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Judge orders FDA to pick up the pace on food safety

Two years after Congress ordered it to do so, the agency has not implemented the new food safety law

Heeren Brothers cantaloupes, recalled in August 2013

After listening to lengthy arguments from the Food and Drug Administration, a federal judge has reached the same conclusion as the General Accounting Office did recently -- namely, that food safety oversight in the United States is fragmented and inconsistent despite a law passed by Congress in 2011 that was supposed to change things.

The Food Safety Modernization Act (FSMA) was intended to beef up government efforts to prevent foodborne illness and consolidate inspection and enforcement under the Food and Drug Administration (FDA). But two years later, FDA is still in the process of implementing the FSMA's provisions -- and one in six Americans are falling ill to food poisoning each year -- to the dismay of food safety advocates.

This chart prepared by the Center for Food Safety shows that foodborne illness outbreaks that have occurred since the food safety law was enacted in January 2011.


Advocates file suit

Buurma Farms cilantro, recalled in August 2013

Tired of waiting, the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) sued the FDA and its commissioner, Dr. Margaret Hamburg, in August 2012, seeking to force the development and implementation of the regulations that would fully implement the FSMA and now, U.S. District Judge Phyllis Hamilton has ordered the FDA to start meeting the deadlines established by Congress.

“This ruling is clear; FDA must step up and protect public health as it has been directed by Congress.  Postponing these rules unnecessarily only endangers more lives. Center for Food Safety is pleased by today’s ruling and will continue to work to ensure consumers have a safe and healthy food supply,” said George Kimbrell, senior attorney for the Center for Food Safety.

In April, Judge Hamilton granted the plaintiffs request for summary judgment and declared that the FDA had violated the food safety law and the Administrative Procedure Act "by failing to promulgate the regulations by the statutory deadlines" and ordered the FDA to issue the new rules by June 2013.

The new rules cover seven separate topics. Four have been published in draft form but none has yet made it into final form. A fifth is expected to be published in November 2013.

Still undone are rules covering sanitary transport and intentional adulteration. 

Not til 2017

Bolthouse Farms carrots recalled in November 2012

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 -- six years behind schedule.

Why so long? Well, the FDA argued that intentional food contamination is an area it has never regulated before and said it needs more time to consult with the food industry about how it has been handling the problem.

Judge Hamilton agreed to a 60-day extension for the sanitary transport rule, as did the plaintiffs, but he said time had run out on the intentional adulteration rule.

"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." 

None of this is sitting very well in Congress. 

A few weeks ago, Rep. Rosa DeLauro (D-Conn.) suggested "special interests" were pressuring the FDA to slow the process in an effort to water down the rules.

“American families are already living with the specter of foodborne illnesses and contamination hanging over them," DeLauro said. "It is shameful that in a country as wealthy and prosperous as ours, with all the scientific and technological knowledge we possess, parents still have to worry if ground beef, cantaloupe, spinach, or any other number of foods, will send their children to the hospital, or possibly even their death."

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