2. Evolution of Vp Controls Prior to 2008 Focus Vp Levels in Growing Areas After Illnesses Occurred Time to Temperature Control Limited Post Harvest Temp Controls –Shading –Harvest Time Restrictions

3. Vp Control Evolution Moved from Sampling After Illnesses Occurred to a Risk Based Approach Assumptions made on Vp Levels based on historical data in the state Utilized Triggers Moved to Preventing Illnesses Risk Analysis using factors such as Avg Water & Air Temps Considered Post Harvest Temp Controls on Harvest Vessel

4. Vp Control Plans Developed Limited the oyster exposure to elevated temperatures on harvest vessels to keep Vp levels lower State established Harvest Time Controls Established Harvest Vessel Temp Controls (ie; Shading or Evap. Cooling) Time from Dock Off-Loading to Temp Controls

5. Post Harvest Oyster Cooling Its NOT Just About Ambient Temperatures It’s about Product Temperatures !!! Oyster Product Cooling is About the Method of Refrigeration & the Science of Refrigeration

6. Harvest to Temp Control Analyzed the NJ 2008 Vp Outbreak Evaluated the Temperature Controls Post- Harvest Based on 08 Vp Cp Limited Harvest to Refrigeration Based on Risk Assessment Model including Post Harvest Shading on Vessels

7. South Jersey

8. What Happened to Oysters after Harvest Water/Air Temps 85F-90F + Shading on Vessels Stabilized the Oyster Temps in the 80’s F Next @ Dock Transport by Vehicle to Dealer (Avg 1 Hour Actual Time) At Dealer Oysters in Bulk Cage (25 Bushel or Bags) Warm oysters loaded onto Refrig Trailers

12. EVAPORATIONAL COOLING 2003 SUMMER SEASON STUDY NEW JERSEY DEP –BUREAU OF MARINE WATER MONITORING FDA REG SHELLFISH SPECIALIST NJ OYSTER INDUSTRY –BIVALVE PACKING CO …NJ 1 SS

15. 10 bushel haul

17. STUDY COMPONENTS TOTAL Vp in CFU/gm –O HOUR @ HARVEST –END of HARVEST DAY FULL SUN –END of HARVEST DAY WATER SPRAY O HOUR from DREDGE USE of SAMPLE CAGE @ WITHIN HARVEST CAGE for OTHERS SAMPLES

18. TOTAL Vp RESULTS JULY 9, 2003 0-HOUR 1 ST DREDGE……………109 CFU/gm FULL SUN ………………………….610 CFU/gm EVAPORATIONAL COOLING..100 CFU/gm –WATER SPRAY (25.5C-29.2C) –AIR TEMP. (29.3C-37.4C) –LGT-MOD. BREEZE

19. TOTAL Vp RESULTS JULY 22, 2003 O-HOUR 1 ST DREDGE……………40 CFU/gm FULL SUN (END HARVEST)……19,800 CFU EVAPORATIONAL COOILING… 7,000 CFU –WATER SPRAY (26.1C-26.4C) –AIR TEMP (25.5C-32.7C) –MODERATE BREEZE

20. What Happened to Oysters @ Some Dealers Before 2009 ? Oysters Off-Loaded at NJ Dealer Off-Loaded from Tarped Unrefrigerated or Refrigerated Truck or Vessel @ Dock Oyster Temps in the 80’s F at this Point Bulk Oysters Taken into Walk-in Cooler OR Loaded onto Refrigerated Trailers for several Hours of Interstate Trailers

21. First Focused on Harvest to Temp Control Temperature Control can be Mechanical Refrigeration or Ice (NSSP) We measure the Ambient Temp of the Mechanical Refrigeration Unit Does ALL Mechanical Refrigeration Actually Reduce Oyster Internal Temps.?

