1. David Nicholas, MPH New York State Department of Health Bureau of Community Environmental Health and Food Protection David.nicholas@health.ny.gov National Voluntary Environmental Assessment Information System (NVEAIS) National Center for Environmental Health Environmental Health Services Branch Original Presenters: Carol Selman, MPH Team Lead, Food Safety Team, Environmental Health Services Branch, Division of Emergency and Environmental Health Services, NCEH Kristin Delea, MPH, REHS Health Scientist/Epidemiologist

2. Overview  Background  EHS-Net  NVEAIS  Environmental Assessments: A systems approach to foodborne illness outbreak investigations  Systems Theory  Contributing Factors  Environmental Antecedents  NVEAIS – Data Collection  Information the data can provide  How can we use the data  Training/ E-learning

3. BACKGROUND

4. Environmental Health Specialist Network  EHS-Net (pronounced S-Net) is a collaborative forum of environmental health specialists whose mission is to improve environmental health practice.  These specialists collaborate with epidemiologists and laboratorians to identify and prevent environmental factors contributing to foodborne and waterborne illness outbreaks.

5. EHS-Net Background  Environmental Health Specialists Network  Collaboration between: US Centers for Disease Control and Prevention o National Center for Environmental Health o Environmental Health Services Branch US Food and Drug Administration o Center for Food Safety and Applied Nutrition US Department of Agriculture 8 sites o California, Cerro Gordo Iowa, Minnesota, New York, New York City, Rhode Island, San Mateo California and Tennessee

6. EHS-Net Background  EHS-Net work is based on a system theory.  EHS-Net assists state health departments in their efforts to improve the practice of environmental health service programs.  EHS-Net conducts environmental assessments to determine why an agent was present in the environment in such a way that the host could be exposed.  EHS-Net works to  Identify environmental antecedents (underlying factors) to illness and disease outbreaks.  Translate findings into improved prevention efforts using a systems- based approach.  Offer training opportunities to current and future environmental health specialists.  Strengthen collaboration among epidemiology, laboratory, and environmental health programs.

7. NVEAIS Background  EHS-Net Foodborne Outbreak Study  Objective: To identify contributing factors to foodborne illness outbreaks in food-service facilities and to describe the characteristics, policies and practices of those facilities.  What we learned  No consensus on what a foodborne illness environmental assessment was  No standard methodology for conducting foodborne outbreak environmental assessments  Need for training on how to conduct a foodborne outbreak environmental assessment using a systems approach

8. The Need to Improve Reporting of Environmental Factors to Foodborne Illness Outbreaks  Environmental factor data are key to  To improve hazard surveillance.  To inform foodborne disease prevention policies  Understanding how and why outbreaks occur.  Preventing future outbreaks.  Limited environmental factor data are currently reported to CDC’s existing National Outbreak Reporting System (NORS).  Inspectors (environmental health specialists) need training on collecting environmental factor data during outbreak investigations. 8

9. The Need to Improve Reporting of Environmental Factors to Foodborne Illness Outbreaks 9 Contributing factors Factors that caused the outbreak How the outbreak occurred Environmental antecedents Circumstances that led to the contributing factors Why the outbreak occurred Environmental factors

10. The Need to Improve Reporting of Environmental Factors to Foodborne Illness Outbreaks Environmental antecedents Worker in a hurry Worker had not been trained on avoiding cross contamination Contributing factor Cross contamination Worker used same utensils on raw ground beef and salads Outbreaks E. Coli Outbreak caused by salads eaten at Restaurant A

11. NCEH/EEHS Activities to Improve Reporting of Environmental Factors to Foodborne Illness Outbreaks  Developed  National Voluntary Environmental Assessment Information System (NVEAIS)  e-Learning on Environmental Assessment of Foodborne Illness Outbreaks  Launched in April 2014  Purpose  NVEAIS: Discover environmental factors that cause foodborne outbreaks to prevent next one  e-Learning: Improve competency in collecting environmental factor data during foodborne outbreak investigations http://www.cdc.gov/nceh/ehs/NVEAIS/index.htmhttp://www.cdc.gov/nceh/ehs/NVEAIS/index.htm; http://www.cdc.gov/nceh/ehs/elearn/ea_fio/http://www.cdc.gov/nceh/ehs/elearn/ea_fio/

12. NVEAIS Purpose  Identify factors that can be routinely monitored by food control authorities to prevent or reduce the risk of foodborne outbreaks  Characterize food vehicles and monitor trends  Identify and monitor contributing factors and environmental antecedents  Hypothesis generation  Guide planning, implementation and evaluation of food safety programs

