The questionable assumptions include six main issues: a) high consumer body weight,b) low estimates of seafood consumption, c) failure to include a cancer risk assessment for naphthalene, d) failure to adjust for early-life susceptibility to PAHs, e) short exposure duration, and f) high cancer risk benchmarks. Taken together, these flaws illustrate a failure to incorporate the substantial body of evidence on the increased vulnerability of subpopulations to contaminants, such as PAHs, in seafood.
Environmental risk assessment requires the use of scientifically founded assumptions and appropriate default estimates about the exposed population, the intensity and duration of exposure, and the dose–response relationship. The risk assessment methods used by the FDA to set safe exposure levels for Gulf Coast seafood after the oil spill do not incorporate current best practices and do not protect vulnerable populations. The FDA’s conclusions about risks from Gulf seafood should be interpreted with caution in coastal populations with higher rates of seafood consumption and in vulnerable populations such as children, small adults, and pregnant women. Our analysis demonstrates that a revised approach, using standard risk assessment methods, results in significantly lower acceptable levels of PAHs in seafood and identifies populations that could be at risk from contaminants in Gulf Coast seafood. Health advisories targeted at high-end consumers would better protect vulnerable populations such as pregnant women, women who may become pregnant, and children. Our approach did not address infant exposure to PAHs via maternal seafood consumption and lactational transfer. The NRC (2008) found up to 50-fold interindividual variability in cancer risk and recommends incorporation of estimates of uncertainty, as well as population risk distributions, into future risk assessments.Improved public health protection from contaminants in food will require reforming FDA risk assessment practices.