As FSMA promises to increase the responsibility of food laboratories, companies must pave a path forward by working more closely with industry as a whole, government and non-government organizations, as well as with each other. This was the clear message relayed by Pamela Wilger , assistant director of global food safety at Cargill, at IAFP 2015.
“We consider a lab any person generating data,” said Wilger, who emphasized the “lab” is not just the room itself. Lab testing should not focus on a single narrow view (i.e., one test); companies should be efficiently applying their resources, considering both science and risk. “Non-science based testing can lead to conflicts between suppliers and customers and manufacturers and regulators, and destruction of wholesome product.”
Here’s where improvement is needed in food labs:
Disseminating best practices. “We don’t even share that [as an industry],” said Wilger. “We don’t have time to replicate the same work.”
Aligning international rules
Cooperating with national regulators, including local/regional entities.
Testing and improving compliance policies
Building consumer trust and confidence
Training/competency development. Finding the right people, and encouraging employee knowledge sharing
Being prepared for the next intentional economic adulteration
Palmer Orlandi, Ph.D., CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, shared insights on how FSMA will affect lab responsibilities moving forward, with a focus on prevention versus reaction. The objective for lab capacity programs is to facilitate submission and acceptance of meaningful and actionable data to all regulatory agencies, he said.
Reset, expand and integrate: A need to focus on resources
Method performance and “fit for purpose”, harmonized standards
Large-scale focused surveillance activities; statistical significance, real-time evaluation of data generated
Real-time communications, bioinformatics, IT infrastructure, data-sharing platforms
Technology and innovation partnerships, including on an international basis
A notable section of the Food Safety Modernization Act (FSMA) calls for the development and implementation of model laboratory standards. To ascertain the level of laboratory standards currently employed by food laboratories, a laboratory testing services company commissioned a survey of laboratory directors, quality assurance managers and technical supervisors. One area of questioning focused on certified reference materials (CRM).
According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials. (Click to enlarge)
In response to whether their laboratory uses CRM, 65% of respondents said yes. Most of the remaining survey respondents (31%), volunteered that they sometimes use these materials, if required. Only 4% replied “No” (see Figure 1).
The responses are significant in that they provide a glimpse into current food laboratory quality practices. FSMA tasks the U.S. Department of Health and Human Services with making certain that analytical procedures and quality systems are established and followed. Yet, it is not clear what procedures and systems are currently employed. This survey provides a baseline measure from a segment of the food laboratory community, indicating, that a majority of respondents use certified reference materials.
Quality Controls vs. CRM
A food laboratory aims to provide the correct result every time a test is performed. In order to achieve this consistency and reliability, laboratories should use standard measurements, known as quality controls. Quality controls are essentially the stable norm against which testing processes and instruments may be assessed. By using quality controls, it is possible to find areas in the testing process that may be weak or failing.
CRM, used as a form of quality control, are highly characterized, homogenous, authenticated control materials. Food laboratories often have options available for obtaining commercially sourced materials for quality controls, but not all of these options are well characterized or authenticated. CRM are used by laboratories to assess the quality of method validation as well as to trace to an established standard. In the food lab, CRM help provide a level of certainty in the results when instruments and processes are validated and verified. CRM may be obtained from accredited producers, as established under ISO Guide 34.
The survey also asked whether on-site and contract laboratories use quality controls. Interestingly, not all laboratories surveyed are using quality control materials as part of their testing processes and procedures. For on-site laboratories, 81% of survey respondents acknowledged using quality control materials. For contract laboratories, the number slips to 67%. For survey respondents not using quality control materials, it is unknown if or how their test results are validated and verified.
Quality control is a basic component of laboratory testing as well as a requirement for accreditation. Whether CRM or non-certified reference materials are used, quality controls are important components needed to ensure test results are valid and reliable for food consumers and industry alike. As future FSMA rules on model standards are likely to address this essential provision of laboratory testing, these survey results support the use of CRM.
