1. APRIL 2, 2014 Vibrio parahaemolyticus is Coming to a Restaurant Near You ! MHOA-DPH SPRING SEMINAR OFFICE OF LOCAL AND REGIONAL HEALTH MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH 1

2. Introduction/Vibrio parahaemolyticus (Vibrio) 2 Vibrio is an emerging, naturally occurring bacterial pathogen often found in oysters harvested from warmer waters. It has caused illnesses in the Gulf Coast and West Coast of the United States for a number of years. It is not related to pollution of Massachusetts shellfish. When ingested, Vibrio causes watery diarrhea, often with abdominal cramping, nausea, vomiting, fever and chills. Usually these symptoms occur within 24 hours of ingestion and last three days. Severe disease is rare and occurs more commonly in people with weakened immune systems. About ten percent of cases will develop a blood infection that may require hospitalization. Vibrio can also cause an infection of the skin when an open wound is exposed to warm seawater.

3. Vibrio Emerging in Massachusetts Massachusetts has had an increasing number of individuals diagnosed with Vibrio parahaemolyticus in recent years  MA cases investigated by DPH and DMF each year  2011 – 13 cases  2012 – 27 cases  2013 – 58 cases In response to 2011 illnesses, US Food and Drug Administration (FDA) directed MA to implement a Vibrio Control Plan for Eastern Cape Cod Bay (ECCB) for 2012 In 2012 harvest areas outside of ECCB were linked to illnesses, therefore FDA directed MA to expand Vibrio Control Plan statewide for 2013 3

4. Vibrio Emerging in Massachusetts (cont.) Of the 58 cases reported to DPH in 2013, 33 cases were traced back to one or more MA-only growing areas  19 Vibrio cases with some relationship to Duxbury  12 Vibrio cases with some relationship to Katama Bay Consistent with guidance in the NSSP Model Ordinance closures were ordered in late August (Duxbury) and September (Katama Bay) As a result of increased confirmed cases in 2013, FDA required additional enhancements for Vibrio Control Plans for 2014 in Massachusetts and other states 4

5. Vibrio Emerging in Massachusetts (cont.) New “Pandemic” Strain  First cases in Pacific Northwest (WA) then the Gulf Coast  May have been introduced through ship ballast or transplanted oysters  Favors more moderate temps  Often associated with water temps < 80°F  Potentially low infective dose  Higher attack rate  Does not test positive for known pathogenic genes  Possible correlation to climate change  Warming harvest waters in MA 5

6. Vp Growth Rates and Doubling Times Oyster Temp (° F) Growth Rate (logs/hr) Doubling Time (hours) 500.00835.8 700.1003.01 900.2921.03 1000.4260.71 6

7. Opportunities for Time/Temperature Abuse 7 Transport by Harvester to Dealer Handling at Harvest Handling by Dealer Handling by Retail Establishment Transport by Dealer to Retailer Receiving Cooling to 50°F per Plan Storage Receiving Storage Service

8. MA Vibrio Control Plan 2014 Effective dates are May 19 – October 19, 2014 Harvesters must ice oysters within two (2) hours of harvest/exposure by tide or before leaving the landing site, whichever occurs first Original dealers must cool oysters ≤ 50° F at their facilities and prior to release for shipping Harvesters required to maintain Vibrio Logbooks documenting all harvest activities Dealers have additional HACCP and recordkeeping requirements 8

9. Intertidal Subtidal Oyster Harvest Techniques 9

10. Intertidal Harvest Potential for exposure to air and sunlight for up to 4 hours a day 10

11. “Oysterplex” Pre-collection Oyster Culture Activities 11

12. Wet Storage Tumbling More Oyster Culture Activities 12

13. Transportation of Oysters The MA Vibrio Control Plan requires specific criteria in order for oysters to be considered adequately iced The Plan also provides specific requirements for adequate shellfish containers All oysters must be adequately iced within 2 hours of harvest and/or exposure by tide and prior to transport from the landing site 13

14. Adequate Ice Dealer Facility Oyster Handling at Wholesale 14

15. Temperature Control Time/Temperature Abuse Oyster Handling at Retail 15

16. Oyster Handling at Retail Maintain temperature control  Required temperatures  Receive at ≤ 45°F  Cool ≤ 41°F within four (4) hours prior to service  Store and display at ≤ 41°F  Immediate placement oysters into refrigerated storage upon receipt  Encourage the use of ice where practicable  e.g. oysters removed from refrigerated storage for preparation for service Remember: Time/temperature abuse is cumulative Cells are inactivated at ≈ 50°F but are not killed They may double again with further time/temp abuse (≥ 50°F) 16

17. Oyster Handling at Retail (cont.) Maintain traceability  Approved source  ISSL Certified Dealer  Licensed in-state dealer  Shellfish tags must retained for 90 days  Ensure that shellstock from one container is not commingled with shellstock from another container  Encourage recording the date when the last oyster from the container is sold on the tag  Invoices – Under the NSSP shippers are required to include shipping records with each shipment that contain:  Name, address, and certification number of the shipping dealer  Name and address of the major consignee  Kind and quantity of the shellfish product 17

18. Oyster Handling at Retail (cont.) Prevent cross-contamination  Separation of shellfish from other raw foods during storage, preparation, holding and display  Especially those that contain chitin, e.g. shrimp, lobsters, etc.  Proper cleaning and sanitizing procedures where oysters are handled  Especially areas where they are shucked  Proper hand washing by food handlers  Prevent bare hand contact by food handlers  Change into a new pair of gloves when handling other foods Remember:  Oysters contaminated with Vp can cross-contaminate other foods 18

