Pu#ng Public Health into Food Safety: an Evolving Effort at FSIS for the Last 20+ Years

Transcription

1 Pu#ng Public Health into Food Safety: an Evolving Effort at FSIS for the Last 20+ Years Dr. David Goldman Assistant Administrator Office of Public Health Science Food Safety and InspecJon Service June 17,

2 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 2

3 FSIS Mission* As the public health regulatory agency at USDA, FSIS is responsible for ensuring that the najon's commercial supply of meat, poultry, and processed egg products is: Safe Wholesome Correctly labeled and packaged * JurisdicJon 7,600 inspectors at 6,000 slaughter and further processing establishments operajng under daily government inspecjon every shia; shared jurisdicjon with FDA in- commerce administered at distribujon points of sale/storage outside of Federal establishments; primary statutes - - Federal Meat InspecJon Act, Federal Poultry Products InspecJon Act, Egg Products InspecJon Act, and the Humane Methods of Slaughter Act; changed to public health focus in mid s through introducjon of HACCP and pathogen reducjon performance standards; focus on biological, chemical, and physical food safety hazards 3

4 FSIS- Regulated Products Red meat = beef, veal, pork, minor species, raw and Ready- to- Eat (RTE) Poultry = chicken, turkey, minor species, raw and RTE Liquid and dried pasteurized egg (not intact eggs) Cakish = raw and RTE Other U.S. agencies involved in food safety Food and Drug AdministraJon USDA Agriculture MarkeJng Service NOAA NaJonal Marine Fisheries Service State and local agencies 4

5 Hazards of Public Health Concern in FSIS Regulated Products Microbes Residues Allergens and Food AddiJves 5

6 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 6

7 Target Pathogens Salmonella- raw and RTE products Campylobacter in raw poultry E. coli O157:H7 and non- O157 shiga toxigenic E. coli (STEC) in raw beef Listeria monocytogenes in RTE products Other pathogens and indicator bacteria as necessary for exploratory and invesjgajve purposes. 7

8 FSIS Regulatory TesJng Goals Regulatory monitoring programs Monitoring programs to verify process control Risk- based performance criteria for priorijzing establishments for addijonal scrujny. e.g., PR- HACCP tesjng programs Zero tolerance tesjng programs A pathogen- posijve result = non- compliance Risk- based vs. non- risk- based sampling e.g., RTE tesjng programs, monitoring ground beef for E. coli O157:H7 8

9 Special TesJng AcJviJes Baseline tesjng programs Non- targeted stajsjcally weighted sampling e.g., raw product commodijes/carcasses Special tesjng acjvijes InvesJgaJve/outbreak- related tesjng PFGE subtyping (i.e., parjcipajon in PulseNet) Other genejc and subtyping tests Whole Genome Sequencing 9

10 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 10

11 U.S. Healthy People 2020 Pathogen Baseline Case Rate (infections from all foods per 100,000 population)* 2013 Actual FoodNet Case Rate 2020 Healthy People Target* Campylobacter Escherichia coli O157:H Listeria monocytogenes Salmonella Food Safety: hsp://healthypeople.gov/2020/topicsobjecjves2020/objecjveslist.aspx?topicid=14 ; applies to all food sources, not just meat, poultry, and processed egg products *hsp://www. healthypeople.gov/2020/topicsobjecjves2020/objecjveslist.aspx?topicid=14 8

12 PR- HACCP Timeline 1996 Pathogen ReducJon Hazard Assessment and CriJcal Control Point (PR- HACCP) Rule published; Established performance standards for Salmonella and generic E. coli in different product classes 2006 Established performance categories for FSIS regulated establishments 2010 Established new performance standards for Salmonella and Campylobacter for chicken and turkey carcasses and Salmonella in raw non- intact poultry 12

13 Focus on Salmonella Rates of salmonellosis have not decreased significantly since the incepjon of FoodNet Salmonella is found in nearly all foods, but most commonly found in poultry and meat products FSIS is raising expectajons for food producers through more stringent performance standards and implementajon of an Agency acjon plan for Salmonella 13

