FDA risk assessment after Gulf oil spill may need updating

The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States with polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants.

October 20, 2011

The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States with polycyclic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels (Levels of Concern) of PAH contaminants in Gulf Coast seafood. In a study published in Environmental Health Perspectives, researchers evaluated the degree to which FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood.

The researchers—both from the National Resources Defense Council—found that the FDA’s Levels of Concern significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to:

  • Account for the increased vulnerability of the developing fetus and child
  • Utilize appropriate seafood consumption rates
  • Include all relevant health endpoints
  • Incorporate health protective estimates of exposure duration and acceptable risk.

For benzo(alpha)pyrene and naphthalene, revised levels of concern are between 2–4 orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised levels of concern, revealed that up to 53% of Gulf shrimp samples were above levels of concern for pregnant women who are high end seafood consumers.

The researchers concluded that the FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.

In response to the study, Robert W. Dickey from the FDA Gulf Coast Seafood Laboratory, sent a letter to the journal stating that “Although Rotkin-Ellman et al. present a well-intentioned case for determining PAH levels for at-risk populations, their interpretation of several factors involved in the derivation of levels of concern (LOC) differs substantially from those used in the BP oil spill risk assessment.” Dickey goes on to address the issues that the researchers raise in the study.

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FDA Letter

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