Loophole keeps FDA in the dark on tainted food imports

SAN FRANCISCO -- About 150 imported food shipments a month are tested at a laboratory here for contaminants consumers shouldn't eat, like mercury in swordfish, salmonella in shrimp and filth in mushrooms.

At least 10% of the time, the lab finds the shipments contaminated, says David Eisenberg, chairman of Anresco Labs.

Most of the time, the lab tells no one but the importer who's paying for the test, Eisenberg says. The Food and Drug Administration is none the wiser.

The practice has been going on for years, at Anresco and other labs that test imported food. The FDA gets the favorable test results, but failing ones aren't sent to the FDA if importers tell labs not to send them, five lab operators told USA TODAY.

This is not news to the FDA, which regulates most of the imported foods consumers eat. There is no regulation requiring labs to send all tests to the agency. The FDA proposed that in 2004 but never followed through.

Even now, with imported food safety high on Congress' priority list, nobody has proposed closing that loophole. Some lab operators say it should be because it puts the public at risk and forces labs to sacrifice full disclosure in order to retain importer clients. "We don't lie. We have to do what we have to do to … keep our customers. We're working for the importer," Eisenberg says.

He says the FDA's failure to require labs to submit all test results forces labs to protect importers more than the public. He also says the situation undercuts confidence in the private lab industry, which he wants the FDA to entrust with more testing on imported foods.

"The system is my big complaint," Eisenberg says. "I figure Anresco and the public will benefit from an honest system."

Keeping failing results from the FDA doesn't necessarily mean that bad food gets past the FDA to consumers. Without a passing test result, the food the labs test automatically gets rejected by the FDA as unfit.

The concern is that unscrupulous importers who get bad test results from one lab will hire another lab to test the food, get a passing result and give only that to the FDA. The agency would then likely give the food a green light for sale in the USA.

"The idea is the importer will go to a different lab and hope to get a different result," says Lars Reimann, chief scientific officer for lab Eurofins Scientific.

Like Eisenberg, Reimann says he's had importers threaten to take business elsewhere if labs insist on reporting results showing tested products violated FDA standards.

Rolando Perez, technical director of Florida's Adpen Laboratories, says his lab has been recently threatened with lawsuits by Chinese seafood producers who didn't want bad results submitted to the FDA. He also says he's had importers take product that his lab found in violation to another lab for retesting.

The situation "puts us in a bind," Perez says. "We're supposed to be an independent lab."

The selective reporting of test results has raised the ire of congressional investigators reviewing the FDA's oversight of food safety.

David Nelson, senior investigator for the House Committee on Energy and Commerce, testified before lawmakers in October that not reporting test failures is "common practice" by the private labs, which aren't formally regulated or inspected by the FDA yet test thousands of imported food shipments a year.

"We've heard that there are labs that don't find products … ever to be out of compliance," Nelson testified. "And we've found labs that don't report all test results."

The FDA doesn't dispute that not all test results get reported. "We're not happy with that," says Domenic Veneziano, director of the FDA's division of import operations.

But neither does the agency have evidence that importers are, in fact, sneaking contaminated food through by hiding bad results and having their products retested by other labs that miss problems. "I'm not aware of any instances of that," says David Acheson, the FDA's assistant commissioner of food safety. "But no one could say it's not a potential concern."

By mid-2008, he says, the FDA will issue guidance setting standards for imported food testing by the labs, including the use of labs accredited by an outside body as a way to ensure quality.

Details are in flux. Acheson couldn't say whether the standards would include that labs submit all test results. "We need to do a better job of assuring that if there is a hole there, we plug it," he says.

Rep. Bart Stupak, D-Mich., who has held three congressional hearings this year on the government's oversight of food safety, said in a statement that the FDA needs to require reporting of all lab test results so that "food importers do not cherry-pick the results in order to sneak tainted foods into our nation."

A system that has allowed test results to go unreported for years, Stupak says, is "another glaring example of the many gaping holes in our nation's food safety net."

'Import alert' status

The FDA tried to fix the problem in 2004 when it proposed requiring that all test results from private labs be reported directly to the FDA. The agency sought to "prevent importers from choosing not to submit results from violative shipments" so that shipments could be retested "into compliance and admitted into the United States," according to its proposal.

Some importers may not "choose to report results showing that the shipment is a health hazard and instead take the shipment to another port," the FDA said then.

