The Evolution of Testing

Features - Lab Management

Lab management — yesterday and today

July 31, 2019

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By Lisa Lupo

It’s 2011: FDA has been directed by FSMA to establish a program for laboratory accreditation to ensure that U.S. food-testing laboratories meet high-quality standards (due two years after enactment). Forward three years to 2014: Although the development of laboratory accreditation for the analyses of foods is a key component of FSMA, FDA has not yet proposed a rule. Fast forward another three years to 2017: The establishment of a program for accrediting laboratories remains the missing piece of the FSMA puzzle.

It’s now 2019. Even while the industry continues to await a FSMA-mandated program, other testing requirements, and general developments in lab tests and technologies, have advanced significantly in the near-decade since the enactment of FSMA.

“When the PC (preventive controls) rules were released, we saw an incredibly large spike in environmental monitoring programs, and the industry amassed a large amount of data, often with no reference to what the data meant or how to apply it,” said bioMérieux Scientific Marketing Manager Joy Dell’Aringa. “Over the last several years we’ve seen some really smart applications of data analytics to ensure environmental monitoring samples are being taken at the right frequency, in the right places, and tested for the right microorganisms.” This is continually evolving, but questions such as “How much is enough? What does my data mean?” need to be addressed, she said.

Some of the areas in which Dell’Aringa sees the evolution are the increase in testing volume, which drives the need for efficiencies, reliability, and cost-competitive solutions; industry awareness of the impact of environmental sanitation on final product; and novel sanitizing practices that can impact the effectiveness of microbial recovery in the laboratory, increasing the need for validation and verification and communication between production and the laboratory.

Citing Aristotle’s theory that “nature abhors a vacuum,” Hygiena Chief Scientific Officer and General Manager Martin Easter said, “Microbes do not stand still.” Bacteria are opportunistic, he explained, so pathogens are being seen as causing food poisoning in unexpected foods (such as flour, cantaloupe, peanut butter).

This means that methods must be validated for different applications. Because genomic studies continue to redefine microbial taxonomy and relatedness of risk, some tests also need to be made more inclusive, e.g., infant formula testing should detect the Cronobacter genus rather than Enterobacter sakazakii. FSMA also requires more preventive due diligence throughout the supply chain based on risk assessment, in both product and environmental hygiene, to manage cross-contamination hazards, Easter said. “Simple screening methods and specific detection methods together provide a portfolio of technology to manage quality and safety hazards.”

ALLERGEN TESTING. As focused on allergens, Bia Diagnostics Laboratory Manager Luke Emerson Mason said, “It is a global market, so we are seeing more harmonization of allergens — and the number of samples — that need to be tested.” For example, the U.S. has the Big 8 allergens, but Canada has 10, Australia 12, and the EU 14. Thus, he said, “In the U.S., we will need to start looking at testing more, as some need to be labeled now for these markets, and therefore there is a need to harmonize allergens.” Along the same lines, he said, companies often struggle with how low testing needs to go. No government regulations specify exactly what peanut-free means. But since there is no such thing as zero, we can go only as low as can be reasonably detected. Since different allergens have different dose-response rates, today’s methods try to meet the needs of the manufacturer and the consumer through a dose-response analogue.

ENVIRONMENTAL MONITORING. The increase in FDA swabbing is allowing for more surveillance of higher-risk products and facilities, and it provides companies with an opportunity to work with FDA to fine tune food safety practices, Dell’Aringa said. “From a testing perspective, it is also an opportunity for companies to proactively sample internally and learn their facility’s microbiological risks and composition ahead of FDA swabbing events,” she explained. “This can show that the company has good due-diligence practices and also arms them with knowledge of harborage sites, biofilm areas, and potential risk points so meaningful and effective corrective action plans can be deployed before an issue arises.”

FDA’s use of whole genome sequencing (WGS) also has an impact. Food manufacturers are exploring how they can use it for apples-to-apples comparison and protect their company and brand, she said. But questions often arise, such as: “If I find a pathogen and apply WGS, is that sequence then discoverable?” and “Will good due diligence and good science help or hurt my business?” With the industry working collaboratively to help answer such questions, some are starting to conduct WGS more routinely on their own, she said.

CONSUMER IMPACT. “From a microbiological perspective, consumers are aware more now than ever of recalls and outbreaks,” Dell’Aringa said. “A brand image can suffer greatly from one viral post about a rancid or spoiled item.” Thus, both manufacturing and consumer demand continues to rise for faster turn times that don’t compromise results. It is a product of a highly competitive marketplace and the increasing global reach of the food supply, she said.

