FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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July 19, 2005

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Quantitative Risk Assessment on the Public Health Impact of
Pathogenic Vibrio parahaemolyticus in Raw Oysters

Table of Contents

Appendix 10: Additional Information: What-if Scenarios

Table A10-1.Predicted Mean Annual Illnesses with and without Mitigation
Region Season Predicted Mean Number of Illnesses per Annuma
Baseline Immediate Refrigeration (~1 log10 Reduction) 2-log10 Reduction 4.5-log10 Reduction
Gulf Coast Louisiana Spring 505 (36, 1.6x103) 54 (3.0, 180) 5.2 (0.35, 17) 0.017 (1.1x10-3, 0.053)
Summer 1,406 (109, 4.4x103) 139 (7.6, 490) 15 (1.1, 47) 0.046 (3.5x10-3, 0.15)
Fall 132 (6.4, 470) 8.8 (0.34, 34) 1.3 (0.060, 5.0) 4.2x10-3 (2.0x10-4, 0.016)
Winter 6.7 (0.16, 26) 0.80 (0.04, 2.5) 0.070 (1.7x10-3, 0.30) 2.2x10-4 (3.9x10-6, 9.8x10-4)
Gulf Coast (Non-Louisiana) Spring 193 (13, 630) 29 (1.5, 98) 2.0 (0.13, 6.3) 6.2x10-3 (4.1x10-4, 0.020)
Summer 299 (22, 980) 42 (2.6, 140) 3.1 (0.22, 10) 9.7x10-3, (7.0x10-4, 0.032)
Fall 51 (2.0, 180) 7.7 (0.32, 28) 0.51 (0.021, 1.8) 1.6x10-3 (6.6x10-5, 5.8x10-3)
Winter 2.9 (0.08, 11) 0.72 (0.04, 2.3) 0.028 (9.0x10-4, 0.11) 8.8x10-5 (1.4x10-6, 3.5x10-4)
Mid-Atlantic Spring 4.4 (0.25, 15) 0.53 (0.024, 2.0) 0.045 (2.7x10-3, 0.16) 1.4x10-4 (8.5x10-6, 5.1x10-4)
Summer 6.9 (0.36, 25) 0.83 (0.040, 3.2) 0.070 (3.8x10-3, 0.26) 2.2x10-4 (1.2x10-5, 8.0x10-4)
Fall 3.8 (0.08, 17) 0.64 (0.025, 2.4) 0.037 (8.0x10-4, 0.16) 1.2x10-4 (1.5x10-6, 5.2x10-4)
Winter 0.012 (1.0x10-3, 0.041) 0.01 (5.0x10-4, 0.037) 1.1 x 10-4 (5.4x10-6, 4.1x10-4) 3.4x10-7 (0.0, 2.3x10-6)
Northeast Atlantic Spring 3.0 (0.07, 12) 0.33 (0.013, 1.2) 0.031 (8.0x10-4, 0.13) 9.7x10-5 (1.8x10-6, 3.9x10-4)
Summer 14 (0.64, 53) 1.7 (0.099, 6.2) 0.14 (7.0x10-3, 0.53) 4.4x10-4 (2.1x10-5, 1.6x10-3)
Fall 1.7 (0.05, 6.8) 0.55 (0.029, 1.8) 0.018 (5.0x10-4, 0.073) 5.6x10-5 (0.0, 2.3x10-4)
Winter 0.027 (1.0x10-3, 0.083) 0.024 (1.1x10-3, 0.081 2.5 x 10-4 (1.1x10-5, 8.7x10-4) 8.6x10-7 (0.0, 4.9x10-6)
Pacific Northwest (Dredged) Spring 0.42 (1.9x10-3, 1.5) 0.051 (9.0x10-4, 0.16) 4.7x10-3 (1.7x10-5, 1.7x10-2) 1.5x10-5 (0.0, 5.1x10-5)
Summer 3.9 (0.06, 16) 0.37 (0.010, 1.5) 0.044 (6.0x10-4, 0.20) 1.4x10-4 (1.5x10-6, 6.5x10-4)
Fall 0.024 (6.0x10-4, 0.085) 8.1 x 10-3 (4.0x10-4, 0.031) 2.1 x 10-4 (6.6x10-6, 7.4x14) 6.7x10-7 (0.0, 4.2x10-6)
Winter 6.0 x 10-4 (0.0, 2.2x 10-3) 5.0 x 10-4 (1.9x10-5, 2.0x103 5.5 x 10-6 (0.0, 2.2x10-5) 1.5x10-8 (0.0, 0.0)
Pacific Northwest (Intertidal)b Spring 18 (0.03, 82) 10 (0.02, 50) 0.22 (3.0x10-4, 1.1) 7.0x10-4 (0.0, 3.5x10-3)
Summer 173 (3.8, 750) 96 (1.9, 420) 2.1 (0.039, 9.4) 6.8x10-3 (1.3x10-4, 0.03)
Fall 1.0 (0.01, 4.3) 0.49 (0.01, 1.7) 8.5x10-3 (1.0x10-4, 0.029) 2.7x10-5 (0.0, 1.1x10-4)
Winter 3.3 x 10-3 (1.0x10-4, 0.013) 3.2 x 10-3 (1.0x10-4, 0.013) 3.4 x 10-5 (0.0, 1.4x10-4) 9.2x10-8 (0.0, 0.0)

aValues in parentheses are the 5th percentile and 95th percentile of the uncertainty distribution. Values rounded to 2 significant digits. See Appendix 7 for actual illness numbers
b After intertidal exposure