14 Baseline Estimate Poultry Attributed to ~202,000 Salmonella Illnesses Foodborne salmonellosis cases in the U.S. = 1.2 M illnesses CDC FoodNet (15.4 cases/100,000 X 307M population) FSIS contribution = 36% Simple outbreaks (method Painter et al., 2013) FSIS responsible for 414,000 (1.2M X 0.36) Product specific Salmonella illnesses = 414,000 X attribution fraction 1.2 M Illnesses 414,000 Illnesses (baseline) non- FSIS- Asributable PorJon 64% FSIS- Asributable PorJon 36% pork 31% deli 13% meat 7% poultry 49% 14

15 AsribuJon Priority Ranking Summary Using asribujon FSIS is about to rank the number of Salmonella illnesses associated with the different regulated products Poultry: ~202,000 Pork: ~128,000 Deli: ~54,000 Meat: ~30,000 FSIS tracks Campylobacter illnesses internally A similar analysis shows illnesses associated with Campylobacter primarily from poultry

16 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 16

17 HP2020 Risk Assessment Approach 1. The HP2020 Risk Assessment approach explicitly used the Salmonella 25% reducjon goal (or 33% Campylobacter reducjon goal) to esjmate performance standard opjons that can meet the HP2020 goal 2. The approach uses three steps: Use baseline sampling data to esjmate the distribujon of posijve samples per establishment, weighjng by producjon volume EsJmate the maximum number of acceptable posijves to meet the HP2020 goals EsJmate the number of establishments inijally non- compliant with the performance standard opjons FSIS internal use only - DRAFT 17

18 How does FSIS go from the HP2020 najonal public health goals to developing programs to achieve those goals? 1. Priority ranking of FSIS- regulated products Food source asribujon (i.e., what foods cause what illnesses) EsJmate number of illnesses associated with FSIS products 2. Develop performance standards that explicitly are designed to meet HP2020 Perform baseline survey on target commodity to determine najonal prevalence Use a risk assessment approach that esjmates number of illnesses averted 3. Implement performance standards to reduce contaminajon Announce draa performance standards and seek public comment

19 Baseline Surveys StaJsJcally- designed, microbiological surveys that sample a specific regulated product or animal species from federally inspected establishments Sampling frequency based on producjon volume Designed to esjmate najonal prevalence and determine percent posijve and levels of specific pathogens and indicator bacteria of public health concern on/in food Provides data for risk assessments and risk- based sampling programs Assists with policy and regulatory decisions, such as performance guidance/standards Collects data on microbiological loads from previously not sampled/ unregulated products

20 Risk Assessment Summary A risk assessment is used to link the Salmonella contaminajon at an establishment level to salmonellosis Using this approach performance standard opjons that meet HP2020 were designed In the example 7 acceptable posijves out of 52 samples was the preferred performance standard opjon given it met at least a 25% reducjon in Salmonella cases 8/52 was just short of the 25% reducjon AlternaJvely, 6/52 was also an opjon given it also exceeded the HP2020 goal

21 IllustraJve Model Output - Performance Standard OpJons to Meet HP2020 Performance standard % reduc@on Estbs. Ini@ally non- compliant 6/52 28% 71% 7/52 25% 63% 8/52 22% 55% 9/52 19% 47%

22 AcJon Plan to Reduce Salmonella Ø Implement pre- harvest lessons learned Ø Modernize poultry and swine slaughter rules Ø Revise sampling acjvijes and performance standards Ø Revise and develop in- plant and enforcement strategies and expedited feedback to industry Ø Provide improved food safety messages related to Salmonella Ø Implement focused research e.g., Ø Does Salmonella from lymph nodes provide a contaminajon pathway?

