Supplier Approval Programs. Norlyn C. Tipton, Ph.D. FSQA Director Specialty Meat & Seafood Companies, Sysco Corp. BIFSCO Conference March 02, 2016

Transcription

1 Supplier Approval Programs Norlyn C. Tipton, Ph.D. FSQA Director Specialty Meat & Seafood Companies, Sysco Corp. BIFSCO Conference March 02, 2016

2 Outline Background on Beef Supplier Approval NOIE HACCP Logic Supplier Approval Must Haves Box In & Out Suppliers Intact Processed Product Beef Whole Muscle Non Intact Products Beef Raw Material for Grinding Subrimal Testing for E. coli O157:H7 Examples of Verification Documents 2

3 Background on Beef Supplier Approval FR Docket No N E. coli O157:H7 Contamination of Beef Products October 7 th, 2002 FSIS believes that the availability of certain scientific data on E. coli O157:H7 constitutes a change that could affect an establishment's hazard analysis or alter its HACCP plans for raw beef products. Therefore, under the HACCP regulations, if establishments have not already reassessed their HACCP plans for raw beef products in light of this data, they must do so now. 3

4 Background on Beef Supplier Approval FR Docket No N E. coli O157:H7 Contamination of Beef Products October 7 th, 2002 All establishments producing raw beef products are required to reassess their HACCP plans. However, establishments receiving product for grinding may have purchase specifications requiring all their suppliers to have one or more critical control points (CCPs) validated to eliminate or to reduce E. coli O157:H7 below detectable levels. Such establishments may determine that no additional steps to address this pathogen are necessary in their production process. Establishments adopting this approach should incorporate these purchase specifications and their means of ensuring that their specifications are met in their HACCP plans, in their Sanitation SOPs, which FSIS has recognized as prerequisites for HACCP, or in other prerequisite programs. 4

5 Background on Beef Supplier Approval As a result of the Oct FSIS FR Notice on E. coli O157:H7 many further processors implemented or enhanced Purchase Specifications in the form of Supplier Approval Programs that obtained annual Food Safety Letters of Guarantee from each beef supplier. These programs became common justification for why E. coli O157:H7 was Not Reasonably Likely to Occur in Non Intact Beef at Further Processing Operations. 5

6 Background on Beef Supplier Approval Typical wording on these letters (from 2007 Cargill Meat Solutions Letter of Guarantee): In connection with the October 7, 2002, USDA FSIS notice on E. coli O157:H7 prevalence, Cargill Beef has reassessed the HACCP plans for all of the beef harvest plants located in the U.S. As noted in the October 7, 2002 FSIS notice, because of recent research reports indicating that cattle have a higher incidence of E. coli O157:H7 than previously reported, establishments that harvest and process raw beef product must include E. coli O157:H7 as a hazard reasonably likely to occur in all HACCP plans. As interventions, beef plants have installed pre-evisceration acid rinse cabinets, steam vacuums, post-evisceration acid rinse cabinets, and steam pasteurization cabinets in the fed cattle beef slaughter plants in the U.S. In the Cargill Regional Beef facilities, those companies have installed steam vacuums, an acid rinse cabinet and steam pasteurization cabinets or thermal cabinets. In an attempt to eliminate or reduce E.coli O157:H7 to below detectable levels, Cargill Meat Solutions Corporation, beef and its affiliated companies have identified the validated steam pasteurization intervention as a CCP. The critical limit of this CCP is 6 seconds in an environment of 180 degrees. This CCP is validated by use of Data-Pak time/temperature monitoring probes. 6

7 Background on Beef Supplier Approval Unfortunately many establishments only obtained letters once, or when annually obtaining those letters did not have any meaningful verification activity (Binders on shelves with letters) Then came 2007 & 2008 Dramatic increase in E. coli O157 related outbreaks, recalls, positive test results and the Topps Recall. Annual Third Party Independent Food Safety Audit Results started to be routinely incorporated into Supplier Approval Programs around this time. 7

