FDA Political Interference with BPA Science

Matt Shudtz

May 22, 2009

The Milwaukee Journal-Sentinel continued its impressive BPA reporting Sunday with disturbing revelations about former FDA political appointees’ utter disregard for the agency’s career scientists. Using the Freedom of Information Act, the Journal-Sentinel uncovered e-mails showing that high-level officials went to industry lobbyists for advice about new research on bisphenol A (BPA) before asking FDA career staff.

In one instance, the U.S. Food and Drug Administration's deputy director sought information from the BPA industry's chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.

"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," Mitchell Cheeseman, deputy director of the FDA's center for food safety and applied nutrition, said in an e-mail seeking advice from Steven Hentges, executive director of the trade association's BPA group.

BPA is a chemical used to make clear and rigid plastics – everything from water bottles to dental fillings to DVDs. Its ubiquity in commerce translates to pervasive levels of human exposure: it is found in the urine of 93 percent of Americans. Unfortunately for that 93 percent of us, BPA is a known endocrine disruptor. Its ability to mimic natural hormones, which operate at infinitesimally low levels, raises difficult questions about how health and safety officials might want to regulate its use.

Endocrine disruption is most dangerous at certain early stages in a person’s life – in the womb, during infancy, and during puberty – when a person is least able to comprehend and avoid dangerous levels of exposure. That is why many consumer health and environmental groups are working to ban BPA, especially in products like baby bottles.

But the science on endocrine disrupting chemicals in general, and BPA in particular, is still evolving, which is what makes FDA’s actions so troubling. High level FDA officials should not be abusing their seniority to force industry talking points on career scientists. Instead, top-level officials should be working to address the issue – by establishing inter-agency workgroups and facilitating a coordinated government-wide response to the problem. While FDA has the responsibility for regulating BPA in food containers, there are numerous other regulatory agencies that have responsibilities for keeping us safe from other exposures: CPSC for consumer products, OSHA for workplace exposures, and EPA for other environmental exposures. On top of that, there are multiple agencies that don’t have any regulatory power, but have top-notch scientists researching the risks posed by BPA – the National Toxicology Program, CDC, and NIH to name a few.

Instead of working to make all of those spinning wheels mesh, FDA political appointees spent their time throwing monkey wrenches into the regulatory process. The resulting absence of leadership at the federal level has prompted many state and local governments to take action. Their responses, much to the chagrin of chemical manufacturers, have been outright bans on BPA in certain products. Unless the federal government steps in, we’re sure to see more of these local bans.

Read More by Matt Shudtz
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