FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report

We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.

The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.

The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.

Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.

Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.

Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.

For a copy of the Subcommittee Report, go to:
http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.

Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H.

"The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option."

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FDA’s Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A

As part of an ongoing effort, a subcommittee of the FDA's Science Board will hold a public meeting on the safety of bisphenol-A (BPA) in plastics, review an Agency Task Force report on the topic, and deliver its findings to the Board's annual meeting this fall.

Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.

In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA. "The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products," said Torti.

Following this review, the Task Force will make recommendations to Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA has been reviewing emerging literature on BPA on a continuous basis for years and its Center for Food Safety and Applied Nutrition initiated a formal reexamination of the safety of BPA in early 2007. In April 2008, the National Toxicology Program (NTP) of the National Institutes of Health published a Draft Brief indicating that some studies in animals suggest that BPA may raise concerns for developmental effects in humans. The NTP is collecting public comments on the draft and has scheduled a June 11 peer review meeting for its Draft Brief.

In the Draft Brief, NTP stated that, based on animal studies, it had "some concern" for neural and behavioral effects in fetuses, infants, and children at current human exposures, and also had "some concern" for exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females.

In addition to the NTP's Draft Brief on BPA, the FDA Task Force is reviewing available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide.

Water Bottle Safety a Concern

The safety of plastic water bottles continues to rise as an issue of concern to consumers. A University of Georgia expert says the key lies in using the right plastics the right way and keeping your water bottles sanitized.

“The FDA regulates materials and substances used for plastic packaging for water bottles as indirect food additives,” said Elizabeth Andress, a UGA Cooperative Extension food safety specialist. They “assess the migration potential of plastics and the substances with which they are made.”

"One of the common concerns surrounding plastic water bottles is whether or not the chemicals can migrate from the plastic into the water. Although convenience-size pre-filled plastic water bottles are made for single use, they are tested for both single and repeated use," Andress said. "These pre-filled bottles are made from PET plastic, a kind of polyethylene," she said.

Lately, Andress has heard concerns that focus on polycarbonate plastic, a hard plastic that is designed for repeated daily use. These concerns also focus on whether or not chemicals can migrate from the plastic into water or other liquids stored in the bottles.

“There’s still not scientific evidence to disallow the use of this plastic,” she said. “Even the amount of leaching that can occur is not agreed upon. And, it would seem, if it occurs, to be well below acceptable levels.”

In freezer, use plastics designed for freezing

Other plastic bottle concerns focus on whether the bottles should be used in the freezer. Again, Andress said, studies in this area are not yet conclusive.

“We would not automatically expect freezing to cause a problem unless the plastic itself goes through some breakdown,” she said. “But repeated freezing and thawing of plastic not intended to be used that way could lead to structural breakdown.”

"Until research studies determine an actual health risk related to plastic water bottles, there are ways to reduce your family’s health risks," she said.

Although pre-filled water bottles in the grocery stores and vending machines are not deemed chemically unsafe if used repeatedly, they are not intended to last structurally through prolonged re-use.

Use pre-filled bottles once

Andress discourages repeated use of these bottles. Above all, she recommends using plastic bottles only as the manufacturer intended.

If you do choose to buy and use a polycarbonate plastic bottle for water and other liquids, Andress says to take steps to reduce any microbiological risks. Wash the bottle with warm soapy water every day. Use a clean bottle brush to clean in and around the bottle neck. Scrub the lids with a bottle brush, too. Rinse well and allow the bottle and lid to air dry.

By Allie Byrd
University of Georgia

Allie Byrd is a student writer with the University of Georgia College of Agricultural and Environmental Sciences.