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Pathogen Specification - FDA Regulation

Non - RTE Foods

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#1 BALA Prasanna

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Posted 10 March 2019 - 09:55 AM

Hi Team,

               I already share my product category. (Our Products is Non RTE Category (Milled Grain with Spices & processed Vegetables)


Can any one help the pathogen specification for following microbes (as per FDA norms).


Bacillus cereus                        -   1000 CFU/g

Clostridium perfringenes         -    500 CFU/g

Staphylococcus aureus           -   1000 CFU/g

Clostridium botulinum              -   Negative/g

E.coli (Pathogenic)                  -    Negative/g

Salmonella                              -    Negative/g

Listeria monocytogenes          -    Negative/g


Is there any changes required?


Bala Prasanna



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#2 Slab


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Posted 10 March 2019 - 02:33 PM

The FDA establishes action levels for pathogens when one or more organism is present in a 25/g sample. "Adulterated" by definition of 21 CFR is generally considered the presence of pathogens, filth, foreign matter, etc under federal food code regulations. I'm sure there is some exception to the term 'adulterated' that may or not be regulated by the FDA, but I would not even begin to guess what those exceptions are.


Here is a non-binding draft for 21 CFR part 121  Attached File  PCHF-Guidance-Chapter-3_01-17-2018.pdf   334.37KB   48 downloads which lists the following:


  • Bacillus cereus 
  • Campylobacter jejuni 
  • Clostridium botulinum 
  • Clostridium perfringens 
  • Shiga-toxin producing Escherichia coli such as O157:H7 
  • Listeria monocytogenes  
  • Salmonella spp
  • Shigella spp
  • Staphylococcus aureus 



The only reference for Staph A. is in regards to action levels is the presence of enterotoxin, or presence of organism 10^4/g (MPN) that i can find is in Appendix 5, Table A-5 Seafood Hazards Guidance:



Attached File  Appendix 5 FDA and EPA Safety Levels in Regulations and Guidance.pdf   1.92MB   34 downloads


I wouldn't make this list all inclusive, but these are the most common sources of food-borne illness.

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#3 Charles.C


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Posted 11 March 2019 - 10:21 AM

Hi Slab,


FDA PC compilation after signif. guessing appears to yield something like-


Attached File  mic.hazs-raw grain,spices,vegs.xlsx   8.46KB   26 downloads


I would expect levels for B.cereus and C.perfringens(?) but never seen any (USA) published (and not my product area).


@ Kasi4

Assumed to be cooked.

zero tolerant items are IMEX more often designated "not detected/25gram"

Packaging / Storage may also be relevant.

PS - the above is from a HACCP POV, if you are concerned with import regulations, the answer may be different.

Edited by Charles.C, 11 March 2019 - 11:42 AM.

Kind Regards,



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