APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`
` This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not
`
` create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an
`
`
` alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want
`
` to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot
`
` identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
`
`above 50°F (10°C) but below 135ºF (57.2ºC))
`should be limited to 2 hours (3 hours if
`
`Staphylococcus aureus (S. aureus) is the only
`pathogen of concern),
`
`OR
`
`
`Alternatively, exposure time (i.e., time at
`
`internal temperatures above 50°F (10°C) but
`
`below 135ºF (57.2ºC)) should be limited to
`
`4 hours, as long as no more than 2 of those
`
`hours are between 70°F (21.1°C) and 135ºF
`(57.2ºC);
`
`OR
`• If at any time the product is held at internal
`temperatures above 50°F (10°C) but never
`above 70°F (21.1°C), exposure time at internal
`temperatures above 50°F (10°C) should be
`limited to 5 hours (12 hours if S. aureus is the
`only pathogen of concern);
`
`OR
`• The product is held at internal temperatures
`below 50°F (10°C) throughout processing,
`
`OR
`
`
`Alternatively, the product is held at ambient
`
`air temperatures below 50°F (10°C) throughout
`processing.
`
`For cooked, ready-to-eat products:
`• If at any time the product is held at internal
`temperatures above 80°F (26.7°C), exposure
`time (i.e., time at internal temperatures above
`50°F (10°C) but below 135ºF (57.2ºC)) should
`be limited to 1 hour (3 hours if S. aureus is
`the only pathogen of concern),
`
`OR
`
`
`
` This appendix contains information on the growth
`
` and inactivation of bacterial pathogens.
`
`Table A-1 contains information on the minimum
`water activity (aw), acidity (pH), and temperature;
`the maximum, pH, water phase salt, and
`
`temperature; and oxygen requirements that will
`
`sustain growth for the bacterial pathogens that are
`
`of greatest concern in seafood processing. Data
`
`shown are the minimum or maximum values,
`
`the extreme limits reported among the references
`
`cited. These values may not apply to your
`
`processing conditions.
`
`
`
`Table A-2 contains information on maximum,
`
`cumulative time and internal temperature
`
`combinations for exposure of fish and fishery
`
`products that, under ordinary circumstances, will
`
`be safe for the bacterial pathogens that are of
`
`greatest concern in seafood processing. These
`
`maximum, cumulative exposure times are derived
`
`from published scientific information.
`
`
`
`
`Because the nature of bacterial growth is
`logarithmic, linear interpolation using the
`
`time and temperature guidance may not be
`
`appropriate. Furthermore, the food matrix effects
`
`bacterial growth (e.g., presence of competing
`
`microorganisms, available nutrients, growth
`
`restrictive agents). Consideration of such attributes
`
`is needed when using the information in Tables
`A-1 and A-2.
`
`In summary, Table A-2 indicates that:
`
`For raw, ready-to-eat products:
`• If at any time the product is held at internal
`temperatures above 70°F (21.1°C), exposure
`time (i.e., time at internal temperatures
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`417
`
`PARAGON - EXHIBIT 2029
`
`

`
`
`at these temperatures and the time necessary
`
`for significant growth is longer than would be
`
`reasonably likely to occur in most fish and fishery
`
`product processing steps. However, if you have
`
`processing steps that occur at these temperatures
`that approach the maximum cumulative exposure
`times listed in Table A-2 below for the pathogenic
`
`bacteria of concern in your product, you should
`
`consider development of a critical limit for
`
`control at these temperatures.
`
`
`
`
`
`
`
`It is not possible to furnish recommendations
`for each pathogenic bacteria, process, type of
`
`fish and fishery product, and temperature or
`
`combination of temperatures. Programmable
`
`models to predict growth rates for certain
`
`pathogens associated with various foods under
`
`differing conditions have been developed by
`
`the U.S. Department of Agriculture’s (Pathogen
`
`Modeling Program (PMP)) and the United
`
`Kingdom’s (Food MicroModel (FMM) program).
