Apr 9, 2009

Pistachio recall has FDA seeking expanded powers

by Michael Scott Leonard
April 08, 2009

SALMONELL2_PISTACHIOS

Diane Rusignola/Medill

As the nationwide salmonella-related pistachio recall continued to widen Tuesday, an FDA official said the agency is negotiating with Congress for broader authority to regulate the food industry.
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One day after a nationwide pistachio recall widened to include the entire 2008 crop of the country’s second-largest processor, a Food and Drug Administration official said the agency is negotiating with Congress for broader authority to regulate the food industry than it enjoyed under the Bush administration.

Dr. David Acheson, associate commissioner for foods, confirmed Tuesday the agency is seeking the power to issue mandatory recalls of suspect food products.

“That’s a very active dialogue we’re having between the F.D.A., [Health and Human Services] and Congress,” Acheson said. “Right now, we do not have mandatory recall authority except for infant formula, but it’s one of those things we asked for in 2007 and it remains under active discussion with the Hill.”

A spokeswoman for the Illinois Department of Public Health said Tuesday the department is “not aware of any cases of salmonella in Illinois linked to eating pistachios or products containing pistachios.”

Indeed, the F.D.A. has not confirmed any salmonella cases at all linked to the tainted pistachios traced by Kraft Food Inc. two weeks ago from a facility of the Skokie-based Georgia Nut Co. — an external manufacturer of Kraft's Planters and Back to Nature products — to a California processing plant run by Setton Pistachios of Terra Bella Inc. That’s what makes the agency’s recent advice that consumers avoid pistachios altogether so unusual.

Acheson said recent salmonella outbreaks led to renewed efforts by the F.D.A. to expand its enforcement powers. Hundreds were sickened during this winter’s mass peanut recall and a scare last summer in which peppers, not tomatoes, turned out to be the culprit.

“Right now, the law doesn’t even require testing,” Acheson said. He said Kraft had voluntarily turned its samples and test results over to the F.D.A. after it identified the salmonella’s source.

“Georgia Nut discovered that there was the possibility of salmonella, and they contacted us,” a spokeswoman from the Northfield-based Kraft said. “Given that there were tainted products moving through the distribution process, in recognition that there is a possibility there are [tainted] products out to consumers, we reached out to the F.D.A.”

Georgia Nut Co. put out a statement March 26 alerting customers throughout Illinois and Wisconsin that it was issuing a voluntary recall “as a precautionary measure.”

“We identified the potential as a result of a rigorous sampling and testing regimen we conducted with respect to shelled pistachios provided by a third-party supplier,” the statement read in part.

A statement from Setton Pistachio, the nation's second-largest pistachio processor, called the recall the company’s first and stressed that it was voluntary.

“This voluntary recall is not in any way related to any inspection conducted by ... the United States Food and Drug Administration,” the statement said.

Acheson said the companies are behaving responsibly, the way “99 out of 100” companies do when confronted with a public health problem, but enforcing current good manufacturing practices against that one uncooperative company out of 100 is currently a cumbersome process that requires a court order. He warned that updating the agency’s regulatory apparatus would not be simple.

“It raises all of those questions” about how much testing disclosure should be mandatory, Acheson said. “If you do require firms to share their data, one of the concerns would be that they would simply stop testing.

“There’s a variety of levels and complexities wrapped around this issue,” he said.

Even without broad reforms, the F.D.A. response already marks a departure after years of caution. By coordinating a preemptive mass recall — with new products added to the list every day this week — despite no confirmed cases of illness, the agency is signaling it will aggressively enforce existing standards. Some experts are praising the F.D.A. for prizing public health above deference to industry.

Dr. Ronald C. Hershow, an infectious disease specialist at the University of Illinois at Chicago School of Public Health, commended the swiftness of the recall action.

“Some have accused the F.D.A. of being slow to act and then conversely of acting too extensively in ordering huge recalls,” he said. “[But] the concern is that the first wave of pistachio-related cases may represent only the ‘tip of the iceberg.’”

Acheson said while any recall is “a reactive phenomenon” and a sign of previous monitoring failures, the F.D.A. is already learning from recent mistakes.

“Better that it’s a recall before people get sick than after they get sick,” Acheson said. “So from that perspective, even though it’s large, [it’s] a lot better than the peanut issue.”

In an average year, salmonella sickens a reported 40,000 Americans, though the F.D.A. estimates that hundreds of thousands of mild cases go undiagnosed. About 400 Americans die every year with acute salmonellosis.

But those numbers may be on the rise. Hershow said the recent high-profile outbreaks of food-borne illness could be due to agribusiness consolidation. Only a few growers typically produce any given crop. That single crop — such as pistachios — is then shipped to distributors around the country, potentially tainting scores or hundreds of food products.

Hershow said consolidation also makes it harder to pinpoint which products contain contaminated ingredients, leaving regulators to “err on the side of broad warnings.”

“Specific information is not always immediately available before specific products can be identified as safe or unsafe,” he said.

Acheson agreed with Hershow’s diagnosis, but he proposed an additional reason behind the increase in reported outbreaks. Acheson said biotechnology and information technology now enable genetic matching of cases that as recently as five years ago might have been considered unconnected.

When a case of salmonella is reported, he said, researchers isolate the offending bacterium and go to work mapping its genetic material, which is then stored in a national database. When another strain appears elsewhere, its genetic map is entered into the database and compared against recent cases.

“When salmonella pops up in Vermont and California, they go into the same database that links together multi-state outbreaks,” Acheson said.

He said he isn’t sure the total number of instances of food-borne illness is on the rise.

“I think we’re getting better at detecting outbreaks,” Acheson said.

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