FDA inspectors not keeping pace with imports

October 22, 2011

Inside the giant warehouse, past the labyrinth of cubicles and corner offices, behind the security door marked “Authorized Personnel Only,” the smell isn’t all that bad today.

“Sometimes it’s unbearable,” said Denise Williams, a supervisor in the U.S. Food and Drug Administration’s Division of Import Operations here in Southern California.

The warehouse is one of several in the Los Angeles district where Williams and FDA investigators spend their days sorting and inspecting thousands upon thousands of boxes that fill an area larger than four football fields.

The FDA reported that in 2010 it refused nearly 16,000 food-related shipments out of the more than 10 million that arrived at more than 320 U.S. ports.

“If it comes in here and it’s bad,” said Williams, “we’re gonna get ’em.”

Except when they don’t.

The FDA admits it is simply not up to the task of ensuring the safety of food imports, which are entering this country in ever-growing numbers. The FDA expects 24 million shipments of FDA-regulated goods to pass through the nation’s ports of entry this year, up from 6 million a decade ago.

During that time, the number of FDA investigators stayed constant at about 1,350. The agency began adding investigators in 2009 and now has about 1,800 — still far short of the number required to keep up with the pace of imports.

In 2010, FDA inspectors physically examined 2.1 percent of all food-related imports. The FDA expects only 1.6 percent of all food imports to be examined this year and even less — only 1.5 percent — next year, according to its Office of Regulatory Affairs.

Filthy food

“The Nose” prepares to sniff his way down a mahi-mahi fillet.

Steve Angold works out of a narrow lab at the FDA’s new $40 million testing facility in Irvine, Calif. He is one of about 25 FDA specialists across the country who rely on their senses of sight, touch, taste and smell to detect decomposition or filth in food products.

“It’s either pass or fail,” Angold said. “Ocean grimy smells would be passing; even stale or fishy odors would be passing.”

But if the food smells like turnips or cabbage, it’s probably spoiled, he said.

Reaching the tail, Angold laid the fish on a sterilized countertop.

“There’s nothing wrong with this fish,” he announced. “It’s pretty good.”

Organoleptic testing is one of several methods the FDA uses to determine the safety of food products. Others include chemical and microbiological tests as well as tests to detect insects.

A few doors down from Angold, entomologist John Sedwick placed a sample of sugar cane under a microscope. He moved the petri dish slowly under the lens until he spotted black ants — some whole, some cut in half, all dead — among the particles of sugar.

The FDA is tolerant of ants and other field insects that get mixed in with foods before harvesting because they pose little threat to human health.

“Other things like blowfly maggots, cockroaches, they carry a whole host of foodborne pathogens,” such as bacteria and viruses as well as parasites, Sedwick said, “so there’s a very low tolerance for those kinds of insects.”

The FDA rejects food products with those insects, ordering the food to be either destroyed or returned to the country it came from.

Circumventing the system

At a warehouse in East Los Angeles, FDA investigators Arnold Shih and Dennis Hoang watched as 50 boxes of preserved bean curd from China were emptied into a grinding machine.

The monstrously loud apparatus worked its way through 1,800 glass bottles, grinding the glass and spitting out a stream of chunky yellow ooze. This ooze is then collected, treated and disposed of in the sewer system.

Investigators had decided the bottles of bean curds were improperly heat-sealed and as a result were susceptible to harmful bacteria such as botulism, which can be fatal.

The case of the bean curds was relatively straightforward: It had been flagged as suspect as soon as it arrived in port and was sent directly to an FDA warehouse for testing.

That’s not always how it happens.

In order to avoid holding up commerce, food shipments often are allowed to proceed directly from a port to the importer. The FDA may decide to physically inspect a shipment only after it has been moved.

Inspectors then look at the riskiest shipments first, based on factors including the firm’s history of violations, the type of product — seafood and fresh fruit are more likely to be inspected than other products — the season and the country of origin.

To thwart investigators, importers may re-label a shipment or swap out the original product for something more likely to pass FDA inspection, Williams said.

Importers also have been known to circumvent orders to destroy or return shipments to their home countries, she said. For example, they might place contaminated food on top of a shipment and load the bottom with rocks or debris, hoping that federal inspectors, who must be present during export or destruction, will check only the boxes on top.

FDA investigators admit they can’t catch every risky import. There’s just too much to catch.

Technological challenges

The Food Safety Modernization Act, passed earlier this year, gives the FDA a new mandate to make certain that food is safe for U.S. consumers. Among the requirements are stricter rules for imported foods and more inspections.

The law places more responsibility for food safety on foreign manufacturers. And it calls for the FDA to inspect at least 600 foreign food facilities within the next year and double those inspections every year for the next five years. That would mean 19,200 foreign inspections in year six.

The FDA estimates it will inspect 994 foreign food establishments in 2011.

In a report issued in July titled “Pathway to Global Product Safety and Quality,” the FDA said the 2011 goal might be attainable but not the rest.

“It would be impossible for FDA to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the report said.

More resources also are needed for intelligence-gathering and technological improvements, such as a global data-information-sharing system, the FDA report said.

Technology has long been the biggest weak spot in the FDA’s ability to monitor food imports, said Carl Nielsen, former director of the FDA’s Office of Regulatory Affairs Division of Import Operations and Policy.

In 2000, FDA officials came up with a list of 10 things they needed to better monitor imports, and seven had to do with technology, Nielsen said.

“And I promise you, they’re still not done,” he said.

Additional resources are unlikely as Congress cuts spending in an effort to reduce the nation’s debt. A measure in the House would cut $285 million from the agency’s 2012 budget, with $35 million coming from food safety.

— News 21

This report was produced as part of the Knight-Carnegie News21 program, a  national university reporting project headquartered at the Walter Cronkite School of Journalism and Mass Communication at Arizona State University. Student reporters worked from the Cronkite School and from the Philip Merrill College of Journalism at the University of Maryland.

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