AOAC INTERNATIONAL Meetings

WILEY AWARD SYMPOSIUM: ACHIEVING NEW HEIGHTS FOR FOOD SAFETY, QUALITY, AND SECURITY - ANALYTICAL TECHNOLOGY CONTRIBUTIONS AND THE AOAC ROLE
Over the past three to four decades, amazing advances have been achieved in analytical technology, particularly with regard to limits of detection. Those concerned with food safety, quality, and security have aptly applied these advances to the quantitation of desirable as well as undesirable components of the food supply. The technological advances and their practical applications will be presented, illustrated and discussed. Despite the technological advances, however, the longstanding difficulty of assuring agreement of results from laboratory to laboratory still presents a challenge to the food analytical community. Advanced analytical technologies have not provided a means to reduce the laboratory to laboratory variability compared to their predecessor methods. AOACI continues to provide a key element to analytical quality in the food community by assuring adequate multilaboratory validation to all methods that become Official Methods of Analysis. As a result, new heights for food safety, quality, and security are being achieved with confidence.

CO-CHAIR: Barry V. McCleary, CEO and Technical Director, Megazyme International Ireland, Ltd.
CO-CHAIR: Mary W. Trucksess, Research Chemist, U.S. FDA – CFSAN

Mary W. Trucksess, U.S. FDA – CFSAN
• Advances in Modern Mycotoxicology
Lauren S. Jackson, U.S. FDA - CFST
• Food Processing: Improving Food Safety or Creating New Concerns?
Barry V. McCleary, Megazyme International Ireland, Ltd.
• Application of Biochemical Techniques to Food Analysis
Paul Wehling, General Mills, Inc.
• Practical Approaches to Optimizing the Value of AOAC Collaborative Studies

EMERGING TECHNOLOGIES FOR RAPID DETERMINATION OF MYCOTOXINS
Classical analytical methods such as gas and liquid chromatography, with any of a variety of detectors, provide selectivity, low limits of detection, good precision and accuracy. However, novel and emerging techniques such as surface plasmon resonance, fluorescence polarization, molecularly imprinted polymers, and others, provide new opportunities. This symposium will explore the application of several of these techniques to the determination of mycotoxins in foods and feeds, with a focus on advantages and limitations.

CO-CHAIR: Gary A. Lombaert, Manager, Laboratory Operations, Health Canada
CO-CHAIR: Hans P. van Egmond, Head, Section of Natural Toxins, National Institute of Public Health and the Environment (RIVM)

Chris Rowe Taitt, U.S. Naval Research Laboratory
• Array-Based Biosensors for Detection of Mycotoxins
Michelangelo Pascale, Institute of Sciences of Food Production
• Fluorescence Polarization Immunoassays for the Determination of Mycotoxins in Cereals
Hans P. van Egmond, National Institute of Public Health and the Environment (RIVM)
• Electrochemical Immunosensor Method for the Determination of Type A-Trichothecenes in Breakfast Cereals and Cereal-Based Baby Foods
Rudolf Krska, University of Natural Resources and Applied Life Sciences
• NIR and MIR (Reflection) Spectroscopy for Rapid Detection of Mycotoxins in Cereals

1:30 pm to 5:00 pm

FRAUD IN FOOD AND DRUG SAFETY
Fraud and fakery in the food and drug industries has been around for quite some time. Schemes that included fake jams made with grass seed and toxic elixirs of sulfanilamide provided significant justification for regulatory oversight. The recent cases involving melamine contamination in pet foods and milk demonstrates that the fraud is still with us today. These sessions will cover the technical and regulatory issues related to the impact of fraud on the safety of food and drug products.

CO-CHAIR: Michael A. McLaughlin, Director Scientist, U.S. FDA - CFSAN
CO-CHAIR: Alexander J. Krynitsky, Chief, Bioanalytical Methods Branch, U.S. FDA – CFSAN

Martin Stutsman, U.S. FDA - CFSAN
• Economic Adulteration of Foods Fraud and Potential Safety Hazard
Jonathan R. Deeds, U.S. FDA - CFSAN
• DNA Barcoding for the Identification of Fish: Protecting the Public's Health and Preventing Seafood Fraud
Tom Phillips, Maryland Department of Agriculture
• Melamine: A State Perspective
David Hammond, Eurofins Scientific
• Using Advanced Analytical Methodologies to Prevent Drug Counterfeiting and Process Patent Infringement
Dana A. Krueger, Krueger Food Laboratories, Inc.
• Detection of Adulterated Pomegranate Juice
Shannon M. Cole, Grocery Manufacturers Association (GMA)
• Fake Foods: The Analytical Challenges Presented by Economic Adulteration

Oral Poster Presentations:
Franz Ulberth, European Commission - Institute for Reference Materials and Measurements
• Results of an International Proficiency Test to Assess the Capabilities of Control Laboratories to Measure Melamine in Skimmed Milk Powder and Starch-Containing Foods
Vincent A. McKie, Megazyme International Ireland Ltd
• A Rapid and Sensitive Method for the Analysis of Lactulose
Deepali Mohindra, Dionex Corporation
• Determination of Steviol Glycosides in Sugar Substitutes by HPLC-UV Detection

3:30 pm to 5:00 pm

DISINFECTION: EXOTICA
EPA has certain requirements for label claims for sanitizers, disinfectants and liquid chemical sterilants. These requirements stipulate microorganisms and methods acceptable to The Agency. Supplemental claims must be substantiated using the microorganisms specified. However, some clinically important agents are difficult to cultivate or cannot be cultured in the laboratory. This symposium looks at Protozoa; a clinically relevant spore-forming anaerobe; viruses that do not efficiently replicate in vitro; and prions. Speakers will discuss their experiences working with the agents.

