Can Regulators Keep Up? Risk Assessments are Needed Now.

Yesterday, I was reading the NY Times opinion pages about “Where OSHA Falls Short, and Why” and the unfortunate event of the fertilizer plant explosion in West, Texas. Many of the opinions posted in the NY Times were along the lines of OSHA has few resources, regulations are out-dated, and empower the regulators to be tougher. While all of this may be true, it is a matter that regulatory agencies will never be able to keep up with industry, nor should they. It comes down to a matter that companies must put in management systems to correctly evaluate environmental, health and safety risks. Risk assessment processes need to be established and implemented. This should not be the regulators responsibility to perform the risk assessments for the companies. In addition, regulators will never be able to hire enough qualified inspectors to properly evaluate and follow-up on even a fraction of the highest risk facilities in the country.

For example, take the challenge of permissible exposure limits (PELs). Currently, about 500 PELs exist. But, there are literally tens of thousands of hazardous compounds that are in use today. OSHA would never be able to established PELs for even a fraction of these compounds. Industries need to take the lead similar to what has been done in the pharmaceutical industry. In the pharmaceutical industry there are thousands of active pharmaceutical ingredients that are potentially hazardous from an occupational exposure¬†standpoint. Did occupational health professionals in the industry just sit back and say “Oh well, we will wait till OSHA passes some PELs.” No they didn’t. It is now common industry practice to develop and establish internal occupational exposure limits for the APIs that they may handle or process. The occupational health professionals then perform risk assessments, evaluate processes, and establish controls to reduce the risk.

The Risk Assessment Equation

In its most simple form, most risk assessments are based on the following equation:

Risk = (Hazard or Severity) X (Probability of Occurrence)

There are many risk assessment models that have been in use for years. These include HAZOP, What-If, Process Hazard Analysis, FEMA, and others.

So what needs to be done? Industries of every size need to step up and take the lead. They need to proactively establish risk assessment processes and implement controls to reduce risk. People can argue all they want about ineffective regulatory agenices, but in the end, they still wouldn’t be able to keep up.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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