Chemophobes continue attack on FDA

Regulatory agencies, like umpires, don’t have friends. They are often asked to make tough calls—and when they do, the side that benefits from their decision believes that the call was the only possible conclusion the agency could have made based on the evidence they were provided. The side that loses, however, questions the agency’s judgment, its ability to understand basic information, even its integrity—and runs immediately to friendly reporters and bloggers to tell their tale of woe.
 

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Such a scenario is currently playing out at the Food and Drug Administration (FDA). On March 30, the FDA sent a 15-page letter to the Natural Resources Defense Council (NRDC) denying, in its entirety, a petition NRDC had sent requesting that FDA issue a regulation prohibiting the use of bisphenol A (BPA) in human food and food packaging, and to revoke all regulations permitting the use of any food additive that may result in BPA becoming a component of food.
 
BPA is an industrial chemical that has been present in many hard plastic bottles and metal-based food and beverage can liners since the 1960s. Thus far, according to the FDA, studies employing standardized toxicity tests have supported the safety of human exposure to BPA. FDA’s letter explained the agency’s framework for evaluating BPA’s safety, and discussed the results of its review of studies NRDC provided on how humans metabolize the substance; its potential toxicity; and possible effects on reproduction, human behavior, the cardiovascular system, and four other areas.
 
The FDA found that in every case, NRDC’s evidence was either not applicable to human health or did not meet the agency’s basic threshold of demonstrating either harm or undue risk to human health. “FDA is denying your citizen petition in its entirety,” the letter states. “FDA has determined that its continued scientific study…and review of all new evidence as it becomes available is the most appropriate course of action at this time.”
 
In response, Dr. Sarah Janssen, one of the two NRDC officials to whom the letter was addressed, said, “the agency has failed to protect our health and safety…the FDA is out-of-step with scientific and medical research.  This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”  In other words, “kill the umpire.”
 
Others followed NRDC’s lead. In the New York Times, Nicholas Kristof blamed “Big Chem” for somehow having “blocked strict regulation (of BPA) in the United States.”  His May 2, 2012 article in the Times did not even mention FDA’s response to NRDC—much less attempt to rebut it.  An April 30, 2012 story in the Lexington Herald Leader referred to FDA’s decision as a “disgrace”—again, without any attempt to come to grips with what the decision actually said.
 
However, an impartial observer reading FDA’s letter to NRDC, or the large amount of information FDA has placed on its website on the subject, would almost certainly agree that the agency has reviewed the current evidence in an honest, complete and forthright manner, and has complied with the Obama Administration’s mandate to all Executive Branch agencies to have science and the scientific process guide administration decisions.
 
Bill Klem, a major league umpire for 37 years, was famous for saying “I never called one wrong.”  Regulatory agencies like FDA may not be able to make the same boast, but their mistakes are rarely a result of lack of effort.  With respect to BPA, the FDA has done its job well, and it is now up to those who would ban the chemical to either prove the agency wrong—or, better yet, to provide FDA with information that will assist it in future discussions of the subject.
 
Chasen is a medical and health writer and consultant, and a retired member of the federal government's Senior Executive Service.


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