23 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 23

24 Focus on Listeria monocytogenes 1987 Listeria monocytogenes (Lm) declared as an adulterant in ready- to- eat products 2001 Lm tesjng of Food Contact Surfaces 2003 Interim Final Rule for control of Lm in RTE products 2005 Random and risk- based sampling of RTE products for Lm (and Salmonella) 2006 Risk- based sampling of RTE products, food contact surfaces, and environmental surfaces in establishments with post- lethality exposure 24

25 Incidence of Listeriosis 0.9 Incidence of Foodborne Illnesses : Listeria Preliminary FoodNet data on the incidence of infection with pathogens transmitted commonly through food 10 States, 2012 Incidence per 100, Calendar Year National Health Objective: 0.2 Cases per 100,000 (InformaJon from CDC FoodNet Preliminary Data sources published on web at hsp:// 25

26 Limited AsribuJon to Meat/Poultry In Recent Years Hot Dogs Deli Meats Year Cases Deaths Cases Deaths (Adapted from Cartwright et al 2013 and current FSIS data) 26

27 TesJng for Lm in RTE Products at FSIS regulated establishments Percent (Data from FSIS data warehouse) Calendar Year* *Starting with CY2008, annual microbiological results are reported by sample collection date as opposed to analysis end date. 27

28 Percent of Lm- posijve Samples in MPN/g ranges (LOD = 0.03/gram) % domes@c Lm- posi@ve samples % 47.9% 28.4% (Data from FSIS data warehouse) 33.8% 22.4% 14.1% 7.5% 7.5% 2.1% 2.1% < to < to < to <30 >30 Lm MPN/g Lm MPN data for CY2008 Lm MPN data for CY

29 Current FSIS AcJviJes 29

30 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 30

31 Focus on STECs In 1994 FSIS began tesjng raw beef products for E. coli O157:H7. Non- intact beef products containing E. coli O157:H7 were declared to be adulterated. In 2012 FSIS announced that the presence of addijonal shiga toxin- producing E. coli strains (STEC) in raw beef trim would render that product adulterated. On June 4, 2012 FSIS began sampling beef manufacturing trimmings for the top 6 non- O157 STECs O- groups: O26, O45, O103, O111, O121, and O145 Strain must also include the virulence genes eae and stx Proposed new traceback and recall procedures Completed risk assessment for mechanically- tenderized beef rule Beef and Veal Carcass Baseline 31

32 Focus on STECs Foodborne related illnesses associated with STEC Other STECs 21,423 STEC asribujon to commodity Root 6% Sprout 2% Fish 0% Vine 9% Crustacean 0% Dairy 6% Eggs 5% Mollusk 0% Top 6 non- O157 STEC 91,329 O157 63,153 Fungi 0% Leafy greens 17% Fruits- Nuts 6% Oils- Sugars 3% Poultry 2% Grains- Beans 10% Pork 3% Beef 29% Game 2% Adapted from Scallan, et al., 2011 Data collected from Adapted from Painter, et al., 2013 Data collected from

33 E. coli O157:H7 percent posijve in RGB E. coli O157:H7 must be considered hazard likely to occur HACCP ImplementaJon complete Started risk based sampling

34 STEC Test Results (June 4, 2012 through April 27, 2014) Raw Ground Beef Components (RGBC) Serotype E. coli O157:H7 Total non- O157 STECs Trim Follow- up to RGB at Supplier Follow- up to RGBC 0.42% 0.81% 0.54% (22/5249) (5/618) (8/1476) 0.70% 1.42% 2.03% (34/4887) (7/492) (26/1279) Number of non- O157 STECs isolated from samples O O O O O O

35 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 35

36 Baseline on Beef and Veal Carcasses (BVCBS) To gain informajon on the effecjveness of sanitary dressing post- hide removal and slaughter intervenjons pre- chill in beef/veal slaughter establishments; To provide process control criteria for beef/veal slaughter establishments; To esjmate the prevalence and quanjtajve level of pathogenic organisms; To esjmate the presence and quanjtajve levels of indicator organisms 36

