AOAC 133rd Annual Meeting - Final Program

Scientific Sessions | Wednesday

4:05 PM Efficacy of DNA, HPTLC, and Microscopy in Discriminating M. piperita from M. spicata : A Single-Laboratory Botanical Identification Study Sidney Sudberg, Alkemists Laboratories, Robert LaBudde, Least Cost Solutions A small-scale single-laboratory study was carried out to illustrate methodology for establishing equivalence between different analytical methods used for identifying botanicals. Samples of different lots from different sources of known inclusion (known positive) and exclusion (known negative) species were obtained, and measurements made in replicate by DNA, HPTLC, and microscopy on each sample. Special statistical methodology for proving the claim of equivalency among methods is illustrated and the results discussed. WEDNESDAY, SEPTEMBER 11, 2019 SYMPOSIUM: Community Perspectives of Food Allergen Measurement 8:15 AM – 9:45 AM Grand Ballroom 1 Chairs: David Bunk, U.S. National Institute of Standards and Technology Carmen Diaz-Amigo, FOCOS Food Consulting Strategically Jupiter Yeung, Nestlé 8:20 AM Regulatory Perspective of the Measurement of Protein Allergens in Food Terry Koerner, Health Canada It is well recognized that some foods represent a significant health hazard for those who have an allergy or intolerance. It is also known that both the allergic reactions and the intoler- ance are due to particular proteins or protein fractions in the food. Because of this, regulations typically refer to the proteins and assessments include the level of these proteins as part of determining the risk to the public. ELISA methods have been used almost exclusively to determine the level of allergen and assess the risk to the public, but these methods are not perfect. Industrial processes and a multitude of different matrices could potentially reduce the accuracy of these methods. Reference materials and incurred materials will be useful in assessing a method as fit-for-purpose for a specific matrix and process, but these combinations appear endless. Some current issues will be discussed as well as some potential future considerations will be addressed.

8:40 AM Assay Manufacturers Perspective of the Measurement of Protein Allergens in Food Jason Robotham, BioFront Technologies With an expanding list of critical food protein allergens that must be tested to assure that food is safe for consumers with food allergies, the development and production of reliable and sensitive assays faces ongoing challenges. The testing of food ingredients and processed foods often require assays of differ- ent formats and robustness. The considerable variety of food matrices is a considerable challenge in the development of the optimal extraction procedures necessary before protein allergen measurement. Given all of these factors, manufacturers of food protein allergen assays must ensure that their assays meet the current needs of their users and be proactive about future needs. 9:00 AM Food Manufacturers Perspective of the Measurement of Protein Allergens in Food Sneh Bhandari, Steven Zbylut, Mérieux NutriSciences Corporation, Lauren Jackson, U.S. Food and Drug Administration Presence of undeclared allergens is a major cause of food recalls in the U.S. This is a concern not only for food manu- facturers but also for consumers and regulatory agencies. Consumers with food allergies rely on food labels to accurately disclose the presence of allergenic ingredients. However, foods can contain undeclared allergens due to labeling errors and cross-contact during food manufacture, storage, and transpor- tation. Ingredients not meeting the allergen-free requirement of the process is another mechanism by which allergens can be inadvertently introduced into food. Allergen risk management strategies are an integral part of a plan to control allergens in the food processing environment. It is necessary to evaluate the effectiveness of allergen management strategies by peri- odically testing ingredients, product and the food production environment for the presence of allergens. Analytical tools used for evaluating allergen control procedures include total protein analyses/swabs, immunochemical methods (ELISA; lateral flow devices), DNA-based assays, and LC-MS based methods. The choice of method used depends on various factors. Methods applied for monitoring allergens in food and food processing environment should be validated for the purpose. In addition, sampling plans should be developed to ensure that proper food and environmental samples are obtained for analysis. Most of the commercially available methods are adequately validated and some of them are accredited by AOAC INTERNATIONAL. In-house verification of the method performance helps in proper application of the method. 9:20 AM Reference Materials for Quality Assurance of the Measurement of Protein Allergens in Food David Bunk, Ashley Beasley Green, Melissa Phillips, U.S. National Institute of Standards and Technology To improve the repeatability, comparability, and accuracy of the measurement of protein allergens in food, there has been consid- erable international effort to develop appropriate reference

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