Table A10-2. Predicted Mean Levels of Pathogenic Vibrio parahaemolyticus per gram in Oysters at Retail after Mitigation Treatments that Reduce Pathogen Levels
Predicted Mean Levels of Pathogenic Vibrio parahaemolyticus per grama
Region Season No Mitigation Immediate Refrigeration (~1 log10 Reduction) 2 log10 Reduction 4.5 log10 Reduction
Gulf Coast (Louisiana) Spring 39 (12, 88) 4.2 (0.84, 12) 0.39 (0.11, 0.89) 1.2x10-3 (3.6×10-4, 2.8×10-3)
Summer 100 (37, 220) 10 (2.3, 29) 1.0 (0.36, 2.2) 3.3×10-3 (1.2×10-3, 6.8×10-3)
Fall 10 (1.8, 25) 0.65 (0.09, 2.1) 0.10 (0.016, 0.24) 3.1×10-4×(5.0×10-5,×7.7×10-4
Winter 0.48 (0.04, 1.6) 0.059 (0.013, 0.16) 5.0×10-3 (3.9×10-4, 0.018) 1.6×10-5 (9.9×10-7, 5.7×10-5)
Gulf Coast (Non-Louisiana) Spring 28 (7.6, 65) 4.2 (0.82, 12) 0.28 (0.075, 0.65) 8.8×10-4 (2.4×10-4, 2.0×10-3)
Summer 73 (24, 160) 10 (2.4, 28) 0.73 (0.24, 1.6) 2.3×10-3 (7.5×10-4, 5.0×10-3)
Fall 4.4 (0.64, 12) 0.65 (0.09, 2.1) 0.043 (5.6×10-3, 0.12) 1.4×10-4 (1.8×10-5, 4.0×10-4)
Winter 0.23 (0.026, 0.80) 0.060 (0.014, 0.17) 2.3×10-3 (2.7×10-4, 7.5×10-3) 7.2×10-6 (5.0×10-7, 2.4×10-5)
Mid-Atlantic Spring 7.3 (1.7, 18) 0.88 (0.14, 2.7) 0.073 (0.015, 0.17) 2.3×10-4 (5.1×10-5, 5.4×10-4)
Summer 21 (3.8, 54) 2.6 (0.46, 7.6) 0.21 (0.036, 0.54) 6.7×10-4 (1.1×10-4, 1.7×10-3)
Fall 0.54 (0.035, 2.0) 0.09 (0.014, 0.32) 5.1×10-3 (3.3×10-4, 0.019) 1.6×10-5 (9.7×10-7, 6.0×10-5)
Winter 2.4×10-3 (4.0×10-4, 5.8×10-3) 2.3×10-3 (4.0×10-4, 5.4×10-3) 2.4×10-5 (3.5×10-6, 6.1×10-5) 7.5×10-8 (0.0, 5.0×10-7)
Northeast Atlantic Spring 0.88 (0.064, 3.0) 0.097 (0.015, 0.29) 8.9×10-3 (6.2×10-4, 0.032) 2.8×10-5 (1.5×10-6, 1.0×10-4)
Summer 4.3 (0.68, 12) 0.52 (0.11, 1.5) 0.042 (6.8×10-3, 0.11) 1.3×10-4 (2.1×10-5, 3.7×10-4)
Fall 0.088 (0.012, 0.29) 0.030 (7.1×10-3, 0.08) 9.9×10-4 (1.2×10-4, 3.4×10-3) 3.2×10-6 (0.0, 1.2×10-5)
Winter 2.5×10-3 (4.0×10-4, 6.3×10-3) 2.3×10-3 (4.2×10-4, 5.9×10-3) 2.4×10-5 (3.5×10-6, 6.1×10-5) 8.3×10-8 (0.0, 5.0×10-7)
Pacific Northwest (Dredged)b Spring 0.22 (0.002, 0.87) 0.022 (1.1×10-3, 0.076) 2.1×10-3 (2.0×10-5, 9.2×10-3) 6.9×10-6 (0.0, 3.0×10-5)
Summer 2.3 (0.10, 11) 0.20 (0.02, 0.68) 0.023 (9.9×10-4, 0.097) 7.4×10-5 (3.0×10-6, 3.1×10-4
Fall 5.8×10-3 (6.0×10-4, 0.018) 1.9×10-3 (4.0×10-4, 5.0×10-3) 4.9×10-5 (5.9×10-6, 1.4×10-7) 1.7×10-7 (0.0, 9.9×10-7)
Winter 1.9×10-4 (2×10-5, 6.1×10-4) 1.7×10-4 (1.9×10-5, 5.6×10-4) 1.9×10-6 (0.00, 6.4×10-6) 5.5×10-9 (0.0, 0.0)
Pacific Northwest (Intertidal)c Spring 3.7 (0.014, 19) 1.9 (9.2×10-3, 9.7) 0.035 (1.2×10-4, 0.20) 1.1×10-4 (3.9×10-7, 6.3×10-4)
Summer 38 (2.0, 140) 20 (0.95, 84) 0.38 (0.018, 1.5) 1.2×10-3 (5.6×10-5, 4.9×10-3)
Fall 0.086 (3.0×10-3, 0.30) 0.038 (2.2×10-3, 0.13) 6.9×10-4 (3.0×10-5, 2.3×10-3) 2.2×10-6 (8.7×10-8, 7.3×10-6)
Winter 4.0×10-4 (3.0×10-5, 1.4×10-3) 3.7×10-4 (3.0×10-5, 1.3×10-3) 4.0×10-6 (3.4×10-7, 1.4×10-5) 1.3×10-8 (1.1×10-9, 4.3×10-8)

