AOAC 2018 Preliminary Program

WEDNESDAY, AUGUST 29, 2018 8:15 am – 9:45 am Roundtable: Opportunities and Challenges in Botanical Ingredient Traceability Efforts — Selecting the Right Test Method for the Specification. Current Good Manufacturing Practice regulations for Dietary Supplements have been in place since 2007, and full compli- ance has been required since 2010. At the same time food safety modernization act (FSMA) from FDA was signed into law in January 2011. Traceability of botanical ingredients from seed to supplement or field to finished food is of the high- est importance for addressing their safety and authenticity. There are numerous logistical, analytical, and processing steps that can be taken to assure quality. However, the proper approach to setting specifications and to testing against specifications can be difficult to define. Identifying the right test for the right purpose seems straightforward enough, but past experience is littered with examples of improper test method selection. Establishing the pathway to product integrity in a global supply chain requires air-tight chain of custody documentation, specification setting, and appropriate test methods for each evaluation or transfer point. Selecting test methods requires defining the purpose of the method as well as evaluating the fitness of the method for its purpose. Both specifications and fitness for purpose are affected by the supply chain. Methods appropriate for field use at the harvest point are not likely to be fit for use at some remove from the field. Plant anatomy at the macro level will not be suitable for botanical identification of powdered biomass, and DNA methods may not be suitable for botanical extracts. This roundtable will provide an interactive discussion on this topic with audience and a panel of select industry experts. CO-CHAIR: Amit Chandra, AMWAY In this global world, the food method developers still face the challenge of multiple validations for the same rapid test kit and or innovative methodology. Requirement for those validation vary from jurisdiction to jurisdiction resulting to high cost for the industry. Although efforts have been made to harmonize microbiology method validation, still lots need to be done. The role of Health Canada in the validation field is not always well understood. Although based on ISO 16140, the Health Canada or the Government of Canada validation guide includes specific and unique requirement and criteria to assess validation data to introduce rapidity and flexibility to food testing with a high confidence to the result that will be used for regulatory purposes. This session will bring forward why Canada need specific validation guideline and highlight the specificity of the requirement. CO-CHAIR: Joe Betz, National Institutes of Health Symposium: Microbiology Method Validation and implementation — A Canadian Perspective

CO-CHAIR: Quanyin Gao, Herbalife International of America Inc. CO-CHAIR: Peter Chang, Herbalife International of America Inc. CO-CHAIR: Gabriel Giancaspro, U.S. Pharmacopeia (USP) • Gabriel Giancaspro, U.S. Pharmacopeia (USP) USP Approaches for a Soy Protein Monograph Development • Barry Tulk, Dupont Soy Protein Quantitation at Industrial Scale: Challenges and Recommendations • Huiyong Ma, Herbalife International of America Inc. Herbalife Approaches for Soy Protein Ingredient • Spencer Carter, Genysis Labs Contract Lab’s Approaches for ID and Protein Content Determination Symposium: Characterization of Micro-Organisms by WGS & MALDI-TOF Technologies — the Roadmap to the 21st Century Adoption Nowadays, the food industry is quite familiar with AOAC- PTM/OMA-, Health Canada- or ISO 16140-certified methods. Furthermore, these qualitative/quantitative methods have been fully accepted by the competent food safety authorities, and their adoption has also been acknowledged in the regional regulations, encouraging their applications to a variety of food matrixes. If screening methods have become faster and more reliable, the confirmation of presumptive positive results for pathogen testing has remained relatively laborious, combining conventional phenotyping assays with biochemical tests and latex agglutination assays. With the development of technologies such as WGS and MALDI-TOF, it’s now time to move to the 21st century with faster, more reliable and more exhaustive results. Therefore, what is the road map to ensure the recognition of these 21st century technologies by the food safety authorities, in order to facilitate their adoption by the food industry and leave the conventional methods to the former century? Food safety authorities have started investigating these high-through- put technologies and their inputs in anticipating emerging risks, investigating outbreaks and in tracking isolates. But at this point of time, some of the challenges remain such as (i) ensure the global acceptance of these new tools, and (ii) facilitate the method implementation in routine testing laboratories. What are the opinions of the regulation agencies? What is required for recognition by the food safety authorities? What are the performances of these technologies and inputs in the laboratory workflow? This session will be presented through three talks given by regulatory agencies, method performance assessors, and end-users. CO-CHAIR: Erin Crowley, Q Laboratories, Inc. CO-CHAIR: Patrice Arbault, Nexidia • Thomas Hammack, U.S. Food and Drug Administration Regulatory Perspectives for the Global Recognition of MALDI-TOF and WGS in Food Testing • Irene Iugovaz, Health Canada Recognition and Added Values of Confirmatory

CO-CHAIR: Irene Iugovaz, Health Canada CO-CHAIR: Sarah Mcilwham, Health Canada • Sarah Mcilwham, Health Canada Canadian Perspective on Method Validation: A Multi-Facetted Approach to Validation

Identification Using MALDI-TOF • Patrick Bird, Q Laboratories, Inc. Global Certification Scheme and Implementation of Omics-Methods in Daily Analyses

22 AUGUST 26 – 29, 2018 SHERATON CENTRE TORONTO HOTEL