Arlyn G. Riskind
Director, Media Relations
Phone: (301) 941-0240; Cell: (202) 431-9495
Email: ariskind@endo-society.org

Aaron Lohr
Manager, Media Relations
Phone: (240) 482-1380
Email: alohr@endo-society.org

 

THE ENDOCRINE SOCIETY SUPPORTS FDA SCIENCE BOARD'S ACTIONS ON BISPHENOL A

Subcommittee established to review FDA's draft assessment of Bisphenol A for use in food contact applications

WASHINGTON, DC—Today, as the U.S. Food and Drug Administration's (FDA) Science Board formally accepted the findings of its Subcommittee on Bisphenol A(BPA) regarding the FDA Draft Assessment of Bisphenol-A for Use in Food Contact Applications, The Endocrine Society supports the findings and recommendations presented in the Subcommittee's report. 

Increasing public concern and media attention surrounding the safety of BPA led the FDA to examine the risk posed by the presence of BPA in food containers, focusing on exposure of infants.  The Subcommittee was established to perform scientific peer-review of the FDA's draft assessment.

The purpose of the Subcommittee was to provide advice and make preliminary recommendations regarding the FDA draft assessment for subsequent action by the full Board. The Subcommittee identified several significant concerns with the Assessment in its current form.

The Endocrine Society emphasizes the following points made in the Subcommittee report:

·         The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment. Specifically, the Subcommittee does not agree that the large number of non-GLP [Good Laboratory Practices] studies should be excluded from use in the safety assessment. … The draft lacks a clear description of the criteria for eliminating an increasing number of non-GLP studies that indicate the possibility of toxic effects that are not mediated by interaction of BPA with the estrogen receptor, and the Subcommittee does not agree with the exclusion of the non-GLP studies in the safety assessment.

·         Consistent and credible criteria for study inclusion, recommended by the Subcommittee, would be to use those studies that are judged as "adequate" by CERHR [Center for the Evaluation of Risks to Human Reproduction] in the FDA hazard, dose-response and safety assessment of BPA. In addition, several studies of effects of BPA on adult humans and animal species that were published after the draft assessment was finished should be considered for inclusion in the final assessment.

·         The weight-of-the-evidence, including studies identified by CERHR as adequate and having utility, provides scientific support for use of a point of departure substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment.

"While The Endocrine Society supports the FDA's continuing efforts to evaluate the safety of BPA, it is concerned that policy on BPA and other endocrine disrupting chemicals is being developed that doesn't consider the weight of all the available data," stated Society President Robert M. Carey, M.D., M.A.C.P. "We are especially concerned that low-dose studies examining important endocrinological endpoints have been excluded from the FDA's draft assessment of risk."

President Carey went on to say, "Many of the excluded endocrinological studies of low-dose effects are well designed, heavily reviewed, NIH-funded work.  This research is among the best in the world and many of the results indicate effects at exposures substantially lower than those deemed safe in the FDA's draft assessment."

 

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Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.