FDA Statement on Bisphenol-A and Microwaving Food

The Food and Drug Administration (FDA) is actively reviewing the safety of bisphenol-A. FDA has recently completed a review of the available pharmacokinetic data and several animal studies, including two recently completed multigeneration reproductive studies (one in the rat and one in the mouse).

These multigeneration reproductive studies, which were completed per regulatory guidelines and included some developmental endpoints as well as a wide range of doses, do not indicate a safety concern at the current exposure level for infants or adults. We will continue to monitor data on BPA to determine if a safety concern exists. If such a concern exists, FDA will take the appropriate post-market regulatory action.

Considering all the evidence, including the very low dietary exposure to BPA (3.7 ppb) based on measurements by FDA chemists of levels found in canned foods or migrating from baby bottles, and the fact that bisphenol-A has not demonstrated adverse effects when consumed by animals in amounts far higher (orders of magnitude) than humans would consume, FDA sees no reason at this time to ban or otherwise restrict the uses now authorized.

FDA 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.

FDA POSITION ON MICROWAVING FOOD

FDA evaluates plastics for their safety in contact with food by extracting them with simulating solvents at temperatures representative of use temperatures. The most important variables are food type (aqueous, fatty or dry), temperature and time. Approvals would not be specific to microwaves but may specify holding food during cooking. Generally, microwave cooking takes less time and the highest temperature reached would be the temperature of the food, boiling water being the highest except, possibly, microwave popcorn. Water and a fat stimulant would be used to extract the plastic as measurements can be more sensitive in the absence of a complex food matrix.

Estimates are made of a person's daily intake based on how much food is likely to contact the plastic, and how much substance is extracted into the simulating solvents. As the estimated intake increases, the requirements for toxicity testing increase. A safety factor is applied to ensure that human intake is far below amounts that have no effect on laboratory animals (at least 100 times lower and sometimes 1000 or more times lower, depending on the specific animal tests.

Amounts of packaging getting into food will always be far below levels that could have acute effects but are geared to look for effects from lifetime consumption. Toxicity data required range from a low of a general profile for minor exposure to 90 testing in two species and up to lifetime animal testing in two species. The 100 fold safety factor is used when lifetime data are available.