CHAIR: Donna B. Suchmann, President, MICROBIOTEST

S. Steve Zhou, MICROBIOTEST
• Efficacy Evaluation of Disinfectants on Hard-to-Culture Viruses Using PCR Assays
Christopher J. Silva, USDA
• Disinfectants and Prions
Daniel A. Klein, STERIS Corporation
• Testing Clostridium Difficile
Donna B. Suchmann, MICROBIOTEST
• Disinfectant Efficacy Challenges Presented by Protozoa

125 YEAR AOAC HISTORY OF ANALYTICAL TESTING, PART 1
This 2-part symposium will feature analytical techniques used during the 125 year history of AOAC. Speakers will discuss the history of the AOAC process and methodologies utilized in their field of expertise in 1884, 1984 and today. While this symposium focuses on history, it will also highlight the tremendous strides that have been made in the analytical field over the course of AOAC’s existence. This will provide an interesting retrospective for AOAC members. The main topic areas will include agricultural methods, contaminants methods, and general food testing methods along with the AOAC process history.

CO-CHAIR: Wayne C. Ellefson, Senior Client Manager, Covance Laboratories
CO-CHAIR: Albert E. Pohland, Chief Science Officer, AOAC INTERNATIONAL

Albert E. Pohland, AOAC INTERNATIONAL
• An Anecdotal History of AOAC from Poison Squad to Poison Squad
Darryl M. Sullivan, Covance Laboratories
• History of the AOAC Method Validation Process
Jonathan W. DeVries, Sr., Medallion Laboratories/General Mills
• AOAC-Key Player in Quality Food Nutrition Analysis

Tuesday, September 15, 2009

8:15 am to 9:45 am

125 YEAR AOAC HISTORY OF ANALYTICAL TESTING, PART 2

CO-CHAIR: Wayne C. Ellefson, Senior Client Manager, Covance Laboratories
CO-CHAIR: Albert E. Pohland, Chief Science Officer, AOAC INTERNATIONAL

Russell S. Flowers, Silliker Group Corp.
• History of the AOAC Research Institute
Frank Ross, Working Solutions
• Agricultural and AOAC INTERNATIONAL: From the Poison Squad to Today
Alexander J. Krynitsky, U.S. FDA - CFSAN
• History of Contaminant Methods: 1884-2009

ANALYTICAL CHALLENGES IN THE GLOBAL JUICE MARKET
Juices have historically presented special analytical challenges. New and exotic juices, together with increased regulations promulgated by agencies around the world continually add to analytical challenges. Identifying unique marker compounds for each juice product and determining their “standard” concentrations to substantiate authenticity and associated label claims are key aspects of regulation and are the topics of this symposium.

CO-CHAIR: Edward B. Walker, Professor of Chemistry, Weber State University
CO-CHAIR: Michael Wade Pugh, Director, Research and Development, Xango, LC

Edward B. Walker, Weber State University
• Monitoring Marker Compounds in Juices
Melissa Meaney Phillips, National Institute of Standards and Technology
• Development of Cranberry Juice Cocktail and Related Berry Reference Materials
Heidi Isbell, XanGo, LLC
• Juice Product Registration and Regulatory Challenges and Hurdles in the Global Market

Oral Poster Presentation:
Robert W. Durst, Oregon State University
• Pomegranate: Composition of a Superfruit

ALLERGEN OVERSIGHT FROM SAMPLING TO TESTING
Monitoring for the incidental presence of allergens requires the establishment of proper sampling plans, which is a critical step in the analytical process. In this case, food allergens behave as other food contaminants as they may be present in the food in a heterogeneous manner. This will be one of the main focuses of the session as well as analytical initiatives for food allergens. Moreover, the session will also address analytical challenges of gluten testing. The Codex new position on gluten labeling, has already been adopted by the EU, establishes threshold values of 20 ppm for “gluten-free” and 100 ppm for “very low gluten”. This new position makes testing critical to ensure accurate labeling.

