Last year, nearly 550 food products were recalled in the United States. Nearly half of those recalls were a result of biological contamination, a whopping 65% of which was due to Listeria monocytogenes, according to Rentokil. The company recently released an infographic about the cost of a product recall, pulling out some of the key trends in food product recalls in the United States and the United Kingdom. Next to biological contamination, mislabeling continues to be a large issue.
Over the past few days, there have been two more large meat recalls. In both cases, there have been no confirmed reports of adverse reactions due to product consumption.
Golden Gourmet has recalled more than 5,000 pounds of frozen waffle and turkey sausage products over concerns of contamination with Listeria monocytogenes. The issue was uncovered when the company received a letter of notification from US Foods, its supplier, that products had been recalled. The Class I recall involves products that were produced and packaged on December 21, 28, 29 and 30, 2016 and shipped to locations in Georgia, Iowa, Illinois, Ohio, South Carolina and Tennessee.
FSIS also announced a Class II recall initiated by Armour Eckrich Meats, LLC over concerns of metal contamination. The company recalled nearly 91,000 pounds of ready-to-eat fully cooked pork, turkey and beef breakfast sausage products that were produced and packaged from April 26 through April 28, 2017 and shipped to distribution centers in Arkansas, Indiana, Kansas, Louisiana, Oklahoma and Texas. Armour Eckrich Meats discovered the problem when it was notified by an FSIS-regulated establishment that pieces of metal were embedded in the sausage product produced by Armour Eckrich.
The food processing environment is ripe with hot spots where biofilm can hide. A rapid biological hygiene indicator in the form of a spray gel has been developed to provide companies with a visual indication of biofilm on a surface. Once the gel makes contact with biofilm it produces foam within two minutes. Manufactured by Sterilex, Indicon Gel does not require mixing and is appropriate for seek-and-destroy missions. It enables detection of microorganisms that include Listeria, E.coli and Salmonella on both large surfaces as well as niches that cannot be accessed by a swab.
On May 5, Pinnacle Foods, Inc. announced a voluntary recall of all Aunt Jemima Frozen Pancakes, Frozen Waffles and Frozen French Toast Slices due to concerns over Listeria monocytogenes contamination. The products were distributed across the United States (and one product in Mexico) but no illnesses have been reported. Two additional products—Aunt Jemima French Toast & Sausage and Hungry Man Selects Chicken & Waffles—were recalled in conjunction with the USDA.
In a press release posted today by Pinnacle Foods, the company announced that it will exit certain “low low-margin and non-strategic” Aunt Jemima frozen breakfast products: Frozen waffles, French toast slices and pancakes. “The decision to exit these products now was the appropriate action for Pinnacle,” said company CEO Mark Clouse in the release. “It is consistent with our plans to enhance the on-going margin of the Company and focus our efforts and investments on more profitable growth opportunities longer term. While the timing of this exit was accelerated by the voluntary recall we initiated last week, these items are low-margin, non-strategic SKUs that we expected to exit at some point in the foreseeable future.” The company will continue to market its mini pancakes, French toast sticks, breakfast entrees and Griddle Poppers.
3M has announced that its Molecular Detection Assay 2 has won the Gold Edison Award in the diagnostic tools category. The 2017 Edison Awards recognize innovators that have had a positive impact globally. The assay platform is a next-generation of tests, which also previously won an Edison award.
The technology is powered by isothermal DNA amplification and bioluminescience detection to provide a faster molecular detection of pathogens. Its single assay protocol enables batch processing of up to 96 different samples simultaneously and can provide same-day results.
The platform can be used to identify Salmonella, Listeria, Listeria monocytogenes, and E.coli O157 in food or environmental samples, and Cronobacter in powdered infant formula.
The previous article discussed the various decontamination options available to eliminate Listeria. It was explained why the physical properties of gaseous chlorine dioxide make it so effective. This article focuses on one company’s use of chlorine dioxide gas decontamination for both contamination response and for preventive control.
