The Bisphenol A Saga Continues

The current stance of the U.S. Food and Drug Administration (FDA) is that, while the Agency sees the results of some novel studies as providing "a reason for some concern about the potential effects of bisphenol A (BPA)" on fetuses, infants, and children, it does not recommend a change to infant formula or foods, having determined that a stable source of good nutrition outweighs the risks of BPA exposure.^[1] Its counterpart in Europe, the European Food Safety Authority (EFSA), has gone further, concluding that existing exposures to bisphenol A (BPA) when used in food packaging do not pose a health or safety threat to the population as a whole or to infants and children in particular.^[2] Nonetheless, state and local authorities in the U.S. and some international governments continue to implement legislation restricting or banning its use in these applications.

BPA is a monomer used in the synthesis of epoxy-type coatings that line the interior of metal cans to prevent interaction between the can and the packaged food. It is also a building block for polycarbonate, a durable plastic used in certain bottles and other food containers, as well as in a number of consumer goods ranging from compact disc cases to dental devices.

The States Act

While the provisions of the various state laws differ in some respects, the laws enacted thus far generally address the use of BPA in polycarbonate baby bottles and other articles intended for use by children three years of age or younger. They by and large have left alone coatings for food cans, mainly because there are no proven substitutes that appear to be as effective.

For example, last October, California adopted the Toxin-Free Infants and Toddlers Act,^[3] joining ten other states that impose restrictions on the use of BPA in food contact materials. The California law mandates that "[o]n and after July 1, 2013, no person shall manufacture, sell, or distribute in commerce any bottle or cup that contains bisphenol A at a detectable level above 0.1 part per billion (ppb), if the bottle or cup is designed or intended to be filled with any liquid, food, or beverage intended primarily for consumption from that bottle or cup by children three years of age or younger."^[4]The California measure—like similar legislation adopted in Delaware, Maryland, Minnesota, New York, Massachusetts, and Washington—was borne out of concerns over potential developmental harms to sensitive populations that may result from dietary exposure to BPA, even at very low levels.

The surprising thing is that such laws are being enacted even though polycarbonate manufacturers have voluntarily withdrawn from the polycarbonate baby bottle and children's products markets in response to increasing public pressure, which was voiced effectively by the manufacturers' retail customers. Indeed, the American Chemistry Council (ACC) last fall petitioned FDA to amend the agency's food additive regulation that authorizes polycarbonate in food packaging applications on the basis that such uses of the additive have been abandoned, among other reasons.^[5] Specifically, ACC asked FDA to narrow the scope of uses for polycarbonate resins to exclude infant feeding bottles and spill-proof cups designed to help babies drink (so-called "sippy cups") from the type of applications authorized under the regulation.^[6]

The petition focuses on current trends among polycarbonate manufacturers given the current legislative landscape, rather than issues of public safety, acknowledging that "all major manufacturers have abandoned the use of polycarbonate resins in baby bottles and sippy cups."^[7] ACC's stated intent is to ensure that FDA's regulations remain in line with measures that have been implemented in Europe, Canada, and China, stressing that the ACC proposal to FDA on behalf of the polycarbonate industry is "not based on [new] scientific evidence or [concerns about] safety."^[8]

In contrast to the polycarbonate situation, can makers do not have the option of voluntarily replacing BPA-based coatings with other products, even if it were justified on health or safety grounds. Can linings are complex formulations of often numerous different resins that are cured to form a finished coating. Years of testing are necessary to qualify new coating formulations. The canned food industry has not accepted any non-BPA based coatings as having been proven as effective at ensuring the safety of packaged food or beverages.

Meanwhile, in Europe

Certain legislatures are convinced BPA's harm outweighs its utility, even in cans. The French National Assembly passed a bill that would prohibit the use of BPA in all food packaging by 2014.^[9] The measure received public support by the French Health Minister after the release of a report by the French Food Agency, ANSES, expressing concerns over the potential health risks associated with BPA exposure.^[10] If signed into law, France would become the first country to ban the use of BPA in all food contact materials.

The legislation that has been proposed in France is based on the notion that any dietary intake of BPA is harmful; however, controversy surrounds the testing methods that were used to reach this conclusion. Another recently released study, which was funded and conducted by FDA, stands in contrast to the ANSES report, indicating that low levels of dietary exposure to BPA do not cause harmful effects in animals. The FDA study examined developmental markers such as behavior and hormone levels, and for the first time also assessed neurobehavioral changes such as birth and body weight.^[11] The researchers concluded that neither mothers nor their pups was affected by the levels of BPA exposure evaluated in the study.^[12]

EFSA considered the French report late last year and found that it did not warrant a shift in the agency's view of BPA expressed in 2010.^[13] EFSA cited limited research as one potential explanation for why the groups reached different conclusions. EFSA's 2010 opinion on BPA is based on a full risk assessment of the chemical taking into account lifetime exposure for all human populations, while the work done by ANSES was limited to hazard identification.^[14] EFSA reiterated that the tolerable daily intake (TDI) for BPA set in 2006 of 0.05 mg BPA per kg body weight was established to protect all human populations, including sensitive sub-populations such as pregnant and lactating women, infants, and young children.^[15]

EFSA also pointed out that ANSES' conclusions were based in part on data developed from exposure to BPA through non-oral routes.^[16] The concern designed to be addressed by the various laws banning BPA in food packaging is one of safety through ingestion. In principle, safety determinations should be based on the most relevant data taking into account routes of exposure that mimic the end use applications being implicated.

The saga continues. And it likely will do so for a while. EFSA intends to reconsider BPA this year once additional studies at FDA are completed and the data are available. FDA is compelled to consider the issue even before then. The agency agreed in December to respond to a lawsuit filed by the Natural Resources Defense Council seeking to withdraw all existing clearances for BPA in food packaging.^[17] FDA says that it intends to issue a final decision by March 31, 2012.