Food manufacturers that think strategically understand that labor efficiency is a measure of how effectively a workforce completes a task in comparison to industry. Companies frequently access efficiency and other metrics to identify weak points in their operations, with the end goal of enhancing data quality and streamlining costs. This approach has led many food and beverage manufacturers to embrace lean manufacturing and six sigma programs in their organizations. These leaders have a clear understanding that labor is money (or money is stored labor), and money equals margins. Food and beverage manufacturers often acquire several raw materials and convert them into finished products for consumers to purchase. These manufacturers have found that robotics and automation have greatly increased productivity and enhanced product quality while maximizing resources and profitability.
LIMS offer a variety of benefits. Image courtesy of ATL
Ease Operations with Automation
Analytical testing laboratories within food manufacturing firms leverage LIMS to realize automation savings. LIMS is an acronym for Laboratory Information Management System, which can also be a manual paper/Excel based solution, however, this article will focus on completely automated, computerized, enterprise, software solutions. Manual systems are cumbersome, costly, and lack efficiency.
Just as automation and robotics have transformed the food manufacturing process, intelligent laboratory operations leverage LIMS, because it enables increased quality and faster turnaround, while providing significant cost savings. LIMS are computerized systems that organize, manage and communicate all of the laboratory test data and related information such as Standard Operating Procedures (SOPs) and Certificates of Analysis (COAs), final analysis reports, invoices, nutritional labels, formulations and information to support an organization’s operations and meet regulatory compliance goals.
Traditional LIMS facilitate overall laboratory organization, from sample management to test data to final reporting and disposal. LIMS begin with sample management and typically the generation of barcoded labels (of a unique identification number), testing is automatically assigned based on project or sample type (Note: Additional tests can be added or deleted, and ad hoc samples can also be logged). Some laboratories test all raw materials that arrive to confirm acceptance criteria against the COA, in addition to in-process, final product testing and environmental testing. Once samples are logged into the system, worklists are created in the LIMS of the samples to be run and the information is scanned via barcode and sent to the instrument controller. Tests that include associated quality control data are run by loading instruments. Results are electronically imported back into the LIMS from instrumentation (this is the most common and most efficient method). For manual, subjective tests that require interpretation, results must be entered into the LIMS by hand. Managers can also manage and track samples that have been subcontracted to other laboratories (i.e., for testing capabilities that do not exist internally). Once the subcontracted data is submitted back to the laboratory in an electronic format, it can be directly imported into the LIMS, and all data related to the sample is stored in a single, secure database.
Automation significantly reduces cost, enhances quality and provides a means to rapidly scale production. This image shows a cheese processing plant. Image courtesy of ATL
This approach offers a major advantage, especially to global operations, due to the ability to deliver real-time data across an enterprise. End-users can leverage the technology to make intelligent buying decisions based on product specifications of incoming raw materials, customer demand, specification criteria and blending simulations.
Managers can view a variety of metrics, including the number of samples that have been run for a particular product, statistical process control charts, instruments in service for workload management, and supplier performance in any given period. Complete product traceability is possible.
LIMS has evolved to manage many additional functions, such as communications with ERP/SAP systems, shelf life studies, performing skip lot testing, formulations, and field and plant data collection by integration with tablets and smartphones for real-time updates, managing competitive analysis data as well as special projects. A few of the major areas in which LIMS are leveraged include:
Sample management of all testing initiated
Quality assurance (including in process quality checks)
Workflow management (optimization of processes)
Regulatory compliance (FSMA, GFSI, HACCP, FDA)
Specification management, formulations and blending
Dashboards for real-time updates (in a single site or across operations)
Customer relationship management (organizing and responding to customer inquiries)
Reporting (COA, final analysis and invoice reports)
Inventory management and product release
Enabling Standardization
A LIMS not only enhances communication across a laboratory, but also across a global organization with multiple sites, ensuring effective cooperation and relationships between suppliers, production and customers. A LIMS promotes standardization in global firms and gives management teams real-time data access from site to site, so that data is readily available for better management and resource allocation decisions. Standardization makes business and financial sense, as organizations can realize cost savings in buying testing equipment and supplies in larger quantities, exchanging staff to different sites (potentially reducing training costs), and managing a user-friendly, single secure database that supports localization (each site can implement LIMS in its native language). Standardization does not mean that systems must be ridged; each facility can leverage its own unique workflows and terminology while saving data to a standard database format.
