On any day, search for the term “food safety testing” on the internet and you will get millions of results, of testing labs who help detect pathogens such as E. coli, Listeria, and Salmonella; pesticides and other chemical residues present in food; metals and glass fragments..., all pointing to the critical nature of food-safety testing.
|U.S. Food Safety Testing Market, BCC Research
The U.S. market for food-safety testing was valued at $3.3 billion in 2011 and is projected to grow slightly in 2012, according to an analysis from BCC Research1
. This market forecast is projected to reach nearly $4.4 billion in 2017, growing at an annual rate of 5.6 percent.
Pathogen testing is the major contributor (89 percent) to this market, estimated at nearly $3 billion. This segment is projected to grow at a rate of 5.7 percent to reach $3.9 billion in 2017.
In terms of volume of tests, the U.S. food processing industry performed 213.2 million microbiology tests in 2010, the volume of which grew by just over 10 percent between 2008 and 20102.
During that same three-year period, however, the volume of tests for detecting pathogens such as Salmonella, Listeria, Campylobacter, and E. coli O157 increased by more than 30 percent.
While “routine” tests, used as screening or indicators of the presence and levels of microorganisms in the plant or the food product, accounted for 78 percent of all food microbiology tests performed in the U.S., the remaining 22 percent were pathogen tests, used to detect pathogenic organisms with the potential to cause human disease.
To understand some key trends in food microbiology testing market, Food Safety Tech spoke with four experts on outsourcing of food safety testing, considerations when choosing a testing method or a lab, emerging technologies, and what the industry would like to see in a “food lab of the future.”
Increased outsourcing given cost pressures, new regulations
Attendees at this year’s International Association of Food Processors’ (IAFP) annual meeting in Providence, RI, witnessed more than 20 food safety testing labs as exhibitors, pointing to the increase in food safety testing outsourcing and the growth in specialized technologies and lab capabilities.
Mark Carter, President of MC Squared
, thinks that food companies are deciding to outsource more than ever before due to cost considerations, especially in the current economic scenario.
“Everyone’s feeling the pressure to cut costs, so it’s hard for food companies to set apart the capital expenditure needed for some of the equipment and justify that expenditure,” Carter explains.
“If I make a product, my in-house people have to be experts in food safety testing; but when I hand the testing over to contract testing labs, they specialize in these capabilities,” Carter adds. Contract labs seem more suitable to adopt new technologies and spread the capital expenditure across a number of different tests and clients.
Carter, who has worked earlier with QC Laboratories, Silliker, and Kraft Foods, is confident that outsourcing of food safety testing will continue to grow and that the different players in the market will find different niches to specialize in. For instance, “Silliker can help you with all kinds of testing needs, having a wide range for technical expertise. But niche labs have their own place in the market, and specialize in specific testing areas, such as food mycology etc.
J. Stan Bailey, Ph.D., Director of Scientific Affairs, for bioMérieux Inc
., refers to the Food Safety Modernization Act (FSMA) driving companies to do more testing, specifically in-product testing and points out that increasingly, smaller and medium sized companies are now doing more tests. “While this has increased volume of testing within company labs, third party labs are also doing more testing,” explains Bailey, who is seeing attractive growth in testing for pet foods, and increased environmental testing for Salmonella, especially for products such as flours and nuts.
With respect to outsourcing, Bailey sees a mixed bag. “While overall cost per test matters the most, other issues are also involved. For instance, for pathogen testing, companies may not want to introduce any pathogen into their product handling area, or processing floor, and hence may prefer to outsource the testing. But it’s also critical that you work with someone who understands the data, and knows how to interpret it,” Bailey explains.
For Douglas Marshall, Ph.D., Chief Scientific Officer at Eurofins
, the model for outsourcing can work best for the industry because cost efficiencies are higher. Many labs associated with manufacturing plants often have high costs, are inefficient, and have high turnaround, translating into high costs per tests, he explains.
“Food manufacturers are in the business of manufacturing food, and testing labs are in the business of testing foods,” Marshall adds, saying that there’s growing appreciation for labs that are able to have robust quality systems in place and save time on testing.
And new regulations should help. Marshall feels that a couple of items in FSMA, depending on how FDA interprets them, could be valuable to their business model. New stipulations such as verification of the effectiveness of companies’ food quality control programs, and the need for a robust supplier verification program could result in increased testing.
Accuracy and cost matter, but speed matters most
There are new microbiological technologies released almost every day. So what kind of testing is sought after and what do companies look for in a testing method or a contract lab?
“Something that is efficient and accurate, can get fast results, easy to use and has the ability to update data automatically to the LIMS,” lists Bailey.
