Topics. History Issues of Concern Process Control. Summary. Transfer Points Growth Niches Redesign or Manage Trends

Transcription

1 Lessons Learned The battle with this organism has caused more change to producers of RTE deli meat products than any one single factor or event in the last 30 years. ur scars are numerous and deep.

2 Topics History Issues of Concern Process Control Transfer Points Growth Niches Redesign or Manage Trends Summary

3 History Early 90 s Product and contact surface sampling dominated Growth niches discovered in hollow rollers Industry recognized benefits and needs of separation painted lines on floor

4 History Mid 90 s Equipment teardown became common Seek & Destroy concept developed Internal equipment redesign became commonplace. Suppliers were informed of design problems. Conflicting design expectation evolved. Equipment manufacturers were given a moving target. Floor problems persisted. Floors/drains were recognized at harborage areas and chronic problem areas. Methods to clean floors continuously failed. Drains were not expected to be Ls free.

5 History Mid 90 s Persistent deep equipment growth niches were discovered and recognized as root cause problem areas. Facility areas were recognized as sources of Listeria harborage walls, freezer walls, absorbent materials in doors, wet floors and cracks in floors. Mid-shift cleanups were recognized as problem causing sources of recontamination.

6 History Late 90 s Benefits of dry floors were realized Cooking/pasteurization of equipment became commonplace Large area sampling became commonplace Numerous large recalls DNA linkage evolves Methods for construction process control evolves Spread of organisms from growth niches became more understood. Physical separation of RTE areas became common place

7 AMI Workshops USDA Product Sampling began CDC surveillance Food Net AMI Guidelines utbreak and major recalls DNA Linkage - recall FDA-FSIS Risk Assessment Deli Meats Mexican Cheese Turkey Frank fatality USDA Product Sampling continually ratcheted up Not For Cause Risk Verification Testing

8 History March 2000 During Bruce Tompkin s Armour-Swift-Eckrich copacker workshop, the concept of the AMI Listeria Intervention and Control Workshop was developed. November 2000 First AMI Workshop Consensus in methods and Best Practices was attained ctober 2001 AMI Board declared Food Safety Not Competitive 2001 to today Many lines and processes became under control Elimination of single growth niches produced new levels of control. More aggressive sampling was deployed.

9 History 2001 to today Pasteurization of large chubs and roasts became common place The use of DNA analysis (ribotyping, PFGE, Rep PCR) to ID sources of growth niches and degree of the diversity of RTE contamination. AMI Equipment Design Task Force chartered first presentation in Jan 2003 Some plants had achieved new levels of control. ne year without drain positive. Lactate diacetate recognized to control growth AMI Facility Design Task Force chartered first presentation May Most (>75%) of the Lm recalls are due to Plant not holding product being tested

10 Appreciates the efforts of the following companies:

11 AMI EQUIPMENT DESIGN TASK FRCE Kraft Sara Lee Con Agra Minot Excel Hormel Bar S Smithfield Foods Hatfield Quality meats Tyson Foods

12 AMI FACILITY DESIGN TASK FRCE

13 Regulatory History Sampling of finished products May 1989 FSIS went from 1 gram to 25 grams Required recall of positive product

14 Myth Busters The organism is airborne Raw meat is (20-40% Lm +) highly contaminated with the organism It cannot be removed from the processing environment Drains will always be positive

15 The Evolution of Environmental Pathogen Control Stage Awareness Control Methods Sample Product Enlightenment Preventative Predictive Recognized existence of Growth niches. Sample contact and some floor and environmental to surfaces control. Starting the redesign phase. Potential Growth niches mapped. Some scheduled intervention practices in place. Managing Critical Factors of the Sanitation process. Engaged in Equipment and Facility redesign. Early warning sampling in place. Intervention practices in place with all RTE equipment. Focus on zone 4 and facilities. Advanced phases of both Equipment and Facility redesign.

