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Protecting the Food Supply

January 2005

FDA Actions on New Bioterrorism Legislation

Overview of Bioterrorism Act Establishment and Maintenance of Records Final Rule

(Final Rule, 69 FR 71561, December 9, 2004)

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Table of Contents
  1. Overview of Bioterrorism Act Establishment and Maintenance of Records Final Rule
  2. Regulatory Development of Rule
  3. Significant Changes Between NPRM and Final Rule
  4. Significant Changes Between NPRM and Final Rule (cont.)
  5. Significant Changes Between NPRM and Final Rule (cont.)
  6. Significant Changes Between NPRM and Final Rule (cont.)
  7. Significant Changes Between NPRM and Final Rule (cont.)
  8. Final Rule: Overview of Some Significant Definitions
  9. Definitions (cont.)
  10. Definitions (cont.)
  11. Examples of FDA-Regulated Food
  12. Examples of FDA-Regulated Food
  13. Examples of FDA-Regulated Food (cont.)
  14. What Foods Does FDA Not Regulate?
  15. Definitions (cont.)
  16. Definitions (cont.)
  17. Definitions (cont.)
  18. Definitions (cont.)
  19. Definitions (cont.)
  20. Definitions (cont.)
  21. Definitions (cont.)
  22. Who is subject to this subpart?
  23. Who is excluded from all of the regulations in this subpart?
  24. Who is excluded from all of the regulations in this subpart? (cont.)
  25. Who is excluded from all of the regulations in this subpart? (cont.)
  26. Who is subject only to the record access and prohibited act provisions?
  27. Who is subject to only the record access and prohibited act provisions?
  28. Who is subject to only the record access and prohibited act provisions?
  29. Substance, Activity, Coverage Chart
  30. Partial Exclusions
  31. Partial Exclusions
  32. Establishment and Maintenance of Records by Non-Transporters
  33. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Previous Source (IPS)
  34. Records Non-transporters Have To Establish And Maintain to Identify the IPS (cont.)
  35. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Subsequent Recipient (ISR)
  36. What Information Must Non-Transporters Keep in Records to Identify the ISR (cont)?
  1. What Information Must Non-Transporters Keep in Records to Identify the ISR (cont)?
  2. Non-transporters’ Records Regarding the ISR
  3. Example 1: Common Storage Silo for An Ingredient (e.g., Flour)
  4. Example 2: Dedicated Storage Silos for Each Ingredient Source
  5. Requirements for Transporters to Establish and Maintain Records
  6. Requirements for Transporters to Establish and Maintain Records
  7. Various Transportation Companies
  8. One Transportation Company with Multiple Modes of Transportation
  9. Requirements for Transporters to Establish and Maintain Records (cont.)
  10. Requirements for Transporters to Establish and Maintain Records (cont.)
  11. Agreements Between Non-Transporters and Transporters Must Contain:
  12. Requirements for Agreements (cont.)
  13. Requirements for Agreements (cont.)
  14. Record Retention Periods
  15. What are the record retention requirements?
  16. Consequences: New Prohibited Acts
  17. Consequences: New Prohibited Acts (cont.)
  18. What are the compliance dates?
  19. Calculating FTE’s for compliance date purposes:
  20. Do other recordkeeping requirements in statutes and regulations still apply?
  21. Can Existing Records Satisfy the Requirements of this Subpart?
  22. What are the record availability requirements?
  23. What records are excluded from BT Act records access?
  24. Economic Impact of Final Rule
  25. Economic Impact of Final Rule
  26. FDA Draft Records Access Guidance: FDA Procedures
  27. FDA Draft Records Access Guidance Procedures (cont)
  28. FDA Draft Records Access Guidance Procedures (cont)
  29. FDA Draft Records Access Guidance Procedures (cont)
  30. FDA Draft Records Access Guidance: How Will FDA Make a Request?
  31. FDA Draft Records Access Guidance:
  32. FDA Draft Records Access Guidance:
  33. For Further Information . . .
  34. Outreach Materials and Tutorials Available on FDA's Website
  35. Coming soon: Records Guidance and. . .
  36. Questions?
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Hypertext updated by dav/cjm February 7, 2005