FDA wants states to grade their own inspectors

After years of scant federal oversight, Georgia food inspectors soon will come under scrutiny from new regulators: themselves.

The U.S. Food and Drug Administration wants states to assess their own inspection programs, even after Georgia’s failed to prevent a salmonella outbreak traced to a Blakely peanut plant, exposing broad gaps in the nation’s food safety system.

Shifting responsibility unburdens the FDA from a task that, in Georgia at least, it has left undone.

Each year, the FDA is supposed to evaluate the performance of states it pays to inspect food processors on its behalf. But the agency hasn’t formally reviewed Georgia since at least 2001. During that time, eight people contracted botulism from chili sauce canned in Augusta, contaminated peanut butter from Sylvester sickened hundreds, and salmonella-tainted products from Peanut Corporation of America have been blamed for nine deaths and more than 700 illnesses.

With no feedback, inspectors at the state Agriculture Department have assumed they were doing a good job.

“If they haven’t raised issues, they don’t have any issues with how we conducted those inspections,” said Oscar Garrison, Georgia’s assistant agriculture commissioner for consumer protection, referring to the FDA. “That’s all we have to go on.”

This no-news-is-good-news approach is but one of many fissures in a system intended to guarantee safe food supplies, according to food safety experts, former FDA officials and other observers.

The FDA has delegated about

80 percent of food processing inspections to state regulators. But it pays states far less than it would spend to conduct its own inspections, and Georgia inspectors spend far less time in food plants than their federal counterparts.

Agencies with food safety responsibilities often don’t communicate with each other and, in some cases, are prevented by law from sharing information. When catastrophes such as the Peanut Corp. salmonella outbreak occur, no single federal, state or local agency has the authority to take charge.

And, faced with chronically inadequate budgets, the FDA is shifting more responsibilities to states not only to conduct inspections, but to assess their own performance. After months in the spotlight for missed chances in the Peanut Corp. case, Georgia has until October to complete its first evaluation. Among the components of the examination: certifications that inspectors have adequate training, laboratories are properly funded, and state regulations conform with federal food safety standards.

Many food safety experts are skeptical that self-analysis will lead to more rigorous application of food safety laws.

“That will work only if FDA is auditing and monitoring those programs,” said Caroline Smith Dewaal, food safety director for the nonprofit Center for Science in the Public Interest. “FDA over the years has relied essentially on an honor system.”

The FDA “hasn’t created a truly integrated program of inspection and enforcement so that, in a systematic way, all the pieces go together,” said Michael Taylor, a professor of health policy at George Washington University and a former deputy commissioner of the FDA.

FDA spokeswoman Susan Cruzan said Saturday that the agency’s Atlanta office has “provided adequate oversight” of Georgia inspectors with “frequent interaction and collaboration.” But she said the FDA will begin giving the state written feedback.

“FDA has found Georgia staff performance to be acceptable,” Cruzan wrote in an e-mail.

FDA officials acknowledged at a recent congressional hearing that Georgia inspectors should have picked up on conditions at Peanut Corp. that allowed salmonella bacteria to spread. When FDA inspectors swarmed the plant in January, after the nationwide outbreak was traced to Blakely, they found what they have described as obvious violations of sanitation standards in plain sight.

An honest evaluation of Georgia’s inspections, experts say, would reveal a fundamental flaw in the federal government’s regulatory plan: States are expected to conduct inspections that are as thorough and as professional as the FDA’s, but at a significantly lower cost.

The typical federal inspection takes about a day and a half, said William Hubbard, a former FDA associate commissioner. Expenses for such an examination, he said, can run as high as $5,000.

The FDA’s current contract with Georgia calls for the Agriculture Department to inspect 225 food firms and seafood processors during the fiscal year that ends Sept. 30. For each inspection, the federal government pays the state $524.15 to $657.15. The contract provides the state no money for travel, training or other expenses.

The state employs about 60 inspectors to oversee food processing plants, groceries, bakeries and food warehouses. In response to the Peanut Corp. case, state legislators recently allocated $160,000 for a new Agriculture Department unit of five inspectors and one supervisor who will concentrate on the food processors.

From 2006 until the Peanut Corp. contamination came to light this year, state inspectors usually spent less than two hours examining peanut processors, according to a recent review of inspection reports by The Atlanta Journal-Constitution.

“Why are they doing these much shorter inspections?” said Hubbard, who advises the Alliance for a Stronger FDA, which promotes increased funding for the agency. “They’re supposed to be doing the equivalent of an FDA inspection.”

But FDA inspections aren’t what they used to be, said Hubbard, who retired from the agency in 2005 after a 27-year career.

As recently as the 1980s, he said, FDA inspectors visited every food processing plant at least once every two years. Now the agency conducts about 7,000 inspections a year — for 150,000 domestic processing firms. At that rate, it could take more than 21 years to inspect each plant once.

“Unless the food is considered a high-risk food, they rarely get a visit from FDA,” Hubbard said. “FDA is not in these facilities the way they once were and should be. Therefore, there is no way to check the inspection process and what the state is doing.”

Georgia inspectors cited food safety violations at Peanut Corp. six times from 2006 to 2008, most recently in October. But state reports contain no evidence that inspectors followed up on whether the plant made corrections.

Those inspections, experts say, illustrate the pitfalls in allowing states to judge themselves.

“This episode was an example of failure on a lot of people’s part,” said Taylor, of George Washington University. “The inspection system failed. It’s evident these conditions existed. Inspectors from the state were in there, and no action was taken.”

State officials say inspections offer a mere snapshot, and they describe Peanut Corp. as a rogue operation intent on bending the rules.

Despite the series of outbreaks of food-borne illnesses that originated in Georgia, the FDA has sent the state no reviews of its work and has not audited individual inspectors as the contract mandates, said Garrison, the state agriculture official.

The state Agriculture Department and the FDA tend to communicate informally, Garrison said. For instance, he said, supervisors in the FDA’s district office in Atlanta may telephone the Agriculture Department to ask for follow-up inspections of certain food processors.

But such requests, Garrison said, don’t reflect doubts about his department’s inspectors.

“All I’ve heard,” he said, “is rave reviews.”