FDA Must Accelerate Food Safety Rulemaking

(CN) - A federal judge was unsympathetic to demands by the Food and Drug Administration for more time to implement already overdue food-safety laws.

The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) sued the FDA and is commissioner, Dr. Margaret Hamburg, in August 2012, seeking to force the development and implementation of regulations under the Food Safety Modernization Act (FSMA).

Regulators have championed the FSMA, enacted by Congress in 2011, as the most sweeping reform in food safety laws in over 70 years. The act is intended to shift focus from response to prevention of contamination of the U.S. food supply.

Though the FDA was required under the act to develop and implement provisions of the new law in seven separate areas by designated dates, it missed all deadlines, prompting the lawsuit at hand.

The Federal Register has published proposed rules in four of the seven areas, but none have moved into final rule status, the court found. A fifth proposed rule is anticipated for November 2013.

U.S. District Judge Phyllis Hamilton noted that the court granted the plaintiffs summary judgment this past April, declaring that the FDA had violated the food safety law and the Administrative Procedure Act "by failing to promulgate the regulations by the statutory deadlines."

As for injunctive relief, the court accepted the plaintiffs' proposals for new deadlines in June 2013.

Moving to amend that order, the FDA said it cannot complete the final two proposed rules by the required date.

Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said the proposed rule on sanitary transport will not be ready for publication until early 2014. He estimated having the proposed intentional adulteration rule ready in the second half of 2015, with an anticipated publication of the final in the second half of 2017.

The FDA justified the extension requests by arguing that intentional food contamination is an area it has previously never regulated, and that preventative controls have always been voluntary. It said it needs more time to develop criteria that includes approaching the industry about how vulnerability is currently assessed.

Though the plaintiffs agreed to a 60-day extension for the sanitary transport rule, they refused to let the FDA delay the intentional adulteration rule.

Hamilton agreed.

"The court understands the FDA's position, and is in sympathy with it, but remains of the opinion that the dispute here is between the FDA and Congress," the seven page opinion states. "The court is unwilling to grant extension after extension, or to permit the FDA to continually delay publication of this rule, in the face of the clear Congressional directive that this be a closed-end process."

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