Next month Stewart Parnell, the former CEO of Peanut Corporation of America (PCA), is scheduled to be sentenced for his role in a deadly salmonella outbreak involving shipping contaminated peanut products nationwide. Parnell, who could spend the rest of his life in jail, was found guilty on 71 counts, including conspiracy, obstruction of justice and wire fraud. This landmark case sends a strong message about accountability to both industry and consumers, said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness, at the IAFP 2015 conference in July.
“His actions resulted in technically more deaths than that of Charles Manson,” said Detwiler, who indicated that Parnell is still very much in denial over his role in the salmonella outbreak. “This might be one snapshot—one look at one person in one industry, in one business—but think about how many companies are out there [and] of this mindset—the idea that they’ll never get caught.”
Food companies should be held strictly liable when it comes to consumer safety, ensuring that they take preventive measures so that illness and death never happen. The sentencing of Parnell next month could set a precedent for how future cases involving companies responsible for foodborne illnesses and outbreaks are handled.
Today FDA announced the winner of the 2014 Food Safety Challenge. The Purdue University team snagged the $300,000 grand prize for its physical method for concentrating Salmonella to detectable levels via automated microfiltration. The technique can potentially reduce sample preparation time from 24-48 hours to a two- to three-hour timeframe.
Runner-up Pronucleotein received $100,000 for its portable device that enables rapid pathogen screening via DNA aptamer-magnetic bead sandwich assays.
Rapid technologies address the trend toward environmental testing versus finished product testing.
During the past decade, incidences of Salmonella have failed to drop, and the pathogen continues to pose a serious problem to the food supply. Meredith Sutzko, Product Manager, Food Pathogens at Romer Labs North America discusses current technology needs for the food industry.
Q: What are processors looking for in Salmonella detection methods?
Sutzko: I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing. Instead of waiting to test finished products at the end of a production cycle, we’re finding that processors are taking a lot of environmental samples from the production line in different areas in order to find contamination further upstream so that when they get to the product testing, they have a lot of confidence that the product is going to be pathogen-free.
Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results. By using test methods on-site, they can immediately take action upon getting the test result.
Q: How is RapidChek® differentiated from other rapid methods currently available?
Sutzko: The RapidChek method is an innovative, simple and easy-to-use test. With this test, we typically focus on the enrichment portion of the rapid method, because if salmonella is present in the environment, it’s going to be present at very low levels. The enrichment portion (or the growth phase), is important to get that pathogen to higher concentrations for detection.
We use innovative bacteriophage technology in our enrichment media. The bacteriophage act as selective agents during enrichment to inhibit the growth of competing microorganisms, which could be present. The phages allow an optimal growth environment for Salmonella, if it’s present, by reducing the growth of these other competitors. It helps to provide a fast time to result. Then we combine the enrichment media with a state-of-the art-lateral flow test, which uses highly purified antibodies that have been optimized for the sensitive and specific detection of Salmonella.
The technology is simple and easy to use. The end user doesn’t need any expensive equipment to run it. The method comes all-inclusive with everything necessary to run it, so there are no additional expenditures on consumables. Producers are able to do a lot more testing using the RapidChek, because it’s so cost effective. If they find contamination or a growth-niche, they can sanitize, take action and do more testing to make sure they’ve gotten rid of the pathogen.
Q: What’s the significance of Salmonella detection right now as it relates to the risk that the pathogen poses to the food supply?
Sutzko: Historically, Salmonella has been associated with meat and poultry. Recently we’ve seen a lot more outbreaks in different types of food products and matrices that historically have not been associated with Salmonella. Also, the food supply is being globalized. We’re receiving a lot of foods from different countries, possibly where their food safety standards are not as stringent as we have in the United States. We’re seeing an increased level of awareness by producers. They look at their suppliers and their raw materials to make sure they’re testing the materials before they put it into their supply chain.
Also with regulations like FSMA, we see retailers driving food safety and quality systems through third-party certification bodies such as GFSI. Retailers are requiring their suppliers to have effective food safety quality management systems in place in order to do business. These practices will help to ensure safe food is being supplied to the consumer from farm-to-fork.
In less than two weeks, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland. The agency will be awarding $500,000 to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce.
A few months ago, Capt. Palmer Orlandi, Ph.D., senior science advisor at FDA’s Office of Veterinary Medicine, describes exactly why FDA is offering such a hefty prize. It can take between three and five days to detect Salmonella in product, and with full serotyping, it can take as long as two to three weeks to obtain results.
By 2020, the CDC has targeted a reduction in Salmonella cases at 11.4 per 100,000 people (last year’s rate was 15.4 per 100,000). Considering that the number of cases has not declined in the past 10+ years, regulators and industry will need to work together more closely on utilizing methods and technologies that provide effective pathogen detection.
Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr
It is a well-known fact within the food safety industry that Salmonella is the second most common foodborne illness in the United States, and the bacteria comes in first place in the category of foodborne illnesses that lead to hospitalization or death. Unfortunately, there has been no change in the number of confirmed infections between the 2006-2008 period and last year, according to the CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) 2014 Food Safety Progress Report.
“The major threat Salmonella poses is that its public health impact has remained largely unchanged despite many years of regulatory oversight and technological improvements,” says Evan Chaney, Ph.D., senior manager, scientific affairs at Roka Bioscience. “Reducing the existing public health burden of Salmonella is a complex challenge that will require new and innovative thought, research, and technological developments or processes.”
Each year Salmonella makes its way into the food supply through a variety of sources, sickening more than 1 million people in the United States and costing the country nearly $3.7 billion, according to the USDA. Although it is most commonly found in contaminated animal-derived products, the level of serious outbreaks over the past few years is cause for concern, as the bacteria have appeared in processed foods such as peanut butter and fresh produce, including cucumbers, cantaloupes, alfalfa sprouts and jalapeno peppers.
USDA’s Food Safety and Inspection Service (FSIS) proposed federal measures in January to lower the rate of Salmonella in poultry, including a pathogen reduction performance standard for chicken parts, and ground chicken and turkey. FSIS began the sample project for raw chicken parts in March (only for firms that produce more than 1,000 lbs of chicken parts daily) and a verification testing program for poultry carcass inspection, using a moving window of sampling results, in May (view the full Federal Register notice).
Technologies Taking Down Salmonella
Providing rapid pathogen detection for Salmonella in less than 24 hours has been a priority for industry. Companies want to both prevent contaminated foods from entering the market as well as ensure that products can be quickly tested so that they are not sitting in a warehouse for days awaiting results. With this focus comes a need to provide testing in the processing environment.
“I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing,” says Meredith Sutzko, Product Manager, Food Pathogens of Romer Labs North America. “Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results.”
From enzyme immunoassays (EIA) and enzyme-linked immunosorbent assays (ELISA) to PCR assays, there are a large variety of established testing and identification technologies on the market. However, in taking a different approach to lowering the risk of Salmonella from entering the market, companies can employ limits testing as an additional tool to verify process control within a production shift. Salmonella limits testing is a semi-quantitative method that provides a “positive” or “no-go” result based on initial contamination levels of a sample, and does so within a day.
Limits testing provides a semi-quantitative approach to lowering Salmonella levels. Image courtesy of Roka Bioscience
“A key difference in this testing approach is the utilization of a pathogen test as a means of process control or intervention, an example of a tool utilized in a new manner,” says Chaney, adding that in most cases, pathogen testing is conducted on finished product or on lots of product in concordance with COA requirements. While it is important to provide results that indicate both qualitative (presence or absence) and quantitative (estimates concentration), having insight into actual concentration levels provides another layer of risk mitigation. “We need tools to help us understand what Salmonella loads are in the system in a rapid manner so that action can be taken. This is the purpose of limits testing.”
As a case example of limits testing being used in the field, Cargill asked Roka Bioscience to develop a limits-based approach for testing its ground turkey for Salmonella. Roka was required to provide Salmonella detection levels at about 1 CFU/g in a 375 g sample size of ground meat in less than eight hours (total time to result). Roka successfully developed the limits application, and Cargill now uses the tool to make product disposition decisions prior to shipping its ground turkey. Roka is also looking at other areas in which limits testing can be used, from the pre-harvest to live production environments.
Calling on industry to push harder to innovate in foodborne pathogen detection, FDA announced its 2014 Food Safety Challenge last fall. The agency is offering a hefty prize—$500,00—to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce. The finalists, announced last month, have received $20,000 to further develop their concepts and are being mentored by FDA in food safety and pathogen testing.
A handheld magnetoelastic biosensor and surface-scanning detector that can be passed over food to detect surface contamination. The portable device can be used both in a process facility as well as remote locations in which produce is being harvested and delivers results in minutes, according to the team’s leader, Bryan Chin, director of the Auburn University Detection and Food Safety Center.
Patented high-throughput technology for capturing Salmonella in large sample volumes. Developed by UC Davis School of Veterinary Medicine and scientists from Mars, Inc., the test uses fluidized bed technology to detect bacteria in less than four hours and presents potential for larger food processors. View the UC Davis video
DNA aptamer-magnetic bead sandwich assay, for use with a handheld florescence reader. Developers of the assay are from Pronucleotein, Inc. and Xgenex
Method for concentrating salmonella to detectable levels using automated microfiltration, developed by Purdue University.
Portable system for multiplexed detection of foodborne pathogens in microfluidic biochips through isothermal DNA amplification and electrical detection, developed by University of Illinois and Purdue University.
On July 7, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland where the finalists will present their refined concepts to judges from the FDA, USDA, and CDC, and a live audience. The winner of the Food Safety Challenge will also be announced sometime next month.
