1. Foodborne Outbreak and Recalls Mansour Samadpour IEH Laboratories and consulting Group Seattle, Washington Mansour Samadpour IEH Laboratories and consulting Group Seattle, Washington

2. Why do we have so many foodborne outbreaks Many food producers with respect to food safety unknowingly play a game of Russian Roulette Food safety becomes a focus only when it becomes an issue (outbreak, recall, NOS, NOIE, customer specification) Even after a major outbreak, in most cases, for the rest of the members of a given industry the guys with the problem had “done something wrong” They wish for them to go away/bankrupt. Only with repeated outbreaks the industry and or regulators will come up wit ha workable solution Sometimes the entire industry takes actions (beef, almond) Many food producers with respect to food safety unknowingly play a game of Russian Roulette Food safety becomes a focus only when it becomes an issue (outbreak, recall, NOS, NOIE, customer specification) Even after a major outbreak, in most cases, for the rest of the members of a given industry the guys with the problem had “done something wrong” They wish for them to go away/bankrupt. Only with repeated outbreaks the industry and or regulators will come up wit ha workable solution Sometimes the entire industry takes actions (beef, almond)

3. How outbreaks are detected In most instances outbreaks detect epidemiologist With better epidemiology we will see a lot more outbreaks In most instances outbreaks detect epidemiologist With better epidemiology we will see a lot more outbreaks

4. The Current State of Epidemiology Most of the action (if not all) happens at the county and state level CDC is increasingly loosing interest/leadership Several states have a don’t ask don’t tell foodborne surveillance programs The entire surveillance relies on the cooperation of clinical labs, with the assumption that lab tests will be ordered, and pathogens will be isolated for foodborne illnesses In the absence of effective surveillance programs most outbreaks will not be detected Very few states have real time foodborne illness investigation programs We need to reduce the time that it takes to detect outbreaks Most of the action (if not all) happens at the county and state level CDC is increasingly loosing interest/leadership Several states have a don’t ask don’t tell foodborne surveillance programs The entire surveillance relies on the cooperation of clinical labs, with the assumption that lab tests will be ordered, and pathogens will be isolated for foodborne illnesses In the absence of effective surveillance programs most outbreaks will not be detected Very few states have real time foodborne illness investigation programs We need to reduce the time that it takes to detect outbreaks

5. The Ultimate source of food contamination

6. Why do they happen? Lack of control and verification over the entire span of food production Lack of Regulatory oversight (in case of FDA regulated industries) Non-validated interventions Non-validated SSOPs Insufficient CPs and CCPs Incompetent regulation and regulatory instruments Economics of food safety Lack of control and verification over the entire span of food production Lack of Regulatory oversight (in case of FDA regulated industries) Non-validated interventions Non-validated SSOPs Insufficient CPs and CCPs Incompetent regulation and regulatory instruments Economics of food safety

7. Economics of Food Safety Resembles the current administration's Economic Policy No one wants to pay for the cost There is no premium attached to comprehensive food safety programs in the buyer community (retailers, and most food service operations), Producers have to pay the full cost, in a competitive market which is slow to adjust or reward for the food safety costs Resembles the current administration's Economic Policy No one wants to pay for the cost There is no premium attached to comprehensive food safety programs in the buyer community (retailers, and most food service operations), Producers have to pay the full cost, in a competitive market which is slow to adjust or reward for the food safety costs

8. How likely is a company to have an outbreak/recall? No food company is immune to recalls or outbreaks The likelihood of getting involved in a RC/OB is a function of:  Inherent risks associated with their products:  Beef trim vs. ground beef for food services vs. ground beef for retail, vs. frozen ground beef/patties for retail  Chemical, physical, biological hazards  Nature of the processing: Do we have a kill step  Control of the process  Verification: in-house vs. independent  QAQC reporting to production No food company is immune to recalls or outbreaks The likelihood of getting involved in a RC/OB is a function of:  Inherent risks associated with their products:  Beef trim vs. ground beef for food services vs. ground beef for retail, vs. frozen ground beef/patties for retail  Chemical, physical, biological hazards  Nature of the processing: Do we have a kill step  Control of the process  Verification: in-house vs. independent  QAQC reporting to production

