SPSG #11: The Technocracide

Since it kills the Safety Assessment Paradigm every time, it has always been very clear that arsenic would never make it as a food additive. Although arsenic commonly occurs in food as a contaminant, the concern for arsenic in food was always mitigated by the fact that the largest exposures have generally been from drinking water. That equation changed in 2001, when the EPA passed a regulation for arsenic in drinking water that changed that equation. Because the drinking water rule required a cost-benefit analysis, the decision process was supported by a risk assessment that produced risk estimates; in spite of the guidelines, it was consistent with the risk assessment paradigm. However, the Office of Water did find it necessary to hire outside consultants to accomplish that goal. In any case, arsenic exposure from water was reduced and arsenic in food became a relatively bigger issue as a result. As a result of public attention in 2011, the FDA issued guidance "action" levels for arsenic in apple juice in 2013 and rice in infant foods in 2016. From a risk management standpoint, both efforts were abject failures. Although risk assessments were produced, they didn't really support the guidance in either case. At least part of the reason is that setting levels usually isn't an effective way to manage risks from contaminants. Preventing something from getting into the food in the first place can be far easier, but that isn't always possible. Nonetheless, the FDA went ahead anyway with action levels anyway. In the case of apple juice, it isn't too hard to figure out why; the FDA commissioner publicly promised an action level before the risk assessment was done. The reasoning that went into the rice guidance is more mysterious. Even though there is nothing in the risk assessment to indicate that they are uniquely susceptible to arsenic, the FDA advised both infants and pregnant women to reduce their rice intake, but gave no advice for anyone else. In fact, the exposure assessment indicated that the greatest exposures to arsenic from rice are in adult males. On a more positive note, the FDA cancer risk assessments for both apple juice and rice solved the default option problem by using probability trees to represent the theoretical probability associated with the dose-response relationship for arsenic and both lung and bladder cancer. The main lesson to be learned from those exercises is that regardless of how well an assessment represents current science, if the message takes precedence over the result, there will be no reason to expect public health to improve.