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New FDA Rules Focus on Food Production to Prevent Illness, Outbreaks

E. coli, salmonella targets of new Food and Drug Administration rules released today.


Preventing foodborne illnesses caused by salmonella and E. coli are behind stringent new rules proposed Friday by the US Food and Drug Administration.

The proposed rules implement the bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days.

“The FDA Food Safety Modernization Act is a commonsense law that shifts the food safety focus from reactive to preventive,” Health and Human Services Secretary Kathleen Sebelius said on the FDA website.

“With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families.”

One in six Americans suffer from a foodborne illness every year, the FDA said. Of those, nearly 130,000 are hospitalized and 3,000 die from their illnesses.

As an example, 33 people died from listeria linked to cantaloupes grown in Colorado nearly two years ago, The Associated Press reported.

Then, three more people died and 260 became ill last year.

Also in 2012, inspectors found salmonella throughout a peanut processing facility in New Mexico after 42 illnesses were reported.

The first rule would require producers – foreign or domestic – to develop formal plans for preventing foodborne illness and how to react if they do.

That could be as simple as ensuring workers wash their hands and keeping animals away from farmers’ fields, ABC News said.

The second proposal is focused on farms producing and harvesting fruits and vegetables.

The FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.

“We know one-size-fits-all rules won’t work,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

Additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards to strengthen the quality of third party food safety audits overseas.

An estimated 15 percent of food consumed in the US is imported, with much higher proportions in certain higher risk categories, such as produce.

The FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed today for human food.