aValues in parentheses are the 5th percentile and 95th percentile of the uncertainty distribution. Values rounded to 2 significant digits. See Appendix 7 for actual predicted levels.

Table A10-3. Predicted Mean Numbers of Pathogenic Vibrio parahaemolyticus per Serving of Oysters after Mitigation Treatments that Reduce Pathogen Levels
Region Season At Harvesta No Mitigationb Immediate Refrigeration 2 log10 reductionb 4.5 log10 reductionb
Gulf Coast (Louisiana) Spring 320 7.9×103 (2.3×103, 1.8×104) 840 (170, 2.4×103) 78 (22, 180) 0.25 (0.072, 0.57)
Summer 720 2.1×104 (7.5×103, 4.4×104) 2.0×103 (470, 5.8×103) 210 (73, 440) 0.66 (0.23, 1.4)
Fall 80 2.0×103 (320, 5.1×103) 130 (18, 420) 20 (3.2, 49) 0.06 (0.01, 0.16)
Winter 18 98 (8.1, 330) 12 (2.6, 33) 1.0 (0.078, 3.6) 3.2×10-3 (2.0×10-4, 0.012)
Gulf Coast (Non-Louisiana) Spring 320 5.6×103 (1.5×103, 1.3×104) 850 (170, 2.4×103) 56 (15, 130) 0.18 (0.048, 0.41)
Summer 720 1.5×104 (4.9×103, 3.2×104) 2.0×103 (480, 5.7×103) 150 (49, 320) 0.47 (0.15, 1.0)
Fall 80 880 (110, 2.5×103) 130 (19, 430) 8.6 (1.1, 25) 0.027 (3.7×10-3, 0.08)
Winter 18 47 (5.1, 160) 12 (2.7, 35) 0.46 (0.054, 1.5) 1.5×10-3 (1.0×10-4, 4.9×10-3)
Mid-Atlantic Spring 66 1.5×103 (330, 3.5×103) 180 (27, 550) 15 (3.1, 35) 0.047 (0.01, 0.11)
Summer 260 4.3×103 (750, 1.1×104) 520 (92, 1.5×103) 43 (7.3, 110) 0.14 (0.023, 0.34)
Fall 18 110 (7.1, 410) 18 (2.8, 64) 1.0 (0.07, 3.9) 3.2×10-3 (2.0×10-4, 0.012)
Winter 1.2 0.48 (0.09, 1.2) 0.46 (0.08, 1.1) 4.9×10-3 (7.0×10-4, 0.012) 1.5×10-5 (0.0, 1.0×10-4
Northeast Atlantic Spring 14 180 (12, 620) 20 (2.9, 59) 1.8 (0.13, 6.5) 5.7×10-3 (3.0×10-4, 0.02)
Summer 78 860 (130, 2.5×103) 100 (22, 300) 8.5 (1.4, 23) 0.027 (4.2×10-3, 0.074)
Fall 12 17 (2.4, 57) 6.1 (1.4, 16) 0.20 (0.024, 0.68) 6.4×10-4 (0.0, 2.4×10-3)
Winter 1.2 0.5 (0.09, 1.2) 0.47 (0.085, 1.2) 4.9×10-3 (7.0×10-4, 0.012) 1.7×10-5 (0.0, 1.0×10-4)
Pacific Northwest (Dredged) Spring 4 43 (0. 4, 160) 4.5 (0.23, 15) 0.43 (4.1×10-3, 1.9) 1.4×10-3 (0.0, 6.0×10-3)
Summer 24 460 (21, 2.1×103) 40 (4.7, 140) 4.7 (0. 2, 19) 0.015 (6.0v10-4, 0.062)
Fall 0.68 1.2 (0.12, 3.6) 0.39 (0.081, 1.0) 9.9×10-3 (1.2×10-3, 0.03) 3.3×10-5 (0.0, 2.0×10-4)
Winter 0.08 0.04 (0.00, 0.12) 0.034 (3.9×10-3, 0.11) 3.8×10-4 (0.0, 1.3×10-3) 1.1×10-6 (0.0, 0.0)
Pacific Northwest (Intertidal) Spring 280 740 (2.6, 3.7×104) 380 (1.9, 2.0×103) 7.1 (0.025, 40) 0.022 (8.0×10-5, 0.13)
Summer 3.0×103 7.5×103 (370, 3.0×104) 4.1×103 (190, 1.7×104) 77 (3.6, 310) 0.24 (0.011, 0.98)
Fall 10 17 (0.50, 74) 7.7 (0.45, 27) 0.14 (5.6×10-3, 0.47) 4.4×10-4 (2.0×10-5, 1.5×10-3)
Winter 0.18 0.08 (0.01, 0.28) 0.075 (6.6×10-3, 0.26) 8.0×10-4 (7.0×10-5, 2.8×10-3) 2.5×10-6 (2.2×10-7, 8.7×10-6)

