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.


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.