USDA FSIS has awarded a contract to 3M Food Safety for its pathogen detection instruments and kits. 3M’s molecular detection system will be the primary method used by the agency to detect Salmonella, Listeria monocytogenes and E. coli O157. The technology combines isothermal DNA amplification and bioluminescence detection for a fast, accurate and simple solution that also tackles some of the constraints of PCR methods. Users can concurrently run up to 96 different tests for many organisms across food and environmental samples.
Today Clear Labs announced the availability of its next-generation sequencing (NGS) platform, Clear Safety, for pathogen testing. Competing head-to-head with PCR, the product intends to bring NGS into the routine production environment. Clear Labs is launching the product at the IAFP Annual Meeting this week in Salt Lake City.
“Until the launch of Clear Safety, there was the duality between PCR and whole genome sequencing (WGS) where PCR was more applicable to routine testing and faster results,” says Mahni Ghorashi, co-founder of Clear Labs. “WGS is more expensive and slower, so the food industry has been using the technology as complementary until this time. This platform out competes PCR virtually on every level.”
Clear Safety was in the pilot phase only a couple of months ago when Ghorashi sat down with Food Safety Tech to give a brief overview of the technology. Now that the platform is officially out of pilot mode, it is accessible to all of the food industry, from third-party service labs to any food company that has an in-house lab. With less human labor involved, the platform reduces the potential for errors and does not require additional expertise. The process from sample to result has been simplified, and the bacterial enrichment and sample prep stages are identical to PCR, according to Ghorashi, who says that all a lab technician has to do is load the plates on the box and press “go”. Within 18 hours, test results are ready and can be accessed through a software platform.
In discussing the capabilities of Clear Safety versus PCR, Ghorashi named a few other key differentiators:
- Molecular profiling: The ability to drill down from species-level resolution to serotype to strain-level all in a single test within 24 hours (as opposed to today’s three-to-five-day timeframe)
- Better accuracy and more automation, reducing human error
- Multi-target analysis: The ability to run different kinds of pathogens at the same time
- Software: LIMS built specifically for food safety testing
Clear Safety’s first area of focus is Salmonella. Ghorashi estimates that 90% of the poultry market, 80% of the pet food market and half of all contract service labs have piloted the platform. Next year E.coli and Listeria testing capabilities will be rolled out.
The last word a manufacturer wants to hear is “recall”. During 2017, recalls involved everything from salad mix contaminated with a dead bat to hash browns infused with shredded golf balls.
Not all recalls are created equal. Both the USDA and the FDA have three classifications of recalls to indicate the relative degree of health hazard presented by the product being recalled:
- Class I: A Class I recall is the most serious classification, involving a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.
- Class II: A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.
- Class III: A Class III recall involves a situation in which eating the food will not cause adverse health consequences.
During 2017, there were 456 recalls recorded in the United States. The number one reason for those recalls was undeclared allergens.
Identify the weak links in your supply chain: Attend the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MD | Learn moreFoodborne illnesses continue to be widespread, as well. In 2017, we saw Robin Hood flour contaminated with E.coli, Soygo yogurt with Listeria, tomatoes, cantaloupe, and ground turkey tainted with Salmonella, and even shredded coconut was responsible for causing a Salmonella outbreak in the United States and Canada. Foodborne illness outbreaks can happen at restaurants, corporate events, private parties, schools and cruise ships—anywhere and everywhere food is served.
Recalls and foodborne illnesses are 100% preventable. Incidents occur because of human error, and all it takes is one weak link to cause serious—and potentially fatal—problems. That’s it. One weak link can cause the traumatic deaths and/or illnesses of customers, and cost your company billions of dollars, loss of sales, plummeting stocks, negative media coverage and a severely damaged reputation.
When there’s a recall or a foodborne illness, products must be destroyed, which is lost revenue for manufacturers, retailers, restaurants, etc. Finding the source of the contamination can be a massive undertaking. The manufacturer may need to close all of their plants for cleaning until the source is identified, which adds up to a tremendous financial burden, and also requires significant time and effort. Class 1 recalls can cost hundreds of millions of dollars or more, to identify the source of contamination, recall products, sanitize facilities, and keep consumers safe.