8 Background on Beef Supplier Approval Subsequently: N60 Addendums or other E. coli O157:H7 program assessment addendums have been added to annual audits at slaughter/fab plants. Event Day Programs emerged as part of supplier approval programs. Annual frequency of verification began to be questioned by FSIS. FSIS Directive Rev 3 (3/31/2010) 8

9 Background on Beef Supplier Approval FSIS Directive Rev 3: Chapter IV II. MEASURES TO ADDRESS E. coli O157:H7 A. There is no one, absolute way in which an establishment is to control or prevent E. coli O157:H7. IPP may find in verifying the approach to the pathogen that the establishment is using CCPs in its HACCP plan, its Sanitation SOPs, another prerequisite program, or a combination of these mechanisms, to do so. B. An establishment receiving, grinding, or otherwise processing raw beef products may address E. coli O157:H7 by conducting finished product testing before pre-shipment review. In addition, an establishment may incorporate procedures for washing product when removed from Cryovac bags and trimming the outer surface of the product before producing non-intact product, using antimicrobials or other lethality treatments, or taking some other validated measures. 9

10 Background on Beef Supplier Approval FSIS Directive Rev 3 : Chapter IV II. MEASURES TO ADDRESS E. coli O157:H7 C. Establishments receiving, grinding, or otherwise processing raw beef products may use their Sanitation SOPs or other prerequisite programs to prevent E. coli O157:H7. The establishment in its hazard analysis is to have supporting and ongoing verification documentation that establishes that the pathogen hazard is not reasonably likely to occur in its operation because of the design and execution of its prerequisite program. Such prerequisite programs may include the use of purchase specifications, but purchase specifications without on-going verification by the receiving establishment are not adequate (see 9 CFR 417.4(a)). D..Given this fact, a prerequisite program involving an annual letter of guarantee and an annual third part audit would not be adequate because the prerequisite program does not include any provision for meaningful on-going verification. A third party audit once a year does not provide the type of continuing activity that would constitute on-going verification. Establishments may utilize the Internet (e.g., information or current information available on a Web page) to provide up-to-date information on prerequisite programs. Given the sporadic, low-level occurrence of E. coli O157:H7, frequent verification is necessary to provide assurance that the presence of this pathogen is being successfully prevented by the prerequisite program. 10

11 Background on Beef Supplier Approval FSIS Directive Rev 3 : Chapter IV II. MEASURES TO ADDRESS E. coli O157:H7 E. If the establishment uses purchase specifications in a prerequisite program to support the effectiveness of the program, FSIS expects the establishment to have: 1. a document (e.g., letter of guarantee) from each supplier that provides assurance that the supplier employs CCPs that address E. coli O157:H7 and that describes the CCP, the monitoring of the CCP, and the use of any interventions. It is important to know whether the CCP is applied during slaughter (pre-chill) versus post-chill because further processing post-chill may introduce or re-distribute contamination on the product; 2. certificates of analysis (COAs) (i.e., actual test results) and the sampling method used (e.g., N-60) by the supplier for product meant for grinding. It is important to know whether the production lot represented by the COA at the receiving establishment covers more than the amount of product represented at the receiving establishment; and FSIS Directive 10, records (e.g., the receiving establishment s own testing results, ongoing communication with suppliers, or third party audits) that verify on an ongoing basis that the receiving establishment is executing its program to achieve the first two conditions in E. above in a consistent and effective manner to ensure that it is receiving product in which E. coli O157:H7 is not detectable. 11

12 Background on Beef Supplier Approval FSIS Directive (August 20, 2015): Chapter II HACCP Verification Activities A. IPP are to use the instructions in Table 1 when performing Raw Intact and Raw Non-Intact HAV Tasks. TABLE 1: STEPS IN PERFORMING THE HAZARD ANALYSIS VERIFICATION (HAV) TASK IN RAW INTACT AND RAW NON-INTACT BEEF PRODUCTS Step 5 Review prerequisite programs and other supporting programs, including written programs, records, and employee activities. Verify the implementation of prerequisite programs. Does the establishment use prerequisite programs to support hazard analysis decisionmaking? Does the establishment s antimicrobial intervention preventive measures on incoming raw materials incorporate the critical operating parameters (e.g., product or carcass coverage) identified in the establishment s scientific support? 12

