to advertise their availability to conduct third-party audits
so facility owners and operators can identify potential auditors before
there is a need to conduct a third-party compliance audit.
3. Incident Investigations and Root Cause Analysis
Many commenters argued that the proposed four-year compliance date
is too long. Commenters offered alternative timeframes such as 12
months, 18 months, and three years. A local agency suggested a one-year
compliance date, arguing that many complex facilities are already
conducting root cause analyses. One commenter argued that provisions
that are triggered by an accident should be required in an accelerated
timeframe. Other commenters argued that the compliance date should be
required as soon as possible.
EPA disagrees with the commenters and is finalizing a four-year
compliance date for incident investigations involving root cause
analyses. For any incident that occurs four years after the effective
date of the final rule and results in (e.g. an RMP reportable accident)
or could reasonably have resulted in a catastrophic release, the owner
or operator must investigate the incident and conduct a root cause
analysis. This will allow facility owners and operators sufficient time
to establish training and program development activities. EPA
encourages facility owner or operators that are already conducting root
cause analyses to continue to do so for any incident that resulted in
(e.g. an RMP reportable accident) or could reasonably have resulted in
a catastrophic release during the compliance timeframe.
4. STAA
A local agency supported the four-year compliance timeframe but
numerous commenters argued that the proposed timeframe is too long.
Many commenters, including mass mail campaigns joined by approximately
14,000 commenters and multiple advocacy groups, requested that EPA
expedite compliance with STAA requirements. A mass mail campaign joined
by approximately 300 commenters stated that the proposed compliance
period is unlawful and arbitrarily long. The commenter argued that EPA
has no lawful legal basis to extend the STAA compliance date
[[Page 4677]]
beyond three years. Another commenter suggested that EPA should
consider following the NJ model to implement IST requirements and
require an initial review report within 120 days of the rule's
effective date.
However, other commenters thought the proposed timeframe was too
short. One commenter cited the complexity of the IST/ISD analysis as a
reason to extend the compliance date into a second PHA cycle to allow
more time for engineering studies and design. Another commenter
supported the U.S. Small Business Administration (SBA) recommendation
to defer the STAA requirement for three years for small facilities so
that EPA can gather information on their experience and assess how
often safer alternatives were identified and at what cost.
EPA disagrees with commenters and is establishing a four-year
compliance date for STAA. EPA believes that in many cases sources will
prefer to perform a full PHA update when implementing the STAA
requirements. Sources subject to this provision are among the largest
and most complex sources regulated under 40 CFR part 68, and therefore
PHAs and PHA updates at these sources typically require a significant
level of effort. Since PHA updates are normally done at five year
intervals, EPA believes it would be appropriate to allow most sources
to adopt these provisions in their normal PHA update cycle if they so
choose. Sources that performed their most recent PHA update immediately
prior to this rule's effective date will have up to four years to
perform their next PHA update and adopt the STAA provisions. Most
sources could schedule their PHA updates to incorporate the new STAA
provisions on their normal PHA update schedule. EPA also intends to
publish guidance on STAA and once complete, facility owners and
operators will need time to familiarize themselves with the new
materials and incorporate them into their risk management programs.
EPA disagrees with the recommendation to defer the STAA requirement
for three years for small facilities in order to allow EPA to gather
information. STAA for a source is a site-specific determination and
would be difficult to compare among facilities. EPA believes it would
be impractical to gather/analyze information on STAA implementation to
determine the utility of the provision for small facilities.
5. Emergency Response Coordination
EPA received comments supporting the proposed one-year compliance
date for emergency response coordination activities. One commenter
requested clarification on how to calculate the annual coordination
activities, recommending that it be based on a calendar year.
EPA agrees with commenters and is finalizing a one-year compliance
date for emergency response coordination activities. EPA believes that
a flexible schedule is appropriate for scheduling annual coordination
and agrees with the recommendation to base the coordination on a
calendar year timeframe.
6. Emergency Response Program
One commenter suggested that EPA should allow a minimum timeframe
of 12 months for a non-responding facility to transition to a
responding facility. The commenter further suggested incorporating an
extension request to local agencies in the event of compliance delays
that fall outside the owner/operator's control (such as budget
constraints or inability to procure response resources). Another
commenter expressed support for the timeframe to develop an emergency
response program; however, expressed concerns with the ongoing costs
associated with that requirement.
EPA is finalizing a three-year compliance date for a facility owner
or operator to develop an emergency response program once he or she
determines a need for a program. EPA is not incorporating an extension
request to address compliance delays that may fall outside the owner or
operator's control. EPA notes that the two provisions from Sec. 68.90
of the proposed rule that would have made the owner or operator's
decision to develop an emergency response program contingent on the
outcome of local coordination activities, and required the owner or
operator to develop an emergency response program upon receiving a
written request to do so from the LEPC or local response authorities,
were not included in the final rule. EPA believes that by making these
changes, the regulatory provisions that would potentially have caused
many sources to convert from being non-responding sources to responding
sources have been removed from the final rule. However, as the
emergency coordination provisions of the final rule require regulated
sources to coordinate annually with local responders and to document
coordination activities, EPA acknowledges that it is possible that
these more frequent coordination activities may still prompt some
sources to implement an emergency response program (i.e., for a non-
responding source to become a responding source). In such cases, EPA
believes a three-year timeframe is appropriate to establish a program
that meets the requirements of Sec. 68.95.
7. Facility Exercises
One commenter objected to the proposed four-year compliance date
for emergency response exercises arguing that exercises should be
required within one year of when coordination activities must begin.
EPA disagrees with the commenter and is finalizing a four-year
compliance date for conducting emergency response exercises. This means
that the owner or operator has four years after the effective date of
this rule to conduct a notification exercise, consult with local
emergency response officials to establish a schedule for conducting
tabletop and field exercises, and complete at least one tabletop or
field exercise. EPA believes that this timeframe will allow owners and
operators to develop an exercise program that is appropriate for their
facility, train personnel, and coordinate with local emergency response
officials. EPA also expects to develop guidance on emergency response
exercises and facility owners and operators will require time to
familiarize themselves with the guidance.
8. Information Availability
A professional organization stated that the proposed timeline for
information sharing should be shortened to three years for information
that is shared with the public. The commenter recommended that
information sharing with facility workers should begin immediately
after the implementation of the rule. Another commenter asserted that
the proposed rulemaking provisions and compliance dates are
inappropriate for the sharing of information, arguing that provisions
triggered by an accident should be required in an accelerated
timeframe.
EPA disagrees with commenters and is finalizing a four-year
compliance date for information availability provisions. This means
that four years after the effective date of the rule, the facility
owner or operator must have notifications in place to inform the public
that information specified in Sec. 68.210(b) is available upon
request. For any RMP reportable accident occurring later than four
years after the effective date of the rule, the owner or operator of a
source must hold a public meeting within 90 days of the accident. EPA
believes that this timeframe is sufficient to allow facility staff an
opportunity to determine the best method for providing notifications to
the public and to assemble and format
[[Page 4678]]
information to prepare to respond to information requests.
9. Update and Resubmit RMP
EPA received no comments on the proposed five-year compliance date
for owners or operators to update RMPs to reflect the new and revised
data elements in subpart G of the rule. EPA is finalizing a five-year
compliance date for this provision, as proposed. This timeframe will
allow owners and operators an opportunity to begin to comply with
revised rule provisions prior to certifying compliance in the RMP.
Additionally, the Agency will revise its online RMP submission system,
RMP*eSubmit, to include the additional data elements, and sources will
not be able to update RMPs with new or revised data elements until the
submission system is ready. Also, once it is ready, allowing an
additional year for sources to update RMPs will prevent potential
problems with thousands of sources submitting updated RMPs on the same
day.
D. Compliance Date Examples
The following examples demonstrate the compliance dates for the
final rule as described in Table 6: Final Rule Provisions and
Corresponding Compliance Dates.
Table 6--Final Rule Provisions and Corresponding Compliance Dates
------------------------------------------------------------------------
Initiated after an
Rule provision Compliance date RMP reportable
accident?
------------------------------------------------------------------------
Third-party audit............... March 15, 2021.... Yes.
Root cause analysis............. March 15, 2021.... Yes (also required
after near
misses).
STAA............................ March 15, 2021.... No.
Emergency response coordination March 14, 2018.... No.
activities.
Owner/operator determines that Within three years No.
the facility is subject to the of the
emergency response program determination.
requirements of Sec. 68.95.
Emergency response exercises.... March 15, 2021.... No.
Information sharing............. March 15, 2021.... Partially-public
meeting within 90
days.
Update RMP...................... March 14, 2022.... No (but previously
existing
correction
requirements of
Sec. 68.195
still apply).
------------------------------------------------------------------------
Example 1: Provisions That Apply to a Non-Responding Stationary Source
Source A (see Table 7) is a non-responding stationary source with a
regulated process subject to Program 2 requirements. Source A's owner
submitted the latest RMP update to EPA on January 20, 2015 and
completed its latest compliance audit on August 11, 2017. The source is
not in NAICS 322, 324, or 325, and therefore is not subject to the STAA
provisions. The source has not had any RMP reportable accidents since
the effective date of the final rule.
Table 7--Example 1, Source A
------------------------------------------------------------------------
Source A--Program 2, non-responding stationary source
-------------------------------------------------------------------------
Last compliance
Date of last RMP update audit Last accident
------------------------------------------------------------------------
January 20, 2015................. August 11, 2017..... N/A.
------------------------------------------------------------------------
In this example, the following provisions apply:
Annual emergency response coordination activities in
accordance with Sec. 68.93;
Notification exercises (Sec. 68.96(a)); and
Information availability provisions (Sec. 68.210).
The owner or operator must coordinate response needs with local
emergency planning and response organizations as described in Sec.
68.93 (i.e., to determine how the source is addressed in the community
emergency response plan and to ensure that local response organizations
are aware of the regulated substances at the source, their quantities,
the risks presented by covered processes, and the resources and
capabilities at the facility). Coordination activities must occur
annually and be documented.
Source A is a non-responding facility, and the owner or operator is
required to conduct annual notification exercises. The owner or
operator is also required to provide ongoing public notification that
certain information is available to the public upon request.
Finally, beginning five years after the rule effective date, the
owner or operator must update the RMP to include all revised data
elements specified in subpart G. In this case, the owner or operator
would update their RMP no later than January 20, 2020 (the source's
next scheduled five-year update), and again by March 14, 2022 (the
required resubmission date for the final rule).
Table 8: Summary of provisions that apply to a non-responding
stationary source summarizes the provisions that apply to Source A.
Table 8--Summary of Provisions That Apply to a Non-Responding Stationary
Source
------------------------------------------------------------------------
Additional
Applicable provisions information When to complete *
------------------------------------------------------------------------
Emergency response Occurs annually..... Complete
coordination activities. coordination
activities before
March 14, 2018 and
document
coordination.
Notification exercise....... Occurs annually..... Complete first
notification
exercise by March
15, 2021.
------------------------------------------------------------------------
Information availability provisions
------------------------------------------------------------------------
Information to the public... Ongoing. Includes Complete first
notification that calendar year
specifies the notification by
information that is March 15, 2021.
available and
provides
instructions on how
to obtain, and
links to community
preparedness
information.
Update RMP.................. Owner's next five- Update RMP on
year resubmission regular schedule
date occurs prior (by January 20,
to effective date 2020) and again to
for provision, so include new
owner must update information by
RMP twice. March 14, 2022.
------------------------------------------------------------------------
[[Page 4679]]
If the Source A's owner or operator determines that the facility is
subject to the emergency response program requirements (i.e., the
facility has toxic substances and is not included in the community
emergency response plan or the facility has flammable substances and
has not coordinated response actions with the local fire department),
then he or she would have three years from the determination date to
develop and implement an emergency response plan, obtain equipment, and
train personnel in relevant procedures.
Once the owner has developed an emergency response program, the
source is a responding facility and must also comply with tabletop and
field exercise requirements for responding facilities.
Example 2A: Provisions That Apply to a Responding Stationary Source
Source B (see Table 9) is a responding stationary source with a
process subject to Program 3 requirements. Its latest RMP update was
submitted June 30, 2020. Its latest compliance audit was performed on
April 6, 2020. The source is not in NAICS 322, 324, or 325, and
therefore is not subject to the STAA provisions, and the source has not
had any RMP reportable accidents since the effective date of a final
rule.
Table 9--Example 2A, Source B
------------------------------------------------------------------------
Source B--Program 3, responding stationary source
-------------------------------------------------------------------------
Last compliance
Date of last RMP update audit Last accident
------------------------------------------------------------------------
June 30, 2020.................... April 6, 2020....... N/A.
------------------------------------------------------------------------
In this example, the following provisions apply:
Annual emergency response coordination activities in
accordance with Sec. 68.93;
Emergency response exercises (Sec. 68.96); and
Information availability provisions (Sec. 68.210).
The owner or operator must coordinate response needs with local
emergency planning and response organizations as described in Sec.
68.93. Coordination activities must occur annually and be documented.
Additionally, since Source B is a responding facility, the owner or
operator is required to conduct annual notification exercises and
tabletop and field exercises. The frequency of the tabletop and field
exercises will be determined in consultation with local emergency
response officials, but at a minimum, shall be every three years for
tabletop exercises and every ten years for field exercises. EPA expects
that within four years of the effective date of the final rule, that
the owner or operator will consult with local emergency response
officials to establish a schedule for conducting at least one tabletop
and/or field exercise.
The owner or operator is also required to provide ongoing public
notification that certain information is available the public upon
request.
Finally, by five years after the rule effective date, the owner or
operator must update the RMP to include all revised data elements
specified in subpart G. Table 10: Summary of provisions that apply to
Source B summarizes the provisions that apply in this example.
Table 10--Summary of Provisions That Apply to Source B
------------------------------------------------------------------------
Additional
Applicable provisions information When to complete *
------------------------------------------------------------------------
Emergency response Occurs annually..... Complete
coordination activities. coordination
activities before
March 14, 2018.
------------------------------------------------------------------------
Emergency response exercises (Sec. 68.96)
------------------------------------------------------------------------
Notification exercise....... Occurs annually..... Complete first
notification
exercise by March
15, 2021.
Field and tabletop exercises Tabletop exercise Complete first
every three years, tabletop or field
field exercise once exercise by March
every ten years. 15, 2021.
------------------------------------------------------------------------
Information availability provisions
------------------------------------------------------------------------
Information to the public... Ongoing. Includes Complete first
notification that calendar year
specifies the notification by
information that is March 15, 2021.
available, provides
instructions on how
to obtain, and
links to community
preparedness
information.
Update RMP.................. .................... Update RMP to
include new
information by
March 15, 2021.
------------------------------------------------------------------------
Example 2B: Additional Provisions That Apply to a Responding Stationary
Following an RMP Reportable Accident.
See Table 11.
Table 11--Example 2B, Source B
------------------------------------------------------------------------
Source B--Program 3, responding stationary source
-------------------------------------------------------------------------
Last compliance
Date of last RMP update audit Last accident
------------------------------------------------------------------------
June 30, 2020................... April 6, 2020...... July 5, 2021.
------------------------------------------------------------------------
In this example, Source B has an accidental release on July 5, 2021
that meets the reporting requirements of Sec. 68.42. As a result of
the accident, Source B's owner is required to comply with the following
additional provisions:
Third-party audit provisions of Sec. 68.80;
Incident investigation and root cause analysis
requirements of Sec. 68.81; and
Public meeting within 90 days of an RMP reportable
accident, pursuant to Sec. 68.210(e).
Chronologically, the first provision that applies is the
requirement to host a public meeting. Section 68.210(e) requires the
owner or operator to hold a public meeting within 90 days after the
accident to inform the public about the accident, including information
required under Sec. 68.42, and other relevant information.
An incident investigation must be initiated promptly, but no later
than 48 hours following the incident. The incident investigation
provisions require the owner or operator to complete an incident
investigation that includes a root cause analysis and other elements
specified in Sec. 68.81(d), and an incident investigation report,
within 12 months of the incident, unless the implementing agency
approves an extension of time.
The third-party audit provisions require the owner or operator to
hire a third-party auditor to perform a third-
[[Page 4680]]
party compliance audit and complete an audit report within 12 months of
the accident (unless the implementing agency approves an extension).
The owner or operator must also complete an audit findings response
report within 90 days of receiving the audit report from the third-
party auditor. The owner or operator must also provide the audit
findings response report, as well as a schedule to address deficiencies
identified in the audit findings response report and documentation of
actions taken to address deficiencies, to the owner or operator's audit
committee of the Board of Directors, or other comparable committee or
individual, if applicable.
By five years after the rule effective date, the owner or operator
must update the RMP to include all revised data elements specified in
subpart G and Sec. 68.42. Finally, if the owner or operator's response
to the incident utilizes the facility's emergency response plan, tested
the objectives of an exercise as described in Sec. 68.96(b)(1)(ii),
and documents response actions as described in Sec. 68.96(b)(3), then
the owner or operator may use the response to satisfy the field
exercise requirements of the final rule.
Table 12 summarizes the additional provisions that apply to Source
B following an RMP reportable accident (in addition to complying with
new requirements triggered by an RMP reportable accident, the owner or
operator must annually coordinate response needs with local emergency
planning and response organizations, document coordination activities,
and comply with the other information disclosure provisions as
previously described).
Table 12--Summary of Additional Provisions That Apply to Source B Following an RMP Reportable Accident
----------------------------------------------------------------------------------------------------------------
Applicable provisions following
an RMP reportable accident: Compliance date Additional information When to complete *
----------------------------------------------------------------------------------------------------------------
Public meeting................... March 15, 2021........... The accident occurred Hold public meeting by
after the compliance October 3, 2021.
date for this
provision, therefore,
schedule a meeting
within 90 days after
the RMP reportable
accident.
Incident investigations.......... March 15, 2021........... The accident occurred Complete report by July
after the compliance 5, 2022.
date for this
provision, therefore,
initiate within 48
hours, complete
investigation and root
cause analysis within
12 months.
Third-party audit................ March 15, 2021........... The accident occurred Complete third-party
after the compliance audit by July 5, 2022
date for this Complete findings
provision, therefore, response report within
complete within 12 90 days of completing
months of the RMP audit.
reportable accident.
Field exercise................... March 15, 2021........... May use the response to Document the response
satisfy the field within 90 days of the
exercise requirements incident (i.e., by
of the rule when all October 3, 2021), if
objectives of the using response to
exercise are tested and satisfy field exercise
the response is requirements.
documented.
Accident history information in ......................... Correct RMP within 6 Correct RMP by January
RMP. months of accident 5, 2022.
(existing requirement).
----------------------------------------------------------------------------------------------------------------
Example 3: Compliance Date Example for Sources Subject to STAA
Requirements
Source C (see Table 13) is a petroleum refinery in NAICS 32411. Its
latest RMP update was submitted on March 31, 2018. Its latest PHA
revalidation was completed on March 7, 2017.