It takes years for companies to establish a solid reputation, and food recalls and foodborne illness outbreaks can obliterate a brand’s reputation overnight. Consumers lose confidence much faster than they gain it, and bad news travels fast (especially in this time of social media where news spreads instantly and widely). And on top of that, there may be litigation as a result of the recall, incident or outbreak, which will result in attorney fees and potential settlements that could be very significant. If the risk of massive expense and bankruptcy isn’t enough, for the past few years, the U.S. District of Justice has been issuing fines and prison terms to company leaders involved in foodborne illnesses outbreaks and food recalls.
The government, media and general public are holding companies (and their leadership) accountable now, so you’d think that recalls and foodborne illness incidents would be on the decline but, unfortunately, that’s not the case. And with advancements in technology, why are we still having so many issues surrounding the safety of our food?
Many media outlets report that foodborne illnesses have been rising considerably in the past few years. However, according to the CDC, a study showed that the six most common foodborne illnesses have actually declined in frequency by 25% over the last two decades. Having said that, though, the severity of foodborne illness outbreaks seems to be increasing, and the number of outbreaks connected to produce has risen, as well. Some experts believe the increases may be due to better reporting processes rather than an actual increase in the number of foodborne illnesses.
There are various theories as to why foodborne illnesses may be getting worse. Some government agencies indicate it has to do with farming policies. The CDC disagrees. More widely accepted beliefs are the increase in popularity of organic produce—grown with manure rather than chemical fertilizer—which can transfer bacteria to the produce. Additionally, there’s debate that the use of antibiotics can cause bacteria that causes foodborne illnesses to become resistant.
Recalls may occur for a variety of reasons. Products may be pushed beyond their shelf life by the manufacturer, or maybe the design and development around the product was insufficient (equipment, building, etc.). Is the manufacturing facility designed in a manner that can prevent contamination—structurally and hygienically? Maybe the production quality control checks failed. Did the manufacturer conduct an adequate food safety risk assessment prior to launching the new product? Profit margins are often thin—did financial incentives prevent the company from implementing a thorough food safety program?
Getting back to the basics of food safety would reduce recalls and foodborne illnesses significantly. Manufacturers must be certain about food safety as well as the integrity of the ingredients they use. They need to be honest with themselves and understand the risks of the ingredients, processes and finished products that they are handling.
Human error is a given. It’s the corporation’s responsibility to minimize the risk. Implement ongoing food safety education and training for all employees, explaining the proper food safety protocols and processes. Develop internal auditing systems, using innovative digital tools. Get rid of the pen and paper forms, where it’s more likely for errors to occur and for pencil whipping to happen. Digital solutions provide more effective internal auditing, meticulousness in corrective action systems including root cause analysis, allergen management, and controls relating to packing product into the correct packaging format—all fundamental to keeping foods, consumers and businesses healthy and safe.
Shiga toxin-producing E. coli in dry flour, and then romaine lettuce. E. coli O104 in fenugreek sprout seeds. Recent announcements of foodborne illness outbreaks have begun involving unusual combinations of bacteria and foods. These out-of-the-ordinary outbreaks and recalls are a small but growing part of the 600 million documented food poisonings that occur worldwide every year according to the World Health Organization. Preventing outbreaks from these new combinations of pathogen and food demand a range of accurate tests that can quickly identify these bacteria. Over the past several years, outbreaks from unusual sources included:
- E. coli O121 (STEC) in flour: Last summer, at least 29 cases of a E. coli O121 infection were announced in six Canadian provinces. The source arose from uncooked flour, a rare source of such infections because typically flour is baked into final products. Eight people were hospitalized, and public health officials have now included raw, uncooked flour as well as raw batter and dough as a source of this type of infection.