CO-CHAIR: John Szpylka, Technical Manager, Medallion Laboratories/General Mills
CO-CHAIR: Carmen Westphal, Research Biologist, U.S. FDA - CFSAN

Franz Ulberth, European Commission - Institute for Reference Materials and Measurements
• Contribution of Sampling Uncertainty to the Uncertainty of Allergen Measurements
John Szpylka, Medallion Laboratories/General Mills
• Sampling Considerations When Testing for the Presence of Food Allergens
Steve L. Taylor, University of Nebraska
• Gluten Testing - Practical Experiences
Bert Popping, Eurofins Scientific Group
• Recent Advances in Allergen Analysis in Europe

Oral Poster Presentation:
Hiromu Taguchi, House Foods Corporation, Somatech Center
• PCR Methods for Differential Detection of Allergenic Shrimp and Crab

10:15 am to11:45 am

MASS SPECTROMETRIC APPROACHES TO DETECTING PATHOGENS
A little over 50 years ago the very first mass spectrum of a derivatized tripeptide was reported. Since then, the field of mass spectrometry has expanded beyond what anyone could have imagined at the time. Mass spectrometry of whole proteins is now a routine practice. Advances in instrumentation allow for the detection of analytes in the attomole (10^-18sup> mole ~ 1,000,000 molecules) range. The joint advances in instrumentation, computation, and genetic sequencing have lead to the proteomics revolution. These remarkable advances are a prolog to a spectacular future. This symposium will describe four contemporary approaches to identifying and quantitating pathogens. One method uses “top down” proteomics to detect foodborne pathogens. Another uses LC/MS/MS to differentiate slow growing Mycobaterial strains. A third approach uses LC/MSMS to quantitate viable pathogens. The fourth method uses differences in fatty acid composition to identify pathogens.

CHAIR: Christopher J. Silva, Research Chemist, USDA - ARS

Clifton K. Fagerquist, USDA Agricultural Research Service
• "Top-Down" Proteomic Identification of Foodborne Pathogens
Matthew M. Champion, Applied Biosystems
• Discrimination of Secreted Proteins from Mycobacterial Strains Using Quantitative LC/MS/MS
Christopher J. Silva, USDA
• Mass Spectrometry of Prions: Approaches to Conformational Distinction

Oral Poster Presentation:
Maria Hoffmann, U.S. FDA
• Evaluation of GC-FID/FAME Analysis for Identification of Vibrio Isolates

ANALYTICAL INSIGHTS INTO FORMATION AND CONTROL OF MYCOTOXINS
For more than four decades numerous analytical methods for mycotoxins have been published, however, there still remain huge gaps in our knowledge and understanding of the conditions favoring mycotoxin productions, and subsequently the development of control strategies. The recent advances in emerging analytical techniques and novel approach in isolating untargetted analytes from complex matrices, have begun to provide new insights to solve many of the mycotoxin problems. In this session four very different areas will be used to illustrate this growing understanding of formation and control of mycotoxins. The isolation and identification of natural fungal inhibitors from tree nuts, such as the walnuts, has elucidated some of the control mechanism that can possibly be applied to other agricultural commodities. The use of LC-TOF/MS as a screening tool for untargetted analysis could open the opportunity for complete fungal metabolite profiling in water-damaged houses, foods or feeds. LC/MS/MS methods have historically been used for determining “free mycotoxins” without examining the presence of the significant amounts of “hidden” or bound mycotoxins which might have toxicological significance. Despite these cutting edge techniques which are providing new insights into the mycotoxin areas, there is a need for validation of method performance. The EU Community Reference Laboratory (CRL) has a program for the mission of improving analytical measurement and providing useful insights into method performance.

CO-CHAIR: Hamide Senyuva, Senior Research Scientist, TUBITAK-ATAL
CO-CHAIR: Mary W. Trucksess, Research Chemist, U.S. FDA - CFSAN

Joerg Stroka, European Commission - JRC-IRMM
• Insights into Analytical Methods Performance for Mycotoxins
Franz Berthiller, University of Natural Resources and Applied Life Sciences
• Analysis of Masked Mycotoxins
Russell Molyneux, USDA - ARS
• Novel Fungal Inhibitors Identified in Tree-Nuts
Sarah de Saeger, Ghent University
• Investigations into Emerging Mycotoxins in Water-Damaged Buildings

Oral Poster Presentation:
Joe Romano, Waters Corporation
• Fast Analysis for Aflatoxins without Derivatization in Cereal, Peanuts and Corn Using UltraPerformance LC^®

ROUNDTABLE ON LESSONS LEARNED AND SUCCESS STORIES FROM REAL MANUFACTURING FOR ALLERGEN MANAGEMENT
The rate of food allergy in the U.S. appears to be increasing, especially in young children. Consumers with food allergies have to have the ability to avoid specific allergens that are present in products, and food manufacturers therefore have to identify those allergens intentionally and unintentionally in all the ingredients forming the product and label or remove them. However, undeclared allergens can be inadvertently introduced into a food via cross-contact during manufacturing. Therefore, it is important for manufacturing quality assurance personnel to work towards best practices on allergen control programs. This roundtable presentation will showcase effective allergen management programs in real life manufacturing facilities. While dry cleaning is known to be challenging, there is little information on the effectiveness of cleaning procedures for removing allergenic materials from processing equipment. Our panelists will share their experiences, best practices and offer guidelines to help food establishments to address this important issue.

CHAIR: Forouzan (Betty) A. Zakeri, President and Founder, Food Safety Consulting, Training and Testing LLC

1:00 pm to 2:30 pm

PERFORMANCE TESTED METHODS^SM
The performance claims and validation results of recently approved Performance Tested Methods^SM will be reviewed.