22. Harvest to Temp Control Analyzed the NJ 2008 Vp Outbreak Evaluated the Temperature Controls Post- Harvest Based on 08 Vp Cp Limited Harvest to Refrigeration Based on Risk Assessment Model including Post Harvest Shading on Vessels

23. Vp Control Plans Options TIME FROM HARVEST To REFRIGERATION 5 Hours or Risk Assessment Model based on factors such as Avg Water Temp/Avg Air Temp & Other Controls to Reduce Post Harvest Oyster Temp

24. Vp Control Plans Option to Limit Time from Harvest to Refrigeration The Time from Harvest to Refrigeration KEY FACTOR TYPE of REFRIGERATION Impact on Internal Oyster Temps Vs Air Temps

25. Refrigeration & Oyster Cooling Met with NJ Oyster Industry Industry Workgroup Formed Delaware Bay Shellfish Council –NJ DEP –NJDHSS –FDA –Refrigeration Experts

26. Refrigeration Facts The cooling of Any Food Product Depends on Several Factors The Density of the Food Product Air Circulation Around the Product or Product Containers The Type, Size, Depth of the Product Containers Initial Temperature of the Food Product Placed Under Refrigeration Factors Also Include the Type of Refrigeration Unit Forced Air Cooling =Walk-In Cooler Unit Passive Cooling Unit=Refrigerated Truck/Trailer Source : Dr. Patrick Brecht-PEB Commodities

27. Refrigeration Facts Continued Forced-Air Cooling Walk-In Refrigeration Unit-Cooling Rapid Cooling of Products Factors Include –Size of the Walk-in –Compressor Rating/Capacity –Air-Circulation Around Container –Location of Air Blower Fans Source: Dr. Peter Brecht-PEB Commodities Inc.

28. Bulk ready for cleaning and sorting

30. Refrigeration Facts Continued Passive Cooling Refrigerated Trailers/Trucks Most Are Not Designed to Rapidly Lower Product Temperatures These Units Are Designed To Maintain Product Temperatures; NOT to Cool an Above-Temperature Load - Source Thermo-King Operators Manual page 167 attached “These Products Must be Pre-Cooled to Proper Temperature Before Loading” –Source Thermo-King Operators Manual page167 attached

38. Comparisons of Cooling Rates of Foods in General Passive Air (ie;Refrigerated Trailer) Typical Cooling Times: 20-100 Hours Forced-Air (ie; Walk-in Cooler) Typical Cooling Times:1-10 Hours Data Provided on attached e-mail to this document by Dr. Patrick Brecht Expert in Refrigeration Technology and Transport of Perishable Foods Source: Dr Patrick Brecht of PEB Commodities and University of California

43. Actual Oyster Cooling Studies Cooling Rates to Monitor Internal Oyster Meat Temps. using Temp Recording Device 1.2003 Study State of Alabama and FDA for Oysters in Mesh Sacks (15 Sacks/Pallet). Monitored internal meat temp post harvest in a walk-in cooler 2.2003 Study State of New Jersey and FDA for Oysters stored in Metal Cages (approx. 25 Bushels/Cage). Monitored internal meat temp post harvest in a walk-in cooler. Source: Attached time-temperature study summaries and cooling response rate graphs.

44. Oyster Cooling Rate Studies Study #1 State of Alabama July 18 th 2003 Oysters Stored in a Walk-in Cooler Oysters in Mesh Sacks with 15 Sacks/Pallet See Charts-Internal Shellfish Temps using TRD

45. Meteorological Conditions during Harvest LocationCedar Point, AL DateJuly 18, 2003 Avg Air Temp85 F Avg Water Temp84 F ConditionsPC/Hot

46. Storage Conditions @ Dealer Walk-in Cooler Cooler Set Temperature42 F Cooler Air Temp Range33-44 F Cooler LoadMedium Shellstock ContainerPalletized Sack Oysters 15 Sacks/Pallet

47. Time to Temperature of Middle Sack Receipt Time and Temp 12:30 pm/86.9 F Product In Cooler 1:35 pm/82.4 F Product @ 70 F 3:00 pm/69.8 F Time to 70 F 1 Hr. 25 Min Product @ 50 F 5:25 pm/50 F Time to 50 F 4 Hr. 50 Min

48. Time to Temperature of Middle Sack Receipt Time & Temp.12:30 pm/86.9 F Product in Cooler 1:45 pm/84.2 F Product @ 70 F 4:15 pm/69.8 F Time to 70 F 2 Hours 30 Min Product @ 50 F 7:10 pm/50.0 F Time to 50 F 5 Hours 25 Min

49. Oyster Cooling Rate Studies Study # 2 State of New Jersey July 9 th 2003 Oyster Stored in Walk-in Cooler Oysters in Metal Cages at 25 Bushels per Cage See Charts-Internal Shellfish Temps using TRD

51. Oyster Cooling Rate Studies State of New Jersey July 9 th, 2003 Oysters Stored in Walk-in Cooler Oysters in Metal Cages @ 25 Bu/Cage Use of Computerized TRD-Internal Oyster Temperature

