1. United States Department of Agriculture Food Safety and Inspection Service 1

2. The Poultry Federation (AR/MO/OK), Branson, MO 3/8/16 Daniel Engeljohn, PhD Assistant Administrator Office of Policy and Program Development, FSIS, USDA Food Safety and Inspection Service

3. United States Department of Agriculture Food Safety and Inspection Service High level overview of the February 2016 FR Notice on Salmonella and Campylobacter Validation Sanitary Dressing NPIS Questions Food Safety and Inspection Service Outline of Highlighted Policy Updates

4. United States Department of Agriculture Food Safety and Inspection Service On 2/11/16, the final pathogen reduction performance standards for chicken parts and comminuted poultry issued (81 FR 7285); an advance copy posted on 2/4/16 Title: New Performance Standards for Salmonella and Campylobacter in Not-Ready-To-Eat Comminuted Chicken and Turkey Products and Raw Chicken Parts and Changes to Related Agency Verification Procedures: Response to Comments and Announcement of Implementation Schedule In response to the 1/26/15 FR Notice (80 FR 3940) Notable change from the proposed actions Using data from a 3-month moving window for calculating category status rather than a 6-month moving window Goes into effective May 11, 2016 (90 days) Food Safety and Inspection Service New Pathogen Reduction Initiatives

5. United States Department of Agriculture Food Safety and Inspection Service Will sample large volume establishments 4-5 times monthly; lower volume establishments sampled less frequently Comminuted poultry will be a 325 g sample Parts will be a 4 lb sample Standards: Comminuted Chicken 25.0 % for Salmonella (13 of 52 allowed) 1.9 % for Campylobacter (1 of 52 allowed) Comminuted Turkey 13.5 % for Salmonella (7 of 52 allowed) 1.9 % for Campylobacter (1 of 52 allowed) Chicken Parts 15.4 % for Salmonella (8 of 52 allowed) 7.7 % for Campylobacter (4 of 52 allowed) Food Safety and Inspection Service 1/2016 FR Notice Actions

6. United States Department of Agriculture Food Safety and Inspection Service Broiler carcass minimum number for Salmonella process control increased by 1 to 11 of 52 in order to eliminate a zero tolerance if fewer samples collected whereas the minimum number for Campylobacter remains at 10; turkey carcass minimum number remains at 14 for Salmonella and 19 for Campylobacter Will categorize into three categories: Category 1 – 50 % or less of the current standard Category 2 – Greater than 50 % of the current standard Category 3 – Failing the current standard Pass/Fail – For comminuted poultry regarding Campylobacter Food Safety and Inspection Service 1/2016 FR Notice Actions (continued)

7. United States Department of Agriculture Food Safety and Inspection Service Mechanically Separated (Kind) Product Concerned with wholesomeness of the product May implement a pathogen reduction performance standard particularly if evidence of the following: Product is used in a domestic not-ready-to-eat product % positive rate is unchanged or there is an upward trend over the next year Steps are not taken by industry to reduce contamination of the source carcass frame materials over the next year Food Safety and Inspection Service 1/2016 FR Notice Actions (continued)

8. United States Department of Agriculture Food Safety and Inspection Service Minor Species and Excluded Products 3-4 times annually FSIS will sample: Religious exempt product Minor species (e.g., goose, ratite, lamb) Low volume operations (1,000 lbs or less annually Posting Carcasses Establishments producing poultry carcasses will have their category status posted no sooner than May 11, 2016 Category status will be determined based on results from May 2015 for the carcass sampling programs Parts/Comminuted Posting will begin after the 52-week sampling completed (approximately 1 year) unless evidence of poor process control by industry (e.g., increase in positives); will use the minumum number rather than full allowable number; August 9, 2016, aggregate data will be posted Food Safety and Inspection Service 1/2016 FR Notice Actions (continued)

9. United States Department of Agriculture Food Safety and Inspection Service Failure to Meet the Standard PHRE scheduled; FSA may result Repetitive pathogen of public health concern findings (e.g., top 20 strains identified by CDC as the most common causes of illness) Repetitive antibiotic resistant strains PFGE or WGS strains associated with outbreaks Will collect 16 or 8 follow-up samples daily or per shift basis (consistent with STEC testing) based on volume/HACCP size Will notify CDC and public health partners (States) about the establishments poor performance May collect consignee list 90 days to effective correct the food safety system or enforcement action may follow (e.g., NOIE) Food Safety and Inspection Service 1/2016 FR Notice Actions (continued)

10. United States Department of Agriculture Food Safety and Inspection Service The HACCP system is defined in 9 CFR 417.1 as the HACCP plan in operation, including the HACCP plan itself, the hazard analysis, and supporting documentation including prerequisite programs and all HACCP records Initial validation encompasses activities designed to determine whether the entire HACCP system is functioning as intended Food Safety and Inspection Service Validation

11. United States Department of Agriculture Food Safety and Inspection Service Initial validation has two parts: Scientific support for the design of the HACCP system In-plant data for a period of 90 calendar days (e.g., 60 production days for large or 13 for small) that shows that the system can perform as intended Large plants had until January 4, 2016 and small and very small plants had until April 4, 2016 to gather in- plant validation data they may no longer have Food Safety and Inspection Service Validation (continued)

12. United States Department of Agriculture Food Safety and Inspection Service IPP will verify validation compliance (i.e., whether the scientific and technical support and in-plant data is on file and matching the actual process) via the HAV task; EIAO will do a more in-depth verification of the establishment records as part of the FSA Thus far, no significant findings or problems have been reported to OPPD regarding initial validation verificaiton Food Safety and Inspection Service Validation (continued)

13. United States Department of Agriculture Food Safety and Inspection Service Plants are expected to have written procedures both for preventing fecal contamination throughout operations and to conduct sampling to monitor their ability to maintain process control also for enterics Sampling was intended to be part of the plants procedures to demonstrate prevention of contamination and not to replace the procedures. Nationwide, the average number of NRs/month was 11.7 (1 st qtr FY16) SPS predominantly (almost half), then general sanitary dressing, then HACCP, then SSOP Fecal/ingesta, issues with reprocessing, general insanitary conditions, equipment sanitation/maintenance/calibration, inadequate feed withdrawal, antimicrobial failure, small bird size Food Safety and Inspection Service Sanitary Dressing

14. United States Department of Agriculture Food Safety and Inspection Service Over 50 plants have opted in 35 chicken, over 10 turkey, and a few of mature chicken and goose/duck Over 40 large and 10 small plants Some of the chicken plants also slaughter other species through the SIP process As of 3/7/16, 39 plants have converted including the 25 former HIMP plants Food Safety and Inspection Service NPIS

15. United States Department of Agriculture Food Safety and Inspection Service Questions? Food Safety and Inspection Service Thanks