View source for Process Safety Management (OSHA regulation)

'''Process Safety Management''' '''of Highly Hazardous Chemicals''' is a regulation promulgated by the [[U.S. Occupational Safety and Health Administration]] (OSHA).<ref name="OSHAPSM">{{cite web |date=2023-08-17 |title=Code of Federal Regulations, Title 29, Subtitle B, Chapter XVII, Part 1910, Subpart H § 1910.119 Process Safety Management of Highly Hazardous Chemicals |url=https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-H/section-1910.119 |access-date=2023-08-20 |work=eCFR |publisher=}}</ref> It defines and regulates a [[process safety management]] (PSM) program for [[Physical plant|plants]] using, storing, manufacturing, handling or carrying out on-site movement of [[Dangerous goods|hazardous materials]] above defined amount thresholds. Companies affected by the regulation usually build a compliant process safety management system and integrate it in their [[safety management system]]. Non-U.S. companies frequently choose on a voluntary basis to use the OSHA scheme in their business. 

The PSM regulation was the culmination of a push for more comprehensive regulation of facilities storing and/or processing hazardous materials, which began in the wake of the 1984 [[Bhopal disaster]]. The regulation was promulgated by OSHA in 1992 in fulfilment of requirements set in the [[Clean Air Act (United States)#1990 amendments|1990 amendments]] to the [[Clean Air Act (United States)|Clean Air Act]].<ref>{{Cite web |date=1990-11-15 |title=S. 1630 (101st): Clean Air Act Amendments of 1990 |url=https://www.govtrack.us/congress/bills/101/s1630/text |url-status=live |archive-url=https://web.archive.org/web/20220715203324/https://www.govtrack.us/congress/bills/101/s1630/text |archive-date=2022-07-15 |access-date=2023-08-20 |website=[[GovTrack]]}}</ref><ref name=":2">{{Cite book |last1=Mannan |first1=M. Sam |title=Encyclopedia of Chemical Processing and Design |last2=Makris |first2=Jim |last3=Overman |first3=H. James |publisher=[[Marcel Dekker]] |year=2002 |isbn=0-8247-2621-9 |editor-last=Anthony |editor-first=Rayford G. |volume=69: Supplement 1 |location=Basel and New York, N.Y. |pages= |chapter=Process Safety and Risk Management Regulations: Impact on Process Industry |author-link=M. Sam Mannan |editor-last2=McKetta |editor-first2=John J. |editor-link2=John J. McKetta}}</ref> The EPA followed suit with a similar and complementary regulation in 1996.<ref name=":2" /> 

==Compliance==
Any U.S. facility that stores or uses a hazardous material above thresholds defined in section (a)(1) and Appendix A must comply with the PSM regulation. For individual chemical species listed in Appendix A, threshold quantities vary from as low as 100 lb (45 kg; e.g., [[Monomethylhydrazine|methyl hydrazine]], [[phosgene]]) to as much as 15,000 lb (6804 kg; e.g., [[Ammonia solution|ammonia solutions]], [[Chloromethane|methyl chloride]]). The threshold for flammable gases and liquids (the latter defined as having a [[flash point]] below 100{{Nbsp}}°F or 37.8{{Nbsp}}°C) is 10,000 lb (4536 kg).<ref name="OSHAPSM" />

Usually, these facilities are also subject to another, similar regulation issued by the [[United States Environmental Protection Agency|Environmental Protection Agency]] (EPA), known as the [[Risk Management Program (EPA regulation)|Risk Management Program]] (RMP) rule (Title 40 CFR Part 68).<ref>{{Cite web |date=2023-08-17 |title=Code of Federal Regulations, Title 40, Chapter I, Subchapter C, Part 68 Chemical Accident Prevention Provisions |url=https://www.ecfr.gov/current/title-40/chapter-I/subchapter-C/part-68 |access-date=2023-08-20 |website=eCFR}}</ref> The [[Center for Chemical Process Safety (CCPS)|Center for Chemical Process Safety]] (CCPS) of the [[American Institute of Chemical Engineers]] (AIChE) publishes guidelines for building PSM systems that comply and exceed OSHA's expectations.  These include for example guidelines on process safety documentation<ref name="PSD1995">{{cite book |author=CCPS |url= |title=Guidelines for Process Safety Documentation |publisher=[[AIChE]] |year=1995 |isbn=9780816906253 |location=New York, N.Y. |language=en}}</ref> and implementing process safety management systems.<ref name="PSM1994">{{cite book |author=CCPS |url= |title=Guidelines for Implementing Process Safety Management Systems |publisher=[[AIChE]] |year=1994 |isbn=9780816905904 |location=New York, N.Y. |language=en}}</ref>[[File:29 CFR 1910.119 14 Elements of Process Safety Management.png|thumb|380x380px|Fourteen elements of OSHA's process safety management program]]

