EAST LOS ANGELES, Calif. — At a sprawling warehouse here, two investigators from the U. S. Food and Drug Administration watched intently 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 spewing out a stream of chunky yellow ooze that would be collected, treated and disposed of in the sewer system.
FDA investigators had decided that the bottles of bean curds were improperly heat-sealed and, as a result, were susceptible to harmful bacteria like botulism, which can be fatal.
The case of the destroyed bean curds was relatively straightforward: They had been flagged as suspect as soon as they arrived in port due to a defective heat seal and were sent directly to an FDA warehouse for testing.
That’s not always how it happens.
The FDA’s Los Angeles district is one of the busiest in the U. S., overseeing the inspection of more than half a million food shipments arriving through 24 ports of entry in the L.A. area. Through the port stream products like Cambodian rice by the ton, tapioca pearls from the Philippines, tea biscuits from China, sugar cane and fish from around the world.
In 2010, about 3,500 shipments here were refused entry because they were contaminated with filth, pesticides, drug residue or traces of salmonella, according to a News21 analysis of the FDA's database of import refusals. Some of the imports contained unsafe color additives or were mislabeled. And some were even poisonous.
Nationwide, the FDA said that last year it rejected nearly 16,000 food-related shipments out of more than 10 million that arrived in more than 320 ports.
“If it comes in here and it’s bad,” said Denise Williams, a supervisor in the FDA’s Division of Import Operations in Southern California, “we’re gonna get ‘em.”
Except when they don’t.
Critics, including the U.S. Government Accountability Office, say the FDA 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.
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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 2.06 percent of all food-related imports. The FDA expects only 1.59 percent of all food imports to be examined this year and even less — only 1.47 percent — next year, according to its Office of Regulatory Affairs.
Which shipments get inspected is increasingly determined by a new computer system called PREDICT, or Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting, that is now used at 70 percent of U.S. import operations at land, sea and air ports. It analyzes information such as a manufacturer’s history with the agency, lab test results and even current weather patterns, assigning a risk-based score to each shipment to direct investigators toward the riskiest ones.
After a shipment is flagged, it's up to a person to investigate further. Investigators give top priority to the items with the highest scores and work their way down — at least, to the point they can with limited staff.
This summer, the FDA gave News21 unusual behind-the-scenes access at its largest operating district to show the ways in which front-line operations attempt to keep unsafe food from reaching American supermarket shelves and dinner tables.
“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.
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“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.
“The worst ones are fecal,” Angold continued, the fish inches from his face. “Some people refer to it as baby diapers. I don’t have kids, so …”
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 — or the evaluation of a food's taste, appearance, smell and texture — 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.
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A few doors down from Angold, entomologist John Sedwick placed a sample of sugar cane under a microscope and 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 prior to harvesting because they pose little threat to human health. If investigators are uncertain, they can consult the “Food Defect Action Levels,” a manual that sets out exactly how many insect parts, larvae or animal hairs are acceptable.
“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.”
Entomologists also look for “anything that a human would find repulsive or aesthetically displeasing,” he said.
“I’ve had samples where I’ve found rat hair, shrew hair, bat hair … beetles, maggots … all in one sample,” he said.
Those are the food products the FDA rejects, either ordering the food to be destroyed like the Chinese bean curd or returned to the country it came from.
Circumventing the system
The food inspection system is far from foolproof.
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.
But once food products are in the hands of the importer, there are opportunities for fraud. To thwart investigators, importers may re-label a shipment or swap out the original product for something more likely to pass FDA inspection, said Williams, the FDA supervisor.
Sometimes importers will mislabel products they know will get scrutiny.
“And they do get clever,” Williams said.
A section of the Long Beach warehouse called “the museum” houses hundreds of confiscated items that importers tried to slip into this country by calling them something other than what they are.
The counterfeit Nike shoes piled onto one table were labeled rice sticks, Williams said. These will be passed to U.S. Customs and Border Protection, which might slap the importer with a fine.
FDA investigators admit they can’t catch every risky import. There’s just too much.
The FDA outlined some of the ways it is trying to keep up in a special report issued in July 2011 titled “Pathway to Global Product Safety and Quality.” In the report, the agency said it has opened offices in several large food-exporting countries, including China, India and Costa Rica, and has boosted the number of inspections in other countries in an attempt to stop problems at the source.
Still, the report paints a gloomy picture of the FDA’s ability to cope. “Despite … recent improvements, FDA does not — nor will it — have the resources to adequately keep pace with the pressures of globalization,” the report states.
Carl Nielsen, former director of the FDA’s Office of Regulatory Affairs Division of Import Operations and Policy, said the biggest problem the FDA faces is an antiquated structure that focuses mostly on domestic food.
The FDA has about 1,800 investigators who oversee more than 44,000 U.S. food manufacturers and more than 100,000 additional registered food facilities, such as warehouses and grain elevators.
At the same time, the agency is responsible for nearly 200,000 foreign food facilities that have registered with the FDA in order to import the millions of food shipments that arrive in the U.S. each year.
With numbers like that, “Where would you want the people?” Nielsen said. “Would you want some people at the border? Well, there’s very few.”
FDA Public Affairs Officer Patricia El-Hinnawy said the number of investigators assigned to examine imported food shipments nationally is 277 full-time equivalents. That’s just five more than in 2009. These employees do field exams, sample collections and conduct security reviews, among other things, at ports of entry around the country.
Nielsen said the FDA’s food import operations are “still a bastard child” within the FDA. Until the agency sets up a separate, well-financed division devoted to food imports, inspections are “not going to happen effectively for a very, very long time,” he said.
A new mandate
The Food Safety Modernization Act, passed earlier this year, gives the FDA a new mandate to make certain 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 to double the number of inspections each year for the next five years. That would mean 19,200 foreign inspections in year six.
By the numbers: FDA in brief
The FDA inspected 354 foreign food establishments in 2010 and estimates it will inspect 994 in 2011.
In its July report, 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.
Where does your food come from?
See America's food-related trade history by rolling over the foreign country on the map.
- Where does your food come from?
Technology, Nielsen said, has long been the biggest weak spot in the FDA’s ability to monitor food imports. In 2000, FDA officials came up with a list of 10 things they needed to better monitor imports, and seven of them 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 U.S. House of Representatives would cut $285 million from the agency’s 2012 budget, with $35 million coming from food safety, according to the Agriculture Appropriations Bill.
Los Angeles District Director Alonza Cruse said the FDA has made major improvements over the past decade, including better communication and collaboration with other agencies such as U.S. Customs and Border Protection and the use of PREDICT, the new computer system that is helping pinpoint which shipments should be inspected.
But while PREDICT is a powerful tool, the safety of food imports still lies largely in the hands of investigators like Denise Williams and scientists like Steve Angold.
Until someone invents a robot that can distinguish safe food from unsafe food, Cruse said, it’s “a person who has to ultimately decide, yea or nay.”
While tools may be able to help do that more quickly, he said, ultimately "it all comes down to a person.”
Coming Tuesday: As farmers markets thrive, so do concerns