WASHINGTON — The Food and Drug Administration proposed sweeping new rules on Friday that would require food importers like Walmart and Cargill to make sure that their foreign growers and processors were following American food safety standards to prevent contamination in an increasingly globalized food supply.

About 15 percent of food that Americans eat comes from abroad, including nearly two-thirds of fresh fruits and vegetables.

The rules, if made final, would shift the responsibility for ensuring that food is safe from the F.D.A. to companies. American companies would have to prove that their foreign suppliers had controls in place through actions like auditing the foreign facilities, testing food, and reviewing records. American importers would have to keep their own records on foreign suppliers. They would be allowed to hire outside auditors to make on-site inspections.

These are the last major rules needed to implement the Food Safety and Modernization Act, a landmark law passed by Congress in 2010 that was the first significant update of the agency’s food safety authority in 70 years. The administration has been criticized for not moving more quickly to carry out the law. The first set of rules, which applied to domestic producers, was proposed in January. The new rules proposed Friday exempt importers of seafood and fruit juices.

The cost to industry of the new rules on imports would be $400 million to $500 million, said Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the F.D.A.

“If you look at the cost of doing it all by the feds, what you end up with is inadequate dollars,” said Dr. David Acheson, a former F.D.A. official who is currently with Leavitt Partners, a food safety and health care consulting firm in Washington. The current system, he said, “doesn’t work anymore. So let’s leverage the private sector.”

The new rules would represent a major shift in the way the United States handles food safety by subjecting imported foods to the same safety standards as food produced domestically. Under the current system, the F.D.A. has very limited authority to ensure the safety of food produced abroad. It inspects less than two percent of all imported food.

“We don’t live in local land anymore,” said Dr. Acheson. “Though many people want to buy local, the reality is most Americans are buying things in big stores and relying on imported products.”

Consumer advocates said it remained to be seen whether the new rules would have a real effect, and that the test would be whether importers would be required to make sure their foreign sellers were adhering to new standards, or whether it would be voluntary. The Obama administration has also been criticized for taking two years to complete the rules, with some complaining that the White House was more concerned about protecting itself from Republican criticism than about public safety.

The draft rules will be open to comment from the public for 120 days, the agency said. The comment period will end in the late fall for Friday’s rules as well as the ones proposed in January.

The Food and Drug Administration is responsible for the safety of about 80 percent of the food that Americans consume. The rest falls to the Agriculture Department, which is responsible for meat, poultry and some eggs.

Mr. Taylor said the goal of the changes is to build a system that prevents food contamination rather than reacting to it.

“Less than 2 percent of import shipments are physically examined, and we’re up to around 10 million food products annually,” he said. “We all realize we need to do more.”

The agency, which has about 1,600 investigators handling imports of everything from food to drugs and medical devices, has also asked for more funds. President Obama’s 2014 budget reflects that, Mr. Taylor said, requesting about $260 million in additional resources, much of which would go to build the system to regulate imports.

Erik Olson, a researcher at the Pew Charitable Trusts, which advocated for passage of the law, said the new rules would work only if they required an audit and that it was not clear that they did.

“That could end up as a paper exercise,” he said. “We view on-site verification as absolutely critical to a successful program.”

Mr. Olson said that 8 of the 19 multistate food outbreaks linked to F.D.A. regulated products that have occurred since January 2011 when the bill was signed into law have been linked to imports. Most recently, pomegranate seeds from Turkey sickened more than 140 people across the country with hepatitis A.

Article source: http://www.nytimes.com/2013/07/27/health/fda-proposes-rules-to-ensure-safety-of-imported-food.html?partner=rss&emc=rss