1. Safety-Based Use-By Date Labeling Robert L. Buchanan DHHS Food & Drug Administration Center for Food Safety & Applied Nutrition

2. Presentation Background Background NACMCF working group NACMCF working group Subcommittee’s initial thoughts Subcommittee’s initial thoughts Next steps Next steps

3. Background Listeria monocytogenes risk assessment emphasized the importance of the duration and temperature of refrigerated storage Listeria monocytogenes risk assessment emphasized the importance of the duration and temperature of refrigerated storage

4. Background The risk assessessments emphasize that The risk assessessments emphasize that The risk of acquiring foodborne listeriosis is primarily associated with RTE foods that have high levels of L. monocytogenes The risk of acquiring foodborne listeriosis is primarily associated with RTE foods that have high levels of L. monocytogenes The risk of foodborne listeriosis is generally associated with foods that support the growth of L. monocytogenes at refrigerated temperatures The risk of foodborne listeriosis is generally associated with foods that support the growth of L. monocytogenes at refrigerated temperatures

5. Background Extending period of refrigerated storage Extending period of refrigerated storage Increases the potential for the growth of psychrotrophic pathogenic bacteria Increases the potential for the growth of psychrotrophic pathogenic bacteria Listeria monocytogenes Listeria monocytogenes Non-proteolytic Clostridium botulinum Non-proteolytic Clostridium botulinum Yersinia enterocolitica Yersinia enterocolitica Psychrotrophic Bacillus cereus Psychrotrophic Bacillus cereus Others???? Others???? Increases the likelihood that the product will be exposed to a period of transitory abuse Increases the likelihood that the product will be exposed to a period of transitory abuse

6. Background FDA/FSIS Listeria monocytogenes Action Plan FDA/FSIS Listeria monocytogenes Action Plan Objective #5, Subobjective #3 Objective #5, Subobjective #3 FDA and FSIS will seek the advice from a scientific advisory committee on the scientific basis for establishing safety-bassed “use by” date labeling for refrigerated, ready-to-eat foods.”

7. National Advisory Committee on Microbiological Criteria for Foods

8. NACMCF New “Performance Standard” Working Group New “Performance Standard” Working Group “Requisite Scientific Parameters for Establishing Safety-Based Use-By Dates for Refrigerated Ready-to-Eat Foods” “Requisite Scientific Parameters for Establishing Safety-Based Use-By Dates for Refrigerated Ready-to-Eat Foods”

9. Questions for NACMCF 1. What are the scientific parameters for establishing safety-based “use by” date labels for refrigerated RTE foods? 1. What are the scientific parameters for establishing safety-based “use by” date labels for refrigerated RTE foods?

10. Questions for NACMCF 2. Should safety-based “use by” date labels for refrigerated RTE foods be established using mathematical modeling techniques? If so, what modeling approaches are best suited to the development of safety-based “use by” date labels for refrigerated RTE foods? 2. Should safety-based “use by” date labels for refrigerated RTE foods be established using mathematical modeling techniques? If so, what modeling approaches are best suited to the development of safety-based “use by” date labels for refrigerated RTE foods?

11. Questions for NACMCF 3. What data needs to be acquired to scientifically validate and verify the adequacy of a proposed safety- based “use by” date label for a refrigerated RTE food? 3. What data needs to be acquired to scientifically validate and verify the adequacy of a proposed safety- based “use by” date label for a refrigerated RTE food?

12. Questions for NACMCF 4. What effect do the multiple factors that influence the growth and survival of L. monocytogenes and other psychrotrophic pathogens (e.g., strain differences, food matrices, production and distribution systems, consumer susceptibility) have on the establishment of safety-based “use by” date labels for refrigerated RTE foods? 4. What effect do the multiple factors that influence the growth and survival of L. monocytogenes and other psychrotrophic pathogens (e.g., strain differences, food matrices, production and distribution systems, consumer susceptibility) have on the establishment of safety-based “use by” date labels for refrigerated RTE foods?

13. Questions for NACMCF 5. What impact would safety-based “use by” date labels likely have on the control of other non- psychrotrophic, foodborne pathogens in refrigerated RTE foods? 5. What impact would safety-based “use by” date labels likely have on the control of other non- psychrotrophic, foodborne pathogens in refrigerated RTE foods?

