NGOs Challenge US FDA Decision on Perchlorate in FCMs

Nine NGOs have filed an objection to the US Food and Drug Administration’s (FDA) decision to continue to allow perchlorate in dry food packaging materials. The consumer advocacy groups are seeking a formal evidentiary public hearing to secure an independent judgment of the determination.

Their action follows the FDA’s announcement last month that it was rejecting the NGOs’ 2014 food additive petition (FAP). This had called on the agency to:

> revoke its 2005 approval of "threshold of regulation" (TOR), which allows up to 1.2% SODIUM PERCHLORATE MONOHYDRATE in dry food packaging;

> prohibit the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents used in food contact articles; and

> remove Potassium Perchlorate as an allowed additive in sealing gaskets for food containers.

The agency did complete the third request – to revoke the use of potassium perchlorate. But it says it did so at the request of the Plastics Industry Association (PLASTICS – formerly SPI), following the trade group’s claim that use of the substance has been abandoned by industry.

This, says the FDA, rendered the petitioners’ third request "moot".

Regarding the first two asks, the agency says these were outside the scope of a FAP. And it says the data provided by the NGOs do not back up the conclusion that the existing TOR exemption is not supportable.

‘Flawed interpretation’

In their objection to the FDA, the consumer advocacy groups say that the denial "is based on a flawed interpretation of the law and the science".

The decision and its underlying analysis "grossly underestimate" the extent to which perchlorate migrates from food packaging, they say. And the agency "shows a disturbing failure to account for the accumulating body of evidence that the substance poses a risk of irreversible harm to the foetal and infant brain".

With regard to the requests falling outside the scope of a FAP, the NGOs argue that the FDA accepted and then took public comment on these requests; it is "arbitrary and capricious for the agency to unilaterally reverse its position without explaining why its initial interpretation was flawed."

And they criticise as "poor public policy" the agency’s granting of an industry petition that was filed three months after they filed suit against the FDA for its failure to meet the statutory deadline for responding to their own petition.

"FDA’s job is to protect the public from toxic chemicals," says Cristina Stella, staff attorney at petitioning organisation the Center for Food Safety. "The agency’s denial of our petition is irresponsible, illegal and indefensible."

The NGOs have requested a public hearing before an administrative law judge, to challenge the decision.

Hearings of this kind are rare, say the groups – the most recent appear to have taken place in the 1970s.