==Process Safety Management elements==
The Process Safety Management program is divided into 14 "elements": 

* Employee participation
* Process safety information
* [[Process hazard analysis]]
* Operating procedures
* Training
* Contractors
* Pre-startup safety review
* Mechanical integrity
* [[Hot work]] permit
* [[Change management (engineering)|Management of change]]
* [[Accident analysis|Incident investigation]]
* Emergency planning and response
* Compliance [[Audit|audits]]
* [[Trade secret|Trade secrets]]

All the elements are interlinked and interdependent. Every element either contributes information to other elements for the completion or utilizes information from other elements in order to be completed. 

=== Employee participation ===
Under PSM, employers must consult with employees and their representatives on the conduct and development of [[process hazard analyses]] and on the development of the other elements of process management, and they must provide to employees and their representatives access to process hazard analyses and to all other information required to be developed by the standard.<ref name="OSHAPSM" /> Employee participation in process safety activities and processes helps the organization build a positive climate of collaboration across management and workers, which sustains in turn a strong process [[safety culture]].<ref name=":1">{{Cite book |last=CCPS |title=Guidelines for Risk Based Process Safety |publisher=[[John Wiley & Sons]] |year=2007 |isbn=978-0-470-16569-0 |location=Hoboken, N.J. |language=en}}</ref>

=== Process safety information ===
Process safety information (PSI) refers to key documentation for identifying and understanding the hazards posed by the plant activities involving highly hazardous chemicals. In order to be in compliance with the OSHA PSM regulation, process safety information should include information pertaining to three areas: hazardous chemicals used or produced, technology of the process, and equipment in the process.{{ref label|EPA|5|^}}

Information pertaining to the material hazards (which is usually collected in dedicated [[Safety data sheet|Material Safety Data Sheets]] [MSDS]) shall consist of at least:
* [[Toxicity]] information
* [[Permissible exposure limit|Permissible exposure limits]]
* Physical data
* [[Reactivity (chemistry)|Reactivity]] data
* Corrosivity data
* Thermal and chemical stability data
* Hazardous effects of inadvertent mixing of different materials that could foreseeably occur
Information pertaining to the technology of the process shall include at least:
* A block [[flow diagram]] or simplified [[process flow diagram]]
* Process chemistry and its properties
* Maximum intended inventory
* Safety upper and lower limits for such items as temperatures, pressures, flows or compositions
* An evaluation of the consequences of deviations, including those affecting the safety and health of the employees

Information pertaining to the equipment in the process should include the following:
* Materials of construction
* [[Piping and instrumentation diagram|Piping and instrumentation diagrams]] (P&IDs)
* Electrical classification
* Relief system design and design basis
* Ventilation system design
* Design [[Technical standard|codes and standards]] employed
* [[Mass balance|Material]] and energy balances
* Safety system (for example [[Interlock (engineering)|interlocks]], detection and suppression systems)

The employer shall document that equipment complies with "recognized and generally accepted good engineering practices" ([[RAGAGEP]]).

=== Process hazard analysis ===
{{Main article|Process hazard analysis}}

A process hazard analysis (PHA) (or process hazard evaluation) is an exercise for the identification of hazards of a [[Process manufacturing|process]] facility and the qualitative or semi-quantitative assessment of the associated [[risk]]. A PHA provides information intended to assist managers and employees in making decisions for improving safety and reducing the consequences of unwanted or unplanned releases of [[Hazardous chemical|hazardous materials]]. A PHA is directed toward analyzing potential causes and consequences of fires, explosions, releases of toxic or flammable chemicals and major spills of hazardous chemicals, and it focuses on equipment, instrumentation, utilities, human actions, and external factors that might impact the process.<ref name="OSHAPSM" />

