Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act

Federal RegisterMar 14, 2016

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 68

[EPA-HQ-OEM-2015-0725; FRL-9940-94-OLEM]

RIN 2050-AG82

Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA), in response to Executive Order 13650, is proposing to amend its Risk Management Program regulations. The proposed revisions include several changes to the accident prevention program requirements including an additional analysis of safer technology and alternatives for 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 proposed 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:

Comments.

Comments and additional material must be received on or before May 13, 2016. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before April 13, 2016.

Public Hearing.

The EPA will hold a public hearing on this proposed rule on March 29, 2016 in Washington, DC.

ADDRESSES:

Comments. Submit comments and additional materials, identified by docket EPA-HQ-OEM-2015-0725 to the Federal eRulemaking Portal:

http://www.regulations.gov

. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (

i.e.,

on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit

http://www2.epa.gov/dockets/commenting-epa-dockets

Public Hearing.

A public hearing will be held in Washington, DC on March 29, 2016 at William J. Clinton East Building, Room 1153 (Map Room), 1201 Constitution Ave. NW., Washington, DC 20460. The hearing will convene at 9:00 a.m. through 8:00 p.m. The sessions will run from 9:00 a.m. to 12:00 Noon, with a break between 12:00 Noon and 1:00 p.m., continuing from 1:00 p.m. to 4:30 p.m., with a break from 4:30 to 5:30 p.m., and continuing from 5:30 p.m. to 8:00 p.m. Persons wishing to preregister may be assigned a time according to this schedule. The evening session beginning at 5:30 p.m. will be extended one hour after all scheduled comments have been heard to accommodate those wishing to make a comment as a walk-in registrant. Please register at

https://rmp-proposed-rule.eventbrite.com

to speak at the hearing. The last day to preregister in advance to speak at the hearing is March 24, 2016. Additionally, requests to speak will be taken the day of the hearing at the hearing registration desk, although preferences on speaking times may not be able to be fulfilled. If you require the service of a translator or special accommodations such as audio description, we ask that you pre-register for the hearing, on or before March 21, 2016, to allow sufficient time to arrange such accommodations.

The hearing will provide interested parties the opportunity to present data, views or arguments concerning the proposed action. The EPA will make every effort to accommodate all speakers who arrive and register. Because this hearing is being held at U.S. government facilities, individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. Please note that the REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. If your driver's license is issued by Alaska, American Samoa, Arizona, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Montana, New York, Oklahoma or the state of Washington, you must present an additional form of identification to enter the federal building. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses and military identification cards. In addition, you will need to obtain a property pass for any personal belongings you bring with you. Upon leaving the building, you will be required to return this property pass to the security desk. No large signs will be allowed in the building, cameras may only be used outside of the building and demonstrations will not be allowed on federal property for security reasons.

The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the rulemaking. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearing to run either ahead of schedule or behind schedule.

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 Notice of Proposed Rulemaking (NPRM) and related news releases are available on EPA's Web site at

http://www.epa.gov/rmp

. Copies of this NPRM are also available at

http://www.regulations.gov

SUPPLEMENTARY INFORMATION:

Acronyms and Abbreviations.

We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

ACC American Chemistry Council

ACUS Administrative Conference of the United States

AFPM American Fuel & Petrochemical Manufacturers

AMWA Association of Metropolitan Water Agencies

AN ammonium nitrate

ANSI American National Standards Institute

API American Petroleum Institute

ASTM American Society for Testing and Materials

AUC Allied Universal Corp

AWWA American Water Works Association

AXPC American Exploration & Production Council

BSEE Bureau of Safety and Environmental Enforcement

BTMU Bank of Tokyo Mitsubishi

CAA Clean Air Act

CAAA Clean Air Act Amendments

CARB California Air Resources Board

CAS Chemical Abstracts Service

CBI confidential business information

CCHS Contra Costa County Health Services

CCPS Center for Chemical Process Safety

CEM European Committee for Standardization

CFATS Chemical Facility Anti-Terrorism Standards

CFR Code of Federal Regulations

CGA Compressed Gas Association

CI Chlorine Institute

CO2 Carbon dioxide

COS Center for Offshore Safety

CPCD Coalition to Prevent Chemical Disasters

CPSC Consumer Product Safety Commission

CRA Corn Refiners Association

CSAG Chemical Safety Advocacy Group

CSB Chemical Safety and Hazard Investigation Board

CSD Center for Science and Democracy

CSISSFRRA Chemical Safety Information, Site Security and Fuels Regulatory Relief Act

DHS Department of Homeland Security

DOI Department of the Interior

EPA Environmental Protection Agency

EPCRA Emergency Planning & Community Right-To-Know Act

FCC Federal Communications Commission

FDA Food and Drug Administration

FEMA Federal Emergency Management Agency

FOIA Freedom of Information Act

FPC Formosa Plastics Corporation

FR Federal Register

FRP facility response plan

GHG greenhouse gas

GHS Globally Harmonized System of Classification and Labelling of Chemicals

GPA Gas Processors Association

HAZOP hazard and operability study

HF hydrofluoric acid

IPAA Independent Petroleum Association of America

ISD inherently safer design

ISO industrial safety ordinance

ISOM isomerization

ISS inherently safer strategies

IST inherently safer technology

LEPC local emergency planning committee

LPG liquefied petroleum gas

MACT maximum achievable control technology

MIC methyl isocyanate

MKOPSC Mary Kay O'Connor Process Safety Center

MOC management of change

NACD National Association of Chemical Distributors

NAICS North American Industrial Classification System

NAM National Association of Manufacturers

NAS National Academy of Sciences

NASTTPO National Association of SARA Title III Program Officials

NIST National Institute of Standards and Technology

NJDEP New Jersey Department of Environmental Protection

NOPA National Oilseed Processors Association

NPRM Notice of Proposed Rulemaking

NRC Nuclear Regulatory Commission

NSPS New Source Performance Standards

NTTAA National Technology Transfer Advancement Act

NYDFS New York State Department of Financial Services

OCA offsite consequences analysis

OCS outer continental shelf

OHMERC Oklahoma Hazardous Materials Emergency Response Commission

OMB Office of Management and Budget

OSHA Occupational Safety and Health Administration

PCAOB Public Company Accounting Oversight Board

PE professional engineer

PHA process hazard analysis

PRA Paperwork Reduction Act

PREP preparedness for response exercise program

PSI process safety information

PSM process safety management

PSSAP Process Safety Site Assessment Program

PVC polyvinyl chloride

PwC PricewaterhouseCoopers

RAGAGEP recognized and generally accepted good engineering practices

RCRA Resource Conservation and Recovery Act

RFA Regulatory Flexibility Act

RFI request for information

RMP Risk Management Plan

SARA Superfund Amendments and Reauthorization Act

SBAR Small Business Advocacy Review

SBREFA Small Business Regulatory Enforcement Fairness Act

SDS safety data sheet

SDWA Safe Drinking Water Act

SEC Securities and Exchange Commission

SEMS Safety and Environmental Management Systems

SER small entity representative

SERC state emergency response commission

SOCMA Society of Chemical Manufacturers and Affiliates

SOP standard operating procedure

STAA safer technology and alternatives analysis

TCPA Toxic Catastrophe Prevention Act

TEPC tribal emergency planning committees

TERC tribal emergency response commission

TPA Texas Pipeline Association

TQ threshold quantity

TSCA Toxic Substances Control Act

UMRA Unfunded Mandates Reform Act

USCG United States Coast Guard

UST underground storage tank

USW United Steel Workers

VCM vinyl chloride monomer

VCS voluntary census standards

Organization of this Document.

The contents of this preamble are:

I. General Information

A. Executive Summary

B. Does this action apply to me?

II. Background

III. Additional Information

A. What actions are not addressed in this rule?

B. What is the agency's authority for taking this action?

IV. Prevention Program Requirements

A. Incident Investigation and Accident History Requirements

B. Third-Party Compliance 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. Proposed Public Disclosure Requirements to LEPCs or Emergency Response Officials

B. Proposed Revisions to Requirements for Information Availability to the Public

C. Alternative Options

VII. Risk Management Plan Streamlining, Clarifications, and RMP Rule Technical Corrections

A. Deletions From Subpart G

B. Revisions to Subpart G

C. Additions to Subpart G

D. Proposed Amendments and Technical Corrections

VIII. Compliance Dates

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

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, President Obama issued Executive Order 13650, “Improving Chemical Facility Safety and Security,” on August 1, 2013.

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 agency program presently in existence is the Risk Management Program implemented by EPA under section 112(r) of the Clean Air Act (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. As part of this effort 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 a “Request for Information” notice or “RFI” (79 FR 44604).

EPA believes that 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. These revisions are a result of a review of the existing Risk Management Program and information gathered from the RFI and Executive Order listening sessions.

2. Summary of the Major Provisions of the Regulatory Action

This action proposes to amend 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 specificity and rigor over three program levels (

i.e.,

Program 1, Program 2, and Program 3).

The major provisions of this proposed 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 proposed revisions is introduced in the following paragraphs of this section and described in greater detail in sections IV through VI, later in this document.