The summer of 2015 saw multiple ice cream manufacturers affected by Listeria monocytogenes. The ice cream facility detailed in this article never had a supply outage, but ceased production for a short amount of time in order to investigate and correct their contamination. After a plant-wide review of procedures, workflows, equipment design and product testing, multiple corrective actions were put into place to eliminate Listeria from the facility and help prevent it from returning. One such corrective action was to decontaminate the production area and cold storage rooms using chlorine dioxide gas. This process took place after the rest of the corrective actions, so as to decontaminate the entire facility immediately before production was set to resume.
The initial decontamination was in response to the Listeria monocytogenes found at various locations throughout the facility. A food safety investigation and microbiological review took place to find the source of the contamination within the facility in order to create a corrective action plan in place. Listeria was found in a number of locations including the dairy brick flooring that ran throughout the production area. A decision was made to replace the flooring, among other equipment upgrades and procedural changes in order to provide a safer food manufacturing environment once production resumed. Once the lengthy repair and upgrade list was completed, the chlorine dioxide gas decontamination was initiated.
The facility in question was approximately 620,000 cubic feet in volume, spanning multiple rooms as well as a tank alley located on a different floor. The timeline to complete the decontamination was 2.5 days. The first half-day consisted of safety training, a plant orientation tour, a meeting with plant supervisors, and the unpacking of equipment. The second day involved the setup of all equipment, which included chlorine dioxide gas generators, air distribution blowers, and a chlorine dioxide gas concentration monitor. Gas injection tubing was run from the chlorine dioxide gas generators throughout the facility to approximately 30 locations within the production area. The injection points were selected to aid its natural gaseous distribution by placing them apart from one another. Gas sample tubing was run to various points throughout the facility in locations away from the injection locations to sample gas concentrations furthest away from injection points where concentrations would be higher. Sample locations were also placed in locations known to be positive for Listeria monocytogenes to provide a more complete record of treatment for those locations. In total, 14 sample locations were selected between plant supervisors and the decontamination team. Throughout the entire decontamination, the gas concentration monitor would be used to continuously pull samples from those locations to monitor the concentration of chlorine dioxide gas and ensure that the proper dosage is reached.
As a final means of process control, 61 biological indicators were brought to validate that the decontamination process was effective at achieving a 6-log sporicidal reduction. 60 would be placed at various challenging locations within the facility, while one would be randomly selected to act as a positive control that would not be exposed to chlorine dioxide gas. Biological indicators provide a reliable method to validate decontamination, as they are produced in a laboratory to be highly consistent and contain more than a million bacterial spores impregnated on a paper substrate and wrapped in a Tyvek pouch. Bacterial spores are considered to be the hardest microorganism to kill, so validating that the process was able to kill all million spores on the biological indicator in effect also proves the process was able to eliminate Listeria from surfaces. The biological indicators were placed at locations known to be positive for Listeria, as well as other hard-to-reach locations such as the interior of production equipment, underneath equipment and inside some piping systems.
In order to prepare the facility for decontamination, all doors, air handling systems, and penetrations into the space were sealed off to keep the gas within the production area. After a safety sweep for personnel, the decontamination was performed to eliminate Listeria from all locations within the production area.
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After being informed by its supplier Deutsch Kase Haus, LLC that its specialty Longhorn Colby cheese may be contaminated with Listeria monocytogenes, Sargento Foods, Inc. recalled several retail cheese products. The recalled Colby and Pepper jack cheeses (available on the company’s website) were packaged at Sargento’s Plymouth, Wisconsin plant. The company also recalled several other cheeses that were packaged at the same time “out of an abundance of caution”.
The recall involving Deutsch Kase Haus is not limited to Sargento. Guggisberg Cheese, Inc., Meijer and Sara Lee have recalled their Colby and Pepper jack cheeses. According to a release by US Foods, the product recalls were initiated after a notification by the Tennessee Department of Agriculture that some products manufactured on November 3, 10 and 18 could be contaminated with Lm.
Taylor Farms also recalled products that contained the cheese products—the company’s Class I recall involved 6,630 pounds of chicken and pork salad products that were produced and packaged from February 6–9, 2017.
