A decade of inspections at J.M. Smucker Company’s production facility in Lexington, KY, leaves questions about how Salmonella found its way into products and spread to consumers.
This May, the outbreak strain of Salmonella Senftenberg was found in the J.M. Smucker Company’s production facility in Lexington, KY.
On July 27, the CDC declared its investigation of the Salmonella outbreak connected to J.M. Smucker Co. over. It revealed 21 illnesses in 17 states. Four people required hospitalization and no deaths were reported.
The true number of sick people in an outbreak is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses, according to the CDC. This is because many people recover without medical care and are not tested for Salmonella.
Whole Genome Sequencing (WGS) analysis showed that samples from sick people in this investigation are closely related genetically to a sample collected in 2010 from the environment at J.M. Smucker Company’s facility in Lexington, KY, where some Jif brand peanut butter is produced.
“The analysis shows that this 2010 environmental sample matches the strain causing illnesses in this current outbreak. Epidemiologic evidence indicates that Jif brand peanut butter produced in the J.M. Smucker Company facility located in Lexington, KY, is the likely cause of illnesses in this outbreak,” according to a public alert issued by the Food and Drug Administration.
Food Safety News has obtained more than 10 years of FDA and Kentucky Department of Public Health inspection reports for J. M. Smucker Company facility in Lexington, KY.
The FDA selects facilities for inspection based on risk. The Food Safety Modernization Act, enacted in 2011, required FDA to immediately increase inspections of both foreign and domestic food facilities, including manufacturers/processors, packers, repackers, and holders of foods under FDA jurisdiction and mandated an inspection frequency, based on risk, for food facilities. All high-risk domestic facilities must be inspected within five years of enactment and at least once every three years after that.
FDA inspects food facilities to ensure food safety and compliance with regulations. During an inspection, FDA inspectors may identify potential violations of the Food, Drug, and Cosmetic Act as well as other applicable laws and regulations.
The question that must be asked: was this salmonella outbreak the result of negligence on the part of the J.M. Smucker Company facility? The violations cited below by federal and state at the facility over the years merit consideration.
FDA — 08/31/2009 Establishment Inspection:
There were no objectionable conditions observed and an FDA 483 form, List of Observations, was not issued.
There were no objectionable conditions noted.
FDA — 6/21/2010 Establishment Inspection:
Although no FDA 483 was issued, the following 4 observations were discussed with the firm. The four observations that were discussed with the firm at the close-out meeting:
1. A FDA inspector observed an employee leaving the production plant and cross the street to go to the BP Express to purchase an item. This employee was wearing the company issued white smock, beard cover, bouffant hair cap, and shoe covers.
2. A FDA investigator and state inspector observed an employee use her fingers to reach inside fallen jars along the production line to set them upright.
3. A FDA inspector observed an employee entering into the (redacted) room from outside through the west door in building (redacted) and use the sanitation pan. The sanitation pan was not positioned directly in front of this door. There is a control panel to the left of the door that provides a walkway behind the panel from the door into the (redacted) room. The sanitation pan is located in front of the control panel but to the right allowing for an open walkway between the panel and the sanitation pan.
The sanitation pan for the north outside door in building (redacted) was located to the left of the door, leaving space between the doorway and the sanitation pan.
4. A wash station was not located in the room with production line (redacted).
Salmonella detection:
Two environmental samples for Salmonella were collected at the firm; INV549177 and INV549178. Two subs from INV549178 were reported positive with genus Salmonalle: sub 152 and sub 200. The firm reported that their swabbing sub 152 was also positive but they did not report that sub 200 was positive.
The FDA 484 was issued to Bill Erikson (William E. Erikson, Plant Manager) for both sample numbers, INV549177 and INV549178.
Samples Collected:
INV549178 sub sample 152 is located in zone (redacted) along the wall at a doorway between the (redacted) room and the (redacted) room near a broom rack. FDA did receive a phone call from Bill Erickson who stated that the swab taken by JM Smucker personnel at the same location also came back positive. His investigation discovered that the broom on the wall had been used outside and was then brought back inside.
INV549178 sub 200 is located in zone (redacted) and was first taken from the back side of a personnel fan in the warehouse. This was not deemed to be an immediate risk to the food production. The corresponding JM Smucker swabbing was not positive.
Voluntary Corrections:
The firm has repositioned sanitation pans in building (redacted) so that they are directly in front of the doors.
The cleaning brooms throughout the facility are to be destroyed and replaced with color coded brooms indicating that they are to be used only for food production areas and inside the plant.
FDA — 03/02/2011 Establishment Inspection:
A follow-up “Request for Inspections and Environmental Sampling for Salmonellae at Firm Producing Nut and Nut Products” — High Priority, DFPG #10-03 due to the previous salmonellae positive results during the last EI (Establishment Inspection) 6/21-24/2010.
Although no FDA-483 Inspectional Observations was issued, four verbal observations were discussed with the firm at the end of the inspection. The observations were corrected and verified during the current inspection.
Verbal observations:
- Failure to maintain the piping and ceiling around the (redacted) and (redacted) room with ingredients in (redacted) systems free of excessive dust.
- Failure to maintain Northwest corner and floor below stairs free of peanut spillage at the feeding side of roaster (redacted).