Certain proposed 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 document.

a. Accident Prevention Program Revisions

This action proposes three changes to the accident prevention program requirements. First, the proposed rule would require 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 proposed rule would require regulated facilities with Program 2 or 3 processes to contract with an independent third-party to perform a compliance audit after the facility has a reportable release. 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 proposed revision to the prevention program would add 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) would be required to conduct a safer technology and alternatives analysis (STAA) as part of their PHA, and to evaluate the feasibility of any inherently safer technology (IST) identified. The current PHA requirements include consideration of active, passive, and procedural measures to control hazards. The proposed modernization effort continues to support the analysis of those measures and adds consideration of IST alternatives. The proposed 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. Data compiled from RMPs suggest processes in these NAICS codes have a disproportionate share of reportable releases.

At this time, EPA is not proposing any additional requirements either for location of stationary sources (related to their proximity to public receptors) or emergency shutdown systems. However, EPA seeks comment on whether such requirements should be considered for future rulemakings, including the scope of such requirements, or whether the Agency should publish guidance.

b. Emergency Response Enhancements

This action also proposes to enhance the rule's emergency response requirements. Owners or operators of all facilities with Program 2 or 3 processes would be required to coordinate with the local emergency response agencies at least once a year to ensure that resources and capabilities are in place to respond to an accidental release of a regulated substance. As a result of improved coordination between facility owners and operators and local emergency response officials, EPA believes that some facilities that are currently designated as non-responding facilities may become responding

facilities (

i.e.,

develop an emergency response program in accordance with § 68.95).

Additionally, all facilities with Program 2 or 3 processes would be 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 proposes to require that all facilities subject to the emergency response program requirements of subpart E of the rule (or “responding facilities”) conduct a full field exercise at least once every five years and one tabletop exercise annually in the other years. Responding facilities that have an RMP reportable accident would also have to conduct a full field exercise within a year of the accident. 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.

c. Enhanced Availability of Information

This action proposes various enhancements to the public availability of chemical hazard information. The proposed rule would require all facilities to provide certain basic information to the public through easily accessible means such as a facility Web site. If no Web site exists, the owner or operator may provide the information at public libraries or government offices, or use other means appropriate for particular locations and facilities. In addition, a subset of facilities would be required, upon request, to provide the Local Emergency Planning Committee (LEPC), Tribal Emergency Planning Committee (TEPC)

or other local emergency response agencies with summaries related to: Their activities on compliance audits (facilities with Program 2 and Program 3 processes); emergency response exercises (facilities with Program 2 and Program 3 processes); accident history and investigation reports (all facilities that have had RMP reportable accidents); and any ISTs implemented at the facility (a subset of Program 3 processes). The proposed rule would also require all facilities to hold a public meeting for the local community within a specified timeframe after 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.

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 proposes revisions to clarify or simplify the RMP submission. These changes are intended to reduce the compliance burden on facilities and increase their understanding of the RMP requirements. We are also proposing technical corrections to various provisions of the rule.

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 proposed rule changes. 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

Sector

NAICS codes

Total facilities

Chemical uses

Administration of environmental quality programs (

i.e.

, governments)

924

1,923

Use chlorine and other chemicals for treatment.

Agricultural chemical distributors/wholesalers

111, 112, 115, 42491

3,667

Store ammonia for sale; some 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, 72

248

Use chemicals for wastewater 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

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 (except 22131, 22132)

343

Use chlorine (mostly for water treatment).

Warehousing and storage

493

1,056

Use mostly ammonia as a refrigerant.

Water/wastewater Treatment Systems

22131, 22132

102

Use chlorine and other chemicals.

Total

12,542

Table 2 presents a summary of the annualized costs estimated in the regulatory impact analysis.

In total, EPA estimates annualized costs of $158.3 million at a 3% discount rate and $161.0 million at a 7% discount rate.

A full description of costs and benefits for this proposed rule can be found in 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).

Table 2—Summary of Annualized Costs

[Millions, 2014 dollars]

Provision

(percent)

Third-party Audits

$5.0

Incident Investigation/Root Cause

0.8

STAA

34.8

Coordination

6.3

New Responders *

33.0

35.6

Notification Exercises

1.4

Facility Exercises

60.7

Information Sharing (LEPC)

11.7

Information Sharing (Public)

4.0

Public Meeting

0.4

Rule Familiarization

0.3

Total Cost

158.3

161.0

* Reflects costs for some facilities to convert from “non-responding” to “responding” as a result of improved coordination with local emergency response officials.

+ Totals may not sum due to rounding.

The largest average annual cost of the proposed rule is the exercise costs for current responders ($60.7 million), followed by new responders (facilities that will comply with the emergency response program requirements of § 68.95 as a result of local coordination activities or receiving a written request from the facility's LEPC) ($35.6 million), STAA ($34.8 million), and information sharing (LEPC) ($11.7 million). The remaining provisions impose average annual costs under $10 million each, including coordination ($6.3 million), third-party audits ($5.0 million), information sharing (public) ($4.0 million), notification exercises ($1.4 million), incident investigation/root cause analysis ($0.8 million), public meetings ($0.4 million), and rule familiarization ($0.3 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 proposed 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 a final rule. Table 3 presents a summary of the quantified damages identified in the analysis.

Table 3—Summary of Quantified Damages

[2014 dollars]

Unit value

10-Year total

Average/

year

Average/

accident

On-site

Fatalities

$8,583,113

$497,820,554

$49,782,055

$328,161

Injuries

50,000

105,150,000

10,515,000

69,314

Property Damage

2,054,895,236

205,489,524

1,354,578

On-site Total

2,657,865,790

265,786,579

1,752,053

Offsite

Fatalities

$8,583,113

$858,311

$5,658

Hospitalizations

36,000

6,804,000

680,400

4,485

Medical Treatment

1,000

14,807,000

1,480,700

9,761

Evacuations

181

6,992,327

699,233

4,609

Sheltering in Place

40,920,849

4,092,085

26,975

Property Damage

11,352,105

1,135,211

7,483

Offsite Total

89,459,394

8,945,939

58,971

Total

2,747,325,184

274,732,518

1,811,024

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 ($0.9 million), evacuations ($0.7 million), and hospitalizations ($0.7 million).

In total, EPA estimated monetized damages from RMP facility accidents of $275 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 proposed 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.

Table 4—Summary of Social Benefits of Proposed Rule Provisions

Broad benefit category

Explanation

Specific benefit categories

Accident Prevention

Accident Mitigation

Non-RMP accident prevention and mitigation

Avoided Catastrophes

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

• 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.

Information Disclosure

Provision of information to the public and LEPCs

• Improved efficiency of property markets.

• Improved 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 below 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 Proposed Action

Sector

NAICS Code

Administration of Environmental Quality Programs

924.

Agricultural Chemical Distributors:

Animal Production and Aquaculture

112.

Crop Production

111.

Farm Supplies Merchant Wholesalers

42491.

Support Activities for Agriculture and Forestry

115.

Beverage Manufacturing

3121.

Food Manufacturing

311.

Chemical and Allied Products Merchant Wholesalers

4246.

Chemical Manufacturing

325.

Oil and Gas Extraction

211.

Other

313, 326, 327, 33, 44, 45, 48, 54, 56, 61, 72.

Other Wholesale:

Merchant Wholesalers, Durable Goods

423.

Merchant Wholesalers, Nondurable Goods

424.

Paper Manufacturing

322.

Petroleum and Coal Products Manufacturing

324.

Petroleum and Petroleum Products Merchant Wholesalers

4247.

Utilities

221 (except 22131 and 22132 described below).

Warehousing and Storage

493.

Water/Wastewater Treatment Systems:

Sewage Treatment Facilities

22132.

Water Supply and Irrigation Systems

22131.

II. Background

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.

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, such as the explosion that occurred at the West Fertilizer facility in West, Texas, on April 17, 2013.

In addition to the tragedy at the West Fertilizer facility, 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.

On April 2, 2010, an explosion and fire at the Tesoro Refinery in Anacortes, Washington, killed seven people.

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.

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.

For descriptions of NAICS codes, see

http://www.census.gov/cgi-bin/sssd/naics/naicsrch

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

CSB. January 2016. Final Investigation Report, West Fertilizer Company Fire and Explosion, West, TX, April 17, 2013. REPORT 2013-02-I-TX.

http://www.csb.gov/west-fertilizer-explosion-and-fire-/

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.

http://www.csb.gov/assets/1/19/CSBFinalReportBP.pdf

CSB. May 2014. Investigation Report: Catastrophic Rupture of Heat Exchanger, Tesoro Anacortes Refinery, Anacortes, Washington, April 2, 2010. Report No. 2010-08-I-WA.

http://www.csb.gov/assets/1/7/Tesoro_Anacortes_2014-May-01.pdf

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.

http://www.csb.gov/assets/1/19/CSB_Chevron_Richmond_Refinery_Regulatory_Report.pdf

CSB. June 27, 2013. Testimony of Rafael Moure-Eraso, Ph.D. Chairperson, CSB Before the U.S. Senate Committee on Environment and Public Works, pg. 8.

http://www.csb.gov/assets/1/19/CSB_Written_Senate_Testimony_6.27.13.pdf

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 has informed this proposal. Readers are encouraged to review the RFI, as this action will not reiterate the full discussion of all of its topics.

EPA received a total of 579 public comments on the RFI. Several public comments were the result of various mass mail campaigns and contained numerous copies of letters or petition signatures. Approximately 99,710 letters and signatures were contained in these several comments. Discussion of RFI public comments pertaining to topics included in this proposal can be found below in section IV. Prevention Program Requirements, section V. Emergency Response Preparedness Requirements and section VI. Information Availability Requirements.

