Enhesa - Global EHS & Product Compliance Assurance

Ask Enhesa Vol. 9

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Featuring contributions from Sarah Toussaint, Tjeerd Hendel-Blackford, Jill Bernstein, Dusan Sevic

You asked and we answered!

Enhesa’s team of multilingual regulatory analysts are committed to providing quality insight and analysis around the latest EHS news and developments via our Enhesa Flash, webinar series, and blog posts. In response, our team often receives a variety of questions regarding the broad realm of the EHS topics we cover. To meet this demand, we launched “Ask Enhesa”, a reoccurring blog series where our senior thought leaders will take the lead in answering all of your most relevant and topical EHS questions.

What countries have programs similar to OSHA's Process Safety Management (PSM)?

JB and DS:

First let us remind readers what OSHA’s PSM is…

In the United States, the management of workplace hazards associated with highly hazardous chemicals is regulated under OSHA’s Process Safety Management of Highly Hazardous Chemicals Standard (PSM Standard) (29 CFR 1910.119). Appendix A of 29 CFR 1910.119 includes a list of toxic and reactive highly hazardous chemicals that present a potential for a catastrophic event at or above a certain threshold quantity. Generally, facilities that are covered by the PSM Standard include those with a process that involves a chemical at or above the specified threshold quantities listed in Appendix A.

In this context, it is also worth mentioning that the United States also manages the use of extremely hazardous substances under the Risk Management Plan (RMP) Rule, which implements Section 112(r) of the Clean Air Act (CAA). Under the RMP Rule, facilities that use extremely hazardous substances must develop a Risk Management Plan and submit the plan to the EPA every five years.

Now to answer the question- which countries have similar programs to PSM/RMP- the first and most obvious example to mention actually applies to 28 countries – the Member States of the European Union. The law in question is the so-called “Seveso” Directive – named after an Italian industrial disaster in 1976. Both PSM/RMP and Seveso have as their end goal the protection of people and the environment from major industrial accidents.

Directive (Directive 82/501/EEC) which has been amended over the years (Directive 96/82/EC and Directive 2012/18/EU) applies to more than 12,000 industrial establishments in the European Union where dangerous substances are used or stored in large quantities, mainly in the chemical and petrochemical industry, as well as in fuel wholesale and storage sectors.

The influence of the Seveso Directive goes wider than just the EU member states, however. For example, Serbia, although not a EU Member State – replicates the SEVESO requirements through numerous pieces of legislation adopted under the Emergency Situations Act OGRS 111/2009, 92/2011 and 93/2012, and the Act on Environmental Protection OGRS 135/2004, 36/2009, 72/2009, and 43/2011. The laws in question specifically refer to “Seveso installations”.

There are also laws seeking to prevent major industrial accidents in many other countries around the world. To take just a few examples[1]:

China

  • Emergency Response Law (Presidential Ordinance No.69 of 30 August 2007)
  • Safe Production Law (29 June 2002, National People’s Congress, as last amended on 31 August 2014)

India

  • Environment (Protection) Act No. 29 of 26 May 1986
    • Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 (consolidated version with subsequent amendments)
    • The Chemical Accidents (Emergency Planning, Preparedness, and Response) Rules, 1996

Japan

  • Industrial Safety and Health Law (Law No. 57 of 8 June 1972)
    • Enforcement Ordinance of Industrial Safety and Health Law (MHLW Ordinance No.32 of 30 September 1972)
  • Fire Services Law (Law No.186 of 24 July 1948)
    • Cabinet Order on the Control of Dangerous Substances (Cabinet Order No.306 of 26 September 1959)
  • Basic Law on Disaster Countermeasures (Law No.223 of 15 November 1961)

Australia

In Australia industrial accidents are regulated at the level of states. For example, in New South Wales:

  • Explosives Act 2003
    • Explosives Regulations 2013
  • Work Health and Safety Act 2011
    • Work Health and Safety Regulation 2011

Mexico

  • General Law of Ecological Equilibrium and Environmental Protection (LGEEPA), of 28 January 1988
    • Federal Occupational Health and Safety Regulation
    • NOM-028-STPS-2012, System for Labor Management regarding safety in processes of hazardous chemical substances, of 6 September 2012

How can we categorize audit findings to determine which ones should be elevated to board member? What audit findings do senior management generally want to know about and ultimately act upon?

ST:

From our experience at Enhesa, senior management are most interested in compliance audit findings which fall in to one of two categories:

  1. High risk findings, which present significant risk to continuing operations or which must be acted upon to prevent implications to the environment or personnel safety
  2. Repeat findings, which had already been identified during earlier audits.

To determine high risk findings, you can use the risk assessment function in the Enhesa ScoreCard. The ScoreCard classifies risk by High, Medium or Low and uses three parameters - risk exposure, likelihood, and consequence to determine the classification. Risk Exposure identifies how often there is a situation where things could go wrong. Likelihood (AKA probability) assesses how likely or unlikely it is that things go wrong. Consequence (AKA severity) is the effect of what happens if things go wrong. By selecting the appropriate level from the drop-down menu for each of these parameters, the ScoreCard will automatically assign the risk classification using the built-in formulas. Any non-compliance findings that fall into the high-risk category can be highlighted to senior management.

With regard to repeat findings, identifying findings that repeat or partially repeat, previous audit findings should be a key focus for compliance audits. This is because they indicate an absence of action by the site in managing known compliance issues. To be able to do this, review of the previous audit report(s) should always be part of the audit preparation. At Enhesa we simply add a notation at the beginning of the findings description “Repeat Finding” for repeat findings.

Does Enhesa participate in the European Federation of Pharmaceutical Industries and Associations (EFPIA) or the Pharmaceutical Product Stewardship Work Group (PPSWG) (USA)?

THB: The short answer is no.

Enhesa is a private company selling regulatory compliance intelligence, forecasting and support services. We help global multinationals to understand and comply with the regulations that are in place and inform them of change, but we do not seek to influence law or policy.

Enhesa does, however, count many of the world’s pharmaceutical companies amongst its clients. Enhesa provides regulatory intelligence and forecasting across all our clients’ locations around the world, giving them a truly global view on current and future EHS compliance challenges. We would be happy to provide references!

How do multinational companies track multi-country legislation changes effectively?

THB: There are various options and approaches, but the best is to use Enhesa! Enhesa works with many of the world’s multinational companies to keep them up to date with regulatory change, wherever they operate.

Enhesa’s EHS Regulatory Forecaster service allows companies to keep track of emerging regulatory issues (laws, proposals, policies), globally, per jurisdiction. Companies will receive monthly reports with a detailed analysis of up-and-coming issues.

The Regulatory Forecaster Service includes the following elements:

  • Regulatory Foundations – a list of all EHS laws within your contracted scope, with consolidated summaries of each law and access to the full, original legal text
  • Monthly email alerts on reports published in the previous month, which each user can tailor by jurisdiction (s) and by thematic topic (s)
  • Enhesa Business Impact Analysis – a company-specific analysis of steps you might need to take
  • Issue Manager to assign reports within your team and manage follow-up actions
  • Client Service Training & Support – receive training and support on the use of Enhesa’s services from our dedicated Client Service team

Optional additional support is provided through Enhesa’s Expert Support Services – such as Forecaster Review Calls – where Enhesa consultants can provide additional analysis and respond to questions in periodic conference calls.

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