Foodborne disease registry urged in wake of outbreak

Feb 5, 2009 (CIDRAP News) – A woman whose 7-year-old son became severely ill after eating tainted peanut butter crackers told a Senate committee today that the nation needs an electronic registry of foodborne disease cases to help public health agencies recognize outbreaks and find their causes faster.

The suggestion, from Gabrielle Meunier of South Burlington, Vt., was one of a variety offered by witnesses at a hearing focusing on the nationwide Salmonella outbreak linked to peanut butter.

Among other recommendations, experts said the Food and Drug Administration (FDA) needs to imitate the US Department of Agriculture (USDA) and require detailed food safety plans at all food processing plants.

Senators who listened to testimony from FDA officials about the outbreak response said the FDA needs the authority, now lacking, to require food processing facilities and private laboratories to report any Salmonella findings in food.

Other recommendations included new tools for public health agencies at all levels, greater investments by state and local agencies in outbreak detection and response, and splitting the FDA into two separate agencies, one for food and one for drugs.

And Sen. Saxby Chambliss, R-Ga., ranking minority member of the committee, called for strong enforcement of existing laws. "I'd like to see someone go to jail for this," he said, referring to the Salmonella contamination in the Peanut Corp. of America (PCA) peanut processing plant in Blakely, Ga., which has been linked to the outbreak.

Dr. Stephen Sundlof of the FDA said the case count in the 43-state outbreak reached 575 as of yesterday, 25 more than were reported 2 days ago. A total of 127 patients required hospitalization, and the number of deaths related to the outbreak remained at 8, said Sundlof, director of the FDA Center for Food Safety and Applied Nutrition.

The most recent illness onset in the outbreak was Jan 27, he said. When the outbreak finally ends, officials won't know it until 2 to 3 weeks later, given the lag time in identifying linked cases, he added.

Boy was 'violently ill'
Meunier put a human face on the numbers by describing the case of her son, Christopher, who had his first symptoms of salmonellosis on Nov 25. "Two days later his health deteriorated dramatically and he became violently ill and was in tremendous pain," she said. His condition finally stabilized after "6 terrorizing days."

It took days to figure out the cause of her son's illness, Meunier said. "We thought he had terrible internal injuries; never once did anyone mention Salmonella poisoning. Never once did we think that a cracker could contain poisoning."

She said his illness was complicated by a Clostridium difficile infection, a pathogen that often causes serious infections in hospitals. "My concern is, was it in this cracker [that he ate]?" she said. "We do not know how he got it."

Adding that her son now has arthritis as a result of the infection, she said, "I don’t know if he'll fully recover from that ever."

Meunier said her son's case has inspired her to work to change the food safety system. "I believe that technology is the key to improving our response to foodborne illnesses at every step on the way," she said.

She called for the creation of a national foodborne disease registry to record and share information about cases and outbreaks. Such a database would make it possible for patients with foodborne infections to record much sooner what foods they ate before getting sick and would enable physicians treating such patients to learn quickly about similar cases, she said.

Meunier said her son's doctors had to inquire on their own whether local pediatricians had any similar patients. "If there had been a national database they'd have seen there were similar cases," she said. "Also, if there were to be a terrorist attack using food, this information would be invaluable."

She also said she had trouble contacting the CDC and that it appeared that the CDC did not share information about her son's case with the FDA, because an FDA official asked her the same questions the CDC had asked her previously.

A call for HACCP plans
On the prevention side of the issue, William Hubbard, former senior associate commissioner for policy, planning, and legislation at the FDA, recommended that the FDA require all food processing plants to use the same type of food safety plans that the USDA requires in meatpacking plants and that the FDA already requires for seafood and juice.

The USDA requires meat facilities to have "hazard analysis and critical control point," or HACCP, plans, wherein they identify possible sources of contamination and list specific steps to control them.

