FDA Requests BPA Info; BPA Science Review Released
The Food and Drug Administration is requesting assistance in the identification of types
of FDA-regulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the possible leaching of BPA from the packaging to the product and/or from the product from the product following human administration.
BPA is a chemical commodity used primarily in the production of polycarbonate plastics and epoxy resins. Such plastics and resins have many valuable applications, including as components of
packaging for food and drink, and as components of certain medical products and their packaging. Consequently, low levels of residual BPA may be present in such products. On April 14, 2008, the
National Toxicology Program (NTP) released a draft brief on BPA for public comment and peer review. MassTortDefense posted about that. The NTP draft brief raised some possible concerns that exposure to BPA could be linked to developmental problems of the endocrine system in infants and young children. The NTP draft brief also contains an exposure estimate to BPA for infants and young children due to leaching of BPA to food from plastic baby bottles and the linings of certain baby food containers. NTP has subsequently released a final report on BPA on September 3, 2008.
In response to the NTP draft brief, FDA Commissioner von Eschenbach convened an agency-wide task force to facilitate cross-agency review of current research and new information on BPA for all FDA-regulated products. The review will include the NTP brief and all other available information on the exposure of US consumers to BPA from FDA-regulated products.
During the course of this process the task force has been making an inventory of all FDA-regulated products that are known to contain BPA. The task force has already completed a thorough
assessment of the potential exposure to BPA due to leaching from food-contact materials and is now expressing interest in additional information on other types of products, specifically medical devices, biological products (including blood, blood products, vaccines, and cell and gene therapies, and drugs.
For devices, in particular, FDA is asking about:
- The rate and extent of BPA release from devices under clinically relevant extraction conditions.
- What conditions affect the release and leaching of BPA?
- Estimates of patient exposure to BPA from use of the device.
- Possible alternatives to BPA and any associated risks.
In other BPA news, to address the “low-dose” issues that have been raised in some quarters, the Harvard Center for Risk Analysis convened a panel of scientific experts to critically review the relevant low-dose BPA studies of reproductive and developmental effects. In 2004, the Harvard Panel “found no consistent affirmative evidence of low-dose BPA effects for any endpoint.” In 2006, the Gradient Corp. consulting group organized and participated in an expert scientific panel that conducted an updated weight-of-evidence evaluation, looking at articles published since the Harvard review and using the same methodology as the Harvard Panel.
This year, Gradient conducted yet another expert scientific panel review, again using the same methodology as the Harvard Panel, and including literature published through July, 2008. The effort was funded by the Polycarbonate/BPA Global Group and the panel’s report has been published in the peer-reviewed journal, Critical Reviews in Toxicology (Goodman et al., Weight-of-evidence evaluation of reproductive and developmental effects of low doses of bisphenol A, Critical Reviews in Toxicology, 2008). The findings of all three reviews were consistent with one another and with reviews conducted by most government bodies worldwide. As concluded overall, “The weight of evidence does not support the hypothesis that low oral doses of BPA adversely affect human reproductive and developmental health.”
