AIFST 48th Convention Allergens in manufactured foods: calculating and communicating the risks 11 August 2015
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1 The VSEP The Science Evolving Simon Brooke-Taylor PhD AIFST 48th Convention Allergens in manufactured foods: calculating and communicating the risks 11 August 2015
2 Dose Response for Allergens? Magnitude of response Dose?
3 The VITAL Scientific Expert Panel Formed: Jan 2011 (VSEP) Role: Advise Allergen Bureau on VITAL review Collaboration between: The Allergen Bureau; FARRP (Food Allergy Research and Resource Program (University of Nebraska) and; TNO (The Netherlands Organisation for Applied Scientific Research) Unilever Access to new data sources Expertise in Allergen Risk Assessment
4 VSEP members Steve Taylor (FARRP) Joe Baumert (FARRP) Ben Remington Geert Houben (TNO ) Astrid Kruizinga, Ellen Dutman & Harrie Buist Rene Crevel (Unilever) Katie Allen (Royal Chrildrens Hospital, University of Melbourne),, Jennifer Koplin Simon Brooke Taylor (Food Safety/Risk Analysis Consultant, AB)
5 VSEP January 2011
6 Food Allergen Risk Assessment Hazard Identification What are allergens of concern? Severe IgE mediated response ANZFSC, EU, Codex Hazard Characterisation Objective symptoms Clinical challenge data DBPCFC Exposure Assessment Consumption data Risk Characterisation Qualitative or Quantitative?
7 Allergens of concern Cereals containing gluten Milk Egg Peanuts Fish Crustacea Molluscs (EU) Soybeans Sesame seeds Tree Nuts (EU, Canada named nuts) Added Sulphites 10 mg/kg Celery (EU) Lupins (EU) Mustard (EU, Canada) Mandatory labelling if intentionally added Codex, ASEAN, ANZ, EU, USA, Canada etc Gendel SM Regulatory Toxicology and Pharmacology 2012
8 Predictive Risk Assessment Qualitative Animal tests & in vitro approaches (verification from clinical data) NOAEL, LOAEL Expressed as safe / acceptable exposure ADI, ArfD, PTWI etc Food additives, contaminants VITAL v.1 vs Quantitative Retrospective Human epidemiological and clinical data Population profiles Expressed as a probability or percentage No absolute or safe exposure microbiological hazard, genotoxic carcinogens VITAL 2.0
9 Population at Risk Distribution of response from Crevel et al 2008
10 VSEP approach Review Clinical Challenge Data Published literature Raw data from FARRP and TNO publications Unpublished clinical data European clinics and FARRP studies DBPCFC Screen for individual NOAEL and or LOAELs Objective responses Population Dose Distribution Modeling
11 Managing the data Statistical modelling 3 probability models: log-normal, log-logistic, and Weibull look for the model that provides data best fit goodness of fit in low dose part of the dose range important can we combine paediatric and adult data points? combine data from different clinics? use cumulative and/or discrete doses? Does the choice of statistical model make a difference? different models for different allergens?
12 Characterising the Risk Identify Population Thresholds eg ED01, ED05, ED10 predictive for the whole population weighted to include individuals who react to very low amts & those who require large amts Eliciting Dose Protects: ED01 99% ) of allergic population ED05 95% ) Exquisitely allergic consumers not protected need other risk mgt strategies e.g. not eat processed foods without contact with manufacturer
13 Dose Distribution Modelling from Crevel et al Food Chem Toxicol 2007
14 Dose Distribution Modelling Taylor et al 2014
15 Allergen Total No. individuals Reference Dose (mg) Basis Peanut ED01 Milk ED01 Egg ED01 & ED05 95% lcl Hazelnut ED01 & ED05 95% lcl Soybean ED05 95% lcl soy flour Wheat ED05 95% lcl Cashew provisional ED05 95% lcl Mustard ED05 95% lcl Lupin ED05 95% lcl Sesame ED05 95% lcl Shrimp ED05 95% lcl gulf shrimp Celery 39 Insufficient data - Fish 19 Insufficient data -
16 Allergen dose distribution models Log-normal from Dano et al All data, except sesame, from Taylor et al Sesame as updated by Dano et al 2015
17 VSEP May 2015 Incorporation of EuroPrevall data focus on 5 foods (Hazelnut, Peanut, Shrimp, Celeriac & Fish) Criteria / Protocols to signal reference dose review systematic process Address issues raise by public health & clinical communities Advice for industry on intake assumptions IFAAM project comparing country consumption data How to include Australian data? TNO probabilistic modelling EU Principles accepted by ILSI EU Food Allergy Expert Group EFSA - Reference doses justifiable and provide protection for the public UK, Germany, France all reference VITAL UK &French Authorities used VITAL re: almond / peanut contamination of paprika & cumin. USA/ Canada Some interest but legal concerns
18 Clinical study design sample size and dosing schemes Klein Entink et al 2014 (TNO) random selection from VSEP database peanut, egg, soy flour superimposed dosing schemes: EuroPrevall (0.003, 0.03, 0.3, 3, 30, 100, 1000, 3000mg) Late Start (>3mg protein) Early Start (<100mg protein) largest relative gains in accuracy between n=20 to n=60 EuroPrevall best choice / highest accuracy for (ED01 -ED50) some adjust may be necessary Dano et al 2015 (Nancy, France) sesame. (35 in VSEP database + 14 new challenges) optimal dosing scheme EuroPrevall from mg
19 probabalistic modelling (TNO) Reference quantity & consumption frequency from population surveys not manufacturer decision as in VITAL 2.0
20 Future challenges Continuous improvement in modelling Global acceptance/implementation: Agreement on testing methodology Data analysis acceptable levels of risk (ED01 99%?) Communication: Informing consumers and clinicians about use of risk assessment in allergen labelling decisions Relating population data to individual thresholds
21 Thank You Thanks to: The Allergen Bureau Ltd Kirsti Grinter Rob Sherlock Julie Newlands Simon Brooke-Taylor
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