1. OFFICE OF THE TEXAS STATE CHEMIST Texas Feed and Fertilizer Control Service Agriculture Analytical Service OTSC Statistically Derived Risk-Based Plan-of-Work Susie Dai Assistant Research Professor Mary Sasser Manager Field Operations K.M Lee Associate Scientist Tim Herrman Professor, State Chemist and Director

2. OFFICE OF THE TEXAS STATE CHEMIST Outline  Who are we?  Sampling: Risk Management  What ?  Why ?  How?  Regulatory Science

3. OFFICE OF THE TEXAS STATE CHEMIST

4. Where do We Receive the Authority  Texas Commercial Feed Control Act  Texas Agricultural Code Chapter 141  Agricultural Analytical Service  Three teams  Feed and Fertilizer Control Service  Field investigators  Registration  Compliance

5. OFFICE OF THE TEXAS STATE CHEMIST Office of the Texas State Chemist, Texas Agricultural Experiment Station, Texas A&M University System Sample Chain of Custody Sample Received Sample Information Stored Official Sample Official Feed Seal Placed on Sample Information Entered Sample Shipped Sample Prepared for Analysis Reports Mailed to Manufacturer Analytical Results to FFCS Each analytical result must be surrounded by sample integrity. Without proof of the sample chain of custody, an analytical result is just a number. Texas Commercial Feed Control Act Texas Agriculture Code Chapter 141

6. OFFICE OF THE TEXAS STATE CHEMIST Risk = Probability x Consequence = X Risk: A characteristic of a situation or action wherein two or more outcomes are possible, the particular outcome that will occur is unknown, and at least one of the possibilities is undesired.

7. OFFICE OF THE TEXAS STATE CHEMIST What is Our Sampling Plan Codex Alimentarius Animal Feed Taskforce: "Guidelines on application of risk assessment for feed" and a “list of hazards in feed”

8. OFFICE OF THE TEXAS STATE CHEMIST What is Our Sampling Plan Biological  Bacterial (Salmonella, Brucella)  Endoparasites (Toxoplasma and Taenia spp.)  Prions Chemical  Mycotoxin (aflatoxin, fumonisin, ochratoxin, DON, T-2)  Industrial contaminants (Dioxin and PCB)  Heavy metals  Drug residue  Pesticide residue

9. OFFICE OF THE TEXAS STATE CHEMIST Communication for Plan-of-Work  January: administrative planning  April: development & implementation  October: mid-year review

10. OFFICE OF THE TEXAS STATE CHEMIST Why: AFRPS Standard 8 Planning and Resources Requirement Summary  Documented work plan to support its inspection and sample collection  Conduct an evaluation of resource needs to complete inspection and sample collection projections  Evaluate resources to fully implement AFRPS Program Elements  Work plan to include: inspection projections, sample, timeframe  Resources including adequate staff, equipment and funding  Conduct a review of resources required to implement the AFRPS including IT, funding, staff, equipment and other.

11. OFFICE OF THE TEXAS STATE CHEMIST Why OTSC Plan of Work FDA Plan-of-Work  Inspection-based  Facility inventory  Risk ranking  Samples to support inspection as evidence  Rely upon states to conduct the majority of inspection (60-70%) OTSC Plan-of-Work  Sample-driven  Targets coverage of all establishments in state  Directs inspections based on violation history  Builds into the POW FDA inspections

12. OFFICE OF THE TEXAS STATE CHEMIST How ? Plan of Work Attributes:  Scalable including the ability to adjust sample numbers based on state-wide tonnage, shifts in the use of different ingredients, and weighted by establishments risk factor and tonnage.  Adaptable including continuous updating subject to quarterly review.  Assessable such that conformance to the plan is possible real time.  Automated using project management software.  Differentiates between investigational, surveillance and monitoring sample collection.  Transitional to facilitate process-control regulatory oversight including one-sample-strategy and HACCP adoption.  Portable to enable field investigators to perform work at any point in the state and avoid duplication.

