Science panel faults FDA assessment of plastics additive

Factiva: "An independent scientific advisory panel slammed the Food and Drug Administration's assessment that a controversial plastics additive is safe, saying it failed to take into account numerous scientific studies and came to faulty conclusions."

The scientists determined that the agency's assessment raises "several significant concerns," including the lack of an adequate number of infant formula samples -- the agency took 14 samples for its exposure assessment -- and the failure to account for the variability in samples.

FDA also focuses solely on food contact applications without considering potential cumulative effects from non-food contact exposures to the chemical, the scientists note. For example, FDA initially decided to leave out biomonitoring studies that could have helped understand those cumulative exposures, leaving the agency with a "limited approach."

Furthermore, since FDA excludes a large number of scientific studies from its analysis because they do not meet certain guideline requirements, even the focus on food contact applications is not sufficient. "A lack of consideration of the totality of exposures from other sources severely limits the usefulness of the safety assessment with respect to food contact applications," the report says.