13. NATIONAL VOLUNTARY ENVIRONMENTAL ASSESSMENT INFORMAITON SYSTEM Improving Surviellance

14. Definition  Environmental Assessment  The component of an outbreak investigation that fully describes how the environment contributed to the introduction and or transmission of agents that cause illness. Environment is everything external to the host, including air, food, water, animals, plants, climate, etc as well as people, social and built environments. All aspects of the external environment can be listed as variables that, in relation to transmission, are neutral, conducive or protective. From this description contributing factors and environmental antecedents to an outbreak can be determined.  NOT an inspection

15. Foodborne Outbreak Environmental Assessment  Conducted as part of the foodborne illness outbreak team  A reconstruction of past events in the context of the outbreak investigation  Taking a systems approach  Inputs - Are the items which feed into the system  Process - Are the steps and methods to which the inputs are subjected  Internal System Variables - Are the factors that exert positive, negative and neutral influences on all other aspects of the system  Outputs - The immediate results of the system  Outcomes - What happens as a result of the outputs  External Feedback to System

16. Contributing Factor Definition  The factors likely to be conducive to the contamination and survival of the etiologic agent or suspected agent and/or to its growth or proliferation.  Contamination Factors Toxic substance part of the tissue, Contaminated raw product, Cross- contamination of ingredients, Bare-hand contact by a food handler/worker/preparer who is suspected to be infectious  Proliferation Factors Improper cold holding due to malfunctioning refrigeration equipment, Improper hot holding due to improper procedure or protocol, Prolonged cold storage  Survival Factors Insufficient time and/or temperature during cooking/heat processing, Insufficient time and/or temperature during reheating  Contributing factors are NOT food code violations

17. Definition Environmental Antecedents Definition  Root causes  Supporting factor(s) to the contamination, survival or increase of biological or chemical agents in food  They may be related to  People  Equipment  Process  Food  Economics  Behavior  Other circumstances

18. Environmental Antecedents

19. Equipment Economics Processes Food Environmental Antecedents Related to Food System Variables People Location of hand wash sinks Availability of supplies for hand wash sinks Training Supervision Water available for hand wash sinks Availability of a supply of gloves

20. People Economics Processes Food Equipment Design Construction Cleanability Maintenance Placement Installation Environmental Antecedents Related to Food System Variables

21. People Equipment Economics Food Processes Handling after kill step No kill step where kill step is required Multiple- step processes Environmental Antecedents Related to Food System Variables

22. People Equipment Economics Processes Food Source pH Water activity (A w ) Viscosity Environmental Antecedents Related to Food System Variables

23. Food People Equipment Processes Economics Shifting food trends Profit margins Operational costs such as Cost of food Cost of equipment Cost of facilities Cost of staffing and training Environmental Antecedents Related to Food System Variables

24. Example: Understanding environmental causes of foodborne illness  An E. coli outbreak associated with salads eaten at a restaurant is caused when a restaurant worker uses the same equipment to first handle raw ground beef and then ready-to-eat salads without cleaning the equipment in between.  Contributing factor: Cross contamination from ground beef to ready-to-eat food through contaminated equipment  Environmental antecedents: Food worker was in an hurry and had not been trained on the importance of preventing cross contamination

25. The Food Establishment System Final Food Item Ingredients Organisms Chemicals Customer Health Customer Satisfaction Profit External Feedback to System Receive Store Prep Cook Cool Reheat Assemble Hold Serve Processes Internal System Variables People Food Economics Equipment

26. Example  Thorough understanding of the problem  On the ground assessment by Environmental Health Specialist or Environmental Engineer  Identification of underlying causes of problems (not just symptoms)  Contributing Factors  Environmental Antecedents

27. DATA COLLECTION

28. Data Collection  Data collection for FBIO environmental assessments  Standardized data collection instrument to report information FBIO environmental assessments  Validated questions  Identifying contributing factors  Understanding how selected environmental antecedents are related to contributing factors, vehicles, and agents  Is not a form or template for conducting a FBIO environmental assessment

29. Data Collection Tool  Part I General Characterization of Outbreak  Part IIEstablishment Description  Part IIIManager Interview  Part IV Establishment – Observation  Part V Food Vehicle  Part VI Sampling  Part VII Contributing Factors (CF)  Part VIII National Outbreak Reporting System (NORS)

30. Part I – General Characterization of Outbreak  Part Purpose  To provide the epidemiological context for the outbreak. This section also allows linkage within the Environmental Health Specialists Network Information System (EHSNIS) of all environmental assessments conducted within a state that is associated with a single outbreak event.