EPA seeks comment on the proposed amendments. Any suggestions for alternative options should include an appropriate rationale and supporting data for the Agency to be able to consider it for a final action.

A. Overview of EPA's Risk Management Program Regulations

Both EPA's 40 CFR part 68 RMP regulation

and Occupational Safety and Health Administration's (OSHA) 29 CFR 1910.119 Process Safety Management (PSM) standard were authorized in the Clean Air Act Amendments of 1990 (1990 CAAA). 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.

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

http://www2.epa.gov/rmp

for more information on the Risk Management Program.

The 1990 CAAA 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)).

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”)

and published the RMP final regulation, containing risk management requirements for covered sources, in 1996 (61 FR 31668, June 20, 1996) (the “RMP rule”).

13 14

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.

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.

Documents and information related to development of the RMP rule can be found in EPA docket number A-91-73.

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 § 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).

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.

NAICS codes 325181 and 325188 are now combined and represented as 2012 revised NAICS code 325180 (other basic inorganic chemical manufacturing). NAICS code 325192 is now 2012 revised NAICS code 325194 (cyclic crude, intermediate, and gum and wood chemical manufacturing).

On July 22, 2015, OSHA issued a revised interpretation to its PSM retail exemption at 29 CFR 119(a)(2)(i).

This

interpretation now only allows facilities in NAICS codes 44 and 45, the retail trade, to be eligible for the retail exemption. As a result of this change, many agricultural chemical distributors who sell bulk anhydrous ammonia and some chemical warehouses, are no longer exempt from the PSM standard. This makes them subject to RMP Program 3 requirements, whereas before most were covered under Program 2.

See OSHA PSM Retail Exemption Policy

https://www.osha.gov/pls/oshaweb/owadisp.show_

document?p_table=INTERPRETATIONS&p_id=29528.

EPA believes 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, 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. What actions are not addressed in this rule?

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 solicited public comment on potential options for improving chemical facility safety. Additionally, EPA gathered information from the public regarding potential changes to EPA's Risk Management Program regulations (40 CFR part 68) via a RFI (79 FR 44604, July 31, 2014). Using the results from these efforts as well as information collected through implementing the Risk Management Program, EPA is proposing revisions to the RMP rule to advance chemical facility safety. However, this proposed rule does not address all of the topics included in the RFI. For example, EPA is not proposing any revisions to the list of regulated substances and is therefore not addressing ammonium nitrate (AN) in this proposed rule. EPA may propose listing additional hazardous substances in a separate action.

Currently AN is not listed as a regulated substance under the RMP rule or the OSHA PSM standard. Required safe handling and storage practices for AN are covered under OSHA's Explosives and Blasting Agents Standard (29 CFR 1910.109) and includes coverage of fertilizer grade AN in section 1910.109(i). Section 1910.109(k)(2) requires that manufacturing of explosives must meet requirements under OSHA's PSM standard (29 CFR 1910.119); this would include any explosive manufacturing process involving AN. OSHA is considering whether AN should be added to the § 1910.119 Appendix A list of chemicals subject to the PSM standard, which could expand the standard's applicability to include processes at fertilizer mixers, distributors and wholesalers who store and handle AN. OSHA is also considering whether to make changes to the AN storage and handling requirements in their Explosives and Blasting Agents standard, which has requirements for AN stored with and without, explosives and blasting agents. DHS is considering potential modifications of its Chemical Facility Anti-Terrorism Standards (CFATS) regulation, including reviewing the applicability and/or modification of screening TQs for chemicals of interest in Appendix A in 6 CFR part 27, which include AN (79 FR 48693, August 18, 2014).

We plan to coordinate any potential change to the list of substances 40 CFR part 68 with the actions of these other agencies. Therefore, EPA is not presently proposing that AN be added to the list of substances subject to the RMP rule, but the Agency may elect to propose such a listing at a later date.

CFATS. 79 FR 48693, August 18, 2014.

http://www.regulations.gov/#!documentDetail;D=DHS-2014-0016-0001

B. What is the 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 propose to modify 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 [Oct. 20, 1993]). The prevention program provisions discussed below (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 112(r)(7)(B)(i)). This paragraph calls for EPA's regulations to recognize differences in “size, operations, processes, class and categories of sources.” In this document, we propose to maintain 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.

IV. Prevention Program Requirements

A. Incident Investigation and Accident History Requirements

1. Summary of Existing Investigation Requirements

Currently, owners or operators of facilities with processes subject to Program 2 and Program 3 are required to investigate each incident which resulted in, or could reasonably have resulted in a catastrophic release (§§ 68.60 and 68.81). The RMP rule defines a catastrophic release in § 68.3 as a major uncontrolled emission, fire, or explosion, involving one or more regulated substances that presents an imminent and substantial endangerment to public health and the environment. Imminent and substantial endangerment includes offsite consequences such as death, injury, or adverse effects to human health or the environment, or the need for the public to shelter-in-place or be evacuated to avoid such consequences.

Facility owners or operators are required to determine the factors that contributed to the incident and develop recommendations resulting from the investigation. The PHA (§ 68.67 (c)(2)) is required to address previous incidents which had a likely potential for catastrophic consequences. In the preamble to the existing final rule, EPA explained that while most catastrophic releases affect workers first, there are incidents where workers are protected but the public and the environment may be threatened (

e.g.,

emergency relief devices are designed to vent hazardous atmospheres away from the workplace

and into the air where they may be carried downwind). The PHA should recognize and address the potential offsite impact associated with safety measures that protect workers (

e.g.,

by installing a control device on an emergency vent). The RMP rule requires that facility owners and operators consider such possibilities and integrate the protection of workers, the public, and the environment into one program. Thus, RMP facility owners and operators must investigate each significant incident which resulted in, or could reasonably have resulted in a catastrophic release with on- or offsite consequences.

2. Catastrophic Release Definition

In the 1996 final rule (61 FR 31687, June 20, 1996), EPA developed a definition of catastrophic release similar to the definition OSHA used in the PSM standard, with modifications to cover events that presented imminent and substantial endangerment to public health and the environment.

This ensured that owners or operators of sources covered by both OSHA and EPA requirements investigated not only accidents that threatened workers, but also those that threatened the public and the environment. Because EPA modified OSHA's definition of catastrophic releases so that offsite impacts were covered, there has been confusion among some owners and operators of facilities subject to the RMP rule; some believe they should not have to investigate accidents involving only workers for the purposes of fulfilling requirements under the RMP rule. EPA recognized that the PHA process must address potential offsite impacts associated with safety measures that also protect workers, and that the final rule would ensure that all sources routinely consider such possibilities and integrate protection of workers, the public and the environment into one program. In similar fashion, EPA believes that incident investigation was not intended to be and should not be limited to only those incidents with offsite impacts.

The OSHA definition of

catastrophic release

is similar to the current definition of the term in the RMP rule. However, OSHA's definition pertains to incidents that present serious danger to employees in the workplace. (see 29 CFR 1910.119(b) for the full definition)

Learning from accident causes identified from incident investigations involving only workers can also lead to preventing incidents with further impacts to the surrounding community and therefore, findings and recommendations from all incidents, regardless of who is impacted, should be addressed. In the preamble to the 1996 final RMP rule (61 FR 31711, June 20, 1996), EPA emphasized that “any incident with the potential for catastrophic consequences in the workplace will also have had the potential for catastrophic consequences offsite.” Thus, facility owners or operators should be investigating incidents even if they only impacted workers, as these could have potentially been an accident impacting the public or the environment.

EPA has not defined or clarified the term “imminent and substantial endangerment” but did make revisions in the 1996 final RMP rule in order to better define accidents to be reported under the RMP accident history requirements. To make the requirement less vague and less subject to a wide variety of interpretations, the final rule required that accident history shall include all 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 also provided a definition for “offsite” and “injury.”

EPA is proposing to modify the definition of catastrophic release to be 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, replaces “that presents imminent and substantial endangerment to public health and the environment” with impacts 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. This better defines the impacts for incidents requiring investigations that caused or could have caused these impacts and clarifies EPA's intent, rather than leaving it open for interpretation. This is consistent with the accident impacts that must be reported under the 5-year accident history, which EPA considered relevant to include in 1996 “because it 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.”

EPA. May 24, 1996. Risk Management Plan Rule, Summary and Response to Comments. Volume 1, pp. 3-11 and 17-4. Docket No. A-91-73, Document No. IX-C-1.

As required by section 609(b) of the RFA, the EPA convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives (SERs) that would potentially be subject to the rule's requirements. As part of the SBAR Panel process, some SERs indicated that EPA's proposed modification of the definition of catastrophic release would in effect expand that definition, and thereby require investigation of incidents that did not fall under the previous definition. SERs noted that EPA's current definition includes releases that present an imminent and substantial endangerment to public health and the environment, and that such releases represent only “major” accidents, and not smaller releases that endanger only workers or on-site property. As noted above, EPA's view is that accidents with only on-site impacts warrant investigation because they have the potential to affect offsite areas. Additionally, since such accidents already clearly fall within the accident history reporting criteria, regulated sources would already need to investigate them, even without the incident investigation provisions, in order to determine the accident history information required under § 68.42, which includes data (

e.g.,

initiating event and contributing factors) that could only be determined through an investigation. Therefore, EPA believes that redefining the term catastrophic release to include the categories of accidents that require reporting under the accident history provisions clarifies, rather than expands, that definition. Nevertheless, EPA seeks comment on the proposed revision to the catastrophic release definition, whether it expands the scope of the current definition instead of clarifying it, and whether the definition should be limited to loss of life; serious injury; significant damage; or loss of offsite property.