A Certificate of Analysis (COA) provides a level of confidence in the quality and purity of its product. Companies should take this document a step further and assess what the results mean. Using Failure Modes and Effects Analysis (FMEA) can help a company identify, quantify and assess risks associated with pathogen detection methods, giving them the background information they need to trust the results. FMEA can help companies understand the differences between testing methods by individually identifying the risks associated with each method on its own. Maureen Harte, President and CEO at HartePro Consulting, and Lean Six Sigma Master Black Belt, talks about the challenges a company faces when assessing results on a Certificate of Analysis and the role of FMEA.
Whole Foods Market voluntarily recalls packaged raw macadamia nuts due to possible Salmonella contamination. Recalled items were sold in AR, AZ, CA, CO, HI, KS, LA, NM, NV, OK, TX, and UT Whole Foods Market Stores. No illnesses have been reported to-date. Based upon routine testing conducted by an FDA-contracted laboratory, it was determined that the raw macadamia nuts tested positive for Salmonella.
Beech-Nut Nutrition recalls approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass… The baby food product was produced on December 12, 2014: 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken. The problem was discovered after the firm received a complaint from a consumer who found a small piece of glass in the product. The company has received a report of an oral injury associated with consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products.
Beech-Nut responds: “At Beech-Nut, we strive to make baby food with the best ingredients nature has to offer – freshly prepared and packaged in clean, safe and environmentally-friendly packaging. So, when any product of ours falls short of those standards, we take swift action to correct it.”
The cured and uncured pork items were produced on various dates between August 7, 2014 and April 1, 2015… The problem was discovered when an FSIS inspector was conducting a Food Safety Assessment and observed a processing deviation.
So far, 61 outbreaks have been associated with raw sprouts, sickening at least 11,179.
The U.S. Centers for Disease Control reports this outbreak appears to be over.
A total of 115 people infected with the outbreak strains of Salmonella Enteritidis were reported from 12 states. Twenty-five percent of ill persons were hospitalized. No deaths were reported.
Collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicated that bean sprouts produced by Wonton Foods, Inc. were the likely source of this outbreak.
In interviews, 61 (72 percent) of 85 ill persons reported eating bean sprouts or menu items containing bean sprouts in the week before becoming ill.
In November 2014, Wonton Foods Inc. agreed to destroy any remaining products while they conducted a thorough cleaning and sanitization and implemented other Salmonella control measures at their firm. The firm resumed shipment of bean sprouts on November 29, 2014.
Contaminated bean sprouts produced by Wonton Foods, Inc. are likely no longer available for purchase or consumption given the maximum 12-day shelf life of mung bean sprouts.
Although this outbreak appears to be over, sprouts are a known source of foodborne illness. CDC recommends that consumers, restaurants, and other retailers always follow food safety practices to avoid illness from eating sprouts.
Be aware that children, older adults, pregnant women, and persons with weakened immune systems should avoid eating raw sprouts of any kind (including alfalfa, clover, radish, and mung bean sprouts).
We count 61 outbreaks associated with raw sprouts, sickening at least 11,179.
The top 15 pathogens, which includes Salmonella, Listeria monocytogenes, Campylobacter and E. coli O157:H7, make up 95 percent of illnesses and deaths from food in the U.S.
Salmonella ranks first among the top 15 most costly foodborne illnesses, raking up around $3.7 billion every year in medical costs for Americans.
According to the latest estimates from USDA’s Economic Research Service, the top 15 pathogens, which also include Listeria monocytogenes (ranked third), Campylobacter (ranked 5) and E. coli O157:H7 (ranked 9), make up 95 percent of illnesses and deaths from food in the U.S.
Salmonella’s cost is $3.7 billion, with 1,027,561 total cases, 19,336 hospitalizations and 378 deaths.
Listeria monocytogenes’s cost is $2.8 billion, with 1,591 cases, 1,173 hospitalizations and 306 deaths.
Campylobacter’s is $1.9 billion, with 845,024 cases, 8,463 hospitalizations and 76 deaths.
E. coli O157’s is $271 million, with 63,153 cases, 2,138 hospitalizations and 30 deaths.
Deaths tend to account for the bulk of the total costs. Death associated with salmonella, for example, cost nearly $3.3 billion, or almost 90 percent, of its $3.7 billion cost.
This article looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6 percent false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).
While at IAFP this year, I met with Heather Jordan, who directs food PT programs at API. The proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.
More proficiency testing but less proficiency?
In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI. Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).
In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.
In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?
Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results? Surprisingly, that’s not what the API research found…
API study: Performance accuracy for food pathogens remains problematic
In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.
Over the 14-year period, “False negative results ranged from 3.3 percent to 14.0 percent for E. coli O157:H7; 1.9 percent to 10.6 percent for Salmonella spp; 3.4 percent to 11.0 percent for L. monocytogenes; and 0 percent to 19.8 percent for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6 percent.
As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.
The cumulative average false positive rate was 3.1 percent, less than half of the false negative rate for the same period.
The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”
Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone. It also points to a number of follow-on questions:
Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
And finally, is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?
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