`
`These programs can provide growth curves
`
`for selected pathogens. You indicate the
`
`conditions, such as pH, temperature, and salt
`
`concentration that you are interested in and the
`models provide pathogen growth predictions
`(e.g., growth curve, time of doubling, time of
`
`lag phase, and generation time). FDA does not
`
`endorse or require the use of such modeling
`
`programs, but recognizes that the predictive
`
`growth information they provide may be of
`
`assistance to some processors. However, you
`
`are cautioned that significant deviations between
`
`actual microbiological data in specific products
`
`and the predictions do occur, including those for
`the lag phase of growth. Therefore, you should
`validate the time and temperature limits derived
`
`from such predictive models.
`
`
`
`Table A-3 contains information on the
`
`
`destruction of Listeria monocytogenes (L.
`monocytogenes). Lethal rate, as used in this
`
`
`table, is the relative lethality of 1 minute at the
`
`designated internal product temperature as
`
`compared with the lethality of 1 minute at the
`
`reference internal product temperature of 158°F
`
`(70°C) (i.e., z = 13.5°F (7.5°C)). For example, 1
`
`
`Alternatively, if at any time the product is
`
`held at internal temperatures above 80°F
`
`(26.7°C), exposure time (i.e., time at internal
`
`temperatures above 50°F (10°C) but below
`
`135ºF (57.2ºC)) should be limited to 4 hours,
`
`as long as no more than 1 of those hours is
`above 70°F (21.1°C);
`
`OR
`• If at any time the product is held at internal
`temperatures above 70°F (21.1°C) but never
`above 80°F (26.7°C), exposure time at
`internal temperatures above 50°F (10°C)
`
`should be limited to 2 hours (3 hours if S.
`aureus is the only pathogen of concern),
`
`OR
`
`
`Alternatively, if the product is never held at
`
`internal temperatures above 80°F (26.7°C),
`
`exposure times at internal temperatures
`
`above 50°F (10°C) should be limited to 4
`
`hours, as long as no more than 2 of those
`hours are above 70°F (21.1°C);
`
`OR
`• If at any time the product is held at internal
`temperatures above 50°F (10°C) but never
`above 70°F (21.1°C), exposure time at internal
`temperatures above 50°F (10°C) should be
`limited to 5 hours (12 hours if S. aureus is
`the only pathogen of concern);
`
`OR
`• The product is held at internal temperatures
`below 50°F (10°C) throughout processing,
`
`OR
`
`
`Alternatively, the product is held at ambient
`air temperatures below 50°F (10°C)
`throughout processing.
`
`Note that the preceding recommended
`
`critical limits do not address internal product
`
`temperatures between 40°F (4.4°C), the
`
`recommended maximum storage temperature
`
`for refrigerated fish and fishery products,
`
`
`and 50°F (10°C). That is because growth of
`
`foodborne pathogenic bacteria is very slow
`
`
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`418
`
`

`
`
`minute at 145°F (63°C) is 0.117 times as lethal as
`
`1 minute at 158°F (70°C). The times provided
`
`are the length of time at the designated internal
`
`product temperature necessary to deliver a 6D
`
`process for L. monocytogenes. The length of
`
`
`time at a particular internal product temperature
`
`needed to accomplish a six logarithm reduction
`in the number of L. monocytogenes (6D) is,
`
`
`in part, dependent upon the food in which it
`
`is being heated. The values in the table are
`
`generally conservative and apply to all foods.
`
`You may be able to establish a shorter process
`
`time for your food by conducting scientific
`
`thermal death time studies. Additionally, lower
`
`degrees of destruction may be acceptable in
`your food if supported by a scientific study of
`the normal initial levels in the food. It is also
`
`possible that higher levels of destruction may be
`
`necessary in some foods, if especially high initial
`levels are anticipated.
