1. Animal Feed Program Standards Cooperative Agreement Program ISO 17025:2005 Laboratory Accreditation Competition: Program Session 1 Ruiqing Pamboukian Ph.D., Laboratory Accreditation Program Lead FDA Office of Regulatory Science Teresa Y. Bills, Project Officer FDA Office of Partnerships February 2, 2016

2. SPEAKERS & PRESENTATION TITLES Teresa Bills, Project Officer, Office of Partnerships, Contracts and Grants Staff (CGS) Title: Mid-Year Progress Report – What is expected? Isaiah Isakson, OP SIS AFRPS Technical Advisor, Office of Partnerships (OP), Standards Implementation Staff (SIS) Title: AFRPS Sampling Agreement-Plan Ruiqing Pamboukian Ph.D., Laboratory Accreditation Program Lead, LCDR, U.S. Public Health Service, Office of Regulatory Science Title: Sample Agreement-Plan Template and Instructions 2

3. SPEAKERS & PRESENTATION TITLES Eric Nelson, Director of Compliance, Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance, Division of Compliance Title:Present and Future State Feed Contaminants CPGM Mark LeBlanc, Director of Agricultural Chemistry, Louisiana Department of Agriculture and Forestry & President of Association of American Feed Control Officials (AAFCO) Title: Feed Sampling State Perspective Laboratory/Program Perspectives 3

4. Teresa Y. Bills Project Officer Office of Partnerships (OP) Contract and Grants Staff (CGS ) Mid-Year Progress Report What is expected?

5. Mid-Year Progress Report Only one (1) Mid-Year report is due from the AFRPS CA grantees The laboratories do not need to prepare a separate Mid- Year report for ORS The laboratory progress report information provided in the Mid-Year report will be shared with ORS MID-YEAR PROGRESS REPORT DUE DATE: MARCH 31, 2016 5

6. Mid-Year Progress Report Mid-Year report –is a comprehensive report that will provide the specific information referenced in the grantee’s Notice of Grant Award (NGA) –will indicate the progress of the Regulatory and Laboratory grantees jointly What to put in email Subject Line –AFRPS CA Grant Number –Grantee Names: Regulatory Agency & Laboratory Names –2015/16 Mid-Year Report 6

7. Mid-Year Progress Report Suggested template –will be provided but not a requirement to use 7

8. Mid-Year Progress Report At the top of Progress Report, add a Report Header –Author of Report Name, phone number & email address –PI Name, phone number & email address –Grant Number –Grantee names & addresses: Regulatory and Laboratory –Report Period covered/Project Period/Budget Period/Project Title –Report Submission Date Who do I send my Mid-Year Progress Report to: –Daniel.Lukash@fda.hhs.govDaniel.Lukash@fda.hhs.gov –Teresa.Bills@fda.hhs.govTeresa.Bills@fda.hhs.gov Please also “cc” your Mid-Year Progress Report to: –Assigned OP SIS AFRPS Technical Advisor –Assigned ORS Assessor 8

9. Mid-Year Progress Report Per your NGA, the following information required in the Mid-Year Progress Report 1.Description of project activities covering the applicable reporting period –Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application –Status report on the hiring and training of feed program personnel –Certification of current State appropriation funding levels for the State animal feed regulatory program 9

10. Mid-Year Progress Report Per your NGA, the following information required in the Mid-Year Progress Report continues… –Submission of the following documents in the most current version of the AFRPS. These documents must be current and fit for use. Appendix 2.1 or alternate form that is equivalent Appendix 3.1 or alternate form that is equivalent Appendix 4.1, 4.3, 4.6, 4.8, 4.10, 4.11 or alternate form that is equivalent Appendix 5.1 or alternate form that is equivalent Appendix 6.1 or alternate form that is equivalent Appendix 7.1 or alternate form that is equivalent Appendix 8.1 or alternate form that is equivalent Appendix 9.1 and 9.2, or alternate form that is equivalent Appendix 10 or alternate form that is equivalent Appendix 11 or alternate form that is equivalent 10

11. Mid-Year Progress Report Additional information requested in the Mid-Year Progress Report 2.Discuss any issues with expenditures 2.List Points of Contact and Project Key Personnel (Regulatory & Laboratory) 11

12. Mid-Year Progress Report In addition to the NGA information, laboratory partners should also report 1.General progress or status of specific items listed below: –Accreditation Action Plan –Proficiency Tests –Participation in FERN activities –Mentor/Mentee Involvement –Sampling Agreement –eLEXNET Data entry 2.Reference any pending issues/concerns 12

13. Isaiah Isakson OP SIS AFRPS Technical Advisor Office of Partnerships (OP) Standards Implementation Staff (SIS ) AFRPS Sampling Agreement-Plan

14. Standard 10: Laboratory Services This standard describes the elements of utilizing regulatory testing laboratory services that support the State animal feed program. (10.1 Purpose)

