BPA Update - Sept 4, 2008
The National Toxicology Program Releases Its Final Report on Bisphenol A.
On September 3, 2008, the National Toxicology Program (NTP) released its final report on bisphenol A (BPA), the building block of polycarbonate. The NTP reached the following conclusions on the possible effects of current exposures to BPA on human development and reproduction. Note that the possible levels of concern are, from lowest to highest, negligible concern, minimal concern, some concern, concern, and serious concern:
1. The NTP has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to BPA.
2. The NTP has minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to BPA.
3. The NTP has negligible concern that exposure of pregnant women to BPA will result in fetal or neonatal mortality, birth defects, or reduced birth weight and growth in their offspring.
4. The NTP has negligible concern that exposure to BPA will cause reproductive effects in non-occupationally exposed adults and minimal concern for workers exposed to higher levels in occupational settings.
5. "There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects," said NTP Associate Director John Bucher, Ph.D. "But we have concluded that the possibility that BPA may affect human development cannot be dismissed."
Commenting on the impact that their findings may have on consumers, NTP's Center for the Evaluation of Risks to Human Reproduction (CERHR) Director Michael Shelby, Ph.D., said, "Unfortunately, it is very difficult to offer advice on how the public should respond to this information. More research is clearly needed to understand exactly how these findings relate to human health and development, but at this point we can't dismiss the possibility that the effects we're seeing in animals may occur in humans. If parents are concerned, they can make the personal choice to reduce exposures of their infants and children to BPA."
The NTP reached the following conclusions on the possible effects of current exposures to bisphenol A on human development and reproduction. Note that the possible levels of concern, from lowest to highest, are negligible concern, minimal concern, some concern, concern, and serious concern.
What is NTP?
NTP is an interagency program of the U.S. Department of Health and Human Services established in 1978. The program was created as a cooperative effort to coordinate toxicology testing programs within the federal government, strengthen the science base in toxicology, develop and validate improved testing methods, and provide information about potentially toxic chemicals to health, regulatory, and research agencies, scientific and medical communities, and the public. The NTP is headquartered at the National Institute of Environmental Health Sciences (NIEHS).
What Role Does the NTP Play in FDA Safety Assessments?
The FDA often uses data and information from the NTP to make safety evaluations of FDA products. Unlike the FDA, the NTP is not a regulatory body. In the case of BPA, the NTP Center for the Evaluation of Risks to Human Reproduction evaluated the available scientific literature on BPA to serve as an environmental health resource for the public, regulatory, health, and research agencies about the potential for exposure to BPA to cause adverse reproductive or developmental effects in people. "We are pleased to see the finalization of the NTP report," noted Frank Torti, M.D., M.P.H., principal deputy commissioner and chief scientist at FDA. "The FDA will consider this final report in our role as a regulatory agency and joins NTP in the call for additional research in this important area."
Source: NTP website/BPA.