CO-CHAIR: Mark R. Coleman, Senior Research Advisor, Eli Lilly & Co
CO-CHAIR: Scott G. Coates, Chief Scientific Officer, Microbiology and Senior Director, AOAC Research Institute

Zerlinde B. Johnson, AOAC Research Institute
• Emergency Response Validation (ERV): Salmonella in Peanut Butter
Yanxiang Y. Cao, Applied Biosystems
• AOAC Performance Tested Method^SM Certification of Two New Real-Time PCR Assays for the Detection of Salmonella and Listeria Monocytogenes
John Mills, bioMérieux, Inc.
• VITEK^®2 Compact GN (Gram-Negative Identification Card), GP (Gram-Positive Identification Card), and BCL (Bacillus Identification Card) AOAC Performance Tested Methods^SM: Rapid, Automated Solution to Microbial Identification
Wendy Lauer, Bio-Rad Laboratories
• Validation of a Simultaneous 8hr Enrichment of E. coli 0157:H7 and Salmonella spp. in Raw Ground Beef and Subsequent Detection by Real-Time PCR
Christine Hilbert, Thermo Fisher Scientific
• Salmonella Rapid Culture Method - Confidence in Food Safety: 2 Steps, 2 Days

REGULATIONS AND ANALYSIS OF CONTAMINANTS IN RAW HERBAL MATERIALS AND DIETARY SUPPLEMENTS
Safety of botanical products (herbs, spices, tea products, dietary supplements, foodstuffs of plant origin etc.) is a very important issue in US as well as the European Community. This session will compare US with EU regulations for herbal products and will give an overview about the state-of-the-art analytical methods and techniques for the trace analysis of contaminants like pesticides, mycotoxins and heavy metals. To harmonize maximum residue levels (MRLs) within the different member states of the EU in September 2009 the EU regulation 396/05/EC became effective. In this directive MRLs for many pesticides have been fixed. For herbal medicinal drugs regulations for pesticide residues are included in the monograph 2.8.13. “Pesticide Residues” of the European Pharmacopoeia (Ph. Eur.). Harmonized MRLs eliminate barriers to trade and increase transparency of these trading parameters to ensure equal competition on the EU internal market and a high level of consumer protection. Pesticide residue testing of dietary supplements in the United States has undergone major changes over the last few decades. The session will provide a historical overview of regulatory methods used starting with the Luke extraction methods from the late 1960’s through modern LC/MS/MS techniques used today. An update on the progress of the FDA-CFSAN method development project will be given. In addition, current challenges faced when working with complex and constantly changing matrices will be presented with workaround solutions. Besides pesticides other contaminants, like heavy metals and mycotoxins are relevant regarding the protection of the consumers. The session will also focus on mycotoxins and heavy metals in dietary supplements and will give an overview about the analysis and legal situation for these contimnants.

CO-CHAIR: Klaus Reif, Chemist, PhytoLab GmbH & Co., KG
CO-CHAIR: Jat Rana, Research Associate, Analytical Services, AMWAY

Bernhard Klier, PhytoLab GmbH & Co. KG
• Pesticide Testing According to the European Pharmacopoeia (Ph.Eur.): Legal Requirements and Practical Approach
James Neal-Kababick, Flora Research Laboratories
• Pesticide Residue Analysis in Dietary Supplements: Review of Historical Perspectives and Current Trends in Approaches and Methodology
Frank Kareth, Eurofins DILU GmbH
• Mycotoxins and Heavy Metals in Dietary Supplements: Analysis and Legal Situation

Oral Poster Presentation:
Catherine A. Rimmer, National Institute of Standards and Technology
• Status of NIST Activities to Produce Standard Reference Materials for Dietary Supplements

TDRM SYMPOSIUM: WHAT DO YOU DO WHEN CRMs ARE NOT AVAILABLE?
Speakers will provide 15-minute presentations on preparation and use of control materials. A 30-minute Question and Answer discussion with panel members and the session chair will follow.

CHAIR: Katherine E. Sharpless, Research Chemist, National Institute of Standards and Technology

Hendrik Emons, European Commission - Institute for Reference Materials and Measurements
• Designing Non-Certified Reference Materials for Quality Control Purposes
Mark A. Mozola, Neogen Corporation
• Validation of Microbiological Test Kits in the Absence of CRMs
John Budin, Silliker, Inc
• Perspectives from the Independent Laboratory
Pieter Scheelings, Queensland Health Scientific Services
• The Development of Reference Materials in the Asia Pacific Region

3:00 pm to 4:30 pm

TDRM SYMPOSIUM: CERTIFYING NOTHINGNESS - BLANK MATRIX REFERENCE MATERIALS
Various well-characterized materials are required for the development, validation and verification of methods for the analysis of food and feed. This includes frequently matrix-matched materials which should "not contain" the analyte of interest. This symposium is devoted to the presentation and discussion of approaches by which such blank matrices can be qualified as certified reference materials (CRMs), which information has to be provided to the users and how such CRMs should be properly used in the analytical laboratory.