Table 13--Example 3, Source C
------------------------------------------------------------------------
Source C--Program 3, NAICS 32411
-------------------------------------------------------------------------
Date of last RMP update Last PHA revalidation
------------------------------------------------------------------------
March 31, 2018............................ March 7, 2017.
------------------------------------------------------------------------
Because the source is in NAICS 32411, it is subject to the STAA
provisions of Sec. 68.67(c)(8). Therefore, March 15, 2021, the owner
or operator must complete a PHA revalidation that addresses safer
technology and alternative risk management measures, and determine the
practicability of the ISTs and ISDs considered.
By March 14, 2018 the owner or operator of Source C must comply
with the emergency response coordination provisions, and by March 15,
2021, the owner or operator must also comply with other applicable rule
provisions including: Third-party audits; incident investigations;
emergency response exercises; and information availability (including
public meetings).
By March 14, 2022, the owner or operator of Source C must update
the RMP to include all revised data elements specified in subpart G.
Table 14: Compliance date example for sources subject to STAA
requirements, summarizes the STAA provisions that apply to Source C.
Table 14--Compliance Date Example for Sources Subject to STAA
Requirements
------------------------------------------------------------------------
When to complete
Applicable provisions Additional information *
------------------------------------------------------------------------
STAA.......................... Occurs every five By March 15,
years as part of PHA 2021.
revalidation.
Update RMP.................... ...................... By March 14,
2022.
------------------------------------------------------------------------
[[Page 4681]]
IX. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is an economically significant regulatory action that
was submitted to the Office of Management and Budget (OMB) for review.
Any changes made in response to OMB recommendations have been
documented in the docket. The EPA prepared a Regulatory Impact Analysis
(RIA) of the potential costs and benefits associated with this action.
This RIA is available in the docket and is summarized here (Docket ID
Number EPA-HQ-OEM-2015-0725).
1. Why EPA Is Considering This Action
In response to catastrophic chemical facility incidents in the
United States, President Obama issued Executive Order 13650,
``Improving Chemical Facility Safety and Security,'' on August 1, 2013.
The Executive Order establishes the Chemical Facility Safety and
Security Working Group (Working Group), co-chaired by the Secretary of
Homeland Security, the Administrator of EPA, and the Secretary of Labor
or their designated representatives at the Assistant Secretary level or
higher, and comprised of senior representatives of other Federal
departments, agencies, and offices. The Executive Order requires the
Working Group to carry out a number of tasks whose overall goal is to
prevent chemical accidents.
Section 6(a)(i) of Executive Order 13650 requires the Working Group
to develop options for improved chemical facility safety and security
that identify ``improvements to existing risk management practices
through agency programs, private sector initiatives, Government
guidance, outreach, standards, and regulations.'' Section 6(c) of
Executive Order 13650 requires the Administrator of EPA to review the
Risk Management Program. As part of this effort to solicit comments and
information from the public regarding potential changes to EPA's RMP
regulations (40 CFR part 68), on July 31, 2014, EPA published an RFI
(79 FR 44604).
EPA believes that the RMP regulations have been effective in
preventing and mitigating chemical accidents in the United States;
however, EPA believes that revisions could further protect human health
and the environment from chemical hazards through advancement of PSM
based on lessons learned. These revisions are a result of a review of
the existing Risk Management Program and information gathered from the
comments on the proposed rulemaking, SBAR panel, public hearing, RFI,
and Executive Order listening sessions, and are finalized under the
statutory authority provided by CAA section 112(r) as amended (42
U.S.C. 7412(r)).
2. Description of Alternatives to the Final Rule
EPA analyzed in the RIA the requirements finalized in this action
as well as several alternatives for each.
a. Third-Party Audits (Program 2 Sec. Sec. 68.58 and 68.59 and Program
3 Sec. Sec. 68.79 and 68.80)
The existing rule requires Program 2 and Program 3 processes to
conduct a compliance audit at least once every three years. The revised
rule requires facilities to contract with an independent third-party,
or assemble an audit team led by an independent third-party, to conduct
the next scheduled compliance audit following an RMP reportable
accident or after an implementing agency determines that certain
circumstances exist that suggest a heightened risk for an accident. The
third-party would have to be someone with whom the facility does not
have an existing or recent relationship and who meets specific
qualification criteria. The low cost alternative applies only for
Program 2 and Program 3 processes after an RMP reportable accident or
at the request of the implementing agency. The medium cost alternative
applies every three years for all compliance audits conducted for all
Program 3 processes. The high cost alternative applies every three
years for all compliance audits conducted for Program 2 and Program 3
processes.
b. Incident Investigations/Root Cause Analysis (Sec. Sec. 68.60 and
68.81)
The rule requires facilities to conduct a root cause analysis as
part of an incident investigation following an RMP reportable accident
or an incident that could reasonably have resulted in an RMP reportable
accident (i.e., ``near miss''). A root cause analysis is a formal
process to identify underlying reasons for failures that lead to
accidental releases. These analyses usually require someone trained in
the technique. The low cost alternative applies the provision only to
RMP reportable accidents or near misses in Program 3 processes. The
medium/high cost alternative applies to RMP reportable accidents or
near misses involving Program 2 and Program 3 processes.
c. STAA (Sec. 68.67)
Under the final rule, facilities in NAICS codes 322 (paper
manufacturing), 324 (petroleum and coal products manufacturing), and
325 (chemical manufacturing) with Program 3 processes are required to
conduct a STAA for each process as part of their PHA, which occurs
every five years. The STAA includes two parts: The initial analysis to
identify alternatives, and a practicability study to determine the
costs and assess the reasonableness of implementing technology
alternatives. The final rule is the low cost alternative, which applies
to all facilities with Program 3 processes in NAICS codes 322, 324, and
325. The medium cost alternative applies the requirement to all Program
3 processes. The high cost alternative applies the requirement to all
Program 3 processes and require facilities to implement practicable
IST/ISD.
d. Emergency Response Program Coordination With Local Responders
(Sec. Sec. 68.90, New 68.93, and 68.95)
Under the final rule, all facilities with Program 2 or Program 3
processes are required to coordinate with local response agencies
annually to determine how the source is addressed in the community
emergency response plan and to ensure that local response organizations
are aware of the regulated substances at the source, their quantities,
the risks presented by covered processes, and the resources and
capabilities at the facility to respond to an accidental release of a
regulated substance. The owner or operator must document coordination
activities.
Alternatives to this provision are similar to the finalized
requirements. One alternative that imposes the same costs as the final
rule option includes an option for local officials to request that a
facility owner or operator comply with the emergency response program
requirements of Sec. 68.95. This would be analogous to the
requirements under the Oil Pollution Prevention regulation (40 CFR part
112) where all facilities subject to the FRP provisions at Sec. 112.20
are required to prepare and implement an emergency response plan for
oil discharges into navigable waters or adjoining shorelines.
e. Facility Exercises (Sec. 68.96)
Notification exercises. All facilities with Program 2 or Program 3
processes are required to conduct a notification
[[Page 4682]]
exercise annually to ensure that the contact list to be used in an
emergency is complete, accurate, and up-to-date.
Tabletop and field exercises. The rule requires responding
facilities to conduct exercises of their emergency response plans and
invite local emergency response officials to participate. Under the low
cost alternative, facilities would conduct tabletop exercises every
three years. Under the final rule, which is the medium cost
alternative, facilities will establish the frequency of exercises in
consultation with local emergency response officials, but at a minimum,
full field exercises will be conducted at least once every ten years
and tabletop exercises conducted at least once every three years.
Responding facilities that have an RMP reportable accident, and
document the response activities in an after-action report comparable
to the exercise evaluation reports may use that response to satisfy the
field exercise requirements. Furthermore, owner and operators of
responding facilities that conduct exercises to meet other Federal,
state or local exercise requirements may satisfy the RMP exercise
requirements provided that the scope of the exercise includes the
objectives of an RMP exercise. Under the high cost alternative,
facilities would conduct full field exercises annually.
f. Information Availability (Sec. 68.210)
The rule requires all facilities to provide certain basic chemical
hazard information to the public, upon request. The owner or operator
of the facility shall provide ongoing notification of availability of
information elements on a company Web site, social media platforms, or
through some other publicly accessible means. The information to be
disclosed includes names of regulated substances at the facility; SDS;
accident history information; emergency response program information;
and LEPC or local response agency contact information.
EPA proposed requirements for facilities to provide certain
information to the LEPC, Tribal Emergency Planning Committee (TEPC) or
other local emergency response agencies. However, rather than prescribe
information elements that must be provided upon request, EPA is
requiring the owner or operator of a stationary source to share
information that is relevant to emergency response planning as part of
the coordination activities that occur annually between facility
representatives and local emergency response agencies.
Finally, the rule requires facilities to hold a public meeting for
the local community within 90 days of an RMP reportable accident. The
medium cost alternative would require Program 2 and Program 3
facilities to hold a public meeting at least once every five years and
within 90 days of an RMP reportable accident. The high cost alternative
would require all facilities (i.e., including Program 1 facilities) to
hold a public meeting at least once every five years and immediately
following an RMP reportable accident.
3. Summary of Costs
Approximately 12,500 facilities have filed current RMPs with EPA
and are potentially affected by the revised rule. These facilities
range from petroleum refineries and large chemical manufacturers to
water and wastewater treatment systems; chemical and petroleum
wholesalers and terminals; food manufacturers, packing plants, and
other cold storage facilities with ammonia refrigeration systems;
agricultural chemical distributors; midstream gas plants; and a limited
number of other sources that use RMP-regulated substances.
Table 15 presents the number of facilities according to the latest
RMP reporting as of February 2015 by industrial sector and chemical
use.
Table 15--Number of Affected Facilities by Sector
----------------------------------------------------------------------------------------------------------------
Total
Sector NAICS codes facilities Chemical uses
----------------------------------------------------------------------------------------------------------------
Administration of environmental quality 924 1,923 Use chlorine and other chemicals
programs (i.e., governments). for treatment.
Agricultural chemical distributors/ 111, 112, 115, 42491 3,667 Store ammonia for sale; some in
wholesalers. NAICS 111 and 115 use ammonia as a
refrigerant.
Chemical manufacturing................... 325 1,466 Manufacture, process, store.
Chemical wholesalers..................... 4246 333 Store for sale.
Food and beverage manufacturing.......... 311, 312 1,476 Use mostly ammonia as a
refrigerant.
Oil and gas extraction................... 211 741 Intermediate processing (mostly
regulated flammable substances and
flammable mixtures).
Other.................................... 44, 45, 48, 54, 56, 248 Use chemicals for wastewater
61, 72 treatment, refrigeration, store
chemicals for sale.
Other manufacturing...................... 313, 326, 327, 33 384 Use various chemicals in
manufacturing process, waste
treatment.
Other wholesale.......................... 423, 424 302 Use (mostly ammonia as a
refrigerant).
Paper manufacturing...................... 322 70 Use various chemicals in pulp and
paper manufacturing.
Petroleum and coal products manufacturing 324 156 Manufacture, process, store (mostly
regulated flammable substances and
flammable mixtures).
Petroleum wholesalers.................... 4247 276 Store for sale (mostly regulated
flammable substances and flammable
mixtures).
Utilities................................ 221 445 Use chlorine (mostly for water
treatment) and other chemicals.
Warehousing and storage.................. 493 1,056 Use mostly ammonia as a
refrigerant.
------------
Total................................ .................... 12,542
----------------------------------------------------------------------------------------------------------------
Table 16 presents a summary of the annualized costs estimated in
the RIA. In total, EPA estimates annualized costs of $131.2 million at
a 3% discount rate and $131.8 million at a 7% discount rate.
[[Page 4683]]
Table 16--Summary of Annualized Costs
[Millions, 2015 dollars]
------------------------------------------------------------------------
Provision 3% 7%
------------------------------------------------------------------------
Third-party Audits...................... $9.8 $9.8
Incident Investigation/Root Cause....... 1.8 1.8
STAA.................................... 70.0 70.0
Coordination............................ 16.0 16.0
Notification Exercises.................. 1.4 1.4
Facility Exercises...................... 24.7 24.7
Information Sharing (Public)............ 3.1 3.1
Public Meeting.......................... 0.4 0.4
Rule Familiarization.................... 3.9 4.6
Total Cost *............................ 131.2 131.8
------------------------------------------------------------------------
* Totals may not sum due to rounding.
The largest average annual cost of the final rule is the STAA costs
($70.0 million), followed by the exercise costs ($24.7 million),
coordination ($16 million), and third-party audits ($9.8 million). The
remaining provisions impose average annual costs under $5 million each,
including rule familiarization ($3.9 to 4.6 million), information
sharing (public) ($3.1 million), incident investigation/root cause
analysis ($1.8 million), notification exercises ($1.4 million), and
public meetings ($0.4 million).
The rule includes three prevention program provisions--third-party
audits, root cause analysis, and STAA--involving information collection
and analysis activities that can lead to a wide range of outcomes, and
therefore costs, if and when the owner acts upon the findings and/or
recommendations generated by the audit, investigation, or analysis.
Although resolving audit and investigation findings is required under
the existing rule provisions, and the rule does not require
implementation of practicable IST alternatives, EPA believes it is
possible that there may be costs associated with resolving findings
from the third-party audit and root cause analysis provisions that go
beyond the costs of the existing provisions, and that some owners or
operators may have additional costs due to voluntary implementation of
IST. EPA acknowledged the wide range of outcomes from these provisions
and the significant uncertainties associated with their costs, and
requested information in the proposed rulemaking on whether these costs
should accrue to the rule. EPA did not receive any data from commenters
that illustrates the: Types of costs that result from independent
audits (other than the cost of the audit) that are different from self-
audit costs; the types of costs that result from root cause
investigations as compared to non-root-cause investigations; and for
the STAA provisions, information to project what changes facilities are
likely to voluntarily undertake (e.g., cost data or studies for
implementation of IST changes).
4. Summary of Potential Benefits
EPA anticipates that implementation of this rule will result in a
reduction of the frequency and magnitude of damages from releases.
Accidents and releases from RMP facilities occur every year, resulting
in fires and explosions, property damage, acute and chronic exposures
of workers and nearby residents to hazardous materials, and resultant
damages to health. Although we are unable to quantify what specific
damage reductions may occur as a result of these revisions, we are able
to present data on the total damages that currently occur at RMP
facilities each year. The data presented are based on a 10-year
baseline period, summarizing RMP accident impacts and, when possible,
monetizing them. EPA expects that some portion of future damages would
be prevented through implementation of this rule. Table 17 presents a
summary of the quantified damages identified in the analysis.
Table 17--Summary of Quantified Damages
[Millions, 2015 dollars]
----------------------------------------------------------------------------------------------------------------
Unit value 10-Year total Average/year Average/accident
----------------------------------------------------------------------------------------------------------------
On-site
----------------------------------------------------------------------------------------------------------------
Fatalities.............................. $8.6 $497.8 $49.8 $0.33
Injuries................................ 0.05 105.2 10.5 0.69
Property Damage......................... ................ 2,054.9 205.5 1.4
-----------------------------------------------------------------------
On-site Total....................... ................ 2,657.9 265.8 1.8
----------------------------------------------------------------------------------------------------------------
Offsite
----------------------------------------------------------------------------------------------------------------
Fatalities.............................. 8.6 8.6 0.86 0.01
Hospitalizations........................ 0.4 6.8 0.68 0.004
Medical Treatment....................... 0.001 14.8 1.5 0.01
Evacuations *........................... 0.0 7.0 0.70 0.004
Sheltering in Place *................... 0.0 40.9 4.1 0.03
Property Damage......................... ................ 11.4 1.1 0.007
-----------------------------------------------------------------------
Offsite Total....................... ................ 89.5 8.9 0.06
-----------------------------------------------------------------------
Total........................... ................ 2,747.3 274.7 1.8
----------------------------------------------------------------------------------------------------------------
* The unit value for evacuations is less than two hundred dollars and for sheltering in place is less than one
hundred dollars so when expressed in rounded millions the value represented in the table is zero.
[[Page 4684]]
EPA monetized both on-site and offsite damages. EPA estimated total
average annual on-site damages of $265.8 million. The largest monetized
average annual on-site damage was on-site property damage, which
resulted in average annual damage of approximately $205.5 million. The
next largest impact was on-site fatalities ($49.8 million) and injuries
($10.5 million).
EPA estimated total average annual offsite damages of $8.9 million.
The largest monetized average annual offsite damage was from sheltering
in place ($4.1 million), followed by medical treatment ($1.5 million),
property damage ($1.1 million), fatalities ($0.86 million), evacuations
($0.7 million), and hospitalizations ($0.68 million).
In total, EPA estimated monetized damages from RMP facility
accidents of $274.7 million per year. However, the monetized impacts
omit many important categories of accident impacts including lost
productivity, the costs of emergency response, transaction costs,
property value impacts in the surrounding community (that overlap with
other benefit categories), and environmental impacts. Also not
reflected in the 10-year baseline costs are the impacts of non-RMP
accidents at RMP facilities and any potential impacts of rare high
consequence catastrophes. A final omission is related to the
information provision. Reducing the probability of chemical accidents
and the severity of their impacts, and improving information disclosure
by chemical facilities, as the provisions intend, would provide
benefits to potentially affected members of society.
Table 18 summarizes four broad social benefit categories related to
accident prevention and mitigation including prevention of RMP
accidents, mitigation of RMP accidents, prevention and mitigation of
non-RMP accidents at RMP facilities, and prevention of major
catastrophes. The table explains each and identifies ten associated
specific benefit categories, ranging from avoided fatalities to avoided
emergency response costs. Table 18 also highlights and explains the
information disclosure benefit category and identifies two specific
benefits associated with it: Improved efficiency of property markets
and allocation of emergency resources.
Table 18--Summary of Social Benefits of Final Rule Provisions
------------------------------------------------------------------------
Specific benefit
Broad benefit category Explanation categories
------------------------------------------------------------------------
Accident Prevention............. Prevention of Reduced
future RMP Fatalities.
facility
accidents.
Accident Mitigation............. Mitigation of Reduced
future RMP Injuries.
facility
accidents.
Non-RMP accident prevention and Prevention and Reduced
mitigation. mitigation of Property Damage.
future non-RMP Fewer
accidents at RMP People Sheltered
facilities. in Place.
Avoided Catastrophes............ Prevention of rare Fewer
but extremely Evacuations.
high consequence Avoided
events. Lost
Productivity.
Avoided
Emergency
Response Costs.
Avoided
Transaction
Costs.
Avoided
Property Value
Impacts.*
Avoided
Environmental
Impacts.
Information Disclosure.......... Provision of Improved
information to efficiency of
the public. property markets.
