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Court Puts FDA on a Health Regimen

Last Friday, a federal judge ordered the Food and Drug Administration (FDA) to pick up the pace on rulemaking to implement the nation’s watershed food safety law. Clipping a two-year process that has gone well into overtime, the U.S. District Court for the Northern District of California ordered the agency to complete outstanding Food Safety Modernization Act (FSMA) rules by November 30 of this year.

That means some important areas tardily left gray by the agency will have to be inked in before year end, at least as proposed rules for public comment. They include:
• Foreign Supplier Verification Program
• Accreditation of Third Party Auditors
• Preventive Controls for Animal Feed
• Sanitary Transportation of Food and Feed, and
• Intentional Contamination

The court also set deadlines for the steps leading to the issuance of final rules. Typically, proposed rules are open for a public comment period of several months, and the agency weighs the input of trade groups, government agencies, corporations and individuals in crafting a final rule. Under the court order, public comment periods on the outstanding rules must end by March 31, 2014, and the FDA must publish final rules by June 15, 2015.

FSMA was signed into law on January 4, 2011 with a stipulation that the FDA complete the rulemaking process within two years. The agency has moved the goalposts several times, sliding past legal mandates and its own rulemaking schedule. At 30 months out, the agency is in technical noncompliance with the law itself.

These delays have stymied full implementation of FSMA, along with rampant confusion and even paranoia as industries struggle to adapt their current food safety procedures to the strictures of the new law. In some cases, companies are making unnecessary demands on suppliers and importers in order to get out in front of uncertain regulatory demands.

Likely, it’s this scenario that led the California Center for Food Safety and Center for Environmental Health to file an action against the agency, which ultimately resulted in last week’s order. The plaintiffs succeeded in securing an injunction forcing the agency to act. Deadline determination was left to the parties to negotiate. However, the court stepped in to set the deadlines after it deemed the agency’s proposed “target timeframes” inadequate and the plaintiffs’ request to curtail the comment periods and order progress reports to be overly restrictive.

FSMA is a landmark act highlighting the FDA’s goal of modernizing the nation’s food safety system, putting a focus on enforcing preventive measures rather than reacting to problems after the fact. The statute deploys some fundamental changes to the food safety system, including mandatory FDA food recalls, prior notice requirements for imported foods and importers’ legal responsibility for the safety of the foods they import. The law applies to all facilities that manufacture, process, pack or hold food for human or animal consumption.

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