9. A food producer is as good as it’s worst production facility or it’s worst supplier or.. The weakest link in the chain What control do we have over imported foods?  We need identical programs not equivalent programs  Importing “cheap foods” breeds economic fraud and forces suppliers to take short cuts The weakest link in the chain What control do we have over imported foods?  We need identical programs not equivalent programs  Importing “cheap foods” breeds economic fraud and forces suppliers to take short cuts

10. How to reduce the risk of outbreaks and recalls Two types of food safety systems:  Validation/Verification Based  Faith Based Two types of food safety systems:  Validation/Verification Based  Faith Based

11. E. Coli O157 testing program for ground beef production 100% trim lot testing for E. coli O157. Each lot about 5 tons. One composite sample (60 pieces) of 375 grams per lot Positive lots are sent to industrial cookers or to rendering Program went into effect on Dec. 15, 2002. 100% trim lot testing for E. coli O157. Each lot about 5 tons. One composite sample (60 pieces) of 375 grams per lot Positive lots are sent to industrial cookers or to rendering Program went into effect on Dec. 15, 2002.

12. Consequences of 100% testing for E. coli O157 About 1500 less reported cases of E. coli O157 infections in the population in 2003 vs. 2002. This represents ca. 36% reduction in human cases solely attributed to the impact of testing and the actions taken by the food industry in response to having positive test results. About 1500 less reported cases of E. coli O157 infections in the population in 2003 vs. 2002. This represents ca. 36% reduction in human cases solely attributed to the impact of testing and the actions taken by the food industry in response to having positive test results.

13. Beef Industry Success FSIS E. coli O157:H7 Testing Program 0.0 0.2 0.4 0.6 0.8 1.0 1994 1995 1996199719981999200020012002 20032004 2005 2006 Year Percent Positive Samples 25g -> 325g New method http://www.fsis.usda.gov/Science/Ecoli_O157_Summary

15. Case Study: Ground Beef Ground Beef is the main source of exposure to O157 in beef Ground beef producers are the recipients of upstream process failure They have little control over their process or the fate of their company They receive beef trim that has already been tested for E. coli O157, and has tested negative The FSIS test results show that although the use of primary tested trim has resulted in decreasing the incident of positive O157 ground beef by 50%-60% Ground Beef is the main source of exposure to O157 in beef Ground beef producers are the recipients of upstream process failure They have little control over their process or the fate of their company They receive beef trim that has already been tested for E. coli O157, and has tested negative The FSIS test results show that although the use of primary tested trim has resulted in decreasing the incident of positive O157 ground beef by 50%-60%

16. Case Study: Ground Beef We need a second firewall between the grinders and the trim suppliers The FSIS data shows that the exposure fro ground beef can be further reduced if grinders conduct their own secondary testing of the trim, followed by verification testing of their final products This will result in drastic reduction of O157 incidents in ground beef to a point that can remove it from the public health radar We need a second firewall between the grinders and the trim suppliers The FSIS data shows that the exposure fro ground beef can be further reduced if grinders conduct their own secondary testing of the trim, followed by verification testing of their final products This will result in drastic reduction of O157 incidents in ground beef to a point that can remove it from the public health radar

17. ConclusionsConclusions We need a single food safety agency FSIS vs. FDA An expanded version of FSIS with it’s own Foodborne Diseases Epidemiology Division, with expanded authority (including some currently held by APHIS) may be the answer We have to address the cost associated with food safety (consumers, retailers, food service) We can do better in epidemiological investigations: what is done in most cases is too little too late We need a single food safety agency FSIS vs. FDA An expanded version of FSIS with it’s own Foodborne Diseases Epidemiology Division, with expanded authority (including some currently held by APHIS) may be the answer We have to address the cost associated with food safety (consumers, retailers, food service) We can do better in epidemiological investigations: what is done in most cases is too little too late