A LIMS can manage an entire organization’s laboratory SOPs or work instructions, and documents associated with the following:
Today, LIMS’ have expanded to manage all aspects of laboratory operations and have significant overlap with ERP, SAP systems and other enterprise solutions. The goal is to move away from multiple separate databases and distinct islands to one centralized data management solution. Amazingly, some laboratories do not make the investment in new LIMS technology and continue use in-house created database systems, manual paper systems and Excel spreadsheets (or a combination of these systems) to manage portions of the critical product testing data. These systems are often costly, labor intensive, subject to data loss, and difficult to manage and maintain.
A LIMS ensures that analytical resources have been best utilized to maximize productivity and efficiency to generate high-quality data to support operations, while facilitating regulatory compliance goals. Organizations that embrace quality often leverage technology such as LIMS, and typically hold ISO 17025 certification and embrace six sigma, lean manufacturing and other best practices.
Robotics has transformed food manufacturing to allow greater volumes of final product to be produced, with an emphasis on speed, standardization, consistent product quality and volume, with increased efficiency and cost savings. LIMS’ have transformed the manufacturing process and the laboratory analysis process from raw material testing to in-process /environmental testing and finished product testing. For example, on-line monitors can feed data into an LIMS (i.e. flow, temperature from freezers or incubators), and if there are any alarming data points, instant notification is provided to the team via email or a phone call. This rapid response saves time for a corrective action to be put into place. Within the laboratory, if a shelf life study is underway and the incubator fails, an alert can be sent after one out-of-range temperature measurement, allowing the problem to be corrected and the study saved, versus having to start over.
The analytical testing group in any food and beverage testing facility generates hundreds, thousands, even millions of data points a year. They gather data on raw materials (based on COAs), in-process manufacturing (quality checks, statistical process control and specification confirmation), environmental monitoring, and finished product testing as well as performing competitive analysis. These are some of the main areas that are impacted by sample collection and testing. LIMS and laboratory automation have transformed the way that data is collected, monitored and analyzed. Today’s LIMS’ are based on modern technology, providing a valuable tool to ensure that product is within specification, and collected and disseminated in real-time to improve efficiency, reduce costs, increase profitability.
Accuracy and validity of food test results hinge on purified water and annual water testing.
Laboratory-grade water literature is well documented among the large life science water manufacturers. General levels of resistivity, total organic carbon (TOC), particles and bacteria in water classify into Types 1, 2, or 3, with Type 1 having the most stringent requirements. Each type is useful for a different application depending on the procedure:1,2,3
Type 3. Generic applications where water will not come into contact with analytes during the procedure
Type 2. Standard applications such as media and buffers
Type 1. Critical applications such as GC, MS, HPLC analyzers4
Achieving high-quality water requires purification through a polishing step such as deionization (DI), reverse osmosis (RO), ultraviolet light (UV), filtration or distillation, which removes specific impurities.3,5
This classification system gets muddled, as different agencies have their own standard that examines different end-point analysis and levels:
ISO (International Organization for Standards)
CLSI (Clinical and Laboratory Standards Institute)
ASTM (American Society for Testing & Materials)
USP (United States Pharmacopoeia)2,5
With all these standards and testing in place, many labs assume that their installed DI water supply is clean, yet in reality, the water in general would be closer to Type 3 rather than the required Type 1.
