Tag Archives: Testing

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

Steven Guterman, InstantLabs
In the Food Lab

Save Seafood with Digital Tracking

By Steven Guterman, Sarah McMullin, Steve Phelan
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Steven Guterman, InstantLabs

The combination of improved digital tracking along the food supply chain, as well as fast, accurate DNA testing will provide modern, state-of-the-art tools essential to guarantee accurate labeling for the ever-increasing quantities of foods and ingredients shipped globally.

The sheer scale of the international food supply chain creates opportunities for unscrupulous parties to substitute cheaper products with false labels. We know fraud is obviously a part of the problem. Some suppliers and distributors engage in economically motivated substitution. That is certain.

It’s equally true, however, that some seafood misidentification is inadvertent. In fact, some species identification challenges are inevitable, particularly at the end of the chain after processing. We believe most providers want to act in an ethical manner.

Virtually all seafood fraud involves the falsification or manipulation of documents created to guarantee that the label on the outside of the box matches the seafood on the inside. Unfortunately, the documents are too often vague, misleading or deliberately fraudulent.

Oceana, an international non-profit focused solely on protecting oceans and ocean resources, has published extensively on seafood fraud and continues to educate the public and government through science-based campaigns.

Seafood fraud is not just an economic issue. If the product source is unknown, it is possible to introduce harmful contamination into the food supply. By deploying two actions simultaneously, we can help address this problem and reduce mistakes and mishandling:

  • Improved digital tracking technologies deployed along the supply chain
  • Faster, DNA-based in-house testing to generate results in hours

Strategic collaborations can help industry respond to broad challenges such as seafood fraud. We partner with the University of Guelph to develop DNA-based tests for quick and accurate species identification. The accuracy and portability produced by this partnership allow companies to deploy tests conveniently at many points in the supply chain and get accurate species identification results in hours.

Our new collaboration with SAP, the largest global enterprise digital partner in the world, will help ensure that test results can be integrated with a company’s supply chain data for instant visibility and action throughout the enterprise. In fact, SAP provides enterprise-level software to customers who distribute 78% of the world’s food and accordingly its supply chain validation features have earned global acceptance.

The food fraud and safety digital tracking innovations being developed by SAP will be critical in attacking fraud. Linking paper documents with definitive test results at all points in the supply chain is no longer a realistic solution. Paper trails in use today do not go far enough. Product volume has rendered paper unworkable. Frustrated retailers voice concerns that their customers believe they are doing more testing and validation than they can actually undertake.

We must generate more reliable data and make it available everywhere in seconds in order to protect and strengthen the global seafood supply chain.

Catfish will become the first seafood species to be covered by United States regulations as a result of recent Congressional legislation. This change will immediately challenge the capability of supply chain accuracy. Catfish are but one species among thousands.

Increasingly, researchers and academics in the food industry recognize fast and reliable in-house and on-site testing as the most effective method to resolve the challenges of seafood authentication.

DNA-based analyses have proven repeatedly to be the most effective process to ensure accurate species identification across all food products. Unfortunately, verifying a species using DNA sequencing techniques typically takes one to two weeks to go from sample to result. With many products, and especially with seafood, speed on the production line is essential. In many cases, waiting two weeks for results is just not an acceptable solution.

Furthermore, “dipstick” or lateral-flow tests may work on unprocessed food at the species level, however, DNA testing provides the only accurate test method to differentiate species and sub-species in both raw and processed foods.

Polymerase chain reaction (PCR), which analyzes the sample DNA, can provide accurate results in two to three hours, which in turn enhances the confidence of producers, wholesalers and retailers in the products they sell and minimizes their risk of recalls and brand damage.

New technology eliminates multi-day delays for test results that slow down the process unnecessarily. Traditional testing options require sending samples to commercial laboratories that usually require weeks to return results. These delays can be expensive and cumbersome. Worse, they may prevent fast, accurate testing to monitor problems before they reach a retail environment, where brand and reputational risk are higher.

Rapid DNA-based testing conducted in-house and supported by sophisticated digital tracking technologies will improve seafood identification with the seafood supply chain. This technological combination will improve our global food chain and allow us to do business with safety and confidence in the accuracy and reliability of seafood shipments.

DuPont BAX System, Salmonella detection

PCR Assay for Salmonella Detection Gets AOAC-RI Certified

By Food Safety Tech Staff
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DuPont BAX System, Salmonella detection
DuPont BAX System, Salmonella detection
DuPont BAX System X5 PCR Assay for Salmonella detection

Today DuPont announced that the AOAC Research Institute (AOAC-RI) approved a method extension of Performance Tested Method #100201 to include the company’s BAX System X5 PCR Assay for Salmonella detection. Introduced this past July, the PCR assay provides next-day results for most sample types following a standard enrichment protocol and approximately 3.5 hours of automated processing. The lightweight system is smaller and designed to provide more flexibility in testing.