14. NACMCF DLWG R. Buchanan – Chair D. Acheson D. Bernard C. Donnelly D. Englejohn S. Garrett M. Kunduru J. Luchansky M. Neill B. Swamanathan K. Swanson B. Tompkin Working Group Members

15. NACMCF DLWG FDA technical liaisons: FDA technical liaisons: Richard Whiting Richard Whiting Diana Hao Diana Hao Andreas Keller Andreas Keller

16. Date-Label Working Group: Progress Report

17. Scope of Report Identify classes of foods where date labels would useful Identify classes of foods where date labels would useful Identify scientific parameters to be considered in developing date labels Identify scientific parameters to be considered in developing date labels Recommend approaches and requirements for validating date labels Recommend approaches and requirements for validating date labels

18. Scope of Report Focus on Refrigerated RTE products Focus on Refrigerated RTE products that are consumed directly with minimal preparation that are consumed directly with minimal preparation where the risk of foodborne disease may increase as a result of the growth of a psychrotrophic foodborne pathogen during adequate refrigerated storage where the risk of foodborne disease may increase as a result of the growth of a psychrotrophic foodborne pathogen during adequate refrigerated storage where date labeling would limit the extent of growth where date labeling would limit the extent of growth

19. Scope of Report Not covered are: Not covered are: Foods that do not support the growth of psychrotrophic pathogens of concern Foods that do not support the growth of psychrotrophic pathogens of concern Foods that remain frozen until just prior to consumption Foods that remain frozen until just prior to consumption Foods that are consumed so quickly after manufacture that a psychrotrophic pathogen would not have time to initiate growth Foods that are consumed so quickly after manufacture that a psychrotrophic pathogen would not have time to initiate growth

20. Current Label Uses Most common date label is “sell by” dates Most common date label is “sell by” dates NIST – Handbook 130 NIST – Handbook 130 “…(a sell-by date label) allows a reasonable period after sale for consumption of the food without physical spoilage, loss of value, or loss of palatability. A reasonable period for consumption shall consist of at least one third of the approximate total shelf life of the perishable food.” “…(a sell-by date label) allows a reasonable period after sale for consumption of the food without physical spoilage, loss of value, or loss of palatability. A reasonable period for consumption shall consist of at least one third of the approximate total shelf life of the perishable food.”

21. Current Label Uses Currently, variety of other types of date labels are used with food products Currently, variety of other types of date labels are used with food products “Consume by,” “Best if purchased by,” “Best if used by,” etc “Consume by,” “Best if purchased by,” “Best if used by,” etc These labels are almost always used to describe product quality These labels are almost always used to describe product quality Focus groups indicate that consumer interpret them as meaning “Safe to consume until” Focus groups indicate that consumer interpret them as meaning “Safe to consume until”

22. Current Label Uses There are a few examples where date labels are used for safety purposes There are a few examples where date labels are used for safety purposes Date marking in Food Code Date marking in Food Code Use-by dates on infant formula (nutrient loss based) Use-by dates on infant formula (nutrient loss based)

23. Label Types Initial thoughts is that likely to require two label system Initial thoughts is that likely to require two label system Sell-by date Sell-by date Use-within instructions from time of purchase Use-within instructions from time of purchase

24. Factors Affecting Growth Primary determinants are the factors that affect growth Primary determinants are the factors that affect growth Varied Varied Interactive Interactive This information is known, either specifically or generally, for primary growth determinants This information is known, either specifically or generally, for primary growth determinants Temperature *** Temperature *** Water activity Water activity pH pH

25. Factors Affecting Growth One of the key question is what temperature should be used to calculate safety-based use-by date labels One of the key question is what temperature should be used to calculate safety-based use-by date labels Adequate refrigeration (e.g., 4  C)? Adequate refrigeration (e.g., 4  C)? Marginal abuse (e.g., 10  C)? Marginal abuse (e.g., 10  C)? Distribution of observed temperatures to calculate value of mean + 2SD? Distribution of observed temperatures to calculate value of mean + 2SD?

