1 Webinar: Assessment of the risk of human salmonellosis associated with the consumption of tree nuts Monday, July 22 nd 12 – 1 pm ET

Webinar outline: Today’s webinar will contain 3 parts Today’s webinar content: 1.Welcoming remarks 2.Risk assessment plans, Federal Register notice, and data gaps 3.Questions and Answers 2

Webinar outline: Today’s webinar will contain 3 parts Today’s webinar content: 1.Welcoming remarks 2.Risk assessment plans, Federal Register notice, and data gaps 3.Questions and Answers 3

Webinar outline: Today’s webinar will contain 3 parts Today’s webinar content: 1.Welcoming remarks 2.Risk assessment plans, Federal Register notice, and data gaps 3.Questions and Answers 4

Introduction: The interdisciplinary risk assessment team The risk assessment team (in alphabetical order): 1.Karin Hoelzer (FDA/CFSAN/OAO) – project lead / modeling 2.Rhoma Johnson (FDA/CFSAN/OFS) – tree nut industry knowledge 3.John W. Larkin (FDA/CFSAN/OFS) – performance standards 4.Haiping Li (FDA/CFSAN/OFS) – microbiology / predictive modeling 5.Regis Pouillot (FDA/CFSAN/OAO) – mathematical modeling 5

Outline: Today’s webinar covers these topics 1.Background & Rationale  Reasons for conducting the risk assessment 2.Risk assessment approach & methodology 1.Risk assessment approach 2.Key risk assessment model parameters 3. The Federal Register notice 1.FR notice content & identified data gaps 2.Process for submitting data & comments 4. Questions & Answers 5. Closing remarks 6

Outline: Today’s webinar covers these topics 1.Background & Rationale  Reasons for conducting the risk assessment 2.Risk assessment approach & methodology 1.Risk assessment approach 2.Key risk assessment model parameters 3. The Federal Register notice 1.FR notice content & identified data gaps 2.Process for submitting data and comments 4. Questions & Answers 5. Closing remarks 7

Rationale: Salmonella contaminated tree nuts are a concern 1. Outbreaks of salmonellosis have occurred, e.g.: -Raw almonds (2000/2001 & 2003/2004) -Pine nuts (2011) -Desiccated Coconut (1999) 2. Product has been recalled due to Salmonella contamination, e.g.: -Pistachios (2009/2010) - Pine nuts (2011) -Walnuts (2010) - Macadamia nuts (2013) -Hazelnuts (2009, 2013) 3. Salmonella has been isolated from product during surveys, e.g.: -Almonds - Macadamia nuts -Cashew nuts - Walnuts -Brazil nuts - Pistachio nuts 8 For references: please see Federal Register Notice or contact the presenters

Outline: Today’s webinar covers these topics 1.Background & Rationale  Reasons for conducting the risk assessment 2.Risk assessment approach & methodology 1.Risk assessment approach 2.Key risk assessment model parameters 3. The Federal Register notice 1.FR notice content & identified data gaps 2.Process for submitting data and comments 4. Questions & Answers 5. Closing remarks 9

Risk assessment: Tree nuts that may be considered The risk assessment may consider all / some of the following nuts: -The tree nut varieties consumed in the U.S. -Domestically produced & imported tree nuts -Tree nuts treated / not treated to reduce microbial contamination As detailed in the FR notice, we would appreciate comments on: -The types of tree nuts to evaluate in the risk assessment -The types of tree nuts that enter the U.S. market ‘untreated’ 10

Risk assessment: The risk Assessment Framework Conduct & Manage Process Step 1: Commission Step 2: Data collection & evaluation Step 3: Develop model/report Step 4: Review & clearance Step 5: Issue 11

Risk assessment: Choosing a quantitative approach We anticipate the following model outputs: -Expected number of cases / serving or cases / year -Quantified impact of interventions through “what-if scenarios” Model likely based on peer-reviewed risk assessment models: –e.g. Lambertini et al., 2012 (developed for U.S. almonds) –Plan to evaluate product pathway: harvest to consumption Expected extensions beyond currently published models: –Adaptation to consider other tree nuts in addition to almonds –Quantification of uncertainty –Sensitivity analysis 12

Risk assessment: Proposed model outline 13 Salmonella prevalence at harvestSalmonella concentration at harvest Pre-process storage Post-harvest treatment Post-process storage Retail storage Consumer home storage Risk of illness per annum & risk per billion servings Dose-Response model Serving size Number of servings

Risk assessment: Data needs for modeling 1.Salmonella prevalence & concentration on tree nuts 2.Salmonella survival & inactivation on tree nuts during storage 3.Salmonella inactivation through post-harvest treatments 4.Salmonella dose-response relationships (we currently plan to use published Salmonella dose-response models) 5.Tree nut consumption in the U.S. 14

Outline: Today’s webinar covers these topics 1.Background & Rationale  Reasons for conducting the risk assessment 2.Risk assessment approach & methodology 1.Risk assessment approach 2.Key risk assessment model parameters 3. The Federal Register notice 1.FR notice content & identified data gaps 2.Process for submitting data and comments 4. Questions & Answers 5. Closing remarks 15

