Management at the Jif peanut butter plant in Lexington, Kentucky, knew that some Jif peanut butter products manufactured between December 2021 and late February 2022 were contaminated with Salmonella, but did not report this to the FDA or initiate a product recall at the time.

This information is contained in documents supplied to eFoodAlert by the US Food and Drug Administration (FDA) in response to a Freedom of Information Act request.

The Lexington plant is owned and operated by The J.M. Smucker Co. (Smucker).

The backstory

In the first quarter of 2022, the CDC began to receive reports of individuals who had become infected with a single genetic strain of Salmonella Senftenberg.

Thirteen patients were interviewed, all of whom reported having consumed Jif peanut butter in the week before becoming ill.

Ultimately, the CDC would identify twenty-one outbreak victims, residing in 17 states. Four of the victims were hospitalized.

Upon learning of the link to Jif peanut butter, the FDA carried out genetic fingerprinting of a strain of Salmonella Senftenberg that had been found at the Jif manufacturing plant during a 2010 inspection. That strain was a genetic match for the strain recovered from the outbreak victims.

On May 19, 2022, a team of investigators from the FDA arrived at the Lexington facility to begin their inspection, which included the collection of environmental samples for lab analysis, review of documentation, and a visual inspection of the premises.

On May 20, 2022, The J. M. Smucker Co. recalled multiple production lots of various Jif Peanut Butter products, encompassing items produced between October 1, 2021 and May 20, 2022 (Lot codes with the first four digits of 1274 through 2140).

On May 21, 2022, the CDC released a Food Safety Alert, advising consumers of the outbreak and the product recall.

The FDA inspection results

According to the Inspectional Observations (FDA Form 483) issued on June 9, 2022, following completion of the inspection, the company had found sporadic Salmonella contamination in the production environment beginning in 2018 and continuing through 2021.

Some of the Salmonella-positive results were from samples taken on the floor near the peanut roasters.

In addition, the company’s finished product sampling program found Salmonella in finished, ready-to-eat peanut butter in 2017 (March 21), 2018 (February 18), 2020 (April 14 and November 17), 2021 (October 22 and December 15) and 2022 (February 4, 9, 10, 20 and 21).

The report does not indicate whether the contaminants found by the company were Salmonella Senftenberg.

The company did not recall any products when it first learned of the Salmonella-positive results. Nor did it report either the Salmonella findings or the equipment defect that was behind the contamination to the FDA’s Reportable Food Registry.

According to the FDA, “Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.” (emphasis added)

During the course of its inspection, the FDA collected 205 environmental swab samples from various parts of the production lines and plant environment.

None of the FDA’s swab samples yielded Salmonella.

The FDA also tested two jars of Jif Creamy Peanut Butter obtained in response to consumer complaints, without finding Salmonella in either jar.

What went wrong

The company installed two new roasters in the fall of 2021. The first of these went into full production on November 4, 2021, and the second on December 10, 2021.

Peanut butter produced from these roasters had been distributed since November 2021, even before the second roaster was in full production.

On February 17-18, 2022, after finding Salmonella in samples of ready-to-eat peanut butter produced on February 4, 9 and 10, 2022, management discovered a puddle of water in the bottom of both roasters.

The source of the puddles was traced to a defective flange on the roasters’ [redacted] inlets, which allowed rainwater and unfiltered air to enter the roasters and contact the roasted peanuts after the roasting step.

This defect had been in place since the installation of the roasters, and had gone unnoticed for several months.

The roasters were cleaned on February 17th and February 18th, respectively, and were returned to production.

On February 20th and again on February 21st, in-line samples consisting of jars of finished product were found to be Salmonella-positive.

The bottom line

A single paragraph on the third page of the list of Inspectional Observatioons (Form 483) sums up the situation (FDA’s redactions indicated as []).

“Furthermore, on 05/31/22, we observed you did not address contaminated, or potentially contaminated, finished peanut butter distributed to consumers. On 02/17-18/22, you identified a breach in the [] systems, which contaminated the [] of roasters [] and []. Based on your investigation, the breach was determined to be an approximate 1 inch opening in the [] gasket and had existed since the installation of roasters [] and []. Peanut butter produced using roasters [] and [] had been distributed since November 2021. You did not take any measures to alert consumers and/or recall the contaminated peanut butter distributed between December 2021 and February 2022. Additionally, you did not report this event in the FDA’s Reportable Food Registry (RFR).”

Inspectional Observation from FDA Form 483, supplied in response to Freedom of Information Act request

The FDA has not yet released the complete Establishment Inspection Report (EIR), which was also sought as part of eFoodAlert’s Freedom of Information Act request.

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Read more about Salmonella in peanut butter in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.