FDA changes approach to food safety inspections

FDA changes approach to food safety inspections

Hoping to shore up sagging public confidence, the Food and Drug Administration has abandoned the use of random inspections to ensure food safety in favor of inspections targeted at high-risk production sites.

Under the new approach outlined this month, the agency will focus its attention on farms with poor safety records, importers with lower quality standards, and other at-risk food suppliers.

FDA has struggled with its image this year because of its sluggish response to a salmonella outbreak. It took months to find the source - peppers grown in Mexico - and several more weeks to find the farm that grew the peppers.

The new approach is the first step toward modernizing the inspection process, said Dr. David Acheson, FDA's associate commissioner for foods.

 "We're trying to make better use of the data we've got. Do we need more data? Probably," Acheson said in an interview this month. "But it shouldn't be: ?Well, we don't have enough data, so we'll just do random inspections.'"

But critics say the agency doesn't have enough data to know which farmers and distributors are high risk. The problem is particularly acute for imported food, they claim, because less than 1 percent of imported food is tested.

"How do they determine risks when they're doing so little testing?" asked Patty Lovera, assistant director of Food and Water Watch, a nonprofit consumer advocate. "Only a fraction of the food ever sees a lab."

Americans eat about 40 percent more imported food today than in 1995; the food is produced by more than 189,000 facilities. The growing volume of imports means FDA has little choice but to conduct risk-based inspections: It costs, on average, $16,700 to inspect a foreign facility, so the cost of inspecting each facility once - $3.2 billion - exceeds FDA's annual budget.

The agency is trying to cut down those costs by opening field offices overseas. The first one, in China, opened last month; FDA planned to open two offices in India this month, but Acheson said the attacks in Mumbai will delay those openings.

The foreign offices will lower the cost per inspection, but they will still tax the agency's resources, according a Government Accountability Office report released earlier this year.

"[The] establishment of an FDA field office in China will likely require a long-term commitment of agency resources," GAO wrote. "The overall resource need could be significant."

And the small number of offices - FDA currently plans to open less than a dozen - means the agency is still able to inspect only a small percentage of foreign food facilities.

"What will it take for them to inspect a higher proportion of imports?" Lovera asked. "That's where the cracks show. ... The agency is completely outgunned when it comes to imports."

Critics, including GAO, say the food protection plan also doesn't have enough benchmarks. There are fewer outbreaks of food-borne illness today than a decade ago, but that doesn't necessarily mean FDA is doing a better job at inspections.

"There's not a lot of assessment as to whether they're being effective," said David Plunkett, a senior staff attorney at the Center for Science in the Public Interest. "There are no benchmarks."

Acheson said identifying the highest-risk producers, and inspecting them more frequently, would be one benchmark for measuring the plan's effectiveness.

FDA will also improve food safety by working more closely with the private sector - but will not turn over inspections to private companies, he said.

"We're not in the business of contracting out FDA inspections," he said.

Instead, the agency wants to take advantage of the private inspection data that many companies already collect. Major food retailers, for example, require their produce suppliers to meet certain standards, and they inspect those suppliers regularly. Acheson said FDA could use that information to shape its high-risk list.

FDA is working on a pilot program with several major shrimp producers. The companies will send FDA information about how they certify suppliers; Acheson said the agency would periodically send its own inspectors to "look over their shoulders."

The agency also wants to improve its computer systems to better analyze complaints about food products, Acheson said.

"We're trying to pick up the more subtle signals around consumer complaints that are harder to mine," Acheson said. "Say we get complaints about a canned product. ... If you mine the data, and the cans all come from one manufacturer, maybe the canning process at that firm is not up to snuff."

Consumers generally make those complaints to their state health agencies, which send information to the federal Centers for Disease Control and Prevention in Atlanta.

FDA intends to ask Congress for a big investment in food safety. It received a $150 million supplemental at the end of 2008; Acheson said he'd like a similar amount added to FDA's budget for the next few years.

Some of the money would be used to hire new inspectors. The agency is trying to conduct more inspections each year: It conducted about 5,900 in fiscal 2008, up from 2007, but still below the 6,000 it conducted in 2004. The decline is largely due to the agency's perennially tight budgets.

The agency also wants Congress to act quickly to pass its legislative agenda. FDA wants to require food facilities to register with the agency every two years; that would give the agency an up-to-date list of producers, and a steady source of fees. FDA also wants the authority to issue mandatory recalls of contaminated food products.

"There's been a lot of language from the Hill, but nothing has ever turned into a bill," Acheson said.


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