aMean number of pathogenic V. parahaemolyticus consumed per serving (average over variabilities and uncertainties)
bValues in parentheses are the 5th percentile and 95th percentile of the uncertainty distribution. Values rounded to 2 significant digits. See Appendix 7 for actual predicted levels.

Impact of overnight submersion of oysters during intertidal harvesting on the predicted risk of illness

Table A10-4. Effect of Overnight Submersion of Oysters during Intertidal Harvest on Predicted Risk in the Pacific Northwest Harvest Region
Type of Harvest Season Mean Risk per Serving
Baseline Intertidal Harvest Winter 1.7×10-9
Spring 1.3×10-5
Summer 1.4×10-4
Fall 3.9×10-7
Overnight Submersion of Intertidal Harvesta Winter 8.1×10-10
Spring 8.7×10-7
Summer 1.0×10-5
Fall 2.7×10-8

aThis assumes levels of V. parahaemolyticus in oysters after submersion overnight are similar to dredged.

Predicted Effects of Maximum Time-to-Refrigeration on Illness Using Ice (Rapid Refrigeration) or Conventional Refrigeration (Air- Circulated)

Tables A10-5 to A10-8 show the impact of rapid cooling with ice on predicted reduction in levels of total V. parahaemolyticus at-retail compared with the baseline levels. Figures A10-1 to A10-6 show predicted effects on illness of maximum time-to-refrigeration of oyster shellstock with conventional refrigeration (i.e., up to 10 hours to reach no-growth temperatures) for each season and region. Figures A10-7 -A10-12 show predicted effects on illness of maximum time-to-refrigeration of oyster shellstock with rapid cooling on ice (i.e., 1 hour to reach no-growth temperatures) for each season and region. Figures A10-13 to A10-18 compare the predicted effects between conventional refrigeration and rapid cooling for the summer harvest of all 6 harvesting regions. As mentioned in Chapter VII of the technical document, predicted reductions for regions and seasons with lower air temperatures are less dramatic than those with higher air temperatures as shown in the figures below.

Effect of Limiting Time to Refrigeration followed by rapid cooling (icing) on the mean and 90th %-tile of total Vp/g at retail (point of consumption)

Table A10-5. Best estimate of the Mean total Vp/g at retail for all region/seasons
Region Season Time-to-Refrigeration
1 hr 2 hr 3 hr 4 hr baseline
Gulf Louisiana winter 25a 31 37 44 290
spring 970 1.6×103 2.5×103 3.8×103 2.3×104
summer 2.3×103 3.8×103 6.1×103 9.1×103 6.0×104
fall 170 270 400 610 5.7×103
Gulf non-Louisiana winter 26 31 36 42 140
spring 970 1.6×103 2.4×103 3.4×103 1.6×104
summer 2.3×103 3.8×103 5.8×103 8.3×103 4.2×104
fall 176 265 383 528 2.5×103
Northeast Atlantic winter 1.3 1.4 1.4 1.4 1.5
spring 28 40 56.0 77 510
summer 165 230 310 410 2.5×103
fall 14 16 18 20 52
Mid-Atlantic winter 1.3 1.3 1.3 1.3 1.4
spring 190 320 500 750 4.2×103
summer 680 1.0×103 1.5×103 2.1×103 1.2×104
fall 32 43 567 73 300
Pacific Northwest (dredged) winter 0.007 0.007 0.007 0.007 0.008
spring 0.54 0.74 1.0 1.3 9.1
summer 4.1 6.1 8.7 12 100
fall 0.070 0.080 0.091 0.102 0.230
Pacific Northwest (intertidal) winter 0.015 0.015 0.015 0.015 0.017
spring 47 54 60 63 150
summer 520 600 660 700 1.7×103
fall 1.6 1.6 1.8 1.9 3.9

aLevels of V. parahaemolyticus at-retail after cooling at various time intervals after harvest; values are rounded to 2 significant digits