The problem with using lower quality water in food testing labs is that the accuracy and validity of tests will be compromised. Many of the analyzers requiring Type 1 water would recognize contamination from lower quality water, creating difficulty in identifying actual contamination or yielding false positives. False positives can result due to microorganism contamination in the water that is amplified through the testing procedure. In addition, dirty water can damage expensive machinery, because tools in the laboratory that are designed for a high-purity water supply can malfunction when less-pure water is used. For example, a system with microfilters can become rapidly clogged with lower quality water, introducing the possibility of flooding when tubing bursts, if left unnoticed.
Newer regulations in regards to ISO 11133:2014, along with ISO 17025:2005, provide clarity on food microbiology water parameters for the laboratory. ISO 11133:2014 “Microbiology of food, animal feed and water–Preparation, production, storage and performance testing of culture media” describes how water for culture media must be purified. The purification recommended is distilled, demineralized, DI, or RO, and stored in an inert container. To verify purity, labs must regularly test the water to assure microbial contamination is kept to a minimum. Regarding 17025:2005, which refers to food microbiology requirements for accreditation, there should be daily, weekly and monthly testing of the laboratory’s water source to verify required quality for microbiological water. Daily testing examines resistivity of water; monthly testing examines the water’s chlorine levels and aerobic plate counts; yearly testing examines heavy metals in the water. Therefore, accuracy and validity of food test results critically revolve around producing purified water and annual water testing.
When President Barack Obama in 2011 signed the Food Safety Modernization Act, the most sweeping reform of American food safety laws in more than 70 years, the Food and Drug Administration’s job got a lot tougher.
As the FDA’s Palmer Orlandi explained at Pittcon [on March 9], they might need your help to get that job done. Orlandi, who spoke as part of the two-day Food Safety Tech Food Labs Conference at Pittcon, is the agency’s acting chief science officer in the office of food and veterinary medicine. The FDA traditionally has been very good at reacting to safety issues in our food supply as they arise and finding the source of the problem, Orlandi said. But, now the agency is charged with more of a preventive role, which means identifying the biggest risks before they become a threat to the public. That’s a big job, and the FDA can’t do it alone. “We’re looking for burden-sharing,” Orlandi said.
Partnerships with other federal agencies such as the Department of Agriculture and the Department of Homeland Security are part of the solution. They’re also working with state-level laboratories and even the private sector, he said. As an example, he cites the Food Emergency Response Network, which includes food-testing laboratories at the local, state, and federal levels. Initially formed to deal with bioterrorism threats, Orlandi said it has become a useful food safety network as well. FERN-affiliated labs recently tested 1,600 samples of avocados for salmonella and listeria, he said.
Much of the burden of this new preventive approach will fall on food producers. Orlandi said FDA is willing to work with private labs to develop standards. This can be tricky, however, because the agency doesn’t want to create the impression that it is somehow favoring one private sector entity over another. Meanwhile, private companies have their own trade secrets to protect. “Where is the middle ground where we can cooperate?” Orlandi asked rhetorically.
FDA has developed validation standards that field labs can use, he said. But, he concedes, the agency hasn’t done a good job compiling and publishing those standards into an accessible document or reaching out to stakeholders to make sure they’re up to speed. “That’s another thing on our to-do list,” he said.
Funding for these efforts is scarce. Joe Konschnik, a market research manager for Restek Chromatography Products who attended Orlandi’s presentation, helps to supply scientists working in College Park, MD to develop new procedures to analyze pesticides. Traditionally, once the research is published, the researchers’ jobs are over. Konschnik says now they’re trying to send the information out to other labs in the U.S. and overseas. That way, everyone can work from the same page to validate the work and create consistent standards.
One of the problems is that, for example, aerating seeds to run multilevel validation studies can cost $35,000, he said. But the FDA only has about $75,000 to fund such studies, which obviously would run out very quickly. “There’s no money to fund the back-end stuff,” Konschnik said. He said he works with the American Council of Independent Laboratories, which is willing to do the testing for free. But it still costs money for the FDA to make samples, send them to the labs, gather the data, and validate the data.