Improved
emergency
response resource
allocation.
------------------------------------------------------------------------
* These impacts partially overlap with several other categories such as
reduced health and environmental impacts.
5. Discussion of Comments on Estimated Costs and Benefits
a. General Comments
EPA costs underestimated or based on outdated information. Several
commenters stated that EPA's cost estimates in the RIA for the proposed
rulemaking were generally inaccurate and underestimated the true costs
that facilities will face. Some commenters indicated that EPA's
estimated labor rates were based on outdated (2014) information.
Several commenters representing industry trade associations and
regulated facilities expressed specific concerns about the estimated
costs of each individual proposed rulemaking element, as well as EPA's
estimate of the costs of rule familiarization. Some of these commenters
provided specific cost information or estimates to support their
claims.
EPA considered this information and made substantial adjustments to
the cost estimates for every rule provision, including rule
familiarization. In addition to adjusting the cost estimate for the
final rule to incorporate cost information submitted by commenters, EPA
also adjusted the estimate to delete costs associated with proposed
rulemaking provisions that were not included in the final rule (e.g.,
Information availability to LEPCs), and to account for structural
changes between proposed and final rule provisions for certain rule
elements (e.g., the final rule requires emergency field and tabletop
exercises to be conducted less frequently than EPA had proposed). EPA
also updated its estimated labor rates to the most recent (2015) values
available from the Bureau of Labor Statistics.
Benefit concerns. Several commenters also addressed EPA's
assessment of benefits in their public comment submissions. While some
commenters indicated that the proposed requirements would improve
safety and prevent chemical releases, other commenters stated that the
proposed requirements would not provide any benefits, or that the costs
associated with the rule would severely outweigh any benefits. Other
commenters indicated that EPA had failed to quantify any benefits of
the rule, making a cost-benefit comparison impossible. Other commenters
stated that EPA overestimated benefits or inappropriately counted
benefits that actually accrue from OSHA's PSM standard as benefits of
the proposed rulemaking. One commenter also stated that EPA's benefit
categories would be offset by unstated additional costs, including
losses in reputation or brand value, higher insurance premiums, and
difficulty hiring and retaining workers that facilities may incur as a
result of an accident.
EPA disagrees that the proposed rulemaking would not provide
benefits or that the costs of the rule would necessarily outweigh its
benefits. As EPA explains in the RIA for the final rule, the benefits
of the final rule include reductions in the number of people killed,
injured, and evacuated or otherwise inconvenienced by sheltering in
place; reductions in the damage caused to property on-site and offsite
including product, equipment, and buildings; reductions in damages to
the
[[Page 4685]]
environment and ecosystems; and reductions in resources diverted to
extinguish fires and clean up affected areas. The final rule also
provides other benefits, such as increased public information, which in
addition to helping to minimize the impacts of accidents on the offsite
public, may also lead to more efficient property markets in areas near
RMP facilities.
EPA acknowledges that it is not possible to estimate quantitative
benefits for the final rule. EPA has no data to project the specific
impact on accidents made by each final rule provision. The accidents
themselves have highly variable impacts that are difficult to predict.
However, it is clear from the RMP accident data and other available
data that chemical accidents can impose substantial costs on firms,
employees, emergency responders, the community, and the broader
economy. Reducing the risk of such accidents and the severity of the
impacts when accidents occur, and improving information provision, as
the final rule intends, provides benefits to the potentially affected
members of society.
EPA disagrees that the final rule takes credit for benefits that
should accrue to the OSHA PSM standard. None of the provisions
contained in the final rule are duplicated in the OSHA PSM standard.
EPA also disagrees that regulated facilities will suffer losses in
reputation or brand value, higher insurance premiums, or have
difficulty hiring and retaining workers as a result of the final rule.
If, as EPA expects, the final rule results in the prevention of
accidents, then it should have the opposite of these effects, to the
extent they relate to chemical accidents.
b. Estimate of Rule Familiarization Costs
Several industry trade associations stated that EPA's estimate of
the costs of rule familiarization were too low. These commenters stated
that EPA's estimate only included time spent by management level
employees but should be expanded to include the cost of training all
relevant facility employees. Some of these commenters recommended
alternate approaches to estimating the costs of rule familiarization
that included estimates of time spent by additional labor categories
(e.g., attorneys, engineers, production staff, etc.). One commenter
also recommended that EPA consider adjusting its rule familiarization
estimate to better track with the estimate used by the NJ DEP for
revisions to the NJ TCPA regulations.
EPA agrees with these comments, and adjusted its rule
familiarization estimate accordingly, resulting in an increase of the
estimated costs of rule familiarization.
c. Third-Party Audit Costs
Many commenters including industry trade associations and
facilities stated that EPA's estimate of the costs of third-party
audits was too low. Many commenters also stated that third-party
auditor fees will be much higher than EPA's estimate, partially due to
the low availability of qualified auditors. Several commenters
submitted cost information from external audits to support their
estimates.
EPA generally agrees with these comments. Shortly after the
proposed rulemaking was published, EPA received cost information
relating to a series of third-party audits conducted by a facility as a
result of an enforcement action taken by EPA under CAA section 112(r).
The average cost of these audits was approximately double EPA's
estimate in the proposed rulemaking, and comparable to cost estimates
submitted by commenters. Therefore, EPA adjusted its cost estimate for
this provision of the final rule accordingly, resulting in the
estimated costs of third-party audits under the final rule nearly
doubling. EPA notes that the third-party audit provisions of the final
rule also relaxed, to some extent, the independence and competency
criteria for third-party auditors. The Agency believes that these
changes will increase the availability of qualified auditors, and
therefore make such audits less costly than might otherwise have been
the case.
d. Incident Investigation/Root Cause Costs
Several commenters stated that EPA's estimate of costs of incident
investigations and root cause analysis was inaccurately low. Some of
these commenters suggested that the required number of investigations
will increase significantly as a result of EPA's proposal to re-define
the term ``catastrophic release,'' and that this would cause the cost
of this rule element to increase substantially. Other commenters stated
that incident investigations require more labor hours than were
accounted for in EPA's cost estimate, and that the Agency needs to
significantly raise its estimate in order to account for these issues.
Some of these commenters submitted cost information to support their
estimates.
Although EPA disagrees that its proposed changes to the definition
of ``catastrophic release'' would have increased the number of
investigations required under the rule, the Agency elected not to
finalize the proposed changes to that definition, so no increase in
incident investigation costs will result from it. Regarding commenters'
concerns that EPA had not accounted for enough labor hours for
investigations in the RIA for the proposed rulemaking, after
considering these comments, the Agency generally agrees that its
estimate was too low. EPA incorporated the cost information submitted
by commenters into its estimate for the final rule. EPA also notes that
unlike the estimate for the proposed rulemaking, the final rule
economic estimate did not assume that investigations of near misses
would require fewer labor hours than investigations of actual release
events. This change also accounted for some of the increase in the
estimated cost of this rule element. Overall, these changes resulted in
the estimated cost of this rule element approximately doubling for the
final rule.
e. STAA Costs
STAA costs too low. EPA received several comments stating that the
Agency's estimate of costs for the proposed STAA provisions was too
low. Most of these comments addressed both EPA's estimate of the cost
of the initial study of safer technology options, as well as the
Agency's estimate of costs for the required evaluation of the
practicability of IST considered during the STAA.\121\ Some commenters
submitted alternate cost estimate information for both the initial
analysis of options and the practicability study.
---------------------------------------------------------------------------
\121\ EPA used the term ``feasible'' rather than
``practicability'' in the proposed rulemaking.
---------------------------------------------------------------------------
EPA notes that in general, commenter's cost estimates for the
initial analysis were higher than EPA's estimates, although not in
every case. EPA incorporated these estimates into the RIA as
appropriate--the Agency assumed that cost estimates for the STAA
initial analysis submitted by trade associations representing a
particular category of facilities (e.g., refineries, complex chemical
manufacturers, etc.) were the best representation of estimated costs
for those categories of facilities, and adjusted its own estimate
accordingly. In most cases, this cause the estimated costs for the STAA
initial analysis to increase.
Practicability study costs. For the practicability study, several
commenters stated that EPA's estimate was far too low, and indicated
that EPA should adopt an alternate approach that estimated the cost of
the practicability study as a fixed fraction of the cost of the project
being considered.
[[Page 4686]]
After reviewing these comments, EPA conducted additional research
on this subject which confirmed that these commenters were generally
correct on this point. EPA therefore adjusted its approach to
estimating the costs of practicability studies accordingly, which
resulted in a significant increase for the cost of this provision.
EPA's research on this topic and the resulting cost estimation approach
is explained in detail in Appendix D to the RIA for the final rule.
STAA implementation. EPA also received several comments stating
that the Agency should assume that the STAA provision will result in
some facilities implementing safer technologies, and include the costs
associated with such implementation in its economic estimate.
EPA disagrees with these comments. While the Agency agrees that
some facilities may elect to implement IST, the final rule does not
require facilities to do so. Therefore, the Agency believes that
implementation of IST will result from the owner or operator's own
judgement that it is beneficial for the source, after considering all
relevant factors. The STAA required under this rule may facilitate such
decision making, but does not require it.
f. Emergency Response Program Coordination With Local Responders' Costs
Emergency response program costs. The Agency received several
comments relating to the proposed emergency coordination provisions.
Some of the comments on this topic related to the Agency's projected
estimate of the cost for some sources to develop an emergency response
program, stating that EPA's estimate of these costs was too low.
EPA is not finalizing the proposed rulemaking provisions that it
believes would have resulted in many sources developing emergency
response programs. Therefore, these ``new responder'' costs were not
included in the RIA for the final rule.
Annual coordination burden. EPA also received comments that stated
its estimate of burden for the annual coordination provision, a
modified form of which is included in the final rule, were too low. One
commenter provided emergency coordination cost information for large
complex facilities, which was substantially higher than EPA's estimate
for the category of facilities.
EPA incorporated the emergency coordination cost information into
the revised economic estimate in the RIA for the final rule. EPA also
revised its estimate for this element to account for the fact that
changes to the annual coordination provision in the final rule, as well
as the Agency's decision not to finalize a portion of the information
availability provisions of the proposed rulemaking, may result in
greater information exchange occurring during annual coordination
meetings than was estimated under the proposed rulemaking. Under the
information availability provisions of the proposed rulemaking, the
owner or operator would have been required to annually provide certain
information to local emergency responders. The final rule does not
include this provision; however, the annual coordination provisions in
the final rule require the owner or operator to provide local response
officials with information relevant to emergency planning upon request.
The net effect of these changes was to more than double the estimated
costs of the annual emergency response coordination provision of the
final rule.
g. Facility Exercise Costs
Several commenters disagreed with EPA's approach to estimating the
costs of emergency response exercises, and in general, characterized
EPA's estimate as too low. Two of these commenters submitted alternate
cost estimates for this provision. However, the cost estimate provided
by one commenter did not appear to apply to facilities represented by
the commenter's industry association. The information submitted by the
other commenter appeared credible, but projected costs for large
complex facilities that were lower than EPA's estimate.
As a result of these comments EPA determined that its NPRM cost
estimate for large complex facilities was inflated, and lowered its
estimate to better reflect industry experience. The Agency also notes
that the final rule requires emergency exercises to be conducted less
frequently than was proposed in the NPRM. The net effect of the
structural changes to the final rule and EPA's adjustment of its cost
estimation approach resulting from public comments was to substantially
reduce the estimated costs of this rule provision.
h. Information Availability Costs
EPA received some comments stating that EPA's estimate of costs for
the proposed rulemaking's information availability provisions was too
low. These commenters indicated that EPA underestimated the time
required for facilities to prepare information required to be disclosed
to the public, and that EPA underestimated the cost of holding public
meetings. One commenter indicated that renting space for a public
meeting would cost as much as $10,000 per day.
Based on these comments, EPA increased its cost estimate for the
public information availability provision for large complex facilities.
EPA did not change its cost estimate for public meetings because
commenter's high estimates of the costs of public meeting space did not
comport with EPA's research and prior experience with the costs of
public meetings.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
submitted for approval to the OMB under the PRA. The Information
Collection Request (ICR) document that the EPA prepared has been
assigned EPA ICR number 2537.02 and OMB Control Number 2050-0216. You
can find a copy of the ICR in the docket for this rule, and it is
briefly summarized here.
This ICR amends a previously approved ICR (1656.15), OMB Control
No. 2050-0144. That ICR covers the risk management program rule,
originally promulgated on June 20, 1996; the current rule, including
previous amendments, is codified as 40 CFR part 68. This ICR addresses
the following information requirements that are part of the revised
rule:
(1) Make certain information related to the risk management program
available to the public, upon request;
(2) Hold a public meeting within 90-days of an accident subject to
reporting under Sec. 68.42 (i.e., an RMP reportable accident);
(3) Hire a third-party to perform or lead a compliance audit after
an RMP reportable accident or after an implementing agency determines
that conditions at the stationary source could lead to an accidental
release of a regulated substance or identifies problems with the prior
third-party audit;
(4) Conduct and document a root cause analysis after an RMP
reportable accident or a near miss;
(5) Conduct and document a STAA for a subset of Program 3
facilities in North American Industrial Classification System (NAICS)
codes 322 (paper manufacturing), 324 (petroleum and coal products
manufacturing), and 325 (chemical manufacturing);
(6) Meet and coordinate with local responders annually to exchange
emergency response planning information;
[[Page 4687]]
(7) Conduct an annual notification drill to verify emergency
contact information; and
(8) Responding facilities conduct and document emergency response
exercises including:
A field exercise at least every ten years, and
A tabletop exercise at least every three years.
EPA believes that the RMP regulations have been effective in
preventing and mitigating chemical accidents in the United States.
However, EPA is revising the rule to further protect human health and
the environment from chemical hazards through advancement of PSM based
on lessons learned--resulting in better coordination between
facilities, LEPC's, and the public. State and local authorities will
use the information in RMPs to modify and enhance their community
response plans. The agencies implementing the RMP rule will use RMPs to
evaluate compliance with part 68 and to identify sources for inspection
because they may pose significant risks to the community. Citizens may
use the information to assess and address chemical hazards in their
communities and to respond appropriately in the event of a release of a
regulated substance. These revisions are a result of a review of the
existing Risk Management Program and are finalized under the statutory
authority provided by section 112(r) of the CAA as amended (42 U.S.C.
7412(r)).
Some of the elements mandated in the regulation for the RMP may
require the submittal of data viewed as proprietary, trade secret, or
confidential. As described previously, EPA has adopted procedures for
sources to claim certain information as confidential business
information. EPA encourages facilities that have CBI claims to submit
substantiation with the RMP.
Respondents/affected entities: Manufacturers, utilities,
warehouses, wholesalers, food processors, ammonia retailers, and gas
processors.
Respondent's obligation to respond: Mandatory (CAA sections
112(r)(7)(B)(i) and (ii), CAA section 112(r)(7)(B)(iii), 114(c), CAA
114(a)(1)).
Estimated number of respondents: 14,280.
Frequency of response: On occasion.
Total estimated burden: 1,778,244 hours (per year). Burden is
defined at 5 CFR 1320.3(b).
Total estimated cost: $130,578,842 (per year), includes $8,285,600
annualized capital or operation & maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 and 609(b) of the RFA the EPA prepared an
initial regulatory flexibility analysis (IRFA) for the proposed
rulemaking and convened a Small Business Advocacy Review (SBAR) Panel
to obtain advice and recommendations from small entity representatives
that potentially would be subject to the rule's requirements. Summaries
of the IRFA and Panel recommendations are presented in the proposed
rulemaking at 81 FR 13637, March 14, 2016.
As required by section 604 of the RFA, the EPA prepared a final
regulatory flexibility analysis (FRFA) for this action. The FRFA
addresses the issues raised by public comments on the IRFA for the
proposed rulemaking. The complete FRFA is available for review in the
docket and is summarized here.
1. Statement of Need and Rule Objectives
The purpose of this action is to improve safety at facilities that
use and distribute hazardous chemicals. In response to catastrophic
chemical facility incidents in the United States, including the
explosion that occurred at the West Fertilizer facility in West, Texas,
on April 17, 2013 that killed 15 people (on May 11, 2016, ATF ruled
that the fire was intentionally set),\122\ President Obama issued
Executive Order 13650, ``Improving Chemical Facility Safety and
Security,'' on August 1, 2013. Section 6(a)(i) of Executive Order 13650
requires that various Federal agencies develop options for improved
chemical facility safety and security, including modernizing
regulations. As a result, EPA is finalizing revisions to the Risk
Management Program (40 CFR part 68).\123\
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\122\ See ATF Announces $50,000 Reward in West, Texas Fatality
Fire, https://www.atf.gov/news/pr/atf-announces-50000-reward-west-texas-fatality-fire.
\123\ For more information on the Executive Order see https://www.whitehouse.gov/the-press-office/2013/08/01/executive-order-improving-chemical-facility-safety-and-security.
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EPA believes that the RMP regulations have been effective in
preventing and mitigating chemical accidents in the United States;
however, EPA believes that revisions could further protect human health
and the environment from chemical hazards through the advancement of
process safety based on lessons learned. These revisions are a result
of a review of the existing Risk Management Program and information
gathered from the comments on the proposed rulemaking, SBAR panel,
public hearing, RFI, and Executive Order listening sessions, and are
finalized under the statutory authority provided by CAA section 112(r)
as amended (42 U.S.C. 7412(r)). For more information on the proposed
rulemaking, SBAR panel and outreach efforts for this action, see the
docket for this rulemaking (Docket ID Number EPA-HQ-OEM-2015-0725).
2. Significant Comments on the IRFA
a. General Comments
A Federal elected official, Federal agency, facility, and multiple
industry trade associations commented that EPA is not fulfilling its
obligations under the Regulatory Flexibility Act because the Agency did
not provide itself with enough time to consider the comments of either
the SBAR panel report or the SERs in the proposed rulemaking. Many of
these commenters asked that the SBAR panel recommendations be
incorporated in the final rule.
A facility stated that the proposed rulemaking will be burdensome
to small facilities. An association of government agencies expressed
concern that the costs of a more prescriptive risk management program
will fall on small communities. An industry trade association and
Federal agency claimed that the proposed rulemaking imposes a
disproportionate burden on small facilities and asserted that EPA
should eliminate impractical, unjustifiable, or non-cost-effective
requirements. Several industry trade associations and a facility
commented that the proposed rulemaking will result in more facilities
being required to become responders, which will be costly and difficult
for small businesses.
Multiple facilities commented that EPA should withdraw its proposed
rulemaking and coordinate more closely with OSHA's PSM rulemaking. An
industry trade association stated that OSHA's PSM program and EPA's RMP
proposal is creating confusion for small entities in the water sector.
