US FDA sued over Rejected perchlorate FCM petition
October 31, 2019
The move comes after years of back-and-forth between the NGO community and the agency over the substance, which is used as a propellant in rocket fuel and was approved for use as an anti-static agent in food contact applications in 2005.
In 2014, the plaintiffs and others petitioned the FDA to revoke its authorization for the use of perchlorate in food contact applications, citing the agency’s research and other evidence that exposure has been linked to developmental delays, reduced growth, and impaired learning capabilities. After two years of silence on the petition, they filed suit against the agency over its failure to act.
The FDA finally denied the petition in 2017 and then rejected a subsequent objection in April of this year. In support of its position, the agency said that the NGOs’ requests were outside the scope of a food additive petition (FAP), which is the mechanism for regulating food contact materials.
The Environmental Defense Fund said at the time that the organizations were considering their legal options to challenge the decision in the courts.
And October 29, EDF was joined by five other organizations in filing a complaint, that seeks the court to invalidate the petition denial and compel the FDA to reassess the issue.
“We’ve petitioned, been stalled, our objections and arguments ignored, and our request for a public hearing rejected,” said Lisette van Vliet, from Breast Cancer Prevention Partners. “It’s now time that the FDA answer in court for not protecting our health.”
In response to questions on the lawsuit from Prop 65 News the FDA said it “does not comment on possible, pending or ongoing litigation”.
The NGOs’ complaint says that the FDA ignored crucial evidence in denying the original petitions, including:
- FDA research showing that perchlorate concentrations in foods spiked in the years following its approval for use in food-contact articles;
- the “very likely possibility” that foods will come into contact with perchlorate during the various stages of production, transportation and preparation for sale;
- the cumulative effect on human health of exposure to perchlorate and any chemically- or pharmacologically-related substances in the diet, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act); and
- administrative procedure requirements.
The plaintiffs are bringing the action on behalf of their members, which include “individuals and families who eat and feed their children foods in which perchlorate has been detected and foods that have been handled or packaged with material containing [it]”. They argue that these individuals have been injured by the FDA’s decision to allow the continued use of perchlorate in materials that contact food.
The case is being heard in the US district court for the southern district of New York.
The NGOs suing the agency are:
- Natural Resources Defense Council (NRDC);
- Breast Cancer Prevention Partners (BCPP);
- Center for Environmental Health (CEH);
- Center for Food Safety (CFS);
- Environmental Defense Fund (EDF); and
- Environmental Working Group (EWG).
These organizations also spearheaded the earlier petitions over the agency’s posture on the substance.
Ammonium and potassium perchlorate are both listed as Proposition 65 carcinogens.