31. Part II - Establishment Description  Part Purpose  This section is designed to gather basic information about the sanitation infrastructure of the establishment and to identify those establishments where a translator was needed and / or used to communicate with the manager. Information gathered will be based on the menu review and initial discussion with the manager, characterize the establishment’s menu and theme.

32. Part II - Establishment Description  Information about the establishment  Facility type  Type of establishment Type of food preparation  Information about the menu  Type of food served Ingredients  Raw food consumption advisory

33. Part III. Manager Interview  Part Purpose  To characterize the policies and practices in this establishment based on a manager interview.  Sections  Establishment – General  Kitchen Manager  Food Workers  Policies

34. Part III. Manager Interview  Establishment – General  Chain or Independent  Number of meals served  Changes in the menu  Where is the food in the establishment purchased  Kitchen Manager  Number of managers  Meals served daily  Food safety training and certification  Language  Paid sick leave policies

35.  Food Worker  Number of workers  Food safety training and certification  Language  Policy  Cleaning  Glove use  Health policies Part III. Manager Interview

36. Part IV. Establishment – Observation  Part Purpose  This section collects information concerning the establishment based on observation of the facility and the practices employed during the environmental assessment.  To describe the existing circumstances /practices before employees become influenced by the fact that an outbreak investigation is underway. Physical facilities and food handling practices are expected to be very similar if not the same as those during the time of the exposures occurred.  Observations  Food preparation  Storage  Food worker behavior

37. Part V – Food Vehicle  Part Purpose  A systematic review of the food preparation process of the suspected / confirmed vehicle is necessary to identify contributing factors to the outbreak and to describe the specific foods or food items involved. This section captures specific information on the foods suspected and/or confirmed in the outbreak.  Ingredient information  Is this food a single specific ingredient (ground beef or lettuce) or multi- ingredient (hamburger sandwich, garden salad)?  Is the food suspected or confirmed  Most complex food preparation  Ingredient description

38. Part V – Food Vehicle  Aid with food attribution  The description of the food provides more detail Animal/plant product Beef/Poultry/Pork/Lamb /Miscellaneous meat (goat, rabbit)/ Seafood/Dairy/Eggs Chicken/Turkey/Duck/Goose/Other (Please describe) (ex: Ostrich, Emu, etc) Best description of the plant product upon arrival in the establishment o Raw, non-frozen o Raw, frozen o Raw, intended for raw service (for ex; oysters, steak tartar) o Commercially processed (precooked; may require heating for palatability, examples include deli meat, hot dogs, ready to heat and eat chicken nuggets, canned ham, etc.) o Commercially processed (further cooking required, examples include chicken nuggets that require a cook, pre-formed hamburger patties, etc.) o Dried / Smoked o Other (Please describe)

39. Part VI - Sampling  Part Purpose  Provides information on any environmental sampling. Food Environmental Does NOT include human samples

40. Part VII - Contributing Factors (CF)  The factors likely to be conducive to the contamination and survival of the etiologic agent or suspected agent and/or to its growth or proliferation.  Contamination Factors (C1-15)  Proliferation Factors (P1-12)  Survival Factors (S1-4)  Contributing factors are NOT code violations

41.  Was this the primary CF for this outbreak?  How was this CF determined? (choose all that apply) Routine environmental inspection Environmental Assessments Other environmental investigation Assumed based on etiology Interview of operator and/or food worker Environment/food sample culture Clinical samples / Syndrome Epidemiologic investigation (case-control or cohort study)  In the determination of this CF, was there discussion between the food regulatory program and the communicable disease control program? Part VII - Contributing Factors (CF)

42. Part VIII - National Outbreak Reporting System (NORS)  This section reflects information as reported to the National Outbreak Reporting System (NORS).  Used to help tie data in NVEAIS to NORS  CDC currently looking for ways to link both reporting mechanisms.

