Apr 24, 2013

Deadline debate continues for FSMA

Two days after a federal judge ruled that FDA is taking too long to implement new food safety regulations, the agency officially extended the comment periods on a pair of rules contained in the wide-reaching Food Safety Modernization Act (FSMA) until Sept. 16.

On Monday, U.S. District Judge Phyllis J. Hamilton in Oakland, Calif., ruled in favor of two California-based advocacy groups in finding that FDA must set a new timetable to implement delayed food safety reforms.

“(This) is a good day for food safety and for consumers,” said George Kimbrell, senior attorney for the Center for Food Safety (CFS), in a statement following Monday’s ruling. “Every day without the FSMA regulations is another day where consumers are at unnecessary risk. Because of this decision, our food will soon be safer from e. coli and other threats.”

The nonprofit CFS and the Center for Environmental Health (CEH) joined in the suit in fall 2012, alleging FDA had failed to meet a mandatory 18-month deadline to enact the new rules following passage of FSMA by Congress in 2011.

In her ruling, Hamilton held that “Congress signaled its intention that the process be close-ended, rather than open-ended. Thus, the court finds that imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the FSMA.”

The court then ordered FDA to meet with CFS and CEH and prepare a joint statement setting forth proposed deadlines by May 20.

“We look forward to working with FDA towards tighter regulations to protect Americans from unsafe food products and practices,” said Michael Green, executive director of CEH.

FDA has said it cannot comment on the decision pending further possible litigation, and it was unclear how the court’s ruling would impact the deadline extensions.

On Wednesday, FDA issued Federal Register notices to extend the comment periods on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (the Preventive Controls rule) and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety rule) until Sept. 16.

The proposals, originally published in the Federal Register for public comment on Jan. 16, are the first of five proposed rules that would establish the foundation of FSMA. The other three proposed rules – Preventive Controls for Animal Food, Foreign Supplier Verification Program and Accreditation of Third Party Auditors – are under review.

The agency said it granted the extension of the comment period “based on formal, written requests from many interested persons and groups that indicated more time was needed to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues in the two proposed rules.”

– Gary Pullano