System features must be balanced with the type of people using it, he points out: “If you need someone with precise microbiological training, then it increases the cost of the test.”
Eurofins bases a lot of testing on platform technologies such as ELISA based methods to detect pathogens, and genetic testing, due to the perception of customers that those older technologies are more sound and reliable compared to newer ones.
“We are pretty conservative,” describes Marshall. “We don’t usually want to be first in the space unless the technology’s completely vetted.”
And how do they choose the microbiology testing method? The interaction with and service provided by the vendors seem critical. Marshall refers to a few different factors: What kind of support is the vendor offering on a program with the equipment? How long will it be before preventive maintenance is needed? How quickly will the vendor give me new equipment, how much time will a replacement take? On the reagent side, availability and quality control of those reagents are critical.
In addition, more basic factors such as ease of use, cost of consumables per test, turnaround time, rate of false positives and false negatives, ability of those results to be automatically entered in the LIMS are important.
Gerry Broski, Senior Marketing Director for Food Safety at Neogen Corporation
, lists efficiency (or time taken for results), accuracy, cost of testing, ease of use, ability to analyze or mine that data and level of training required as various considerations that go into selecting a specific testing method.
Broski notices a trend toward isothermal alternative rapid micro methods to PCR, which are driven by greater convenience, friendlier workflows, and lower costs and thinks that isothermal assays are going to grow in popularity due to their simplicity. Another trend is for multi-analyte detection in some areas such as veterinary drug residues, and awareness of new contaminants such as E. coli STECs.
He stresses that time to results is critical to the food production industry. “Food is perishable so a higher throughput can bring fresher products to market. But the need for speed cannot be at the expense of quality. The scientific community has done a good job of developing faster assays for microbiological testing, but the bottleneck remains the enrichment time,” Broski explains out, and refers to Neogen’s Acumedia business unit working on new methods to improve enrichment time through advanced media formulations.
Cost of testing will always be an issue because if you add up the volume of testing on a per product or per factory basis, it is significant, Broski points out. “You cannot “test-in” the quality of a product, but testing can be used to confirm that decisions involved in the production of food are backed by data.
“Our society demands safe food and producing safe food is the number one priority of all food companies. Nobody can afford to release unsafe food into the market, but yet we still have recalls and threats to food safety because food production is a dynamic system. There are many variables and, as much as we’d like to think we have food down to a science, nature is still in charge,” Broski says.
Adding that ease of use and automation is critical because we now live in the era of the “app, Broski says that people have come to expect simplicity in everything, no matter how high the technology.
Neogen recently introduced a rapid pathogen test – Amplified Nucleic Single temperature Reaction or ANSR. “With this test we have brought DNA-based testing down to a level of simplicity and price point which puts it in reach of many smaller processors,” says Broski, who equates this move as a mainframe-style PCR machines to PC-level pathogen detection. It doesn’t take a Ph.D., a software programmer and gigawatt of energy to operate ANSR. The instrument even processes smaller batches of samples more efficiently reducing operating costs and offering a more user-friendly workflow, he describes.
Gaps in using lab data
Carter points to the opportunity in the industry for companies to manage information obtained from food testing to understand what the data means in overall process of food safety testing.
“Many companies have been doing Salmonella testing for years. There are multiple ways to slice and dice that data to understand what that means, and identify trends,” points out Carter.
This may be a powerful opportunity for companies to be able to optimize and change their testing patterns to get more out of what they are doing. Labs, for instance, can quickly and easily analyze large amount of data and look for patterns, and could potentially offer this as a service to their clients. Such data management and pattern recognition could add true value to the client and help companies make better informed decisions about their products’ safety, adds Carter.
While new generation LIMS are great at managing data internally and in terms of operating the labs and meeting regulatory requirements, there is a need to go beyond that, he feels.
Arguing for the other side, Neogen’s Broski cautions that data generation could be a double-edged sword because of the amount of data modern instruments can generate. The key is producing actionable data or data which makes sense and offers the ability to make an intelligent decision, he feels. “Lot of people in business are suffering from information overload, and scientific instruments and process analyzers can generate a lot of data. The bottom line is that the operator, manager or leader wants to know that the food is safe and meets quality standards, and that the data backs up decisions to release product into the market.”
One of the gaps that bioMérieux’s Bailey sees is not having a plan in place for food testing. “In the short term, industry should make sure that their testing programs are statistically valid—they need to ensure that the method being used is correct and it is being done the way it is supposed to be done; that there are statistically valid sampling plans; and you know how to interpret the data.” You shouldn’t do the first two if you don’t know what you are going to do with the data, Bailey cautions.
