WASHINGTON — More than two years after Congress passed a landmark law meant to prevent the import of contaminated food that sickens Americans, the Food and Drug Administration (FDA) proposed rules that for the first time put the burden on companies to police the food they import.
Major food importers and consumer advocates generally praised the new rules issued Friday, but the advocates also said they worried the rules might give the companies too much discretion about whether to conduct on-site inspections of the places where the food is grown and processed. They said such inspections must be mandated.
About 15 percent of food Americans eat comes from abroad, more than double the amount 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, Dr. Margaret Hamburg, FDA commissioner, estimated. About 130,000 are hospitalized and 3,000 die.
The FDA has tried to keep tabs on imports, but inspects only 1 to 2 percent of all imports at U.S. ports and borders.
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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 their foreign suppliers had controls in place with audits of the foreign facilities, food tests and reviews of records, among other methods. The companies also would have to keep records on foreign suppliers. They would be allowed to hire outside auditors to make on-site inspections, if such inspections were ultimately required. The auditors would be vetted in a process approved by the FDA.
Consumer advocates said the test would be whether importers were required to conduct such on-site audits, or whether that was 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 were “an important improvement over the weak current import system.”
Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA, said the different options reflected an effort to be flexible regarding a complex food supply.
These are the last major rules needed to put into effect the Food Safety and Modernization Act, a law passed by Congress in 2010 that was the first significant update of the agency’s food-safety authority in 70 years. The Obama administration has been criticized for taking more than two years to propose the rules. Some complained the administration 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 they already do much of what they would be required to do to avoid food outbreaks that could damage their global brands.
“What we’re really looking for is a level playing field here,” said Michael Robach, vice president for food safety at Cargill.
Consumer groups said outbreaks had persisted under the current system, and noted that a significant share of imports were brought to the United States by smaller companies.
The new rules on imports would cost $400 million to $500 million, 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 the food that Americans consume. The rest falls to the Agriculture Department, which is responsible for meat, poultry and some eggs.
The agency is asking for more resources for itself because its employees will be responsible for auditing the new company records. The FDA has about 1,600 investigators handling imports of everything from food to drugs and medical devices, a spokeswoman said. President Obama has requested about $260 million more in his 2014 budget, much of which would go to build the system to regulate imports.
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.