Statement from the FDA, from a written communication dated January 29, 2008

The Agency's current position on the presence of BPA impurities in food-contact polymers is as follows. BPA is used in the manufacture of two types of polymers used for food-contact articles (i.e., polycarbonate (PC) polymers and epoxy-based enamels and coatings) and is present at very low levels in the finished food contact materials. Typical uses of PC polymers include food processing equipment, such as popcorn makers, and water and infant baby bottles intended for repeated use. BPA-based epoxy coated cans are used in a variety of canned food and beverage applications, including cans used to hold infant formula. The Agency is aware of several reports stating that BPA has estrogen-like activity. However, there are other reports that appear to dispute any reason to expect harm at the low exposures that humans experience. A March 2007 report from a consumer group included studies showing the levels of BPA found in canned foods and migrating out of PC baby bottles and included claims that these levels are unsafe. FDA scientists have reviewed the available information from this report and have concluded that the BPA levels found in canned foods or migrating out of PC baby bottles are not significantly different than the very low levels previously found by FDA chemists and other laboratories, levels that result in a dietary exposure that is orders of magnitude below the levels known to not cause toxic effects in animals.

The agency has been actively reviewing the safety of BPA and has completed a review of the available data obtained from animal studies, and migration studies. Based on the results of the migration studies conducted by FDA chemists, we have determined that the dietary exposure to BPA is low (3.7 ppb), the level that is orders of magnitude below the levels known to cause toxic effects in animals. Considering the low dietary exposure and the fact that BPA had not demonstrated adverse effects when consumed by animals in amounts of much higher (orders of magnitude) than humans would consume, FDA sees no reason at this time to ban or otherwise restrict the uses now authorized. Our conclusion is based on our ongoing review of all available data. We will continue to monitor data on BPA to determine if its use would raise a safety concern. If such a concern exists, FDA will take the appropriate post-market regulatory action.

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