Food

Evaluation and Definition of Potentially Hazardous Foods - Appendix B. Data from Industry and Trade Organizations - Challenge Studies

Table of Contents

Challenge Studies - "Potentially Hazardous Foods"
Product Microorganism Rep Inoculation Method Level Endpoint T Incubation t other Enumeration methods Pass/fail criteria Other
Italian Salad Dressing S. Enteritidis no   3log/g >10 35°C 5 min covered FDA's BAM no growth/ pass  
S. Typhimurium no   3log/g >10 35°C 5 min covered  
67 Salad Dressings Salmonella spp (3 ck)     500cfu/g not detected       XLD agar, enrich in lactose broth/FDA BA protocol no Salmonella within 72 h pass
3 Barbecue Sauces Salmonella spp (3 ck)     500cfu/g not detected       XLD agar, enrich in lactose broth/FDA BA protocol no Salmonella within 72 h pass
Pumpkin Pie S. aureus 3 on and in
filling
106, 107, 108,
 109/g (1 ml)
103, 103, 106, 106/no toxin* Room T 6 d (3 samp) bagged, open air, or box BHI agar/oxoid staph test no toxin production/pass *> 1ng/g
Pumpkin Pie S. aureus 3 in pie filling 140/g (0.05 ml) 140cps <100 cps/g 25°C 3 d (2 samp)   Baird - Parker /coagulase + no growth /g/pass  
Lemon Meringue Pie S. aureus (2 cultures)/ L. monocytogenes (2 cultures) 3 rows in filling, intersection,
and merengue.
3,000/1,500/
sample
<10 / sample Room 5 d (3 samp)   Baird - Parker and Mox agar no growth/pass TPC, Salmonella -
Hush Puppy Mix B. cereus 2   ~3.5log/g ~3log 35°C 8 h   ICMSF and FDA's BAM no growth  
S. aureus 2   ~4log ~5log 35°C 4 h    
~6.5log 8 h  
S. senftenberg 2   ~2.3log ~2.5log 35°C 8 h    
~6log 19 h  
Hush Puppy Mix w/Onions S. aureus 2   ~2.3log ~2.3log, ~3.3log 35°C 4 h, 8 h   ICMSF and FDA's BAM no growth/pass at 4 h  
Product Microorganism Rep Inoculation Method Level Endpoint T Incubation t other Enumeration methods Pass/fail criteria Other
Apple - Cheese Danish S. aureus ck, (5) 2 in four places 360/g 320, 395, 10/g 25°C 24 h, 4d, 11d in sterile bags Baird - Parker no growth at 14 - 18h/pass  
L. monocytogenes 2 in four places 435/g 235, 160, 10/g 25°C 24 h, 4d, 11d in sterile bags Mox  
E. coli ck (2) 2 in four places 1900/g 470, 10,10/g 25°C 24 h, 4d, 11d in sterile bags E. coli petrifilm  
S. enteritidis/typhimurium ck(5) 2 in four places 145/g 15,10,10/g 25°C 24 h, 4d, 11d in sterile bags XLD  
Blueberry - Cheese Danish S. aureus ck, (5) 2 in four places 360/g 340, 215, 10/g 25°C 24 h, 4d, 11d in sterile bags Baird - Parker no growth at 14 - 18h/pass  
L. monocytogenes , 2 in four places 435/g 190, 235, 50/g 25°C 24 h, 4d, 11d in sterile bags Mox  
E. coli ck (2) 2 in four places 1900/g 300, 35, 10/g 25°C 24 h, 4d, 11d in sterile bags E. coli petrifilm  
S. enteritidis/typhimurium ck(5) 2 in four places 145/g 70,10,10/g 25°C 24 h, 4d, 11d in sterile bags XLD  
Cherry - Cheese Danish S. aureus ck, (5) 2 2 2 2 in four places 360/g 170, 170, 170/g 25°C 25°C 25°C 24 h, 4d, 11d in sterile bags Baird - Parker no growth at 14 - 18h/pass  
L. monocytogenes , 2 in four places 435/g 275, 25, 30/g 25°C 24 h, 4d, 11d in sterile bags Mox  
E. coli ck (2) 2 in four places 1900/g 155, 30,10/g 25°C 24 h, 4d, 11d in sterile bags E. coli petrifilm  
S. enteritidis/typhimurium ck(5) 2 in four places 145/g 25,10,10/g 25°C 24 h, 4d, 11d in sterile bags XLD  
Eclaires Salmonella spp ck (4)   in filling 90/g <100, <100, <100 26,12,7°C 4 d in sterile bags XLD no growth or toxin at 4.5 days/fail  
S. aureus ck (5) in filling 2.3 x 102/g <5log, 2log, <100 26,12, 7°C 4 d in sterile bags Baird - Parker  
L. monocytogenes ck in filling 4.8 x 102/g <4log, 4log, 4log 26,12, 7°C 4 d in sterile bags Mox  
RTE Chocolate Pie and Donut Filling S. aureus ck (5)     8 x 2log not detected 10, 32°C 21 d in sterile bags Baird - Parker no growth or toxin at 1.5 x shelf - life/pass at 2 weeks  
L. monocytogenes (2)     1.5 x 3log ~200 10, 32°C 21 d in sterile bags Mox  
B. cereus (2)     3 x 2log not detected 32°C 21 d in sterile bags MYP  
S. enteritidis/typhimurium (6)     ~2.5 x 2log not detected 10, 32°C 21 d in sterile bags/ana XLD  
C. sporogenes (2)     2log not detected 32°C 21 d SFP  
Fettuccine Alfredo with Chicken C botulinum ck     4log cfu/ml no toxin 12, 21°C 60 d, 5 d     no toxin for 5 d at 21°C or 60 d at 12°C pass  