Table A10-6. Best estimate of the 90th percentile of the distribution of total Vp/g at retail for all region seasons
Region Season Time-to-Refrigeration
1 hr 2 hr 3 hr 4 hr Baseline
Gulf Louisiana winter 35a 40 45 51 120
spring 1.1×103 1.9×103 2.9×103 4.4×103 4.6×104
summer 3.8×103 6.8×103 1.1×104 1.8×104 2×105
fall 160 210 280 370 2.8×103
Gulf non-Louisiana winter 35 39 44 48 84
spring 1.2×103 1.9×103 2.8×103 3.9×103 2.6×104
summer 3.8×103 6.7×103 1.1×104 1.6×104 1.2×105
fall 160 210 270 330 1.0×103
Northeast Atlantic winter 2.3 2.3 2.3 2.3 2.3
spring 27 33 39 45 100
summer 240 330 440 560 2.5×103
fall 18 19 21 22 28
Mid-Atlantic winter 2.1 2.1 2.1 2.1 2.2
spring 140 190 260 330 1.3×103
summer 990 1.5×103 2.2×103 3.1×103 2.2×104
fall 23 27 29 31 48
Pacific Northwest (dredged) winter 0.015 0.015 0.016 0.016 0.017
spring 0.70 0.86 1.0 1.2 2.6
summer 5.7 7.6 9.8 12 40
fall 0.098 0.10 0.11 0.12 0.15
Pacific Northwest (intertidal) winter 0.028 0.028 0.028 0.028 0.030
spring 11 13 14 15 27
summer 240 280 310 330 800
fall 0.40 0.40 0.41 0.42 0.51

a aLevels of V. parahaemolyticus at-retail after cooling at various time intervals after harvest; values are rounded to 2 significant digits

Effect of Limiting Time to Refrigeration followed by conventional cooling on the mean and 90th %-tile of total Vp/g at retail (point of consumption)

Table A10-7. Best estimate of the Mean total Vp/g at retail for all region/seasons
Region Season Time-to-Refrigeration
1 hr 2 hr 3 hr 4 hr Baseline
Gulf Louisiana winter 43a 55 70 89 290
spring 4.0×103 6.2×103 8.9×103 1.2×104 2.2×104
summer 9.8×103 1.5×104 2.3×104 3.1×104 6.0×104
fall 620 950 1.4×103 1.9×103 5.7×103
Gulf non-Louisiana winter 43 55 68 82 140
spring 4.0×103 6.1×103 8.6×103 1.1×104 1.6×104
summer 9.8×103 1.5×104 2.2×104 2.8×104 4.2×104
fall 620 930 1.3×103 1.7×103 2.5×103
Northeast Atlantic winter 1.4 1.4 1.4 1.4 1.5
spring 90 140 200 270 510
summer 460 670 930 1.2×103 2.5×103
fall 21 25 30 35 52
Mid-Atlantic winter 1.3 1.3 1.4 1.4 1.4
spring 860 1.3×103 1.9×103 2.5×103 4.2×103
summer 2.4×103 3.7×103 5.2×103 6.9×103 1.2×104
fall 78 110 150 190 310
Pacific Northwest (dredged) winter 0.007 0.008 0.008 0.008 0.008
spring 1.5 2.2 3.1 4.3 9.1
summer 14 21 32 44 100
fall 0.10 0.12 0.15 0.17 0.23
Pacific Northwest (intertidal) winter 0.016 0.016 0.017 0.017 0.017
spring 110 130 140 150 150
summer 1.2×103 1.4×103 1.5×103 1.6×103 1.7×103
fall 3.6 3.6 4.0 4.2 3.9

aLevels of V. parahaemolyticus at-retail after cooling at various time intervals after harvest; values are rounded to 2 significant digits

Table A10-8. Best estimate of the 90th percentile of the distribution of total Vp/g at retail for all region seasons
Region Season Time-to-Refrigeration
1 hr 2 hr 3 hr 4 hr baseline
Gulf Louisiana winter 48a 56 65 73 120
spring 4.3×103 7.3×103 1.2×104 1.8×104 4.7×104
summer 1.9×104 3.4×104 5.5×104 8.3×104 2.0×105
fall 340 470 650 880 2.8×103
Gulf non-Louisiana winter 48 56 63 70 84
spring 4.3×103 7.2×103 1.1×104 1.6×104 2.6×104
summer 1.9×104 3.3×104 5.3×104 7.5×104 1.3×105
fall 340 470 610 760 1.0×103
Northeast Atlantic winter 2.3 2.3 2.3 2.3 2.3
spring 45 57 68 80 100
summer 590 840 1.1×103 1.5×103 2.5×103
fall 22 23 25 26 28
Mid-Atlantic winter 2.1 2.2 2.2 2.2 2.2
spring 330 480 650 830 1.3×103
summer 3.3×103 5.3×103 7.9×103 1.1×104 2.2×104
fall 31 35 39 42 48
Pacific Northwest (dredged) winter 0.016 0.016 0.016 0.016 0.017
spring 1.2 1.4 1.7 2.0 2.6
summer 12 17 22 27 40
fall 0.12 0.13 0.13 0.14 0.15
Pacific Northwest (intertidal) winter 0.029 0.029 0.029 0.029 0.030
spring 21 24 26 27 27
summer 550 650 730 780 800
fall 0.49 0.49 0.50 0.51 0.51

aLevels of V. parahaemolyticus at-retail after cooling at various time intervals after harvest; values are rounded to 2 significant digits

Effect of Limiting Time to Refrigeration (Conventional Cooling and Rapid cooling on Ice) on Average Levels of Total Vp/g at Retail (Point of Consumption)

Figure A10-1. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast, Non- Louisiana Harvest).