In short, the partnerships FDA is building remain a work in progress. But it has a new tool: the America Competes Act, which gives federal agencies the authority to award prizes for solving significant problems. The FDA has issued a “food safety challenge,” Orlandi said, looking for ways to reduce turnaround times on food safety tests, checking for salmonella, for example, from a few weeks to a day or two. The agency has a $500,000 prize pool, with $400,000 potentially going to the winner. This article originally appeared in CEN media group’s Pittcon Today on Tuesday, March 10 and has been republished with permission.
The company has broadened species identification product line created in partnership with University of Guelph and plans to release additional test kits during the year.
InstantLabs announced today the expansion of its SpeciesID product line by offering DNA-based tests for Atlantic and Coho salmon. InstantLabs SpeciesID™ tests provide accurate DNA verification in under two hours.
The launch of the salmon test kits highlights InstantLabs’ efforts to meet market demand by expanding the affordable, simple-to-use InstantID™ product line. The company already offers kits to identify Atlantic Blue Crab, pork and horse meat. The InstantLabs’ system gives food wholesalers, processors and inspectors a fast and reliable option for product tests.
The two new products were created in partnership with the University of Guelph, an international leader in agricultural and food science. The InstantID test kits for Atlantic (Salmo salar) and Coho salmon (Oncorhynchus kisutch) are the first of four salmon assays planned for release during 2015. InstantLabs will launch InstantID™ for Chinook (Oncorhynchus tshawytscha) and Sockeye (Oncorhynchus nerka) salmon later this year.
Expanding its presence in the high-demand seafood market, the Baltimore-based manufacturer of the Hunter® system expects to also release InstantID™ kits for snapper, catfish, grouper, and tilapia.
“Producers, wholesalers and government entities needs robust tools to combat seafood fraud,” said Steven Guterman, chief executive officer of InstantLabs. “InstantLabs’ real-time PCR testing systems and reagent kits can become an integral part in a testing program to verify labeling accuracy.”
InstantLabs’ Hunter® Real-Time PCR instrument combines accuracy, speed, and ease-of-operation into a compact portable system. The Hunter system is designed for use at points-of-need to detect and analyze a wide variety of food samples by targeting DNA. Results delivered quickly allow seamless integration into food industry firms’ processes and facilities.
Dr. Robert Hanner, Ph. D., has directed the University of Guelph’s research in conjunction with InstantLabs. “This collaboration has been essential in commercializing DNA-based food authentication tests for the seafood industry,” said Dr. Hanner, associate professor at the Center of Biodiversity Genomics. “This technology will help safeguard against existing supply chain vulnerabilities, protecting both businesses and consumers from food fraud.”
InstantLabs identification tests are designed for use on the Hunter, a real-time PCR system developed by the company, and are also available for use with other PCR instruments.
Seafood industry reports continue to highlight concerns about fraud, species substitution and consumer preferences to use sustainable fish stocks. Approximately one-third of all fish sold in the U.S. was mislabeled, reported a recent survey from Oceana. The U.S. Food and Drug Administration identifies a range of lower valued fish regularly substituted for 20 higher-priced species. InstantLabs will provide critical tool sets needed by the industry to ensure the integrity of the supply chain.
ABOUT INSTANTLABS:
InstantLabs, a molecular diagnostic device company, developed and markets the Hunter® Accelerated-PCR system, a fully-integrated, easy-to-use, portable and affordable real-time polymerase chain reaction (RT-PCR) platform for rapid, accurate pathogen detection. InstantLabs Medical Diagnostics Corp., the legal entity, offers the Hunter® system for use with several food-borne pathogen test kits for the global food industry. The Hunter® system is especially well suited for use at points-of-care and points-of-need to detect and analyze a wide variety of common and problematic pathogens. InstantLabs’ growing worldwide customer base includes some of the world’s leading food companies. InstantLabs is also developing products for additional markets, including medical diagnostics where gold-standard accuracy, combined with Ease-of-use and rapid results, are critical. Founded in 2008, InstantLabs is located in Baltimore, MD. For more information please visit www.instantlabs.com.