It also said that importers may choose not to submit results so as not to "disrupt the count of consecutive non-violative shipments" needed to get off import alert.

Most of the 9 million imported food shipments coming to the USA each year pass FDA muster within seconds of arriving.

The foods being tested by the private labs face a much higher hurdle. The FDA has put them on "import alert" because they have a history of safety violations. That happened in April with wheat gluten from China after contaminated product led to the biggest pet-food recall ever.

Foods on import alert are automatically detained by the FDA, and they're not cleared for sale unless the importer proves them safe. Typically, importers hire private labs such as Anresco, one of the biggest, to test the product and give those results to the FDA.

Foods that don't pass are supposed to be exported, destroyed or brought up to standard. For example, a product declared filthy may be cleaned and then pass.

To get off import alert, shippers need at least five consecutive clean shipments. Other criteria, such as proving to the FDA that the shipper has adopted new manufacturing practices, may also be required. Getting off import alert is a big deal because food shipments are more likely to be subject to regular review by the FDA, which inspects 1% of food imports.

Eisenberg says some shippers on import alert don't want to report bad results to the FDA because they know it'll break their string of consecutive clean shipments, and they'll have to start over.

If no result is submitted, shippers think there's a chance that the FDA's record-keeping system won't catch it and won't count it against the string of five. They hope to "game the system," Eisenberg says.

The FDA says that's a false hope, even though its own 2004 proposal mentioned it as an incentive for importers to not report failed results. The agency says that a shipment that isn't proved to be clean because no lab results are submitted breaks the string just as an unfavorable lab result does.

"It happens all the time. If you don't get a passing result, it counts against you," says Martin Mitchell, director of Certified Laboratories in New York, another large lab that does FDA import food testing.

Mitchell says Certified also won't submit test results if the importer says not to. But Mitchell says that "happens rarely" and that it's not a concern because a food shipment covered by an alert "gets refused, which is what this is all about."

Importers who try to hide bad test results and sneak product in by getting it retested also run the risk of criminal prosecution. When test results get submitted to the FDA, importers sign statements saying that the results represent all the tests done on the shipment.

"It's not foolproof," says Peter Kmieck, director of Kappa Laboratories. But it is "a checks-and-balance system."

Lots of work at a handful of labs

The FDA estimated in 2004 that 100 labs test imported food, but industry executives say a handful do the bulk of the business.

Anresco employs 30 people at its lab in a gritty industrial and residential neighborhood on San Francisco's south side. Inside, appliances familiar in any household kitchen — such as blenders and refrigerators — stand near gleaming $300,000 instruments that detect drug residues in fish.

FDA-related work accounts for 40% of Anresco's $2.8 million in annual revenue, Eisenberg says. That business is up 30% this year because of new import restrictions on some Chinese seafood and other products, he says.

The private labs have toiled in obscurity for years. But they took a public beating in July when congressional investigators testified at a hearing that two FDA lab officials had told them that some labs' work was "shoddy," "scary" and "spooky." The FDA officials, who check the private labs' work when considering whether to allow a food shipment into the USA, were not identified.

Lab directors and importers dispute such broad characterizations. They are unfounded statements, "without verifiable proof," Michelson Laboratories said in a statement.

Last summer,a coalition of food importers even proposed that the FDA allow private labs to test more imported food than they do now. Lawmakers derailed the idea, partly out of concern that the FDA would outsource work from its 13 labs to private ones.

Different issues blocked the FDA's 2004 proposal for better regulating the private lab system. Along with full reporting of favorable and unfavorable tests, the proposal included numerous ways for the FDA to regulate the industry. One was to require importers to tell the FDA ahead of time which lab would test shipments so that the FDA could catch possible fraud if a different lab submitted test results.

The proposal has languished and faced opposition from food importers, a lab association and others. They argued in filings to the FDA that the proposal failed to establish national standards and failed to address lab accreditation. At the time, the FDA said it was "premature" to require that private labs be accredited because it had questions about which standards to use and how it would ensure that the accrediting body was competent. Acheson says the FDA is now considering accrediting the labs itself, which the agency has previously said it lacked resources to do. Stupak says the FDA's current plans for accreditation are vague. He says the labs should be certified, inspected and accredited by the government.

"The FDA hasn't done the hard work of establishing standards," says Benjamin England, a former FDA attorney who now consults to companies on import regulations. "The lack of standards promotes an impression that (the labs) are out of control. But it's not the labs' fault. It's really the FDA's fault."