16 Issues of Concern

17 Issues of Concern Most cases are sporadic / isolated; not associated with outbreaks CDC estimates 99% of listeriosis is foodborne and: ~ 2500 cases / year ~ 500 deaths / year ~ 90% of reported cases require hospitalization ~ 20% of cases are fatal ~ 0.02% of total foodborne illness but 28% of deaths

18 1986 CDC began active surveillance in certain regions of the country to estimate the incidence of diarrheal disease In addition, isolation of Lm from a normally sterile site (blood, spinal fluid) in a patient led to a report to CDC The isolates of Lm also were sent to CDC for study

19 1996 FoodNet was established to: investigate the causes of diarrheal disease obtain a more accurate estimate of diarrheal disease / foodborne illness In addition, listeriosis was included among the diseases reported from clinical labs within the FoodNet system to CDC

20 Public health agencies are now looking harder and smarter to link foods to listeriosis For example, all Lm isolates from USDA are sent to CDC for finger printing CDC and state agencies are looking for clusters or outbreaks of listeriosis by matching Lm isolates from food and plant samples with those from clinical cases. Many state agencies and other groups are testing food at various stages throughout the food chain.

21 In the past: CDC and others looked for unusual an number of cases of listeriosis (i.e., peaks). Today: It is possible to detect an outbreak that involves widely scattered cases that would otherwise go unnoticed. These outbreaks may involve large numbers of people distributed over a long period of time or small numbers over varied geographical areas Post 911 activities have increased funding and lab capacities

22 Scenarios 1 Single isolated event ne package of product contaminated via transfer point in process 2 nly this batch or lot Line contaminated via transfer point Normal cleaning eliminates line contamination 3 Cluster - outbreak with multiple lots of food from a single source Growth niche in a packaging line A one time event that impacts several days of production like a construction event

23 TREND IS DWNWARD Lunchmeat Percent Positive RTE Meat & Poultry Year

24 Incidence of Foodborne Illness : Listeria* Incidence per 100,000 Population Healthy People 2010 National Health bjective: *Preliminary FoodNet Data on the Incidence of Foodborne Illnesses -- Selected sites, United States, 2004

25 Regulatory Control Procedures for Lm in RTE Products Intensified Verification Testing (IVT) IVT should be triggered when product or contact surfaces test positive for L. monocytogenes (for all alternatives presented in the L. monocytogenes interim final rule). IVT should also begin if continuing sanitation issues are identified by Agency inspection personnel, or when multiple contact or product positives for Listeria spp. or Listeria-like organisms occur. IVT History verall, positives were found in 68% of establishments where IVTs were held A total of 5.7% of samples tested positive from PFGE analysis of Lm isolates demonstrated harborage conditions, including one establishment where patterns from product, FCS, and NFCS matched, and one establishment with closely related patterns from environmental samples collected 6 months apart.

26 Recent Events The last outbreak was multi-state Upper Midwest to Northeast ccurred over a several month period Several elderly nursing home/hospital deaths Turkey rolls implicated No processor implicated There was retail involvement in Midwest

27 Legal Lessons Learned Regulatory Investigations Designed to define legal cause DNA linkage and Investigator observation We have had entire plants shut down multiple rooms with multiple lines and multiple product types implicated with minimal product and contact surface positives No illness or fatalities minimal public exposure bservational data of potential maintenance cross contamination between lines

28 Legal Lessons Learned Early in the game we learned: 1. What you don t know can and will hurt you. 2. Keep your head stuck in the sand and you will get your head cut off Dennis Johnson lsson Frank & Weeda on Listeria This continues to be reinforced with every ratcheting of the regulations

29 Dose-Response Relations Cannot experimentally determine if L. monocytogenes has a threshold Basic biology indicates that each cell has some small but finite possibility of causing an infection Large differences the susceptibility of different human subpopulations Have to assume a non-threshold model and deal with dose-response relations in a probabilistic manner -Robert Buchanan FDA