19. Illness Investigation Procedures 2014 1) Illnesses are reported to DPH Food Protection Program (FPP) and/or DPH Bureau of Infectious Disease. 2) Infectious Disease epidemiologists contact local health nurses to conduct personal interviews with those that become ill. 3) Following these interviews, FPP, assisted by local boards of health (LBOH), reviews shellfish tags and other shipping records to determine which oysters may be implicated in each illness. 4) FPP and LBOH evaluate retail shellfish handling practices, including time/temperature control of implicated oysters. 19

20. Illness Investigation Procedures 2014 (cont.) 5) FPP then evaluates shellfish handling practices and compliance with MA Vibrio Control Plan by all dealers providing oysters to retail establishments. 6) When specific harvesters are identified, FPP and Department of Fish and Game (DMF) evaluate harvester shellfish handling practices and compliance with MA Vibrio Control Plan. 7) May result in DPH recall of implicated shellfish among wholesale dealers and closure of beds by DMF. 20

21. Environmental Assessment - Traceability Discussion with Person In Charge (PIC)  Which dealer(s) supplied the establishment with its oysters?  Are there multiple dealers?  Is more than one variety of oyster sold?  Which oysters were served on the consumption date?  Determine the delivery dates Shellfish Tags - Wholesale dealer  Collect the tags that identify oysters likely served on the consumption date  Proximate to consumption date  Are they properly completed?  Harvest date and area, quantity, etc. Invoices  Collect invoices that identify oysters served on the consumption date  Do they match shipping information on the tag? 21

22. Environmental Assessment - Traceability (cont.) Check the Menu  “Happy Hours” - often use a less expensive, out-of-state oyster  “Medleys” – an oyster sampler  Mix of local and out-of-state varieties Oyster Substitution  Very common occurrence, e.g. “Blue Points”  Usually similar oysters when menu item is unavailable  Sometimes less desirable oysters for more expensive varieties Register Tapes  Often indicate a general harvest area or “brand” of oyster Dealer Records  FPP compares tags and invoices to dealer’s required sales records 22

23. Harvester Tag Note: The direct sale of shellfish by a harvester to a retail establishment is prohibited under Food Protection Program regulations 105 CMR 533 and FDA’s Food Code. 23

24. Wholesale Dealer Tag Dealer Name Dealer’s Address Dealer’s Certification Number (permit #) Original Shipper Certification Number Harvest Date Harvest Area Type of Shellfish Quantity of Shellfish 24

25. Reshipper Tag Reshipper (RS) - means a person who purchases shellfish from dealers and sells the product without repacking or relabeling to other dealers, wholesalers, or retailers. Note: Same info required as dealer tag with additional fields provided at bottom to indicate reshippers and dates shipped 25

26. Actual Wholesale Dealer Tags 26

27. Unidentified Oysters Lot Identity Maintained Traceability During an Investigation 27

28. Environmental Assessment - Time/Temp Evaluation Observe and record the time-temperature control in the establishment  All areas where oysters are held  walk-in cooler, kitchen raw, etc.  Is there potential exposure to possible heat sources?  Compressors, ovens, etc. How were oysters handled?  Were they received ≤ 45°F?  Were they immediately placed in refrigerated storage?  Were they cooled to ≤ 41°F prior to service?  Was there adequate ice and/or refrigeration at the raw bar?  Were oysters held without temperature control?  If so, how long? 28

29. Environmental Assessment - Time/Temp Evaluation (cont.) Review temperature records for storage area used for implicated product  Review records for dates that product was held at the establishment  Temperature at receiving - receiving log  Temperature of walk in cooler  Thermometer calibration records  Is thermometer calibrated/working properly? Observe and record temperature and age of remaining product  Is remaining product held at ≤ 45°F?  Crosscheck age of product with records  Do tags match invoices?  Are quantities correct?  Harvest date and area  Are they “branded” oysters? 29

30. Environmental Assessment - Time/Temp Evaluation (cont.) Observe controls to prevent cross-contamination of product  Is there potential contact with foods such as shrimp or lobster?  Vibrios are attracted to organisms that produce chitin  Half-shell oysters are especially vulnerable to cross-contamination  Oysters contaminated with Vp can cross-contaminate other foods  Are handlers practicing proper hand washing procedures?  Are handlers wearing gloves?  Are oysters washed prior to service?  Are oysters from different lots commingled? Is any implicated product remaining?  Place under embargo  Possible sample collection 30

31. Shellfish Recalls NSSP Procedures provide additional requirements for State Shellfish Control Authority and industry in addition to FDA’s 21 CFR Part 7.  Prompt reporting enables state to determine the need for:  Harvest area closures  Advisories  Recalls  Initiated by producing state  Notification of FDA and the ISSC  Wholesale dealer responsibilities  Notify receivers  Instruct receivers to notify their customers  Product to remain on premises until FPP determines final disposition 31

32. Environmental Assessment Form Please document the findings of your investigation of implicated oysters on the Environmental Assessment form available at: http://www.mass.gov/eohhs/docs/dph/environmental/foods afety/foodborne-illness/risk-assessment-form.pdf Please submit completed Environment Assessment form with all documentation collected during the investigation to the Food Protection Program. 32

33. A Vibrio Haiku Conduct the trace back Get shellfish tags, invoices … call Food Protection! - E. Hickey 33

34. Questions? 34

35. Eric M. Hickey Dockside Testing / Vibrio Mgt. Coordinator Office of Local & Regional Health Department of Public Health Bureau of Environmental Health 250 Washington St., 7th Floor Boston, MA 02108 Phone: 617-624-5745 Email: eric.hickey@state.ma.useric.hickey@state.ma.us 35