43. INFORMATION THE DATA CAN PROVIDE

44. Food Processing  Characterization of the establishment (Part II)  81.6 % Complex  15.6 % Cook / Serve  2.9 % Prep / Serve  Characterization of suspect food preparation (Part V)  25.3 % Complex  27.2 % Cook / Serve  47.5 % Prep / Serve  31.2% served raw or undercooked animal products (Part I)  Of these, 61% did not have a customer advisory

45. Part – III Establishment Characteristics  Facilities  91% restaurants Independent68%  Median meals/day 240  Busiest on weekends  In 50% food handler to kitchen manager ratio ≤ 4:1

46. Part III- Busiest Day

47. Part III - Training Kitchen manager TrainingCertification n (%) Yes206 (84.4)Yes177 (72.5) No 36 (14.8)No 64 (26.2) Missing 2 (0.8)Missing 3 ( 1.2) Food Handlers Training n (%) Yes188 (77.1) No 48 (19.7) Missing 8 (2.2)

48. Part III - Food Safety Food Handlers≥ 1 Certified managers 1-440 (57.1) 5-843 (69.4) 9-1642 (76.4) >1650 (92.6)

49. Part III - Paid Sick Leave Kitchen Managers n(%) Yes 164 (67) No 76 (31) Missing 4 ( 2) Food Worker Yes 81 (33) No 154 (63) Missing 8 ( 4)

50. Disposable Gloves YesNoMissing Glove Policy*193 (79.1) 48 (19.7) 3 (1.2) Glove Supply**198 (81.1) 41 (16.8) 5 (0.4) Glove Use**159 (65.2) 72 (29.5)13 (5.3) *Part III **Part IV

51. Part V- Suspected Food Vehicles in Foodborne Disease Outbreaks

52. HOW CAN WE USE ENVIRONMENTAL ASSESSMENT DATA

53. Goal 1: Describe outbreaks and outbreak responses  Descriptive analyses  This would tell us the whats, basically describing the outbreaks: what people are doing, how many, and how often  Frequencies, means, proportions etc. to describe: Outbreaks Outbreak responses

54. Goal 2: Describe environmental factors associated with outbreaks  Descriptive analyses  Frequencies, means, proportions etc. to describe: Environmental antecedents o Also examined by classification Economics, equipment, food, people, processes Contributing factors o Also examined by category contamination, proliferation, and survival

55. Goal 3: Describe the associations between environmental antecedents and contributing factors  Tests for association and logistic regression models.  This type of analysis allows us to determine which environmental antecedents contribute to the presence of the contributing factor, and the relative degree of impact that each environmental antecedent has in the presence of that contributing factor  Bivariate Analysis  Multivariate Analyses

56. TRAINING

57. The Need for Training  In 2001 Selman and Green surveyed local and state Environmental Health Specialists (EHS) and found  EHS focus on pathogens during outbreaks instead of contributing factors and their environmental antecedents  A lack of communication between epidemiologist and EHS was found to be a barrier to EHS active engagement in foodborne illness outbreak environmental assessments  Local EHS staff require training because they are not involved in outbreaks often enough to attain competency in environmental assessments  EHS were in need of a basic training in how to conduct foodborne illness outbreak environmental assessments Selman, CA and Green, LR (2001). Environmental health specialists’ self-reported foodborne illness outbreak investigation practices. Journal of Environmental Health, 20(6),16-21.

58. Using Environmental Assessments to Investigate Illness Outbreaks  Environmental Health Specialists are accustomed to look for violation of regulations  not contributing factors and their environmental antecedents  Performing an environmental assessment (EA) requires a different mindset than other environmental food safety activities  No two outbreaks are alike  No single ‘checklist’ applies to all environmental assessments  Conducting an EA requires a complex set of knowledge and skills including the ability to apply ‘critical thinking’  Training must promote development of competency in the field and not just the acquisition of knowledge

59. Goal of this Training Effort  Use cutting-edge e-learning technologies to develop competency with Foodborne Illness Outbreak Environmental Assessments and deliver training free of charge over the Internet to enhance global food safety

60. Incorporation of ‘Gaming’  Each virtual learning experience scenarios is framed as a forensic investigation mystery of an outbreak  Participants decide  Who to interview  What topics to interview about  Which actions to take  What observations to perform and samples to collect  At end, learners must identify contributing factors and environmental antecedents  Actions and conclusions are tracked and evaluated  Learners receive individual feedback on results

61. Accompany the Worker

62. The Cognitive Domain  Involves knowledge and the development of intellectual skills  Includes 6 categories of behavior  Knowledge (recall data or information)  Comprehension (understanding the meaning)  Application (use a concept in a new situation)  Analysis (separate materials into component parts)  Synthesis (build a pattern from diverse elements)  Evaluation (make judgments)