Every year, FDA conducts thousands of food safety inspections and issues approximately 2,500 Form 483s to food companies. When the FDA investigators complete their inspection, they use the Form 483 to list the violations about which they are most concerned. Sometimes, if the violations are serious enough, and the company does not provide an adequate written response, FDA will send a follow-up warning letter threatening to shut the company down. The information contained in the 483s and warning letters issued to companies can be a useful tool to predict what FDA investigators will be looking for when they visit your own facility.
To see what FDA has been up to, we took a close look at some higher-profile 483s and warning letters recently issued by the agency.
Shawn Stevens will lead the webinar, “Who’s Getting FDA Form 483s? Recent Issues You Can Learn From” on February 23, 2017 at 1 pm ET Just recently, FDA issued a warning letter to a raw cookie dough manufacturer, threatening to shutter the company. The inspection was extremely extensive and lasted a total of eight business days. During the inspection, FDA investigators collected more than 100 environmental samples and tested them for the presence of Listeria monocytogenes (Lm). Four of the samples, collected from a ladder, pallet jack and other non-food contact surfaces, were positive. The company also had a handful of recent positive Lm samples from its own in-house testing program. FDA insisted on access to the company’s own isolates and conducted whole genome sequencing on all the positive samples. The strains of the environmental samples matched, and FDA urged the company to recall all products produced over a four-month period. In the warning letter that followed, FDA warned the company that “it is essential to identify harborage sites in the food processing plant and equipment where [Lm] is able to grow and survive and take such corrective action as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.”
This pattern is reflective of FDA’s new investigational approach during routine inspections. During a similar inspection of SM Fish Corp. last summer, FDA collected and tested 105 environmental samples (many of them taken from Zone 3 and Zone 4 areas, which were far-removed from the production of food) for the presence of Lm. When 29 of the 105 environmental samples collected tested positive for Lm, the agency withdrew the company’s registration and urged a massive recall. FDA adopted this aggressive stance even though no food contact surfaces or finished products tested positive for Lm during the routine inspection.
More recently, while FDA was performing a routine inspection of the Sabra Dipping Company, LLC’s manufacturing facility in Colonial Heights, Virginia, the agency adopted a nearly identical approach. After performing extensive microbiological sampling within the facility, the agency confirmed that 27 samples of more than 100 collected tested positive for Lm. Although none of the samples were collected from food contact surfaces or finished products, the agency nevertheless urged the company to announce a recall of hummus products that it had shipped.
These are just a few examples highlighting the significant consequences that can result from any routine FDA inspection. FDA is moving increasingly closer toward a zero-tolerance attitude toward Lm in the processing environment, and companies should heed the message contained in these most recent 483s and warning letters. With some careful preparation, you can avoid the mistakes of others and increase the likelihood that your own FDA inspection will end with much better results.
Building the right food safety culture around environmental monitoring requires a realistic approach to your processes. “Culture starts with understanding your process,” Zephyr Wilson, product manager at Roka Bioscience told Food Safety Tech at the 2016 Food Safety Consortium. “You need to ask questions—a lot of questions.”
In the following video, Wilson talks about food safety culture in the context of environmental monitoring and how companies should approach environmental monitoring. “Understand all of your processes,” she said. “Take an honest look at your metrics and make sure you’re encouraging your employees to find the Listeria.”
She also reviews the steps a company should take when undergoing self-auditing, and encourages companies to work under the direction of an attorney to ensure that all results are confidential.
“Drop the Mop! Take a Clean New Look at Condensation Control in Food Processing Facilities” is available on-demand Little beads of water on overhead surfaces can cause big problems. Remember the Listeria contamination that affected Blue Bell Creameries? FDA investigators spotted condensation dripping right into food and food contact surfaces. In a response to an FDA Form 483, Blue Bell wrote “As part of our internal review, we are extensively reconfiguring lines and equipment to eliminate the potential for condensation forming on pipes above processing equipment”.
Condensation can form on overhead surfaces during sanitation processes, which poses potentially serious issues. During an upcoming webinar, “Drop the Mop! Take a Clean New Look at Condensation Control in Food Processing Facilities”, experts from the University of Nebraska, Maple Leaf Foods, General Mills, Smithfield Foods, and 3M Corporate Research Materials Laboratory will discuss tips on how to manage condensation, along with the challenges associated with condensation.
