Jun 27, 2013
By Debbie Phillips-Donaldson
The wheels of justice turn slowly, as the saying goes, but they have finally turned in the direction toward safer petfood, animal feed and human food -- and toward clarity for producers of those products. On June 21, a US federal court ordered the Food and Drug Administration (FDA) to complete the new food safety regulations of the 2011 Food Safety Modernization Act (FSMA) by November 30 of this year.
According to the ruling, issued by Judge Phyllis Hamilton of the US District Court for the Northern District of California, FDA must publish all proposed FSMA regulations by November 30, open a public comment period through March 31, 2014, and have all final regulations published in the Federal Register no later than June 30, 2015.
Getting to this point has been a long, rather sordid saga. Under FSMA, FDA was supposed to issue new regulations in seven key areas, including risk-based preventive controls for petfood/feed, by July 2012. It didn't even come close to hitting that deadline, so a month later, the Center for Food Safety (CFS) and Center for Environmental Health sued the agency through that Northern District of California court. The lawsuit must have had some effect, because before the court could rule, in January FDA issued two of the seven regulations: one on preventive controls for human foods and one detailing safety regulations for produce.
Still, that left five areas unaddressed. In April, the court ordered FDA and the complainants to meet and agree on deadlines to be submitted by May 20. Naturally, the agency missed that deadline, too, asking for an extension of 20 days.
So, on June 20, did FDA and the two centers present the court with an agreement? Not by a long shot. Instead of submitting a joint proposal as required, the two entities issued separate timelines for implementing the remaining regulations. In fact, FDA didn't even give specific dates in most cases.
For example, with the foreign supplier verification program, which will create new regulations for importing food products and ingredients, FDA set a deadline for a proposed rule by this summer, without setting a date, while CFS set a deadline of August 31, 2013. For the final rule, FDA set a deadline of summer 2015, while CFS set a deadline of December 31, 2013.
Obviously (and fortunately), the court did not appreciate this willful flouting of its orders; hence, the ruling the next day ordering the new deadlines. "Congress indicated that the rule-making process should be close-ended, rather than open-ended," the order read. "Thus, the court finds defendant's 'target timeframes' to be an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction."
Of course, there is no guarantee FDA will hit these new deadlines; after all, the original deadlines were also mandated by law under FSMA. Yet whether you like FSMA or its intentions, I believe most petfood manufacturers will be relieved to know the US government system of checks and balances may help them soon, finally, see and be able to comment on new regulations that will greatly affect their businesses. After all, clarity is always a good thing.
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