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Protecting the Food Supply

May 2005

FDA Actions on New Bioterrorism Legislation

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