- Failure to maintain floor of (redacted) system free of grease spillage next to roaster (redacted).
- Failure to seal small openings on warehouse shipping doors (redacted) and (redacted).
Sanitation:
The firm appears to have a detailed Sanitation Standard Operation Procedure which outlined its (redacted) and (redacted) sanitation of equipment.
According to Mr. Harter, Microbiological Lab Manager, the firm performs (redacted) environmental testing, rotates swabbing to different areas from zone (redacted). According to Mr. Mahanes, the firm performs swab testing on peanut (redacted) and (redacted).
In addition to the environmental swabs and other pathogens, the firm also tests for aflatoxin for incoming products and during processing (redacted).
Mr. Mahanes stated that since the last two positive swabs from the last inspection on 6/24/10, the firm conducted a recall to see where the positive could have come from and made changes by adding a new color coding system with new SOP for cleaning supplies (brooms). In addition, the firm added a new floor, sanitized the area, filled the floor with (redacted), (redacted), a flexi concrete material for cracks, re-swabbed before and after, placed new sanitation bath (redacted) (redacted) and supplied new broom for the area. The firm refused review of the environmental swabbing results, and would not share what other pathogens were routinely monitored at the plant. When asked by a FDA investigator if there has been any positive swabs, Mr. Mahanes also stated that the firm has had zero positive results for salmonella since the last FDA inspection on 6/24/10.
Samples collected:
One environmental sample was collected from the firm; INV677913 consisted of sub samples 1-106 collected on 2/28/2011 one FDA 484 (Receipt for Samples) for the sample collected was issued to the firm 3/2/2011 during the close-out meeting. Two finished product samples were collected during the inspection: 677914 consisted of 12 “18 OZ” jars of Creamy Peanut Butter Jif brand with best buy date: March 2, 2013 and product code 1 039 423 19:37 1 located in row (redacted) within the warehouse, and 676629 consisted of 10 “18 OZ” jars of Crunchy Peanut Butter Jif brand, with best buy date: February 28, 2013, and product code 1 039 423 19:37 1 located in row (redacted) within the warehouse.
Finished product samples 677914 and 676629 were collected for aflatoxin sampling. Two FDA 484s for the finished product samples were issued to the firm on 3/2/2011 during the close-out meeting.
Commonwealth of Kentucky Department of Public Health
8/21/2012 — Food Plant Inspection:
Product Testing/Sanitation:
The firm has an environmental monitoring program with (redacted) swabbing by the quality assurance group. The swabbing sites vary (redacted) and finished products are sent to a third-party lab for analysis. The firm uses the laboratory (redacted) located at (redacted).
A master sanitation and cleaning schedule includes (redacted) and (redacted) activities. General cleaning and sanitation takes place each shift and is listed on a master sanitation program schedule. The firm utilizes (redacted) sanitizer on the “(redacted)” area for equipment that is not part of the (redacted) system. The (redacted) system equipment is referred to as the “(redacted)”, is part of the clean-in-place approach and conducted (redacted). Finished product samples are taken immediately after the cleaning process to ensure effectiveness.
The firm has previously installed a (redacted) foot bath prior to entry into the building and when entering different processing areas of the plant.
All plant employees were wearing uniforms, hairnets, beard nets (if applicable), hard-toed shoes, smocks, ear protection, and were not allowed jewelry or possess personal drinks in the processing, production, storage, or other areas where manufacturing was being conducted.
FDA — 03/13/2015 — Establishment Inspection Report:
One objectionable condition, a leaking roof, was observed and a FDA-483, Inspectional Observations was issued for failure to maintain buildings in repair sufficient to prevent food from being contaminated, as rainwater was observed dripping in the corner of building (redacted) an area used to store and clean (redacted) and (redacted) super sacks of raw peanuts. The leak was quickly repaired by maintenance.
No samples were collected.
General Sanitation:
Sanitation, housekeeping and cleaning appear adequate.
Environmental Swabs:
Quality control does collect, aseptically, (redacted) environmental swabs that can be anywhere throughout the facility, (redacted) who performs the analysis and provides the QA department with the results.
FDA — 2/28/2018 — Establishment Inspection Report:
The establishment inspection on 2/28/2018 covered the manufacturing process of Jif Creamy Peanut Butter (Net WT 28 oz.), facility sanitation, interstate distribution and the firm’s HACCP plan.
Sanitation:
Per the firm, (redacted) task sheets, all manufacturing equipment and food contact surfaces are cleaned and sanitized immediately after or throughout production. All other major sanitizing procedures are conducted (redacted). During the inspectional walk-through, a buildup of food and debris was observed accumulating on the underside of the protective cover on the manufacturing line (redacted).
On 2/28/2018, a closeout meeting was held at the firm and attended by Ellis W. Miller, Plant Manager, and John M. Lefevre, Manager of Quality Assurance, (redacted) Quality Specialist. FDA informed management that no inspectional observations were noted throughout the inspection, but discussed one deficiency in detail.
- On 2/26/2018, An FDA inspector observed open jars of peanut butter being conveyed immediately below the protective cover of production line number (redacted) which contained a build up of food and debris. As FDA informed management of the concern, Mr. Ellis suspended production until the manufacturing line was (redacted) cleaned.
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