OSHA PSM · Seveso III · Major-accident hazards
Process safety management compliance for sites that handle highly hazardous chemicals.
OSHA's process safety management standard and the EU Seveso III Directive both expect a working, documented system that prevents catastrophic releases and major accidents, and neither issues a certificate. Sterling's expert and experienced consultants map the obligations that apply to your sites, close the gaps with your operations and engineering teams, and keep the evidence ready for the regulator's inspection, working alongside your legal advisers. We help our clients put it into practice and prove it.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced health and safety consultants, with safety management systems consulting delivered across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. No certificate exists for PSM or Seveso compliance; the regulator inspects and enforces, and Sterling does not certify or approve anything
8,100+ client engagements in 60+ countries.
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What it is
What is process safety management and what is it used for?
Process safety management is the discipline of keeping hazardous substances inside the equipment designed to hold them. It deals with low-frequency, high-consequence events: toxic releases, fires and explosions.
Two regulatory regimes define it for many operators. In the United States, the Occupational Safety and Health Administration (OSHA) sets the standard "Process safety management of highly hazardous chemicals", 29 CFR 1910.119. Its stated aim is to prevent or minimise the consequences of catastrophic releases of toxic, reactive, flammable or explosive chemicals. In the European Union, Directive 2012/18/EU of 4 July 2012, known as Seveso III, governs the control of major-accident hazards involving dangerous substances and obliges operators to take all necessary measures to prevent major accidents and limit their consequences.
Current texts. OSHA PSM applies as currently published in the Code of Federal Regulations, 29 CFR 1910.119, with Appendix A listing the highly hazardous chemicals and their threshold quantities. Seveso III replaced the earlier Directive 96/82/EC and had to be transposed by Member States by 1 June 2015; the European Commission's implementation report of September 2025 found it overall well implemented and did not propose a revision. Because Seveso III is a directive, your operative duties sit in the national law of the Member State where the establishment is located.
Who it is for
Who needs OSHA PSM or Seveso III compliance?
Applicability is decided by what you hold, how much and where, not by your industry label. OSHA PSM covers processes involving listed highly hazardous chemicals at or above their threshold quantities, and certain flammable liquids and gases; the regulation also names exemptions, among them retail facilities, oil or gas well drilling or servicing operations, and normally unoccupied remote facilities. Seveso III covers establishments where dangerous substances are present at or above the quantities set in the Directive. Operators come to Sterling from four starting points:
- A customer or joint-venture partner asks for evidence. Majors, licensors and insurers want to see a process safety programme that runs, with hazard analyses, mechanical integrity and management of change on record.
- A tender or permit application depends on it. A new unit, storage expansion or change of inventory can bring a site into scope or move an establishment to a higher tier.
- The regulator has been in touch. An inspection, a notification request or a finding needs a structured response and a programme that stands up at the next site visit.
- Group companies need one approach. Sites in the United States and in EU Member States answer to different texts; a common management framework with local compliance maps avoids running two unrelated programmes.
Requirements
What are the main process safety management requirements?
OSHA PSM is written as a set of elements an employer must implement for each covered process; Seveso III places duties on the operator that scale with the establishment's tier. The list below summarises both at title level, for orientation only; your programme is built against the regulation and the national text itself, with your legal advisers.
- PSM: employee participation and process safety information: consult employees on hazard analyses and the other elements, and compile written information on chemical hazards, process technology and equipment.
- PSM: process hazard analysis: evaluate the hazards of each covered process, then update and revalidate the analysis at the intervals the standard sets.
- PSM: operating procedures, training and contractors: written procedures for safe operation, initial and refresher training, and oversight of contractor safety.
- PSM: pre-startup safety review, mechanical integrity and hot work permits: confirm safety before new or modified processes start, maintain and inspect critical equipment, and control hot work.
- PSM: management of change and incident investigation: manage modifications to processes and procedures, and investigate incidents connected with a catastrophic release.
- PSM: emergency planning, compliance audits and trade secrets: an emergency action plan, periodic certified evaluations of the programme, and access to the information people need to work safely.
- Seveso III: notification and major-accident prevention policy: notify the competent authority, and set out a written prevention policy put into practice through a safety management system proportionate to the hazards.
- Seveso III: safety report and emergency plans (upper tier): produce a safety report, draw up an internal emergency plan and supply what the authorities need for the external plan.
- Seveso III: domino effects, modifications and public information: address domino effects between neighbouring establishments, revisit obligations when an installation, establishment or storage facility is modified, and inform the public.
What evidence does a process safety inspector expect?
Current process safety information, hazard analyses with recommendations tracked to closure, operating procedures, training and contractor records, equipment inspection histories, change files, incident investigations and the last compliance audit or safety report. We organise these around your covered processes in Effivity, so evidence is produced by the work rather than gathered for the visit.
Compliance process
How do you achieve OSHA PSM and Seveso III compliance?