54. Meteorological Conditions During Harvest LocationDelaware Bay NJ DateJuly 9, 2003 Avg. Air Temp.86 F Avg. Water Temp. 83 F ConditionsSunny/Hot

55. Storage Conditions @ Dealer Walk-in Cooler Cooler Set Temp.40 F Cooler Air Temp. Range41-45 F Cooler LoadMedium Shellstock Container3x4x3 Cage 25 Bu/Cage

56. Bulk ready for cleaning and sorting

57. Rapid Cooling Cool Oysters before Boxing Oysters Allow Adequate Air Circulation Around Containers Contact Refrigeration Experts on Unit Tonnage Based on Factors such as: –Max Amount of Product Stored –Temp of Product Stored –Size of Unit –Air Circulation in Unit

60. Time to Temperature Internal Oyster Temps. Receipt Time & Temp2:30 pm/83.7 F Product in Cooler3:15 pm/80.6 F Product @ 70 F4:00 pm/69.5 F Time to 70 F45 Minutes Product @ 50 F6:10 pm/49.8 F Time to 50 Fapprox 3 Hours

61. Results of AL & NJ Studies The Data Validates the Technical Information provided by Refrigeration Experts regarding Rapid Cooling Rates in a Walk-in Cooler/Forced Air 1-10 Hours

62. Where Did We Go From Here ? In New Jersey Meetings Late 08 with State & Industry to Explain Refrigeration Facts State & FDA Led Meetings/Industry Workgroup Explained How Extended Hours to Cool Oysters is Factor in Vp Ilnesses Provided Data and Information from Refrigeration Experts & Studies in Al & NJ Requested that NJ Develop a New VpCP for 2009

63. NJ 2009 Vp CP State will Require during 09 Summer Season: Shortened Harvest Hours Shortened Transfer to Forced-Air Refrig. No Interstate Transport of Oysters until next day (midnight). No Transport Until Oyster Pre-Chilled to Temps to 50 F or Below !!!

64. NJ “09” Vp CP Also Requiring Continuous Recording of Refrigeration Unit (Ambient) Appropriate Thermometer to Temp Oysters (Product) ie; Infrared Gun Separate HACCP Plans by Dealers for Vp CP Reviewed by NJDHSS & FDA Adequate Inspections by State Adequate FDA Review/Assistance

65. Vp CP HACCP Plans Oyster 1 st Level Dealer HACCP Plans reviewed approved by T. Foca NJDHSS HACCP Plans include: –Monitoring/Records for oyster temps. @ Dock –Monitoring/Records for oyster temps @ Receipt- Certified Plant –Time of Dock Off Loading –Time of Receipt @ Plant –Time & Temp of Oysters Prior to Shipment –Oyster Temp < 50 F

66. HACCP Corrective Actions NJDHSS Required Continues Temp Recorders in Coolers Corrective Action if Cooler Temp Elevated > 45 F Hold Product & Evaluate Time/Temp Several Plants getting Emergency Generators

67. Port Norris NJ Newly Constructed 20’ x 30’ Cooler with 2-5hp units

69. 5/16/09 Rebuilding Permanent Walk-in Cooler for 09 Vp CP season Temporary Trailer during Renovations

70. 5/13/09 22 ft long x 7 ft 1/2 in wide truck with 1- 2 ton compressor Not Approved

71. Port Norris-Retrofit Refrigeration 8 ft Trailer with 3 Ton Diesel and 4 Ton Electric Compressor 5/13 Prior to Installation of addl. 4 Ton Compressor

72. Large Walk-in Cooler

74. NJ 324 SS River Road Clam House- Gary Lubaczewski 5/16/09 Rebuilding Permanent Walk-in Cooler for 09 Vp CP season Temporary Trailer during Renovations-Continuous Temp Recorder

76. Compressor Unit Temp Guage

82. Interstate Shellfish Sanitation Conference (ISSC) As a Result of New Jersey Findings and Post Harvest Temperature Study Results 2009 NJ Vp Control Plan Requirements for Pre-Chilling to 50 F Prior to Shipping NJ Industry Support FDA Proposed and the ISSC Approved in October 2009 a MO Requirement for Pre- Chilling of Oyster by States under Vp Control

83. Oysters on the Half-Shell Oysters and clams have been an important item in man’s diet for thousands of years.