`
`
`
`Table A-4 contains information on the destruction
`
`
`of Clostridium botulinum (C. botulinum) type B
`(the most heat- resistant form of non-proteolytic
`C. botulinum). Lethal rate, as used in this table, is
`
`
`the relative lethality of 1 minute at the designated
`
`internal product temperature as compared with
`
`the lethality of 1 minute at the reference product
`
`internal temperature of 194°F (90°C) (i.e., for
`
`temperatures less than 194°F (90°C), z = 12.6°F
`
`(7.0°C); for temperatures above 194°F (90°C),
`
`
`z = 18°F (10°C)). The times provided are the
`
`length of time at the designated internal product
`
`temperature necessary to deliver a 6D process
`for C. botulinum. The values in the table are
`
`
`
`generally conservative. However, these values
`may not be sufficient for the destruction of non­
`proteolytic C. botulinum in dungeness crabmeat
`
`
`because of the potential protective effect of
`
`
`lysozyme. You may be able to establish a
`
`shorter process time for your food by conducting
`
`scientific thermal death time studies. Additionally,
`
`lower degrees of destruction may be acceptable
`
`in your food if supported by a scientific study of
`
`the normal innoculum in the food.
`
`
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`419
`
`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`anaerobe4
`facultative
`
`anaerobe3
`
`anaerobe3
`
`anaerobe3
`aerophile2
`
`
`
`micro­
`
`anaerobe4
`facultative
`REQUIREMENT
`
`
`
`OXYGEN
`
`
`
`45°C
`113°F
`
`
`
`3.3°C
`37.9°F
`
`
`
`48°C
`118.4°F
`45°C
`113°F
`55°C
`131°F1
`
`
`
`
`
`
`
`
`10°C
`50°F
`30°C
`86°F
`4°C
`39.2°F
`
`
`
`MAX. TEMP.
`
`MIN. TEMP.
`
`MAX. % WATER
`
`PHASE SALT
`
`TABLE A-1
`
`7
`
`5
`
`10
`
`6
`
`10
`
`20
`
`5.2
`
`8
`
`10
`
`6.5
`
`7
`
`5
`
`10
`
`1.7
`
`10
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`42°C
`107.6°F
`43°C
`109.4°F
`45.3°C
`113.5°F
`43°C
`109.4°F
`48°C
`118°F
`50°C
`122°F
`47.1°C
`116.8°F
`46.2°C
`115.2°F
`45°C
`113°F
`49.4°C
`120.9°F
`52°C
`125.6°F
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-1.3°C
`29.7°F
`8°C
`46.4°F
`5°C
`41°F
`10°C
`50°F
`10°C
`50°F
`7°C
`44.6°F
`6.1°C
`43°F
`5.2°C
`41.4°F
`-0.4°C
`31.3°F
`6.5°C
`43.7°F
`10°C
`50°F
`
`
`
`10
`
`10
`
`11
`
`10
`
`9.8
`
`10
`
`9.3
`
`9.5
`
`9.4
`
`10
`
`9
`
`9
`
`9
`
`9.5
`
`4.2
`
`5
`
`4.8
`
`5
`
`4
`
`4
`
`4.8
`
`3.7
`
`4.4
`
`4
`
`5
`
`5
`
`4.6
`
`4.9
`
`4.3
`pH
`MIN.
`LIMITING CONDITIONS FOR PATHOGEN GROWTH
`
`9.3
`pH
`MAX.
`
`4. Grows either with or without oxygen.
`3. Requires the absence of oxygen.
`2. Requires limited levels of oxygen.
`1. Has significantly delayed growth (>24 hours) at 131°F (55°C).
`
`0.945
`
`YERSINIA ENTEROCOLITICA
`
`0.96
`
`0.94
`
`0.97
`
`0.85
`
`0.83
`
`0.96
`
`0.94
`
`0.92
`
`0.95
`
`0.93
`
`VIBRIO VULNIFICUS
`PARAHAEMOLYTICUS
`
`VIBRIO
`
`STAPHYLOCOCCUS AUREUS
`
`VIBRIO CHOLERAE
`TOXIN FORMATION
`
`STAPHYLOCOCCUS AUREUS
`
`GROWTH
`
`SHIGELLA SPP.
`
`SALMONELLA SPP.