13 NOIE Findings/Basis for Action From March 22, 2010, through May 21, 2010, Enforcement Investigation and Analysis Officer (EIAO) conducted a Food Safety Assessment (FSA) at your establishment. The purpose and scope of this assessment was to review the food safety systems for regulatory compliance and to determine if the systems were scientifically sound and supported. The HACCP system, SSOP program, and prerequisite program records along with supporting documentation for XXXXXXX. 's food safety systems were reviewed. In the course of this review, the Raw Not Ground HACCP program was found to be inadequate. The HACCP plan in operation does not meet the requirements set forth in Title 9 CFR 417. Specifically, XXXXXXXX lacked documentation sufficient to support the decisions made in the hazard analysis that the prerequisite programs and decision making documents utilized to address E. coli O157:117 are adequate to support that E. coli O157:H7 is not likely to occur in the Raw Not Ground process in accordance with Title 9 CFR 417.5(a)(1). Your establishment was unable to support the development and placement of your CCPs as required under Title 9 CFR 417.5(a)(2) and failed to identify all steps during the production a fabrication of food products as required under Title 9 CFR 417.2(a)(1) and (a)(2). 13

14 NOIE HACCP Regulatory Requirement, Title 9 CFR XXXXXX failed to demonstrate that the design and implementation of the Supplier Approval Program, decision making documents, sanitizing of tenderizing machines and cubing machines during processing, and in-house sampling are adequate to support your decision in the Raw Not Ground HACCP program that E. coli O157:H7 is not reasonably likely to occur in beef products, a regulatory noncompliance under Title 9 CFR 417.5(a)(l). Your establishment, at the steps of "receiving" and "processing/fabrication," has identified that E. coli O157:H7 was not a hazard reasonably likely to occur in the production of mechanically tenderizing, cubing, or bonding beef production. Your establishment has cited a number of scientific articles and USDA-FSIS issued articles regarding non-intact beef products to support your decisions made in the hazard analysis at the step of receiving. However, the cited documents were inconclusive and failed to support your decision that E. coli O157:H7 was not a hazard reasonably likely to occur in the production of non-intact beef products, a regulatory noncompliance under Title 9 CFR 417.5(a)(1). 14

15 HACCP Logic Process Step Process Step Receive meat and poultry products Refrigerated or Frozen STEP 1 Potential hazard introduced, controlled or enhanced at this step Bio: Pathogens (i.e. E. coli O157:H7, non 157 STEC, Salmonella, Campylobacter) Bio. Other: Bovine Spongiform Encephalopathy (BSE) Trichenella spiralis (bacon) Chem: lead shot (lead residue); Allergens Is the potential food safety hazard significant? Risk: Severity B: No C: No Scientific Justification of Hazard Analysis B: See Attached Decision Making Documentation C: See Attached Decision Making Documentation If hazard is reasonably likely to occur, what control measures can be applied to prevent the significant hazards? Is this step a critical control point? (CCP)? No No Phy. Foreign material, needles, paper, lead shot, glass, wood, nails P: No P: See Attached Decision Making Documentation No 15

16 HACCP Logic Receiving: Currently available scientific data relative to E. coli O157:H7 occurrence on meat cuts is summarized in the Beef Industry Food Safety Council s (BIFSCO) 2006 Best Practices: Pathogen Control During Tenderizing/Enhancing of Whole Muscle Cuts. This paper states at the bottom of page 3and top of page 4 that: Several studies indicate that E. coli O157:H7 is not a hazard reasonably likely to occur on the surface of intact meat portions. A study was conducted by Warren et al. (2003) where sponge samples were taken of 1,014 subprimal cuts from six beef processing plants February 2006 over a five-week period. Only two samples (0.2%) tested positive for E. coli O157:H7. Enumeration indicated that each of the two positive samples had <3.0 CFU per 200 cm2 sampled. Two later studies were conducted by ABC Research Corporation (Gainesville, Fla.) throughout 2004 to determine the prevalence of E. coli O157:H7 and indicator organisms on the surface of beef subprimals that would be used as raw materials for tenderizing or enhancing operations. These studies used cuts of meat specifically used for tenderizing or enhancing operations, namely, briskets, rounds, chucks and middle meats. One study (I) focused on raw materials produced during the winter months (January and February); the second study (II) collected data during the late summer and fall (August into November). 16

