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Human Factors in Major Accident Hazard Regulation and Guidance: A Descriptive Overview

Human Factors are now central to managing major accident risk. But how are they actually embedded in regulation and guidance around the world?

Human Factors (HF) are now widely recognised as central to preventing and mitigating major accidents in the process industries. But how do regulations differ around the world?

Looking back at well-known incidents such as the Piper Alpha or Longford, we know that serious incidents are rarely the result of a single technical failure. Instead, they often emerge from complex interactions between people, technology, organisations, and operating context. This has highlighted the need to prevent incidents and near-misses from a systemic perspective, rather than focusing solely on technical controls.

Across many countries and sectors, this understanding is reflected in major accident hazard regulation and authoritative guidance. This blog provides a descriptive overview of how HF are embedded within these frameworks across several jurisdictions. Specifically, it considers the approaches taken in the European Union (EU), United Kingdom (UK), Norway, Singapore, Brazil, and the United States.

The jurisdictions included have been selected to illustrate how different regulatory models address Human Factors within major accident hazard regulation – some are new and some have been established for a long time. While the core regulatory expectations are broadly similar, important differences exist in how HF are articulated, interpreted, and examined in practice.

This blog tries to capture some of the high level similarities and differences between jurisdictions. 

A shared foundation for managing major accident risk

Each jurisdiction applies its major accident hazard framework using different terminology and regulatory structures. Across all of the frameworks considered, duty holders are generally expected to:

  • Identify major accident hazards
  • Demonstrate effective control measures
  • Implement a safety management system
  • Prepare and maintain a safety report or equivalent
  • Ensure emergency preparedness and response

Human Factors are addressed within this structure as part of how major accident risks are managed. These expectations are typically expressed through requirements relating to:

  • Organisation and personnel
  • Operational control and procedures
  • Competence, training, and supervision
  • Management of change
  • Emergency preparedness

Regulatory guidance, inspection practice, and in some cases industry-led standards play a key role in clarifying how the human and organisational contribution to risk should be addressed in practice.

European Union

The European Union regulates major accident hazards through the Seveso Directive, first introduced in 1982 following the Seveso chemical accident in Italy and now in its third iteration (Seveso III Directive (Directive 2012/18/EU)).

Seveso provides a high-level European framework for major accident hazard control. It requires operators to establish a Major Accident Prevention Policy (MAPP) and implement a Safety Management System proportionate to the risks presented by their activities. While it does not explicitly mention HF, it requires operators to establish a Safety Management System covering specific elements set out in Annex III of the Directive. These include organisation and personnel, operational control, training and competence, management of change, and emergency planning.

While framed at a high level, these requirements necessarily encompass the human and organisational contributors to major accident risk. The Directive is intentionally non-prescriptive, leaving Member States flexibility in how these expectations are implemented in national legislation and guidance. As a result, the way HF is articulated and examined in practice varies between countries, depending on regulatory interpretation, industry sector, and organisational capability.

United Kingdom (UK)

The United Kingdom implemented the Seveso framework through the Control of Major Accident Hazards (COMAH) Regulations, first introduced in 1999 and most recently updated in 2015.

Under COMAH, duty holders must demonstrate that risks to people and the environment are reduced as low as reasonably practicable (ALARP). Supporting guidance issued by the Health and Safety Executive (HSE) makes clear that this includes the human and organisational contribution to major accident risk, outlining HF topics such as procedures and process design. Additionally, UK regulatory guidance supports the use of task-level Human Factors analysis, including approaches such as Safety Critical Task Analysis (SCTA), where human performance is important to the control of major accident hazards.

Offshore oil and gas activities are regulated through the Offshore Installations (Offshore Safety Case) Regulations. It is distinct from COMAH, but has broadly similar requirements to demonstrate effective control of major accident hazards through technical, operational, and organisational measures. In the offshore context, HF expectations are supported by regulatory guidance and inspection practice like the Offshore Management of Human Factors Inspection Guide

A difference between the onshore and offshore sector are the HF topics listed in the respective guidance. The COMAH Delivery Guide groups HF expectations into six broad topic areas, whereas the offshore Human Factors inspection guidance sets out 11 distinct topic areas, providing a more detailed and granular framework for examining human and organisational contributions to major accident risk. A further distinction is that onshore major hazard sites are required to produce a Safety Report, while offshore oil and gas installations produce Safety Cases.