There is no application and no certificate at the end. Compliance is a continuing state that the regulator checks through notifications, reports and inspections. Sterling helps you build and run the programme; judgements on legal applicability stay with your legal advisers, and enforcement stays with the authority.
- 01Establish applicability and scope.Compare inventories and processes with Appendix A and the Seveso quantities, with your legal advisers, and fix which processes or establishments and which tier are in scope.
- 02Gap analysis: compare current practice with each element and duty.Review what exists for every covered process, keep what works and agree actions, owners and dates for the gaps.
- 03Build the programme with operations and engineering.Hazard analyses, procedures, mechanical integrity, management of change, emergency plans and, where required, the safety report, prepared with the people who run the plant.
- 04Train, operate and check.Train operators and contractors, run the programme long enough to produce records, then audit it against the regulation and close the findings with evidence.
- 05Engage the regulator and keep it current.Notifications and reports go to the authority on time; inspections find a live programme, and periodic audits, revalidations and reviews keep it that way.
Check the route before you sign. No legitimate provider can certify you as PSM or Seveso compliant, because no such certificate exists; treat any offer of one with caution. Confirm which authority is competent for each of your sites and read the obligations in the official text, eCFR for OSHA PSM and EUR-Lex plus the national legislation for Seveso III.
Cost
How much does process safety management compliance cost?
One covered process with mature engineering records differs greatly from a multi-unit establishment writing its first safety report. The proposal is sized on your processes and inventory, and every component is visible.
| Cost component | What affects it |
|---|---|
| Consulting and programme build | Number of covered processes or establishments, the Seveso tier, the state of existing hazard analyses and drawings, and whether you choose Design™ or Drive™ |
| Specialist studies | Hazard analysis facilitation, consequence modelling or equipment inspections that your engineering team or third parties may need to carry out |
| Internal resources | Time from operators, engineers and maintenance staff, training hours and any plant modifications arising from the analyses |
| Software and learning | Included in a Sterling engagement: Effivity for the programme and Sterling Academy access for your people, confirmed in the proposal |
| Continued support | Compliance audits, revalidations, updates after change and refresher learning under Sustain™ |
What moves the price
- Number of sites, countries and covered processes
- Lower-tier or upper-tier status under Seveso III
- Quality of existing process safety information
- Regulatory deadlines and open inspection findings
- Languages and the number of contractors on site
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions in writing
- Third-party studies identified separately
- Effivity, training and Academy access itemised at no additional cost
- Payment milestones tied to deliverables
- One all-inclusive proposal. No surprises, ever
Timeline
How long does process safety management compliance take?
Pace depends on how complete your process safety information is, how many hazard analyses need to be done or redone, the availability of engineering staff and any dates set by the authority. As an estimate, building a programme typically takes four to nine months; running it is permanent, because the regulations expect periodic audits, revalidations and reviews.
| Phase | What determines the pace |
|---|---|
| Applicability and gap analysis | Access to inventories, drawings, records and the people who run each unit |
| Hazard analyses and procedures | Number of covered processes, study team availability and the recommendations raised |
| Implementation and training | Operator and contractor schedules, shift patterns and equipment work arising from the studies |
| Audit and regulatory submissions | Time to close audit findings, and the authority's timetable for notifications, reports and inspections |
Your engagement
What your process safety engagement includes
Sterling OS™ structures the work. You choose the level of support: Design™, where we guide and your team builds, or Drive™, where we manage the work with your team; they are alternatives, not stages. Automate™ is Effivity, running the programme from the first workshop, and Sustain™ keeps it current once it is in place. Sterling does not certify, inspect or approve anything, and gives no legal advice; we work alongside your legal advisers.
Applicability map and gap analysis
By process and establishment, with owners, dates and decisions agreed before work starts.
Programme documents built with your teams
Procedures, management of change, mechanical integrity and emergency arrangements, written with operations and engineering.
Effivity ISO & GRC software
Your programme runs in Effivity, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for your audit team, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Compliance audit support
Audits against the regulation conducted or facilitated as agreed, with findings closed with evidence.
Inspection readiness
Evidence organised for the regulator's site visit and support in responding to what it raises.
Compliance is determined and enforced by the regulator; there is no certificate.
Often combined with
Standards organisations pair with Process safety management (OSHA PSM and Seveso III)
- API Spec Q1API Spec Q1 certification consulting for oil and gas suppliers: contract review, design, purchasing and release controlled, prepared for the APIQR audit.
- AWS StandardAWS water stewardship certification to the Alliance for Water Stewardship Standard: what it is, who asks for it and how Sterling prepares your site for audit.
- CHAS, SafeContractor and AchillesCHAS, SafeContractor and Achilles accreditation for UK contractors: what each scheme is, who asks for it and how Sterling prepares your evidence.
- GRESBGRESB assessment explained: Real Estate, Infrastructure and Development components, the annual cycle, validation and ratings, and how Sterling prepares you.
