Relating Microbiological Testing and Microbiological Criteria to Public Health Goals. Washington

Transcription

1 Relating Microbiological Testing and Microbiological Criteria to Public Health Goals Washington Industry uses of microbiological testing and microbiological criteria in the manufacturing and marketing of processed foods J.L. Cordier NN-QS/OP Name of chairman Different types of criteria exist They are used to determine the acceptability of a food. 2 1

2 Microbiological standards Public Health Authorities Codex Principles They are used to determine the acceptability of a food or compliance with regard to a regulation or policy Industry Control Authorities 3 Microbiological guidelines Control Authorities Industry Associations Are advisory and may be established to indicate expectations when best practices are applied to manufacture safe foods. Control Authorities Industry 4 2

3 Microbiological specifications Industry Retail Purchase specifications defining the microbiological limits for an ingredient or a finished product. Supplier Customer 5 How are criteria established? Basic Texts Codex Alimentarius PRINCIPLES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA FOR FOODS CAC/GL Based on principles of the ICMSF (Vol 2) 6 3

4 New approach From MRA ALOP FSO/PO MC FSO Micro Criteria Goal for process design to obtain acceptable food. Applied to processing operations Statement of conditions that differentiates acceptable from unacceptable lots of food. Applied to individual lots or consignements of food. (Comparison of a few elements only; for more see ICMSF Vol 7) 7 Food Chain - Example Performance objective Performance objective Performance objective Food Safety Objective primary production manufacturing transport retail preparation cooking consumption exposure Performance criterion Performance criterion Performance criterion [Performance criterion] Public health burden Control Measure Control Measure Control Measure 8 4

5 How are FSO or PO used by industry? H o - Σ R + Σ I RC+G FSO / PO Starting level Increase RC: Recontamination G: Growth Hazard level at moment of consumption Reduction Hazard level in the food chain 9 Food Chain - Ingredients MANUFACTURE Specifications 10 5

6 Ingredients - Specifications Milk Powder Different usage Different specifications 11 Ingredients - Specifications High Risk Level - Ingredient Low Historical data Usage and further processing Type of finished product Requirements Supplier audits etc. Confidence Level - Supplier High 12 6

7 Food chain Finished Goods MANUFACTURE Specifications Criteria Guidelines Specifications 13 Why not relying only on end product testing? 0.1% contaminated 10 samples ~1% probability of detection 10 samples 20 % contaminated ~35% probability of acceptance 14 7

8 Food chain Manufacturing In processing testing MANUFACTURE Specifications Criteria Guidelines Specifications 15 Food chain Example of Infant Formula CCP WET DRY 16 8

9 How to control Salmonella or Enterobacteriaceae? Medium Hygiene High Hygiene Zoning includes appropriate Design of building(s), Design of air handling/flow, Flow of people and materials 17 How to control Salmonella or Enterobacteriaceae? WET WET CLEANING DRY CLEANING 18 9

10 How to control Salmonella or Enterobacteriaceae? Hygiene Indicator H 2 O H 2 O ENTEROBACTERIACEAE H 2 O H 2 O SALMONELLA Consequences of wet cleaning SALMONELLA TIME 19 How to control Salmonella or How to control E. sakazakii? Enterobacteriaceae? Low levels of EB can only be achieved in the total absence of water H 2 O ENTEROBACTERIACEAE EB/ E.sakazakii TIME 20 10

11 Food Chain Manufacturing In processing testing MANUFACTURE Product / Semi-finished product Line Food contact surfaces including residues Environment Points close to remote from line 21 Line samples - Examples Sampling of food contact surfaces - line samples 22 11

12 Environmental samples - Examples 23 Environmental samples - Examples Sampling of the processing environment 24 12

13 Environmental samples - Examples Sampling of the processing environment 25 Environmental samples - Impact Deviations in environmental samples such as Positive Salmonella result Enterobacteriaceae above an defined level Abnormal situations maintenance, cleaning, etc. have an immediate impact on sampling frequencies of line samples and finsihed product samples

14 How to model relationship between line and product samples? n 2 =4 Line (first powder, sieve output, first & last can) L sample P L Proportion of positive results c L,t sample c L,t? c P,t? +/- +/- +/- +/- sample L sample P L Product (can/soft pack) sample sample n 1 =2 +/- +/- Proportion of positive results C P,t 27 How to model relationship between line, product and environmental samples? n 3 =20 c E1,t ~N(???,???) E 1 Environment E1 n 2 =4 Line Product n 1 =2 E 1 E 1 E 1 E 1 c L,t ~N(????,????) c L,t? L L L P c P,t? Perfomance of processing line c P,t ~N(????,????) P E 1 L ρ P,E1 =??? ρ P,L =??? 28 14

15 Trend analysis to see effects or to detect impact of modifications or deviations Trends of Enterobaocateriaceae in high hygiene zone after the implementation of more stringent preventive measures <10/g /g 100/g % of samples Month 29 Trend analysis to see effects or to detect impact on finished product. 120 %of critical environmental samples < > Jul 03 Aug 03 Sep 03 Oct 03 Nov 03 Dec 03 Jan 04 Feb

16 Trend analysis to see effects or to detect impact on finished product % of lots positive in Jan 03 Feb 03 M ar 03 Apr 03 May 03 Jun 03 Jul 03 Aug 03 Sep 03 Oct 03 N ov 03 Dec 03 Jan 04 Feb Comparison of sampling plans Performance (Enterobacteriaceae) 1 Probability acceptance Probability of acceptance n = 2; c = 0, m = 0 (10g) FP n = 7 (+5); c = 0, m = 0 (10g) FP + L n = 12 (+10), c = 0, m = 0 (10g) FP + L Codex or EU n = 10, c = 0, m = 0 (10g) - FP Codex (new ) ICMSF-Case 15 (V=10g) ICMSF-Case 14 (V=10g) ICMSF-Case 13 (V=10g) Nestec (CP ) Boué Boué (+environmental) ICMSF n = 15, 30, 60 n 12 = (cfu/g) Concentration cfu/g 32 16

17 Effective methods to test FP, L, E Influence of temperature 100% 80% 60% 40% 20% 0% 30 C 37 C 42 C Others C. freundii A. calco. E. coli E. sakazakii E. cloacae E.agglomerans E. sakazakii difficult (if at all) to find in environmental samples if competitive flora (EB) important