ABOUT THE UNIVERSITY OF GUELPH:
Acknowledged as one of the leading public research universities, the University has 39 Canada Research chairs in natural sciences, energy, health services and social sciences. With a commitment to student learning and innovative research, University leaders are dedicated to cultivating the essentials for our quality of life – water, food, environment, animal and human health, community, commerce, culture and learning. The University community also shares a profound sense of social responsibility, an obligation to address global issues and a concern for international development. Learn more at www.uoguelph.ca.
Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.
Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.
In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.
In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.
Employing a LIMS to meet the demanding FSMA requirements
The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:
Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.
Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.
Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.
For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.
Case Studies: LIMS providing traceability for food worldwide
Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.
Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.
Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.
In the last three years, there have been four major foodborne illness outbreaks caused by Listeria monocytogenes in dairy products (Oasis fresh curd cheese; Roos raw hard cheese; Crave Brothers pasteurized farmstead cheese; and Frescolina Marte pasteurized ricotta cheese). Before 2012, there have been multiple outbreaks due to raw and pasteurized Mexican-style soft cheeses and in pasteurized milk in 2007.
Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories , recently spoke about Implementing an effective Listeria control plan for Dairy Products in a recent presentation. He described the pathogen as “a gram-positive bacteria, which is facultatively anaerobic, psychotrophic (can even multiply at refrigeration temperatures – though at slower rates), sensitive to heat processing, even found in healthy cows, raw milk and dairy processing environments, and can survive most cheese ripening processes.”
Though, listeriosis, the infection caused when a person is infected with LM, is relatively rare – only affecting about 1600 individuals a year – it has a high mortality rate, highest among foodborne illnesses, especially among high-risk individuals.
Dr. Marshall listed some of the contributing factors to a LM outbreak:
Inadequate thermal processing
Refrigeration temperature being too high
Inadequate product flow through processing plant
Inadequate personal hygiene
Product shelf-life too long
Inadequate cleaning and sanitation
Inadequate environmental monitoring and control
Inadequate end product testing
Thermal processing is a time-temperature process, and it can be inadequate if either the temperature is too low, or the process time is too short.
It is common knowledge that whether it’s during transportation, or at retail or at homes, often temperature of food storage is not adequately maintained. Dr. Marshall said that as high as 55 percent of household units and 32 of retail store units had refrigeration temperatures of greater than 9 °C. “And once you get past that temperature threshold of 10 °C, the bacteria reaches maximum population level within six days (average shelf life).”
Inadequate cleaning & sanitation is another major cause for LM contamination and this is often the battle between production & sanitation. Floor drains are a common culprit, responsible for 63 percent incidence of LM. Dr. Marshall also referred to other sources of inoculation that you are not getting effective control of such as filler heads and high pressure water sprays or air sprays, which can aerosolize bacteria and spread the contamination to other surfaces.
Inadequate product flow is usually due to the failure to segregate pasteurized product form raw product or the failure to segregate employees working in raw vs. pasteurized locations. Address this by mapping out product and employee flow (along with equipment) and look for areas where cross contamination can occur, advises Dr. Marshall, who cautions facilities to monitor and control the following direct food contact surfaces that can be cross-contaminated:
Product movement items, such as racks, bins, tubs and buckets
Spiral coolers, blast freezers
Hand tools, gloves, aprons
Inadequate personal hygiene is another contributing factor and this can include clothing such as outerwear and gloves. Maintenance personnel should be thorough in their hand-washing and it’s recommended they use alcohol based wipes after hand-washing.