CO-CHAIR: Hendrik Emons, Head of Unit, European Commission - Institute for Reference Materials and Measurements
CO-CHAIR: Donna L. Zink, Director, AIM Research Enterprises

Hendrik Emons, European Commission - Institute for Reference Materials and Measurements
• Why to Certify and Use Blank Matrix Materials
Steve W. Wood, LGC Limited
• Nothing in It - How Can We Be Sure? Critical Steps in the Production of Blank RMs
David L. Duewer, National Institute of Standards and Technology
• Blank? Who Needs a Blankety-Blank Blank?

Oral Poster Presentation:
Pearse McCarron, National Research Council of Canada
• A Mussel Tissue Certified Reference Material for Azaspiracids

ROUNDTABLE ON WHAT ARE TODAY'S GREATEST NEEDS OF FORMULATION METHODS DEVELOPMENT AND ANALYSES?
This Roundtable will focus on product chemistry and pesticide formulations. The panel will include representatives from state, Federal, and industry who are involved in the analyses, method development, and registration of pesticides in the United States. The Roundtable will provide interested participants to identify and discuss various analytical and registration concerns, problems, and needs facing pesticide formulation registration, methods development. Topics for discussion include: a) Validation strategies for standardized independent lab validation of analytical methods especially as related to batch analysis studies. b) Identification and determination of significant impurities and/or related compounds in technical grade and formulated products. What impurities analyses are required and are currently being done especially regarding post patent products? What might the future hold? c) Independent laboratory validation for enforcement analytical methods, especially as related to batch analysis studies and on post patent pesticide products. d) Characterization of inerts and the registration of a new inert. e) Type of necessary data to support tank mixes. f) Product Chemistry Product Properties Guidelines as requirements for pesticide registration. g) Third party, referee analysis for disputes regarding state FIFRA enforcement. h) The best way(s) to find all of the EPA guidance documents associated with product chemistry studies. i) And any other topic of interest relating to formulation analysis and/or registration.

CO-CHAIR: Adrian W. Burns, Analytical Chemist, U.S. EPA
CO-CHAIR: Diane M. Rains, Analytical Chemist, U.S. EPA

Marian Weber, Nufarm Americas Inc.
Walter K. Gavlick, Monsanto Company
Rose M. Nelson, Dow AgroSciences LLC
Shyam B. Mathur, U.S. EPA
Oliver Bennett, Kansas Department of Agriculture

ROUNDTABLE ON TESTING FOR PURITY IN A GMP CONTEXT

CO-CHAIR: Jana Hildreth, Scientific Liaison, Blaze Science Industries, LLC
CO-CHAIR: Jat Rana, Research Associate, Analytical Services, AMWAY

Mark C. Roman, Tampa Bay Analytical Research Inc.
• Scientifically Sound Methods
Joseph M. Betz, National Institutes of Health
• Designing and Setting Product Specifications
James N. Kababick, Flora Research
• Testing Against Specifications
Jana Hildreth, Blaze Science Industries, LLC
• Qualifying Third Party Contract Laboratories

Wednesday, September 16, 2009

8:15 am to 9:45 am

DEVELOPING, VALIDATING AND FUNDING METHODS FOR THE AGRICULTURAL MATERIALS COMMUNITY
As founding stakeholders of AOAC, agricultural material suppliers, regulators and chemists have a history of valued service and have validated many AOAC methods. Due to recent inactivity, there have been few updates or new validations. Older methods are seldom used and, in many cases out dated. Stakeholders have initiated efforts establishing and funding a community. They have been working to: revise older methods, validate new methods providing users with relevant, “fit for purpose” methods. Community formation, funding, organization, current issues and activities will be discussed along with a roadmap for building communities. Activities and presentations include: Identifying Stakeholders; Fundraising; Revising Methods; Improving Efficiency & Performance; ICP OES Methods of Analysis for Nutrients and Contaminants; SLV Results of Multiple Agricultural Material Methods and Developing Methods for New Analytes.

CHAIR: William L. Hall, Senior Product Stewardship Specialist, Mosaic Crop Nutrition

William L. Hall, Jr., Mosaic
• Developing, Validating and Funding Fertilizer Methods for the Agricultural Materials Community
L.C. Medina, University of Florida
• Methodologies to Characterize Nitrogen Release Patterns of Slow-Release Fertilizers
Joseph Kloepper, Auburn University
• Developing Methods to Assess Microbial Compounds Designed to Enhance Plant Growth
James Bartos, Office of the Indiana State Chemist
• SLV Results for Phosphorus and Potassium Analysis of Fertilizers by ICP-OES
Sharon F. Webb, University of Kentucky
• Simultaneous Determination of Nutritive and NonNutritive Metals in Fertilizers by ICP-OES

THE THREAT OF THE UNKNOWN CONTAMINANTS: WHEN YOU DON'T KNOW AND WHAT YOU DON'T KNOW
The focus on food safety for chemical contaminants has largely been on targeted analysis. This is very effective for contaminants such as pesticides and veterinary drugs. However, as the recent tragedies associated with melamine have been illustrated, targeted analysis fails to help us detect food contaminants before their effect is felt. In this session, our speakers talk about both strategies to screen food for contaminants which are unknown, as well as respond when a new chemical contaminant is identified.