Traceability also plays a role, she said. It’s not only about “What’s in my food?” but also “Where did my food come from?” While this doesn’t directly impact the lab operation, labs could use blockchain concepts and tools to “attach” lab results to food as it travels through the supply chain.

Consumers also have had an impact on allergen testing, said Bia Diagnostics Owner Tom Grace. Fifteen to 20 years ago, the industry was using ATP microbiological tests for quality control, but these didn’t address allergens. Then consumers began pushing FDA for the labeling of allergens and that lead to FALCPA. FDA allergen recalls, which peaked a few years ago, have decreased significantly in percent of recalls, with most of today’s allergen recalls due to labeling problems rather than cross contact. “Companies have done a very good job in their HACCP programs and testing,” Grace said, adding, “Regulatory, auditor, and food safety professionals are becoming more educated with food safety requirements – especially allergens; this has increased in the last decade and resulting in a decrease in recalls.”

INDUSTRY TRENDS. As the exchange with the four experts proved, the list of specific changes in the last decade could go on for pages, such as Easter’s assertions that there is continued development of automation of media prep, sample prep, growth media and colony counting for traditional cultural microbiology; the development and use of specific substrates has improved diagnostic testing for bacteria; and alternative methods using novel end detection technologies to screen for microbial contamination in food continue to be develop but few see widespread adoption. “The reasons are either due to costs or limited applications or comparison to the cultural gold standard methods that are themselves highly variable,” he said.

Easter also sees primary producers (e.g., of leafy green and ready-to-eat foods) having a sampling and detection challenge in being required to test for the absence of pathogens in increasing sample size from 25/100g to 375g. “Being able to segregate or divert raw material for different processing methods enables industry to be cost effective and demands enumeration methods for some pathogens. More complex ready meals and complex processing/filling methods demand higher standards of hygiene and prevention with the potential for more regulatory inspection.”

“Other tangential initiatives that many companies are tackling, such as sustainability, water conservation, and ethical sourcing practices, also have impacts in the food testing laboratory,” Dell’Aringa said. “New approaches to manufacturing, distribution, and supply chain can create food safety and quality gaps that must be addressed and validated in partnership with the food-testing laboratory.” Advanced analytics and predictive modeling applications also will impact the future of food labs, she said. “As we look at our data in different and creative ways, new insights about how to prevent adverse safety and quality events will continue to emerge.”

In describing a new broad-spectrum test method employing a multiplex system that can detect and quantify up to 10 protein analytes at the same time from the same sample down to one or two ppm, Grace said, “There is a need to prove and verify that any test method is fit for the purpose and that there is nothing in the matrices which might interfere with the testing method, possibly producing false negative or false positive results.”

WHAT’S NEXT? Dell’Aringa sees the use of next-generation sequencing for predictive and precise food safety as “the next frontier of our field that will see rapid growth and advancement in the next decade.” Additionally, she said, in-line testing opportunities will increase, and new pathogen markers will be identified to better protect public health while also minding the bottom line.

Noting that allergen lists could begin to include some fruits, Grace cited the case of a boy who died from an allergic reaction to strawberry residue in a fast-food vanilla milkshake. When it occurred there was no effective test, but today, he said, “We can employ PCR technology to perform DNA testing which can verify the presence of an allergen.”

Emerging foodborne pathogens and problems continue to evolve with recalls for pathogens in foods not previously known to occur. Thus, Easter said, applications need to be developed and methods validated for food types not normally associated with food poisoning. While he expects continued development of alternative microbiological methods using novel end-detection technologies to screen for microbial contamination, he said, “Comparing trends of the results from new methods without conversion back to the variable CFU (colony-forming unit) of cultural methods is an impediment to the adoption of alternative methods.” Because alternative methods offer faster, more meaningful microbial activity data, he said, “We need to move away from blind belief in the CFU; we need a new metric, e.g., Microbial Activity Unit.”

Lab operations, practices, and tests will continue to evolve as the industry works toward ever-lower detection and ever-higher food safety. But such improvements will not evolve in a vacuum. As food safety professionals and leaders continue to collaborate outside of the lab, especially with non-scientific disciplines, Dell’Aringa expects to see increased awareness and support for the critical role of the food safety lab. “We will continue to see the trend that the food lab isn’t a cost-center, but a partner in cost-avoidance,” she said.

The author is Editor of QA magazine. She can be reached at