17 HACCP Logic Receiving (cont.): Results of the Warren et al. (2003) and Kennedy and Badmaruk 2004, 2005 papers cited in the previous excerpt of the 2006 BIFSCO Best Practices: Pathogen Control During Tenderizing/Enhancing of Whole Muscle Cuts were later published in the Journal of Food Protection as the respective papers of: 1. Heller et al. - Decontamination of Beef Subprimal Cuts Intended for Blade Tenderization or Moisture Enhancement - Journal of Food Protection, Vol. 70, No. 5, 2007, Pages Kennedy et al. - Prevalence of Escherichia coli O157:H7 and Indicator Organisms on the Surface of Intact Subprimal Beef Cuts Prior to Further Processing - Journal of Food Protection, Vol. 69, No.6, 2006, Pages As a note, the results of the Kennedy and Badmaruk 2004, 2005 studies were combined into one single paper for publication in the Journal of Food Protection. 17

18 HACCP Logic Receiving (cont.): We acknowledge that steps must be taken to prevent, eliminate or reduce to an acceptable level any pathogen contamination. Based on Federal Register Notice (Vol. 67, No. 194, Oct. 7, 2002), FSIS considers an acceptable reduction for E. coli O157: H7 to be reduction to an undetectable level. Because controls reduce the risk of E. coli O157: H7 contamination when the product is still intact may be the best means of controlling the hazard, FSIS believes that slaughter establishments should strongly consider putting in place one or more validated CCP s that are designed to eliminate or reduce E. coli O157:H7 and other pathogens. Therefore we must address the reduction of E. coli O157:H7 and procedures to control the growth if the microorganism is present on the raw material. To the best of our knowledge, there are no known interventions that can be applied at the point of receiving chilled product that have been proven to achieve an undetectable level of E. coli O157:H7/STEC. Therefore, our contention is the most viable option is to rely on verification of interventions at supplier slaughter operations. SSMC s have Purchase Specifications (Supplier Approval Program) that require approved beef suppliers to provide documentation for proven, validated intervention methodology that reduces pathogens to an acceptable level per USDA FSIS regulation, and has ongoing verification of controls for E. coli O157:H7/STEC and other pathogens (Beef for non intact production). 18

19 HACCP Logic FSIS Data Says It s Still True Source Federal Plants Trim Verification** * Follow-up to RGB Positive Raw Ground Beef Components (RGBC) As of December 31, 2013 As of December 31, 2014 * Number Number Percent Number Number Percent Analyzed Positive Positive Analyzed Positive Positive 5, , , , * Bench Trim Subprimal Testing Began in 2014 Follow-up to RGBC Positive Other RGBC Verification Bench Trim Verification , Imports *Results are posted according to the sample analysis completion date. 19

20 HACCP Logic FSIS Data Says It s Still True Source Federal Plants Trim Verification* ** Raw Ground Beef Components (RGBC) As of February 22, 2015 As of February 21, 2016 Number Number Percent Number Number Percent Analyzed Positive Positive Analyzed Positive Positive Follow-up to RGB Positive Follow-up to RGBC Positive Other RGBC Verification Bench Trim Verification Imports

