Did FDA Imperil Pregnant Women, Children after Gulf Oil Spill?

The FDA failed to take into account risks to pregnant women and children when it issued reports indicating that Gulf seafood is safe to eat in the wake of the Deepwater Horizon oil spill, suggests a new article by researchers from the Natural Resources Defense Council (NRDC) that appeared in the journal Environmental Health Perspectives.

Lead author Miriam Rotkin-Ellman identified six areas in which she said FDA science was flawed, including basing its estimates of safe levels of consumption of polycyclic aromatic hydrocarbons, or PAHs (compounds that have been linked to cancer), on a person weighing approximately 80 kg, or 176 pounds. Close to 70% of the U.S. female population weighs less than that, and children considerably less, the NRDC authors note.

They also criticize the FDA for failing to evaluate potentially increased risks

to the developing fetus or child, given the known fact that prenatal exposure to PAHs can cause damage to a developing fetus.

Rotkin-Ellman wrote in her blog: “According to our calculations, the risk of cancer associated with eating Gulf shellfish contaminated at the levels FDA says is safe could be as high as 20,000 in a million. Put another way, this means that if 1,000 pregnant women (and their children) ate Gulf seafood contaminated at the levels FDA said are safe, 20 of the children born to them would be at significant risk of cancer from the contamination.”

But two leading seafood safety experts disagree.

“I know there are a lot of ways to parse out the data and look at different things, but I think the FDA did take these issues into account,” said William Walton, PhD, an assistant professor at the Auburn University Shellfish Laboratory on Dauphin Island, who serves on the Food Safety Task Force, a group that formed in the aftermath of Deepwater Horizon to advise the seafood industry on how to ensure product safety. “My interpretation is that they were actually very conservative in a great deal of their estimates, and they certainly increased the sensitivity of a number of the analyses.”


David Green, PhD, a professor with North Carolina State University’s Seafood Laboratory, pointed to a flaw in the NRDC analysis. “They also criticize FDA for not calculating the risk of exposure to naphthalene [a common PAH]—but the fact is that the Environmental Protection Agency hasn’t determined a safe exposure for naphthalene,” he said. “It’s not established.”

Dr. Green said that a safety risk profile can be calculated based on any “average” person. “The important thing is risk communication, which really needs to be at the county and state level for specific at-risk populations.”

The NRDC has filed a petition asking the FDA to set new limits on acceptable levels of PAHs in seafood, levels that it says should specifically address vulnerable populations such as pregnant women and children.

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