37 Sampling LocaJons & Microbiological Targets Samples are being collected at two locajons in the slaughter process: Post- hide removal (immediately aaer hide removal, before eviscerajon, and prior to the applicajon of any intervenjons) Pre- chill (at least 1 to 5 minutes aaer the last intervenjon has been applied and no more than one hour in the hotbox) Microbiological targets include: Pathogens - E. coli O157:H7, non- O157 Shiga- toxin producing E. coli (STEC) and Salmonella Indicator organisms - Generic E. coli, Total Aerobic Bacteria, Enterobacteriaceae and coliforms 37

38 Preliminary Shakedown Data Samples scheduled 798 (399 at Post- HR and 399 at Pre- Chill) DistribuJon of Samples by Beef Subclass Samples collected 664 (332 at Post- HR and 332 at Pre- Chill) Samples analyzed 620 (310 at Post- HR and 310 at Pre- Chill) Data from PHIS/Data Warehouse 38

39 Salmonella Data Post- hide Removal Salmonella Percent PosiJve (60/309) 19.42% Serotype distribujon Pre- chill Salmonella Percent PosiJve (10/310) 3.22% Serotype distribujon Serotype Count Percent Montevideo % Anatum % Mbandaka % Newport % Agona 2 5.0% Kentucky 2 5.0% Muenchen 2 5.0% Muenster 2 5.0% Typhimurium 2 5.0% Altona 1 2.5% I 4,[5],12:i: % Infan@s 1 2.5% Total % Serotype Count Percent Newport % Typhimurium % Agona % Heidelberg % Kentucky % Montevideo % Not Reportable % Total 9 100% Data from PHIS/Data Warehouse 39

40 PosiJve Results Table 1. BVCBS PosiJve Sample Results Number of samples (includes both Post- hide and Pre- chill Number of Post- hide removal samples Number of Pre- chill samples Total Number of Analyzed Samples for Salmonella Posi@ve for E. coli O157:H Posi@ve for non- O157 STEC Posi@ve for both Salmonella and E. coli O157:H Posi@ve for both Salmonella and non- O157 STEC Posi@ve for both E. coli O157:H7 and non- O157 STEC Posi@ve for Salmonella, E. coli O157:H7, and non- O157 STEC Table 2: Breakdown of BVCBS PosiJve STEC Serogroups Month Project E. coli Serogroups O157:H7 O26 O45 O103 O111 O121 O145 TOTAL January February March S52_PSTHR S52_PRECH 1 1 S52_PSTHR S52_PRECH S52_PSTHR S52_PRECH TOTALS S52_PSTHR S52_PRECH GRAND TOTALS

41 Beef/Veal Breakdown Number of Post- Hide Removal Samples Salmonella E. coli O157:H7 non- O157 STECs Number Analyzed Percent Number of Number Analyzed Percent Number of Number Analyzed Percent Subclass Beef Carcasses Beef Cow % % % Bull % % % Dairy Cow % % % Heifer % % % Steer % % % Total Beef % % % Veal Carcasses Bob Veal % % % Formula- fed Veal % % % Heavy Calf % % % Non- formula fed Veal % % % Total Veal % % % 41

42 Beef Veal Breakdown Number of Pre- Chill Samples Salmonella E. coli O157:H7 non- O157 STECs Number Analyzed Percent Number of Number Analyzed Percent Number of Number Analyzed Percent Subclass Beef Carcasses Beef Cow % % % Bull % % % Dairy Cow % % % Heifer % % % Steer % % % Total Beef % % % Veal Carcasses Bob Veal % % % Formula- fed Veal % % % Heavy Calf % % % Non- formula fed Veal % % % Total Veal % % % 42

43 Timeline Shakedown is complete Started 2 nd Quarter FY2014 (January) Ended April 3, 2014 Actual Study start date 4 th Quarter FY2014 (July) Will last for 12 months 43