Model parameters I: Salmonella Contamination 16

Data Gaps I: Salmonella Contamination Model inputs: Prevalence & concentration of Salmonella at harvest  Data at any stage of the farm-to-fork continuum useful  Possible to infer contamination at harvest (if meta-data available) In the FR notice, we are requesting the following types of data: 1.Prevalence of Salmonella in different tree nuts, with data specifying: -Prior handling (e.g., storage, processing treatment) -Test method; sampling protocol -Size of the analytical unit; number of samples tested & number positives 2.Concentration of Salmonella in tree nuts: -Same information as for prevalence -Raw data in unaggregated form (e.g., MPN patterns)  Data based on tree nut lots that were / were not associated with outbreaks 17

Model parameters II: Salmonella Survival & Inactivation 18 Salmonella prevalence at harvestSalmonella concentration at harvest Pre-process storage Post-harvest treatment Post-process storage Retail storage Consumer home storage Risk of illness per annum & risk per billion servings Dose-Response model Serving size Number of servings

Data Gaps IIa: Salmonella Survival & Inactivation Model inputs: Salmonella inactivation during storage  Survival & inactivation kinetics impact several model parameters  Survival & inactivation kinetics depend on storage conditions In the FR notice, we are requesting data / models to address the following: 1.Differences in Salmonella growth / survival / inactivation among tree nuts: -Effect of nut composition, water activity, etc. -Impact of typical processing, handling and storage conditions -Other factors as applicable 2.Differences in Salmonella growth / survival / inactivation farm-to-fork: -Effect of relative humidity, temperature, etc. -Differences due to geographic regions, season, etc. 3.Difference in Salmonella growth / survival / inactivation in complex foods: -Behavior of Salmonella in foods that contain tree nuts as ingredients 19

Data Gaps IIb: Nut Storage, Handling & Processing Model input: Salmonella inactivation during storage  Storage conditions are important to model inactivation kinetics In the FR notice, we are requesting the following related data: 1.Typical tree nut storage conditions (from harvest to consumption): -Storage times / temperatures / relative humidity -Differences in storage conditions among tree nuts -Expected impacts on Salmonella concentrations 2.Typical consumer handling practices -Types of handling practices & typical handling conditions -Expected impacts on Salmonella concentrations 20

Model parameters III: Post-harvest treatment efficacy 21 Salmonella prevalence at harvestSalmonella concentration at harvest Pre-process storage Post-harvest treatment Post-process storage Retail storage Consumer home storage Risk of illness per annum & risk per billion servings Dose-Response model Serving size Number of servings

Data Gaps III: Post-harvest Treatments Model input: Salmonella inactivation during post-harvest treatments  Treatments may differ in efficacy across tree nuts In the FR notice, we are requesting data / models to address the following: 1. Typical treatments to reduce bacterial contamination: -Types of treatments & frequency of applying these treatments -Differences in treatment among tree nuts -Exact treatment conditions -Efficacy of treatments in reducing contamination with Salmonella 22

Model parameters IV: Tree nut consumption 23 Salmonella prevalence at harvestSalmonella concentration at harvest Pre-process storage Post-harvest treatment Post-process storage Retail storage Consumer home storage Risk of illness per annum & risk per billion servings Dose-Response model Serving size Number of servings

Data Gap VI: Consumption Data Model inputs: Serving sizes & consumption frequency  Consumption data by population subgroup & tree nut type (e.g., variety) In the FR notice, we request the following related data: 1.Consumption practices (i.e., frequency & serving size) in the U.S.: -Consumption by population subgroups (e.g., adults, the elderly etc.) -Consumption of tree nuts in different processing forms: - Raw (i.e., no treatment to reduce bacterial contamination) - After undergoing treatments to reduce bacterial contamination - After the consumer applied treatments that may reduce contamination -Other consumption-related data 24

Federal Register Notice: Logistics (see also FR notice) Federal Register notice can be accessed at: Submission of data and comments to the docket: 1.Submissions must be received by 10/16/ Comments must be submitted to the docket to receive full consideration 3.Submit electronic comments & scientific data and information to 4.Submit written comments and scientific data and information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

Federal Register Notice: Content of the FR notice 1.Background 2.Request for Comments, Scientific Data and Information: 1.Salmonella prevalence & concentration on tree nuts 2.Salmonella survival, growth or inactivation dynamics 3.Relevant food consumption practices in the U.S. 4.Storage, handling and processing conditions 5.Other comments (e.g., types of tree nuts to include)  More details are provided for each topic (as discussed today) 3.Instructions for submission of comments & data 4.References 26

Webinar outline: Today’s webinar will contain 3 parts Today’s webinar content: 1.Welcoming remarks 2.Risk assessment plans, Federal Register notice, and data gaps 3.Questions and Answers 27

Questions & Answers: We invite clarifying questions about: 1.Rationale for conducting the risk assessment 2.Risk assessment scope & approach 3.Data gaps & request for data and information 4.Logistics of data submission 28