13. OFFICE OF THE TEXAS STATE CHEMIST What: Three Components  Economic Sampling Plan of Work  Feed Hazard Sampling Plan of Work  Investigational Plan of Work

14. OFFICE OF THE TEXAS STATE CHEMIST Component 1 Economic Sampling Plan of Work: Why?  Goal: GMP compliance of firms

15. OFFICE OF THE TEXAS STATE CHEMIST Different Firms What and How:

16. OFFICE OF THE TEXAS STATE CHEMIST What and How Different Firms Different Inspection Frequencies

17. OFFICE OF THE TEXAS STATE CHEMIST How: Violation History as a Determinant for Inspectional Frequency

18. OFFICE OF THE TEXAS STATE CHEMIST Results

19. OFFICE OF THE TEXAS STATE CHEMIST Component 2: Feed Hazard Sampling Plan of Work

20. OFFICE OF THE TEXAS STATE CHEMIST Component 2: What: Feed Hazard Sampling Plan of Work

21. OFFICE OF THE TEXAS STATE CHEMIST Wald interval Wilson interval Agresti-Coull interval where, n : sample size; Z  /2 : (1 -  /2) 100 th percentile of the standard normal distribution p : observed sample portion; (T : observed sample frequency) Why: Binomial Probability Statistics

22. OFFICE OF THE TEXAS STATE CHEMIST Sample size (n) where, N : population (a total number of feed products) e : acceptable error Z  /2  (n: average sample size of the past 3 years) Sample Population Sample Distribution Violation Rate (Contamination) Sampling Sample size (n) Presentation of the Population Why: How Many Samples We Need to Take for this Sample Category?

23. OFFICE OF THE TEXAS STATE CHEMIST p (violation rate) : 0.297 corn products (aflatoxins)Product: corn products (aflatoxins) Lower limitUpper limit Wilson interval 0.27660.3189 95% confidence intervals N (population) : 50,000Z  /2 : 1.96 Estimated sample sizes 675 (minimum)  732 (maximum) e (acceptable error) : 0.034 How: Representative Sample Numbers to Estimate the Whole Population Conclusion from Statistics: Taking ~700 corn samples can estimate the aflatoxin contamination in the whole corn industry in TX

24. OFFICE OF THE TEXAS STATE CHEMIST How : POW Total Work Load  Work Plan Summary  Complete list of investigator’s feed & fertilizer facilities  Newly registered firms  Economic feed & fertilizer projections  Economic mycotoxin projections  Funded project projections  Regulatory inspections  One Sample Strategy  Equipment list  Contact lists

25. OFFICE OF THE TEXAS STATE CHEMIST Component 3 Inspections Work Plan

26. OFFICE OF THE TEXAS STATE CHEMIST Alignment of OTSC POW with AFRPS

27. OFFICE OF THE TEXAS STATE CHEMIST Alignment of OTSC POW with AFRPS

28. OFFICE OF THE TEXAS STATE CHEMIST National View of POW What, Why and How USDA FSIS

29. OFFICE OF THE TEXAS STATE CHEMIST Global View of POW: What, Why and How New Zealand EU France CODEX

30. Regulatory Science Graduate Curriculum Advancing the science of creating tools, standards, and practices to improve the protection and compliance of food systems regsci.tamu.edu

31. SCSC 635 Comparative Global Standards in Food Systems SCSC 634 Regulatory Science: Principles & Practices in Food Systems  Globalization and standards  Principles of standards development  Regional food laws and regulations  Impact of food law and regulations on trade, food security and food protection  Emerging field of regulatory science  Food law and policy  Risk analysis  Conducting a risk assessment  Current issues and problems Fall regsci.tamu.edu

32. AGEC 638 Special Topics in Managerial Economics for Regulatory Science SCSC 636 Regulatory Science Methodology in Food Systems  Economic impact of regulations  Financial principles and practice for investments in compliance and oversight  Cost-benefit analysis of regulations governing the food industry  Statistically derived risk-based POW  Compliance Strategies  Inspectional Techniques for food systems  Crisis response & incident command Spring regsci.tamu.edu

33. SCSC 629/VTMI 629 Laboratory Quality Systems  Validity & reliability of laboratory data  Laboratory process control  Quality assurance procedures, tools and methods  Laboratory management Summer regsci.tamu.edu

34. OFFICE OF THE TEXAS STATE CHEMIST

35. Texas Feed and Fertilizer Control Service Agriculture Analytical Service END Acknowledgements: APHL – Feed and Food Subcommittee FDA – Texas Feed Safety and Inspection CAPS Texas A&M AgriLife Research