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 the rules may 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.
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, 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, in reality, only manages to inspect one to two 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 that 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 Taylor, deputy commissioner for foods and veterinary medicine at the FDA, 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 they already do much of what they would require 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. He said the company was still studying the rules to determine what changes, if any, it would have to make.
Consumer groups said outbreaks have persisted under the current system, and noted that a significant share of imports are brought to the United States by smaller companies.
The cost to industry of the new rules on imports would be $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 current system “relies on the FDA detecting and reacting to problems at the border,” Taylor said. “The big paradigm shift is toward prevention and industry being responsible for documenting what they have done to prevent problems.”
The agency is also asking for more resources for itself since staff will be responsible for auditing the new company records, though some observers say Republican opposition in Congress may make additional money to carry out the regulations difficult to obtain.