Two NGOs have called on the US Food and Drug Administration (FDA) to revoke its approval of all per- and polyfluoroalkyl substances (PFASs) for use in food contact applications.
The requests – voiced in separate blog posts from the Environmental Defense Fund and Environmental Working Group – follow a highly publicised May report on the presence of the substances in food (see box), and a more recent news report about PFASs in compostable products.
The US EPA has linked PFASs as a group to certain health effects – such as developmental and immunological problems – but data is limited on the newer, short-chain versions. In June, the FDA updated its website to say it would be taking steps to evaluate the substance’s presence in food, including “reviewing the limited authorised uses of PFAS in food contact applications.”
But in a 5 August blog post, Tom Neltner of the EDF raised questions about that process. In the interim, he recommended that the FDA notify manufacturers that it has determined all 62 PFAS food contact notifications (FCNs) “are no longer effective.” The effect of this would be to force manufacturers to “make their case that the uses are safe”; otherwise the decisions would be made final and the authorisations would be revoked.
In support of this recommendation, Mr Neltner said that the “most protective” reference dose level – the lowest exposure determined to be safe – should be used for all 62 substances. More specifically, he called for application of the minimal risk level (MRL) proposed by the Center for Disease Control (CDC) in its safety review of the long-chain substance perfluorooctane sulfonate (PFOS).
According to EDF research, reevaluating 31 FCNs it received through a 2017 Freedom Of Information Act (FOIA) request using this MRL would result in none of them being approved as food contact substances. The EDF researchers “do not expect a different outcome” for the remaining FCNs.
The blog post highlighted several other recommendations on how the agency should remake its food contact notification (FCN) process, such as:
- ensuring that companies provide all relevant data required by law;
- testing foods for mixtures of PFASs, per the “statutory obligation to consider the cumulative effects of chemically- and pharmacologically-related substances in the diet”;
- requiring companies to provide comprehensive estimates of environmental releases of their products; and
- demanding that companies producing food contact materials (FCMs) provide samples of the products for each FCN.
The EWG pointed to this EDF research in its own blog post, which called for the FDA to “ban” all PFASs from food packaging. It added that news that PFASs are present even in compostable bowls “should be reason enough for the FDA to prohibit these chemicals from winding up in our diets.”
But the FluoroCouncil told Chemical Watch that the EDF post “contains inaccuracies and misleading statements.” Executive director Jessica Bowman said it is “simply untrue” that the CDC’s reference dose should apply to the entire PFAS class.
“We support FDA’s review of the most up-to-date data pertaining to our FCNs, to continue to assure our products are safe for their intended use,” said Ms Bowman. “If FDA concludes that additional data are needed, the agency can require that industry conduct additional tests.”
The FDA did not provide comment on the EDF’s recommendations beyond referring to the agency’s webpage on PFAS.
“To lead [the FDA’s research and analyses of PFAS concentrations in food], in 2019, the FDA formed an internal workgroup and is committed to engaging with consumers, industry, and other federal, state, and local government partners in this process,” it reads.