Focus, Food Service & Agriculture, and Government

The FDA’s stick gets bigger

One of the significant changes requires foreign farms to be compliant with U.S. safety standards.

November 27, 2015
| By Pat Evans |
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FDA Stick
The U.S. Food and Drug Administration has three new legislative tools to help prevent food-borne illnesses. ©Thinkstockphoto.com

The United States Food and Drug Administration is getting a bigger stick to wave to help prevent food-borne illnesses.

The FDA released three new rules last month to move from reactionary to preventive when it comes to food-borne illnesses. These rules come a little more than two months following the 28-year sentence of Peanut Corp. of America CEO Stewart Parnell, who knowingly sent out products contaminated with salmonella that were blamed for nine deaths and making hundreds more sick.

The rules, however, are a result of the Food Safety Modernization Act signed by President Barack Obama in 2011, which directs the FDA to prevent the types of problems across the food system that sicken 48 million people annually, according to the U.S. Centers for Disease Control and Prevention.

The rules include Produce Safety, Foreign Supplier Verification Programs and Accredited Third-Party Certification.

The rules give the FDA far more oversight of producers’ and suppliers’ production methods, testing and recordkeeping. The laws will be phased in during the next three years.

With the three rules, the FDA has finalized five of seven major rules under the FSMA, along with two preventive controls rules for food processing and storage facilities in September. The final two are expected to be finalized sometime in the spring.

“These give the FDA a big stick to wave,” said Chris Predko, a partner at Warner Norcross & Judd who specializes in product regulation, safety and liability.

“Before, there were no real safety measures, and now with more oversight, folks will be more careful.”

These rules come on the heels of several high-profile outbreaks, Predko said.

Aside from the peanut salmonella outbreak, there was also a salmonella outbreak from imported cucumbers that killed four and hospitalized 157. Those outbreaks are exactly what these rules will attempt to address, said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine.

“The FDA is working with partners across the government and industry to prevent food-borne outbreaks,” Taylor said. “The rules will help better protect consumers from food-borne illness and strengthen their confidence that modern preventive practices are in place, no matter where in the world the food is produced.”

The new laws will require farmers, packers and holders to better document procedures, which will require consultants and lawyers, and testing of water, soil and grazing animals, and worker training and hygiene.

Predko said many businesses already are very careful in how they operate, but this will push them to document it.

Of specific note is the Foreign Supplier Verification Program, Predko said; imported foods account for approximately 15 percent of the U.S. food supply, including 50 percent of fresh fruit and 20 percent of fresh vegetables.

The new rule requires U.S. companies that are importing and distributing foreign foods ensure the foreign farms are compliant with U.S. safety standards.

“As we’re sitting down to holiday dinners or shopping, no one thinks how much food is imported,” Predko said. “The second thing is, do we think about what laws those foreign farmers comply with?

“This law should substantially cut down on these illnesses.”

The laws might not completely eliminate food-borne illnesses, but Predko said the FDA will work with local and state health agencies to enforce the new laws. The enforcement might range from drop-ins to checking on documentation or further inspections.

The enforcement ranges from a warning letter to fines, which help fund the inspections. Companies also have to register with the FDA, which gives the agency power to shut down companies.

Predko said the U.S. Department of Justice recently issued a memorandum for U.S. attorneys to ramp up prosecution of food company executives, such as Peanut Corp.’s Parnell.

“They’re getting serious,” Predko said. “With all the people getting severely sick, maybe it’s time they did.”

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