Mid-Year Progress Report - AFRPS Cooperative Agreement Program

1. Animal Feed Program Standards Cooperative Agreement ProgramISO 17025:2005 Laboratory Accreditation Competition: Program Session 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

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

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

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

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

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.gov • Teresa.Bills@fda.hhs.gov • Please also “cc” your Mid-Year Progress Report to: • Assigned OP SIS AFRPS Technical Advisor • Assigned ORS Assessor

9. Mid-Year Progress Report • Per your NGA, the following information required in the Mid-Year Progress Report • 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

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

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

12. Mid-Year Progress Report • In addition to the NGA information, laboratory partners should also report • 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 • Reference any pending issues/concerns

13. Isaiah Isakson OP SIS AFRPS Technical Advisor Office of Partnerships (OP)Standards Implementation Staff (SIS)AFRPSSampling 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 – 10.3Laboratory 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 – 10.3Sample 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. 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

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

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

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.

24. Does your state have a feed sampling agreement/plan in place? Yes No Does your state routinely collect feed samples for analysis? Yes No

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

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

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

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 _______________________ _____________________________

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) • Please also “cc” to: • Teresa.Bills@fda.hhs.gov • Ruiqing.pamboukian@fda.hhs.gov • Assigned OP SIS AFRPS Technical Advisor

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. 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

33. Yearly # of Samples Requested • Domestic (963), Import (845)

34. FY13 Pesticide Data

35. FY12 Mycotoxin Data 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, wheatand swine feed • Zearalenone in swine feed and pet food • Ochratoxin A in oats

37. 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

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

40. “Grand Dog” Wilson Feed SamplingState PerspectiveLaboratory/Program Perspectives Mark LeBlanc, AAFCO President

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. Laboratory/Program Interaction This can be a challenge.

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

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

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

48. Joint Sampling Plan • 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

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

50. THINK HARD & ASK US