3. Root Causes

The cause of an incident is often the result of a series of other problems that need to be addressed to prevent recurrences. For example, an operator's mistake may be the result of poor training, inappropriate procedures, or poor design of control systems; and equipment failure may result from improper maintenance, misuse of equipment (

e.g.,

operating at too high a temperature), or use of incompatible materials. These types of causes are commonly referred to as causal factors (also known as contributing causes, contributory causes, contributing

factors, or critical factors). The Center for Chemical Process Safety (CCPS) defines a causal factor as a major unplanned, unintended contributor to the incident (a negative occurrence or undesirable condition), that if eliminated would have either prevented the occurrence, or reduced its severity or frequency.

These are factors that facilitate the occurrence of an incident such as physical conditions and management practices. Causal or contributing factors usually have underlying reasons why they occurred, which are known as root causes.

CCPS. March 2003. Guidelines for Investigating Chemical Process Incidents, 2nd ed., pp.3, 62, 181, 434. CCPS, American Institute of Chemical Engineers, New York, NY. John Wiley and Sons.

Most root causes are associated with weaknesses, defects or breakdowns in management systems.

Identifying root causes provides the mechanism for understanding the interaction and impact of system management failures, so that the root causes can be addressed and the maximum benefit is obtained from an incident investigation. CCPS defines a root cause as a fundamental, underlying, system-related reason why an incident occurred that identifies a correctable failure(s) in management systems. There is typically more than one root cause for a process safety incident. Correcting only the immediate cause of an incident (

e.g.,

operator error) may prevent the identical incident from occurring at the same location, but may not prevent similar incidents. Instead, identifying and addressing incident contributing factors and their root causes helps eliminate or substantially reduce the risk of reoccurrence of the incident and other similar incidents. The current Risk Management Program incident investigation requirements under §§ 68.60 and 68.81 do not explicitly require root causes to be determined and reported, rather they only require “the factors that contributed to the incident.” Facility owners and operators that conduct incident investigations that only identify “factors that contributed to the incident” may miss identifying the underlying, system-related reason why an incident occurred (which would be revealed in a root cause analysis). Thus EPA is proposing to require a root cause analysis to ensure that facilities determine the underlying causes of an incident to reduce or eliminate the potential for additional accidents resulting from deficiencies of the same process safety management system.

EPA recognizes that some root causes could be events that management systems could not have prevented or protected against. The analytic techniques used to identify root causes account for such events.

4. Lack of Root Cause Analysis for Prior Incidents

Below are examples of incident investigations that identified similar prior incidents within the same facility or company where root causes for the prior incidents were not analyzed and determined. This resulted in missed opportunities to address the proper causes of the incidents, share the lessons learned and prevent further similar incidents.

On January 21, 1997, at a Tosco refinery, effluent piping on a hydrocracker reactor ruptured, causing an explosion and fire, killing one operator and injuring 46 other Tosco and contractor personnel. The accident was caused by an uncontrolled temperature excursion in the reactor resulting in an excessively high temperature that caused the pipe to rupture.

Operators did not follow prescribed emergency depressurizing procedures for extremely high temperature occurrences and attempted to control the temperature by other means. Investigations of prior incidents involving unsafe temperature excursions were inadequate and not all these excursions were documented. Failure to investigate these “near-misses” resulted in a missed opportunity to determine why operators were not following prescribed emergency depressurizing procedures and to develop solutions to address the cause. After the 1997 accident, the company designed the depressurizing system to activate automatically when the reactor temperature exceeded safe operating limits.

EPA. November 1998. EPA Chemical Accident Investigation Report, Tosco Avon Refinery, Martinez, CA. EPA 550-R-98-009.

http://nepis.epa.gov/Exe/ZyPDF.cgi/10003A2E.PDF?Dockey=10003A2E.PDF.

On September 10, 1997, an explosion occurred in a resins production unit at Georgia-Pacific Resins, Inc. in Columbus, Ohio, causing the death of one worker, four injuries, extensive damage to the plant, and sheltering in place for nearby residents, a vocational school and businesses.

Three firefighters received first-degree burns. An accident investigation determined that raw materials and a catalyst were charged too quickly to a reactor, causing a runaway reaction generating too much heat and pressure, which caused the reactor to explode. Prior to the accident, the facility had recently experienced a near miss involving similar circumstances.

An operator added chemicals to a batch resin process at too high a rate. Other alert operators noted the procedural deviation and were able to prevent an accident. The company investigated the accident and disciplined the operator, but took no other actions.

EPA, Office of Solid Waste and Emergency Response. August 1999. How to Prevent Runaway Reactions, Case Study: Phenol-Formaldehyde Reaction Hazards. EPA 550-F99-004.

http://archive.epa.gov/emergencies/docs/chem/web/pdf/gpcasstd.pdf.

Belke, James C (EPA). 1997. Recurring Causes of Recent Chemical Accidents.

http://psc.che.tamu.edu/wp-content/uploads/recurring-causes-of-recent-chemical-accidents.pdf.

An accident on June 22, 1997, at a Shell olefins plant involved a release of flammable gases from a structural failure and drive shaft blowout from a 36 inch diameter failed check (non-return) valve, resulting in a massive explosion and fire causing extensive damage to the facility, damage to nearby residential property, several worker injuries, and sheltering in place for nearby residents. An EPA/OSHA accident investigation determined that these check valves were not appropriately designed and manufactured for the heavy-duty service to which they were subjected in the olefins production unit.

Similar problems with the check valves had occurred previously at the facility and at other facilities owned by the company, but the occurrences were not adequately investigated and did not identify all the factors involved in the valves' failure. The other valve failure occurrences did not result in as severe consequences as the 1997 event and were treated as maintenance failures, not incidents or accidents. Thus, the lessons that could have been learned from these prior failures were not adequately identified, shared, and implemented.

EPA and OSHA. June 1998. EPA/OSHA Joint Chemical Accident Investigation Report, Shell Chemical Company, Deer Park, TX. EPA 550-R-98-005.

http://nepis.epa.gov/Exe/ZyPDF.cgi/100039YA.PDF?Dockey=100039YA.PDF

On April 8, 1998, at a Morton International chemical plant, a runaway reaction in a process kettle caused an overpressure of the vessel, blew off the top hatch, and spewed a stream of gas and liquid through the roof of the building and down onto the surrounding community. Residents in a 100 city-block area were confined to their homes. Nine workers were injured, two with severe burns. The U.S. Chemical Safety Board (CSB) determined that Morton could have corrected safety problems in the process if they had conducted investigations into any of the eight prior instances when process temperatures exceeded

the normal range.

Process and design changes resulting from such investigations could have prevented the 1998 explosion.

CSB. 2000. Investigation Digest: Morton International Explosion, Paterson, NJ, April 8, 1998.

http://www.csb.gov/assets/1/19/Morton_Digest.pdf.

On April 23, 2004, an explosion and fire at the Formosa Plastics Corporation (FPC USA), Illiopolis, Illinois, (Formosa-IL) polyvinyl chloride (PVC) manufacturing facility killed five and severely injured three workers. The explosion and fire destroyed most of the reactor facility and adjacent warehouse and ignited PVC resins stored in the warehouse. Smoke from the smoldering fire drifted over the local community, and as a precaution, local authorities ordered an evacuation of the community for two days. CSB determined that this incident occurred when an operator drained a full, heated, and pressurized PVC reactor and bypassed a pressure interlock.

The safeguards to prevent bypassing the interlock were insufficient for the high risk associated with this activity. Two similar incidents at FPC USA PVC manufacturing facilities highlighted problems with safeguards designed to prevent inadvertent discharge of an operating reactor. The FPC USA Environmental Health & Safety group had received reports of both incidents, but did not recognize a key similarity: Operators could mistakenly go to the wrong reactor and bypass safeguards to open a reactor bottom valve.

CSB. March 2007. Investigation Report: VCM Explosion, Formosa Plastics Corp., Illiopolis, Illinois, April 23, 2004. Report No. 2004-10-I-IL.

http://www.csb.gov/assets/1/19/Formosa_IL_Report.pdf.

On March 23, 2005, at the BP Texas City Refinery in Texas City, Texas, explosions and fires killed 15 people and injured another 180, required shelter-in-place for 43,000 people, damaged nearby houses, and resulted in financial losses exceeding $1.5 billion. The incident occurred during the startup of an isomerization (ISOM) unit when a raffinate splitter tower was overfilled and pressure relief devices opened, resulting in a flammable liquid geyser from a blowdown stack that was not equipped with a flare. The release of flammables led to an explosion and fire. All of the fatalities occurred in or near office trailers located close to the blowdown drum. A CSB investigation found that in the years prior to the incident, eight serious releases of flammable material from the ISOM blowdown stack had occurred, and most ISOM startups experienced high liquid levels in the splitter tower.

The investigation identified root causes of the accident involving senior leadership failures including:

CSB. March 2007. Investigation Report: Refinery Explosion and Fire, BP, Texas City, Texas, March 23, 2005. Report No. 2005-04-I-TX.

http://www.csb.gov/assets/1/19/CSBFinalReportBP.pdf.

• Ineffective safety culture leadership and oversight;

• ineffective evaluation of safety implications or organization, personnel, and policy changes; and

• inadequate resources to prevent major accidents.

