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FDA to double comment period for massive FSMA rules, Hamburg says

WASHINGTON — The Food & Drug Administration plans to extend the May 16 comment period on two food-safety rules by another 120 days, FDA Commissioner Margaret Hamburg announced at an April 18 congressional hearing on FDA's spending plan for fiscal 2014.

Ms. Hamburg appeared before a Senate Appropriations subcommittee to defend the administration's budget proposal when she was asked by Sen. Roy Blunt (R-MO) whether FDA would extend the comment period on the produce safety and preventive controls proposals.

"FDA took two years to draft the rules, yet they're allowing only 120 days for interested parties to comment," he said. "A number of those parties have requested an extension. I'm hoping you're looking at that extension."

"We appreciate these are complex rules, the proposed rules, to go through and analyze, and we do intend to extend the comment period so we can hear all the concerns and address them fully," she said.

Sen. Blunt asked how long the comments would be extended.

"I think a 120 days," the FDA commissioner replied.

The latest announcement comes just days after United Fresh Produce Association and more than 80 other groups asked FDA to extend the comment period due to the sheer size of the regulations and the need to see the other FSMA rules that have yet to be proposed.

"United Fresh appreciates FDA's willingness to provide more time for review of the proposed FSMA rules and looks forward to working with industry stakeholders and FDA during the deliberative review process," United Fresh posted in an alert to members.