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Regulatory Watch

September 1, 2009
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FDA likely to gain more authority

A major overhaul of the nation’s food safety system moved a step closer to reality at the end of July, as the US House of Representatives voted to require the FDA to perform more processing plant inspections and give the agency authority to order recalls of tainted food. Under current laws, the agency can only request a recall.

In addition to giving the FDA more authority, the House voted to give the agency more resources. Under the measure, food companies would have to pay a fee of $500 per year per food processing plant. The Congressional Budget Office estimates the fee would generate $1.4 billion over five years.

The measure has strong support by Congressional Democrats and the White House. Assuming the Senate also approves it this fall, President Obama has said he would sign it into law.

New FDA inspection enforcement plan

Food companies will now have to respond more quickly after a visit from an FDA inspection team. The agency implemented a new enforcement plan, giving food companies a maximum of 15 business days to file a response to an inspection. The new rule takes effect September 15.

Currently, company responses can take months to complete. According to the FDA, the new procedure will encourage prompt voluntary compliance and streamline the process of sending warning letters, when necessary. Under the new rule, companies will respond the way they always have.

Once the agency completes an inspection, the company will receive FDA Form 483, a report that details any objectionable conditions or violations observed during the inspection. The company then may respond with objections to the observations or explanations about any corrective actions taken. The new plan also:

• Requires FDA to work quickly to assess and follow up on corrective action taken by the processor after a warning letter is issued or a major product recall occurs.

• Requires FDA to take immediate action in response to public health risks, moving more quickly and aggressively than in the past.

• Allows FDA to develop and implement a formal warning letter “close-out” process. If the agency can determine a firm has fully corrected violations raised in a warning letter, the agency will issue an official “close-out” notice and post it on line.

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