Tuesday, December 1, 2015

Chemical Risk Assessment Needs the Cold Hand of Regulation

I worked for a large specialty chemical company for 35 years.  The company had a reputation as being a leader in the area of human health risk assessment.   I believe that reputation came as a result of their response to a tragedy that occurred years earlier when some of its workers were unknowingly exposed to a potent carcinogen and many became ill.   The heartbreak of this incidence caused the owners to really understand and act on that fact that you typically cannot manage any risk which has not been first reasonably assessed.  When I came on to the risk assessment scene in the mid-1980s the culture was well in place but the tools for quantitative risk assessments were not (and I must say remain) relatively under-developed.  I did and continue to spend my professional time to this day working on them.

For much of that 30+ years I have been busy working on these tools as applied to compounds that were clearly hazardous.  That is, those designed or discovered to be biologically active.   This included biocides and the “stand out” toxicants such as benzene, formaldehyde, chlorinated hydrocarbons and any other molecules important to the company that had somehow adversely affected human health or had been tested in animals to be carcinogenic, neurotoxic or a reproductive hazard.

This is how essentially all chemical risk assessment is done today and it is lacking.  It is “reactive” risk assessment in which relatively few chemicals are evaluated and the vast majority go unaddressed.   This was convincingly shown in what has been known as the “HPV Challenge”.   An excerpt from an Environmental  Defense  Fund web site:

When it launched the HPV Challenge in 1998, the U.S. Environmental Protection Agency (EPA) acknowledged there were huge gaps in publicly available hazard data even for HPV chemicals (those produced in or imported into the U.S. in amounts equal to or exceeding one million pounds annually). 

This June 2015 web site ( generally asserts a continued lack of information born of missed deadlines and data quality concerns.

After thinking about this literally for decades, I have come to the conclusion that even highly “enlightened” companies such as the one I worked for (and continue to work for as a consultant) will not take on the burden of doing risk assessments on all chemicals by itself.  The systematic, comprehensive and shared risk assessment of chemicals is something that needs to occur in the public interest and therefore should be subject to public governance; that is, regulation.

The “Government” has shown itself to be very capable of screwing things up but I frankly do not see a reasonable alternative.  I suggest that we simply have to do a better job of governing and not throw the risk assessment “baby” out with the governmental “bathwater”.

The European Union has been trying to do this with REACh and more recently in this country we are trying to “reform” the Toxic Substance Control Act.   Ultimately, I believe the cold hand of regulation will be the best and perhaps only way to do rational and comprehensive chemical risk assessment.

As usual, I would love to hear your take on this opinion which I can present here as anonymous if you prefer.


  1. Mike, although the efforts towards chemical risk assessments has been slow, I do not believe regulations is the answer. As you mentioned the government is very capable of screwing things up and it is never efficient in doing anything, just look what it has done with the health insurance industry. One reason this is not being pursued by companies is the cost involved, especially during times when companies are cutting capital and operating budgets. So instead of regulating the work being done the government could incentivize companies to fund the studies and/or give grants to universities to do this work. As you also mentioned the European Union is making an effort, why do we not make a concerted effort to make this more of a global project instead of duplicating efforts around the world?

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