Protection

The Science-Policy Shell Game

The game is played like this:

• Before a technical audience, a proposition is presented as a matter of public policy.
• Before the public, the same proposition is presented as a scientific fact.

Every shell game needs a ball.  In this game, the ball is uncertainty.   

Since it relies on having distinct technical and political audiences, the form of sophistry underlying the science-policy shell game could not have flourished to the extent that is has prior to the last century.  However, tacking on a moral imperative to a mathematical or factual argument is not new; that was a staple of the 16th century doctrine of probabilsm, and Hume's is to ought problem is an 18th century example.  But, frontloading a scientific argument with a moral premise is a more modern  trick.  As a prime example, consider the EPA Reference Dose.

Ought To Is: The Acceptable Daily Intake Becomes the Reference Dose

The safety assessment procedure developed in the 1950’s for the regulation of food additives and pesticides by both the US Food and Drug Administration and the World Health Organization began innocently enough.  The process was quite simple; the Acceptable Daily Intake (ADI) was calculated by applying a safety of 100 to an exposure (or dose) that resulted in no measurable or observable effect in an experiment with laboratory animals. 

In its initial formulation (Lehman and Fitzhugh, 1954), the ADI was clearly articulated as an instrument of regulatory policy, where a moral argument was butressed with some scietific facts:

The “100-fold margin of safety” is a good target but not an absolute yardstick as a measure of safety.  There are no scientific or mathematical means by which we can arrive at an absolute value.  However, this factor of 100 appears to be high enough to reduce the hazard of food additives to a minimum and at the same time allow the use of some chemicals which are necessary in food production or processing.

But, over the next 20 years, the concept of “no observed effect” came to be thought of as an “observed no effect” or a threshold dose at which no effect occurs.  Whether it was intentional or not, this gave birth to the shell game.  It was probably semi-intentional.  Even though it is surely a fairy tale, it would be nice to think that science actually could identify a level that has absolutely no effect.  The concept of a threshold also gave the ADI the semblance of a scientific fact, which happily absolved the regulatory toxicologist from the appearance of passing a moral judgment of what will be considered acceptable by the government (Wagner, 1995). 

When the pesticide program left the FDA in 1971 to join the EPA, the ADI went with it.  There, it came to be used for programs other than pesticide regulation.    Even though the interplay between scientific jargon and political rhetoric began before the EPA was ever formed, at the U.S. EPA in the 1980’s the shell game was deliberately institutionalized. Under pressure from agency management to adopt the guidelines set forth for carcinogen risk assessment (NRC, 1983), a committee of agency toxicologists at the EPA responded with scientific jargon (Barnes and Dourson, 1988): 

In practice, the ADI is viewed by many (including risk managers) as an "acceptable" level of exposure, and, by inference, any exposure greater than the ADI is seen as "unacceptable." This strict demarcation between what is "acceptable" and what is "unacceptable" is contrary to the views of most toxicologists, who typically interpret the ADI as a relatively crude estimate of a level of chronic exposure which is not likely to result in adverse effects to humans.

The “many (including risk managers)” refers to the traditional (i.e. Lehman and Fitzhugh) view of the USFDA.  On the other hand, the “most toxicologists” refers to the members the EPA committee, who then proceeded reinforce their claim of scientific factuality by replacing the terminology associated with the ADI:

• The ADI became the Reference Dose (RfD)
• Safety assessment became risk assessment
• Safety factors became uncertainty factors

The primary reason for this change in terminology is that, contrary to the intent of the 1983 NRC "Redbook" report, the agency toxicologists wanted to keep the decision making process out of the hands of agency decision makers.  I know this because they told me.  I’m sure they thought that I would agree that it was a good thing to do.  However, since I figured public disinformation would lead to a less well informed government, I didn’t think lab cloaking regulatory policy was a very good idea.  That has certainly proven to be true.  However, I didn’t see the other consequence: Political rhetoric disguised as science will choke out actual scientific dialog.  Now, I understand that really well.

The Protection Racket

Institutionalization of the science-policy shell game is not unlike founding a religion.  Soon after I joined the FDA a little over 25 years ago, I had a conversation the Director of the Office of Toxicology about the ADI.  I expressed my concern over the ability of toxicology to identify a threshold where no effect occurs.  Not realizing that I was attempting to turn to clock back 35 years, I also suggested that perhaps that the ADI should be considered as a “practical threshold” where even if there is a risk, the agency will consider it to be negligible.  The response, delivered as a statement of faith: “I believe in practical thresholds”. 

A generation after the founding of RfDeontology, many followers truly believe that the RfD separates heaven from hell.  An industry consultant or right-leaning agency toxicologist like my former office director can use the ADI or the RfD to argue that everything is just fine; we are safe.  But, those on the left have also discovered that the RfD can also be used to argue that a particular exposure is unsafe without ever identifying what the risk actually is.  In fact, the RfD has come to be synonymous with “protection”.  If your exposure is below the RfD, then you are Environmentally Protected.  If it isn’t, then you aren’t.  Do what we say, eat what we tell you eat, and you are protected.  Otherwise, you are on your own
.

The RfD is so simple anyone can misunderstand it.  Most of the new generation of Protectors and Protectees are not toxicologists or even scientists.  Not only do they believe that, as EPA claims, that the threshold concept is necessary for the application of RfD methodology, they may also believe that the RfD itself is the threshold, even though the written gospel says otherwise (Barnes and Dourson, 1988):

 In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

The RfD is useful as a reference point from which to gauge the potential effects of the chemical at other doses. Usually, doses less than the RfD are not likely to be associated with adverse health risks, and are therefore less likely to be of regulatory concern. As the frequency and/or magnitude of the exposures exceeding the RfD increase, the probability of adverse effects in a human population increases. However, it should not be categorically concluded that all doses below the RfD are "acceptable" (or will be risk-free) and that all doses in excess of the RfD are "unacceptable" (or will result in adverse effects).

Really, the confusion is quite understandable.  When an agency uses the RfD as the basis for a regulation, and they do, “below the RfD” does indeed mean acceptable to the agency, while “above the RfD” means unacceptable to the agency.  Ought To Is To Ought: The shell game can drive a country crazy.

References

Barnes DG and Dourson ML (1988).  Reference Dose (RfD): Description and Use in Health Risk Assessments.  Regul Pharmacol Toxicol 8:471-486.  Also at http://www.epa.gov/IRIS/rfd.htm

Lehman AJ and Fitzhugh OG (1954).  100-Fold Margin of Safety.  Quarterly Bulletin of the Association of Food and Drug Officials 18:33-35.

National Research Council (1983).  Risk Assessment in the Federal Government. National Academy Press, Washington, DC. 

Wagner WE (1995). The science charade in toxic risk regulation, Columbia Law Review 95:1613-1720.

Official Post Soundtrack

Williams, Lucinda (2014).  Protection.  In: Down Where the Spirit Meets the Bone.  Disc 1, Track 2.

Post Note

Thesis Post #23.  This is the first post in the Shell Game thread, which is where the promised "political commentary" will be found.  

The soundtrack is especially noteworthy.  I have written many versions of the shell game story over the last 20 years, but this one I wrote with "Protection" playing in the background. I thought about putting the song in the reference list, but instead decided on making it the sound track instead, which put the idea in my head that all the posts should have soundtracks.