FDA proposes rules to enforce standards for imported food

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WASHINGTON -- More than two years after Congress passed a landmark law meant to prevent the importation of contaminated food that sickens Americans, the Food and Drug Administration proposed rules Friday that for the first time put the main onus on companies to police the food they import.

Major food importers and consumer advocates generally praised the new rules, but the advocates also said they worried that the rules may give companies too much discretion about whether to conduct on-site inspections of places where the food is grown and processed. They said such inspections must be mandated.

The law itself was grappling, in part, with problems that have grown out of an increasingly globalized food supply. About 15 percent of food that Americans eat comes from abroad, more than double what it was just 10 years ago, including nearly two-thirds of fresh fruits and vegetables. And the safety of the food supply -- foreign and domestic -- is a critical public health issue. One in every six Americans becomes ill from eating contaminated food each year, FDA Commissioner Margaret Hamburg estimated. About 130,000 are hospitalized, and 3,000 die.

The FDA has tried to keep tabs on imports, but, in reality, only manages to inspect 1 percent to 2 percent of all imports at U.S. ports and borders.

The new rules would subject imported foods to the same safety standards as food produced domestically and require companies importing the food to make sure it meets those standards. U.S. companies would have to prove that their foreign suppliers had controls in place with audits of the foreign facilities, food tests and reviews of records, among other methods. The companies would also have to keep records on foreign suppliers. They would be allowed to hire outside auditors to make on-site inspections -- if such inspections are ultimately required. The auditors would be vetted in a process approved by the FDA.

Consumer advocates said the test will be whether importers are required to conduct such on-site audits, or whether that is left to the companies' discretion -- as one option proposed in the draft rules would allow. If that option becomes final, it would effectively allow the industry to police itself, advocates said.

"Without more clarity, this could end up as a paper exercise," said Erik Olson, head of food programs at The Pew Charitable Trusts. He added, however, that the rules are "an important improvement over the weak current import system."

Michael R. Taylor, the FDA deputy commissioner for foods and veterinary medicine, said the different options simply reflected an effort to be flexible in a very complex food supply. "We envision circumstances in which it would be required to have an on-site audit," he said. "We are trying to -- with these two different options -- flesh out different ways of getting there."

These are the last major rules needed to implement the Food Safety and Modernization Act, a 2010 law that was the first significant update of the agency's food safety authority in 70 years. The Obama administration has been criticized for taking over two years to propose the rules, with some complaining that the White House delayed acting to avoid Republican attacks, at the cost of public safety.

Some of the biggest importers, such as Wal-Mart and Cargill, praised the proposed rules and said their firms already do much of what the regulations would require to avoid food outbreaks that could damage their global brands.

Consumer groups said outbreaks have persisted under the current system.

The cost to industry of the new rules on imports would be $400 million to $500 million, Mr. Taylor said. The money reflects new costs, because, in the past, no one was legally accountable for ensuring safe food production before the food arrived in the United States.

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

The rules proposed Friday will be open to public comment for 120 days. They exempt seafood and fruit juices, which are subject to different rules.

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