The commenter asked that EPA update guidance documents and delay
further development of RMP revisions until OSHA'S PSM SBAR panel
process is complete.
[[Page 4688]]
EPA disagrees that the Agency did not fulfill its obligations under
the Regulatory Flexibility Act or that the Agency did not consider the
comments of the SBAR panel and SERs in the proposed or final rules. In
many locations throughout the proposed rulemaking, EPA discussed SBAR
panel recommendations and requested public comments on regulatory
alternatives recommended by the SBAR panel. EPA also made numerous
adjustments to the final rule to incorporate regulatory alternatives
that were suggested by SERs where those alternatives were also
supported by public comments and were consistent with the Agency's
policy goals. For example, EPA incorporated SBAR panel recommendations
by relaxing the competency and independence criteria for third-party
auditors; reducing the frequency for conducting facility exercises; and
not finalizing the proposed revision to the definition of
``catastrophic release.''
EPA also disagrees that the final rule is disproportionately
burdensome on small entities. In fact, the costliest final rule
provisions--STAA and facility exercises--affect relatively few small
entities. EPA minimized the effect of the STAA provisions on small
entities by applying these requirements to a narrowly-defined set of
facilities in three select industry sectors. EPA minimized the impact
of the exercise requirements on small entities by applying these
requirements only to responding facilities, which tend to more often be
large facilities. EPA also removed language from the final rule that
would potentially have required numerous small entities to become
responding facilities.
Regarding comments requesting that EPA withdraw its rulemaking and
coordinate more closely with OSHA, EPA notes that it did coordinate
with OSHA in the development of the proposed and final rules, and that
OSHA has also completed a SBAR panel as an initial step toward
proposing potential changes to the PSM standard, which may include some
changes that are similar to those in this rule. However, EPA does not
believe it is necessary for the Agency to conduct its rulemaking on
exactly the same timeline as OSHA. The 1990 CAA Amendments contained
separate timelines for the initial OSHA and EPA rulemakings and has no
provisions restricting timeframes for either agency amending its rules.
b. Third-Party Audits
A facility and an industry trade association stated that EPA's
assertion that the proposed requirements for third-party audits will
have ``fairly low impact on small businesses'' is false and the
requirement should be withdrawn entirely. Another industry trade
association commented that third-party audits will be especially costly
to small facilities. An industry trade association commented that the
requirement for third-party audits will lead to a lack of auditor
availability, a particularly difficult problem for small businesses.
EPA disagrees that the final rule's third-party audit requirements
have a disproportionately high impact on small businesses. EPA notes
that the third-party audit provisions will only affect facilities that
experience an RMP reportable accident. Over the last ten years, RMP
facilities reported approximately 150 accidents per year, and over 75%
of these accidents occurred at large businesses.\124\ Based on comments
expressed by SERS and others, EPA also relaxed the final rule's
independence criteria to allow the owner or operator to use third-party
audit teams that include some non-independent members, including
employees of the stationary source being audited. Also, the final rule
allows a third-party audit team to include retired employees of the
facility being audited, if their sole continuing financial attachments
to the owner or operator are employer-financed or managed retirement
and/or health plans. The audit team can also include other persons who
previously provided consulting services as an employee or contractor of
the owner or operator, provided those services were not provided within
the last two years (whereas the proposed rulemaking would have required
a three-year prohibition on previous employment). EPA believes these
changes will increase the availability of auditors and therefore make
third-party audits more cost-effective for small business owners.
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\124\ EPA, 2016. Regulatory Impact Analysis--Accidental Release
Prevention Requirements: Risk Management Programs Under the Clean
Air Act, Section 112(r)(7). Exhibit 7-9.
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c. Facility Exercises
Multiple state agencies, facilities and a Federal agency commented
that the increase in mandatory field exercises for Program 2 and
Program 3 facilities would adversely affect small RMP facilities and
small communities. An industry trade association stated that the
proposed rulemaking for facility coordination with local responders
should be more flexible based on the size of the community and its
existing local response capabilities.
A consultant/engineer stated that small utilities who lack a local
emergency agency with first responder capabilities will have difficulty
meeting the proposed requirements. The commenter requested that EPA
exempt small entities from the emergency response program requirement
and offer increased assistance to LEPCs in small communities.
A Federal agency stated that LEPC concerns should be addressed in a
guidance document instead of a rulemaking.
EPA notes that the final rule includes significant changes to the
exercise requirements to address concerns expressed by the SBAR panel,
individual SERs and other commenters. First, the final rule allows
owners and operators to work with local response officials to establish
an exercise schedule that works for both parties, provided the owner or
operator holds a field exercise at least once every ten years, and a
tabletop exercise at least once every three years. Second, the field
and tabletop exercise requirements only apply to responding facilities,
so non-responding facilities, which include the majority of small
businesses regulated under the RMP rule, are not required to comply
with them. Lastly, EPA did not finalize proposed rulemaking provisions
that would have required many small businesses to become responding
facilities.
d. Public Meetings and Information Disclosure
A Federal agency stated that the public meeting requirement should
include small business flexibility, allowing small business to post the
required information to be disclosed instead of organizing a public
meeting.
While EPA did not implement the recommendation to allow small
businesses to post required information in lieu of holding a public
meeting, EPA notes that the public meeting requirement, like the third-
party audit requirement, only applies to facilities after an RMP-
reportable accident, which minimizes its impact on small businesses.
Also, EPA revised the public meeting requirements to extend the
timeframe within which the meeting must be held (from 30 to 90 days
after an RMP reportable accident).
3. SBA Office of Advocacy Comments and EPA Response
The SBA Office of Advocacy comments urged EPA to consider small
business concerns and provide flexibility to reduce the impact of the
proposed rulemaking on small businesses. The following sections
[[Page 4689]]
describe SBA recommendations and how EPA has revised the rule to
provide additional flexibility that benefits small businesses.
a. Third-Party Audits
Duplicative of existing requirements. SBA suggested that third-
party audits are too burdensome for small businesses and should be
eliminated or reduced significantly in scope. SBA argued that the
requirements are duplicative of the existing requirements for self-
audits and incident investigations and suggested that EPA waive the
requirements if an implementing agency conducts an inspection as a
result of a reportable release or facility noncompliance.
EPA disagrees that third-party audits are duplicative of existing
requirements. Following an accident, incident investigations often
reveal that facilities have deficiencies in some prevention program
requirements related to that process. Incident investigations generally
only evaluate the affected process, and do not necessarily address all
covered processes at a facility, or even all prevention program
elements for the affected process. However, compliance audits entail a
systematic evaluation of the full prevention program for all covered
processes, and EPA expects that third-party audits should identify
deficiencies in any other covered processes at such facilities.
Additionally, EPA does not agree that third-party audits should be
waived if EPA conducts an inspection. Third-party audits do not
constitute enforcement, nor do they substitute for inspections by
implementing agencies. The audits are designed primarily to benefit
owners or operators by assisting them to identify both actual
noncompliance as well as operational or equipment deficiencies,
previously unidentified risk factors, and accident release and/or
regulatory noncompliance precursor conditions which, if uncorrected,
could lead to releases and/or enforcement actions. Proactively
addressing deficiencies, risk factors, and precursor conditions to
accidental releases and regulatory noncompliance will provide
financial, regulatory, and environmental benefits for facility owners
and operators, including small businesses, and communities.
Finally, EPA has reasonably targeted third-party audit requirements
at facilities that have had RMP reportable incidents that may
demonstrate weaknesses in prior self-assessments and at facilities of
heightened concern for implementing agencies. Most small businesses do
not have RMP reportable releases and the implementing agency criterion
focuses on conditions with the potential to lead to accidental
releases, rather than authorizing implementing agencies to require
third-party audits under a potentially wide range of circumstances,
including minor noncompliance. Therefore, EPA does not expect that this
provision will be burdensome for small facilities.
Applicability. SBA recommended that EPA limit the requirement to
Program 3 facilities with major accidents with offsite impacts.
EPA disagrees with this approach. EPA based applicability of third-
party audits on whether a source had an RMP reportable accident or
whether conditions exist that could lead to an accidental release. EPA
believes that these criteria are potential indicators for noncompliance
with prevention program requirements and therefore warrant an
evaluation by a third-party.
Auditor qualifications. SBA expressed concerns with the auditor
qualifications in the proposed rulemaking arguing that it would be
difficult to find auditors with no financial connection to the facility
(such as retirees). SBA recommended that EPA allow small businesses
with less than 250 employees to submit a waiver request of the
independence criteria based on limited availability of independent
auditors. SBA also expressed concern over the PE criterion for third-
party auditors and recommended that EPA consider other
accreditations\125\ to satisfy the competency criterion for third-party
auditors. SBA recommended EPA consider other criteria in place of the
PE criterion to allow additional flexibility such as years of
experience, number of audits conducted at a specific facility type, and
active involvement in developing industry standards.
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\125\ SERs suggested other accreditations including: degreed
chemists, degreed chemical engineers, Certified Safety Professionals
(CSP), Certified Industrial Hygienists (CIH), Certified Fire
Protection Specialists (CFPS), Certified Hazardous Materials
Managers (CHMM), Certified Professional Environmental Auditors
(CPEA) or Certified Process Safety Auditors (CPSA).
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In order to address concerns about the availability of auditors,
EPA modified the third-party auditor qualification criteria in the
final rule to enable more firms and individuals to qualify as third-
party auditors or third-party audit team leaders. The most significant
modification to the third-party auditor qualification criteria is that
only employees of the independent third-party audit firm must meet the
independence criteria of Sec. 68.59(c)(2) and/or Sec. 68.80(c)(2).
For third-party audit teams, the team leader must meet both the
competency and independence criteria of Sec. 68.59(c) and/or Sec.
68.80(c) and all other employees of the third-party auditor firm that
participate on the team need only meet the independence criteria.
Third-party audit teams may also include other personnel, such as
consultants or facility employees and these personnel are not subject
to the third-party qualification criteria of the final rule.
EPA also revised the timeframe within which third-party auditors
cannot provide business or consulting services to two years. EPA added
language indicating that if a third-party-firm employs personnel who
have provided business or consulting services to the facility within
the prescribed timeframe (i.e. within two years of the audit) then the
third-party audit firm must ensure that these personnel do not
participate on the audit team. Additionally, EPA clarified in
regulatory language the circumstances in which a retired employee may
participate in a third-party audit and deleted the PE requirement from
the final rule. Viewed as a whole, these changes serve to increase the
types of personnel who may potentially serve as independent third-party
auditors. Therefore, EPA believes it will be unnecessary for facility
owners or operators to petition for a relaxation of auditor
qualifications.
b. Incident Investigations and Root Cause Analysis
SBA recommended that EPA limit the scope of this requirement to
apply only to reportable releases in order to reduce the burden on
small businesses. SBA further recommended that EPA retain the existing
definition of ``catastrophic release.''
EPA is finalizing the scope of the incident investigation
requirement to apply to an incident that resulted in a catastrophic
release or could reasonably have resulted in a catastrophic release
(i.e. a near miss). However, EPA is not finalizing the proposed
definition for catastrophic release and is instead maintaining the
existing definition. In the final rule, EPA is clarifying what we mean
by near miss to address uncertainty about the term.
c. STAA
SBA recommended mandating an IST analysis only at the design stage
of new processes. Alternatively, to reduce the burden for small
entities, SBA recommended delaying the provision for small firms (with
less than 250 employees) until three years after the rule's compliance
date for larger firms in order to allow EPA a chance to review the
utility of the provision. SBA
[[Page 4690]]
also recommended that EPA exclude processes that are governed by
specifications established by a government agency or by a customer
through a contractual relationship.
EPA is finalizing the STAA provision as proposed. EPA disagrees
that STAA analyses should only be required during the initial design
phase of a facility. While the greatest potential opportunities for
using IST occur early in process design and development, many IST
options may still be practicable after the initial design phase.
Furthermore, STAA involves more than just IST. Safer technology
alternatives also include passive measures, active measures, and
procedural measures, and these measures can be modified and improved
after the initial design of a facility. EPA notes that many RMP-
regulated facilities were originally constructed decades ago, yet major
enhancements have been reported in some plants that have been operating
for many years.\126\ CCPS explains that inherently safer strategies can
be evaluated throughout the lifecycle of a process, including
operations, maintenance and modification, and EPA agrees with this
approach.
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\126\ CCPS. 2009. Inherently Safer Chemical Processes: A Life
Cycle Approach, 2nd ed., American Institute of Chemical Engineers,
CCPS New York, Wiley, p. 25.
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EPA also disagrees with the suggestion to exempt certain groups
(such as batch toll manufacturers) from the STAA requirement. Safer
technology alternatives include many options beyond chemical
substitution or minimization. Therefore, even where a contractual
relationship or regulation requires a regulated batch toll
manufacturing facility to use a particular regulated substance in
specified quantities, owners and operators of batch toll manufacturing
facilities may still consider other potential safer alternatives, such
as passive, active, or procedural measures. Also, the final rule does
not require regulated sources to implement IST or ISD considered, so
there is no conflict between this final rule and other regulations that
may apply to RMP-regulated facilities subject to STAA requirements. For
example, an owner or operator would be in compliance with this rule if
he or she determines that a chemical substitution is not practicable if
the substitution is prohibited by another regulation.
Finally, EPA is not delaying compliance dates for small businesses
to allow time for evaluating the provision at large facilities. STAA
for a source is a site-specific determination and would be difficult to
compare among facilities. EPA believes it would be impractical to
gather/analyze information on STAA implementation to determine the
utility of the provision for small facilities.
d. Emergency Response Program Coordination With Local Responders
SBA recommended that EPA adopt compliance flexibility for small
businesses by limiting their responsibility to making good faith
efforts to coordinate with local responders. SBA further suggested that
EPA remove the provision to allow LEPCs to require sources to develop
emergency response programs. SBA also suggested that EPA provide
guidance to local responders, rather than expand existing regulations,
and focus on implementing and enforcing emergency planning requirements
for LEPCs. Finally, SBA recommended providing guidance on expectations
for coordination between a facility and local responders as well as
clarifying a facility's obligations for preparing an emergency response
program.
EPA is not finalizing the provision that would have required the
source to develop an emergency response program following a written
request from the LEPCs or local response authorities. Furthermore, the
final rule clarifies requirements for coordination activities between
facility personnel and local responders. EPA understands some
communities do not have functional LEPCs, but has accounted for this
possibility by requiring coordination to be with ``local emergency
planning and response organizations.'' This term is intended to
encompass all manner of local public emergency planning and response
organizations. In many cases this will be the LEPC, but in other cases
it may be a local emergency management agency, a local fire department,
or another local response organization. These non-LEPC planning
entities can use this provision to obtain necessary planning
information even when they lack the authority granted LEPCs under EPCRA
303(d)(3). Regardless of whether or not their community has an active
LEPC, EPA expects owners and operators of regulated sources to make
good faith efforts to carry out the coordination activities required in
the final rule. If local emergency planning and response organizations
decline to participate in coordination activities, or the owner or
operator cannot identify any appropriate local emergency planning and
response organization with which to coordinate, the owner or operator
should document their coordination efforts, and continue to attempt to
perform coordination activities at least annually.
The rule also clarifies requirements for facilities that must
develop an emergency response program in accordance with Sec. 68.95.
Responding facilities must comply with all of the provisions of Sec.
68.95, which include developing an emergency response plan, developing
procedures for the use, inspection, and testing of emergency response
equipment, conducting training for employees in relevant procedures,
and updating the emergency response plan to reflect changes at the
source. Any facility that plans to use its employees to take response
actions beyond those specified in its emergency action plan under 29
CFR 1910.38 as a result of an accidental release at the source--which
could include, for example, donning emergency air breathing apparatus
in order to enter an area where a toxic gas leak has occurred with the
intention of stopping or controlling the release--would be expected to
have obtained appropriate equipment and training, and to address these
activities in its emergency response program, even if the facility is
also relying on local responders to supplement its own response, or to
manage offsite response actions such as evacuations and sheltering-in-
place.
e. Exercises
SBA recommends requiring small businesses to only conduct tabletop
exercises and eliminate the field exercises requirement of the proposed
rulemaking.
EPA is requiring that responding facilities conduct both tabletop
and field exercises; however, we have revised the frequency to reduce
the burden on all facilities. The rule requires the owner or operator
to conduct both tabletop and field exercises involving a simulated
accidental release of a regulated substance. As part of the
coordination with local emergency response officials required by Sec.
68.93, the owner or operator is required to consult with these local
officials to establish an appropriate frequency for tabletop and field
exercises. However, in all cases, the owner or operator must conduct a
field exercise at least once every ten years and a tabletop exercises
at least once every three years. Additionally, EPA encourages several
nearby or adjacent facilities to conduct joint exercises, and this may
prompt small facilities to pool their response resources, thereby
reducing the exercise and emergency response burden on each facility.
[[Page 4691]]
f. Information Availability
Availability of information for LEPCs. SBA suggests that EPA
require a one-page summary of information relevant for emergency
response to an accident at the facility. SBA also expressed concern
with the recordkeeping requirement of the proposed provision and
suggested that EPA require the information be provided within a
reasonable time period after receiving a request to allow the facility
time to develop the information.
EPA maintains that it is very important to ensure that LEPCs or
local emergency response officials have the chemical information
necessary for developing local emergency response plans, however, EPA
believes it is unnecessary to specify in the RMP rule the types or
format of information that LEPCs or emergency response officials may
request. Therefore, EPA has eliminated this provision in the final
rule. EPCRA section 303(d)(3) already provides the necessary authority
to allow LEPCs to request information needed to develop the local
emergency response plan. Additionally, EPCRA requires facilities to
provide SDSs and inventory information to LEPCs to assist emergency
planners and responders. Under EPCRA section 312(f), fire departments
have the authority to inspect these facilities to better understand the
risk associated with these chemicals and how to deal with those risk in
the local emergency response plan.
EPA added language to the emergency response coordination
provisions of Sec. 68.93, which requires the owner or operator to
provide ``any other information that local emergency planning and
response organizations identify as relevant to local emergency
planning.'' This approach will allow LEPCs and other local emergency
officials to obtain the information they require to meet their
emergency response planning needs. It will also allow local emergency
planners and response officials to ask questions of facility personnel
about the risks associated with the chemical hazards at the facility
and about appropriate mitigation and response techniques to use in the
event of a chemical release.
Availability of information for the public. SBA recommends that EPA
improve public awareness of existing sources of information through its
own Web site or other public forums rather than requiring small
businesses to repackage existing information. Alternatively, SBA
suggests requiring facilities to indicate where this information can be
obtained.
The final rule requires the owner or operator to make certain
chemical hazard information for all regulated processes at a stationary
source available to the public upon request. The facility must provide
ongoing notification to the public about what chemical hazard
information is available upon request, how the public may obtain such
information, and where to access any other available information on
community emergency preparedness. The facility owner or operator must
provide information to the requester within 45 days of receiving a
request.