`MONOCYTOGENES
`
`LISTERIA
`
`
`
`PATHOGENIC STRAINS OF
`
`ESCHERICHIA COLI
`
`CLOSTRIDIUM PERFRINGENS
`
`0.97
`
`
`
`CLOSTRIDIUM BOTULINUM,
`
`TYPE E, AND NON­
`
`TYPES B AND F
`PROTEOLYTIC
`
`0.935
`
`0.987
`
`0.92
`
`(USING SALT)
`
`MIN. AW
`
`
`
`TYPE A, AND PROTEOLYTIC
`CLOSTRIDIUM BOTULINUM,
`
`TYPES B AND F
`
`CAMPYLOBACTER JEJUNI
`
`BACILLUS CEREUS
`
`PATHOGEN
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`420
`
`

`
`TABLE A-2
`TIME AND TEMPERATURE GUIDANCE FOR
`CONTROLLING PATHOGEN GROWTH AND TOXIN FORMATION IN FISH AND FISHERY PRODUCTS
`
`MAXIMUM CUMULATIVE
`EXPOSURE TIME
`5 days
`
`1 day
`
`6 hours
`
`3 hours
`48 hours
`12 hours
`
` 11 hours
`
`2 hours
`
`
`7 days
`
`2 days
`
`11 hours
`6 hours
`
`21 days
`
`1 day
`
`6 hours1
`
`2 hours
`
`
`
`2 days
`5 hours
`2 hours
`
`7 days
`
`1 day
`
`7 hours
`3 hours
`1 hour
`
`2 days
`
`5 hours
`
`2 hours
`2 days
`
`5 hours
`
`2 hours
`14 days
`
`12 hours1
`
`3 hours
`
`
`
`21 days
`6 hours
`2 hours
`1 hour2
`
`
`
`21 days
`6 hours
`
`2 hours
`1 hour2
`
`21 days
`6 hours
`2 hours
`1 hour2
`
`
`
`1 day
`
`6 hours
`
`2.5 hours
`
`POTENTIALLY HAZARDOUS CONDITION
`
`PRODUCT TEMPERATURE
`
`39.2-43°F (4-6°C)
`44-59°F (7-15°C)
`60-70°F (16-21°C)
`
`Above 70°F (21°C)
`86-93°F (30-34°C)
`Above 93°F (34°C)
`
`
`
` 50-70°F (10-21°C)
`
`Above 70°F (21°C)
`
`
`
`37.9-41°F (3.3-5°C)
`
` 42-50°F (6-10°C)
`
` 51-70°F (11-21°C)
`Above 70°F (21°C)
`
`50-54°F (10-12°C)
`55-57°F (13-14 °C)
`58-70°F (15-21°C)
`Above 70°F (21°C)
`
`
`
`
`43.7-50°F (6.6-10°C)
`
`51-70°F (11-21°C)
`Above 70°F (21°C)
`
`31.3-41°F (-0.4-5°C)
`
`42-50°F (6-10°C)
`
`51-70°F (11-21°C)
`71-86°F (22-30°C)
`Above 86°F (30°C)
`
`41.4-50°F (5.2-10°C)
`
`51-70°F (11-21°C)
`
`Above 70°F (21°C)
`43-50°F (6.1-10°C)
`51-70°F (11-21°C)
`Above 70°F (21°C)
`50°F (7-10°C)
`
`51-70°F (11-21°C)
`
`Above 70°F (21°C)
`
`
`
`
`50°F (10°C)
`
`51-70°F (11-21°C)
`71-80°F (22-27°C)
`Above 80ºF (27ºC)
`
`41-50°F (5-10°C)
`
`51-70°F (11-21°C)
`
`71-80°F (22-27°C)
`Above 80ºF (27ºC)
`
`
`
`46.4-50°F (8-10°C)
`51-70°F (11-21°C)
`
`71-80°F (22-27°C)
`Above 80ºF (27ºC)
`
`29.7-50°F (-1.3-10°C)
`
`51-70°F (11-21°C)
`
`Above 70°F (21°C)
`
`GROWTH AND TOXIN FORMATION
`BY BACILLUS CEREUS
`
`GROWTH OF CAMPYLOBACTER JEJUNI
`
`GERMINATION, GROWTH, AND TOXIN
`FORMATION BY CLOSTRIDIUM BOTULINUM
`
`TYPE A, AND PROTEOLYTIC TYPES B AND F
`GERMINATION, GROWTH, AND TOXIN
`FORMATION BY CLOSTRIDIUM BOTULINUM
`
`TYPE E, AND NON-PROTEOLYTIC
`TYPES B AND F
`
`GROWTH OF CLOSTRIDIUM PERFRINGENS
`
`GROWTH OF PATHOGENIC STRAINS OF
`ESCHERICHIA COLI
`
`GROWTH OF LISTERIA MONOCYTOGENES
`
`GROWTH OF SALMONELLA SPECIES
`
`GROWTH OF SHIGELLA SPECIES
`
`GROWTH AND TOXIN FORMATION BY
`STAPHYLOCOCCUS AUREUS
`
`GROWTH OF VIBRIO CHOLERAE
`
`GROWTH OF VIBRIO PARAHAEMOLYTICUS
`
`GROWTH OF VIBRIO VULNIFICUS
`
`GROWTH OF YERSINIA ENTEROCOLITICA
`
`1. Additional data needed.
