AOAC-03 Preliminary Program

3:00 pm – 4:30 pm

short presentations and question-and-answer (Q&A) interaction to engage speakers and the audience. Some highlights of the round table session include: 1) the update on the recently developed “Food/Feed Testing Laboratories Best Practices Manual” by United States Food and Drug Administration (USFDA) and multiple state participants; 2) the updates of the National Residue Program (NPR) administrated by the United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS), which is also the collaboration between FSIS, FDA, and the Environment Protection Agency (EPA). The session will also discuss product safety testing schemes, laboratory quality systems, industry role in regulation and co-regulation models. This roundtable session will show that how science and regulation can be integrated for a robust food protection system. The speaker/audience discussion on real-life examples will be brain-storming for the AOAC community to advance regulatory science. CO-CHAIR: Susie Dai, Texas A&M University CO-CHAIR: Michael McLaughlin, U.S. Food and Drug Administration CO-CHAIR: Oliver Ou, U.S. Department of Agriculture • Cynthia Mangione, New York State Department of Agriculture and Markets Regulatory Science: Best Practices Manual for Food/ Feed Testing Laboratories • Oliver Ou, U.S. Department of Agriculture Protecting Public Health through Improving Test Methodology and Modernizing the FSIS ALP Program • Ashli Brown, Mississippi State University Food/feed Safety from the State Level and beyond • Timothy Herrman, Office of the Texas State Chemist A Global View of Science Driven Approach for Food Safety Regulation in East Africa Current Good Manufacturing Practice regulations for Dietary Supplements have now been in place since 2007, and full compliance has been required since 2010. At the same time food safety modernization act (FSMA) from FDA was signed into a law in January 2011. Several years of theoretical discussions are in the process of becoming informed by actual laboratory practice and FDA enforcement, and a number of FSMA provisions have just gone into effect, with more to go into effect in the summer of 2016. Two of the more interesting provisions of FSMA are the requirement for laboratory accreditation and the requirement that raw material suppliers create and implement Hazard Analysis Critical Control Points (HACCP) as part of their quality operations. This session will engage the audience in an interactive panel discussion with analysts from supplement company’s in- house laboratories, small and large contract laboratories, an innovative contract research organization, manufacturers “Seed to Shelf” Analytical Roundtable for Regulators and the Regulated: Analytical Methods, Botanical Quality/Safety, FSMA and Dietary Supplements cGMP

Development of LC-MS/MS Methods and Reference Materials for the Analysis of Food Allergens Food allergen testing represents a difficult task for all stakeholders. Traditional immunological-based methods only detect certain epitopes of the allergenic proteins, which might be subject to extensive modifications during food production. This leads to highly diverse results in allergen analysis, which may be overcome by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) methods. Due to the high sensitivity, selectivity, and accuracy of this approach, a wide range of analytical methods using LC-MS/MS are rapidly being developed. Problems of ELISA methods, such as cross- reactivity of the antibody, matrix effects, and altered protein epitopes can be overcome. It is also possible to detect several food allergens in a single run. Additionally, the lack of reference materials is a major problem in allergen analysis and makes the quantification of these analytes particularly challenging. All approaches – including immunological methods, PCR and also LC-MS/ MS – require robust reference material to obtain reliable and comparable results. Extensive input from the scientific community is still required to solve this complex problem. This session will discuss approaches of implementing novel LC-MS/MS methods for the analysis of allergens in food and food ingredients as well as the steps towards the development of allergen reference materials. CO-CHAIR: Carmen Diaz-Amigo, Consultant CO-CHAIR: Sabine Baumgartner, IFA-Tulln • Sabine Baumgartner, IFA-Tulln Food Allergen Detection – Still a Challenge • Roland Poms, MoniQA Association Reference Materials for Food Allergen Analysis • Melanie Downs, University of Nebraska MS Analysis of Food Allergens: Challenges and Potential Solutions • Bert Popping, Merieux NutriSciences Corporation LC-MS/MS: Do we Need Yet another Technology for Allergen Testing? Roundtable: Advancing Regulatory Science in Food Testing—Sound Measurement, Analytical Science, Sampling, and Quality Systems toward Food Safety Regulation The ultimate goal for a food safety regulatory agency is to apply the best possible science for regulatory activities to safeguard human and animal health. Sound measurement science plays an important role in regulatory science and fit-for-purpose analytical data is critical for regulatory decisions. The focus of the proposed roundtable session is how science based surveillance strategy, validated methods, quality control and quality assurance programs need to be integrated for the best practices in food/feed testing laboratories. The roundtable session will utilize

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September 18–21, 2016

Sheraton Hotel, Dallas, Texas

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