- E. coli O104:H4 in fenugreek sprouts: One of Europe’s biggest recent outbreaks (affecting more than 4,000 people in Germany in 2011, and killing more than 50 worldwide) was originally thought to be caused by a hemorrhagic (EHEC) E. coli strain that from cucumbers, but was but was later found to be from an enteroaggregative E. coli (EAEC) strain in imported fenugreek seeds—the strain had acquired the genes to produce Shiga toxins.
- Mycoplasma in New Zealand dairy cows: While not unusual in cattle, the incident reported in August marks the pathogen’s first appearance in cows in New Zealand, a country known for strict standards on agricultural hygiene. The microorganism is not harmful to people, but can drastically impact livestock herds.
- Listeria monocytogenes in food sources: Listeria monocytogenes causes fewer but more serious incidence of food poisoning due to a higher death rate compared to Salmonella and Campylobacter. Whereas Listeria has been historically associated with dairy and ready to eat cooked meat products, recent outbreaks have been associated with fruit, and the FDA, CDC and USDA are conducting a joint investigation of outbreaks in frozen as well as in fresh produce.
- Listeria in cantaloupe: In 2011, one of the worst foodborne illnesses recorded in the United States killed 20 and sickened 147, from Listeria monocytogenes that was found in contaminated cantaloupes from a farm in Colorado. The outbreak bloomed when normal background levels of the bacteria grew to deadly concentrations in multiple locations, from transport trucks to a produce washer that was instead designed for potatoes.
The outbreaks underscore the fundamental need to have a robust food safety program. Bacteria can colonize many different locations and the opportunity is created by a change in processing methods and/or consumer use or misuse of products. So robust risk assessment and preventative QA procedures need to be frequently reviewed and supported by appropriate surveillance methods.
Food safety and public health agencies like the European Food Safety Authority (EFSA) or the CDC have employed a wide range of detection and identification tests, ranging from pulse field gel electrophoresis (PFGE), traditional cell culture, enzyme immunoassay, and the polymerase chain reaction (PCR). In the case of Germany’s fenugreek-based E. coli outbreak, the CDC and EFSA used all these techniques to verify the source of the contamination.
These tests have certain advantages and disadvantages. Cell culture can be very accurate, but it depends on good technique and usually takes a long time to present results. PFGE provides an accurate DNA fingerprint of a target bacteria, but cannot identify all strains of certain microorganisms. Enzyme immunoassays are precise, but can produce false-positive results in certain circumstances and require microbiological laboratory expertise. PCR is very quick and accurate, but doesn’t preserve an isolate for physicians to test further for pathogenic properties.
Identification of the pathogens behind foodborne contamination is crucial for determining treatment of victims of the outbreak, and helps public health officials decide what tools are necessary to pinpoint the outbreak’s cause and prevent a recurrence. Rapid methods such as the polymerase chain reaction (PCR), which can quickly and accurately amplify DNA from a pathogen and make specific detection easier, are powerful tools in our efforts to maintain a safe food supply.
Recently, scientists and a third-party laboratory showed that real-time PCR assays for STEC and E. coli O157:H7 could detect E. coli O121, O26 and O157:H7 in 25-g samples of flour at levels satisfying AOAC method validation requirements. The results of the study demonstrated that real-time PCR could accurately detect stx, eae and the appropriate E. coli serotype (O121, O26 or O157:H7) with no statistical difference from the FDA’s Bacteriological Analytical Manual (BAM) cell culture method.
Agencies like the World Health Organization and CDC have repeatedly stated that historical records of food poisoning represent a very small percentage of true incidents occurring every year worldwide. Many of today’s most common food pathogens, like Listeria monocytogenes, E. coli O157:H7 or Campylobacter jejuni, were unknown 30 years ago. It’s not clear yet if unusual sources of contamination arise from increasing vigilance and food safety testing, or from an increasingly interdependent, globally complex food supply. No matter the reason, food producers, processors, manufacturers, distributors and retailers need to keep their guard up, using the optimum combination of tools to protect the public and fend off food pathogens.
No one has reported falling ill, but Panera Bread Company isn’t taking any chances. After sampling one type of two-ounce cream cheese showed a positive result for Listeria monocytogenes from a single production day, the company decided to recall all varieties of its two-and eight-ounce cream cheese.
