Article

by Carey Gillam

Long-awaited rules aimed at improving the safety of foods imported to the United States were proposed by the U.S. Food and Drug Administration on Friday.

The first-ever draft rules for safety oversight of imported food are part of a larger mandated food safety regulatory overhaul underway at the FDA, and part of a series of rules FDA is proposing that cover everything from vegetables and other produce to dog food.

Under the rules proposed Friday, importers would be accountable for verifying with their foreign suppliers that certain food safety standards are being met. Under current conditions, U.S. food safety inspectors examine food coming into the country but are able to inspect only a small percentage for potential problems. Importers have a market interest in ensuring the safety of the food they bring in, but currently are not required to mandate that their suppliers meet certain standards.

Under the new rules, importers would be required to maintain records verifying that their foreign suppliers have met standards for the production of the food coming into the country. Importers would undergo audits of their records and performance. The change should significantly improve food safety, according to the FDA.

Michael Taylor, FDA's deputy commissioner for foods, said in an interview that the new rule is the "central foundation" for an overall new import safety system.

"It embodies this paradigm shift from relying solely on FDA to detect and respond to problems and instead defining the responsibility and the accountability of the importers to prevent the problems," Taylor said.

FDA will continue to check products at points of entry into the country, and will increase foreign inspections and work more closely with foreign governments, Taylor said.

Food-borne illness is a serious problem in the United States. Roughly one in six Americans suffers from a food borne illness each year, and about 3,000 die, according to the FDA.

The FDA said annually illnesses associated with imported foods that would be subject to the new regulations costs about $1.18 billion, which is more than one-fifth of the entire estimated burden of illness related to foods consumed in the United States.

This summer, at least 150 people in the United States were sickened with Hepatitis A linked to frozen pomegranate seeds imported from Turkey and used in a berry mix sold in U.S. stores.

And cucumbers grown in Mexico and imported to the United States were linked to an outbreak of Salmonella earlier this year that made 84 people in 18 states ill.

The agency has said it cannot estimate quantitatively the benefits of the proposed rule. But while the proposed rule would not itself establish safety requirements for imported food, it would significantly help reduce illness and death by providing additional assurance that imported food is produced in compliance with certain rigorous safety standards, the agency said.

"We are very confident that if we are able to implement this over time we certainly will reduce the burden of illness," said Taylor. "We don't think we'll get to zero. But we know that these conscientious preventive measures work."

Sandra Eskin, director for food safety at The Pew Charitable Trusts non-profit organization, applauded the move as providing important extra protection for consumers.

"We have an ever-growing percentage of the food supply that is imported," she said. "This is important and long overdue."

The new rules are required by the Food Safety Modernization Act (FSMA) that was signed into law in January 2011 and the FDA has come under heavy criticism for taking so long to implement the requirements of the new law. Last August, the Center for Food Safety sued the FDA for missing several deadlines set under the law.

In June, a federal court ordered FDA to finalize all the rules by June 30, 2015 and said all draft rule proposals must be presented to the public by November 30 of this year.

Center for Food Safety senior attorney George Kimbrell said the FDA's new proposed rules were a "good development."

"It's unfortunate it required a court order and litigation," he said.

More rule proposals are in the works. Within the next few months, FDA hopes to issue a proposed rule on preventative controls for animal feed and pet food, Taylor said. It is also working on proposed rules to better control intentional harmful tampering with food and rules for transportation of foods.

"Food safety is a global problem. We're all eager to get this done as expeditiously as possible," said Taylor.

(Editing by Bob Burgdorfer)