30 Relative Susceptibility Condition RS R* Transplant x10-10 AIDS x10-11 Dialysis x10-11 Cancer-Pulmonary x10-11 Cancer-Bladder and prostate x10-12 Cancer-Gynaecological x10- Cancer-Blood x10-11 Cancer-Gastrointestinal and liver x10-11 Non-cancer liver disease x10-12 Diabetes, non-insulin dependent x10-12 Diabetes, insulin dependent x10-12 Alcoholism x10-13 Pregnancy x10-13 ver 65 years old 8 4.0x10-13 Less than 65 years, no other condition 1 5.3x10-14 * Assumed dose: Log Assumed dose: Log 10 = 8.5 = 8.5 -Robert Buchanan FDA

31 Process Control

32 Sources of Ls in High-Risk RTE Area Transferred from Zone 4 area outside of the High-Risk RTE area Homeless, but looking for a harborage location Typically found with a transfer point monitoring positive Growth niches within High-Risk RTE area 1. This means they are established, and have found a protective home in equipment or facility. 2. They may exist in a transient home such as rework pans, trash containers or other difficult to clean mobile container / environment.

33 GRWTH NICHES Locations harboring the organism after the routine sanitation process for that area has been completed. Examples Hollow roller on conveyor transporting food product Hollow rollers not disassembled cleaned and sanitized or heat treated in a manner to eliminate any contaminating organisms can become growth niches.

34 GRWTH NICHES Must either be designed out of the system or managed as a part of the process. Design Examples Equipment is redesigned to eliminate or seal hollow areas Hollow areas of equipment (e.g., frames, rollers) must be eliminated where possible or permanently sealed (caulking not acceptable). Bolts, studs, mounting plates, brackets, junction boxes, name plates, end caps, sleeves and other such items must be continuously welded to the surface of the equipment and not attached via drilled and tapped holes. AMI Equipment Design Task Force

35 Growth Niches Examples of how to minimize with process control techniques Disassemble clean and sanitize Heat sanitize Cook in oven or smokehouse Cover with tarp and inject steam Place in CP tank

36 Growth Niches Minimize with process control techniques The potential to support growth still exists within the machine, part or area» Whenever this becomes the chosen path remember to implement methods that will hold the gains with turnover in both hourly and management ranks.

37 GRWTH NICHES Delrin bolted to stainless steel If product and microorganisms penetrate mating surfaces a growth niche develops. Level of disassembly is a Sanitation Process Control critical factor.

38 GRWTH NICHE CNTRL Sanitation Critical Factors Degree of disassembly Chemical sanitizer treatment Effective coverage (Flood sanitation) Time Chemical concentration Hand scrub Contact Surfaces

39 GRWTH NICHE CNTRL Sanitation Critical Factors cont d Heat treatment Small parts (CP tank) Localized steam Non Daily scheduled sanitation Rotational deep cleaning Equipment pasteurization Effective GMP s after flood sanitization

40 Transfer Points Interim or Temporary Locations Harboring the rganism

41 Transfer Points vs Niches Many positive sites found during monitoring are not growth niches. They are transfer points (i.e., a product handler s gloved hands, floor sample in high traffic pathway). Transfer points are not growth niches because the organism is eliminated during the cleaning and sanitizing process.

42 Transfer Points Any surface between the growth niche and the product. Almost all contact surfaces are transfer points, not growth niches. Contact surfaces are indicator sites of potential product contamination. Contact surfaces are probably not the best early warning predictors of potential product contamination.

43 The Story of John s s Life How do I get inside the box??

44 Transfer Points Break Production Break Production Break Production Break Production Break Production Break Production Production When to sample? Setup Dry clean Sampling objectives? Disassemble Rinse Foam Growth niches Rinse Sanitize Break Assemble Inspect Sanitize Looking for Ls Effectivenessof Sanitation

45 Indicator Sites Post rinse Sample large areas that collect spatter Composite sampling acceptable Improve sampling efficiency Positive results will direct investigation team to a line, pair of lines, or section on a line.