This element has been called "the heart of the program", as it "impacts or interfaces with all of the other elements". PHA relies on availability and completeness of process safety information; it requires employee participation in order to be effective; it may impact operating procedure through its findings and recommendations; it must be embedded in any management-of-change process and any pre-start-up safety review.<ref name=":2" /> 

There are varieties of methodologies that can be used to conduct a PHA, including [[Checklist|checklists]], [[Hazard analysis|Preliminary Hazard Analysis]] (PreHA), [[Hazard Identification (HAZID)|Hazard Identification]] (HAZID) reviews, [[What-If]] reviews and [[Structured What If Technique|SWIFT]], [[Hazard and operability study|Hazard and Operability]] (HAZOP) studies, [[Failure mode and effects analysis|Failure Mode and Effect Analysis]] (FMEA), etc.<ref name="OSHAPSM" />

=== Operating procedures ===
Operating procedures must be consistent with the process safety information and provide clear instructions for safely conducting activities involving hazardous materials. To ensure that a ready and up-to-date reference is available, and to form a foundation for needed employee training, operating procedures must be readily accessible to employees who work in or maintain a process. They must address at least the following elements:

* Steps for each operating phase: initial startup, normal operations, temporary operations, [[Plant process and emergency shutdown systems#Emergency shutdown (ESD)|emergency shutdown]], emergency operations, normal shutdown, and startup following a planned or emergency shutdown.
* Operating limits: consequences of deviation, and steps required to correct or avoid deviation.
* Safety and health considerations: properties and hazards of the chemicals used in the process, precautions (including engineering controls, administrative controls, and [[personal protective equipment]]), control measures to be taken if physical contact or airborne exposure occurs, quality control for raw materials and control of hazardous chemical inventory levels, any special or unique hazards, and safety systems (e.g., [[Interlock System|interlocks]], detection or suppression).

The operating procedures must be reviewed as often as necessary to ensure that they reflect current operating practices, including [[Change management|changes]] in process chemicals, technology, equipment, and facilities. To guard against outdated or inaccurate operating procedures, the employer must certify annually that these operating procedures are current and accurate.

It is mandatory that the following activities be covered in dedicated operating procedures: [[Lockout–tagout|lockout/tagout]], [[confined space]] entry, opening process equipment or piping, and control over entrance into a facility by maintenance, contractor, laboratory, or other support personnel. These safe work practices must apply both to employees and to contractor employees.<ref name=":0">{{Cite book |last=[[Occupational Safety and Health Administration|OSHA]] |url=https://www.osha.gov/sites/default/files/publications/osha3132.pdf |title=Process Safety Management |publisher=[[U.S. Department of Labor]] |year=2000 |series=OSHA 3132 |location=Washington, D.C. |language=en |access-date=2023-07-02}}{{PD-notice}}</ref>

=== Training ===
Training relevant to PSM must include emphasis on the specific safety and health hazards of the process, emergency operations including shutdown, and other safe work practices that apply to the employee’s job tasks. The regulation distinguishes between two types of training relevant to PSM, i.e. initial training and [[refresher training]]. Training records must be kept and maintained.<ref name="OSHAPSM" /><ref name=":0" />

=== Contractors ===
[[Contractor management]] is important in any [[safety management system]], including process safety management programs. A contracting company has to be mindful that outsourced personnel are not necessarily aware of the work site hazards and/or the way the contracting company manages those hazards. Contractors may also introduce new hazards to the plant.<ref>{{Cite book |last=CCPS |title=Introduction to Process Safety for Undergraduates and Engineers |publisher=[[John Wiley & Sons]] |year=2016 |isbn=978-1-118-94950-4 |location=Hoboken, N.J. |language=en}}</ref>

OSHA's PSM includes special provisions for contractors and their employees to emphasize the importance of everyone taking care that they do nothing to endanger those working nearby who may work for another employer. The contracting party must obtain and evaluate the contractor's safety performance and programs, inform the contracted personnel of the relevant fire, explosion, or toxic release hazards, explain to them the applicable provisions of the emergency action plan, evaluate periodically their performance in fulfilling their obligations, and maintain a contract employee injury and illness log. The contracted company must ensure that its employees have sufficient relevant training for the contracted job, ensure that its employees are instructed in the relevant site process hazards and the applicable provisions of the emergency action plan, document that they have received and understood required training, keep a record of key information about the contracted employees on the job and the activities carried out,  and ensure that each contracted employee follows the safety rules of the facility.<ref name=":0" />