“The safety of our guests and associates is paramount, therefore we are recalling all cream cheese products sold in the U.S. with an active shelf life. We have likewise ceased all manufacturing in the associated cream cheese facility. Only one variety of 2-oz cream cheese from a single day yielded the positive result. Our intent is to go above and beyond for our guests. You should expect nothing less from Panera.” –Blaine Hurst, Panera’s President and CEO
The recall only affects cream cheese sold in Panera Bread United States locations, not those in Canada or other Panera food products.
Rich Products Corp. recalled 3.420 pounds of ready-to-eat beef meatball products over concerns that they may be adulterated with Listeria monocytogenes. The recalled products, which were produced on December 17, 2017, include 36-lb cases that contain six bags of “Member’s Mark Casa Di Bertacchi Italian Style Beef Meatballs with a “best by” date of December 17, 2018. The meatballs were shipped to distributors in the South, including Alabama, Florida, Mississippi, North Carolina, Texas and Virginia. The issue was discovered on January 24 when FSIS was notified by Rich Products that it shipped adulterated products into commerce. More information about the meatball recall is available on USDA’s website.
–UPDATE January 12, 2018–
Today Fieldbrook Foods clarified its recall, stating that the voluntary recall also includes 28,751 cases of Raspberry Cream Bars that were included with its orange cream bars in ALDI seasonal split-case purchases. These cases were shipped between March and August 2017.
Yesterday Fieldbrook Foods Corp. issued a voluntary recall due to concerns that two of its products may have ben contaminated with Listeria monocytogenes. The recall is concerning the company’s orange cream bars and chocolate-coated vanilla ice cream bars that were produced last year at Fieldbrook Foods’ Hoyer 1 Line plant in Dunkirk, NY with a “best buy” date of January 1, 2018–December 31, 2018. The FDA’s website lists 21 merchants that sold the bars, including Acme, ALDI, BJ’s, Giant, Kroger and Price Chopper.
Thus far, no illnesses connected to this issue have been reported.
The CDC estimates that Salmonella, E. coli O157, Listeria monocytogenes and Campylobacter cause 1.9 million cases of foodborne illness in the United States. A report just released from the Interagency Food Safety Analytics Collaboration (IFSAC) analyzed data from more than 1000 foodborne disease outbreaks involving these pathogens from1998 through 2013.
The report found the following:
- Salmonella illnesses came from a wide variety of foods (more than 75% came from the seven food categories of seeded vegetables, eggs, chicken, other produce, pork, beef and fruit.
- More than 75% of E.coli O157 illnesses were linked to vegetable row crops, like leaf greens, and beef.
- More than 75% of Listeria monocytogenes illnesses came from fruits and dairy products.
- More than 80% of non-dairy Campylobacter illnesses were linked to chicken, other seafood (i.e., shellfish), seeded vegetables, vegetable row crops, and other meat and poultry (i.e., lamb or duck).
A copy of the report, “Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, is available on the CDC’s website.
Last week, 3M Food Safety announced their 3M™ Molecular Detection Assay 2 – Cronobacter was designated by AOAC International as Performance Tested Method (Certificate #101703). The assay is compatible with their Molecular Detection System, which uses isothermal DNA amplification and bioluminescence detection to test for pathogens.
Cronobacter, a type of bacteria commonly found in powdered foods, supplements and baby formula, can survive for almost two years and exposure to an infant can be life-threatening.
“While less well known than other foodborne pathogens like Listeria or Salmonella, Cronobacter is no less dangerous – particularly because it preys on some of the most vulnerable populations,” says 3M Global Marketing Manager Carolina Riba. “It’s a point of pride for our team that the tests we’ve made for the dangerous pathogen were recognized by an organization like AOAC International.”
Using approved protocols set by the AOAC Research Institute, 3M’s testing process used an independent laboratory. They tested the assay on powdered infant formula, powdered infant cereal, lactose powder and an environmental surface.
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.