Figure A10-2. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Harvest).

Figure A10-3. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Northeast Atlantic Harvest).

Figure A10-4. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Mid-Atlantic Harvest).

Figure A10-5. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest).

Figure A10-6. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Figure A10-7. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Non-Louisiana Harvest).

Figure A10-8. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Harvest).

Figure A10-9. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Northeast Atlantic Harvest).

Figure A10-10. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Mid-Atlantic Harvest).

Figure A10-11. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest).

Figure A10-12. Predicted Effect of Maximum Time to Refrigeration with Rapid (on (on ice) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Figures on Effect of Limiting Time to Refrigeration (conventional cooling and rapid cooling) on the 90th percentile of the distribution of total V. parahaemolyticus/g at retail (point of consumption)

Figure A10-13. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Non- Coast, Louisiana Harvest).

Figure A10-14. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast Louisiana Harvest).

Figure A10-15. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Northeast Atlantic Harvest).

Figure A10-16. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Mid-Atlantic Harvest).

Figure A10-17. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest).

Figure A10-18. Predicted Effect of Maximum Time-to-Refrigeration with Rapid Conventional (Air Circulated) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Figure A10-19. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Non-Louisiana Harvest).

Figure A10-20. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Harvest).

Figure A10-21. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Northeast Atlantic Harvest).

Figure A10-22. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Mid-Atlantic Harvest).

Figure A10-23. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest).

Figure A10-24. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Table A10-9 shows the impact of rapid cooling on ice on reducing the levels of V. parahaemolyticus with the corresponding decrease in risk per serving.

Table A10-9. Percentage Reduction of Vibrio parahaemolyticus /g versus Risk After Immediate Refrigeration with Icing for the Gulf Coast (Louisiana) Summer Harvest
Time-to-Refrigeration (h) % reduction of total Vp/g % reduction of risk per serving
1 96.2% 96.5%
2 93.6% 94.1%
3 89.9% 90.7%
4 84.8% 85.9%

Figures on Effect of Limiting Time to Refrigeration (conventional cooling and rapid cooling) on the Reduction of Risk Per Serving

Figure A10-25. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Harvest).

Figure A10-26. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Northeast Atlantic Harvest).

Figure A10-27. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Mid-Atlantic Harvest).

Figure A10-28. Predicted Effect of Maximum Time-to-Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest).

Figure A10-29. Predicted Effect of Maximum Time to Refrigeration with Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Figure A10-30. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Non-Louisiana Harvest).

Figure A10-31. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Harvest).

Figure A10-32. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Northeast Atlantic Harvest.)

Figure A10-33. Predicted Effect of Maximum Time-to-Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Mid-Atlantic Harvest.)


Figure A10-34. Predicted Effect of Maximum Time to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Pacific Northwest Dredged Harvest)

Figure A10-35. Predicted Effect of Maximum-Time-to Refrigeration with Rapid (on ice) Cooling of Oyster Shellstock (Pacific Northwest Intertidal Harvest).

Comparison on Impact of Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock on Reduction of Mean Risk Per Serving

Figure A10-36. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast, Non-Louisiana Summer Harvest).

Figure A10-37. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Gulf Coast, Louisiana Summer Harvest).

Figure A10-38. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Northeast Atlantic Summer Harvest).

Figure A10-39. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Mid-Atlantic Summer Harvest).

Figure A10-40. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Summer Dredged Harvest).

Figure A10-41. Rapid (on ice) Cooling versus Conventional (Air-Circulated) Cooling of Oyster Shellstock (Pacific Northwest Summer Intertidal Harvest).

Effect of Deviation from Compliance on "At-Harvest" Guidance Levels Scenarios

The impact on illness and effect on harvest at different V. parahaemolyticus guidance levels for "at harvest" control was evaluated in Chapter VI of the technical document. It was recognized that deviation from compliance with these harvest guidance levels can occur in any region and season. The Louisiana Gulf Coast Summer harvest was selected as the region/season combination for illustrative example because the Gulf has the highest summer temperatures and Louisiana has the longest potential time for having oysters out of the water.