=== Pre-startup safety review ===
{{Main articles|Pre-start-up audit}}
A pre-startup safety review ('''PSSR''') shall take place before any highly hazardous material is introduced into a process, i.e. before the plant start-up. The requirement applies to new facilities and modified ones, when the modification causes changes in the process safety information. The review must confirm that:<ref name=":0" />

* Construction and equipment are in accordance with design specifications.
* Safety, operating, maintenance, and emergency procedures are in place and are adequate.
* A process hazard analysis has been performed for new facilities and recommendations have been resolved or implemented.
* Modified facilities meet the management of change requirements.
* Training of each employee involved in operating a process has been completed.

=== Mechanical integrity ===
In the context of OSHA's PSM, mechanical integrity requirements apply to the following equipment:

* [[Pressure vessel|Pressure vessels]] and [[Storage tank|storage tanks]].
* [[Piping|Piping systems]] (including piping components such as [[Valve|valves]]).
* [[Relief valve|Relief]] and vent systems and devices.
* [[Safety instrumented system|Emergency shutdown]] systems.
* Controls (including monitoring devices and sensors, alarms, and interlocks).
* Pumps.

In order to minimize the risk of unwanted releases of hazardous materials, companies must establish and implement adequate maintenance strategies.<ref name=":0" />

PSM schemes other than OSHA's usually extend this element to cover the integrity assurance of [[Safety-critical system|safety-critical systems]] in general,<ref>{{Cite book |last=Energy Institute |title=High Level Framework for Process Safety Management |publisher=[[Energy Institute]] |year=2010 |isbn=978-0-85293-584-2 |edition=1st |location=London |author-link=Energy Institute}}</ref> not just those directly responsible for fluid containment, according to a wider [[Asset integrity management systems|asset integrity management]] strategy that includes systems such as [[Active fire protection|active]] and [[passive fire protection]], [[Fire detection|fire]] and [[Gas detector|gas detection]], sources of [[Emergency power system|emergency power]], etc.<ref>{{Cite book |last=Step Change in Safety |title=Assurance and Verification Practitioners' Guidance Document |publisher=Step Change in Safety |year=2018 |edition=March 2018 |location=Aberdeen}}</ref>

=== Hot work permit ===
Among several safety systems of work relevant to hazardous process plants, OSHA's PSM singles out the [[permit-to-work]] for [[hot work]] as arguably the most critical for the prevention of major process safety accidents. Hot work provides ignition sources to potential flammable vapors, which can cause fires and/or explosions. The permit must document that the fire prevention and protection requirements in OSHA regulations have been implemented prior to beginning the hot work operations. It must indicate the date(s) authorized for hot work and identify the object on which hot work is to be performed. The permit must be kept on file until completion of the hot work.<ref name=":0" />

=== Management of change ===
Undocumented, not properly risk assessed [[Change management (engineering)|changes]] to a plant handling hazardous materials are a recipe for disaster. An eminent example of this is the [[Flixborough disaster]], where improvised changes involving the bypassing of a stage in a reactor train was at the origin of the accident. The change had not been properly thought out, documented and risk-assessed, so that the event of breach of containment had not been identified.<ref>{{Cite book |last=Mannan |first=Sam |title=Lees' Loss Prevention in the Process Industries |publisher=[[Butterworth-Heinemann]] |year=2012 |isbn=978-0-12-397189-0 |edition=4th |location=Oxford |author-link=M. Sam Mannan}}</ref> Changes to a process must be thoroughly evaluated to fully assess their impact on employee safety and health and to determine needed changes to operating procedures. Written procedures to manage changes (except for “replacements in kind”) to process chemicals, technology, equipment, and procedures must be established and implemented. Minimum content of the documentation is:

* The technical basis for the change.
* Impact of the change on safety and health.
* Modifications to operating procedures.
* Necessary time period for the change.
* Authorization requirements.