21 HACCP Logic Intervention: By utilizing PAA as a spray intervention to be applied to the outside surface of all beef utilized at this facility for whole muscle non intact production, we intend to: 1. Effectively increase shelf life of our finished product by decreasing the amount of spoilage bacteria found on the outer surface of raw product received from our suppliers. 2. As a further augmentation measure to act in the unlikely potential that the Supplier Approval Program would be usurped (see Receiving Logic) and physical introduction of E. coli O157:H7/STEC from the exterior to the interior in whole muscle non intact beef would occur. This will be accomplished according to the intervention pre-requisite program via application of the validated PAA intervention to whole muscle beef products prior to rendering them whole muscle non intact. 21

22 Supplier Approval - Must Haves Robust Supplier Approval Program Plus an Intervention for Whole Muscle Non Intact Beef Detailing of Validated CCPs to reduce to Zero or Eliminate E. coli O157:H7/STEC (Food Safety Letter of Guarantee) & SRM Control. Assessment of STEC/E. coli O157:H7 Control Programs & GFSI Certificate/GMP Food Safety Audit (Audit & E. coli Addendum) Trim Test (n60) E. coli O157:H7 Verification Results, Quarterly Ongoing Verification with Direct Supplier Communication and a Justified Verification Frequency (We have chosen annual or quarterly depending on component) 22

23 Supplier Approval - BIBO All suppliers of redistributed products must have on file a current pure food guarantee. SPECIALTY MEAT COMPANY CONTINUING GUARANTY The undersigned, Sysco Corporation on behalf of its Specialty Meat Company subsidiaries CFIA/USDA Establishment numbers 1858, 8983, 2697, 2697C, 27468, 20926, 17081, 2872, 2213D, 31757, 10, 1164, 22076, 4104, CFIA 671, 2106, 20815/P492A, 4195, 17972, 8646, CFIA 664, CFIA 731 and 2213A (collectively Seller ), hereby states that each and every article contained in and comprising each shipment to or on the order of (Buyer), is hereby guaranteed, as of the time and place of each shipment, to be: 1. Not intentionally adulterated or misbranded within the meaning of the US Federal Meat Inspection Act as amended (if applicable), the US Poultry Products Inspection Act as amended (if applicable) and/or Federal Food, Drug and Cosmetic Act, as amended (if applicable), and not an Article which may not, under the provisions of Section 404, 505 or 512 of such Act be introduced into interstate commerce: 2. Not intentionally adulterated or misbranded within the meaning of the Canadian Food and Drugs Act (F&D Act) and the Canadian Food and Drug Regulations (if applicable). 3. Not intentionally altered or misbranded within the meaning of the terms of the US Federal Insecticide, Fungicide and Rodenticide Act: and 4. Not intentionally produced in non compliance with the US Fair Labor Standards Act of 1938, as amended, and of the regulations and orders of the administrator of the Wage and Hour Division issued under Section 14 thereof. 23

24 Supplier Approval Further Processed Beef Intact BIBO plus: All suppliers of further processed raw materials under CFIA/FSIS/TIF authority must have on file a Current Food Safety (e.g. HACCP Program & BSE Control) Letter of Guarantee detailing food safety controls including detailing all pathogen interventions (including validation)and SRM/BSE controls Certification of a passing (according to the audit criteria) Independent Third Party Food Safety Audit (Audit Report with Corrective Actions or GFSI Certificate) from within the most recent past calendar year. 24

25 Supplier Approval Further Processed Beef Whole Muscle Non Intact Further Processed Beef Whole Muscle Intact plus: 1. Quarterly Letter of Guarantee for Food Safety Programs (HACCP Letter & BSE Controls) a. The letter must detail a minimum of one validated pre-chill intervention and one validated post chill intervention designed to address pathogens including reduction of E. coli O157:H7 to below detectible levels on beef carcasses, trim and/or subprimals, as appropriate. b. The letter must also detail how the supplier is addressing non O157:H7 Shiga Toxin Producing E. coli of concern (O26, O45, O103, O111, O121, O145) in raw beef products. c. The letter must also assert that each establishment has a program (e.g. High Event Period program) whereby anomalies in patterns from beef trim pathogen tests are used to investigate potential process control issues and to take action on potentially affected products (trim, subprimals, etc.). d. The letter must detail what action the supplier has taken in response to FSIS Notice to include, at a minimum, the comingling status of packaged subprimal products (see: a2cb-c1b3353c62d2/PolicyPoint pdf?MOD=AJPERES). 25