15. Program Elements – 10.3 Laboratory Services and Agreements State program maintains a list of routine and non-routine analytical services provided by regulatory testing laboratories State program has a documented formal agreement with the laboratory (ies) that conduct routine analytical services, unless the laboratory is managed within the program

16. Program Elements – 11.3.A. Sampling Plan Jointly developed and amended by the State program and laboratories performing routine services Sampling plan outlines the State program’s: –Sampling priorities –Sample analysis schedule –Availability or coordination of analytical support –May include estimates of analytical costs

17. Program Elements – 10.3 Sample Analysis Schedule State program prepares a sample analysis schedule based on a sampling plan in cooperation with laboratories performing routine services to ensure compatibility with laboratory capabilities & capacities At a minimum, sample analysis schedule must include: –Type(s) of feed to be analyzed –Number of samples to be collected –Estimated timeframe for collection –Type(s) of analysis to be performed

18. Program Elements – 10.3. Communication Procedures In collaboration with the laboratories, the State program establishes standard procedures and a means to communicated necessary information for sample:  Submission  Shipping  Preservation  Storage  Retention  Disposal  Chain of custody, and  Report of analysis

19. 19 Ruiqing Pamboukian Ph.D. Laboratory Accreditation Program Lead LCDR, U.S. Public Health Service Office of Regulatory Science Sample Agreement/Plan Instructions

20. Sampling Agreement/Plan Instruction - Template to use 20

21. Importance of Sampling Agreement Supports laboratory in obtaining or expanding scope of ISO 17025 accreditation Supports Animal food program in implementing AFRPS Successful programs will exhibit integrated planning and enhanced/routine communications between the Laboratory and Feed program regarding sampling. Meets the goals of the RFA –Lab commitment to analyze surveillance and emergency samples –Sharing lab results through eLEXNET –Increase national lab capacity and enhance efforts to protect the animal food/feed supply 21

22. EXAMPLE State AFRPS-ISO Sampling Agreement State Laboratory Agency Titles and Address State Feed Regulatory Program Agency Titles and Address Date 22

23. Concerning: The Animal Feed Regulatory Program Standards (AFRPS) and AFRPS Cooperative Agreement (CA) ISO 17025 Competition. The Following sampling agreement is between the _[insert name of State feed regulatory agency]_________and the _[insert state feed laboratory]_________ to ensure a sound plan regarding sampling of animal feed and feed ingredient products for protecting the public’s health (human and animal). This agreement and the program described below support the sampling objective required by the AFRPS Cooperative Agreement and state feed regulatory programs implementation of the AFRPS. 23

24. Does your state have a feed sampling agreement/plan in place? YesNo Does your state routinely collect feed samples for analysis? YesNo 24

25. Please summarize below either your current or your proposed sampling agreement/plan: Number of Samples schedule for FY 16 (breakdown by contaminant/hazard and commodity – corn, cotton, distillers, feed ingredients, finished feed, etc) Types of Analysis to be performed: –Chemical Contaminant: Mycotoxins, Pesticides, Industrial Chemicals, Elements (heavy metals), Dioxin, Antibiotics, etc. –Microbial (Salmonella, E. Coli, Listeria, etc), –Physical Contaminants: metal, wood, etc. –Nutritional (including nutritional deficiencies): vitamins, minerals, etc. –Misc: guarantee analysis, etc 25

26. Sample collection frequency (quarterly, 2x/year, seasonal, etc.) Program (routine inspection, imports, etc.) Outline how these sampling proposals support the animal feed priorities of the State 26

27. Please attach the following supporting documents: Sampling plan outlining the State program’s sampling priorities, the sample analysis schedule, and the availability or coordination of analytical support (AFRPS Std. 11 program elements 11.3 A) –Laboratory capability –Enforcement capability Sampling procedures including methods for collecting, storing and transporting samples, and instructions for documenting the sample collection (AFRPS Std. 11 program elements 11.3 B) Laboratory methods 27

28. The sampling agreement relates to the timelines outlined in the AFRPS Cooperative Agreement (CA) ISO 17025 Competition. Director of Animal Feed Safety Director of the Feed Laboratory ____________________________________________________ 28

29. Sampling Agreement and Sampling Plan Due Date: August 31, 2016 Who do I send my Sampling Agreement and Sampling Plan to: –Assigned ORS Assessor and ISO mail box (ISO@fda.gov)ISO@fda.gov Please also “cc” to: –Teresa.Bills@fda.hhs.govTeresa.Bills@fda.hhs.gov –Ruiqing.pamboukian@fda.hhs.govRuiqing.pamboukian@fda.hhs.gov –Assigned OP SIS AFRPS Technical Advisor 29

30. 30 Eric Nelson Director of Compliance Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance Division of Compliance Present and Future State Feed Contaminants CPGM

31. 31 Present and Future State of Feed Contaminants CPGM FDA, Center for Veterinary Medicine Office of Surveillance and Compliance