Public meetings. SBA recommends allowing small businesses to post
information that would be disclosed at a public meeting rather than
require them to host meetings. Furthermore, SBA suggests that EPA
should provide a longer time period for holding a public meeting to
allow the owner or operator more time to gather information and
adequately prepare for the meeting.
In the final rule, EPA is requiring all facilities to hold a public
meeting after an RMP-reportable accident, but is extending the
timeframe for the public meeting to 90 days in response to comments.
EPA believes that small businesses should host public meetings
following an RMP reportable accident to allow community members an
opportunity to talk with facility personnel. EPA encourages small
businesses to find ways to reduce costs of public meetings such as by
hosting the meetings at inexpensive venues, such as local schools,
community centers, or churches.
4. Estimate of the Number of Small Entities to Which the Final Rule
Applies
The RMP rule affects a broad range of sectors (296 separate NAICS
codes are listed in RMP filings; 240 of these are associated with small
entities). The RMP data include facility and parent company name, as
well as the number of full time equivalents (FTE) for the facility and
the NAICS codes. To develop an estimate of the number of small
entities, the analysis required a series of reviews of the data to
identify the large entities and the small entities that were part of
small firms owning multiple facilities. For more information on the
analysis to estimate the number of small entities, see section 7.2 of
the RIA.
5. Projected Reporting, Recordkeeping and Other Compliance Requirements
of the Final Rule
Under the final rule, all facilities are required to make certain
information available to the public upon request. Program 2 and Program
3 facilities are also required to provide information upon request to
local response officials during annual coordination meetings. Program 1
facilities will likely not have to spend more than an hour per year on
this disclosure because the information disclosed to the public is
information every facility should have readily available and because
the additional information that will be provided, upon request, to
local responders relates to provisions that do not apply to Program 1
facilities. Therefore, the FRFA has not considered Program 1 small
facilities in the analysis of impacts.
Program 2 and Program 3 facilities will incur the same costs for
the other provisions except for the STAA. Each facility will be
required to update information to be disclosed annually, coordinate
with the local responders, and conduct a notification drill annually.
If the facility is a responder, it will have to hold exercises every
three to ten years, including at least one full field exercise every
ten years. Program 3 facilities in NAICS codes 322, 324, and 325 will
have to conduct an STAA as part their PHA every five years.
If a facility has an accident, it will incur costs to hold a public
meeting within 90 days of an RMP reportable accident. The facility will
also incur costs for obtaining an independent third-party to conduct
their next scheduled compliance audit and to conduct a root cause
analysis as part of the incident investigation. In the event of a near
miss, facilities will also be required to conduct a root cause
investigation. Section 7.3.1 of the RIA describes the costs of the
final rule for small entities.
6. Steps Taken To Minimize Economic Impact to Small Entities
The RIA analyzed the proposed new requirements and revisions to
existing requirements as well as several alternatives for each. In most
cases, EPA chose regulatory alternatives that had reduced impacts on
small businesses relative to other alternatives that EPA considered. In
this section, we discuss each final rule provision and explain how the
provision minimizes impacts on small businesses and which of the SBAR
Panel recommendations were implemented.
a. Third-Party Audits (Program 2 Sec. Sec. 68.58 and 68.59 and Program
3 Sec. Sec. 68.79 and 68.80)
EPA is finalizing a requirement for the owner or operator to engage
a third-party auditor to conduct a compliance audit when required by an
implementing agency due to conditions
[[Page 4692]]
at the stationary source that could lead to an accidental release of a
regulated substance or following an RMP reportable accident. Limiting
the applicability of this provision to sources that have had RMP
reportable accidents minimizes its impact to the overall universe of
RMP facilities, and particularly to small businesses. As indicated in
Exhibit 5-18 of the RIA, the estimated cost of the high option ($196
million annualized) is nearly 20 times higher than the estimated costs
of the preferred option ($9.9 million annualized). Furthermore, a
majority of the costs for the option would likely be borne by large
businesses as historically, most RMP accidents have occurred at
facilities that do not meet SBA small business criteria. Table 19 shows
the number of accidents from 2004--2013 that occurred at small and
large facilities.
Table 19--Percentage of Accidents at Small and Large RMP facilities, 2004-2013
----------------------------------------------------------------------------------------------------------------
Program 1 Program 2 Program 3
Sector ------------------------------------------------------------ Total
Small Large Small Large Small Large
----------------------------------------------------------------------------------------------------------------
NAICS 325--Chemical Manufacturing......... 0 6 1 5 53 465 530
NAICS 311, 312--Food/Beverage 0 0 2 0 58 210 270
Manufacturers............................
NAICS 322--Paper Manufacturing............ 0 0 0 0 9 37 46
NAICS 331, 332, 333, 334, 336, 339--Other 0 0 4 0 12 27 43
Manufacturing............................
NAICS 11, 12, 15, 42491--Agricultural 0 0 0 0 91 65 156
Chemical Distributors....................
NAICS 4246, 4247--Chemical/petroleum 0 2 0 0 7 29 38
wholesale................................
NAICS 4244, 4245--Other wholesale......... 0 0 0 0 7 13 20
NAICS 493--Warehouse...................... 0 1 0 0 18 53 72
NAICS 324--Petroleum and Coal Products 2 6 0 0 15 146 169
Manufacturing............................
NAICS 22131, 22132--Water/POTW............ 0 0 14 20 17 24 75
NAICS 211--Oil/Gas exploration............ 4 4 1 0 10 34 53
Other..................................... 3 7 7 4 7 17 45
---------------------------------------------------------------------
Total..................................... 9 26 29 29 304 1,120 1,517
----------------------------------------------------------------------------------------------------------------
While the third-party audit provision should have a fairly low
impact on small businesses, the SBAR Panel made additional
recommendations to further minimize the impacts of this provision on
small businesses, which EPA considered for this final rule. Of the
suggested recommendations, EPA revised the provision to require that
only a third-party leading the audit team must meet the independence
and competency criteria of the rule, and also by allowing that a
retired employee of the source can participate in the audit. EPA also
did not finalize the competency criterion that required a PE to
participate in the audit.
b. Incident Investigation/Root Cause Analysis (Sec. Sec. 68.60 and
68.81)
In the final rule, EPA is requiring a root cause investigation for
any P2 or P3 reportable accident or near miss. Although the Agency
chose the higher cost option, this provision is estimated to be one of
the least costly provisions of the final rule. In fact, the costs for
both options considered were nearly indistinguishable--as indicated in
Exhibit 5-18 of the RIA, both the low and preferred options are
estimated to cost approximately $1.8 million annually. Therefore, EPA
believes that the additional safety benefit of requiring owners and
operators of Program 2 processes to also conduct root cause analyses
after incidents and near misses is warranted. Of the suggested SBAR
recommendations, EPA clarified that near miss investigations are not
intended to cover minor accidents or minor near misses that could not
reasonably have resulted in a catastrophic release. EPA also chose not
to finalize the proposed definition of ``catastrophic release,'' which
some SERs had indicated could increase the number of investigations
required.
c. STAA (Sec. 68.67)
For STAA, EPA is finalizing the least costly option. The final
rule, which applies the STAA requirement to P3 processes in NAICS 322
(paper manufacturing), 324 (petroleum and coal products manufacturing),
and 325 (chemical manufacturing), costs $80.0 million annually and is
approximately $40 million less costly than the medium option ($120.4
million annually), which would have applied the requirement to all P3
processes, and likely far less costly than the high option, which would
require implementation of practicable safer alternatives for all P3
processes. Although the SBAR panel provided recommendations, EPA
finalized this provision as proposed, and estimates that it will affect
relatively few small businesses given the narrow focus of the
provision's applicability.
d. Emergency Response Program Coordination With Local Responders
(Sec. Sec. 68.90, 68.93, and 68.95)
The final rule requires all facilities with P2 or P3 processes to
coordinate with local response agencies annually and document
coordination activities. This provision does not have alternatives, but
the SBAR panel did provide recommendations on streamlining the
provision. In response to these and other recommendations, EPA modified
the extent of required coordination, removed the requirement for the
outcome of coordination to dictate whether a source must implement an
emergency response program, and eliminated the ability for LEPCs to
mandate sources' response capabilities.
e. Facility Exercises (Sec. 68.96)
Notification Exercises. The final rule requires all facilities with
P2 or P3 processes to annually conduct an emergency notification
exercise to ensure that their emergency contact list is complete,
accurate, and up-to-date. This provision is expected to be one of the
least costly rule provisions at $1.4 million annually (only the public
meetings provision is estimated to cost less). Therefore, EPA did not
consider any alternatives to reduce the impact of this provision on
small businesses, nor did the SBAR panel make any such recommendations.
Tabletop and Field Exercises. The final rule requires responding
facilities to conduct a full field exercise at least once every ten
years and tabletop exercises triennially. As this provision only
affects responding facilities, which tend to more often be large
facilities (see Exhibit 3-7 in the RIA), EPA has
[[Page 4693]]
implemented a rule that mitigates the impact on small entities. EPA
also considered a low option that would only require triennial tabletop
exercises. This option would have saved approximately $8 million
annually. EPA did not implement the low option because the Agency
believes that periodic field exercises are an important component of a
comprehensive emergency response program. In response to SBAR panel
recommendations, EPA reduced the required frequency of exercises to
minimize the impact of this provision on small businesses.
f. Information Availability (Sec. 68.210)
Under the final rule requirements, all facilities are required to
make certain chemical hazard information available to the public, upon
request. The owner or operator must provide an ongoing notification to
the public that such information is available as well as instructions
on how to request the information. Facilities are also required to hold
public meetings within 90 days of any RMP reportable accident. Although
EPA has not identified specific alternatives to minimize the impact of
the information disclosure provisions on small businesses, the Agency
believes that in general, smaller facilities will bear lower costs to
comply with these provisions.
In response to the SBAR recommendations, EPA eliminated the
proposed provision that would have had required specific information to
be disclosed to LEPCs and extended the timeline for public meetings
from 30 days to 90 days after an RMP reportable accident. In addition,
information to be provided to the public is only required to be
disclosed to the public upon request.
7. Small Business Compliance Guides
EPA is preparing a Small Entity Compliance Guide to help small
entities comply with this rule. EPA expects that this guide will be
made available on the EPA Web site prior to March 15, 2021, when
facilities will have to comply with new and revised data elements for
the final rule.
D. Unfunded Mandates Reform Act (UMRA)
This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for
state, local, and tribal governments, in the aggregate, or the private
sector in any one year. Accordingly, the EPA has prepared a written
statement required under section 202 of UMRA. The statement is included
in the docket for this action and briefly summarized here.
Over the 16 years of implementing the RMP program and, most
recently through Executive Order 13650 listening sessions, webinars,
consultations, and a public hearing, EPA has engaged states and local
communities to discuss chemical safety issues. In the nine Executive
Order 13650 Improving Chemical Facility Safety and Security listening
sessions and webinars, held between November 2013 and January 2014,
states and local communities identified lack of chemical facility
participation and coordination in local emergency contingency planning
as a key barrier to successful local community preparedness.
Additionally, EPA has had consultations with states and local
communities through participation in the National Association of SARA
Title III Program Officials (NASTTPO) annual meetings to discuss key
issues related to chemical facility and local community coordination
and what areas of the RMP regulations need to be modernized to
facilitate this coordination and improve local emergency preparedness
and prevention. Key priority options discussed with NASTTPO states and
local communities included: improving emergency response coordination
between RMP facilities and LEPCs/first responder and requiring
emergency response exercises of the RMP facility plan to involve LEPCs,
first responders and emergency response personnel.
This action may significantly or uniquely affect small governments.
The EPA consulted with small governments concerning the regulatory
requirements that might significantly or uniquely affect them. Through
the July 31, 2014, RFI (79 FR 44604), EPA sought feedback from
governmental entities while formulating the proposed revisions in this
action. Additionally, EPA participated in ongoing consultations with
affected SERs (including small governmental entities) through the SBAR
panel. EPA convened an SBAR panel in accordance with the requirements
of the RFA, as amended by the Small Business Regulatory Enforcement
Fairness Act (SBREFA). Finally, EPA hosted a public hearing on March
29, 2016 to provide interested parties the opportunity to present data,
views or arguments concerning the rule.
Discussion of comments. EPA received comments concerning unfunded
mandates. Several commenters, including state agencies and a
professional organization, said that the proposed rulemaking adds to
the unfunded mandate for LEPCs, which were never provided with any
source of Federal funding. A few state agencies said that the proposed
field exercises in particular will be a significant unfunded cost for
LEPCs that choose to participate. A state agency, an industry trade
association, and an association of government agencies commented that
these additional costs will adversely affect smaller RMP facilities and
smaller communities with municipal-owned RMP facilities. The industry
trade association also suggested that EPA should consult with these
municipal governments on the impact these proposed requirements will
have on their operating budgets. A professional organization stated
that very few LEPCs are able to support themselves with fees or other
taxes on regulated facilities.
EPA disagrees that this final rule adds to the burden to LEPCs and
local emergency response organizations. EPA believes that the
amendments to the local coordination requirements clarifies existing
requirements. LEPCs are required to develop community emergency
response plans and the revisions to the RMP rule are intended to ensure
that facility representatives coordinate with LEPC and local emergency
response officials in developing those plans. Furthermore, EPA provided
flexibility in the final rule to allow LEPC and local emergency
response officials to participate as their schedules allow. LEPC and
local emergency response officials are encouraged, but not required, to
participate in facility exercises.
EPA agrees that the final rule will bear costs for small facilities
and small governments; however, EPA has built flexibility into the rule
provisions to allow facility owners and operators to tailor their risk
management programs to their facility specific circumstances. Third-
party compliance audits, and public meetings apply only following an
RMP reportable accident, root cause analysis applies only after a
catastrophic release (e.g. an RMP-reportable accident) or after an
incident that could reasonably have resulted in a catastrophic release.
STAA analyses are limited to specific NAICS codes, and exercises apply
only to responding facilities. EPA has further revised information
availability requirement to be provided only upon request by a member
of the public. These provisions should minimize costs of the final rule
for small facilities.
E. Executive Order 13132: Federalism
This action does not have Federalism implications. The EPA
believes, however, that these regulatory revisions may be of
significant interest to local governments. Consistent with the EPA's
[[Page 4694]]
policy to promote communications between the EPA and state and local
governments, and to better understand the concerns of local
governments, EPA sought feedback through the July 31, 2014, RFI (79 FR
44604), through the SBREFA process, and a public hearing on March 29,
2016. EPA also hosted a conference call with governmental entities on
May 4, 2016. A copy of the presentation and notes from the meeting are
available in the docket for this action.\127\
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EPA received comments pertaining to Federalism implications for
this action. An industry trade association asserted that EPA's proposal
to allow local authorities to request that the owner or operator assume
emergency response obligations, which the commenter argues divorces
these organizations from their Federal, state, and/or local legal
obligations, raises Federalism issues by undermining the fundamental
mission of those entities and state delegations of more (or less)
authority to local emergency response organizations. Similarly, other
industry trade associations commented that EPA's proposed delegation of
authority to LEPCs to designate facilities as responding stationary
sources raises significant separation of powers and federalism
concerns. As the basis for this argument, the commenters relied
primarily on the Supreme Court decisions in Printz v. United States
(521 U.S. 898 (1997)) and New York v. United States (505 U.S. 144
(1992)), in which the court held that Federal agencies cannot
``commandeer'' local governments to implement Federal regulatory
programs.
A few commenters, including an associations of government agencies
and an industry trade association, commented that the Agency had missed
a valuable opportunity to engage local governments prior to the rule's
publication, which the commenter described as counter to EPA's internal
``Guidance on Executive Order 13132: Federalism'' (Nov. 2008) that
specifies that States and local governments must be consulted on rules
if they impose substantial compliance costs, preempt state or local
laws, and/or have substantial direct effects on state and local
governments. Because the commenter does not believe that EPA has
adequately engaged local government agencies, an association of
government agencies requested that EPA delay advancing the proposed
rulemaking and perform a local government impact analysis and
consultation with the nation's cities, counties, and mayors before
finalizing the rule.
EPA is finalizing requirements for the stationary source owner or
operator to coordinate annually with local emergency planning and
response officials to ensure that the stationary source is included in
the community emergency response plan (for toxic substances) and/or to
coordinate response activities with local emergency responders (for
flammable substances). However, after considering concerns raised by
commenters related to providing LEPCs with the authority to require a
stationary source to develop an emergency response program in
accordance with Sec. 68.95, EPA has eliminated this provision from the
final rule. EPA did not intend this provision to undermine the
fundamental mission of response agencies nor as a delegation of Federal
authority. EPA expects that some stationary source owners or operators
will self-identify a need to develop an emergency response program if
the result of local coordination indicates that the stationary source
is not included in the community emergency response plan (e.g., when an
LEPC is inactive and there is no community emergency response plan or
the existing plan is outdated).
EPA disagrees with comments that suggest that EPA did not engage
local governments prior to the rule's publication. EPA followed the
agency's internal guidance on Executive Order 13132 when determining
whether to initiate consultation with state and local governments.
Furthermore, through Executive Order 13650 listening sessions,
webinars, consultations, and a public hearing, EPA has engaged states
and local communities to discuss chemical safety issues. Additionally,
EPA has consulted with states and local communities through
participation in the NASTTPO annual meetings to discuss key issues
related to chemical facility and local community coordination and what
areas of the RMP regulations need to be modernized to facilitate this
coordination and improve local emergency preparedness and prevention.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. There are approximately 260
RMP facilities located on tribal lands. Tribes could be impacted by the
final rule either as an owner or operator of an RMP-regulated facility
or as a Tribal government when the Tribal government conducts emergency
response or emergency preparedness activities under EPCRA.
The EPA consulted with tribal officials under the EPA Policy on
Consultation and Coordination with Indian Tribes early in the process
of developing this regulation to permit them to have meaningful and
timely input into its development. EPA hosted a public hearing on March
29, 2016 that was open to all interested parties and hosted a total of
two conference calls for interested tribal representatives on April 20,
2016 and April 26, 2016. A summary of each conference call is available
in the docket for this action.\128\ EPA did not receive any written
comments from tribal representatives.
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As required by section 7(a), the EPA's Tribal Consultation Official
has certified that the requirements of the executive order have been
met in a meaningful and timely manner. A copy of the certification is
included in the docket for this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because the EPA
does not believe the environmental health risks or safety risks
addressed by this action present a disproportionate risk to children.
The EPA believes that the proposed revisions to the Risk Management
Program regulations would further protect human health, including the
health of children, through advancement of process safety. EPA did not
receive any comments associated with this issue.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. This action is not anticipated to have
notable impacts on emissions, costs or energy supply decisions for the
affected electric utility industry. EPA did not receive any comments
associated with this issue.