26 Supplier Approval Further Processed Beef Whole Muscle Non Intact Further Processed Beef Whole Muscle Intact plus (cont): 2. An E. coli O157:H7 Verification Addendum to the Independent Food Safety Audit or a section in the audit for verification of E. coli O157:H7 control programs. 26

27 Supplier Approval Further Processed Beef Whole Muscle Non Intact Further Processed Beef Whole Muscle Intact plus (cont): 3. The E. coli O157:H7 Verification Addendum to the Independent Food Safety Audit or a section in the audit must list all pathogen interventions and pathogen reduction processing aids utilized in the establishment s food safety control process, with at least one of those interventions being a CCP in the process validated against E. coli O157:H7. 27

28 Supplier Approval Further Processed Beef Whole Muscle Non Intact Further Processed Beef Whole Muscle Intact plus (cont): 4. For all company establishments that produce beef manufactured trimmings for raw ground beef production, Verification Results of Trim Testing Procedures for the establishments E. coli O157:H7 testing protocol (i.e. verification results of the n60 testing protocol) provided quarterly. Utilized for verification of the interventions listed in the E. coli Addendum (recently confirmed as acceptable in an appeal of an NOIE received at one of our establishments). 28

29 Supplier Approval Further Processed Beef Raw Material for Grinding Further Processed Beef Whole Muscle Intact plus: 1. Raw materials must be shipped by a unique identifying lot not to exceed five 2000 pound combo bins or must be shipped with an identifiable Pack Date and Establishment Number for non combo domestic product and via a unique identifying lot or a documented Pack Date and Establishment Number. 2. Each raw material combo lot shall be accompanied with a negative E. coli O157:H7 Certificate of Analysis (COA) using a FSIS defined Robust Testing sampling protocol (N=60, 375 gram composite sample See FSIS Directive 10,010.1 Rev 4 - Sampling Verification Activities for Shiga Toxin-producing Escherichia Coli (STEC) in Raw Beef Products ) and a testing methodology at least equivalent to FSIS s currently approved laboratory testing methodology must be used. 3. Verification of COA methodology will be accomplished via obtaining documentation of Quarterly Trim Testing Verification results for E. coli O157:H7 for all affected establishments. 29

30 Supplier Approval Further Processed Beef Raw Material for Grinding Further Processed Beef Whole Muscle Intact plus (cont): 4. In lieu of COA s, Food Safety Letter of Guarantee terminology that covers all raw ground beef products having tested negative for E. coli O157:H7, according to FSIS s defined Robust Testing sampling protocol (e.g. N=60, 375 gram composite sample) via a testing methodology at least equivalent to FSIS s currently approved laboratory testing methodology, may be accepted. Terminology that all affected products have tested negative for E. coli O157:H7 must accompany each received invoice or other similar documentation for the affected product. 30

31 Subrimal Testing for E. coli O157:H7 With a Robust Supplier Approval Program (Whole Muscle Non Intact Raw Beef and Raw Ground Beef) and Validated Interventions for Raw Whole Muscle Non Intact Beef there should be no need for a further processor to test subprimal beef for STEC or E. coli O157:H7* to justify a decision that E. coli O157:H7 is Not Reasonably Likely to Occur in Further Processed Raw Whole Muscle Non Intact Beef. *Remember Poorly designed pathogen testing programs (e.g. a single quarterly test of product from one supplier) unnecessarily put you and the supply base at risk with little to no value as ongoing verification. Well designed testing programs (e.g. slaughter trim n60) require close attention to sampling techniques, frequent sampling (multiple times daily) control programs for process control changes based on results (e.g. Event Programs) and well designed checks on movement of sampled product, among other details. 31

32 Supplier Approval Internet Verification 32

33 Supplier Approval Internet Verification 33

34 Supplier Approval Approved Supplier Log 34

35 Questions? 35