Chopped Lettuce S. Enteritidis, Cholerasuis, and Typhimurium, 2   ~3log ~5log 24°C 24 h sterile containers XLD ?  
L. monocytogenes ck (3)   ~3log ~4log 24°C 24 h sterile containers MOX  
Chopped Onions S. Enteritidis, Cholerasuis, and Typhimurium, 2   ~3log ~2log 24°C 24 h sterile containers XLD ?  
L. monocytogenes ck (3)   ~3log ~4log 24°C 24 h sterile containers MOX  
Tomatoes Salmonella spp     50 ~1log,~7log 30°C 4h, 24 h     ? Distr. At 5°C
Poultry/Bacon/ Cheese - Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaerob
100 - 500 spores/g toxin at aw .98 at 26°C/14d no toxin at aw .89 - 94 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/ pass or fail aw dependant
Chicken/ Cheese - Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g toxin at aw .98 at 26°C/14d no toxin at aw .89 - 94 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/ pass or fail aw dependant
Product Microorganism Rep Inoculation Method Level Endpoint T Incubation t other Enumeration methods Pass/fail criteria Other
Cheese - Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g no toxin at aw .89 - .98 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/  
Ham - Cheese Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g toxin at aw .98 at 26°C/14d, no toxin at aw .89 - 94 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/ pass or fail aw dependant
Precooked Ground Beef/Cheese/Ham - Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g toxin at aw .98 at 26°C/14d, no toxin at aw .89 - 94 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/ pass or fail aw dependant
Cheese - Filled Bread C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g toxin at aw .97 at 26°C/14d, no toxin at aw .89 - 94 26/18/13°C 14 d/1 wk/8 wk   mouse bioassay no toxin for 14d at 26°C, 1 wk at 18°C, and 14 wk at 13/ pass or fail aw dependant
Process Cheese Slices (Monterey) L. monocytogenes   surface inoculated 1000cfu/g 3.3log 30°C (24, 48, 72,) 96h   selective media no growth failed (pass at 24 only)
S.aureus   7log  
Salmonella   1log  
E. coli O157:H7   2.7log  
Process Cheese Slices (Swiss) L. monocytogenes   surface inoculated 1000cfu/g 2.8log 30°C (24, 48, 72,) 96h   selective media no growth pass
S.aureus   3.2log  
Salmonella   1log  
E. coli O157:H7   2.5log  
Process Cheese Slices (American) L. monocytogenes   surface inoculated 1000cfu/g   30°C (24, 48, 72,) 96h   selective media no growth no data
S.aureus      
Salmonella      
E. coli O157:H7      
Cottage Cheese Hot Pack C. botulinum prot. A + B
C. botulinum non - prot. B
  added to
ground
product/
anaero
100 - 500 spores/g   26°C 108 h   mouse bioassay no toxin pass
S. aureus     4log 5log (no toxin) 140°F to 45°F 30h   Baird - Paker agar or SET - EIA kit for toxin no toxin pass
    5log (no toxin) 140°F to 45°F 30h  
    plus 98°F 8h  
    5log (no toxin) 140°F to 45°F 4h  
    2log (no toxin) 45°F 60d  
Product Microorganism Rep Inoculation Method Level Endpoint T Incubation t other Enumeration methods Pass/fail criteria Other
18 Process Cheese Slices (Cream) C. botulinum (mixed strains)   added to
heated
cheese/
agitation into tubes
1000 spores/g   86°F 4 wk, 8wk   mouse bioassay no toxin depending on formulation (salt?)
14 Process Cheese Sauce C. botulinum (mixed strains)   added to
heated
cheese/
agitation into tubes
1000 spores/g   45, 55, 65, 86°F 4 wk, 8wk   mouse bioassay fail  
Process Cheese Sauce (with Spices) C. botulinum (mixed strains)     20 or 70 spores/g   86°F 13 mo (13 sampling times)   mouse bioassay no toxin pass
Process Cheese Spread C. botulinum (mixed strains)   added uniformly to cheese 1000 spores/g   86°F     mouse bioassay no toxin 1 out of 5 fail at 6 mo
Process Cheese Spread C. botulinum (mixed strains)   added uniformly to cheese 1000 spores/g   45, 55, 65, and 86°F 25 wk   mouse bioassay no toxin 1 out of 4 fail at 65°F/12 wk
Cheese Blend (Pizza) S. aureus (3)   added & mixed 630/g 3,700/g No toxin 80°F 10 hr   FDA's BAM no hazardous level / no toxin also used pathogen model 4.0
B. cereus (3)   850/g 10/g No toxin  

 

 

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