I. National Technology Transfer and Advancement Act (NTTAA)
This action involves technical standards. The EPA is requiring
third-party auditors to be experienced with applicable RAGAGEP, which
include
[[Page 4695]]
Voluntary Consensus Standards as well as other measures, for regulated
processes being audited. Numerous different standards apply to
processes regulated under the final rule and their application will
vary depending on the particular process and chemicals involved. EPA is
not listing all the various codes, standards and practices that would
apply to the wide variety of chemical processes covered by this rule as
doing so would be impracticable, given that this rule affects sectors
across many industries and listing the applicable RAGAGEP measures
would require the EPA to update that list every time there was a change
in the industry standards or best practices. The final rule requires
third-party auditors to be familiar with standards applicable to
processes they audit, and to obtain their own copies of applicable
standards where needed. Auditors must be knowledgeable of applicable
consensus standards because the accident prevention program provisions
of the existing rule (subparts C and D) require owners or operators to
comply with RAGAGEP. Therefore, auditors must be knowledgeable of those
practices in order to perform an effective audit. EPA did not receive
any comments associated with this issue.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low income,
or indigenous populations. The results of this evaluation are included
in the RIA, located in the docket. EPA received multiple comments
relating to environmental justice concerns.
Discussion of comments on access to information. Several groups
stated that communities need better transparency and access to
information on hazards and investigations, training on response plans,
and access to inspection and incident reports. A few advocacy groups
commented that the rule should include specific elements to address
disproportionate impacts. A few advocacy groups said that EPA should
create a centralized database available through a Web site and local
community centers and libraries that provides this information. A
facility commented that a Web site is a poor method to communicate
information to individuals in poor or rural communities that may not
have access to computers or the Internet. The commenter also said that
LEPCs already hold public meetings to discuss emergency plans.
A couple advocacy groups stated that the RMP rule fails to ensure
that at-risk communities near RMP facilities have the information they
need to participate effectively in engagement with facilities. The
groups also argued that the rule does not improve access to summaries
of incident investigation reports, safety audits, and STAA, among other
things, which are essential to ensuring fair treatment. Further, the
groups commented that at-risk communities are not given access to
information on prevention opportunities, and are not invited to
participate in prevention analysis and planning. Another advocacy group
said that the RMP rule should facilitate partnerships and interactions
between facilities, local governments, and the community. A different
group said that EPA should require a community meeting within 30 days
of an incident, require publication of response and evacuation plans
for affected areas, and establish an appeals process for communities to
report when information and engagement opportunities are not provided
as required, among other proposals.
EPA agrees with commenters that have requested better access to
chemical hazard information at facilities in their communities and
improved public transparency. EPA is finalizing a requirement for
facility owners and operators to share information with the public that
will assist neighboring communities to understand the hazards in their
communities. Facility owners and operators must notify the public that
specific information is available and provide instructions on how to
request that information as well as how to access evacuation and
shelter-in-place procedures for the community. Additionally, following
an RMP reportable accident, facility owner and operators are required
to host a public meeting within 90 days to communicate information
about the accident. This allows sufficient time for facilities to
gather information about the incident to share with the public. EPA
believes that these provisions provides the public with more
information that they can use to protect themselves and their families
in the event of an accidental release at an RMP-regulated facility.
EPA has included other elements in the final rule that are intended
to address disproportionate impacts of a release to surrounding
communities. For example, EPA is requiring paper manufacturing,
petroleum and coal products manufacturing, and chemical manufacturing
facilities with Program 3 processes to analyze safer technologies for
each process in order to consider ways to reduce and remove hazards.
EPA is also encouraging better coordination between local emergency
response organizations and facility representatives annually and during
facility exercises which will lead to more effective community
emergency response plans and mitigate the impacts of an accidental
release to the surrounding community. EPA encourages facility
representatives to attend LEPC meetings along with the public to
facilitate partnerships among these representatives.
EPA disagrees with commenters that suggest creating a centralized
database available through a Web site and local community centers and
libraries to provide this information. Establishing such a centralized
database would be costly, difficult to maintain, information would
quickly become outdated, and a centralized database could create
security vulnerabilities. See section VI.B of this preamble for more
information on information availability to the public.
EPA recognizes that some community residents want to participate in
prevention planning and have access to incident investigation reports,
safety audits, and STAA. However, community input can be effective in
other ways that relate to community planning. EPA encourages community
residents to become active in their LEPCs who are already working to
reduce hazards for local communities. Providing access to facility
reports outside of existing community planning activities could result
in duplicative work and increased burden for communities, emergency
responders, and facility staff.
Furthermore, developing a risk management program involves process
hazards analyses and hierarchies of controls developed by trained
professionals. Investigation reports, safety audits and STAA are often
complicated and contain technical jargon, which can be difficult to
understand without the proper training. Information in these reports
can also reveal security vulnerabilities which may put communities in
greater danger of terrorism if released.
Discussion of comments on meaningful involvement. A few commenters,
including advocacy groups, said that the only meaningful involvement
EPA has facilitated included collecting input to shape the proposed
rulemaking. The commenters said that there is no analysis in the rule
on whether or how the rule would facilitate meaningful involvement by
at-
[[Page 4696]]
risk or environmental justice (EJ) communities.
EPA believes there were numerous opportunities for the public to
provide meaningful input on this final rule. This final rule was
developed following extensive public feedback through Executive Order
13650 listening sessions, public comments on the RFI and the proposed
rulemaking, and the public hearing held on March 29, 2016. EPA has
incorporated requirements in the final rule to prevent accidental
releases, mitigate the impacts of releases that do occur, and share
chemical hazard information with the public.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 68
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Hazardous substances,
Intergovernmental relations, Reporting and recordkeeping requirements.
Dated: December 21, 2016.
Gina McCarthy,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, part
68, of the Code of Federal Regulations is amended as follows:
PART 68--CHEMICAL ACCIDENT PREVENTION PROVISIONS
0
1. The authority citation for part 68 continues to read as follows:
Authority: 42 U.S.C. 7412(r), 7601(a)(1), 7661-7661f.
0
2. Amend Sec. 68.3 by adding in alphabetical order the definitions
``Active measures'', ``CBI'', ``Inherently safer technology or
design'', ``LEPC'', ``Passive measures'', ``Practicability'',
``Procedural measures'', ``Root cause'', and ``Third-party audit'' to
read as follows:
Sec. 68.3 Definitions.
* * * * *
Active measures mean risk management measures or engineering
controls that rely on mechanical, or other energy input to detect and
respond to process deviations. Examples of active measures include
alarms, safety instrumented systems, and detection hardware (such as
hydrocarbon sensors).
* * * * *
CBI means confidential business information.
* * * * *
Inherently safer technology or design means risk management
measures that minimize the use of regulated substances, substitute less
hazardous substances, moderate the use of regulated substances, or
simplify covered processes in order to make accidental releases less
likely, or the impacts of such releases less severe.
* * * * *
LEPC means local emergency planning committee as established under
42 U.S.C. 11001(c).
* * * * *
Passive measures mean risk management measures that use design
features that reduce either the frequency or consequence of the hazard
without human, mechanical, or other energy input. Examples of passive
measures include pressure vessel designs, dikes, berms, and blast
walls.
* * * * *
Practicability means the capability of being successfully
accomplished within a reasonable time, accounting for economic,
environmental, legal, social, and technological factors. Environmental
factors would include consideration of potential transferred risks for
new risk reduction measures.
Procedural measures mean risk management measures such as policies,
operating procedures, training, administrative controls, and emergency
response actions to prevent or minimize incidents.
* * * * *
Root cause means a fundamental, underlying, system-related reason
why an incident occurred.
* * * * *
Third-party audit means a compliance audit conducted pursuant to
the requirements of Sec. 68.59 and/or Sec. 68.80, performed or led by
an entity (individual or firm) meeting the competency and independence
described in Sec. 68.59(c) or Sec. 68.80(c).
* * * * *
0
3. Amend Sec. 68.10 by:
0
a. Revising paragraph (a);
0
b. Redesignating paragraphs (b) through (f) as paragraphs (f) through
(j);
0
c. Adding new paragraphs (b) through (e); and
0
d. Revising the newly designated paragraph (f)(2).
The revisions and additions read as follow:
Sec. 68.10 Applicability.
(a) Except as provided in paragraphs (b) through (e) of this
section, an owner or operator of a stationary source that has more than
a threshold quantity of a regulated substance in a process, as
determined under Sec. 68.115, shall comply with the requirements of
this part no later than the latest of the following dates:
(1) June 21, 1999;
(2) Three years after the date on which a regulated substance is
first listed under Sec. 68.130;
(3) The date on which a regulated substance is first present above
a threshold quantity in a process; or
(4) For any revisions to this part, the effective date of the final
rule that revises this part.
(b) By March 14, 2018 the owner or operator of a stationary source
shall comply with the emergency response coordination activities in
Sec. 68.93.
(c) Within three years of when the owner or operator determines
that the stationary source is subject to the emergency response program
requirements of Sec. 68.95, pursuant to Sec. 68.90(a), the owner or
operator must develop and implement an emergency response program in
accordance with Sec. 68.95.
(d) By March 15, 2021, the owner or operator shall comply with the
following provisions promulgated on January 13, 2017:
(1) Third-party audit provisions in Sec. Sec. 68.58(f), 68.58(g),
68.58(h), 68.59, 68.79(f), 68.79(g), 68.79(h), and 68.80;
(2) Incident investigation root cause analysis provisions in
Sec. Sec. 68.60(d)(7) and 68.81(d)(7);
(3) Safer technology and alternatives analysis provisions in Sec.
68.67(c)(8);
(4) Emergency response exercise provisions of Sec. 68.96, and;
(5) Availability of information provisions in Sec. 68.210(b)
through (e).
(e) By March 14, 2022, the owner or operator shall comply with the
risk management plan provisions of subpart G of this part promulgated
on January 13, 2017.
(f) * * *
(2) The distance to a toxic or flammable endpoint for a worst-case
release assessment conducted under subpart B and Sec. 68.25 is less
than the distance to any public receptor, as defined in Sec. 68.3; and
* * * * *
0
4. Amend Sec. 68.12 by:
0
a. Revising paragraphs (c)(4) and (5), and adding paragraph (c)(6); and
0
b. Revising paragraphs (d)(4) and (5), and adding paragraph (d)(6).
The revisions and additions read as follows:
Sec. 68.12 General requirements.
* * * * *
[[Page 4697]]
(c) * * *
(4) Coordinate response actions with local emergency planning and
response agencies as provided in Sec. 68.93;
(5) Develop and implement an emergency response program, and
conduct exercises, as provided in Sec. Sec. 68.90 to 68.96; and
(6) Submit as part of the RMP the data on prevention program
elements for Program 2 processes as provided in Sec. 68.170.
(d) * * *
(4) Coordinate response actions with local emergency planning and
response agencies as provided in Sec. 68.93;
(5) Develop and implement an emergency response program, and
conduct exercises, as provided in Sec. Sec. 68.90 to 68.96; and
(6) Submit as part of the RMP the data on prevention program
elements for Program 3 processes as provided in Sec. 68.175.
0
5. Amend Sec. 68.48 by revising paragraph (a)(1) to read as follows:
Sec. 68.48 Safety information.
(a) * * *
(1) Safety Data Sheets (SDS) that meet the requirements of 29 CFR
1910.1200(g);
* * * * *
0
6. Amend Sec. 68.50 by revising paragraph (a)(2) to read as follows:
Sec. 68.50 Hazard review.
(a) * * *
(2) Opportunities for equipment malfunctions or human errors that
could cause an accidental release, including findings from incident
investigations;
* * * * *
0
7. Amend Sec. 68.54 by revising paragraphs (a), (b), and (d); and
adding paragraph (e) to read as follows:
Sec. 68.54 Training.
(a) The owner or operator shall ensure that each employee presently
involved in operating a process, and each employee newly assigned to a
covered process have been trained or tested competent in the operating
procedures provided in Sec. 68.52 that pertain to their duties. For
those employees already operating a process on June 21, 1999, the owner
or operator may certify in writing that the employee has the required
knowledge, skills, and abilities to safely carry out the duties and
responsibilities as provided in the operating procedures.
(b) Refresher training. Refresher training shall be provided at
least every three years, and more often if necessary, to each employee
involved in operating a process to ensure that the employee understands
and adheres to the current operating procedures of the process. The
owner or operator, in consultation with the employees operating the
process, shall determine the appropriate frequency of refresher
training.
* * * * *
(d) The owner or operator shall ensure that employees involved in
operating a process are trained in any updated or new procedures prior
to startup of a process after a major change.
(e) For the purposes of this section, the term employee also
includes supervisors responsible for directing process operations.
0
8. Amend Sec. 68.58 by revising paragraph (a) and adding paragraphs
(f) through (h) to read as follows:
Sec. 68.58 Compliance audits.
(a) The owner or operator shall certify that they have evaluated
compliance with the provisions of this subpart for each covered
process, at least every three years to verify that the procedures and
practices developed under the rule are adequate and are being followed.
When required as set forth in paragraph (f) of this section, the
compliance audit shall be a third-party audit.
* * * * *
(f) Third-party audit applicability. The next required compliance
audit shall be a third-party audit when one of the following conditions
apply:
(1) An accidental release meeting the criteria in Sec. 68.42(a)
from a covered process at a stationary source has occurred; or
(2) An implementing agency requires a third-party audit due to
conditions at the stationary source that could lead to an accidental
release of a regulated substance, or when a previous third-party audit
failed to meet the competency or independence criteria of Sec.
68.59(c).
(g) Implementing agency notification and appeals. (1) If an
implementing agency makes a preliminary determination that a third-
party audit is necessary pursuant to paragraph (f)(2) of this section,
the implementing agency will provide written notice to the owner or
operator that describes the basis for this determination.
(2) Within 30 days of receipt of such written notice, the owner or
operator may provide information and data to, and may consult with, the
implementing agency on the determination. Thereafter, the implementing
agency will provide a final determination to the owner or operator.
(3) If the final determination requires a third-party audit, the
owner or operator shall comply with the requirements of Sec. 68.59,
pursuant to the schedule in paragraph (h) of this section.
(4) Appeals. The owner or operator may appeal a final determination
made by an implementing agency under paragraph (g)(2) of this section
within 30 days of receipt of the final determination. The appeal shall
be made to the EPA Regional Administrator, or for determinations made
by other implementing agencies, the administrator or director of such
implementing agency. The appeal shall contain a clear and concise
statement of the issues, facts in the case, and any relevant additional
information. In reviewing the appeal, the implementing agency may
request additional information from the owner or operator. The
implementing agency will provide a written, final decision on the
appeal to the owner or operator.
(h) Schedule for conducting a third-party audit. The audit and
audit report shall be completed as follows, unless a different
timeframe is specified by the implementing agency:
(1) For third-party audits required pursuant to paragraph (f)(1) of
this section, within 12 months of the release; or
(2) For third-party audits required pursuant to paragraph (f)(2) of
this section, within 12 months of the date of the final determination
pursuant to paragraph (g)(3) of this section. However, if the final
determination is appealed pursuant to paragraph (g)(4) of this section,
within 12 months of the date of the final decision on the appeal.
0
9. Section 68.59 is added to subpart C to read as follows:
Sec. 68.59 Third-party audits.
(a) Applicability. The owner or operator shall engage a third-party
to conduct an audit that evaluates compliance with the provisions of
this subpart in accordance with the requirements of this section when
either criterion of Sec. 68.58(f) is met.
(b) Third-party auditors and auditing teams. The owner or operator
shall either:
(1) Engage a third-party auditor meeting all of the competency and
independence criteria in paragraph (c) of this section; or
(2) Assemble an auditing team, led by a third-party auditor meeting
all of the competency and independence criteria in paragraph (c) of
this section. The team may include:
(i) Other employees of the third-party auditor firm meeting the
independence criteria of paragraph (c)(2) of this section; and
[[Page 4698]]
(ii) Other personnel not employed by the third-party auditor firm,
including facility personnel.
(c) Third-party auditor qualifications. The owner or operator shall
determine and document that the third-party auditor(s) meet the
following competency and independence requirements:
(1) Competency requirements. The third-party auditor(s) shall be:
(i) Knowledgeable with the requirements of this part;
(ii) Experienced with the stationary source type and processes
being audited and applicable recognized and generally accepted good
engineering practices; and
(iii) Trained and/or certified in proper auditing techniques.
(2) Independence requirements. The third-party auditor(s) shall:
(i) Act impartially when performing all activities under this
section;
(ii) Receive no financial benefit from the outcome of the audit,
apart from payment for auditing services. For purposes of this
paragraph, retired employees who otherwise satisfy the third-party
auditor independence criteria in this section may qualify as
independent if their sole continuing financial attachments to the owner
or operator are employer-financed or managed retirement and/or health
plans;
(iii) Not have conducted past research, development, design,
construction services, or consulting for the owner or operator within
the last two years. For purposes of this requirement, consulting does
not include performing or participating in third-party audits pursuant
to Sec. 68.59 or Sec. 68.80. An audit firm with personnel who, before
working for the auditor, conducted research, development, design,
construction, or consulting services for the owner or operator within
the last two years as an employee or contractor may meet the
requirements of this subsection by ensuring such personnel do not
participate in the audit, or manage or advise the audit team concerning
the audit;
(iv) Not provide other business or consulting services to the owner
or operator, including advice or assistance to implement the findings
or recommendations in an audit report, for a period of at least two
years following submission of the final audit report;
(v) Ensure that all third-party personnel involved in the audit
sign and date a conflict of interest statement documenting that they
meet the independence criteria of this paragraph; and
(vi) Ensure that all third-party personnel involved in the audit do
not accept future employment with the owner or operator of the
stationary source for a period of at least two years following
submission of the final audit report. For purposes of this requirement,
employment does not include performing or participating in third-party
audits pursuant to Sec. 68.59 or Sec. 68.80.
(3) The auditor shall have written policies and procedures to
ensure that all personnel comply with the competency and independence
requirements of this section.
(d) Third-party auditor responsibilities. The owner or operator
shall ensure that the third-party auditor:
(1) Manages the audit and participates in audit initiation, design,
implementation, and reporting;
(2) Determines appropriate roles and responsibilities for the audit
team members based on the qualifications of each team member;
(3) Prepares the audit report and where there is a team, documents
the full audit team's views in the final audit report;
(4) Certifies the final audit report and its contents as meeting
the requirements of this section; and
(5) Provides a copy of the audit report to the owner or operator.
