An article published on August 1, 2019 by the non-governmental organization (NGO) Environmental Defense Fund (EDF) expresses concerns about recent statements the U.S. Food and Drug Administration (FDA) made about the presence of per- and polyfluoroalkyl substances (PFAS) in foods, as well as regarding the agency’s planned next steps in addressing the issue. In its statement, the FDA said it “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.” However, the EDF article’s authors “were surprised by FDA’s statement that all is fine given the results the agency published [(FPF reported)] and the evidence about the array of health risks posed by PFAS at extremely low levels.”

EDF is now calling for the FDA to provide more explanation “to show how it reached such a broad conclusion of safety” for PFAS. In particular, the NGO wants to know more details about the analytical and risk assessment methods used in the federal agency’s recent food study (FPF reported) that led to the conclusion that PFAS were not found to be a health concern. EDF has submitted a Freedom of Information Act request to the agency seeking further details on the analytical and risk assessment methods used. The article goes on to also discuss “critical gaps in FDA’s vague and confusing statements on PFAS in the diet.” This includes that “more PFAS in more foods may have been detected” by the agency than currently fully described. Additionally, the agency used an earlier reference dose (RfD) value that has since been updated by the U.S. Centers for Disease Control. EDF is also concerned that an FDA distinction made between long- and short-chain PFAS “is not grounded in the agency’s own science.” The authors write in conclusion that “in light of the evidence we have seen, a transparent review of the safety [of PFAS in food] is essential to protect public health and reestablish consumer confidence.”

In a second article published on August 5, 2019, the same authors call into question the FDA’s existing authorizations for mixtures of PFAS within the Food Contact Substance Notification (FCN) Inventory. The article summarizes their investigation into the existing notifications. EDF found that for 15 FCNs “the exposure estimates for at least one PFAS covered by the notice exceeded the 2016 EPA RfD for PFOA [perfluorooctanoic acid; CAS 335-67-1] and PFOS [perfluorooctanesulfonic acid; CAS 1763-23-1]” and that “all FCNs contained unredacted estimated exposures for the listed PFAS that exceeded the CDC 2018 RfD for PFOS.” This does not yet consider the combined exposure consumers may face to all PFAS. From this review, the authors propose the following recommendations to the FDA:

  • “notify PFAS manufacturers that FDA has determined that all 62 active PFAS FCNs are no longer effective;
  • ensure that companies provide all relevant data as required by law;
  • test foods for mixtures of PFAS in the active FCNs;
  • require companies to provide comprehensive estimates of environmental releases of their products;
  • demand that the companies provide samples of the products for each of the FCNs.”

Read more

Tom Neltner and Maricel Maffini (August 1, 2019). “FDA concluded PFAS in food are safe. Now it has to show how it reached that conclusion.” Environmental Defense Fund

Tom Neltner and Maricel Maffini (August 5, 2019). “FDA must abandon its flawed assumptions when reviewing safety of approved PFAS uses in food.” Environmental Defense Fund

Lisa Martine Jenkins (August 8, 2019). “NGOs push FDA to pull approval of PFASs in food packaging.” Chemical Watch