Engeljohn_Lethality

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					  Processed Meat and Poultry
    Performance Standards
      _________________

   Lethality and Stabilization



Daniel Engeljohn
USDA, FSIS
May 9, 2001
                                 1
              Docket Information
• Docket #97-013P

• Performance Standards for the Production of
  Processed Meat and Poultry Products;
  Proposed Rule

• 66 FR 12589, February 27, 2001

• Comment closing date extended; now due
  June 28, 2001                                 2
      Proposed Definitions Relative to Lethality
• 9 CFR 430.1
     • Fermented product
       – Made ready-to-eat by bacterial enzymes acting
        to lower pH and microbial inhibition
    • Ready-to-eat product
       – Safe to consume without cooking or application
        of some other lethality treatment to destroy
        pathogens
    • Worst case product
       – Defined for lethality requirements in 9 CFR
        430.2(a)(1) for meat and poultry, and in 9 CFR
        430.2(b)(1) for beef                         3
    Proposed Text for Lethality: Salmonella


• 9 CFR 430.2(a)
  – Either a probability of survival
     • No greater than the specified Salmonella organisms
       in any 100 grams of finished product, assuming
       incoming product is worst case
  – Or a log reduction
     • 6.5-log10 reduction for meat
     • 7.0-log10 reduction for poultry
  – Detectable viable Salmonella adulterate ready-
    to-eat product
                                                        4
  Proposed Text for Lethality: E. coli O157:H7


• 9 CFR 430.2(b)
  – Either a probability of survival
     • No greater than the specified E. coli O157:H7
       organisms in any 100 grams of finished (fermented
       beef) product, assuming incoming product is worse
       case
  – Or a log reduction
     • 5.0-log10 reduction for fermented meat or poultry
       product containing beef
  – Detectable viable E. coli O157:H7 adulterate
    ready-to-eat product
                                                           5
           Proposed Text for Lethality


• 9 CFR 430.2(c)
  – Reduction of other pathogens and their toxins or
    toxic metabolites:
     • Validated to prevent product adulteration
• 9 CFR 430.2(d)
  – Maintain the lethality performance standards
    throughout product shelf-life
     • Validated under the conditions in which the food is
       stored, distributed, and held


                                                             6
  Determination of worst case levels: Lethality

• Used highest Most-Probable-Number
  (MPN) results from FSIS national
  microbiology baseline surveys
• MPN samples were frozen; samples were
  companion with those that tested
  Salmonella positive on a qualitative test
• Conservative assumptions were made in
  determining worst case levels

                                                  7
         Hf1gu r u
         ig g / r ny
         s o M d rs
         t mPr p s
          o l 0) o l e
          r oN
          a ( f g ut
                   t
               o o l


     0
     5



     0
     4



     0
     3
counts

     0
     2



     0
     1



     0
      1
      . 1
      5 0
        . . . 0
        0 5 . 1
            0
      - - - 0 5 1
                . . 2
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                    0
                  5 2 5 3
                        . . 4
                        0   . .
                            0
                          5 4   5
                              8
               oN
               g/
                1g
                 (
                 MP
               l 0)
  Salmonella Lethality Performance Standard


• Safety margin:
  – 0.3-log10 added to worst case level resulting in
    the performance standard:
     • Poultry = 7.0-log10
     • Meat = 6.5-log10
  – Implies that after application of the lethality
    treatment on raw product containing worst case
    level of cells, probability of any viable cell is
    39.4%

                                                       9
E. coli O157:H7 Lethality Performance Standard for
                 Fermented Beef

• Safety margin:
   – 0.6-log10 added to worst case level resulting in
     the performance standard:
      • Fermented beef = 5.0-log10
   – Implies that after application of the lethality
     treatment on fermented beef containing worst
     case level of cells, probability of any viable cell
     is 22.2%


                                                           10
          Proposed Text for Stabilization

• 9 CFR 430.3(a)
  – Processing of all ready-to-eat meat and poultry
    products must prevent multiplication of
    toxigenic microorganisms:
     • Clostridium botulinum
     • Allow no more than 1.0-log10 multiplication of
       Clostridium perfringens
• 9 CFR 430.3(b)
  – Processing of all heat treated, not ready-to-
    eat meat and poultry products must meet same
    criteria as in (a) above
                                                        11
          Proposed Text for Stabilization


• 9 CFR 430.3(c)
  – Processing of products applicable to 9 CFR
    430.3(a) or (b) must be validated:
     • to maintain stabilization performance standards
       throughout product shelf-life under conditions in
       which the food is stored, distributed, and held




                                                           12
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                                 13
Determination of worst case level: C. perfringens

• Used results from FSIS national
  microbiological baseline survey
• No finding greater than 105/g
• Worst case is assumed to be 104 C.
  perfringens per gram that become heat
  shocked, germinate, and after a lag period,
  multiply as vegetative cells during cooling



                                                14
             Draft Compliance Guidelines
• Available now:
  – Constituent Update, May 4
  – FSIS Website at:
     • www.fsis.usda.gov/OPPDE/rdad/FRPubs/RTEGuide.pdf
• FSIS requests comment on these
  – Including suggestions for expansion to cover all types
    of ready-to-eat and partially heat-treated meat and
    poultry products
• Draft guidelines
  – Not to be used for regulatory enforcement or
    compliance purposes                               15

				
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