“Many customers rely on AOAC-RI and other third-party certifications as evidence that a pathogen detection method meets a well-defined set of accuracy and sensitivity requirements,” says Morgan Wallace, DuPont Nutrition & Health senior microbiologist and validations leader for diagnostics, in a company release. “Adopting a test method that has received these certifications allows them to use the method right away, minimizing a laboratory’s requirements for expensive, time-consuming in-house validation procedures before they can begin product testing.”

The validation covers a range of food types, including meat, poultry, dairy, fruits, vegetables, bakery products, pet food and environmental samples.

David Hammond, Eurofins, food fraud

Proactive Approach to Preventing Food Fraud

By Food Safety Tech Staff
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David Hammond, Eurofins, food fraud

Several different approaches can be used to verify authenticity of food, from a heteroduplex assay to microsatellite analysis. In part II of a presentation by fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific at the 2015 Food Labs Conference, learn about the DNA methodologies as well as the proactive steps that companies should be taking to prevent food fraud or economically motivated adulteration of product.

3M Molecular detection assay for Listeria

Molecular Detection Assay for Listeria Promises Faster Results

By Food Safety Tech Staff
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3M Molecular detection assay for Listeria

A molecular detection assay for Listeria monocytogenes has been approved by the AOAC Performance Test Methods

3M Molecular detection assay for Listeria
The new test was developed in response to customer engagement and a desire to work with food processors to protect the world’s food supply, says 3M Food Safety.

(PTM) program. Developed by 3M Food Safety, the assay is based on isothermal DNA amplification and bioluminescence detection technologies. With a streamlined workflow that is 30% faster than the first generation assay, the new test is designed to provide expedited, simple and more accurate real-time pathogen detection.

Obtaining AOAC PTM status involved a thorough independent lab examination of the test method’s ability to accurately detect Listeria monocytogenes within a variety of foods. During the validation study, analyzed food samples included beef hot dogs, queso fresco cheese, vanilla ice cream, 4 % milk fat cottage cheese, 3% chocolate whole milk, romaine lettuce, bagged raw spinach, cold smoked salmon, deli turkey, raw chicken, cantaloupe, and various environmental surfaces (plastic, stainless steel, concrete). Achieving AOAC PTM approval certifies that the test kit is equivalent or better than standard reference methods, according to 3M Food Safety.

Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

Food Safety Testing Must Live Up to Higher Expectations

By Maria Fontanazza
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Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.

Key trends:

  • Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
  • Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
  • The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.

Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?

Tim Curran, CEO of Sample6, pathogen detection
Tim Curran, CEO of Sample6

Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].

Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.

Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.

“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.

These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.

Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.

Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.

Michael Koeris, Ph.D., founder and vice president of operations, Sample6, pathogen detection
Michael Koeris, Ph.D., founder and vice president of operations

Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.

FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?

Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.

Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.

Jim Godsey, vice president of research & development, Sample6, pathogen detection
Jim Godsey, vice president of research & development

There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.

FST: How do you expect the final FSMA rules and implementation process will impact industry?

Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.

FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.

Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.

More Food Labs Using Certified Reference Materials

By Karin Pauly
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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.
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.

The survey discussed in this article was commissioned by Microbiologics, Inc.

Why Should Food Manufacturers Consider Lab Automation?

By Dr. Christine Paszko
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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
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
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:

  1. Sample management of all testing initiated
  2. Quality assurance (including in process quality checks)
  3. Workflow management (optimization of processes)
  4. Regulatory compliance (FSMA, GFSI, HACCP, FDA)
  5. Specification management, formulations and blending
  6. Dashboards for real-time updates (in a single site or across operations)
  7. Customer relationship management (organizing and responding to customer inquiries)
  8. Reporting (COA, final analysis and invoice reports)
  9. 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:

  • Laboratory testing
  • Assets
  • Inventory
  • Laboratory chemicals
  • Supplies
  • Formulations
  • Blending
  • Automated calculations
  • Customer interactions
  • Employee training records
  • Laboratory instrumentation
  • Purchase orders
  • Sample storage
  • Reporting
  • Invoicing
  • Facilitating governmental laboratory compliance requirements

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.

Lab technicians use the Hunter device during a test process. InstantLabs manufactures the Hunter system as well as test kits for food pathogens and species identification such as the catfish testing commercialization agreement outlined with the FDA.

New Catfish Test Catches Mislabeling Faster

By Maria Fontanazza
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Lab technicians use the Hunter device during a test process. InstantLabs manufactures the Hunter system as well as test kits for food pathogens and species identification such as the catfish testing commercialization agreement outlined with the FDA.

