A California company has been warned by the U.S. Food and Drug Administration to fully document any manufacturing changes it makes so that two Salmonella strains found in its pistachios and linked to a multistate outbreak this past spring will not recur.
The FDA warning letter, dated Oct. 7, was addressed to Stewart Resnick, owner of The Wonderful Company based in Los Angeles, and concerned Wonderful Pistachios processed by Paramount Farms at 13646 Highway 33 in Lost Hills, CA, about 45 miles northwest of Bakersfield.
The outbreak sickened at least 11 people in nine states and hospitalized two of them. No deaths were reported, according to a final update from the U.S. Centers for Disease Control and Prevention posted May 20.
Among people for whom information was available, illnesses started on dates ranging from Jan. 3 to March 25. Ill people ranged in age from 27 years to 69, with a median age of 41. Sixty-four percent of those sickened were male, according to CDC.
On March 9, The Wonderful Company recalled various flavors and sizes of in-shell and shelled pistachios sold under the brand names Wonderful, Paramount Farms and Trader Joe’s. The recalled nuts were sold nationwide and in Canada, Mexico and Peru. The full list of recalled products is here.
Although CDC declared the outbreak investigation over back in May, since the recalled pistachios have a long shelf life and may still be in people’s homes, the agency noted that consumers unaware of the recall could continue to eat the products and get sick.
FDA’s San Francisco District Office in Alameda told Resnick in the warning letter that, following the Salmonella outbreak, investigators had inspected the company’s pistachio manufacturing process at the Lost Hills facility from March 8 through April 7.
“Based on traceback and epidemiological evidence taken together with inspectional evidence, we have concluded that pistachio nuts produced by your firm are adulterated within the meaning of … the Federal Food, Drug, and Cosmetic Act … in that they bear or contain Salmonella, a deleterious substance which may render them injurious to health …,” the letter stated.
“Based on collaborative epidemiological and investigational efforts between the FDA, CDC, and the California Department of Public Health, we conclude that pistachio nuts produced by Wonderful Pistachios & Almonds LLC were linked to this outbreak of Salmonella infections.”
Of the 11 people confirmed in the Salmonella outbreak, FDA stated that 10 were interviewed. Eight of the 10 reported eating pistachios during the week before they became ill, and five of those reported eating Wonderful brand pistachios. No other specific food was identified as a “suspect vehicle,” according to the warning letter.
Nuts from facility tested positive for outbreak strain
During FDA’s visit to Paramount Farms, inspectors collected three product samples, each consisting of 30 subsamples. In one sample of raw, in-shell pistachios collected from the facility’s silos, five of 30 subsamples yielded positive tests, four for Salmonella Senftenberg and one for Salmonella Liverpool, according to the warning letter.
“Whole genome sequencing determined that the Salmonella Senftenberg isolates were nearly identical to isolates from case patients involved in the outbreak. The most probable number in these subsamples ranged from less than 3 to 23 Salmonella cells/gram,” FDA wrote.
The agency’s letter acknowledged The Wonderful Company recall of pistachio products and its written response to the inspection observations dated April 19. In that response, the company proposed to study the optimal chlorine level in its processing tanks and install a system to remove foreign material prior to moving the pistachios into storage, the warning letter stated.
“However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak,” FDA noted, adding that it would need documentation, including photographs, of corrective actions taken to date and any other pertinent information that might help evaluate such corrections.
As of Thursday, FDA had not yet heard back from Resnick, The Wonderful Company or Paramount Farms, said Sergio Chavez, a compliance officer with the agency’s Alameda office. However, he pointed out that they have 15 working days from receiving the letter to do so.
In response to a request from Food Safety News, Steven Clark, vice president of corporate communications for The Wonderful Company, provided this statement regarding the warning letter:
“Yes, we were surprised to receive this communication from the FDA since we have not heard from them since early April when they inspected our facility. Other than the Oct. 7 letter, neither the FDA nor the CDC advised us of any further action required on our part. Moreover, the CDC closed their investigation last May.
“Though none of the Salmonella cases in question were directly linked to our product, we did voluntarily recall product in an abundance of caution, we implemented enhanced food safety protocols, and no new issues have surfaced. We will continue to cooperate with the FDA to satisfy any concerns they may have.”
Chavez said that FDA can shut down a food facility by revoking its facility registration if it is found to present an imminent hazard to the public, adding, “That finding was not made in this particular instance.”
At this point, it’s not clear to FDA how the Salmonella bacteria got to the pistachios, but there are many potential ways it can happen, he said.
“If we knew how it got in there, we would have put it in that letter,” he noted. “Even if they (the nuts) don’t hit the ground, they’re out in nature and birds do what they do, lizards do what they do. Anything that’s on the nuts is a potential source.”
Chlorine will kill most pathogens, including Salmonella, as long as it is applied in the appropriate concentration and the level is monitored, the water regularly changed, and the chlorine gets directly to where the bacteria are hiding, Chavez explained.
“When you’re talking about cleaning and sanitizing something, germs will hide under anything, including dirt, and if you apply surface sanitizer and it doesn’t penetrate that gunk layer, no matter how thick it may be, it won’t fix the problem,” he said.
FDA will be reinspecting the Paramount Farms facility at some point, although Chavez could not say when.
“For food, we rarely tell people,” he said. “There’s supposed to be compliance all of the time, not just when we come by.”
In addition to Paramount Farms, Resnick and his wife Lynda also own POM Wonderful pomegranate juice, Halos brand mandarin oranges, Sweet Scarletts Texas red grapefruit, Fiji Water, the Teleflora flower-delivery service, Landmark and Justin wines, Suterra pest control, a large beekeeping farm and thousands of acres of California citrus, almond and pistachio orchards.
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