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FDA Denied Request to Extend Terrorism Food Contamination Rule

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WASHINGTONA federal judge on Tuesday denied a request by the U.S. Food and Drug Administration (FDA) for more time to publish regulations that are intended to protect Americans from intentional attempts to contaminate the food supply.

Section 106 of the FDA Food Safety Modernization Act (FSMA) directed FDA to consult with the Department of Homeland Security in examining "biological, chemical, radiological or other terrorism risk assessments" and publish regulations "to protect against the intentional adulteration of food" within 18 months of the law's enactment.

FDA has missed a number of FSMA-imposed deadlines including the one above.

U.S. District Judge Phyllis Hamilton recently ordered the agency to publish final regulations by 2015.  

FDA essentially asked the court to reconsider its decision, in part.  Michael Taylor, FDA's Deputy Commissioner for Foods and Veterinary Medicine, advised the court his agency doesn't anticipate releasing a final rule on intentional adulteration until the second half of 2017.

This is an area the FDA has not previously regulated, Taylor pointed out. The agency must issue what's known as a "draft Advanced Notice of Proposed Rulemaking", which the agency is currently reviewing, he stated in a declaration with the court. In part, the notice is intended to discover how the food industry currently assesses vulnerabilities and protects against intentional adulteration.

In a 7-page order, the judge denied FDA's request for an extension on the intentional adulteration rule. FDA has acknowledged missing deadlines under FSMA, but it has cited the complexity of implementing the regulations under the law's aggressive timelines.

"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," Hamilton wrote. "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."

Shelly Burgess, a spokeswoman with FDA, declined to comment on the ruling, citing the pending litigation.

The Center for Food Safety, which brought a lawsuit against FDA for missing hundreds of deadlines, was obviously pleased with the ruling.

"This ruling is clear; FDA must step up and protect public health as it has been directed by Congress," George Kimbrell, senior attorney for the Center for Food Safety, said in a statement. "Postponing these rules only endangers more lives."

(A report released early this year by the US Pharmacopeial Convention sheds light on food fraud, which includes intentional adulteration of food ingredients. For related information, see image gallery: Food SafetyTainted & Adulterated Foods).


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