Norway

Norway regulates major accident risk primarily through a performance-based regulatory framework, particularly for offshore oil and gas activities. The system is overseen by Havtil and is structured around a set of goal-setting regulations, including the Framework Regulations, Management Regulations, and Facility Regulations.

These regulatory requirements and guidance place strong emphasis on organisational conditions, human–system interaction, and the way work is planned and executed in practice. 

Norway’s approach focuses on ensuring that major accident risks are identified, understood, and managed through systematic risk reduction and barrier management. HF expectations are mentioned throughout the regulatory framework through requirements relating to organisational conditions, competence, human–system interaction, workload, procedures, and how work is planned and executed in practice.

While specific HF methods are not mandated, operators are expected to demonstrate how human and organisational factors influence major accident risk and barrier performance as part of their overall risk management approach.

Singapore

Singapore introduced a COMAH-equivalent Safety Case Regime through the Workplace Safety and Health (Major Hazard Installations) Regulations 2017.

The Ministry of Manpower (MOM) requires operators of Major Hazard Installations to identify and assess major accident hazards, prepare and maintain a Safety Report, implement a Safety Management System, demonstrate that risks are reduced as low as reasonably practicable, and establish emergency preparedness and response arrangements.

Like the UK’s COMAH framework, the Singapore Safety Case Regime also covers other HF topics. Whereas the UK’s has six HF topic areas, the Safety Case Regime covers these topics in four aspects such as Major Accident Prevention Policy, Predictive, Design, and Risk Assessment and Risk Reduction Measures. 

Brazil

Brazil does not currently operate a major accident hazard regulatory framework. However, expectations around operational safety and organisational control are articulated through technical guidance on the management of Human Factors by Brazil’s National Agency for Petroleum, Natural and Biofuels (ANP). 

The guidance places strong emphasis on risk identification, analysis, and reduction, including explicit consideration of human–machine interaction and human contribution to risk. Notably, it promotes the use of quantitative human reliability analysis (HRA) techniques (Petro-HRA, THERP, HEART etc.) to assess the probability of human error within safety-critical tasks and to inform risk reduction measures. 

HF are therefore addressed primarily through quantitative, risk-based analysis, rather than a qualitative approach or explicit safety management system topic areas. This reflects a regulatory style that integrates HF within probabilistic risk assessment, which seems different to COMAH that does not require a quantitative approach and from our experience seems more comfortable with qualitative HRA. 

United States

In the United States, major accident risk is regulated primarily through the OSHA Process Safety Management (PSM) standard. The PSM establishes requirements for hazard analysis, operating procedures, training, and mechanical integrity, and expectations around HF are increasingly expressed through authoritative industry guidance. An example of this would be publications from the Centre for Chemical Process Safety (CCPS). Recent CCPS Process Safety Management guidance for the mining, minerals, and metals industry, explicitly recognises the importance of HF in controlling major accident risk. This guidance highlights the role of human performance in safety-critical controls and promotes structured HF approaches such as Safety Critical Task Analysis (SCTA), procedural analysis, and targeted Human Reliability Analysis where human action is relied upon for risk control.

While CCPS guidance is not regulatory in nature, the good practices outlined can be applied across industry, and increasingly influences how organisations interpret and implement process safety expectations. 

Wrapping up: Regulation and the evolving role of Human Factors

Across the jurisdictions considered in this blog, there is a clear and sustained focus on the control of major hazards in high-hazard industries. Many of these frameworks were introduced in response to major accidents and initially focused on technical integrity and containment. Over time, however, understanding of major accidents has shifted towards a socio-technical perspective, in which human and organisational performance is recognised as central to risk control.

The differences between regimes are therefore less about whether HF are expected, and more about how those expectations are expressed, through regulation, guidance, inspection practice, or industry standards. Through this blog, we’ve seen different countries establishing different expectations. Some embed HF through detailed guidance and regulatory practice, while others approach HF through technical guidance and quantitative risk frameworks.Taken together, this points to a regulatory and governance landscape in which the foundations of major hazard regulation are well established, and the role of HF continues to strengthen over time. For organisations to operate successfully and sustain effective Human Factors management, it is important not only to comply with regulatory requirements, but also to develop the capability to address HF in line with recognised good practice and guidance.