How Does the FDA Know What Is Safe to Eat or Buy If It Doesn't Define Safe?

More than 90 percent of Americans carry residues of the chemical BPA in our bodies, according to the Centers for Disease Control. We encounter the chemical through every day products such canned food, and ATM receipts, and this steady exposure poses significant risks. Independent scientific studies show that BPA interferes with estrogen and alters the development of the brain, prostate, and breast tissue. The evidence is so strong that 11 states have begun to regulate BPA.

The Food and Drug Administration, however, has delayed taking action on BPA for more than five years—effectively leaving consumers to believe it is safe. Yet when public health organizations ask the agency to explain why it hasn’t protected Americans from this harmful chemical, the FDA stonewalls. NRDC recently had to sue the FDA just to make it comply with our Freedom of Information Act request for material on the agency’s BPA review.

It shouldn’t take a lawsuit for the public to find out what government officials think about health risks posed by consumer products. But as detailed in an exposé by Barry Estabrook in the latest edition of NRDC’s OnEarth Magazine, the agency repeatedly fails to protect Americans from known hazards. Not only does it discount the weight of scientific evidence on issues ranging from antibiotic use to raise livestock to mercury contamination in seafood. But it also has refuses to share how it determines something is free of harm.

How do we know if a product is safe to eat or put on our children’s skin or bring into our homes if the FDA won’t explain why it has given its stamp of approval?

The lack of transparency begins with the near absence of risk assessment guidance documents. These documents lay out an agency’s process for defining harmful effects, evaluating toxicology studies, and determining a safe level of exposure. If officials at the Environmental Protection Agency, for instance, are trying to assess the safety of a chemical, they follow clearly defined steps to decide whether a chemical is a carcinogen or developmental toxin and what level is safe to have in our air and water. The EPA doesn’t always stick to its guidelines, but because they are publicly available, when scientific review identifies gaps the public can hold the agency accountable and say: “You didn’t follow your own safety protocol.”

That level of accountability is not possible with the FDA. The agency has some guidance documents, but they do not make them accessible on the website. Some FDA officials say they are reluctant to issue guidelines because it reduces their ability to be flexible and respond to new science. They prefer to handle health hazards on a case-by-case basis.

The trouble with this approach is it can turn safety into a moving target.

After every major oil spill, for instance, the FDA has set different and sometimes wildly divergent standards for how much oil-contaminant is safe in the seafood we eat. When the BP disaster sent roughly 170 million gallons into one of America’s most productive fisheries, the FDA issued standards that were much less protective than the ones it issued after the Exxon Valdez spill and allowed for more contamination.

This change wasn’t because of new research but because the agency decided, this time, that a greater amount of cancer risk was “acceptable.” In addition, the agency relied on outdated science for the risk assessment methods it used to calculate allowable levels of oil spill contaminants in Gulf seafood. As a result, the FDA set levels up to 10,000 times too high to protect the most vulnerable populations—including pregnant women, children, and local fishers who eat more seafood than average Americans—from increased cancer risk.

When the FDA does share the reasoning behind its safety determinations, it often reveals influence from industry. Years of research, for instance, have confirmed that BPA poses health hazards. The nation’s leading group of hormone experts, the Endocrine Society, has said the presence of BPA in food containers is a significant health risk, and the National Institute of Health is focusing its BPA research on low-dose exposures because even that may be harmful. The FDA has chosen to discount hundreds of independent low-dose studies. Instead, it spent years defending its refusal to ban BPA in food by citing studies funded by manufacturers of BPA but twice these proposals have been rejected by outside reviewers. More recently it started doing its own research while continuing to postpone any regulatory decisions.

“Corporations can have too much to say about how the FDA operates,” says former FDA scientist Renee Dufault in the OnEarth article. Dufault was ordered by the agency to stop investigating the presence of mercury in high-fructose corn syrup. "If an industry group has enough clout, the FDA is going to be deferential.”

Several years ago, a group of science advisors conducted an independent review of the agency. They concluded that “The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.” This is not merely some bureaucratic matter. It is a matter of public health. The science advisors’ report said, “The nation is at risk if FDA science is at risk.”

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