Root causes identified involving plant management failures included:

• Lack of an effective reporting and learning culture (incidents were often ineffectively investigated);

• use of outdated plant policies and procedures;

• poor design of the ISOM unit;

• inadequate supervision of operators;

• inadequate training of operators; and

• ineffective consideration of human factors regarding training, staffing, and work schedules for operators.

The ineffective investigation of previous incidents resulted in a failure to identify, or act upon, lessons from incidents and near-misses. This includes a failure to incorporate relevant safety lessons from a British government investigation

of incidents at BP's Grangemouth, Scotland, refinery, which were relevant to the Texas City refinery.

Health and Safety Executive (United Kingdom) and Scottish Environment Protection Agency. August 18, 2003. Major Incident Investigation Report—BP Grangemouth Scotland, 29th June-10th May, 2000. A Public Report Prepared on Behalf of the Competent Authority.

http://www.hse.gov.uk/comah/bpgrange/images/bprgrangemouth.pdf

On August 23, 2010, the Millard Refrigerated Service warehouse in Theodore, Alabama, had a release of approximately 32,000 pounds of anhydrous ammonia from a cracked pipe, when refrigeration equipment malfunctioned. The ammonia travelled directly over a shipyard in Mobile, Alabama, where more than 800 people were working, causing 152 people to be treated at hospitals, four of whom were admitted into intensive care units. An EPA investigation of the incident revealed that Millard failed to adequately address a well-known risk for ammonia production systems called hydraulic shock, which can cause catastrophic equipment failures.

EPA also discovered that Millard had two prior smaller ammonia releases in April 2007 and January 2010 caused by hydraulic shock. Company investigations of those incidents failed to identify and correct this problem, which could have prevented the catastrophic release that occurred in August 2010.

EPA. May 29, 2015.

USA

vs.

Millard Refrigerated Services, LLC,

U.S. District Court for the Southern District of Alabama, Civil Action No. 15-186. pp. 9-11, and 19-20. Case 1:15-cv-00186-WS-M Document 5.

http://www2.epa.gov/sites/production/files/2015-06/documents/millard-cp.pdf.

See also

http://www2.epa.gov/enforcement/millard-refrigerated-services-llc-clean-air-act-caa-settlement

5. Current Use of Root Cause Analysis

Root cause analysis of accidents is an accepted safe management practice used by many industries. The American Chemistry Council (ACC) noted that root cause analysis is conducted routinely under a number of voluntary programs, including Responsible Care.

The Texas Pipeline Association (TPA) stated that a requirement to perform a root cause analysis was not needed because it is a common industry practice.

However, the Compressed Gas Association (CGA) stated that they supported modifying current regulations to include a requirement that root cause analyses be conducted for incidents but not for near misses or process upsets because defining a “near miss” or “process upset” is extremely difficult and will likely vary by industry, process, locations and the like.

EPA addresses the difficulty of defining the term “near miss”, in section IV.A.7. Near Misses.

ACC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0694 on Risk Management Program RFI, p. 43 of 189.

TPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0617 on Risk Management Program RFI, p. 8.

CGA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0633 on Risk Management Program RFI, p. 6

ACC also notes that there are a number of recognized industry resources to aid incident investigations of root causes. For example, CCPS offers several resources, including the “Guidelines for Investigating Chemical Process Incidents,” 2nd edition, which provides valuable, practical reference tools, and focuses on process-related incidents with real or potential catastrophic consequences.

ACC further notes that there are a number of companies that provide excellent root cause failure analysis training.

CCPS 2003. Center for Chemical Process Safety, Guidelines for Investigating Chemical Process Incidents, 2nd Edition, NY: AIChE.

California's Contra Costa County Health Services (CCHS) and the city of Richmond, California, each have incident investigation regulations in their Industrial Safety Ordinances (ISO) similar to those in § 68.81 and, in

addition, require a root cause analysis for each major chemical accident.

35 36

Contra Costa County Board of Supervisors. 2006. California's Contra Costa County ISO, pp. 5, 12-13, 17-19.

http://cchealth.org/hazmat/pdf/iso/Chapter-450-8-RISK-MANAGEMENT.pdf

A major chemical accident is defined in the ISO as one meeting a level 2 or 3 incident classification as determined by the county or one resulting in: One or more fatalities; at least three persons hospitalized for at 24 hours; on- and/or offsite property damage (including clean-up and restoration activities) initially estimated at $500,000 or more; or a vapor cloud of flammables and/or combustibles that is more than 5,000 pounds.

New Jersey's Toxic Catastrophe Prevention Act (TCPA) requires investigation of all extraordinarily hazardous substance accidents or potential catastrophic events. The TCPA requirements have the same incident investigation requirements found in § 68.81, but the TCPA investigation report requires additional information beyond the requirements in § 68.81.

The TCPA investigation report must include:

New Jersey Department of Environmental Protection (NJDEP) TCPA. March 29, 2012. NJDEP. Title 7, Chapter 31 TCPA Program Consolidated Rule Document, p. 62.

http://www.state.nj.us/dep/rpp/brp/tcpa/downloads/conrulerev9_fonts.pdf.

• Time and location of the chemical accident or potential catastrophic event;

• A description of the chemical accident or potential catastrophic event in chronological order, providing all the relevant facts;

• The identity, amount, and duration of the chemical release if these facts can be reasonably determined based on the information obtained through the investigation;

• The consequences, if any, of the chemical accident or potential catastrophic event, including the number of evacuees, injured, and fatalities, and the impact on the community;

• The factors that contributed to the chemical accident or potential catastrophic event that includes an identification of basic and contributory causes, either direct or indirect; and

• The names and position titles of the investigators.

Once the incident scenario is understood and contributory causes identified, this information may be used to determine the incident's root causes which are the underlying systemic reasons related to a failure in a management system.

EPA believes that providing the following information is vital for understanding the nature of the incident and should be included in the incident investigation report:

• The chronological order of details of the incidents,

• the chemical identity,

• amount and duration of the release,

• the impacts of the release, and

• basic and contributory causes, either direct or indirect.

Some facility owners or operators may already include this information in incident investigation reports prepared to comply with the RMP rule; however, EPA is proposing that §§ 68.60 and 68.81 be revised to require this information to ensure clarity and consistency among reports.

To better address causes of incidents and further reduce the occurrence of catastrophic releases, EPA is proposing to require that for all Program 2 and Program 3 process incidents that resulted in, or could reasonably have resulted in, a catastrophic release, the owner or operator determine and identify the factors that contributed to the incident, including immediate and contributory causes, either direct or indirect, and root causes. EPA is proposing to define “root cause” (see § 68.3 for the proposed definition).

Root causes shall be determined by conducting a root cause analysis for each incident using a recognized method or approach. CCPS' “Guidelines for Investigating Chemical Process Incidents” discusses incident investigation approaches and techniques and root cause analysis methods.

OSHA plans to develop a fact sheet on existing resources that explain how to conduct root cause analyses so the regulated community can better understand the causes of incidents and can increase its capability to effectively prevent future occurrences.

CCPS. March 2003. Guidelines for Investigating Chemical Process Incidents, 2nd ed.

Chemical Facility Safety and Security Working Group. May 2014. Executive Order 13650 Report to the President—Actions to Improve Chemical Facility Safety and Security—A Shared Commitment, p. 47.

https://www.osha.gov/chemicalexecutiveorder/final_chemical_eo_status_report.pdf.

In order that lessons learned from incident investigations be applied, EPA is proposing to modify the hazard review requirement in § 68.50(a)(2) and the PHA requirement in § 68.67(c)(2) to require the owner or operator to address findings from all incident investigations required under §§ 68.60 and 68.81, respectively. EPA is also proposing to require that for incident investigations conducted by Program 2 sources, 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 requirement is already part of Program 3 incident investigation requirements, and is a necessary component for investigations that would include analysis of root causes.

EPA seeks comment on the proposed amendments of the incident investigation requirements to require root cause investigations for each incident which resulted in, or could reasonably have resulted in, a catastrophic release and on the proposed definition for root cause. EPA seeks comment on whether a root cause analysis is appropriate for every RMP reportable accident and near miss. Should EPA eliminate the root cause analysis, or revise to limit or increase the scope or applicability of the root cause analysis requirement? If so, how should EPA revise the scope or applicability of this proposed requirement? EPA also seeks comment on proposed amendments to require consideration of incident investigation findings, in the hazard review (§ 68.50) and PHA (§ 68.67) requirements. Finally, EPA seeks comment on the proposed additional requirement in § 68.60 to require personnel with appropriate knowledge of the facility process and knowledge and experience in incident investigation techniques to participate on an incident investigation team.

6. Decommissioned Processes

EPA has encountered some cases where a facility chose not to conduct an incident investigation because the owner or operator elected to decommission the process involved, or because the process was destroyed in the incident. While an investigation would have no impact on a decommissioned or destroyed process, other similar processes or operations at the facility, or at similar facilities, could potentially benefit from its findings.

CCHS and two industry associations commented that there are lessons that can be learned from requiring investigations to be performed, even in cases where the owner or operator elects to decommission the process involved or where the process is destroyed in the incident.

