Bisphenol-A: The Role of the Citizen

U.S. Food and Drug Administration Bisphenol-A Policy

            In 1976, with the passage of the Toxic Substances Control Act (TSCA), the first U.S. law was created to regulate industrial chemicals.  This law “grandfathered” in some 62,000 chemicals, one of which was BPA.  These chemicals were presumed to be safe by the Environmental Protection Agency (EPA) regardless of the fact that no scientific research was undergone to assure the safety of these chemicals.  This law continues to be used to this day with only a few amendments being made in its 30-year history.  Since the inception of TSCA, the U.S. EPA has never used its authority to ban a chemical and has only formally regulated five different chemicals.[1]

            Over thirty years after the inception of the TSCA, FDA policy regarding BPA has not changed. Between 1982 and today, hundreds of studies have been conducted by the government, the industry, and independent researchers with many contradictory results.  Currently, around 200 total BPA studies have been conducted, and, out of these studies, 90% of research done outside of the industry has found adverse effects in animals from BPA exposure at and below current human BPA exposure levels.  However, 100% of industry funded studies found no adverse effects in animals from BPA exposure at current human exposure levels.[2]

            While the BPA research conducted over the last few decades is far from conclusive, over the last few years, the numbers of studies showing adverse health effects from BPA have overtaken those that give support BPA.  As this research began piling up, citizen watchdog organizations expressed outrage over the FDA’s continued support of BPA and began voicing their concerns to citizens.  Still, the most recently released FDA statement on BPA shows no shift in federal BPA policy.  On November 2, 2007, the FDA reaffirmed the safety of BPA but will continue “actively reviewing the safety of bisphenol-A.”  The FDA stated it based its most recent stance on a recently completed review of the available data and several animal studies.  It stated its research tests for adverse effects at all dosage levels, including very small ones, and “does not indicate a safety concern at the current exposure level for infants or adults.”[3]  

            In this most recent decision not to part with its past BPA policy, the FDA came to its conclusions by 1) looking at its own 1990s studies that determined current human exposure levels and then 2) compared these levels with two studies conducted that determined the level of BPA at which adverse effects occurred in animals.[4]  There is no controversy around whether or not BPA-laden products leach BPA – this is known to be true – ;  rather, the controversy lies around the levels at which BPA causes adverse health effects.  This recent federal stance on BPA ignored many independent scientists’ research demonstrating the levels at which BPA causes health effects.  This omission of comprehensive research incited increased outrage and criticism in watchdog groups and independent researchers – so much so that that Congress has been forced to take notice.

Congress Takes Action

            Beginning January 17, 2008, the U.S. House of Representatives’ Committee on Energy and Commerce began its inquiry into FDA bisphenol-a policy.  Chairman of the committee, John D. Dingell, began by sending letters to seven major infant formula manufacturers and to FDA Commissioner Dr. Andrew von Eschenbach in regard to the use of BPA in products intended for use by infants and toddlers.  The infant manufacturers replied that they did not do their own testing of BPA levels in infant formula; however, their use of BPA is in align with FDA standards and regulations. [5]

            The FDA’s response to Rep. Dingell’s requests revealed for the first time that the basis for its current stance is based solely on two studies both sponsored by the American Plastics Council.[6]  The American Plastics Council is a major trade association for the U.S. plastics industry that works to promote the benefits of plastic and the plastic industry.[7]  However, the Chicago Tribune quoted deputy director of the FDA’s office of food additive safety saying that the agency is not biased towards industry.  “The fact is, it's industry's responsibility to demonstrate the safety of their products," he said. "The fact that industry generated the data to support the safety I don't think is an unusual thing."[8]  However, Frederick vom Saal of the University of Missouri reported in 2005 that 90% of independent studies found adverse effects in animals from BPA at low doses while all studies funded by the industry found no problems with BPA at current exposure levels.  Furthermore, one of the two studies was not made public, thus, it was not subject to the standard peer review process that all studies must go through before gaining credibility and legitimacy.[9]  Furthermore, restricting access to this study leaves watchdog groups and citizens powerless to critique the science behind the FDA’s policy.

            Additionally, one of these studies is mired in further controversy for design flaws.  Brought to light by independent researchers, one study used a special breed of rat, Sprague-Dawley, that is only responsive to estrogen at very high doses.[10]  This is significant because since BPA is a synthetic estrogen, rats used in this study would likely be much less responsive to or unaffected by doses of BPA that would affect humans who are indeed sensitive to the hormone estrogen.

Science for Sale

            As an additional part of Rep. John Dingell’s investigation, he sent a letter to the Weinberg Group inquiring about the organization’s involvement in the BPA debate.   This company has worked on defending products linked to health hazards such as Agent Orange, Teflon, hair-dying products, and tobacco and describes itself as a company that it will “harness, focus, and involve the scientific and intellectual capital of our company with one goal in mind – creating the outcome our client desires.” However, Rep. Dingell doubts “whether such outcomes will be congruent with the available scientific evidence.”[11]  The Chicago Tribune quotes Dingell as stating, "The tactics apparently employed by the Weinberg Group raise serious questions about whether science is for sale at these consulting groups, and the effect this faulty science might have on the public health."[12]  Furthermore, congressional investigators say the Weinberg Group was hired by the BPA manufacturer Sunoco.[13]  Given that the FDA admits to relying on the industry to supply the research used for policy decisions, the involvement of the Weinberg Group in industry research is unsettling to say the least.

The Future of BPA Policy

            However, changes in the FDA’s policy on BPA could be realized in the near future.  In a recent landmark decision, the U.S. National Toxicology Program (NTP) (a subsidiary of the National Institutes of Health) released evaluations that went against earlier findings declaring for the first time that some concern exists around effects of BPA on human development, especially for developing fetuses, infants, and children.[14]   This April 16, 2008 decision flies in the face of current FDA policy, and Rep. John Dingell has used the NTP’s recent conclusions to call for the FDA to change its BPA policy.[15]  In response to the NTP’s findings, scientists and private citizens were given a chance to weight in through a public comments period.  After the NTP’s initial finding, public comments were scarce and primarily from the industry.  However, as the NTP has continued to reevaluate BPA, public comments have become much more numerous as scientists and private citizens alike have begun weighing in on the debate and calling for BPA policy change.[16]

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