Selected levels of deviation from compliance (ranging from 0 to 50%) with different guidance levels (ranging from 100 to 100,000/g) were evaluated. The analyses were accomplished by altering the baseline model to represent the potential effect of the different levels of deviation from compliance. In other words, the impact of the different guidance levels determined in the above evaluation of the 10,000 V. parahaemolyticus/g was used as the 100% compliance (or 0% deviation from compliance) control and the outcome when 0, 10, 30, or 50% of the oysters containing more V. parahaemolyticus/g than the guidance level in question were allowed to reach the consumer. As seen in Table A10-10, the lower the standard level in question, the greater the impact of deviation from compliance on both percentage illnesses averted and loss of oyster harvest. At an "at-harvest" guidance level of 100 V. parahaemolyticus/g, a 30% deviation from compliance only reduces illness by 82% as compared to the 98% reduction predicted if 100% compliance were met.

At 10,000 and 100,000 V. parahaemolyticus/g the differences in illness reduction between 100% compliance and 70% compliance are not large. Therefore, as demonstrated in Figures A10-19 to A10-23, as the level of the microbiological criterion increases, the impact of compliance is less important. Conversely, strict microbiological criteria must be matched with a high level of compliance if they are to be effective.

Table A10-10. Effect of Compliance Levels on the Effectiveness of Controlling Total Vibrio parahaemolyticus in Oysters at the Time of Harvest for Gulf Coast Louisiana Summer
Total Vp/g At Time of Harvesta Compliance Levelb Reduction in Mean Risk per Serving (%) Harvest Diverted (%)c Illness Averted (%)d
100/g 50% 47.7% 33.0% 64.9%
70% 66.7% 46.2% 82.1%
90% 85.7% 59.4% 94.2%
100% 95.3% 66.0% 98.4%
1000/g 50% 29.6% 10.6% 37.3%
70% 41.3% 14.9% 50.4%
90% 53.0% 19.1% 62.6%
100% 58.9% 21.3% 68.2%
5000/g 50% 11.4% 2.8% 14.4%
70% 15.9% 3.9% 19.9%
90% 20.4% 5.1% 25.4%
100% 22.7% 5.6% 28.1%
10,000/g 50% 6.4% 1.4% 8.2%
70% 8.9% 2.0% 11.4%
90% 11.4% 2.6% 14.6%
100% 12.7% 2.9% 16.2%
100,000/g 50% 0.57% 0.12% 0.79%
70% 0.77% 0.17% 1.11%
90% 0.99% 0.22% 1.43%
100% 1.10% 0.25% 1.58%

a Assumes that the level of Vibrio parahaemolyticus (Vp) is known in oysters at the time of harvest.
b The compliance level is the percentage oyster harvest, which is removed from the raw oyster consumption market; this percentage is assumed to have the same distribution of Vp/g as under the baseline (no mitigation) scenario.
c Refers to the harvest that would need to be diverted from the "raw market". d Assuming that the volume of product available for raw consumption is impacted (i.e., reduced) according to the estimate of the % of harvest lost from the raw market.

Figure A10-42. Percentage of Illnesses Averted

Figure A10-43. Percentage Reduction in Mean Risk per Serving

Figure A10-44. Percentage of Oyster Harvest Diverted from the "Raw Market" or Subjected to Preventive Controls.

Figure A10-45. Percentage Reduction in Mean Risk per Serving versus Percentage of Harvest Diverted from the "Raw Market" or Subjected to Preventive Controls


Figure A10-46. Percentage of Illnesses Averted versus Percentage of Harvest Diverted From the "Raw Market" or Subjected to Preventive Controls.

Effect of Deviation from Compliance on "At-Retail" Guidance Levels Scenarios

The impact of deviation from compliance at retail was evaluated in a similar manner to that at harvest. Selected levels of deviation from compliance (ranging from 0 to 50%) with different guidance levels (ranging from 100 to 100,000/g) was evaluated. Impact of deviation from compliance at retail is much higher at the higher standard levels at retail compared to that of at-harvest deviation from compliance (compare Tables A10-4 and A10-5). As seen in Table A10-5, like deviation from compliance at harvest, the lower the standard level in question, the greater the impact of deviation from compliance on loss of oyster harvest to the raw market. However, in the case of illness, deviation from compliance at retail appears to have a greater impact when the guidance level is high, even though a compliance rate of 100% does not result in 100% reduction in illness. At a retail guidance level of 100 V. parahaemolyticus/g, a 30% deviation from compliance reduces illness by approximately 90% as compared to the ~100% reduction predicted if 100% compliance were met. A rate of 50% deviation from compliance would result in approximately 74% reduction in illness versus the ~100% predicted if 100% compliance were met. If the guidance level was increased to 5, 000 V. parahaemolyticus/g, 50% compliance results in a larger decrease in the reduction of illness (approximately 63%) compared to ~100% predicted if there was 100% compliance.

At 10,000 and 100,000 V. parahaemolyticus/g the differences in illness reduction between 100% compliance and 70% compliance are larger than at 100 or 1,000. Therefore, as demonstrated in Figures A10-24 to A10-27, as the level of the microbiological criterion increases, the impact of compliance is more important on illness. Conversely, strict microbiological criteria must be matched with a high level of compliance if they are to be effective.

