FDA Publishes 2 FSMA Rules; Asks for Extension on 2 More

On Friday, July 26, the FDA published two more of the long-awaited rules associated with the Food Safety Modernization Act (FSMA): the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and the Proposed Rule on Accreditation of Third-party Auditors.

The foreign supplier verification rule requires that imported foods meet the same safety standards as domestically-produced foods, and put the burden of meeting those standards on the importing companies, which will have to prove their foreign suppliers have adequate controls in place.

Industry reps, food safety professionals, and other experts were largely supportive in their reactions. “FSMA ensures that prevention is the cornerstone of our nation’s food safety strategy and today’s proposed rules embody that same principle,” said the Grocery Manufacturers Association in a statement. “These proposed rules will place new and enhanced requirements on foreign suppliers and the accreditation of third-party auditors that will help further protect the safety of food imported into the U.S.”

The FDA announced a 120-day comment period for the new proposed rules, as well as a 60-day extension for the produce safety and preventive controls rules that were released in the spring, so that the four rules can be analyzed in an integrated fashion.

But some hurdles still stand in the way of full FSMA implementation. In late June, Judge Phyllis Hamilton of the U.S. District Court of Northern California ordered the FDA to release all of the remaining FSMA rules by November 30, 2013.

In a motion submitted to the court in mid-July, the FDA asked for a reconsideration of the ruling. The animal foods rule, it indicated, could also be released by November, but it asked for two additional months for the sanitary transport rule and nearly two years—until June 2015—for the intentional contamination rule, noting that this is the first time the agency has ever regulated against intentional adulteration.

Former FDA associate commissioner of foods David Acheson, MD, who now heads up the food and import safety practice at Leavitt Partners, says that legal wrangling over the rules may backfire. “When the FDA has to divert resources to address lawsuits, it distracts resources away from getting rules written because the legal department that has to review the rules is busy with the court challenges,” he says. “I think FDA has committed to try to do these rules right and with adequate public comment. Anything short of that will result in a mess.”

What might happen if the judge refuses to grant the FDA an extension and the agency doesn’t meet her deadline? “I’ve asked that same question,” comments Acheson. “Good luck suing the FDA. What are they going to do? Throw Mike Taylor in jail? Fine Elisabeth Hagen? What’s the stick here? What are the consequences of not meeting this deadline, other than more legal churn and wasted resources?”


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