Tag Archives: Listeria

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Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

Dollar

Pathogens Drive More Than Half of $12 Billion Global Food Safety Testing Market

By Maria Fontanazza
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Dollar

The importance of food safety testing technologies continues to grow, as companies are increasingly testing their products for GMOs and pesticides, and pathogens and contamination. Last year the global food safety testing market had an estimated value of $12 billion, according to a recent report by Esticast Research & Consulting. Driven by pathogen testing technologies, the global food safety testing market is expected to experience a 7.4% CAGR from 2017–2024, hitting $21.4 billion in revenue in 2024, said Vishal Rawat, research analyst with Esticast.

With a CAGR of 9.3% from 2017–2024, rapid testing technologies are anticipated to lead the market. Testing methods responsible for this growth include immunoassays (ELISA), latex agglutination, impedance microbiology, immune-magnetic separation, and luminescence and gene probes linked to the polymerase chain reaction, said Rawat, who shared further insights about the firm’s market projections with Food Safety Tech.

Food Safety Tech: With the GMO food product testing market expected to experience the highest growth in the upcoming future, can you estimate the projected growth?

Vishal Rawat: The GMO food product testing market is estimated to generate a revenue of approximately $5.2 billion in 2016. The market segment is expected to witness a compound annual growth rate of 8.3% during the forecast period of 2017–2024. This is a global market estimation.

FST: What innovations are occurring in product testing?

Rawat: Nanomaterials and nanobased technologies are attracting interest for rapid pathogen testing. Sustainable technologies such as edible coatings or edible pathogen detection composition can attain a trend in the near future. Also, new rapid allergen testing kits are now emerging out as the latest food testing technology in the market, which are portable and easy to use.

FST: Which rapid pathogen detection testing technologies will experience the most growth from 2017–2024?

Rawat: New and emerging optical, nano-technological, spectroscopic and electrochemical technologies for pathogen detection, including label-free and high-throughput methods would experience the highest growth.

FST: What pathogen testing technologies are leading the way for meat and poultry in the United States?

Rawat: The presence of a microbial hazard, such as pathogenic bacteria or a microbial toxin, in ready-to-eat (RTE) meat or poultry products is one basis on which these products may be found adulterated. The FSIS is especially concerned with the presence of Listeria monocytogenes, Salmonella, Escherichia coli O157: H7, and staphylococcal enterotoxins in RTE meat and poultry products. Rapid pathogen testing for E. coli O157:H7 and Salmonella, for ground beef, steak and pork sausages is going to lead the U.S. market.

An overview of the report, “Food Safety Testing Market By Contaminant Tested (Pathogens, GMOs, Pesticides, Toxins), By Technology (Conventional, Rapid), Industry Trends, Estimation & Forecast, 2015– 2024” is available on Esticast’s website.

Sprouts

FDA Releases Sampling Report on Sprout Contamination

By Food Safety Tech Staff
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Sprouts

In an effort to determine the prevalence of Salmonella, Listeria and E. coli O157:H7 in sprouts, FDA conducted a large sampling study of sprouts, the results of which were released last week.

The agency collected 825 samples from 37 states, Puerto Rico and the District of Columbia and found 14 positive samples at eight of the 94 growers (10 samples came from four growers). Samples were collected from three production process points: Seeds, finished product and spent irrigation water, and tested for contamination. FDA found the following contamination:

  • Salmonella on 2.35% of seed samples, 0.21% in finished sprouts and 0.53% in spent irrigation water
  • Listeria monocytogenes on 1.28% of finished sprouts
  • No positive E. coli O157:H7 results in finished sprout or spent irrigation. Due to limitations of the test method, FDA didn’t test seed samples.

“Sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States linked to sprouts. These outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths.” – CFSAN

In the event that contaminated sprout samples were uncovered, FDA worked with the firms that own or released the affect sprouts to conduct voluntary recalls or destroy them. FDA inspections also followed.

The full report, FY 2014 – 2016 Microbiological Sampling Assignment, is available on FDA’s website.

Dollar

Trends and Real Cost of Product Recalls

By Food Safety Tech Staff
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Dollar

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.

Rentokil Product Recalls 2016
The Cost of a Product Recall in the Food Industry. Infographic courtesy of Rentokil.
Golden Gourmet recall

Industry Hit with More Meat Recalls

By Food Safety Tech Staff
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Golden Gourmet recall

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 Recall

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.

Armour Eckrich Meats Recall

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.

Indicon Gel, biofilm

Spray Gel Detects Biofilm on Surfaces

By Food Safety Tech Staff
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Indicon Gel, biofilm

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.

Fast Facts about Biofilm

Aunt Jemima frozen French Toast recall

Pinnacle Foods Drops Certain Aunt Jemima Products Amidst Listeria Recall

By Food Safety Tech Staff
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Aunt Jemima frozen French Toast recall

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 Molecular Detection Assay 2

3M Receives Edison Award in Diagnostics

3M Molecular Detection Assay 2

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.

Listeria

How One Company Eliminated Listeria Using Chlorine Dioxide Gas

By Kevin Lorcheim
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Listeria

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.

Responsive Decontamination

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.

Click page 2 to continue reading.

Recall

Sargento’s Supplier Has Listeria Concerns, Recalls Ensue

By Food Safety Tech Staff
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Recall

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.