46 High risk situations Drain backup A packaging line is moved or modified significantly. There is an equipment breakdown. Personnel are used interchangeably between raw and cooked products. Construction in or adjacent to CPA. Warm room Wet area or process

47 High risk situations Transfer equipment from storage or another plant Loss of refrigeration in a room Use of high pressure water or air on floor or in a drain Wet in-process clean up Rinsing or cleaning equipment on the floor Equipment used interchangeably between raw and cooked products. Crack in floor that retains water Cooked product is transported through a raw product area

48 Transfer Point Hurdles Floor / Traffic Transfer Foam Dry chemical on floor Sole scrubbers Dedicated footware Foot baths do not work Methods to minimize not eliminate

49 Floor Management Employee Traffic Sole Scrubber For Exit Employee Hallway {Dry} Employee Facilities Sole Scrubber In Gowning Room/Area Product Flow

50 Transfer Point Hurdles Personnel Transfer Hand washing Dress out gowning procedures Sanitizer use during processing Non contact surfaces foamed with high concentration sanitizer Methods to minimize not eliminate

51 Transfer Point Hurdles Hand Tool Transfer Separated from raw products/areas Washing & sanitizing Store during use in sanitizer Dedicated tools Methods to minimize not eliminate

52 Methods or Procedures for Investigation Do Conduct investigations Seek and Destroy perating procedures GMP s. Review SSP s and Line Separation documentation

53 Normal cleaning and sanitation bserve flood sanitization bserve assembly bserve Post assembly sanitizer application bserve normal setup and start up activities Stop operation before product is placed on the line Seek and Destroy Process Are all parts and components being adequately sanitized (chemical or heat)? Are GMP's followed? Is degree of disassembly acceptable? Disassemble to normal daily sanitation level Disassemble any remaining machine components Clean and flood or heat sanitize all disassembled line components Are cleaning methods acceptable? Evidence of unacceptable organic buildup? Inspect and swab any suspect areas If area is Ls positive then it is a growth niche If APC growth is supported then the suspect area is a potential growth niche

54 Before S&D Results Log APC Individ. ucl cl -2 lcl 8 Range ucl cl lcl Individ.: cl: ucl: lcl: * Rule violation Range: cl: ucl: lcl: 0 Subgrp Size 1 S&D Results After Log APC Individ. ucl cl 0 lcl Range ucl cl lcl Individ.: cl: ucl: lcl: * Rule violation Range: cl: ucl: lcl: 0 Subgrp Size 1

55 Resident rganisms Each plant or Rte area

56 Methods or Procedures for Investigation < PDCA Cycle > Part I Location of Growth Niche First phase is directed towards finding and eliminating the growth niche Recycle if growth niche not found Expand scope of investigation < PDCA Cycle > Part II GMP s & Transfer point Management Second phase focuses on procedures and process control systems to minimize or control growth niches or transfer points Use time studies to identify when and where transfer take place Process is recycled until qualification is achieved

57 Prevention and Control Trends ld way Minimal hurdles to prevent entry into RTE Deep Clean when Ls+ Minimal equipment Heat Treating Have not disassembled equipment to find problem growth niches New way Multiple hurdles to prevent entry into RTE Scheduled Deep Cleaning Scheduled equipment Heat Treating Know location of deep growth niches and treat accordingly

58 Listeria Equation Controlled Traffic + Patterns GMP s Sanitary Clean Dry + Design + Uncracked + Equip & Floors Building Effective Sanitation Procedures = Listeria Control

59 Summary of Lessons Learned 1. Growth niches can be identified and eliminated or managed. 2. Transfer points can be identified and their effect minimized with GMP practices 3. Sampling techniques such as post rinse sampling can aid in discovering problems before contact surfaces or product are engaged. 4. Sanitation Process Control Critical Factors can provide the basis for attaining and maintaining control of microbial contaminates in High-Risk RTE areas.

60 Summary of Lessons Learned Growth niche management is required to control exposed product contamination The regulatory environment is going to be very challenging due to not for cause environmental sampling and DNA linkage We must continually build our consumers confidence in our Food Safety system Food Safety incidents, Recalls, Bad Press in our Food Supply System is bad for all in the System None of us benefit by another s loss of control We must share Best Practices and Preventive Designs