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Roundtable Title
Quantification at the Molecular Level: Developing Validation Standards Across Industries
Food Microbiology: What Validation Studies Say About Method Performance and Scope
Regulatory Updates for Chemical Contaminants in Foods and Supplements
Unraveling the Complexities of PFAS Testing: Pitfalls, Solutions, and Best Practices
Cronobacter Species: Current Challenges, Regulations and Detection Methods in Food Production Environments and Finished Products
Method Validation for Unculturable Microorganisms

Quantification at the Molecular Level: Developing Validation Standards Across Industries
Track – Hot Topic: Omics

The future of microbiological risk management is molecular. Culture-based methods are laborious, time-consuming, and many have issues with sensitivity, accuracy, precision, and reproducibility. With certain pathogens, culture-based detection at low levels is particularly challenging. Sequencing, “omic-based”, and other quantitative molecular methods aim to solve these problems. However, the road to a future where molecular methods are universally accepted, and the data well understood, is littered with several obstacles. Specifically, there are currently challenges with developing appropriate study designs, validation guidelines, and alignment on acceptance criteria. 

Contrary to common perceptions, these problems persist whether or not a culture-based reference method exists. The mindset that these methods should be considered the “gold standard” by which all other methods need be compared, is an outdated one. It is time for the microbiology community to come together to align on guidelines for standards development, and statistical models for molecular quantification, without relying on a culture-based reference method. 

Historically, discussions of this type have been narrowly focused on a few food-borne pathogens (e.g., Salmonella in poultry), but the desire to achieve validated molecular methods spans all industries from food, water, cannabis, dietary supplements, biothreat agents, and beyond. This session will convene experts from a broad range of functions, to outline the strategy for developing standardized schemes for quantitative molecular validations. We will discuss current challenges, regulatory expectations, and how to drive acceptance of quantitative molecular methods to advance microbial control across both existing and emerging industries.

Chair: Michael Loewenstein, Q Laboratories

Food Microbiology: What Validation Studies Say About Method Performance and Scope
Track – Laboratory Management, Compliance and Accreditation

“The validation of a rapid method is critical in providing evidence that the method is fit for purpose. Depending on method principle, performance characteristics typically include a comparison with a cultural reference method throughout single and multi-lab studies to evaluate parameters such as probability of detection, sensitivity, specificity, accuracy, reliability, precision, robustness, repeatability and reproducibility. Additionally, the claims and scope of a validated method underline its intended application and limitations. These claims provide guidance to food producers and routine testing laboratories regarding reliability and suitability for use.

Regulators usually prescribe the reference method, technical guidelines, and the validation process to be used in the method comparison to enable recognition of the rapid method in jurisdictions where it would be used and may emphasize specific performance characteristics among others. They may also restrict the scope to the tested matrices or enlarge the scope to food categories. Furthermore, the rules may rely on internationally recognized certification and may require a review by regulatory bodies.

This roundtable aims to convene global experts in food regulations, method validation and accreditation, as well as food producer and routine testing laboratories.  The pros and cons of multiple validation approaches, need for method validation alignment and performance characteristics will be discussed with consideration around validated method reliability in routine testing and application of the defined scope.  Panelists will evaluate how rules used in method validation studies impact testing results recognition critical for import/exports and framework of possible recognition among these schemes by the regulators around the world.

Chair: Erin Crowley, Q Laboratories; Veronique Albert, Health Canada

Regulatory Updates for Chemical Contaminants in Foods and Supplements
Track – Chemical Contaminants and Residues

In the recent survey of the chemical contaminants community, the highest number of responses requested information on current and upcoming regulatory limits.  The food and supplements industry must address official regulatory limits and respond to market opinions that can be drivers for contaminants testing even without established official limits.  Differences in limits between countries create problems for global trade.  Limits established for raw commodities often are applied to processed foods or ingredients and interpretation of test results can be very challenging.  We propose a session where regulators from the US agencies (FDA, EPA, and USDA), and states provide information on current regulatory enforcement activities and policies, and any upcoming changes or new limits, and provide a panel for audience discussion.  Areas of current interest include heavy metals, where there is a lot of guidance and few official regulatory limits, and a lot of market expectations, especially concerning foods for infants and children.  In the pesticides arena there have been recent global enforcement actions that involve pesticides that cannot be tested using multi-residue approaches (chlorate, ethylene oxide, etc.), and testing programs need to address both authorized and non-authorized parameters.  For veterinary drugs, there is the problem of testing to demonstrate “no antibiotics ever”, or to assess novel cultured proteins, or protein-rich supplements.  There is the anticipation of established limits or guidance to assess exposures to PFAS. 

Chairs: Victoria Siegel, Eurofins CAL; Kevin Kubachka, US Food and Drug Administration

Unraveling the Complexities of PFAS Testing: Pitfalls, Solutions, and Best Practices
Track – Chemical Contaminants and Residues

What do scientists, news anchors, regulators, and social media influencers all have in common? They’re all talking about PFAS! These per- and polyfluoroalkyl substances are ubiquitous, and found in our food, water, packaging, and cosmetics. As consumer awareness grows, so does concern about exposure and health implications. Consequently, the demand for laboratory testing is skyrocketing, as many aim to comprehend manufacturing processes, assess raw materials, safeguard consumers, and comply with global regulations. Although some methods exist for food matrices, and an AOAC SMPR was approved for PFAS testing in food in late 2023, the intricacies of advanced analytical testing can be daunting. Where can scientists acquire best practices, identify red flags, tackle common challenges, and gather helpful tips? Join this roundtable discussion to explore the pitfalls of PFAS testing, strategies to overcome analytical setbacks and efficient ways to locate those elusive “needles in the ever-growing haystack”.

Chair: Emily Britton, Waters Corporation

Cronobacter Species: Current Challenges, Regulations and Detection Methods in Food Production Environments and Finished Products
Track – Microbiology and Molecular Biology Methods

Cronobacter sakazakii infection is a critical and preventable cause of foodborne illness in infants, and in 2023, it became a nationally notifiable infectious disease by the United States Centers for Disease Control and Prevention. Infant formula and raw material manufacturers face challenges in both the testing and US regulation of Cronobacter species today. These challenges include the persistence of unconfirmed presumptive positive results on DNA-based rapid methods attributable to extracellular DNA. At the same time, discussions have surfaced around the public health and supply chain impact of testing for all Cronobacter species, as opposed to testing for Cronobacter sakazakii, the primary Cronobacter species of public health concern.

In this roundtable, speakers will discuss the importance of regulating the presence of all Cronobacter species in finished infant formula and technological challenges in testing for Cronobacter species in production environments and finished products. Speakers from public health agencies and academia are invited to join industry manufacturing participants for this discussion, which will align prevailing thoughts and raise visibility for the larger industry.

Chairs: Quynh-Nhi Le, Neogen Corporation; Rocio Foncea, Neogen Corporation

Method Validation for Unculturable Microorganisms
Track – Microbiology and Molecular Biology Methods

Unculturable microorganisms are unable to grow in a laboratory setting because of either their slow growth rates or because they have transitioned into dormancy (e.g., bacteria such as Campylobacter spp., or Listeria spp.), or because there are no protocols that support their growth outside of the host (e.g., viruses such as hepatitis A, and parasites such as Cyclospora cayetanensis). This session will discuss what are the options that can be utilized to validate methodologies to detect and/or identify such microorganisms with representation of regulatory agencies, industry, and academia.

Chair: Socrates Trujillo, US Food and Drug Administration