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 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.
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, estimated Dr. Margaret Hamburg, FDA commissioner. About 130,000 are hospitalized and 3,000 die.
The FDA has tried to keep tabs on imports, but in reality manages to inspect only 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 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 R. 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," Taylor 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 that 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 also is 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.
The FDA has about 1,600 investigators handling imports of everything from food to drugs and medical devices, a spokeswoman said. President Barack Obama has requested about $260 million more in his 2014 budget, much of which would go to build the system to regulate imports.
"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 FDA official who is now with Leavitt Partners, a food safety and health care consulting firm in Washington whose clients include food companies. The current system, he said, "doesn't work anymore. So let's leverage the private sector."
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.
Olson of Pew Charitable Trusts said eight multistate outbreaks of illness linked to imported food products the FDA regulates have occurred since January 2011, when the bill was signed into law.
Caroline Smith DeWaal, the food safety director for the Center for Science in the Public Interest, a consumer health advocacy group, said the fact that there were two different options in the rule for on-site inspections indicated that there was disagreement within government – possibly between the FDA and the White House – over which policy to adopt.
Without on-site visits, she said, "importers could just rely on paperwork and promises that may or may not reflect conditions on the ground in these facilities."