For Douglas Marshall at Eurofins, a big gap in the food testing space is turnaround time. “For many in the industry this is an important issue. While there are some new technologies out there that have the potential to reduce turnaround time, they often come with significant handicaps – for instance, when you reduce time, you could reduce specificity,” warns Marshall.
Futuristic trends: In-line testing and robotic labs
What are some technologies that excite our experts going forward within the food testing space?
Two trends jump out for Carter. The first one is the onset of the next generation of diagnostics into the food industry. “Roka BioSciences’ Atlas system comes to mind because of the level of automation and the number of technologies combined in that system, making it unique and something the food industry hasn’t seen before,” Carter describes. However, he questions whether the industry is ready for investments like that.
Another area that Carter’s excited about is a big jump in technologies involved in sanitation and PCR testing methods. “These tests are getting more creative, and are not as expensive as they were before.”
For instance, earlier this year, Seegene Inc., developer of multiplex molecular technologies and diagnostic tests, and DuPont Nutrition & Health, provider of rapid, molecular diagnostic systems, agreed to jointly develop new, highly-multiplexed, real-time PCR assays that provide for rapid detection and differentiation of 10 or more organisms from a single sample in a single test. The new detection assays combine Seegene’s novel technologies with the powerful chemistry and analytics of the BAX® System from DuPont.
Carter also points out that there is a lot of conversation around pathogen detection, but not much about enumeration technologies. “There’s a mindset of the industry to focus on numbers. But to understand food safety, do you need exact numbers? Wouldn’t it be enough to say it should be less than 100,000, for instance, or get a Yes/ No response?” asks Carter, adding that such an option, which could save significant time during food testing, has not found wide acceptance in the industry.
Bailey is excited about the promise of multiplexing, or looking for multiple pathogens at the same time. Such tests can provide results on Salmonella, what serotype, and specific virulence etc. simultaneously.
How about in-product testing? While Bailey expects to see an increase in in-product testing because of consumer groups and regulations expecting it, he cautions that statistically taking such a small sample could be meaningless, due to the sporadic nature of pathogens which could be a challenge for in-product testing.
“You could test 1000 samples in a row, and not have an issue, or you could have had a positive result because of either a sampling error, or because of the sporadic nature of that pathogen. The actual safety assurance will come from how you are measuring your process control,” he explains, adding that it’s very important to validate the in-product testing process, and then monitor and measure it, and assure that the process is being followed.
Bailey feels sequencing will become much more common in the future, having tremendous ramifications for the industry.
Eurofins’ Marshall envisions a time when real time monitoring becomes a wide practice. “Having a biosensor with great sensitivity in a pure lab setting to do real-time testing is not feasible. However, such inline testing could be done to look for quality or safety attributes, such as detecting a low moisture product. If the critical control point is the water activity of that product, then this instrument today can measure the moisture content. Thus, you can achieve measuring the control point, if not the microbe.”
Marshall talks about Eurofins’ QTA model as a hands-off analytical tool, in which onsite analytical instrumentation is used to collect and test samples online, in real-time. “The instrument is operated remotely and doesn’t need a person physically present. Data is sent real-time via the server, analyzed and sent back to the client. The instrument is also validated remotely,” he describes.
Introduction of robotics to the food microbiology laboratory is one futuristic trend that Marshall would like to see: “Food microbiology is quite labor-intensive with sample prep and reagent transfers. By having robots doing a lot of that, it will help companies save labor costs and time and improve data quality by decreasing or removing human error.”
For Neogen’s Broski, the ideal food lab of the future will be a portable device which can rapidly provide actionable data at the point of production or processing. “It will offer infinitely expandable assays, qualitative as well as quantitative results for both screening and confirmation; will use proven technology, be durable and easy to use, and results will be automatically analyzed and stored in a secure location,” Broski envisions.
The more we learn about food microbiology, the more species and subspecies we recognize as being potential pathogens, Marshall added, referring to USDA and FSIS adding six new E.coli serotypes earlier this year to be tested for in the meat industry. And that’s not the end. It will be a continuing trend and more and more microorganisms will continue to be added, he feels.
So how can a lab stay ahead? “It depends on what the customers need. I can have a new test, be first to market, but it will be a failed product because no customer wants it. A successful food testing lab will need to pay attention to what the customers want, what the outbreak trends are, what new regulatory requirements are, and focus on what they can do to help their customers to stay out of trouble,” concludes Marshall.
Note: This is the first article in the series on “Food Lab of the Future.” Upcoming articles in the series will focus on FSMA/ regulatory impact on food safety testing; analytical chemistry; effect of genome sequencing; lab informatics etc. Want to share your thoughts on a subject? Email the Editor at SViswanathan@InnovativePublishing.net.