- IEC 61511IEC 61511 compliance for process plants: the safety instrumented system lifecycle, functional safety management and the evidence your assessors expect.
- IEC 62443IEC 62443 certification consulting for industrial automation and control systems: zones, conduits and security levels for owners, integrators and suppliers.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you run, automate and evidence a process safety programme.
Every Sterling process safety engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so controlled documents, risk registers, audits, corrective actions, contractor evaluations, maintenance and calibration records, training and management review sit in one place and the inspector sees a programme in daily use. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Controlled documents and drawings
Chemical data, process technology and equipment information held with versions and approvals, so the drawing in use is the drawing that was approved.
Risk register and recommendations
Hazard analysis findings logged against each process, with owners, due dates and revalidation reminders, and open recommendations visible to management.
Procedures and periodic review
Operating procedures issued, acknowledged and reviewed on schedule, with superseded versions withdrawn from use.
Competence records and contractor evaluation
Initial and refresher training per person, linked to Sterling Academy, and contractor evaluations with their safety performance on record.
Maintenance, inspection and calibration
Inspection and test schedules for critical equipment, with each result and deficiency recorded when the work is done.
Workflows for changes
A configurable workflow that routes each change through review, approval and pre-startup checks before it goes live.
Nonconformity and corrective action
Incidents and near misses investigated with root cause, actions tracked to closure and recurring themes reported upward.
Audit programme and management review
Audit plans, findings and follow-up in one place, and legal requirements tracked to the processes they affect.
What this means at the inspection
An inspector asks for the latest hazard analysis and its open recommendations, the change files for recent modifications, equipment inspection histories and the last compliance audit. In Effivity each is a record with dates, owners and attachments, not a search through shared drives. Under Sustain™ the same workspace carries the next audit and revalidation cycle.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Existing documents and records migrated, not retyped
- Admin and user training for your team
- Modules for EMS, OHSMS, ISMS, FSMS and more when you integrate other standards
Sterling Academy · e-learning for your people
Build safety awareness across the workforce, not only in the process safety team.
Sterling Academy delivers e-learning with video lessons, practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential Sterling Academy course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement. Academy learning supports, and does not replace, the process-specific operator training the regulations require.
- Management system awareness for every employee, with completion records
- Internal auditor training for the people who audit the programme, as applicable to your standard, as part of the engagement
- Progress reports by department to support your training records
- New starters trained as they join
- A Sterling consultant reachable when a learner needs one
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Why Sterling
Why choose Sterling for process safety management?
Operators with sites on both sides of the Atlantic face two regimes with different vocabulary and the same goal. Sterling builds one management framework with a compliance map for each jurisdiction, so plant teams follow a single way of working while each site meets its own authority's expectations.
60+ countries since 2003
Management systems delivered across regions with offices in 21 countries, and one engagement team accountable across your sites.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with third-party studies identified separately. No surprises, ever.
A programme operators can use
Procedures written with the people on shift, records created by the work, and fewer documents that nobody reads.
Expert and experienced consultants
Consultants who work with your engineers and legal advisers, and build the programme properly the first time so the inspection confirms what already works.
The Sterling Promise
What our process safety compliance guarantee means
We stay with you until your agreed process safety programme outcome is achieved, supporting implementation, preparation and the response to inspection findings.
The engagement identifies the regulations, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed controls into use. The regulator inspects and enforces, and legal advice remains with your legal advisers. Our commitment concerns the agreed programme support, not a promise of any regulatory outcome or incident-free operation.
FAQs
Frequently asked questions about process safety management
Is there an OSHA PSM or Seveso III certificate?
No. Neither regime certifies operators. OSHA enforces PSM through inspection, and under Seveso III the competent authorities of each Member State receive notifications and reports and carry out inspections. Organisations that want an independent certificate often pair their programme with ISO 45001 certification, which is a separate route.
How do I know if OSHA PSM applies to my facility?
Compare the chemicals and quantities in each process with Appendix A and the flammable-substance provisions, then check the listed exemptions. Applicability is a legal question, so we prepare the inventory analysis and your legal advisers confirm the conclusion.
What is the difference between a lower-tier and an upper-tier Seveso establishment?
The tier depends on the quantity of dangerous substances present, against two thresholds set in the Directive. Every establishment in scope needs a written major-accident prevention policy; upper-tier establishments also produce a safety report and an internal emergency plan and are inspected more often.
How often is a PSM compliance audit required?
At least every three years the employer must certify that it has evaluated compliance with the standard. Process hazard analyses must also be updated and revalidated at least every five years.
Does ISO 45001 cover process safety management?
Not by itself. ISO 45001 gives a management system framework for hazard identification, legal requirements, change and emergency preparedness, which helps a process safety programme run, but it does not replace the specific elements and duties in OSHA PSM or national Seveso legislation.
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