After several years of legal back-and-forth between the US Food and Drug Administration (FDA) and a group of civil society organizations including the Natural Resources Defense Council (NRDC), Chemical Watch reports that a federal judge has ruled in the FDA’s favor over the use of perchlorate (CAS 14797-73-0) in food packaging.
Perchlorate is suspected to harm brain development (FPF reported) and therefore be of particular concern for childhood exposure (FPF reported). A total diet study published by the FDA in 2016 found higher perchlorate levels in foods sampled in 2008-2012 compared to 2003-2006, suggesting a correlation with the increased use of perchlorate in food packaging following its authorization by the agency in 2005 (FPF reported).
The legal debate began in 2015 with an NGO petition to the FDA asking the agency to ban the use of perchlorate as an antistatic agent for use in food contact materials in contact with dry foods (FPF reported). The organizations argued the FDA is ignoring its own studies and is not accounting for the cumulative effects of perchlorate. This was followed by a 2016 lawsuit filed by the organizations against the agency “over its failure to act” on the original petition (FPF reported), a series of delays (FPF reported), a 2017 FDA denial of the petition (FPF reported), an NGO objection (FPF reported), another FDA denial in 2019 (FPF reported), a subsequent NGO lawsuit (FPF reported), FDA’s defense argument in 2021 (FPF reported), and finally the recent ruling.
The FDA argued that perchlorate migrates at such low levels that it is below the threshold of regulation. Judge Vernon Broderick agreed, stating that “there is nothing in the text of the FDA regulations or in the Food Act mandating that the FDA consider the cumulative effects when issuing a TOR [threshold of regulation] exemption.” He also said that the civil society organizations arguments apply more as “an inherent challenge to the FDA’s TOR regulation itself” than a particular argument against perchlorate.
Chemical Watch reported a statement from Tom Neltner of the Environmental Defense Fund, one of the civil society organizations in the suite, that “while we are exploring our options on the court ruling, we hope the agency will use this as an opportunity to address the systemic flaws in the agency’s process to estimate and consider exposure to toxic chemicals in food contact materials.”
In 2021, Representative Schakowsky introduced the Food Chemical Reassessment Act of 2021 to the US House of Representatives which would require the FDA to reassess the safety of certain chemicals including perchlorate every three years (FPF reported). There has been no movement on the bill since it was introduced.
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Kelly Franklin (April 14, 2022). “Federal court rules in US FDA’s favor on perchlorate lawsuit.” Chemical Watch
Judge Vernon S. Broderick (April 12, 2022). “Court ruling – NRDC et al. v. US FDA et al.” Justia.com (pdf).
