In the last blog I discussed the client’s expectation that the
risk assessments we do represent our professional certification of the relative
safety of any scenario under consideration. Of course, the
thoughtful reader will then question: What is safe?
The above assumes that the risk assessment will end with a
“happy face”. That is, that the scenario is deemed in the
report to be relatively safe. The reality is that I have
rarely written an assessment that was not so. Most clients do
not want a determination of significant or unacceptable risk
documented. Typically, if the client has committed to doing a
risk assessment then they are committed to either refining the assessment (with
additional testing and data) to the point of allowing a conclusion of safety
(see previous blog) or applying risk management options that choke down the
exposure and reduce the risk to acceptable (or at least not unacceptable)
levels.
Again we are at essentially the same question: What
is safe or at least not unacceptably risky?
One answer to that question is that a “safe” exposure is an
exposure that does not exceed the exposure limit. For the
purpose of this blog we will assume that the exposure limit is
a “bright line” that defines a safe exposure and then look at it from the
exposure end of things. The factors that make up
exposure are not constant and indeed they are quite variable. In
fact, if you look at monitoring data for the same person doing the same job,
the spread in values is quite large and is often described as a lognormal
distribution with a geometric standard deviation (GSD) of 2 or
greater. When we have a GSD of 2, it means that the ratio of
the 84th percentile/50th percentile of this
distribution and the 50th %tile/16th %tile is
equal to 2. Thus, the 84th%tile/16%tile
is 4 fold. That still leaves 32% of the exposures either less than
1/2th or greater than 2x of the median exposure. As
practical example, a measured distribution with a median exposure of 100 and a
GSD of 2 will have 16% of its values below 50 and 16% above 200. If
the exposure limit is 200 then 16% of the time the exposure limit will be
exceeded by the exposure.
Considering such statistics, many in our profession consider an
exposure “safe” or at least in compliance if it does not exceed the exposure
limit greater than 5% of the time. Thus a median exposure of
100 with a GSD 2 would not be considered “safe” given an exposure limit of
200. The median measured exposure would have to be significantly
lower than 100 assuming the GSD remains at 2.
The above is an ideal case, when we have a lot of data and can accurately estimate the actual distribution of exposures.
The above is an ideal case, when we have a lot of data and can accurately estimate the actual distribution of exposures.
Consider what most often is the case. We take a few
samples and if they are below the exposure limit some of us might often declare the situation
safe. For the above example, it should be obvious that
we should do some statistical analysis on the samples we take. IH
STAT was designed to do just that. This important tool for evaluating our
monitored data is available at:
http://www.aiha.org/get-involved/VolunteerGroups/Pages/Exposure-Assessment-Strategies-Committee.aspx
http://www.aiha.org/get-involved/VolunteerGroups/Pages/Exposure-Assessment-Strategies-Committee.aspx
I will cover this important tool in a future blog. It will tell you how good your data really are at predicting exposure and risk.
If you want a very sobering experience. Download the
free app IH DIG (by Adam Geitgey) on your Android
device (available at the Play Store) and see how good you are at predicting the
actual exposure potential using the above criteria of "safe" from a few
measured values. Like I said, it is a very sobering experience.
Modeling exposure has the same issue. If you are
honest about the variables you put into the models you know that they are not
single values but distributions as well. That means that the
model output of estimated exposure is also a distribution of exposures which can
be compared to an exposure limit. Monte Carlo analysis is the best
way to gauge the input distribution and obtain an output distribution of
predicted exposures. Not surprizing, most output distribution appear to be shaped like lognormal curves. I will go over a simple example in a future
blog but the point is that there will almost always be some level of predicted
exposure in these distributions that is above the exposure limit.
So "how safe is safe?” It turns out that it is a
question to be decided by the body politic as a subjective
judgment. I personally think the 5% level of exceedance
mentioned above seems reasonable to me but that is just my opinion. The
point here is that there is almost always some level of predicted exceedance
based on the inherent variability of reality.
I think it is important to let the client in on this game of
uncertainty analysis to show him/her that there is no such thing as absolute
safety only relative safety expressed in terms of uncertainty.
Just to really complicate matters, the above is just the
exposure half. Can we really think that there is no
uncertainty in the toxicity benchmark or exposure limit half as
well? More above this in next week's blog.
Nice post.
ReplyDeleteI would add that for toxins with chronic effects, variability around the mean will be important for compliance but less so for health. On the other hand, with an acutely acting agent, variability around the mean would be important for both.
David,
DeleteGood point. There is a damping effect for toxins with a long half-life in the body such that daily variation is not as critical.