40 41

Therefore, EPA is proposing to revise §§ 68.60 and 68.81 to clarify that incident investigations are required even if the process involving the regulated substance is destroyed or decommissioned following or as the result of an incident. EPA is also proposing to revise § 68.190, which addresses updates to the RMP, to

require that prior to any de-registration of a process or stationary source that is no longer subject to the Risk Management Program rule, the owner or operator must report any accidents subject to the requirements of § 68.42 and conduct incident investigations as required under §§ 68.60 and/or 68.81. EPA seeks comment on the proposed revisions to require an owner or operator to meet applicable reporting and incident investigation requirements prior to de-registering a process.

CCHS. October 28, 2014. Comment No. EPA-HQ-OEM-2014-0328-0546 on Risk Management Program RFI, p. 12.

Independent Petroleum Association of America (IPAA) AXPC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0584 on Risk Management Program RFI, p. 33.

7. Near Misses

The current incident investigation provisions require facilities with Program 2 and/or 3 processes to investigate incidents that could reasonably have resulted in a catastrophic release. These types of incidents are sometimes characterized as “near misses” but there is confusion about what this term means. Several commenters on the Risk Management Program RFI, including the Society of Chemical Manufacturers and Affiliates (SOCMA),

American Petroleum Institute (API),

Gas Processors Association (GPA),

National Oilseed Processors Association (NOPA), & Corn Refiners Association (CRA),

and American Fuel & Petrochemical Manufacturers (AFPM),

stated that they interpret the current requirements as including near misses. Other commenters (ACC,

TPA,

CGA,

DPC Industries, Inc.,

and Allied Universal Corp [AUC])

urged EPA to not require investigations of near misses because the term is vague, inherently situation-specific and not reducible to a singular definition. 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.

SOCMA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0560 on Risk Management Program RFI, p. 9.

API. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0624 on Risk Management Program RFI, p. 32.

GPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0626 on Risk Management Program RFI, p. 12.

NOPA & CRA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0328 on Risk Management Program RFI, pp. 30-31.

AFPM. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0665 on Risk Management Program RFI, pp. 46-47.

ACC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0694 on Risk Management Program RFI, PDF pp. 44-45 of 189.

TPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0617 on Risk Management Program RFI, pp. 7-8.

CGA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0633 on Risk Management Program RFI, p. 6.

DPC Industries, Inc. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0649 on Risk Management Program RFI, p. 4.

AUC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0646 on Risk Management Program RFI, p. 3.

CCPS. March 2003. Guidelines for Investigating Chemical Process Incidents, 2nd ed., p. 61.

EPA itself may have contributed to the confusion over the meaning of the term “near miss.” In the 1993 proposed RMP rule (58 FR 54200, October 20 1993), EPA indicated that investigation of near misses could provide facilities with important information on problems that should be addressed before a significant accidental release occurs. EPA considered a near miss as a mishap that did not result in a release for some reason, such as employee actions or luck. However, in the primary interpretive guidance document for the RMP rule, “General Guidance on Risk Management Programs for Chemical Accident Prevention (40 CFR part 68)” (RMP Guidance), originally published in 1999, EPA indicated that while the owner or operator “must investigate each incident which resulted in, or could have resulted in, a catastrophic release of a regulated substance,” the owner or operator was not required to investigate “minor accidents or near misses:”

You should also consider investigating minor accidents or near misses because they may help you identify problems that could lead to more serious accidents; however, you are not required to do so under part 68.

See General Guidance on Risk Management Programs for Chemical Accident Prevention (40 CFR part 68), EPA-550-B-04-001, April 2004, page 6-26.

http://www2.epa.gov/rmp/guidance-facilities-risk-management-programs-rmp#general.

Here, EPA intended to differentiate between incidents, which “could have resulted in a catastrophic release,” and “minor accidents and [minor] near misses,” which are unlikely to have led to a catastrophic release.

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 these events did not result in deaths, injuries, adverse health or environmental effects, or sheltering-in-place, if circumstances had been slightly different, a catastrophic release could have occurred. 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.

Facilities regulated under New Jersey's TCPA program are required to investigate each regulated chemical (“extraordinarily hazardous substance”), involved in an accident or potential catastrophic event.

The NJDEP notes that “potential catastrophic event” means an incident that could have reasonably resulted in a catastrophic release of a regulated chemical which includes incidents in which no regulated chemical was released or no regulated chemical was released beyond a permitted level, or in other words, a near miss. Facilities report accidents and potential catastrophic events annually to New Jersey. NJDEP notes that each year, less than fifty percent of the facilities reported that they had one or more incidents.

Most of the incidents reported involved the release of a regulated chemical. The number of near misses reported averaged less than 1 per facility.

NJDEP TCPA. March 29, 2012. NJ Title 7, Chapter 31 TCPA Program Consolidated Rule Document, p. 2.

http://www.state.nj.us/dep/rpp/brp/tcpa/downloads/conrulerev9_fonts.pdf.

NJDEP. October 21, 2014. Comment No. EPA-HQ-OEM-2014-0328-0338 on Risk Management Program RFI, p. 16.

In its comments on the Risk Management Program RFI, GPA reasoned that requiring a root cause analysis for minor near misses would be burdensome and costly and would discourage employees and contractors from reporting near misses because of the burden of conducting a rigorous investigation.

Similarly, some commenters, such as API thought that process upsets should not be included in incident investigation requirements because there is no standard definition; process upsets vary across a wide range from product quality/efficiency issues to ones that represent near-miss situations; and learning from process upset events that do potentially challenge process safety systems can be accomplished via other means. According to API, including all process upsets would overburden the root cause analysis/

investigation resources within a facility.

GPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0626 on Risk Management Program RFI, p. 14.

API. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0624 on Risk Management Program RFI, p. 32.

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.

These include:

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.

http://www.aiche.org/sites/default/files/docs/pages/CCPS_ProcessSafety_Lagging_2011_2-24.pdf.

• 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.

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.

CCPS. March 2003. Guidelines for Investigating Chemical Process Incidents, 2nd ed., p. 68.

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.

Because it is difficult to prescribe the various types of incidents that may occur in RMP-regulated sectors that should be considered near misses, and therefore be investigated, EPA is not proposing a regulatory definition. Instead, EPA will rely on facility owners or operators to decide which incidents to investigate, 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 final 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.

EPA decided to leave it up to the discretion of the owner or operator to determine whether an incident could reasonably have resulted in a catastrophic release and to investigate such incidents.

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.

The intent is not to include every minor incident or leak, but focus on serious incidents that could have resulted in a catastrophic release, although EPA acknowledges this will require subjective judgment.

Finally, EPA expects that lessons learned from near miss incident investigations be considered when conducting a hazard review or PHA. Therefore, the proposed amendments to §§ 68.50(a)(2) and 68.67(c)(2) would require the hazard review and the PHA to include findings from all incident investigations required under §§ 68.60 and 68.81. This includes incidents that could reasonably have resulted in a catastrophic release (

i.e.,

a near miss).

EPA seeks comment on the guidance and examples provided of a near miss. Is further clarification needed in this instance? Should EPA consider limiting root cause analyses only for incidents that resulted in a catastrophic release?

8. Investigation Timeframe

EPA believes incident investigations will result in improved process safety through the dissemination of lessons learned and the implementation of recommended corrective actions. Conducting these investigations as soon as possible after an incident may yield better quality data and information, although it may take time to collect, validate, and integrate data from a range of sources. EPA has discovered situations where owners or operators of regulated facilities indefinitely delayed completing incident investigations. Therefore, in the Risk Management Program RFI, EPA considered whether incident investigations should be required to be completed within a certain amount of time. In their comments on the RFI, Mary Kay O'Connor Process Safety Center (MKOPSC)

stated that the timeframe requirement for an incident investigation to be completed should be based on the following factors: The consequence, the complexity of the incident, the process, the substance, and the investigation team's experience, knowledge and members. ACC

and API

noted that the time to complete an investigation is highly dependent on the complexity of the accident and the process and can require assistance from outside process experts that may not immediately be available. CCHS commented that a specific timeframe for incident investigations to be completed would benefit overall safety and noted that most incidents can be investigated within six months.

However, CCHS stated that it may be appropriate that a specific time be required that could be changed by documented justification. As to timeframes, some of the refineries in Contra Costa County, California, have corporate requirements to complete all investigations within 30 to 60 days. Exceptions can be granted for large events. CCHS noted that there are challenges and limitations to completing an incident investigation within a specified timeframe. Other RFI commenters, such as TPA,

GPA,

and JR Simplot,

noted that having a specific timeline to complete an investigation could cause facilities to focus more on complying with a deadline at the expense of using the appropriate level of rigor and getting the right answer. EPA's own experience with accident investigation has shown that a major accident investigation can take up to a year or more. Taking into consideration the need for completion of an investigation while allowing the proper time to determine the correct root causes, EPA is proposing to require that facility owners or operators complete an incident investigation report within 12 months of an incident that resulted in, or could reasonably have resulted in, a catastrophic release. For very complex incident investigations that cannot be completed within 12 months, EPA is allowing an extension of time if the implementing agency approves, in writing. EPA believes that 12 months is long enough to complete most complex accident investigations but will allow facilities more time if they consult with their

implementing agency and receive approval for an extension of time.

MKOPSC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0543 on Risk Management Program RFI, p. 144.

ACC. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0694 on Risk Management Program RFI, p. 44.

API. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0624 on Risk Management Program RFI, p. 32.

CCHS. October 28, 2014. Comment No. EPA-HQ-OEM-2014-0328-0546 on Risk Management Program RFI, p. 12.

TPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0617 on Risk Management Program RFI, p. 9.

