J.C. McElveen, of Jones Day, contributed the following guest post, for which we thank him. He gets the credit for what follows; we’re just the messengers:

In July of this year, the House of Representatives passed a bill called the Food Safety Enhancement Act of 2009 (H.R. 2749). One of the provisions of that bill deals with bisphenol A (BPA), a monomer used in polycarbonate plastics that are used in (among other things) a wide variety of food contact packaging. Section 215 of that bill, as passed by the House of Representatives, directs the Secretary of Health and Human Services to notify Congress, by December 1, 2009:

“a) Whether the available scientific data support a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women and adults for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers, including reusable food and beverage containers, under the conditions of use prescribed in current Food and Drug Administration regulations.
“b) If the Secretary concludes that such a determination cannot be made for any approved use, the Secretary shall notify the Congress of the actions the Secretary intends to take under the Secretary’s authority to regulate food additives to protect the public health.”

Such actions might include:

“a) Revoking or modifying any of the approved uses of bisphenol A in food and beverage containers, and
“b) Ensuring that the public is sufficiently informed of such determination and the steps the public may take in response to such determination.”

The standard by which the Secretary of Health and Human Services (i.e., the FDA) is to make its determination of the safety of BPA is the “reasonable certainty of no harm” standard which has long been the standard used for approval of food and color additives, and which replaced the Delaney Clause as the safety standard for additives to processed foods in the Food Quality Protection Act of 1996 (P.L. 104–170). By specifying, as the House did, that the determination of “a reasonable certainty of no harm” include a determination as to infants, young children and pregnant women, the House essentially mandated that the determination utilize the additional (usually 10–fold) safety factor for sensitive subpopulations (though that would presumably have been done anyway, because BPA is used in products that infants use, such as baby bottles).

It is interesting that the chemical singled out by the House – BPA – is a so–called “endocrine disruptor,” because it was in the last major overhaul of the food safety laws, the Food Quality Protection Act of 1996 (P.L. 104–170), that Congress mandated that the FDA (and the EPA, for pesticides) consider the potential increased sensitivity of infants and children in its risk assessment processes, and required that a screening program be instituted for chemicals, to determine the nature and extent of endocrine system disruption, by those chemicals.

Although there are a number of so–called “endocrine disruptors,” BPA seems to have become one of the major rallying points for both sides of the debate on the potential hazards of these chemicals with purported estrogenic effects. Allegations exist regarding the “lack of reproducibility” of certain studies which purportedly show adverse effects of BPA in animals, and allegations are made about the “lack of believability” of studies which are funded by industry. Examples of allegations about the quality of the science include: vom Saal, F. and Hughes, C. “An Extensive New Literature Concerning Low–Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment,” Environ. Health Perspect. 2005; 113(8):926–933; Politch, J.A “Bisphenol A and Risk Assessment,” Environ. Health Perspect. 2005; 114 (1):A16; vom Saal “Bisphenol A: vom Saal and Hughes Respond,” Environ. Health Perspect. 2006; 114(1):A16–A17.

More recent studies have looked at endpoints that are not traditional endpoints considered in risk assessments, such as inhibition of adiponectin release in vitro (Environ. Health Perspect. 2008; 116(12):1642–1647) and the induction of preneoplastic lesions in rats (Environ. Health Perspect. 2007; 115(1):80–86).

The National Toxicology Program (NTP) uses a five-level scale of concern about the potential adverse effects of exposures to chemicals. The five levels are:

Negligible Concern
Minimal Concern
Some Concern
Serious Concern

Very recently, the NTP (and its expert panel) made the following statement:

“In the case of BPA, the NTP and our expert panel expressed ‘some concern’ for potential exposures to the fetus, infants and children [for effects in the brain, behavior and prostate gland]. There are insufficient data from studies in humans to reach a conclusion on reproductive and developmental hazards presented by current exposures to bisphenol A, but there is limited evidence of developmental changes occurring in some animal studies at doses that are experienced by humans. It is uncertain if similar changes would occur in humans but the possibility of adverse health effects cannot be dismissed.”

National Institute of Environmental Health Sciences (NEIHS): Since You Asked – Bisphenol A.

So, what does that mean? Even though the above-mentioned web site is directed to the general public, is this enough for the FDA to have to say that it cannot be said that there is “a reasonable certainty that no harm will result” from the “approved use” of BPA? Or is the FDA entitled to rely on its more traditional methods of assessing risk?

In the final analysis, although Congress has periodically singled out specific chemicals, in legislation, for some type of executive agency action, that is not a very efficient way of regulating chemicals. So, the bisphenol A provision, which is not in the current Senate Food Safety bill (S. 510), may not end up becoming law. Stay tuned.


Thanks, and a tip of the cyber hat to John Dubeck, of Keller and Heckman, who pointed out I may have confused some readers with a reference to the Food Quality Protection Act of 1996, in my discussion regarding bisphenol A. Bisphenol A is obviously not a pesticide, so a more correct (and, in fact, concise) statement in the post would have been : “The standard by which the Secretary of Health and Human Services (i,e., the FDA) is to make its determination of the safety of BPA is the “reasonable certainty of no harm” standard, which has long been the standard used for approval of food and color additives.” Period.