A deviation from compliance rate of 30% would substantially impact the reduction in risk of illness per serving (Table A10-11) for the higher guidance criteria. It is interesting to note that like at-harvest guidance, at 50% deviation from compliance of the lower guidance levels (100 and 1,000 V. parahaemolyticus/g), although the harvest is reduced by half of that at 100% compliance, reduction in illness is not equivalent. At the higher guidance levels, reduction in illness at 50% deviation from compliance is closer to half that at 100% compliance.

Effect of Deviation from Compliance on "At-Cooldown" Guidance Levels Scenarios

Table A10-11. Effect of Compliance Levels on the Effectiveness of Controlling Total Vibrio parahaemolyticus in Oysters at Retail for Gulf Coast Louisiana Summer
Total Vp/g At-Retaila Compliance Levelb Reduction in Mean Risk per Serving (%) Harvest Diverted (%)c Illness Averted (%)d
100/g 50% 50.0% 49.0% 74.5%
70% 70.1% 68.6% 90.6%
90% 90.0% 88.2% 98.8%
100% ~100% 98.0% ~100%
1000/g 50% 50.0% 43.5% 71.7%
70% 70.0% 60.9% 88.3%
90% 90.0% 78.3% 97.8%
100% ~100% 87.0% ~100%
5000/g 50% 49.8% 34.5% 67.1%
70% 69.9% 48.3% 84.4%
90% 89.7% 62.1% 96.1%
100% 99.6% 69.0% 99.9%
10,000/g 50% 49.5% 29.7% 64.6%
70% 69.4% 41.5% 82.1%
90% 89.2% 53.4% 96.0%
100% 99.0% 59.3 99.7%
100,000/g 50% 45.3% 13.9% 53.4%
70% 63.4% 19.4% 71.2%
90% 781.6% 25.0% 86.9%
100% 90.6% 27.8% 94.1%

a Assumes that the level of Vibrio parahaemolyticus (Vp) is known in oysters at the time of harvest.
b The % of non-compliant oyster harvest which is removed from the raw oyster consumption market; non-compliant oyster harvest consumed raw is assumed to have the same distribution of Vp/g as (above the compliance level) as under the baseline (no mitigation) scenario.
c Refers to the harvest that would need to be diverted from the "raw market".
d Assuming that the volume of product available for raw consumption is impacted (i.e., reduced) according to the estimate of the % of harvest lost.

Figure A10-47. Percentage of Illnesses Averted

Figure A10-48. Percentage Reduction in Mean Risk per Serving.

Figure A10-49. Percentage of Oyster Harvest Lost to Raw Consumption Market

Figure A10-50. Percentage of Illnesses Averted versus Percentage of Harvest Lost to Raw Consumption Market

Effect of Deviation from Compliance on "At-Retail" Guidance Levels Scenarios

Table A10-12. Effect of Compliance Levels on the Effectiveness of Controlling Total Vibrio parahaemolyticus in Oysters at Retail for Gulf Coast Louisiana Summer
Total Vp/g At-Retaila Compliance Levelb Reduction in Mean Risk per Serving (%) Harvest Diverted (%)c Illness Averted (%)d
100/g 50% 50.0% 47.0% 73.5%
70% 70.0% 65.8% 89.7%
90% 90.0% 84.6% 98.5%
100% ~100% 94.0% ~100%
1000/g 50% 49.7% 37.4% 68.6%
70% 69.8% 52.3% 85.6%
90% 89.9% 67.2% 96.7%
100% 99.8% 74.7% ~100%
5000/g 50% 49.3% 26.4% 62.8%
70% 69.1% 36.9% 80.6%
90% 88.8% 47.5% 94.2%
100% 98.6% 52.8% 99.5%
10,000/g 50% 48.4% 21.5% 59.8%
70% 68.1% 30.1% 77.9%
90% 87.5% 38.7% 92.6%
100% 97.2% 43.0% 98.6%
100,000/g 50% 39.7% 8.3% 45.6%
70% 55.4% 11.7% 62.0%
90% 71.4% 15.0% 77.2%
100% 79.4% 16.7% 84.4%

a Assumes that the level of Vibrio parahaemolyticus (Vp) is known in oysters at the time of harvest.
b The compliance level is the percentage oyster harvest, which is removed from the raw oyster consumption market or subjected to preventive controls; this percentage is assumed to have the same distribution of Vp/g as under the baseline (no mitigation) scenario.
c Refers to the harvest that would need to be diverted from the "raw market" or subjected to preventive controls.
d Assuming that the volume of product available for raw consumption is impacted (i.e., reduced) according to the estimate of the % of harvest lost from the raw market or subjected to preventive controls.

In summary, as the levels increase, the percentage compliance for the at-harvest guidance is not as important in part because fewer numbers of illnesses are prevented at the higher guidance levels. When these same guidance levels are applied at-retail, however, a high percentage of illnesses is prevented, even when compliance is not 100%. For example, to obtain a 60% reduction in illness rates (assuming 50% compliance), the guidance level would need to be 100 at-harvest but at-retail could be as high as 10,000 V. parahaemolyticus/g.


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