(e) Audit report. The audit report shall:
(1) Identify all persons participating on the audit team, including
names, titles, employers and/or affiliations, and summaries of
qualifications. For third-party auditors, include information
demonstrating that the competency requirements in paragraph (c)(1) of
this section are met;
(2) Describe or incorporate by reference the policies and
procedures required under paragraph (c)(3) of this section;
(3) Document the auditor's evaluation, for each covered process, of
the owner or operator's compliance with the provisions of this subpart
to determine whether the procedures and practices developed by the
owner or operator under this rule are adequate and being followed;
(4) Document the findings of the audit, including any identified
compliance or performance deficiencies;
(5) Summarize any significant revisions (if any) between draft and
final versions of the report; and
(6) Include the following certification, signed and dated by the
third-party auditor or third-party audit team member leading the audit:
I certify that this RMP compliance audit report was prepared
under my direction or supervision in accordance with a system
designed to assure that qualified personnel properly gather and
evaluate the information upon which the audit is based. I further
certify that the audit was conducted and this report was prepared
pursuant to the requirements of subpart C of 40 CFR part 68 and all
other applicable auditing, competency, independence, impartiality,
and conflict of interest standards and protocols. Based on my
personal knowledge and experience, and inquiry of personnel involved
in the audit, the information submitted herein is true, accurate,
and complete.
(f) Third-party audit findings--(1) Findings response report. As
soon as possible, but no later than 90 days after receiving the final
audit report, the owner or operator shall determine an appropriate
response to each of the findings in the audit report, and develop a
findings response report that includes:
(i) A copy of the final audit report;
(ii) An appropriate response to each of the audit report findings;
(iii) A schedule for promptly addressing deficiencies; and
(iv) A certification, signed and dated by a senior corporate
officer, or an official in an equivalent position, of the owner or
operator of the stationary source, stating:
I certify under penalty of law that I have engaged a third-party
to perform or lead an audit team to conduct a third-party audit in
accordance with the requirements of 40 CFR 68.59 and that the
attached RMP compliance audit report was received, reviewed, and
responded to under my direction or supervision by qualified
personnel. I further certify that appropriate responses to the
findings have been identified and deficiencies were corrected, or
are being corrected, consistent with the requirements of subpart C
of 40 CFR part 68, as documented herein. Based on my personal
knowledge and experience, or inquiry of personnel involved in
evaluating the report findings and determining appropriate responses
to the findings, the information submitted herein is true, accurate,
and complete. I am aware that there are significant penalties for
making false material statements, representations, or
certifications, including the possibility of fines and imprisonment
for knowing violations.
(2) Schedule implementation. The owner or operator shall implement
the schedule to address deficiencies identified in the audit findings
response report in paragraph (f)(1)(iii) of this section and document
the action taken to address each deficiency, along with the date
completed.
(3) Submission to Board of Directors. The owner or operator shall
immediately provide a copy of each document required under paragraphs
(f)(1) and (2) of this section, when completed, to the owner or
operator's
[[Page 4699]]
audit committee of the Board of Directors, or other comparable
committee or individual, if applicable.
(g) Recordkeeping. The owner or operator shall retain at the
stationary source, the two most recent final third-party audit reports,
related findings response reports, documentation of actions taken to
address deficiencies, and related records. This requirement does not
apply to any document that is more than five years old.
0
10. Amend Sec. 68.60 by:
0
a. Revising paragraph (a);
0
b. Redesignating paragraphs (c) through (f) as paragraphs (d) through
(g);
0
c. Adding a new paragraph (c); and
0
d. Revising the newly designated paragraphs (d) and (g).
The revisions and additions read as follows:
Sec. 68.60 Incident investigation.
(a) The owner or operator shall investigate each incident that:
(1) Resulted in a catastrophic release (including when the affected
process is decommissioned or destroyed following, or as the result of,
an incident); or
(2) Could reasonably have resulted in a catastrophic release (i.e.,
was a near miss).
* * * * *
(c) An incident investigation team shall be established and consist
of at least one person knowledgeable in the process involved and other
persons with appropriate knowledge and experience to thoroughly
investigate and analyze the incident.
(d) A report shall be prepared at the conclusion of the
investigation. The report shall be completed within 12 months of the
incident, unless the implementing agency approves, in writing, an
extension of time. The report shall include:
(1) Date, time, and location of incident;
(2) Date investigation began;
(3) A description of the incident, in chronological order,
providing all relevant facts;
(4) The name and amount of the regulated substance involved in the
release (e.g., fire, explosion, toxic gas loss of containment) or near
miss and the duration of the event;
(5) The consequences, if any, of the incident including, but not
limited to: injuries, fatalities, the number of people evacuated, the
number of people sheltered in place, and the impact on the environment;
(6) Emergency response actions taken;
(7) The factors that contributed to the incident including the
initiating event, direct and indirect contributing factors, and root
causes. Root causes shall be determined by conducting an analysis for
each incident using a recognized method; and
(8) Any recommendations resulting from the investigation and a
schedule for addressing them.
* * * * *
(g) Incident investigation reports shall be retained for five
years.
0
11. Amend Sec. 68.65 by revising the first sentence of paragraph (a)
and the note to paragraph (b) to read as follows:
Sec. 68.65 Process safety information.
(a) The owner or operator shall complete a compilation of written
process safety information before conducting any process hazard
analysis required by the rule, and shall keep process safety
information up-to-date. * * *
(b) * * *
Note to paragraph (b): Safety Data Sheets (SDS) meeting the
requirements of 29 CFR 1910.1200(g) may be used to comply with this
requirement to the extent they contain the information required by
paragraph (b) of this section.
* * * * *
0
12. Amend Sec. 68.67 by:
0
a. Revising paragraph (c)(2);
0
b. Amending paragraph (c)(6) by removing the word ``and;''
0
c. Amending paragraph (c)(7) by removing the period at the end of the
paragraph and adding ``; and'' in its place; and
0
d. Adding paragraph (c)(8).
The revisions and additions read as follows:
Sec. 68.67 Process hazard analysis.
* * * * *
(c) * * *
(2) The findings from all incident investigations required under
Sec. 68.81, as well as any other potential failure scenarios;
* * * * *
(8) For processes in NAICS 322, 324, and 325, safer technology and
alternative risk management measures applicable to eliminating or
reducing risk from process hazards.
(i) The owner or operator shall consider, in the following order of
preference inherently safer technology or design, passive measures,
active measures, and procedural measures. A combination of risk
management measures may be used to achieve the desired risk reduction.
(ii) The owner or operator shall determine the practicability of
the inherently safer technologies and designs considered.
* * * * *
0
13. Amend Sec. 68.71 by adding paragraph (d) to read as follows:
Sec. 68.71 Training.
* * * * *
(d) For the purposes of this section, the term employee also
includes supervisors with process operational responsibilities.
0
14. Amend Sec. 68.79 by revising paragraph (a) and adding paragraphs
(f) through (h) to read as follows:
Sec. 68.79 Compliance audits.
(a) The owner or operator shall certify that they have evaluated
compliance with the provisions of this subpart for each covered
process, at least every three years to verify that the procedures and
practices developed under the rule are adequate and are being followed.
When required as set forth in paragraph (f) of this section, the
compliance audit shall be a third-party audit.
* * * * *
(f) Third-party audit applicability. The next required compliance
audit shall be a third-party audit when one of the following conditions
apply:
(1) An accidental release meeting the criteria in Sec. 68.42(a)
from a covered process at a stationary source has occurred; or
(2) An implementing agency requires a third-party audit due to
conditions at the stationary source that could lead to an accidental
release of a regulated substance, or when a previous third-party audit
failed to meet the competency or independence criteria of Sec.
68.80(c).
(g) Implementing agency notification and appeals. (1) If an
implementing agency makes a preliminary determination that a third-
party audit is necessary pursuant to paragraph (f)(2) of this section,
the implementing agency will provide written notice to the owner or
operator that describes the basis for this determination.
(2) Within 30 days of receipt of such written notice, the owner or
operator may provide information and data to, and may consult with, the
implementing agency on the determination. Thereafter, the implementing
agency will provide a final determination to the owner or operator.
(3) If the final determination requires a third-party audit, the
owner or operator shall comply with the requirements of Sec. 68.80,
pursuant to the schedule in paragraph (h) of this section.
(4) Appeals. The owner or operator may appeal a final determination
made by an implementing agency under paragraph (g)(2) of this section
within
[[Page 4700]]
30 days of receipt of the final determination. The appeal shall be made
to the EPA Regional Administrator, or for determinations made by other
implementing agencies, the administrator or director of such
implementing agency. The appeal shall contain a clear and concise
statement of the issues, facts in the case, and any relevant additional
information. In reviewing the appeal, the implementing agency may
request additional information from the owner or operator. The
implementing agency will provide a written, final decision on the
appeal to the owner or operator.
(h) Schedule for conducting a third-party audit. The audit and
audit report shall be completed as follows, unless a different
timeframe is specified by the implementing agency:
(1) For third-party audits required pursuant to paragraph (f)(1) of
this section, within 12 months of the release; or
(2) For third-party audits required pursuant to paragraph (f)(2) of
this section, within 12 months of the date of the final determination
pursuant to paragraph (g)(3) of this section. However, if the final
determination is appealed pursuant to paragraph (g)(4) of this section,
within 12 months of the date of the final decision on the appeal.
0
15. Section 68.80 is added to subpart D to read as follows:
Sec. 68.80 Third-party audits.
(a) Applicability. The owner or operator shall engage a third-party
to conduct an audit that evaluates compliance with the provisions of
this subpart in accordance with the requirements of this section when
either criterion of Sec. 68.79(f) is met.
(b) Third-party auditors and auditing teams. The owner or operator
shall either:
(1) Engage a third-party auditor meeting all of the competency and
independence criteria in paragraph (c) of this section; or
(2) Assemble an auditing team, led by a third-party auditor meeting
all of the competency and independence criteria in paragraph (c) of
this section. The team may include:
(i) Other employees of the third-party auditor firm meeting the
independence criteria of paragraph (c)(2) of this section; and
(ii) Other personnel not employed by the third-party auditor firm,
including facility personnel.
(c) Third-party auditor qualifications. The owner or operator shall
determine and document that the third-party auditor(s) meet the
following competency and independence requirements:
(1) Competency requirements. The third-party auditor(s) shall be:
(i) Knowledgeable with the requirements of this part;
(ii) Experienced with the stationary source type and processes
being audited and applicable recognized and generally accepted good
engineering practices; and
(iii) Trained or certified in proper auditing techniques.
(2) Independence requirements. The third-party auditor(s) shall:
(i) Act impartially when performing all activities under this
section;
(ii) Receive no financial benefit from the outcome of the audit,
apart from payment for auditing services. For purposes of this
paragraph, retired employees who otherwise satisfy the third-party
auditor independence criteria in this section may qualify as
independent if their sole continuing financial attachments to the owner
or operator are employer-financed or managed retirement and/or health
plans;
(iii) Not have conducted past research, development, design,
construction services, or consulting for the owner or operator within
the last two years. For purposes of this requirement, consulting does
not include performing or participating in third-party audits pursuant
to Sec. 68.59 or Sec. 68.80. An audit firm with personnel who, before
working for the auditor, conducted research, development, design,
construction, or consulting services for the owner or operator within
the last two years as an employee or contractor may meet the
requirements of this subsection by ensuring such personnel do not
participate in the audit, or manage or advise the audit team concerning
the audit;
(iv) Not provide other business or consulting services to the owner
or operator, including advice or assistance to implement the findings
or recommendations in an audit report, for a period of at least two
years following submission of the final audit report;
(v) Ensure that all third-party personnel involved in the audit
sign and date a conflict of interest statement documenting that they
meet the independence criteria of this paragraph; and
(vi) Ensure that all third-party personnel involved in the audit do
not accept future employment with the owner or operator of the
stationary source for a period of at least two years following
submission of the final audit report. For purposes of this requirement,
employment does not include performing or participating in third-party
audits pursuant to Sec. 68.59 or Sec. 68.80.
(3) The auditor shall have written policies and procedures to
ensure that all personnel comply with the competency and independence
requirements of this section.
(d) Third-party auditor responsibilities. The owner or operator
shall ensure that the third-party auditor:
(1) Manages the audit and participates in audit initiation, design,
implementation, and reporting;
(2) Determines appropriate roles and responsibilities for the audit
team members based on the qualifications of each team member;
(3) Prepares the audit report and where there is a team, documents
the full audit team's views in the final audit report;
(4) Certifies the final audit report and its contents as meeting
the requirements of this section; and
(5) Provides a copy of the audit report to the owner or operator.
(e) Audit report. The audit report shall:
(1) Identify all persons participating on the audit team, including
names, titles, employers and/or affiliations, and summaries of
qualifications. For third-party auditors, include information
demonstrating that the competency requirements in paragraph (c)(1) of
this section are met;
(2) Describe or incorporate by reference the policies and
procedures required under paragraph (c)(3) of this section;
(3) Document the auditor's evaluation, for each covered process, of
the owner or operator's compliance with the provisions of this subpart
to determine whether the procedures and practices developed by the
owner or operator under this rule are adequate and being followed;
(4) Document the findings of the audit, including any identified
compliance or performance deficiencies;
(5) Summarize any significant revisions (if any) between draft and
final versions of the report; and
(6) Include the following certification, signed and dated by the
third-party auditor or third-party audit team member leading the audit:
I certify that this RMP compliance audit report was prepared
under my direction or supervision in accordance with a system
designed to assure that qualified personnel properly gather and
evaluate the information upon which the audit is based. I further
certify that the audit was conducted and this report was prepared
pursuant to the requirements of subpart D of 40 CFR part 68 and all
other applicable auditing,
[[Page 4701]]
competency, independence, impartiality, and conflict of interest
standards and protocols. Based on my personal knowledge and
experience, and inquiry of personnel involved in the audit, the
information submitted herein is true, accurate, and complete.
(f) Third-party audit findings--(1) Findings response report. As
soon as possible, but no later than 90 days after receiving the final
audit report, the owner or operator shall determine an appropriate
response to each of the findings in the audit report, and develop a
findings response report that includes:
(i) A copy of the final audit report;
(ii) An appropriate response to each of the audit report findings;
(iii) A schedule for promptly addressing deficiencies; and
(iv) A certification, signed and dated by a senior corporate
officer, or an official in an equivalent position, of the owner or
operator of the stationary source, stating:
I certify under penalty of law that I have engaged a third-party
to perform or lead an audit team to conduct a third-party audit in
accordance with the requirements of 40 CFR 68.80 and that the
attached RMP compliance audit report was received, reviewed, and
responded to under my direction or supervision by qualified
personnel. I further certify that appropriate responses to the
findings have been identified and deficiencies were corrected, or
are being corrected, consistent with the requirements of subpart D
of 40 CFR part 68, as documented herein. Based on my personal
knowledge and experience, or inquiry of personnel involved in
evaluating the report findings and determining appropriate responses
to the findings, the information submitted herein is true, accurate,
and complete. I am aware that there are significant penalties for
making false material statements, representations, or
certifications, including the possibility of fines and imprisonment
for knowing violations.
(2) Schedule implementation. The owner or operator shall implement
the schedule to address deficiencies identified in the audit findings
response report in paragraph (f)(1)(iii) of this section and document
the action taken to address each deficiency, along with the date
completed.
(3) Submission to Board of Directors. The owner or operator shall
immediately provide a copy of each document required under paragraphs
(f)(1) and (2) of this section, when completed, to the owner or
operator's audit committee of the Board of Directors, or other
comparable committee or individual, if applicable.
(g) Recordkeeping. The owner or operator shall retain at the
stationary source the two most recent final third-party audit reports,
related findings response reports, documentation of actions taken to
address deficiencies, and related records.
0
16. Amend Sec. 68.81 by revising paragraphs (a), (d) introductory
text, (d)(1), (d)(3) through (5), and adding paragraphs (d)(6) through
(8) to read as follows:
Sec. 68.81 Incident investigation.
(a) The owner or operator shall investigate each incident that:
(1) Resulted in a catastrophic release (including when the affected
process is decommissioned or destroyed following, or as the result of,
an incident); or
(2) Could reasonably have resulted in a catastrophic release (i.e.,
was a near miss).
* * * * *
(d) A report shall be prepared at the conclusion of the
investigation. The report shall be completed within 12 months of the
incident, unless the implementing agency approves, in writing, an
extension of time. The report shall include:
(1) Date, time, and location of incident;
* * * * *
(3) A description of the incident, in chronological order,
providing all relevant facts;
(4) The name and amount of the regulated substance involved in the
release (e.g., fire, explosion, toxic gas loss of containment) or near
miss and the duration of the event;
(5) The consequences, if any, of the incident including, but not
limited to: injuries, fatalities, the number of people evacuated, the
number of people sheltered in place, and the impact on the environment;
(6) Emergency response actions taken;
(7) The factors that contributed to the incident including the
initiating event, direct and indirect contributing factors, and root
causes. Root causes shall be determined by conducting an analysis for
each incident using a recognized method; and
(8) Any recommendations resulting from the investigation and a
schedule for addressing them.
* * * * *
0
17. Revise Sec. 68.90 to read as follows:
Sec. 68.90 Applicability.
(a) Responding stationary source. Except as provided in paragraph
(b) of this section, the owner or operator of a stationary source with
Program 2 and Program 3 processes shall comply with the requirements of
Sec. Sec. 68.93, 68.95, and 68.96.
(b) Non-responding stationary source. The owner or operator of a
stationary source whose employees will not respond to accidental
releases of regulated substances need not comply with Sec. 68.95 of
this part provided that:
(1) For stationary sources with any regulated toxic substance held
in a process above the threshold quantity, the stationary source is
included in the community emergency response plan developed under 42
U.S.C. 11003;
(2) For stationary sources with only regulated flammable substances
held in a process above the threshold quantity, the owner or operator
has coordinated response actions with the local fire department;
(3) Appropriate mechanisms are in place to notify emergency
responders when there is a need for a response;
(4) The owner or operator performs the annual emergency response
coordination activities required under Sec. 68.93; and
(5) The owner or operator performs the annual notification
exercises required under Sec. 68.96(a).
0
18. Section 68.93 is added to subpart E to read as follows:
Sec. 68.93 Emergency response coordination activities.
The owner or operator of a stationary source shall coordinate
response needs with local emergency planning and response organizations
to determine how the stationary source is addressed in the community
emergency response plan and to ensure that local response organizations
are aware of the regulated substances at the stationary source, their
quantities, the risks presented by covered processes, and the resources
and capabilities at the stationary source to respond to an accidental
release of a regulated substance.
(a) Coordination shall occur at least annually, and more frequently
if necessary, to address changes: At the stationary source; in the
stationary source's emergency response and/or emergency action plan;
and/or in the community emergency response plan.