Employees who operate a process and maintenance and contract employees whose job tasks will be affected by a change in the process must be informed of, and trained in, the change.<ref name=":0" />

=== Incident investigation ===
[[Accident analysis|Incident investigation]] provides a fundamental opportunity to learn from past mistakes and disseminate the new knowledge gathered throughout the organization and, if possible, to external stakeholders.<ref>{{Cite web |title=Introduction to Incident Investigation |url=https://www.aiche.org/ccps/introduction-incident-investigation |url-status=live |archive-url=https://web.archive.org/web/20221020150212/https://www.aiche.org/ccps/introduction-incident-investigation |archive-date=2022-10-20 |access-date=2023-07-19 |website=[[AIChE]]}}</ref> Accordingly, thorough internal investigation of incidents to identify the chain of events and causes is crucial to OSHA's PSM. Investigation must be initiated as promptly as possible, not later than 48 hours following the incident. OSHA establishes requirements for the investigation team selection and the content of the investigation report, which has to conclude with a series of relevant lessons learnt in the form of recommendations. These shall be tracked and closed out accordingly.<ref name=":0" />

=== Emergency planning and response ===
The consequences of an accident can be significantly reduced with effective emergency planning and response.<ref name=":1" /> By way of example, the response to the [[Tacoa disaster]] was largely unorganized and uninformed about the nature of the fire that was burning inside a fuel oil tank. As a result, the responders, as well as scores of bystanders and media workers, stayed well within the area impacted by the violent [[boilover]] that took place, which resulted in the death of more than 150 people.<ref>{{Cite book |last1=Atherton |first1=John |title=Incidents That Define Process Safety |last2=Gil |first2=Frederic |publisher=Center for Chemical Process Safety and John Wiley & Sons |year=2008 |isbn=978-0-470-12204-4 |location=New York, N.Y. and Hoboken, N.J.}}</ref> Additionally, robust emergency management helps an organization safeguard its public image in case of accidents.<ref name=":1" /> Accordingly, the PSM regulation mandates that emergency preparedness arrangements be put in place, including emergency pre-planning and training to make employees aware of, and able to execute, proper actions. The plan must comply with the provisions of other OSHA rules (29 CFR 1910.38).<ref name=":0" /><ref>{{Cite web |date=2023-08-17 |title=Code of Federal Regulations, Title 29, Subtitle B, Chapter XVII, Part 1910, Subpart E, § 1910.38 Emergency Action Plans |url=https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-E/section-1910.38 |url-status=live |archive-url=https://web.archive.org/web/20221228111945/https://www.ecfr.gov/current/title-29/subtitle-B/chapter-XVII/part-1910/subpart-E/section-1910.38 |archive-date=2022-12-28 |access-date=2023-08-20 |website=eCFR}}</ref>

=== Compliance audits ===
Similar to incident investigation, audits are an important tool an organization can use to assess whether its process safety management system is in place and it is effectively applied throughout its ranks.<ref name=":1" /> To be certain process safety management is effective, employers subject to the PSM regulation must certify by way of audits that they have evaluated compliance with the provisions of PSM at least every three years. The compliance audit must be conducted by at least one person knowledgeable in the process and a report of the findings of the audit must be developed and documented noting deficiencies that have been corrected.<ref name=":0" />

=== Trade secrets ===
OSHA's PSM is the only major process safety management code to include [[Trade secret|trade secrets]] among its elements.<ref>{{Cite journal |last1=Nwankwo |first1=C.D. |last2=Theophilus |first2=S. |last3=Arewa |first3=A. |date=2020 |title=A Comparative Analysis of Process Safety Management (PSM) Systems in the Process Industry |journal=Journal of Loss Prevention in the Process Industries |volume=66 |pages=104171ff |doi=10.1016/j.jlp.2020.104171}}</ref> Emphasis is given in the regulation to the fact that trade secrets may in principle restrict circulation of key information in several ambits of process safety management, such as process safety information, compliance audits, operating procedures, process hazard analysis, incident investigation, etc. The regulation makes it compulsory for organizations to release the information to the respective parties, irrespective of whether it is protected by trade secrecy. Nothing in PSM, however, precludes the employer from requiring those persons to enter into confidentiality agreements not to disclose the information.<ref name=":0" />

== See also ==
* [[Process safety]]
* [[Safety management systems]]

==References==
{{reflist}}{{Commonscat}}

[[Category:Process safety|Process Safety Management (OSHA regulation)]]
[[Category:Occupational Safety and Health Administration|Process Safety Management (OSHA regulation)]]
[[Category:Safety codes|Process Safety Management (OSHA regulation)]]
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