August 20, 2009
The Honorable Margaret A. Hamburg
Commissioner
10903 New Hampshire Ave.
Building 1 Room 2217
Silver Spring, MD 20993-0002
Dear Madam Commissioner,
We are writing to express our concern that the Food and Drug Administration’s (FDA’s) reassessment of the plastics chemical and synthetic estrogen bisphenol A (BPA) appears to be heading toward a repetition of FDA’s previous, roundly criticized work on this issue. The course on which the agency seems to have embarked will do nothing to restore public confidence in FDA. Nor will it demonstrate that the agency puts the health of the public before the interests of BPA manufacturers and users. We respectfully request that you take immediate steps to ensure the integrity of the process, as described below.
BPA contamination of food is of direct and vital interest to all Americans. The Centers for Disease Control and Prevention has found that it contaminates the bodies of nearly the entire U.S. population. In recent years, researchers have linked very low concentrations of BPA to an array of serious disorders, including endocrine system disruption, cancer, compromised brain function, infertility and other reproductive system defects, cardiovascular disease, diabetes and obesity.
The rapidly growing body of science on the dangers of low-dose BPA was a major factor in the U.S. House’s vote on July 30 to require FDA to notify Congress by December 31, 2009, whether or not bisphenol A is safe for infants, children, and pregnant women.
As you know, the agency’s Science Board Subcommittee on bisphenol A characterized FDA’s most recent assessment of BPA toxicity as “not supported by the available data and science.”
On June 2, FDA spokesman Michael Herndon announced that Jesse Goodman, the agency’s Chief Scientist, would take “a fresh look” at the safety of BPA. This was a very welcome signal.
But at the August 17 meeting of the Science Board, FDA staff members made several presentations that were not at all encouraging.
We are particularly troubled that Dr. Mitchell Cheeseman, FDA’s deputy director for the FDA Office of Food Additive Safety, remains in a key position to supervise the agency’s BPA review, despite serious questions about the appropriateness of his communications with the chemical industry on the BPA issue.
On May 16 the Milwaukee Journal-Sentinel published excerpts from FDA emails showing that Cheeseman consulted closely with BPA lobbyists in formulating FDA’s position on BPA, sought advice from the American Chemistry Council (ACC) on how to discredit studies of BPA toxicity and then produced the most recent agency review of the chemical’s safety – an assessment that FDA’s Science Board called “incomplete and unreliable.” (http://www.jsonline.com/watchdog/watchdogreports/45228647.html)
At one point, the Journal-Sentinel reported, Dr. Cheeseman emailed Steven Hentges, head of the ACC BPA group, seeking material that might discredit a soon-to-be-published Japanese research study linking BPA to miscarriages.
“I'd like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study,” Dr. Cheeseman wrote, according to the Journal-Sentinel.
Dr. Cheeseman’s remarks during this week’s Science Board meeting only heightened our concerns. He indicated that FDA continues to rely almost exclusively on two industry-sponsored studies that have dismissed low-dose BPA exposure as harmless. As well, he indicated that FDA is still ignoring the more numerous, and more damning, independent research studies, many of them conducted with funding from the National Institutes of Health, that have found that low doses of BPA compromise the health of laboratory animals, especially those exposed in utero.
Another cause to question FDA’s commitment to an unbiased and transparent review is Dr. Goodman’s disclosure to the Science Board that FDA intends to convene yet another expert panel to review the science related to BPA safety.
In April 2008, FDA announced with much fanfare that it had formed an “agency-wide BPA Task force to facilitate review of current research and new information about BPA.”
Two months later, Dr. Frank Torti, Dr. Goodman’s predecessor as FDA’s chief scientist, asked Science Board chair Barbara J. McNeil to set up a subcommittee of independent scientists to review the in-house task force’s work. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116907.htm)
The Science Board’s BPA subcommittee’s critique, issued last October, was scathing. It received extensive press coverage, as did the full Science Board’s decision to stand behind the subcommittee’s recommendations. (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-index.html)
Associate FDA Commissioner Norris Alderson conceded on major points, in December writing the Science Board that FDA staff would pursue “additional information and analysis.” (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-index.html)
It seems only logical for the Science Board BPA subcommittee, which has invested more than a year in exploring the complexities of the issue, to continue overseeing the agency staff’s progress.
To circumvent this panel by setting up another group, many of whom will likely be less experienced and less knowledgeable on the issue, invites the perception, fair or not, that FDA is actively seeking to avert informed criticism. Some might suggest that the agency appears to be stacking a panel more inclined to supply the answers it wants.
We ask that you take steps to remove Dr. Cheeseman from any work related in any way to BPA, and that instead of convening a new panel to evaluate BPA science, you rely on the current, highly qualified Science Board Subcommittee on Bisphenol A for science reviews related to the chemical.
We appreciate your attention to this issue. Thank you in advance for prompt replies to our questions.
Sincerely,
Richard Wiles
Senior Vice President for Policy
CC: Mitchell Cheeseman, Ph.D., Deputy Director, Office of Food Additive Safety
Jesse Goodman, M.D., M.P.H., Chief Scientist and Deputy Commissioner for Scientific and Medical Programs (Acting)