CO-CHAIR: Yolanda Fintschenko, Manager, Food Safety Technologies, Thermo Fisher Scientific
CO-CHAIR: Alexander J. Krynitsky, Chief, Bioanalytical Methods Branch, U.S. FDA - CFSAN

Alexander J. Krynitsky, U.S. FDA - CFSAN
• Response to the Unknown Threat - Melamine, a Case Study
Sneh D. Bhandari, Silliker Laboratory
• Screening of Food Matrices for Unexpected Chemical Contaminants Using Selected Analytical Methods
Darryl M. Sullivan, Covance Laboratories
• Laboratory Scale Up in Response to Chemical Threats

Oral Poster Presentations:

Donna Houchins, Romer Labs, Inc.
• Testing for Melamine Using ELISA-Based Test Kits, HPLC, and LC-MS/MS
Julie A. Kowalski, Restek Corporation
• Addressing the Challenges of Melamine Analysis in Infant Formula via GC/MS and LC-MS/MS
Joe Romano, Waters Corporation
• Fast Screening for Banned Food Colorings in Health Beverages and Powdered Fruit Drinks Using UltraPerformance LC®

MARINE AND FRESHWATER TOXINS: BIOSENSORS AND BIOCHEMICAL TOOLS
Biosensors and biochemical tools for the marine and freshwater toxins have generated extensive interest and remain the subject of much research. What determines their success for failure? In principle these tools could advance seafood safety, and even form the basis for primary monitoring methods if they proved rugged enough and compared favorably with existing officially approved and accepted methods. Speed and ease of use form the mantra for their development and in the case of functional assays can directly reflect health risk via response. Ranging from various forms of immunoassays to enzymatic assays and even membrane/receptor-based assays and cell-based assays, these novel tools bring new capabilities and also new challenges in their development and practical application. This session will examine the needs for these biosensors and biochemical tools, strategies for their development, and their performance in the field. Speakers include those developing, evaluating, and potentially applying these assays.

CO-CHAIR: Lei Bao, Director of Mycotoxins and Marine Toxins Laboratory, Shan Dong Import-Export Inspection and Quarantine Bureau of China
CO-CHAIR: James M. Hungerford, Research Chemist, U.S. FDA - ORA

Benjamin A Suárez-Isla, University of Chile
• The Need for Biosensors and New Field Methods - Electrophysiological Assay and MBA from a Recent Outbreak of PSP in Chile
Stacey M. Etheridge, U.S. FDA - CFSAN
• Need and Current Capabilities for Detecting PSP Toxins - Biosensors, Test Kits, and Separations
Emanuel Hignutt, Jr. , State of Alaska Environmental Health Laboratory
• The Alaskan Experience in Exploring Alternative Methods for PSP Toxins
James M. Hungerford, U.S. FDA - ORA
• Exploring Immunochemical and Enzymatic Screening Tools for Histamine

Oral Poster Presentation:
Atsushi Yoshino, Tropical Technology Center Ltd.
• Single Laboratory Validation Study on the DSP Assay Kit Using Recombinant PP2A

10:15 am to 11:45 am

HOT TOPIC ROUNDTABLE: DEALING WITH THE UNKNOWN - RISK ASSESSMENT AND RISK MANAGEMENT STRATEGIES OF INDUSTRY AND REGULATORS
Key players from food industry and regulators will present their views, experiences and strategies to deal with occurrences of unknown risks and new contaminants. In the past year, several new contaminants have made headlines in newspapers and caused significant losses in tangible and non-tangible assets to industry. Both, industry and regulators had to make risk assessments and deal with these new issues to prevent further damage. In the course of this symposium, important aspects of risk assessment and management procedures based on existing cases like melamine will be discussed, as well as strategies to deal with futures issues. Short presentations by each party will be followed by a round table discussion and interaction with the audience.

CHAIR: Bert Popping, Director Molecular Biology and Immunology, Eurofins Scientific Group

Samuel Godefroy, Health Canada
• Dealing with Emerging Risk: Health Canada’s Approach
Cindy Jiang, McDonald’s Corporation
• Emerging Issue Management: An Industry Perspective
Nega Beru, U.S. FDA – CFSAN
• Dealing with Emerging Risks: The FDA Perspective
Brett Jeffery, MARS
• MARS’ Approach to Managing Raw Materials Risks
Roger Wood, UK Food Standards Agency
• FSA’s New Emerging Risk Protocol

ROUNDTABLE ON DETECTION, MONITORING AND REGULATION OF CONTAMINANTS IN AGRICULTURAL INPUTS
An open discussion on the detection and prevention of contaminants in agricultural materials and food will be presented. Roundtable members representing various agricultural input segments will address the issues. Each panelist will be introduced with reference to their background/expertise relating to benefits and contamination threats to agriculture and ultimately to our food supply. This will be followed by a facilitated panel discussion including questions from the moderator and time allowing the audience. Possible discussion areas include: trace (heavy) metals, melamine, SRM (specified risk materials), recycling unwanted materials – manure/biosolids and other byproducts and microbiological monitoring of fertilizers and soil amendments.