`2. Applies to cooked, ready-to-eat foods only.
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`421
`
`

`
`0.02
`0.03
`0.03
`0.05
`0.07
`0.09
`0.1
`0.2
`0.2
`0.3
`0.4
`0.6
`0.8
`1.0
`1.5
`2.0
`2.7
`3.7
`5.0
`6.8
`9.3
`12.7
`17.0
`
`100.000
`73.564
`54.116
`39.810
`29.286
`21.544
`15.849
`11.659
`8.577
`6.310
`4.642
`3.415
`2.512
`1.848
`1.359
`1.000
`0.736
`0.541
`0.398
`0.293
`0.215
`0.158
`0.117
`
`85
`84
`83
`82
`81
`80
`79
`78
`77
`76
`75
`74
`73
`72
`71
`70
`69
`68
`67
`66
`65
`64
`63
`
`Note: z = 13.5°F (7.5°C).
`185
`183
`182
`180
`178
`176
`174
`172
`171
`169
`167
`165
`163
`162
`160
`158
`156
`154
`153
`151
`149
`147
`145
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`422
`
`TIME FOR 6D PROCESS (MINUTES)
`
`LETHAL RATE
`
`TEMPERATURE (°C)
`INTERNAL PRODUCT
`
`TEMPERATURE (°F)
`INTERNAL PRODUCT
`
`INACTIVATION OF LISTERIA MONOCYTOGENES
`
`TABLE A-3
`
`

`
` *Note: These lethal rates and process times may not be sufficient for the destruction of non-proteolytic C. botulinum in dungeness crabmeat because of the potential that substances that may be naturally
`
`present, such as lysozyme, may enable the pathogen to more easily recover from heat damage.
`
`Note: For temperatures less than 194°F (90°C), z = 12.6°F (7.0°C); for temperatures above 194°F (90°C), z = 18°F (10°C).
`
`
`
`1.0
`1.3
`1.6
`2.0
`2.5
`3.2
`4.0
`5.0
`6.3
`7.9
`10.0
`13.9
`19.2
`27.0
`37.0
`51.8
`
`10.000
`7.940
`6.310
`5.010
`3.980
`3.160
`2.510
`2.000
`1.600
`1.260
`1.000
`0.720
`0.520
`0.370
`0.270
`0.193
`
`100
`99
`98
`97
`96
`95
`94
`93
`92
`91
`90
`89
`88
`87
`86
`85
`
`212
`210
`208
`207
`205
`203
`201
`199
`198
`196
`194
`192
`190
`189
`187
`185
`
`TIME FOR 6D PROCESS (MINUTES)
`
`LETHAL RATE*
`
`TEMPERATURE (°C)
`INTERNAL PRODUCT
`
`TEMPERATURE (°F)
`INTERNAL PRODUCT
`
`INACTIVATION OF NON-PROTEOLYTIC CLOSTRIDIUM BOTULINUM TYPE B
`
`TABLE A-4
`
`APPENDIX 4: Bacterial Pathogen Growth and Inactivation
`423
`
`

`
`• Augustin, J. C., V. Zuliani, M. Cornu, and
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`
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`
` Monday through Friday. As of March 29, 2011,
`
` FDA had verified the Web site address for the
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