Monday, November 24, 2014

We do NOT spend enough on Risk Assessment

I think I mentioned in previous blogs that my friend and colleague, Gurumurthy Ramachandran or “Ram” is a brilliant teacher and researcher.   A few years ago he and J.Y. Choi conducted a survey of technical experts on the occupational oversight framework in this country.  They used nanotechnology as the example.

The mathematical techniques they used were quite sophisticated in their analysis of the survey.   That is not my primary area of expertise but it appears to be very well done.  Indeed, as he always does, it is a very careful piece of research and its conclusions are properly couched in terms of the uncertainty and limitations of the study. Notwithstanding these caveats, I was struck by the following excerpts from the paper:

Despite the large investments in nanotechnology, corresponding investments in studying the health and safety aspects of this technology and its products have been minimal.

The most striking finding is that experts in our sample tend to believe that the current oversight system for chemicals in the workplace is not adequate and effective. About 17 (or 70 percent) of the 25 criteria were scored below 50 out of 100. The mean score of the 25 criteria across all experts is 42.4 and median is 41.3 out of 100.

This reference is:

Choi, J.Y, Ramachandran, G. Review of the OSHA Framework for Oversight of Occupational Environments. Journal of Law, Environment, and Ethics, 37(4):633-650, 2009.

If Ram gives me the OK I will send this to anyone who asks me for it:

Indeed, this has been my general experience during a long career doing product safety risk assessment for the chemical industry.   About 12 years ago I did a calculation of the amount of money being spent by the chemical industry on health and safety research of chemicals by the chemical industry.   This included the 15-20 million USD being spent every year at that time by the Industry sponsored Chemical Industry Institute of Toxicology (CIIT). Compared to the industry’s profits it came out to be in the parts per million range.   This is not to say that other money was not being spent on health and safety research by individual companies but, like the CIIT efforts, they were primarily reactive in nature in that they were responding to obvious problems that were either easily anticipated or brought to them.  

Chemcials that were clearly toxic, like pesticides or proven carcinogens or endocrine disruptors (all most often initially discovered in academia) received the focus of attention.

For many years almost all of the risk assessments I did for my company were focused on these types of products (e.g., recognized sensitizers, carcinogens, etc).   During my tenure, the vast majority of products produced by most companies never really received any proactive attention relative to the risk of their use in commerce. I believe it is the same today.

It would seem that the Europeans have been trying to reverse that trend with the REACh regulations.  There are also noises being made in this country to reauthorize TSCA to be more REACh-like and do proactive assessment of chemical risk as well.

My read of all this here or in Europe is that unless or until proper resources are allocated to do this research, we will continue to flounder in a sea of uncertainty in which we really do not understand the risk of the chemicals we use.   This is not to say that all or even many of the chemicals we are exposed to are harmful at the exposure we encounter them.   I am quite sure, however, that there are unacceptable risks from the chemicals we use out their today that we have not discovered and we will not find them without these resources.  

That is my read but I would very much like to hear other opinions.   After all, this is a discussion group.   The discussion will appear at the bottom of this blog or in the LinkedIn Group in which it is posted.  However, if you write a good and compelled argument or treatise relevant to this issue, I will publish it, along with my comments, here in a future blog.

Relative to last week’s blog (Argument AGAINST Dermal Exposure Modeling), I got very few folks defending the use of dermal modeling.  I was somewhat surprised in that I made sure that the people I know that are or were doing dermal modeling got the blog.  Perhaps it is because everyone is so busy with the holidays and work.   I will leave the question open for a few more weeks in case folks wanted to comment but just did not have the time. 


  1. Dear Mike, Thank you for highlighting this paper. For a variety of reasons, I published it in a journal that does not get much readership from the OH community. So, it is good to get this publicity. Please do go ahead and send the paper to anyone who asks for it.
    We elicited opinions from a group of 27 experts, consisting of representatives
    from industry, academia, and the highest levels of federal agencies (National Institute of Occupational Safety and Health and OSHA). Three groups of criteria were used to evaluate relationships between features of the OSHA oversight system and important outcomes: (1) those associated with the initial development of the system (e.g., establishment of policies, procedures, or regulations); (2) the attributes of the system (e.g., how the system operates for particular processes or decisions); (3) and the outcomes of the system (e.g., social, economic, cultural, health, environmental, and consumer
    impacts). As you point out, the results were striking and dismal. The oversight system was considered neither adequate nor effective, and characterized by inflexibility, inadequate resources, lack of incentives for compliance, lack of transparency, insufficient data on health effects from manufacturers, and the most telling of all - low impact on worker health and safety.
    There is a strong case to be made for changing our approach to regulatory oversight. I would like feedback from the participants of this discussion group.

  2. Mike
    Ram's closing comment seeking feedback prompts this post.
    The consideration for changing the regulatory approach must come from those benefiting (workers) , rather than the advocates (us). I had presumed that I could construct a position paper for use by the Department of Energy enforcement that would restate the statistical reality recognized by OSHA (even a well controlled process would infrequently yield exposures above limits on the order of a 5% occurrence). I gave up when I recognized we already say it in the current AIHA Strategy Book, and have no means to force them to read anything new.
    You witnessed the pressures facing the regulators at Hanford. The pursuit of an ALARA perspective reflects “hazard = risk” culture that is not at all unique to DOE.
    So how do we advocate the change to the regulator community? I don’t have an answer. Our legislative bodies seem incapable of true dialogue and pursuit of a common goal; you constantly hear the Republican side arguing job impacts from regulation, yet the successful worldwide companies have been able to show that worker health protection and reduced risks are compatible goals. And the Democrats expect safety at all cost (read unlimited funds).
    AIHA revisiting the “exposure and risk assessment management” (ERAM) concept should help whomever needs a technical banner to sell. But I don’t see our efforts bearing fruit soon (you have made an audience at Congress and are recognized for leadership in this regard, and know this better than all!) Let’s hope we can influence change sooner rather than later.
    Thanks Steve

  3. Worker education and information. Its all black box unless we explain enough at grass roots. No matter what formal regulations its still in the workers control to demand safety if they know about risks.

  4. My point is that WE have to know and understand about risks and to do this more resources are needed. We can not teach or inform without the basic information. Also, I am honestly not sure that worker have much power in this area to demand safety. When Unions were stronger they did but not as much today.