May 8, 2013
By Debbie Phillips-Donaldson
If a recent US federal court ruling has any impact, we might soon, finally, see new petfood preventive controls safety regulations under the Food Safety Modernization Act (FSMA). In the ruling, issued April 22, the court said the US Food and Drug Administration (FDA) must comply with a schedule set forth by Congress under FSMA to issue new regulations in seven key areas, including risk-based preventive controls.
FDA blew the original deadline for those regulations, July 2012, as reported by John T. Shapiro and Jason R. Klinowski on FoodSafetyMagazine.com. They noted how the food industry (and, as we know, related industries like petfood and animal feed) protested because of the uncertainty and lack of clarity over what promised to be far-reaching new rules.
"Wary of the ever-increasing delay with no apparent end in sight, last fall two organizations took a dramatic step to change the delay dynamic," wrote Shaprio and Klinowski. "Specifically, on August 29, 2012, the Center for Food Safety and the Center for Environmental Health filed a complaint against FDA in the US Federal District Court for the Northern District of California. Therein, the two nonprofits alleged that the FDA had unlawfully delayed issuance of the new rules."
In its defense, FDA argued that it had been working assiduously on the regulations (apparently hoping to score points for activity, even without results) and that in fact, some of the regulations were written and under review by the Office of Management and Budget (OMB). Not such a great defense, since OMB was also named in the suit. FDA also stressed that the issues covered by the regulations were extremely complex, and rushing the rules would not help protect health or safety.
But perhaps the lawsuit had some effect, even before the court ruled, because in January, FDA released two of the seven regulations: one on preventive controls for human foods and one detailing safety regulations for produce.
While the court agreed in its ruling with FDA that ensuring food safety would not be served by the "issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress," and that any schedule set by the court would be arbitrary, the court also ordered FDA and the complainants to meet and agree on deadlines to be submitted by May 20, Shapiro and Klinowski reported.
The authors surmised that implementation of FSMA will is now likely to progress at a faster pace. That should mean FDA will release preventive control regulations for petfood and animal feed very soon -- which will likely build on the ones for human food but differ by necessity because of unique processing methods and the number of different species involved -- along with rules for the Foreign Supplier Verification Program (FSVP), which will significantly affect imported ingredients and food products for humans and animals. Of course, FDA promised to follow up the January release of the first two sets of regulations with the ones for animal feed and FSVP very soon, and here it is May!
Still, there is no doubt the new rules are coming. If your manufacturing facility is not already preparing, you should be. Melanie Neumann, senior director for food and import safety with Leavitt Partners, addressed this topic during Petfood Forum 2013 and recommended that petfood manufacturers look at:
She emphasized that under FSMA, there is a heavy focus on risk and documentation and broad thinking for preventive controls. Learn more by watching this video of Neumann discussing what FSMA means for petfood manufacturers.
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