Address the issue of shelf-life being too long by determining the shelf life based on food safety, and not food quality. Also, run LM challenge test in each product, Dr. Marshall advises.
FDA, in their Preventive Controls rule proposed under the Food Safety Modernization Act, has a section on Environmental Monitoring, based on the rationale that that poor control of the environment can lead to LM cross contamination of finished product, explains Dr. Marshall, adding that inadequate environmental monitoring and control is a key component for LM contamination.
“Invest your testing dollars to find hot spots in your facility and ensure the control mechanisms are working every day,” he says, asking companies to “detect and control hot spots, measure effectiveness of general cleaning and sanitation programs, and test for Listeria species.”
Dr. Marshall asks, “If I were LM and wanted to hide, where would that be? Would it be on an easy to clean surface such as the floor, or would it be in a nook or cranny where it’s hard to reach and clean?” He lists the following as areas that commonly harbor the pathogen and advises extra caution and creativity to clean these spots:
Equipment framework – nuts, bolts, open tubing, spot welds
Floors and drains – standing water
Walls
Ceilings, overhead equipment, catwalks, pipes
Condensate
Exposed, wet insulation around pipes and walls
Fork lifts, trolleys
Cleaning tools – sponges, brushes, scrubbers
Maintenance tools
Conveyors, belts and rollers (need to be broken down and cleaned regularly)
Control panels and switches
Rubber seals (especially if they have cracks)
Trash cans
Air fillers
Motor/ pump housings
Cracked hoses
Ice makers
End product testing is an effective way for testing for LM, but Dr. Marshall points out that there are often arguments against this. “Companies often argue that their HACCP plan is working, their kill step is effective and that they have a history of doing end product testing, and they haven’t had any positive results so far. But this is not a convincing enough argument.” End product testing can address the failure to monitor and control high risk ingredients, and is very useful to detect gross contamination events. It should be used to assess risk of rework, and also test for LM, not just Listeria, Dr. Marshall advises.
How will food labs meet the demands of the future? What role will FSMA regulations play? And how are labs dealing with globalization of the food chain?
Food labs – both within food manufacturing companies and external contract labs – are facing a multitude of challenges: Increasing regulatory changes and compliance pressures; greater volume of testing; newer technologies and testing methods; demand for faster, and more efficient results….. How are labs and lab managers keeping track of, and apace with, all these changes?
David White, Chief Science Officer and Research Director at U.S. Food and Drug Administration (left, in the picture); Dave Evanson, President, EMS (middle); and Alvin Lee, Director, Center for Processing Innovation at the Institute for Food Safety and Health (IFSH), Illinois Institute of Technology (right), talked about these issues in a panel discussion moderated by Marc Carter, President of MC2, Inc. at Food Safety Tech’s Food Labs Conference organized last month in Chicago. We present some excerpts from the discussion below.
What’s keeping you up at night?
Globalization of the food chain is a significant concern. FDA’s David White talked about the emphasis that FDA places on testing food products globally, increasing standards to get global labs on par with FDA’s accepted levels of testing, and using equivalent methods.
“Southeast Asia and China, and the testing done in such regions, will be critical. This will need time and resources, but we should all collectively aim to get there,” White added.
What keeps him up at night? White described that food labs of the future need to help companies be one step ahead of the next contamination. “Who would have thought about melamine, for instance? We need to consider which other products would be ideal for substitution and companies need to identify where their vulnerabilities lie. Everyone has a part to play in food safety – FDA doesn’t have the resources to do everything by themselves. Testing for the unknown, what’s the next melamine, that’s what keeps me up at night,” White explained.
What’s the impact of FSMA regulations on the food lab market?
Getting labs to have in place specific food testing methodologies, HACCP and verification, plans to reduce contamination etc., will all improve under FSMA regulations.
All these will take some time, says White, “but we are communicating to labs about where we stand and how the new rules can help take them to where they need to be.”
