The U.S. Food & Drug Administration (FDA) is still concerned about processing plant contamination that led to the hazelnut recalls last Christmas season by such well known retailers as Whole Foods and Harry and David’s.
FDA on May 10 sent a warning letter to Willamette Shelling Inc., based in Newberg, OR about “niches” of Salmonella contamination found inside the hazelnut plant at the time of the recalls.
“FDA laboratory analyses of the environmental samples collected during our first inspection found the presence of Salmonella,” the warning letter said. “In addition, we found that you have significant deviations from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).”
“These violations and the results of the laboratory analyses cause the foods manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health,” it continued.
Charles M. Breen, FDA’s Seattle district director, penned the warning letter to Benson C. Mitchell, president of Willamette. It was made public May 25.
FDA inspected the Newberg processing facility last Nov. 17-20, and did follow-ups on Nov. 30 and Dec. 9, 2009. On Dec. 17, 2009, Willamette recalled 114,500 pounds of hazelnuts. It was the largest of a half dozen hazelnut recalls that came around Christmas last year.
No illnesses were associated with the Christmas hazelnut recalls.
FDA said during the inspection, its investigators collected several environmental samples from various surfaces throughout the Newberg facility.
Six of these samples tested positive for Salmonella species. FDA said two of these positive environmental samples were collected from food contact surfaces. In addition, two other positive environmental samples were collected near exposed food or food contact surfaces.
Finding Salmonella on or near food contact surfaces and very near to where food is exposed indicates a high risk for product contamination, Breen told the nut processor.
He said the remaining two positive samples were collected from the floor of the facility and a stepladder located in the upstairs room with the grading drum.
FDA says bacteria may enter and/or be transported through a food plant by a variety of routes that include, but are not limited to: the shoes of employees, contractors, and visitors; the wheels of fork lifts, pallet movers, and moveable equipment; soiled pallets; soiled raw material packing; on raw ingredients, particularly tree nuts; roof leaks; and by rodent vectors. Once established on product area floors, the organism can contaminate food and food-contact surfaces through either human or mechanical means.
“It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism,” Breen wrote.
FDA found evidence of rodent and insect activity in the Willamette’s dry storage warehouse.
Breen said the hazelnut processor had responded to FDA’s concerns, “but the effectiveness of your corrections will be verified during a subsequent inspection.”
Under sanitation concerns, FDA said its “investigators observed that the plastic curtains between the in-shell and kernel warehouses had residual organic matter on its surfaces. Further, our investigators observed that hazelnut kernels in a metal tote came in contact with the plastic curtains while the kernels were being transported into the kernel warehouse.
“Our investigators collected environmental sample 519326, subsample number 149, from the bottom of the plastic curtains. The sample tested positive for Salmonella typhimurium.”
FDA found a PFGE pattern match from contaminated hazelnuts found by the Oregon Department of Agriculture and the plastic curtain.
“This finding is significant because it indicates that the Salmonella may have transferred from the plastic curtains to the hazelnuts kernels,” Breen said.
A second food contact surface tested positive for Salmonella. Environmental sample 519325, subsample number 19, was collected from the face of a scraper/rake, which your firm uses to move or rake hazelnuts in the upstairs room with the grading drum.
Other samples were also matches, indicting the Salmonella was transported throughout the facility.
Breen said the plastic curtains were removed and the facility was cleaned, but effectiveness of those steps will be subject to future inspections.
FDA also found Salmonella contamination on the top of a stepladder in an upstairs room, showing how the shoes of employees spread bacteria.
“Our investigators observed one employee stepping on a black plastic stool by the spout of a metal tote when taking samples for grading, and while flattening out heaps of hazelnut kernels,” Breen explained. “The hazelnut kernels exit from this spout when an individual empties the metal tote, such as during packaging. The employee’s shoes were near and above the spout. This practice does not minimize the potential for contamination of your hazelnut kernels.”
FDA fears Salmonella may have found “niche areas” to colonize inside the plant.
“Our investigators also observed cobwebs and dirt on the underside of the metal totes, and that the totes were stacked above other uncovered metal totes of hazelnut kernels in the in-shell warehouse. The bottom of your firm’s totes can and do come into contact with the floor, Breen continued. “Storing totes, which may be contaminated by dirt, debris, or pathogens, by stacking the totes above uncovered totes containing exposed product does not minimize the potential for contamination.”
Willamette has since instructed employees not to use the plastic stool in the tote spout area, and that all metal totes will be covered.
FDA asked the company to respond to the warning letter within 15 business days.