"If we could move toward universal HACCP, we'd have an exponentially safer food system," Hubbard said. "I think the proof is in the pudding in meat and juice and seafood; we've seen outbreaks going down, we've seen better inspection results."

PCA's Blakely plant was inspected periodically by Georgia officials under contract with the FDA. When the FDA officials investigated the plant in January, they found various problems, including mold, roaches, a leaky roof, faulty storage practices, and a dozen cases in which the company sold products that had initially tested positive for Salmonella.

"In my opinion a functioning HACCP plan absolutely would have prevented the problem," Hubbard said.

Agreeing with Hubbard was Caroline Smith DeWaal, food safety director for the consumer group Center for Science in the Public Interest: "Every company should have a food safety plan showing that it's taking steps to minimize contamination. That's the system we have for meat and poultry, but it's not similarly applied to FDA products."

"The key is prevention," DeWaal said. "Let's get written food safety plans in place so they [food facilities] can be audited by the states, maybe even by the federal government."

In a news release yesterday, PCA defended the Blakely plant, saying independent audit and food safety firms "conducted customary unannounced inspections of the Blakely facility in 2008. One gave the plant an overall 'superior' rating, and the other rated the plant as 'Meet or Exceeds audit expectations (Acceptable-Excellent)' ratings."

A 'big loophole' in reporting findings
In other testimony, FDA and CDC officials outlined the course of the outbreak and response.

Rear Admiral Ali S. Khan, assistant surgeon general and deputy director of the CDC's National Center for Zoonotic, Vector-borne, and Enteric Diseases, said the first cluster of 13 cases from 12 states was recognized through Pulsenet, the CDC's DNA fingerprinting system for foodborne pathogens, on Nov 10.

Sundlof said the FDA began investigating peanut butter in institutional food services before it had been conclusively identified as the culprit food. Minnesota health officials' discovery of Salmonella in an open tub of peanut butter served in a Minnesota nursing home steered the FDA  to King Nut, an Ohio-based peanut butter distributor, and then to the PCA plant in Blakely.

Sundlof recounted how the FDA review of testing records at the plant showed that in several instances in the past 2 years, the company had shipped product that had tested positive for Salmonella.

Under questioning by Sen. Tom Harkin, D-Iowa, chairman of the committee, Sundlof said the FDA contracted with Georgia officials to inspect the plant starting in 2006, and the state inspected the plant at least twice a year. The state found some problems there in 2007 and 2008 and reported them to the FDA, he said.

Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said an FDA supervisor felt that the state inspections and resulting corrective actions by PCA "were consistent with observations and corrections the FDA would make. . . . The problems were considered to be somewhat resolved and the state was working with the company."

Sundlof said that unless the FDA has good reason to believe products are contaminated, food facilities are not required to show the agency records of pathogen testing during routine inspections, prompting Harkin to respond, "A company that finds Salmonella does not even have to report that? That's a big loophole. That ought to be closed."

Sundlof later noted that PCA did supply the testing records during the FDA's January investigation in Blakely.

Later, in reference to the Salmonella testing done by an outside lab for PCA, Sundlof testified, "I don't believe we have any direct authority over labs to require them to provide their results, to provide information they could consider proprietary to that firm."

In other comments, Khan said public health agencies need new lab tools and information tools to improve outbreak detection and response. He mentioned tools such as "computer-assisted telephone interviews" and "new ways to standardize and analyze information to understand what's going on."

He added, "The second thing we need is better investment at the state and local level to actually make these diagnoses quickly, do the Pulsenet testing quickly, do the interviews quickly, and then hand that off to FDA as quickly as possible."

"Any lab would be investigating 20 to 25 clusters at any given time, so they need boots on the ground" to speed investigations, Khan said.

See also:

Senate Agriculture Committee
http://agriculture.senate.gov/

CDC's Salmonella outbreak update page
http://www.cdc.gov:80/salmonella/typhimurium/update.html

FDA database of product recalls related to the outbreak
http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm

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