CHAIR: William L. Hall, Jr. , Senior Product Stewardship Specialist, Mosaic Crop Nutrition

Weldon Collier, Florida Department of Agriculture and Consumer Services
William Herz, The Fertilizer Institute
Alexander J. Krynitsky, U.S. FDA – CFSAN
Joseph Kloepper, Auburn University

Oral Poster Presentation:
Hamide Senyuva, TUBITAK-ATAL
• Emerging Risk for Food Contaminants

MARINE AND FRESHWATER TOXINS: MOVING AHEAD IN THE REAL WORLD VIA VALIDATION AND IMPLEMENTATION
What is required of an official method by the users of that method to advance actual monitoring, and what is the international impact of official method approval? These are critical questions that help our toxin community decide on future efforts. A recent example is discussed, an alternative official method for the PSP toxins (OMA 2005.06). Once this method was reviewed and approved by the Marine and Freshwater Toxins Task Force and the OMB of AOAC, it was immediately the object of multiple training courses, EU directives, and Codex Alimentarius reviews. Now implemented within the UK, it was first subjected to method refinements and analyte extensions which boosted its practical application. It was also modified in the US for forensic application. Other aquatic toxins, such as the okadaic acids and the ciguatoxins are, like the saxitoxins responsible for PSP and cyanotoxins impacting water safety, a worldwide problem and accordingly this session will include a group of speakers chosen to give a global view. Experts will discuss methods available now for these many and varied toxins, validation efforts, future needs, the critical need for reference materials, and factors driving implementation.

CO-CHAIR: James M. Hungerford, Research Chemist, U.S. FDA - ORA
CO-CHAIR: Andrew D. Turner, Senior Analytical Chemist, CEFAS

Takeshi Yasumoto, Okinawa Science and Technology Promotion Center
• Marine Biotoxin Monitoring in Japan
Michael A. Quilliam, National Research Council of Canada
• Certified Reference Materials for the Analysis of Marine and Freshwater Saxitoxins
Lorna Murray, Food Standards Agency Scotland
• Applying Modern Shellfish Toxin Methodology: PSP Monitoring of Scotland's Shellfish Under EU 854/2004
Andrew D. Turner, CEFAS
• Analyte Extension, Refinement and Implementation of AOAC 2005.06 OMA for PSP Toxins

Oral Poster Presentation:
Jeffrey M. van de Riet, Canadian Food Inspection Agency
• Practical Application of the Post Column Oxidation Method for the Analysis of PST to the Analysis of Lobster Hepatopancreas: The Road to Regulatory Approval

1:00 pm to 2:30 pm

FINDING NON-TARGET CHEMICAL CONTAMINANTS IN FOOD STUFF
With so many contamination incidents around the world recently, the scientific community would be very interested in a lab’s protocol, methodology and examples in finding non-target (unknown) contaminants. The contaminants might come from the food, processing, or packaging. This session will cover a wide range of contaminants, from pesticides to mycotoxins, and to chemicals from food packaging.

CO-CHAIR: Chin-Kai Meng, Agilent Technologies
CO-CHAIR: Jerry Zweigenbaum, Marketing Development Specialist, Agilent Technologies

Douglas G. Hayward, U.S. FDA
• Multiresidue Pesticide Analysis by Non-Targeted and Targeted Screening Procedures
Steven J. Lehotay, USDA Agricultural Research Service
• Identifying Non-Targeted Organic Chemicals of Interest in Fish Oils Using GCxGC-TOF Mass Spectrometry
Amadeo R. Fernandez-Alba, University of Almeria
• LC-MS Strategies for Pesticide Multiresidue Methods in Fruits and Vegetables
Jana Hajslova, Institute of Chemical Technology
• TOF MS: A Challenging Technology for Tracing of Food Unknowns
Jerry Zweigenbaum, Agilent Technologies
• Accurate Mass Measurements for Screening of Contaminants in Animal Feed and Ingredients
Malcolm Driffield, Food and Environment Research Agency (FERA)
• Identification of Unknown Contaminants in Foodstuffs Migrating from Food Contact Materials

LESS RECOGNIZED AND PRESUMPTIVE FOODBORNE PATHOGENS
Food safety problems continue to be the subject of concern to the industry, regulatory agencies and the consumer. Many so-called “emerging” pathogens, such as Escherichia coli 0157:H7, Listeria monocytogenes, Yersinia enterocolitica, and many other organisms have been implicated in outbreaks of foodborne illness and recalls during the past two decades. While contaminated foods of animal origins and Zoonoses are more frequently involved in food borne illness, outbreaks attributed to novel food sources such as fresh produce, fruits and vegetables and nuts as well as Ready –To- Eat, minimally processed foods are frequently reported in recent years. In addition, suspected and less recognized and presumptive pathogens such Aeromonas, Plesiomonas , non 0157 E. coli, Enterobacter sakazakii, Mycobacterium avium paratuberculosis, Klebsiella pneumoniae , etc. have posed newer challenges to food microbiologists in terms of their detection, characterization and attributing significance to food safety. This symposium will provide much needed update on the status of these often ignored organisms.