26. Factors Affecting Growth Predicted L. monocytogenes growth at pH 6.0, NaCl = 2.5%, NaNO 2 = 20 ppm

27. Factors Affecting Growth Should the lag phase be included in the calculation of a safety-based use-by date label? Should the lag phase be included in the calculation of a safety-based use-by date label?

28. To Lag Phase or Not to Lag Phase? Lm: 4 C, pH 6.5, 1% NaCl Calculated to specified log increase (hr) 1 log 2 log 3 log With Lag 105145189 W/O Lag 4080119 % Lag 62%45%35%

29. Factors Affecting Growth Which microorganism? Which microorganism? Which strain? Which strain? Median? Median? Mean? Mean? Extreme? How extreme? Extreme? How extreme?

30. Other Factors Target for Label: General population? High risk population? Target for Label: General population? High risk population? “Readability” of message? “Readability” of message? Seasonal or regional difference? Seasonal or regional difference? Multiple component foods? Multiple component foods?

31. DLWG Initial Thoughts

32. Initial Thoughts Selection of psychrotoph establishment of safety-based date label: Conduct hazard analysis Selection of psychrotoph establishment of safety-based date label: Conduct hazard analysis Use of surrogate possible but would need to validate against pathogen of concern Use of surrogate possible but would need to validate against pathogen of concern

33. Initial Thoughts Selection of criterion: Selection of criterion: 1 log increase - 10-fold increase in risk)? 1 log increase - 10-fold increase in risk)? 2-log increase – 100-fold increase in risk 2-log increase – 100-fold increase in risk Potential for other criteria is can assume threshold (e.g., production of emetic toxin by psychrotrophic B. cereus) Potential for other criteria is can assume threshold (e.g., production of emetic toxin by psychrotrophic B. cereus)

34. Initial Thoughts Strain selection: Strain that is 2 standard deviations above the mean specific growth rate Strain selection: Strain that is 2 standard deviations above the mean specific growth rate Pre-adaptation of strains to low temperature Pre-adaptation of strains to low temperature Use lag phase observed with pre- adapted cells (i.e. minimum lag phase value) unless know source of contamination or previous impact of processing Use lag phase observed with pre- adapted cells (i.e. minimum lag phase value) unless know source of contamination or previous impact of processing

35. Initial Thoughts Method of inoculation should mimic major mode on contamination Method of inoculation should mimic major mode on contamination Surface? Surface? Internal? Internal? Level of inoculation should be as low as possible while still being practical and eliminating concerns about highly variable responses Level of inoculation should be as low as possible while still being practical and eliminating concerns about highly variable responses

36. Initial Thoughts Inoculated pack studies need to be conducted with sufficient replications to account for variability Inoculated pack studies need to be conducted with sufficient replications to account for variability Pathogen Pathogen Product Product Processing conditions Processing conditions

37. Initial Thoughts Inoculated pack should be conducted at two temperatures? Inoculated pack should be conducted at two temperatures? Adequate refrigeration (4  C) Adequate refrigeration (4  C) 2-standard deviations of expected distribution of refrigeration conditions (8 to 10  C) 2-standard deviations of expected distribution of refrigeration conditions (8 to 10  C)

38. Initial Thoughts Likely to use mathematical models but will have to be careful that are validated or “fail safe” Likely to use mathematical models but will have to be careful that are validated or “fail safe” Will have to provide “default values” for could that do not have the resources to conduct laboratory determinations Will have to provide “default values” for could that do not have the resources to conduct laboratory determinations

39. Next Steps

40. Revised draft document next meeting of the subcommittee Revised draft document next meeting of the subcommittee January, 2003? January, 2003? Presentation of the most recent draft to full NACMCF committee for comment Presentation of the most recent draft to full NACMCF committee for comment February/March, 2003 February/March, 2003 Completion of document Completion of document Late spring 2003? Late spring 2003?

41. Next Steps Interested in hearing scientific input and identification of pertinent studies or committee reports Interested in hearing scientific input and identification of pertinent studies or committee reports Robert.Buchanan @cfsan.fda.gov Robert.Buchanan @cfsan.fda.gov