GPA. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0626 on Risk Management Program RFI, p. 13.

JR Simplot. October 29, 2014. Comment No. EPA-HQ-OEM-2014-0328-0667 on Risk Management Program RFI, p. 31.

EPA notes that the Agency's own requirements under the Petroleum Refinery maximum achievable control technology (MACT) and New Source Performance Standards (NSPS) regulations already require root cause and corrective action analyses for certain release events (see 40 CFR parts 63.648(j)(6) and (j)(7)), and 60.103a(d)) with a more stringent timeframe (

i.e.,

45 days) for completing these analyses than the 12 months specified in this proposed rule. RMP-regulated facilities that are also required to meet the MACT and NSPS root cause analysis requirements must continue to meet the timeframes specified under those rules as applicable. However, root cause analyses conducted to meet those requirements may also be used to comply with the root cause analysis requirements proposed herein, provided the analysis meets the requirements of § 68.60 or § 68.81, as applicable.

EPA seeks comment on the appropriateness of establishing a specific timeframe for incident investigations to be completed and what that timeframe should be. As an alternative, EPA considered whether the incident investigation should be completed prior to restart of the affected process, if the incident resulted in a process shutdown, to ensure that the causes of an incident have been addressed. EPA seeks comment on whether to add this condition to the incident investigation requirements or whether there are other options to ensure that unsafe conditions that led to the incident are addressed before a process is re-started. EPA also seeks comment on whether the different root cause analysis timeframes specified under the MACT and NSPS and proposed herein will cause any difficulties for sources covered under both rules, and if so, what approach EPA should take to resolve this issue.

9. Accident History Reporting

Thorough investigations and reporting may help facilities identify and address root causes. Accident history reporting provides an avenue to disseminate lessons learned. Local communities are interested in whether facilities are investigating incidents and taking steps to prevent future accidents. EPA believes it is important to determine and report results of root cause analysis for accidents with reportable impacts in the RMP accident history. Therefore, EPA has proposed that information on root causes analyzed as part of an incident investigation be included in the RMP accident history in § 68.42. Because there can be numerous potential incident root causes identified for a single incident, and in order to simplify reporting for the RMP accident history, EPA believes that the root cause information should be reported as root cause categories.

Various methods for identifying root causes have been published. Some methods involve the use of root cause trees which show root cause categories for different PSM systems, where each category can be associated with many specific root cause deficiencies.

68 69

One root cause system uses the following list of root cause categories: Procedures; Training; Communications; Administrative/Management System; Personal Performance; Human Factors Engineering; Immediate Supervision; Equipment Design; Equipment/Records; Equipment Reliability/Maintenance; and Equipment Installation/Fabrication. Another uses a slightly different list: Procedures, Training, Quality Control, Communications, Management System, Human Engineering and Immediate Supervision. EPA will modify its on-line reporting system for RMPs (RMP*eSubmit) to incorporate an appropriate list of root cause categories for RMP facility incident investigations of RMP reportable accidents based on these categories.

Paradies, Mark, Unger, Linda and Busch, David. 1996. TapRooT® Root Cause Tree

& User's Manual, Rev. 4. Systems Improvements, Inc., Knoxville, TN.

ABS Group Inc. 1999. Root Cause Map

and Root Cause Analysis Handbook, A Guide to Effective Incident Investigation. ABS Group, Inc., Risk & Reliability Division, Knoxville, TN.

Because EPA is proposing that the incident investigation be required to be completed within 12 months, root causes may not be known until 12 months after an accidental release. Section 68.195(a) currently requires that the accident history information in § 68.42 be submitted within six months of the release. Because EPA is proposing to add accident root cause categories to § 68.42, EPA is also proposing in § 68.195(a)(2) that the root cause categories be submitted in the RMP within 12 months of the release.

EPA seeks comment on the appropriateness of requiring root cause reporting as part of the accident history requirements of § 68.42, as well as the categories that should be considered and the timeframe within which the root cause information must be submitted.

10. Proposed Revisions to Regulatory Text

a. Definitions (§ 68.3)

EPA is proposing to add a definition of “root cause” and modify the definition of “catastrophic release” in § 68.3.

b. Five-Year Accident History (§ 68.42)

EPA is proposing to amend paragraph (b) by adding a new subparagraph (b)(10) to require of incident investigation root cause categories to be reported. Current subparagraphs (b)(10) and (b)(11) will become subparagraphs (b)(11) and (b)(12), respectively.

c. Hazard Review (§ 68.50)

EPA is proposing to amend subparagraph (a)(2) by adding a phrase at the end to require the owner or operator to consider findings from incident investigations. This is similar to the revision proposed for Program 3 facilities in § 68.67(c)(2).

d. Incident Investigation (§§ 68.60 and 68.81)

EPA is proposing 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. Subparagraph (a)(1) applies 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. Subparagraph (a)(2) applies to a near-miss, which is an incident that could reasonably have resulted in a catastrophic release. EPA is also 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 is also proposing 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 requirement in § 68.81(c) for Program 3 processes. Current paragraphs (c) through (f) would become paragraph (d) through (g).

EPA is also proposing to make changes to the new paragraph (d) in § 68.60 and current paragraph (d) in § 68.81 to revise the incident

investigation report requirements. EPA is proposing 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.

Furthermore, EPA is proposing to amend and add new subparagraphs in the new paragraph (d) in § 68.60 and current paragraph (d) in § 68.81 requiring additional elements in an incident investigation report. EPA is proposing 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 new 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. Add language to new paragraph (d)(7) to require that root causes must 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, EPA is proposing to amend the current paragraph (f) which would be the new paragraph (g) to add the word incident before investigation and change “summaries” to “reports” for consistency.

e. Process Hazard Analysis (PHA) (§ 68.67)

EPA is proposing 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). This is similar to the revision for Program 2 facilities in § 68.50(a)(2).

f. Updates (§ 68.190)

EPA is proposing to amend paragraph (c) to require that the owner or operator report any accidents covered by § 68.42 and conduct incident investigations required under §§ 68.60 and/or 68.81 prior to de-registering a process or stationary source that is no longer subject to the RMP rule.

11. Alternative Options

EPA considered limiting these requirements to the original universe of Program 3 processes that existed before OSHA changed its PSM retail exemption. Accidents occur at a higher frequency in these processes as compared to processes covered in Program 2. However, with the shift of many Program 2 processes into Program 3 due to OSHA's revised policy on the PSM retail facility exemption, most of the accidents at remaining Program 2 processes occur at publicly owned water and wastewater treatment facilities that are not in Program 3 because they are not subject to OSHA PSM. State and local government employees at facilities in states under Federal OSHA authority are not covered by the OSHA PSM standard unlike state and local government employees at facilities in states with OSHA approved State Plans. These processes pose the same risk as the publicly owned water/wastewater treatment processes that are in Program 3. EPA decided that there was little justification for limiting the proposed requirements to the changed universe of Program 3 processes after the OSHA retail exemption change; there are fewer than six RMP reportable accidents a year at remaining Program 2 processes. Although the alternative would be slightly less burdensome on the regulated community, it would also likely prevent fewer accidents than the proposed approach. EPA seeks comment on the alternative approach and whether there are any other alternative options that EPA should consider prior to issuing a final action.

B. Third-Party Compliance Audits

In addition to strengthening the incident investigation requirements, EPA is proposing to strengthen the RMP rule's compliance audit provisions to require independent third-party compliance audits after an accident or findings of significant non-compliance by an implementing agency for stationary sources with Program 2 and/or Program 3 processes. Incident investigations often reveal that these facilities have deficiencies in some prevention program requirements related to that process. Compliance audits entail a systematic evaluation of the full prevention program for all covered processes. As described below, in some cases, self-auditing may be insufficient to prevent accidents, determine compliance with the RMP rule's prevention program requirements, and ensure safe operation. Stationary sources that have had accidents and/or substantial non-compliance with Risk Management Program requirements pose a greater risk to the surrounding communities. EPA therefore believes it is appropriate to require such stationary sources to undergo objective auditing by competent and independent third-party auditors. Such independent third-party auditing can assist the owners and operators, EPA (or the implementing agency), and the public to better 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 and the CSB have cited poor compliance audits as a contributing factor to the severity of past chemical accidents. The CSB identified a lack of rigorous compliance audits as a contributing factor behind the March 23, 2005 explosion and fire at the BP Texas City Refinery in Texas City, Texas.

This explosion and fire killed 15 people, injured another 180, led to a shelter-in-place order that required 43,000 people to remain indoors, and damaged houses as far away as three-quarters of a mile from the refinery.

CSB. March 2007. Investigation Report: Refinery Explosion and Fire, BP, Texas City, Texas, March 23, 2005. Report No. 2005-04-I-TX.

http://www.csb.gov/assets/1/19/CSBFinalReportBP.pdf

A CSB investigation of the July 2009 fire and explosion at the Citgo Corpus Christi Refinery found that Citgo had never conducted a safety audit of hydrofluoric acid (HF) alkylation operations at either of its U.S. refineries equipped with HF alkylation units pursuant to recommendations in API Recommended Practice 751, Safe Operation of HF Alkylation Units.

The CSB recommended that within 60 days, Citgo complete a third-party audit of all Citgo HF alkylation unit operations in the United States (Corpus Christi, Texas and Lemont, Illinois) in accordance with API Recommended Practice 751. The CSB also specified qualifications for the selected lead auditor including extensive knowledge of HF hazards, HF alkylation units, and API 751.