63. Analysis of Learner Performance  Learner receives individualized feedback on:  Interview effectiveness Did the learner choose the correct questions?  Interview efficiency Did the learner choose the questions in the correct order?  Observational skills Did the learner find all the important embedded clues in the environment?  Critical thinking Did the learner correctly identify contributing factors and environmental antecedents

64. VIRTUAL WORLD TRAINING E-Learning on Environmental Assessments of Foodborne Illness Outbreaks

65. Promotional Video  https://www.youtube.com/watch?v=77w9aVeROiA&ind ex=1&list=PLvrp9iOILTQaRWTguYiBvPlVB7R-88Wbq https://www.youtube.com/watch?v=77w9aVeROiA&ind ex=1&list=PLvrp9iOILTQaRWTguYiBvPlVB7R-88Wbq

66. Purpose of Module 1  To provide participants with the skills and knowledge to participate effectively in an environmental assessment of a foodborne illness outbreak at a retail point of service

67. M1, L2: Overview of Foodborne Illness Outbreak Environmental Assessments M1, L3: Interviewing M1, L4: Observation M1, L5: Sampling M1, L6: Organizing Assessment information M1,L1: Your Assignment M1, L7: Critical Thinking M1, L8: Concluding actions

68. TRAINING DEMO

69. PHASE II – INCORPORATING NEW MODULES

70. Expanded Purpose of Training based on new FDA and CDC funding  To demonstrate how an environmental assessment is performed in a Manufactured Food setting  To demonstrate the process followed to perform a Traceback investigation  To develop basic awareness of Food Defense concepts and principles.  Expand the target audience  Environmental Health Specialists operating at the local level  Now also including State and Local Environmental Health Specialists, Department of Agriculture Inspectors, FDA Investigators and FDA Consumer Safety Officers

71. Next Modules  Module 2 will be developed to enable participants to practice using EA skills within the context of a simulated outbreak and/or observe how an environmental assessment and/or traceback is conducted. At this point, we expect that the module will include three types of scenarios:  Outbreak linked to a retail point of service  Outbreak linked to a manufactured food setting  Traceback of the manufactured food outbreak

72. Next Modules  Module 3 will be developed to provide basic awareness training on food defense concepts and principles  The content for this module will be based on the new FDA Food Defense E-learning program titled “FDA Food Defense 101”, and specifically the lesson titled “Food Defense Awareness for the Food Professional”  After completing this Module, individuals who wish to learn more about Food Defense Concepts and Principles will be directed to the full program available on the FDA web site at http://www.fda.gov/Food/FoodDefense/ToolsEducational Materials/ucm353774.htm http://www.fda.gov/Food/FoodDefense/ToolsEducational Materials/ucm353774.htm

73. PARTICIPATING IN THE TRAINING

74. Information  www.cdc.gov/nceh/ehs  Provides information about e-Learning on Environmental Assessments of Foodborne Illness Outbreaks and NVEAIS  Registration information  Complete the registration  Take the pre-test

75. Important Websites More information on CDC EHS-Net: –http://www.cdc.gov/nceh/ehs/EHSNet/http://www.cdc.gov/nceh/ehs/EHSNet/ Information on National Voluntary Environmental Assessment Information System (NVEAIS): –http://www.cdc.gov/nceh/ehs/NVEAIS/index.htmhttp://www.cdc.gov/nceh/ehs/NVEAIS/index.htm Additional information on e-Learning: –http://www.cdc.gov/nceh/ehs/eLearn/EA_FIO/index.htmhttp://www.cdc.gov/nceh/ehs/eLearn/EA_FIO/index.htm Register for the e-Learning course at: –https://ehseleafio.cdc.gov/https://ehseleafio.cdc.gov/ National Outbreak Reporting System (NORS) Guidance: –http://www.cdc.gov/nors/pdf/NORS_Guidance_20130219_508c.pdfhttp://www.cdc.gov/nors/pdf/NORS_Guidance_20130219_508c.pdf National Outbreak Reporting System (NORS) Form: –http://www.cdc.gov/nors/pdf/NORS_CDC_5213.pdfhttp://www.cdc.gov/nors/pdf/NORS_CDC_5213.pdf

76. Acknowledgements Centers for Disease Control and Prevention – Carol Selman – Kristin Delea – Erik Coleman – Laura Brown EHS-Net Site Partners Local Health Departments

77. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention (CDC). Thank You! Questions Questions David C. Nicholas, MPH NYSDOH BCEHFP Ph:518-402-7600 Email: Email: David.nicholas@health.ny.gov