A blog post published on November 4, 2018, by the non-profit organization Environmental Defense Fund’s health portal (EDF Health), examined how a chemical company withheld relevant toxicological information to get a food contact substance (FCS) approved by the U.S. Food and Drug Administration (FDA). Tom Neltner, chemicals policy director at EDF, and Maricel Maffini, an independent consultant, reviewed information they received in response to a Freedom of Information Act (FOIA) request of the FDA’s approval of five Food Contact Substance Notifications (FCN) for polymeric per- and polyfluoroalkyl substances (PFASs). All five polymers were made from the monomer 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propeonate (C6SFA, CAS 17527-29-6).
“When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment,” the authors explained. The FDA must then determine a “reasonable certainty of no harm” for the chemical considering 1) the chemical’s consumption due to its use, 2) cumulative effects of chemically and pharmacologically similar chemicals in the diet, and 3) suitable safety factors.
According to Neltner and Maffini’s investigations, Japanese company Daikin omitted “a month-long feeding study in rats showing that the liver and kidney of the animals treated with C6SFA were heavier and showed pathological changes” and “the rats’ incisor teeth showed signs of decreased mineralization (mottled teeth).” Daikin’s notice to the FDA also omitted “an animal study that measured the dose necessary to kill half of the tested animals as well as one additional in vitro study.” Further, Daikin has seemingly not “assessed the toxicological cumulative effect of similar PFAS[s]” as is required. Despite having noticed this incompletion, the FDA “did not appear to request Daikin or any of the other PFAS manufacturers that submitted FCNs to assess safety as a class of chemically-related substances in the diet.”
Neltner and Maffini concluded that “[b]oth FDA and companies must apply the legally mandated requirements when performing chemical safety assessments of food chemicals.” In particular, the authors called on FDA to “demand that Daikin update its notification to include the missing data and reassess whether the use is safe for public health and the environment.” Generally, Neltner and Maffini recommended “a similar reassessment . . . for all PFAS[s] given what is now known about these chemicals.”
Tom Neltner and Maricel Maffini (November 4, 2018). “FDA-approved PFAS: A serious breakdown in assessing food additive safety.” EDF Health