IFSH’s Alvin Lee feels that there will be a lot more demand for documentation because of the new regulations: “Labs will have to establish certain processes or steps with a plan for preventive control, and find effective ways to control and manage data and documentation.”
Echoing this sentiment, White said that labs need to figure out figure out how to manage databases more efficiently. “How do we create and store data, and produce it in a format that’s user-friendly? All these will be key challenges,” White described.
How do food labs manage data currently?
Dave Evanson felt that there is a good history of LIMS being available and used. “Some labs have done a pretty good job of embracing that. But at the other end of the spectrum, there are some labs that still use a lot of paper. But many of these are starting to make changes.
“There is also a lot of interest in going beyond just getting data, and learning more. And there is a push toward the producer of the data to get more information. New generation LIMS need to address this,” Evanson explained.
Efforts are ongoing in many regions to improve food safety; while the objective is obviously linked to public health outcomes, it is the business of food trade that really drives the funding for these activities. The reasoning is pretty simple: If efforts are made to meet the food safety requirements established based on risk (usually by developed nations) in order to enter or stay in trade markets, then the domestic population also benefits from safer foods. It is a win-win situation.
The Asia Pacific Economic Cooperation (APEC) Food Safety Cooperation Forum (FSCF) drives one such effort. The FSCF was established in 2007 to encourage the use of international food safety standards and recognized best practices to improve public health and facilitate trade among APEC member economies. The Forum also promotes information sharing and capacity building activities to accelerate the adoption of these standards and practices. The Forum is currently co-chaired by Australia and China.
Why should we be involved in these initiatives? It is clear that it benefits the health of the U.S. population to improve the safety of food in the entire APEC region because we import it with minimal inspection (at least until FSMA rules come into effect). The U.S. imports just under $25 billion worth of fresh and processed fruits and vegetables, snack foods and red meats from the region. Once again, if we help the region adopt international standards, it also benefits their domestic population. Economically, we also benefit because the trade goes both ways and the region received over 70 percent of U.S. agricultural exports with soybeans, red meat, coarse grains and wheat adding up to ~$44.5 billion in 2012. The adoption of international standards reduces the likelihood that economies will impose their own standards, such as maximum limits (MLs) for example, that are not based on risk and may be hard to achieve using recognized good practices; these may be perceive as non-tariff trade barriers or reasons for devaluating crops from certain countries.
One of the most difficult steps to perform in the establishment of standards for food safety is to assess the risk associated with particular foods for specific populations. Acute response and disease states are easier to spot and link to potential causes, but chronic conditions and responses triggered by combined risk factors are much more challenging, especially when they involve factors that are not food such as underlying diseases, genetic predisposition or environmental exposure. A very large project is active in the APEC FSCF to empower developing economies to perform risk analyses that will support their adoption of standards. Of course, it immediately comes to mind that risk assessment requires access to reliable data, an element that is non-trivial in a developing country environment. How does one measure exposure to a chemical or microbial risk when there are not enough trained analysts, not enough infrastructures or when the tests used are not fit for that purpose? THE APEC FSCF created the Partnership Training Institute Network in 2010 to stimulate a collaborative approach engaging industry, academia and governments to raise the capacity in the region.
The impact of capacity building activities is often more far-reaching than meets the eye. A better understanding of the health and economic reasons behind international standards favors their adoption in countries that are modifying existing or adopting new standards. In turns, harmonization facilitates trade, trade improves the local economy and economic stability favors better health outcomes for the population. Beyond the big picture, there are very tangible benefits. In my line of work for example, we train laboratory analysts to perform tests in order to enable them to monitor their domestic food supply, which in time enables them to perform risk assessments that enable them to participate in international standards setting discussions, but it also benefits exporters to these markets by reducing the likelihood of unreliable results that could initiate shipment refusals or economic depreciation of shipments. International capacity building in food safety is a win-win situation.
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