CSB. December 9, 2009. Urgent Recommendations to Citgo.

http://www.csb.gov/csb-issues-urgent-recommendations-to-citgo-finds-inadequate-hydrogen-fluoride-water-mitigation-system-during-corpus-christi-refinery-fire-last-july/

The CSB found that facility PSM audits failed to detect PSI and operating procedure deficiencies that contributed to the November 2003 chlorine release at DPC Enterprises, L.P. in Glendale,

Arizona.

The CSB recommended that DPC use a qualified, independent auditor to evaluate DPC's PSM and Risk Management Programs against best practices and implement audit recommendations in a timely manner at all DPC chlorine repackaging sites.

CSB. February 2007. Investigation Report: Chlorine Release, DPC Enterprises, L.P., Glendale, Arizona, November 17, 2003. Report No. 2004-02-I-AZ.

http://www.csb.gov/assets/1/19/DPC_Report.pdf

The CSB also found numerous auditing deficiencies following the January 2008 explosion at Bayer CropScience, LP, in Institute, West Virginia.

The CSB recommended that Bayer commission an independent human factors and ergonomics study of all Institute site PSM and Risk Management Program covered process control rooms to evaluate the human-control system interface, operator fatigue, and control system familiarity and training.

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.

http://www.csb.gov/assets/1/19/Bayer_Report_Final.pdf

EPA has required third-party audits in enforcement settlement agreements. For example, EPA found multiple occasions of noncompliance with the Risk Management Program requirements at Tyson Foods, Inc. facilities through a series of inspections and information requests. Dating back to October 2006, violations included failures to follow the general industry standards to test or replace safety relief valves, improperly co-located gas-fired boilers and ammonia machinery, as well as failures to abide by the RMP rule's prevention program and reporting requirements. As part of a 2014 consent decree, Tyson Foods, Inc. agreed, in addition to paying a penalty of $3.95 million, to conduct pipe-testing and third-party audits of its ammonia refrigeration systems to improve compliance with Risk Management Program requirements at all 23 of the company's facilities in four Midwestern states.

Consent Decree,

United States

Tyson Foods, Inc., et al.,

E.D. Miss., April 4, 2013.

http://www2.epa.gov/enforcement/tyson-foods-inc

In March 2015, EPA Region 1 issued an administrative order on consent to Mann Distribution LLC and 3134 Post Road LLC (Respondents) regarding Resource Conservation and Recovery Act (RCRA) and CAA 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 non-compliance. The order requires Respondents to implement an independent third-party inspection program, in addition to imposing other compliance requirements.

Finding of Violation and Administrative Order on Consent, In the Matter of Mann Distribution LLC and 3134 Post LLC, Docket Nos. RCRA-01-2015-0028 and CAA-01-2015-0029, March 17, 2015.

The proposed independent third-party compliance audit requirements include a definition of “third-party audit” in § 68.3; modifications to existing §§ 68.58 and 68.79 to specify when a third-party audit must be performed; and the requirements for third-party auditors and third-party audits in new §§ 68.59 and 68.80. EPA is proposing to require third-party compliance audits to be conducted at stationary sources following an accident meeting the five-year accident history criteria in § 68.42(a). EPA is also proposing a provision to allow an implementing agency to require a third-party audit be performed at a facility under certain circumstances that suggest a heightened risk for an accident. These circumstances are: Non-compliance with the Prevention Program requirements of subpart C (Program 2) or subpart D (Program 3), including non-compliance with the competency, independence, or impartiality criteria of § 68.59(b) or § 68.80(b) regarding a previous third-party audit. All other stationary sources with Program 2 and Program 3 processes will continue to follow the current compliance audit requirements of §§ 68.58 and 68.79.

Sections 68.58 and 68.79 of the RMP regulation (Program 2 and Program 3 Compliance Audits) require owners or operators of stationary sources with processes subject to Program 2 or Program 3 requirements to audit compliance with the provisions of subpart C (Program 2 Prevention Program requirements) or subpart D (Program 3 Prevention Program requirements) at least every three years. The purpose of the compliance audits is to verify that the procedures and practices developed under subparts C and D of the RMP rule are adequate and being followed. These compliance audit provisions are similar to language to that is found in 29 CFR 1910.119(o) of the OSHA PSM standard. Sections 68.58 and 68.79 of the RMP regulation and 1910.119(o) of the OSHA PSM standard require that the compliance audit be conducted by at least one person knowledgeable in the process, that audit findings be addressed promptly, and that a report be generated documenting the findings of the audit.

Currently, neither EPA nor OSHA requires employers to use independent third-parties in conducting compliance audits. However, third-party compliance auditors exist, both the RMP rule and the PSM standard permit their use, and they are utilized by some of the Risk Management Program and PSM regulated community, both voluntarily, and pursuant to enforcement settlement agreements.

EPA discussed the potential to use independent third-party auditors for Risk Management Program compliance audits, in the preamble of the 1996 final RMP rule, as an issue for further consideration.

The preamble endorsed the concept of using third parties, citing the following reasons: To assist in rule compliance and oversight, provided that any third-party proposal not weaken the compliance responsibilities of facility owners or operators; offer cost savings and benefits to the industry, community, and implementing agencies that significantly exceed the cost of implementing the approach; lead to a net increase in process safety, particularly for smaller, less technically sophisticated facilities; and promote cost-effective Agency prioritization of oversight resources. At the time, EPA did not require the use of third-party auditors because the Agency believed that several key issues, including qualification criteria, certification procedures, liability, and others, needed to be investigated. Based on EPA's research of other third-party audit programs as well as the Agency's own experience with third-party auditors in the context of enforcement settlements, the Agency is proposing third-party audit requirements for the rule's accident prevention program.

Accidental Release Prevention Requirements: Risk Management Programs Under CAA Section 112(r)(7), 61 FR 31705, June 20, 1996.

http://www.gpo.gov/fdsys/pkg/FR-1996-06-20/pdf/96-14597.pdf

Third-party audits are required by other Federal programs in appropriate existing rules, and rules currently in development, to ensure safe operations. The Administrative Conference of the United States (ACUS) “Third-Party Programs Final Report” (October 22, 2012) describes a variety of third-party programs in Food and Drug Administration (FDA), Consumer Product Safety Commission, and Federal Communications Commission

regulations.

Further examples follow. The Bureau of Safety and Environmental Enforcement (BSEE) promulgated revisions to their Safety and Environmental Management Systems (SEMS II) requirements (78 FR 20423, April 5, 2013) to help ensure the safe operations of offshore oil and natural gas drilling and production facilities. BSEE's SEMS standard, 30 CFR part 250, subpart S, requires audits conducted by an independent third-party, subject to approval by BSEE, or by designated and qualified personnel if the employer implements procedures to avoid conflicts of interest. BSEE's SEMS II revisions to the standard require that, by June 4, 2015, the team lead for compliance audits must be independent and represent an accredited audit service provider. In the preamble to its SEMS II final rule, BSEE discussed its third-party-auditing requirements as follows:

McCallister, Lesley. October 22, 2012. Third-Party Programs Final Report (2012).

http://www.acus.gov/report/third-party-programs-final-report

Consistent audits performed by well trained and experienced auditors are critical to ensuring that SEMS programs are successfully implemented and maintained on the [Outer Continental Shelf] OCS. As a result, we are adopting industry best practices related to SEMS audits and auditor qualifications. Industry is already voluntarily adopting these practices in many deepwater operations. We believe that the application of these requirements to all OCS operations will result in more robust and consistent SEMS audits. (78 FR 20430, April 5, 2013.)

Independent third-party audits or other forms of compliance verification are also required by a variety of EPA rules to promote compliance with regulatory standards. One example of an EPA regulatory program with built-in third-party verification is the EPA CAA wood stoves rule.

Additionally, EPA is developing a rule for a third-party certification framework for the formaldehyde standards for composite wood products in accordance with the Formaldehyde Standards for Composite Wood Products Act in which Congress mandated that EPA promulgate rules that include a third-party testing and certification program.

Standards of Performance for New Residential Wood Heaters, New Residential Hydronic Heaters and Forced-Air Furnaces, 80 FR 13671, March 16, 2015.

http://www.gpo.gov/fdsys/pkg/FR-2015-03-16/pdf/2015-03733.pdf

Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products, 78 FR 34796, June 10, 2013.

http://www.gpo.gov/fdsys/pkg/FR-2013-06-10/pdf/2013-13254.pdf

. See also the Formaldehyde Standards for Composite Wood Products Act

https://www.gpo.gov/fdsys/pkg/BILLS-111s1660enr/pdf/BILLS-111s1660enr.pdf

Third-party verification and certification approaches are also employed in a variety of state regulatory settings. Examples include the CAA Title II vehicle inspection, maintenance, and emissions programs in authorized states,

California's mandatory greenhouse gas (GHG) reporting program,

and Massachusetts Underground Storage Tank (UST) third-party inspection program.

See, e.g.,

Missouri Dept. of Nat. Resources and Missouri State Highway Patrol, First Annual Oversight Report of the Decentralized Gateway Vehicle Inspection Program (2008).

http://www.dnr.mo.gov/gatewayvip/docs/enforcementrpt.pdf

Cal. Code of Regs. Accreditation Requirements for Verification Bodies, Lead Verifiers, and Verifiers of Emissions Data Reports and Offset Project Data Reports. tit. 17 § 95132(b)(4) (2010);