44 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 44

45 NaJonal Residue Program (NRP) Purpose Provide a structured process for idenjfying and evaluajng chemical compounds of concern in food animals Test for the presence of chemical compounds, including approved (legal) and unapproved (illegal) veterinary drugs, pesjcides, hormones, and environmental contaminants in meat, poultry, and egg products. IdenJfy need for regulatory follow- up when violajve levels of chemicals residues are found 45

46 Distribution of NRP Inspector Generated In- plant Positive Screenings (KIS Test) & Lab conbirmed violative samples (# of violative Animals in parenthesis) by Quarter Q Q ,000 1,800 1,600 1,400 1,200 1, % 1, (307) 1, (371) 1,374 34% 34% 464 (385) 337 (289) 1,253 1,261 27% 27% 340 (273) 1,261 31% 387 (320) 45% 40% 35% 30% 25% 20% 15% 10% 200 5% _Q4 2013_Q1 2013_Q2 2013_Q3 2013_Q4 2014_Q1 0% Total Violations In- plant positive Violation Pct Data from PHIS/Data Warehouse 46

47 NRP Inspector- Generated Sampling Program Results, Jan- March 2014 Sample Collection Month Number of In-plant Screen Tests Number of Positive In-plant Screens tested / (FSIS Lab Chemical Analytes) Number of Carcasses with Violative Samples Number of Labconfirmed Violative Samples Three Most commonly reported chemical violations (Number of Violative Samples per three most reported Total Number of violative chemical Residues violations) January 18, / (25,398) Ceftiofur (34), Penicillin(30), Neomycin (13) 17 February 15, / (25,202) Ceftiofur (35), Penicillin (23), Neomycin (18) 15 March 16, / (31,646) Ceftiofur (36), Penicillin (28), Neomycin (17) 17 Total 50,169 1,236 / (82,246) Ceftiofur (105), Penicillin (81), Neomycin (48) 20

48 NRP Summary Changes to NRP took effect: August 2012 Because the new MRM method is far superior to the Bioassay as a screening tool, comparing results before and aaer August 2012 is not pracjcal Going forward, FSIS is looking very closely at total violajons and any shias in results across the most commonly used anjbiojcs 48

49 NRP InformaJon All informajon related to the NRP including Quarterly Reports; NRP Program Data (Red Book) and NRP Residue Sampling Plans (Blue Book) publicajons; Residue Repeat Violators list; and Residue Related Policies Can be found at the link below hsp:// collecjon- and- reports/chemistry/residue- chemistry 49

50 Outline IntroducJon to FSIS EvoluJon of FSIS as a Public Health Agency Microbiological Pathogen TesJng PR- HACCP Developing Programs to Achieve Healthy People 2020 NaJonal Public Health Goals Listeria monocytogenes Escherichia coli STECs Baselines Chemicals and the NaJonal Residue Program (NRP) Allergens and Other Ingredients of Public Health Concern 50

51 FSIS Ingredients of Public Health Concern Includes the Big 8 allergens Milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans Also includes additives or flavorings known to cause reactions in susceptible persons Sulfites, Yellow #5, monosodium glutamate, nitrate and nitrites Products containing these ingredients are considered misbranded if their presence is absent from label 51

52 Recall Classes Class I a health hazard situajon where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Class II situajon where there is a remote probability of adverse health consequences from the use of the product. Class III situajon where the use of the product will not cause adverse health consequences. 52

53 Allergens and Risk Class I Peanuts Tree nuts Dairy Egg Shellfish Fish Soy Class II Fish Wheat Sulfites MSG 53

54 Undeclared Ingredient (UI) Recalls,

55 Allergens Associated with Recalls, % Undeclared Ingredient Recalls 55

56 FSIS AcJons to Reduce Food- Related Allergens FSIS found undeclared allergens in processed foods and changed verificajon processes Total Recalls Recalls Due to Undeclared Allergens % 35% 26% 34% 13% 19%

57 QuesJons? 57