(b) Coordination shall include providing to the local emergency
planning and response organizations: The stationary source's emergency
response plan if one exists; emergency action plan; updated emergency
contact information; and any other information that local emergency
planning and response organizations identify as relevant to local
emergency response planning. For responding stationary sources,
coordination shall also include consulting with local emergency
response officials to establish appropriate schedules and plans for
field and tabletop exercises required under Sec. 68.96(b). The owner
or operator
[[Page 4702]]
shall request an opportunity to meet with the local emergency planning
committee (or equivalent) and/or local fire department as appropriate
to review and discuss these materials.
(c) The owner or operator shall document coordination with local
authorities, including: The names of individuals involved and their
contact information (phone number, email address, and organizational
affiliations); dates of coordination activities; and nature of
coordination activities.
0
19. Amend Sec. 68.95 by:
0
a. Revising paragraph (a)(1)(i);
0
b. Adding a sentence to the end of paragraph (a)(4); and
0
c. Revising paragraph (c).
The revisions and addition read as follows:
68.95 Emergency response program.
(a) * * *
(1) * * *
(i) Procedures for informing the public and the appropriate
Federal, state, and local emergency response agencies about accidental
releases;
* * * * *
(4) * * * The owner or operator shall review and update the plan as
appropriate based on changes at the stationary source or new
information obtained from coordination activities, emergency response
exercises, incident investigations, or other available information, and
ensure that employees are informed of the changes.
* * * * *
(c) The emergency response plan developed under paragraph (a)(1) of
this section shall be coordinated with the community emergency response
plan developed under 42 U.S.C. 11003. Upon request of the LEPC or
emergency response officials, the owner or operator shall promptly
provide to the local emergency response officials information necessary
for developing and implementing the community emergency response plan.
0
20. Section 68.96 is added to subpart E to read as follows:
Sec. 68.96 Emergency response exercises.
(a) Notification exercises. At least once each calendar year, the
owner or operator of a stationary source with any Program 2 or Program
3 process shall conduct an exercise of the stationary source's
emergency response notification mechanisms required under Sec.
68.90(a)(2) or Sec. 68.95(a)(1)(i), as appropriate. Owners or
operators of responding stationary sources may perform the notification
exercise as part of the tabletop and field exercises required in
paragraph (b) of this section. The owner/operator shall maintain a
written record of each notification exercise conducted over the last
five years.
(b) Emergency response exercise program. The owner or operator of a
stationary source subject to the requirements of Sec. 68.95 shall
develop and implement an exercise program for its emergency response
program, including the plan required under Sec. 68.95(a)(1). Exercises
shall involve facility emergency response personnel and, as
appropriate, emergency response contractors. When planning emergency
response field and tabletop exercises, the owner or operator shall
coordinate with local public emergency response officials and invite
them to participate in the exercise. The emergency response exercise
program shall include:
(1) Emergency response field exercises. The owner or operator shall
conduct field exercises involving the simulated accidental release of a
regulated substance (i.e., toxic substance release or release of a
regulated flammable substance involving a fire and/or explosion).
(i) Frequency. As part of coordination with local emergency
response officials required by Sec. 68.93, the owner or operator shall
consult with these officials to establish an appropriate frequency for
field exercises, but at a minimum, shall conduct a field exercise at
least once every ten years.
(ii) Scope. Field exercises shall include: Tests of procedures to
notify the public and the appropriate Federal, state, and local
emergency response agencies about an accidental release; tests of
procedures and measures for emergency response actions including
evacuations and medical treatment; tests of communications systems;
mobilization of facility emergency response personnel, including
contractors, as appropriate; coordination with local emergency
responders; emergency response equipment deployment; and any other
action identified in the emergency response program, as appropriate.
(2) Tabletop exercises. The owner or operator shall conduct a
tabletop exercise involving the simulated accidental release of a
regulated substance.
(i) Frequency. As part of coordination with local emergency
response officials required by Sec. 68.93, the owner or operator shall
consult with these officials to establish an appropriate frequency for
tabletop exercises, but at a minimum, shall conduct a field exercise at
least once every three years.
(ii) Scope. The exercise shall include discussions of: Procedures
to notify the public and the appropriate Federal, state, and local
emergency response agencies; procedures and measures for emergency
response including evacuations and medical treatment; identification of
facility emergency response personnel and/or contractors and their
responsibilities; coordination with local emergency responders;
procedures for emergency response equipment deployment; and any other
action identified in the emergency response plan, as appropriate.
(3) Documentation. The owner/operator shall prepare an evaluation
report within 90 days of each exercise. The report shall include: A
description of the exercise scenario; names and organizations of each
participant; an evaluation of the exercise results including lessons
learned; recommendations for improvement or revisions to the emergency
response exercise program and emergency response program, and a
schedule to promptly address and resolve recommendations.
(c) Alternative means of meeting exercise requirements. The owner
or operator may satisfy the requirement to conduct notification, field
and/or tabletop exercises through:
(1) Exercises conducted to meet other Federal, state or local
exercise requirements, provided the exercise meets the requirements of
paragraphs (a) and/or (b) of this section, as appropriate.
(2) Response to an accidental release, provided the response
includes the actions indicated in paragraphs (a) and/or (b) of this
section, as appropriate. When used to meet field and/or tabletop
exercise requirements, the owner or operator shall prepare an after-
action report comparable to the exercise evaluation report required in
paragraph (b)(3) of this section, within 90 days of the incident.
0
21. Amend Sec. 68.130 by:
0
a. In Table 1, ``List of Regulated Toxic Substances and Threshold
Quantities for Accidental Release Prevention'', under second column
entitled ``CAS No.'', removing the number ``107-18-61'' adding ``107-
18-6'' in its place; and
0
b. Revising Table 4, ``List of Regulated Flammable Substances and
Threshold Quantities for Accidental Release Prevention''.
The revisions read as follows:
Sec. 68.130 List of substances.
* * * * *
[[Page 4703]]
Table 4 to Sec. 68.130--List of Regulated Flammable Substances \1\ and Threshold Quantities for Accidental
Release Prevention
[CAS Number Order--63 Substances]
----------------------------------------------------------------------------------------------------------------
Threshold quantity
CAS No. Chemical name (lbs) Basis for listing
----------------------------------------------------------------------------------------------------------------
60-29-7.............................. Ethyl ether [Ethane, 1,1'- 10,000 g
oxybis-].
74-82-8.............................. Methane..................... 10,000 f
74-84-0.............................. Ethane...................... 10,000 f
74-85-1.............................. Ethylene [Ethene]........... 10,000 f
74-86-2.............................. Acetylene [Ethyne].......... 10,000 f
74-89-5.............................. Methylamine [Methanamine]... 10,000 f
74-98-6.............................. Propane..................... 10,000 f
74-99-7.............................. Propyne [1-Propyne]......... 10,000 f
75-00-3.............................. Ethyl chloride [Ethane, 10,000 f
chloro-].
75-01-4.............................. Vinyl chloride [Ethene, 10,000 a, f
chloro-].
75-02-5.............................. Vinyl fluoride [Ethene, 10,000 f
fluoro-].
75-04-7.............................. Ethylamine [Ethanamine]..... 10,000 f
75-07-0.............................. Acetaldehyde................ 10,000 g
75-08-1.............................. Ethyl mercaptan 10,000 g
[Ethanethiol].
75-19-4.............................. Cyclopropane................ 10,000 f
75-28-5.............................. Isobutane [Propane, 2- 10,000 f
methyl].
75-29-6.............................. Isopropyl chloride [Propane, 10,000 g
2-chloro-].
75-31-0.............................. Isopropylamine [2- 10,000 g
Propanamine].
75-35-4.............................. Vinylidene chloride [Ethene, 10,000 g
1,1-dichloro-].
75-37-6.............................. Difluoroethane [Ethane, 1,1- 10,000 f
difluoro-].
75-38-7.............................. Vinylidene fluoride [Ethene, 10,000 f
1,1-difluoro-].
75-50-3.............................. Trimethylamine [Methanamine, 10,000 f
N, N-dimethyl-].
75-76-3.............................. Tetramethylsilane [Silane, 10,000 g
tetramethyl-].
78-78-4.............................. Isopentane [Butane, 2-methyl- 10,000 g
].
78-79-5.............................. Isoprene [1,3,-Butadiene, 2- 10,000 g
methyl-].
79-38-9.............................. Trifluorochloroethylene 10,000 f
[Ethene, chlorotrifluoro-].
106-97-8............................. Butane...................... 10,000 f
106-98-9............................. 1-Butene.................... 10,000 f
106-99-0............................. 1,3-Butadiene............... 10,000 f
107-00-6............................. Ethyl acetylene [1-Butyne].. 10,000 f
107-01-7............................. 2-Butene.................... 10,000 f
107-25-5............................. Vinyl methyl ether [Ethene, 10,000 f
methoxy-].
107-31-3............................. Methyl formate [Formic acid, 10,000 g
methyl ester].
109-66-0............................. Pentane..................... 10,000 g
109-67-1............................. 1-Pentene................... 10,000 g
109-92-2............................. Vinyl ethyl ether [Ethene, 10,000 g
ethoxy-].
109-95-5............................. Ethyl nitrite [Nitrous acid, 10,000 f
ethyl ester].
115-07-1............................. Propylene [1-Propene]....... 10,000 f
115-10-6............................. Methyl ether [Methane, 10,000 f
oxybis-].
115-11-7............................. 2-Methylpropene [1-Propene, 10,000 f
2-methyl-].
116-14-3............................. Tetrafluoroethylene [Ethene, 10,000 f
tetrafluoro-].
124-40-3............................. Dimethylamine [Methanamine, 10,000 f
N-methyl-].
460-19-5............................. Cyanogen [Ethanedinitrile].. 10,000 f
463-49-0............................. Propadiene [1,2-Propadiene]. 10,000 f
463-58-1............................. Carbon oxysulfide [Carbon 10,000 f
oxide sulfide (COS)].
463-82-1............................. 2,2-Dimethylpropane 10,000 f
[Propane, 2,2-dimethyl-].
504-60-9............................. 1,3-Pentadiene.............. 10,000 f
557-98-2............................. 2-Chloropropylene [1- 10,000 g
Propene, 2-chloro-].
563-45-1............................. 3-Methyl-1-butene........... 10,000 f
563-46-2............................. 2-Methyl-1-butene........... 10,000 g
590-18-1............................. 2-Butene-cis................ 10,000 f
590-21-6............................. 1-Chloropropylene [1- 10,000 g
Propene, 1-chloro-].
598-73-2............................. Bromotrifluorethylene 10,000 f
[Ethene, bromotrifluoro-].
624-64-6............................. 2-Butene-trans [2-Butene, 10,000 f
(E)].
627-20-3............................. 2-Pentene, (Z)-............. 10,000 g
646-04-8............................. 2-Pentene, (E)-............. 10,000 g
689-97-4............................. Vinyl acetylene [1-Buten-3- 10,000 f
yne].
1333-74-0............................ Hydrogen.................... 10,000 f
4109-96-0............................ Dichlorosilane [Silane, 10,000 f
dichloro-].
7791-21-1............................ Chlorine monoxide [Chlorine 10,000 f
oxide].
7803-62-5............................ Silane...................... 10,000 f
10025-78-2........................... Trichlorosilane [Silane, 10,000 g
trichloro-].
25167-67-3........................... Butene...................... 10,000 f
----------------------------------------------------------------------------------------------------------------
\1\ A flammable substance when used as a fuel or held for sale as a fuel at a retail facility is excluded from
all provisions of this part (see Sec. 68.126).
Note: Basis for Listing:
\a\ Mandated for listing by Congress.
\f\ Flammable gas.
\g\ Volatile flammable liquid.
0
22. Amend Sec. 68.160 by adding paragraphs (b)(21) and (22) to read as
follows:
Sec. 68.160 Registration.
* * * * *
(b) * * *
(21) Method of communication and location of the notification that
chemical hazard information is
[[Page 4704]]
available to the public, pursuant to Sec. 68.210(c); and
(22) Whether a public meeting has been held following an RMP
reportable accident, pursuant to Sec. 68.210(e).
0
23. Amend Sec. 68.170 by revising paragraphs (i) and (j) to read as
follows:
Sec. 68.170 Prevention program/Program 2.
* * * * *
(i) The date of the most recent compliance audit, the expected date
of completion of any changes resulting from the compliance audit, and
identify whether the most recent compliance audit was a third-party
audit, pursuant to Sec. Sec. 68.58 and 68.59.
(j) The completion date of the most recent incident investigation
and the expected date of completion of any changes resulting from the
investigation.
* * * * *
0
24. Amend Sec. 68.175 by:
0
a. Revising the introductory text of paragraph (e), and paragraphs
(e)(1), (5), and (6);
0
b. Adding paragraph (e)(7); and
0
c. Revising paragraphs (k) and (l).
The revisions and addition read as follows:
Sec. 68.175 Prevention program/Program 3.
* * * * *
(e) The most recent process hazard analysis (PHA) or PHA update and
revalidation information, pursuant to Sec. 68.67, including:
(1) The date of completion of the most recent PHA or update and the
technique used;
* * * * *
(5) Monitoring and detection systems in use;
(6) Changes since the last PHA; and
(7) Inherently safer technology or design measures implemented
since the last PHA, if any, and the technology category (substitution,
minimization, simplification and/or moderation).
* * * * *
(k) The date of the most recent compliance audit, the expected date
of completion of any changes resulting from the compliance audit, and
identify whether the most recent compliance audit was a third-party
audit, pursuant to Sec. Sec. 68.79 and 68.80.
(l) The completion date of the most recent incident investigation
and the expected date of completion of any changes resulting from the
investigation.
* * * * *
0
25. Revise Sec. 68.180 to read as follows:
Sec. 68.180 Emergency response program and exercises.
(a) The owner or operator shall provide in the RMP:
(1) Name, organizational affiliation, phone number, and email
address of local emergency planning and response organizations with
which the stationary source last coordinated emergency response
efforts, pursuant to Sec. 68.10(f)(3) or Sec. 68.93;
(2) The date of the most recent coordination with the local
emergency response organizations, pursuant to Sec. 68.93 and
(3) A list of Federal or state emergency plan requirements to which
the stationary source is subject.
(b) The owner or operator shall identify in the RMP whether the
facility is a responding stationary source or a non-responding
stationary source, pursuant to Sec. 68.90.
(1) For non-responding stationary sources, the owner or operator
shall identify:
(i) For stationary sources with any regulated toxic substance held
in a process above the threshold quantity, whether the stationary
source is included in the community emergency response plan developed
under 42 U.S.C. 11003, pursuant to Sec. 68.90(b)(1);
(ii) For stationary sources with only regulated flammable
substances held in a process above the threshold quantity, the date of
the most recent coordination with the local fire department, pursuant
to Sec. 68.90(b)(2);
(iii) What mechanisms are in place to notify the public and
emergency responders when there is a need for emergency response; and
(iv) The date of the most recent notification exercise, as required
in Sec. 68.96(a).
(2) For responding stationary sources, the owner or operator shall
identify:
(i) The date of the most recent review and update of the emergency
response plan, pursuant to Sec. 68.95(a)(4);
(ii) The date of the most recent notification exercise, as required
in Sec. 68.96(a);
(iii) The date of the most recent field exercise, as required in
Sec. 68.96(b)(1); and
(iv) The date of the most recent tabletop exercise, as required in
Sec. 68.96(b)(2).
0
26. Amend Sec. 68.190 by adding a sentence at the end of paragraph (c)
to read as follows:
Sec. 68.190 Updates.
* * * * *
(c) * * * Prior to de-registration the owner or operator shall meet
applicable reporting and incident investigation requirements in
accordance with Sec. Sec. 68.42, 68.60, and/or 68.81.
* * * * *
0
27. Revise Sec. 68.200 to read as follows:
Sec. 68.200 Recordkeeping.
The owner or operator shall maintain records supporting the
implementation of this part at the stationary source for five years,
unless otherwise provided in subpart D of this part.
0
28. Revise Sec. 68.210 to read as follows:
Sec. 68.210 Availability of information to the public.
(a) RMP availability. The RMP required under subpart G of this part
shall be available to the public under 42 U.S.C. 7414(c) and 40 CFR
part 1400.
(b) Chemical hazard information. The owner or operator of a
stationary source shall provide, upon request by any member of the
public, the following chemical hazard information for all regulated
processes, as applicable:
(1) Regulated substances information. Names of regulated substances
held in a process;
(2) Safety data sheets (SDS). SDSs for all regulated substances
located at the facility;
(3) Accident history information. Provide the five-year accident
history information required to be reported under Sec. 68.42;
(4) Emergency response program. The following summary information
concerning the stationary source's compliance with Sec. 68.10(f)(3) or
the emergency response provisions of subpart E:
(i) Whether the stationary source is a responding stationary source
or a non-responding stationary source;
(ii) Name and phone number of local emergency response
organizations with which the owner or operator last coordinated
emergency response efforts, pursuant to Sec. 68.180; and
(iii) For stationary sources subject to Sec. 68.95, procedures for
informing the public and local emergency response agencies about
accidental releases;
(5) Exercises. A list of scheduled exercises required under Sec.
68.96; and
(6) LEPC contact information. Include LEPC name, phone number, and
web address as available.
(c) Notification of availability of information. The owner or
operator shall provide ongoing notification on a company Web site,
social media platforms, or through other publicly accessible means
that:
(1) Information specified in paragraph (b) of this section is
available to the public upon request. The notification shall:
(i) Specify the information elements, identified in paragraph (b)
of this section, that can be requested; and
(ii) Provide instructions for how to request the information (e.g.
email,
[[Page 4705]]
mailing address, and/or telephone or Web site request);
(2) Identify where to access information on community preparedness,
if available, including shelter-in-place and evacuation procedures.
(d) Timeframe to provide requested information. The owner or
operator shall provide the requested information under paragraph (b) of
this section within 45 days of receiving a request from any member of
the public.
(e) Public meetings. The owner or operator of a stationary source
shall hold a public meeting to provide information required under Sec.
68.42 as well as other relevant chemical hazard information, such as
that described in paragraph (b) of this section, no later than 90 days
after any accident subject to reporting under Sec. 68.42.
(f) Classified information. The disclosure of information
classified by the Department of Defense or other Federal agencies or
contractors of such agencies shall be controlled by applicable laws,
regulations, or executive orders concerning the release of classified
information.
(g) CBI. An owner or operator asserting CBI for information
required under this section shall provide a sanitized version to the
public. Assertion of claims of CBI and substantiation of CBI claims
shall be in the same manner as required in Sec. Sec. 68.151 and 68.152
for information contained in the RMP required under subpart G of this
part. As provided under Sec. 68.151(b)(3), an owner or operator of a
stationary source may not claim five-year accident history information
as CBI. As provided in Sec. 68.151(c)(2), an owner or operator of a
stationary source asserting that a chemical name is CBI shall provide a
generic category or class name as a substitute.
[FR Doc. 2016-31426 Filed 1-12-17; 8:45 am]
BILLING CODE 6560-50-P