CO-CHAIR: Purnendu C. Vasavada, Professor and Food Safety and Microbiology Extension Specialist, University of Wisconsin, River Falls
CO-CHAIR: Reginald W. Bennett, Senior Policy Analyst, Division of Microbiology, U.S. FDA - CFSAN

Purnendu C. Vasavada, University of Wisconsin, River Falls
• Less Recognized and Suspected Foodborne Pathogens
Pina M. Fratamico, USDA - ARS - ERRC
• Non-0157 Shiga Toxin-Producing Escherichia coli: Prevalence and Methods for Detection
Yi Chen, U.S. FDA - CFSAN
• Evaluation of a Revised FDA Method for the Detection of Enterobacter sakazakii in Powdered Infant Formula: Pre-Collaborative Study
Reginald W. Bennett, U.S. FDA
• Kinetics and Serological Detection of Thermally Stressed Staphylococcal Enterotoxin

TDLM WORKSHOP: HOW TO DETERMINE LOD/LOQ
As many different approaches are used, confusion and misunderstandings on the vendor/buyer side are likely. This workshop will review the different approaches and clarify when and how they should be used.

CHAIR: Molly F. Mills, Team Leader, Research and Development Liaison and Microbiology, Land O'Lakes, Inc.

Workshop Participant:
Franz Ulberth, European Commission - Institute for Reference Materials and Measurements
• How to Determine LOD/LOQ

3:00 pm to 4:30 pm

TDLM SYMPOSIUM: "NITTY GRITTY" PROBLEMS - VALIDATION, VERIFICATION, RECOVERY, AND USE OF PT RESULTS
Laboratories have been accredited to ISO/IEC 17025 for several years now and are gaining experience with the Management system. As the experience increases, lab’s understanding of the requirements increases and more complex and sometimes subtle questions arise; these are the Nitty Gritty Problems. This symposium addresses several of these problems through presentations and workshop participation. Proficiency Testing is a critical aspect of accreditation; but, how do you respond to unacceptable proficiency results? Validation and Verification have been around for awhile now and they are intricately linked. How much does a lab’s verification depend upon the thoroughness of the validation? The concept of recovery is complicated and rather confusing. What do you do about recovery? What are the most common questions asked by those who validate methods and encounter problems? This session is designed to be practical and provide solutions for these “Nitty Gritty” problems.

CHAIR: Molly F. Mills, Team Leader, Research and Development Liaison and Microbiology, Land O'Lakes, Inc.

Torben Leth, National Food Institute, DTU
• Validation of Chemical Analytical Methods
Lars Jorhem, National Food Administration, Sweden
• Use of Recovery Information in Analytical Measurement
Allen K. Vickers, Agilent Technologies
• How to Get Better Performance in GC Analysis by Troubleshooting During Method Development
Roger M. Brauninger, A2LA - American Association for Laboratory Accreditation
• The Dilemma in Applying Proficiency Test Results

ROUNDTABLE ON MASS SPECTROMETRY FOR BENCH CHEMISTS AND THEIR BOSSES
Mass spectrometry (MS) is the most powerful detection method for organic chemicals, particularly for complex matrices. The purchase and usage of the instruments are increasing in many labs, but the instruments are expensive and complex. Participants from the bench and their managers need independent advice to help them make the most of the powerful analytical tools, and yet understand limitations of MS techniques and instruments, leading to realistic expectations. This session is designed to provide a questions and answers forum for those new to MS and to advanced users looking for practical tips and specific advice.

CO-CHAIR: Steven J. Lehotay, Lead Scientist, USDA – ARS
CO-CHAIR: Perry A. Martos, Lead Scientist, Chemistry Method Development, University of Guelph

David N. Heller, U.S. FDA – CVM
Amadeo R. Fernandez-Alba, University of Almeria
Walter Hammack, Florida Department of Agriculture and Consumer Services
William Holmes, Mississippi State University

MICROBIOLOGICAL METHOD VERIFICATION WORKSHOP
The recent number of outbreaks related to microbiological contamination has spawned the necessity to modify or develop new methods for the detection of microorganisms of concern in several matrices, including food and clinical samples. Depending on the organisms and/or the matrix, laboratories in government, industry, and academia are faced with the paradox to either perform a full collaborative study before they use the method, or due to the urgency, use the method without performing the full collaborative study. This workshop includes a panel of professionals in the area of microbiology that will discuss strategies for microbiological method verification. As it is a requirement of ISO/IEC 17025:2005 (clause 5.4.2: the laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations), and authoritative texts for how to implement properly a standardized method in a laboratory was lacking, AOAC has developed a comprehensive guideline describing what should be done to provide the required evidence. The workshop will build on last year's highly successful TDLM symposium where analytical method verification and strategies for its implementation were discussed. Guided group work, tutorials and an open discussion forum will deepen the understanding of the practical aspects of microbiological method verification.

CHAIR: Dawn M. Mettler, President, Rockbridge Laboratory Services

Workshop Participants:
Dawn M. Mettler, Rockbridge Laboratory Services
• Michele Smoot, Silliker, Inc. Thomas S. Hammack, U.S. FDA - CFSAN