32. Present State Feed Contaminants Program Pesticides, Industrial chemicals Elements Mycotoxins Microbes Dioxin 32

33. Yearly # of Samples Requested Domestic (963), Import (845) 33 DomesticImport Pesticides, Industrial Chemicals 250495 (chem and others) Elements105 Mycotoxin338 Microbes100350 Dioxin150 Antibiotics20

34. FY13 Pesticide Data Category Samples Analyzed Without Residues # (%) Violative Samples # (%) Totals - All Samples420217(51.7)8 (1.9) Sample Origin Domestic254118(46.5)4 (1.6) Import16699(59.6)4 (2.4) Commodity Type Whole and Ground Grains/Seed 178135(75.8)2 (1.1) Mixed Livestock Food Rations 10932(29.4)2 (1.8) Medicated Livestock Food Rations 173(17.7)0 (0.0) Plant By-products 5030(60.0)4 (8.0) Hay and Silage 84(50.0)0 (0.0) Animal By-Products 72(28.6)0 (0.0) Pet Food/Treats 445(11.4)0 (0.0) Other Animal Food Ingredients76 (85.7)0 (0.0) 34

35. FY12 Mycotoxin Data MycotoxinsAnalyzedPositiveRangeAbove Guidance Aflatoxins16619(1.6 - 86.1 ppb)7 Fumonisins5543(0.1 - 7.5 ppm)1 Vomitoxin6018(0.1 - 4.7 ppm)0 Zearalenone377(61 - 250 ppb)NOG Ochratoxin A102(11.6 - 15.9 ppb)NOG Total32889 * 7 samples positive for two mycotoxins Analyses were conducted using either an ELISA multi-mycotoxin residue screen, or a more specific quantitative method for the specific mycotoxins.

36. Mycotoxin Surveillance Program –Aflatoxins in corn, corn and peanut products, and complete feed –Fumonisins in corn, corn products and feed –Vomitoxin (deoxynivalenol) barley, wheat and swine feed –Zearalenone in swine feed and pet food –Ochratoxin A in oats

37. Mycotoxins # of Samples Positive samples Above guidance No%No.% of positive Aflatoxin475762313.118129.0 Fumonisin118465255.17211.0 Vomitoxin47523449.32410.3 Zearalenone5807813.471100* Ochratoxin A2072110.119100* 1994-2012 Mycotoxin Data * No established guidance levels

38. Microbes: Salmonella Objectives –Determine the prevalence of Salmonella –Determine the serovar, genetic fingerprint, and antimicrobial susceptibilities of each isolate –Take action for controlling the presence of Salmonella Assignments –Pet food: 2007 – 2013 –Poultry feed: 2012 –Milk replacer: 2013 38

39. Future State of Feed Contaminants Program Continuation of Surveillance Sampling –Chemical, Biological, Pathogenic Supporting FSMA Compliance –PC Confirmation –Hazard Identification and Prevalence –Policy Development Sample Data Sharing 39

40. Feed Sampling State Perspective Laboratory/Program Perspectives Mark LeBlanc, AAFCO President “Grand Dog” Wilson

41. History States have been regulating animal feed for over 100 years. Original need for regulation revolved around economic adulteration. Need for common methods of analysis drove the creation of methods to determine crude protein, crude fat and crude fiber.

42. For most of the history of feed regulation, the focus has been on economic adulteration. Is the farmer getting what he is paying for? Feed Regulatory Programs have had to adjust as different challenges emerged regarding adulteration. Focus has shifted from entirely economic sampling to include safety for man and animal.

43. Each state will have its own perspective on sampling priority. –Widely different feed commodities –Common adulterants can vary depending on location. For example Aflatoxin in the southeast vs other mycotoxins in the midwest. –Each state has its own perspective on economic vs feed safety sampling. –Each state may have a different perspective on risk

44. This can be a challenge. 44 Laboratory/Program Interaction

45. Tools to improve relationship Communication Mutual understanding Inspector/Analyst exchanges Communication Regular meetings Communication 45 Laboratory/Program Interaction

46. Risk –Economic and safety Opportunity –What is in commerce? Budgetary –Staffing Limitations –Quality vs Quantity? Representativeness vs Practicality 46 Regulatory Program Considerations for Sampling Plan

47. Capacity –Staffing –Throughput Limitations Capability –Instrumentation –Expertise Sample Integrity 47 Laboratory Considerations for Sampling Plan

48. Lab and Program must agree on Sample timing Sample matrices and analytes Sample throughput time Sample integrity/chain of custody Sample storage and retention Record storage and retention Means of sharing analytical data Laboratory security 48 Joint Sampling Plan

49. Mark LeBlanc AAFCO President Director Agricultural Chemistry LSU AgCenter/La Dept. of Ag and Forestry Mark_l@ldaf.state.la.us AAFCO.ORG 49 Questions?

50. 50