As Americans seek to make healthier choices, seafood is becoming more popular than ever before. In fact, U.S. consumers eat 50% more seafood now than they did 50 years ago and spend $80 billion annually on creatures from the sea, according to Oceana. Coupled with the increasing popularity is the growing problem of seafood fraud and mislabeled imports. Oceana’s study in 2013 performed DNA testing on seafood samples taken around the United States and found that nearly 33% of those samples were mislabeled.

FDA has made a significant investment in DNA sequencing to improve its ability to detect misrepresented seafood species in interstate commerce and from other countries. “The Agency has trained and equipped eight field laboratories across the country to perform DNA testing as a matter of course for suspected cases of misbranding and for illness outbreaks due to finfish seafood, where the product’s identity needs to be confirmed,” stated Steven M. Solomon, deputy associate commissioner for regulatory affairs at FDA, before the U.S. Senate’s Committee on Small Business and Entrepreneurship in May. “FDA also trained analysts from the U.S. Customs and Border Protection (CBP) and the National Marine Fisheries Service in its new DNA-based species identification methodology.”

With some of the most common seafood choices including white fish varieties like tilapia and catfish, DNA-based testing plays a critical role in detecting mislabeling of species.  If you’re a knowledge seafood person and you get a whole fish, there’s a high likelihood you can identify it correctly,” says Steven Guterman, CEO of InstantLabs. “However, once that fish has been filleted—let’s call it a white fish—it’s almost impossible for anyone to visually correctly identify that fish. That’s where the DNA testing comes into play.”

Lab technicians use the Hunter device during a test process. InstantLabs manufactures the Hunter system as well as test kits for food pathogens and species identification such as the catfish testing commercialization agreement outlined with the FDA.
Lab technicians use the Hunter device during a test process. InstantLabs manufactures the Hunter system as well as test kits for food pathogens and species identification such as the catfish testing commercialization agreement outlined with the FDA.

InstantLabs offers a series of DNA-based seafood tests for species identification. Last week the company announced a partnership with FDA to co-develop and commercialize a new Ictalurid catfish species identification test that enables much faster sequencing of samples and at a lower cost. “I think everyone is recognizing that the current method industry uses for validation, which is to take a sample and send it out to a lab for sequencing, just takes too long,” says Guterman. There is a typical time lag of about one to two weeks from taking a sample to getting a result.

The Hunter System is a real-time PCR instrument that delivers results in a much shorter period of time. “Switching from a sequencing test to a PCR test where you’re looking for a specific target DNA and getting results on site in two hours, or in a laboratory within a day, changes the way the industry operates,” says Guterman. “It enables better enforcement, and government regulators and suppliers can do validation in a way that’s not disruptive to their normal course of business.”

FDA and InstantLabs began talking about the technology about a year ago, as both have worked closely with the University of Guelph, according to Guterman. FDA was looking for a company that would be able to commercialize a test kit for U.S. catfish, and the new partnership is part of a Cooperative Research and Development Agreement (CRADA) with the agency. U.S. Farm Bill legislation states that only members of the Ictaluridae family can be legally marketed as catfish within the United States.

The FDA-InstantLabs CRADA collaboration will help ensure the integrity of labeling related to U.S. catfish. The Pangasiidae species, which hails from Southeast Asia, has been increasingly mislabeled as U.S. catfish. This is not only a concern from a cost standpoint but also a safety perspective, as FDA has detected toxins in catfish that come from Asia.

Environmental Monitoring Programs and The Cost of Failure

What happens when a food company does not have an effective environmental monitoring program in place? The cost of failure can be significant, warns Prof. Ann Draughon, ranging from placing contaminated food in the markets, to managing product recalls, and businesses getting shut down.

Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.

In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.

What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:

  • Environmental monitoring programs;
  • Sanitation and cleaning requirements;
  • Allergen control;
  • Mitigation of hazards; and
  • Supplier verification.

How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.

She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.

3M-Envi-Monitoring_March2015-1

“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.

Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:

  • 3M-Envi-Monitoring_March2015-2Lack of trend analysis of environmental data;
  • Lack of communication within company about any positives Listeria results;
  • Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
  • The company had a reactive EMS, but not proactive,” she explained.

What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:

  • Increased risk of recall;
  • Increase loss of product;
  • Increased liability exposure;
  • Build-up of pathogens and spoilage agents or chemicals in environment;
  • Lack of regulatory compliance; and
  • Reaction to problems, not prevention.

Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:

  • Focus on having the appropriate indicators and hazards;
  • Ensure the best procedures selected and validated;
  • Strong sampling plan, which is well-designed and dynamic;
  • Data analysis and data management; and
  • Education and training.

Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.