Monday, December 14, 2015

Regulations Need Good Tools for Risk Assessment

In the last blog I asserted the need for the “cold hand of regulation” before risk assessment for the vast majority of chemicals used in commerce would happen.   A colleague wrote to me about that blog and reminded me that having an ostensibly comprehensive set of regulations is no guarantee that good risk assessment will be done.  I have excerpted a portion of the email from this colleague who is literally on the front lines in the application of available risk assessment tools.  Please note that I have always found this IH professional to be insightful and plain-speaking while being dedicated and passionate about making a difference.

“I've recently been doing some more work for U.S.-based multi-national firms reviewing REACh documentation, and I have to say, I am kind of disillusioned about the 'promise' of the REACh regulation's outcomes.  So much of what I see for extended SDSs [Safety Data Sheets] are just cookie-cutter verbiage - or, use Tier I screening tools to justify squishy statements that have very little utility to the end/downstream users of chemical-containing products.   I am sure there are a multitude of reasons for why this has happened, but the end result (IMHO) is going to fall far short of the original intent of the regs.”

I can only say that I completely agree with this observation from this seasoned IH/RA professional.   Indeed, I believe that I know the primary reason for this unfortunate state-of-affairs; namely, it is a lack of well-developed tools particularly in the realm of exposure assessment.

The first threshold or gate in risk assessment is the decision to do a risk assessment.   As I argued in the last blog, to date, that threshold has not been crossed for most chemicals in this country.  It has been different in Europe.  There has been a movement in the EU for the last 15 years or so to cross this threshold.  They are clearly advanced.

Once you are on the hook to do a risk assessment then you need the resources to make it happen.  If you do not have them then you have to develop them.  Since you will be applying them literally to thousands of chemicals, they have to be generally applicable to a large number of chemicals.   The tools for this task need to strike a balance between being “sharp” and incisive enough to render good answers for specific chemicals while being “general” enough to be applicable in a cost-effective manner.  You obviously cannot measure everything everywhere; as such, the development of validated and comprehensive exposure and effects models is critical.

I have asserted for years that we yet to do the basic research needed to properly feed our exposure models and make them “sharp” enough to be generally useful in the above context.  We did our best to lay out a specific template for research for the EU in a series of 2005 Workshops that were sponsored by the European Commission Joint Research Centre (JRC) in Ispra, Italy. These reports, especially the 100+ page report on exposure source characterization used the combined expertise of seasoned and respected scientists from around the world (Berkeley, Virginia Tech, USEPA, EU, Japan, China) to point to where the research was needed.  That document and its recommendations lay on JRC server and in my files and hard drive for years without any action.  I can no longer find it on the JRC servers but I have it and would be happy to send this report to anyone asking at  You can also find it as a downloadable link on my webpage:

Instead of doing the basic, initially expensive but ultimately cost-effective detailed research and tool development, the regulatory community in Europe has developed or adopted light-weight and stop-gap approaches which have resulted in the outcomes as described by my colleague on the front lines; namely, “cookie-cutter verbiage - or, use Tier I screening tools to justify squishy statements that have very little utility to the end/downstream users of chemical-containing products.”

In my opinion, there really is no substitute for doing it right and I hope that someday the research and its work products will fulfill the original intent of the REACh (and hopefully the upcoming US and other world-wide chemical) regulation.



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