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Protecting the Food Supply

May 2003
See also Current Information on Protecting the Food Supply

Overview of Records and Administrative Detention
Proposed Regulations Implementing the Bioterrorism Act

(This document also available in Spanish)

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Index of Presentation Slides

  1. Overview of Records and Administrative Detention
    Proposed Regulations Implementing the Bioterrorism Act
  2. Purpose of Briefing
  3. FDA Regulatory Development: Lead Personnel
  4. Background: FDA's Regulatory Development Timeline
  5. Background: FDA's Regulatory Development Timeline
  6. Proposed Recordkeeping Requirements 68 FR 25188 (May 9, 2003)
  7. Who Would Be Required To Establish And Maintain Records?
  8. Whom Does The Proposed Rule Exclude?
  9. Whom Does The Proposed Rule Exclude?
  10. Whom Does The Proposed Rule Exclude?
  11. Whom Does The Proposed Rule Exclude?
  12. Facilities Engaged in Multiple Activities
  13. What Foods Does the Proposed Rule Cover?
  14. Examples of FDA-Regulated Food
  15. Examples of FDA-Regulated Food
  16. What Foods Does FDA Not Regulate?
  17. Proposed Definitions
  18. Proposed Farm Definition.(cont.)
  19. Proposed Definitions (cont.)
  20. Proposed Definitions (cont.)
  21. Proposed Definitions (cont.)
  22. Proposed Definitions (cont.)
  23. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Previous Source (IPS)
  24. Records Non-transporters Have To Establish And Maintain to Identify the IPS (cont)
  25. Non-transporters' Records Regarding the IPS
  26. Example 1: Common Storage Silo for An Ingredient (e.g., Flour)
  27. Example 2: Dedicated Storage Silos for Each Ingredient Source
  28. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Subsequent Recipient (ISR)
  29. What Information Must Non-Transporters Keep in Records to Identify the ISR (cont)?
  30. Establishment and Maintenance of Records by Non-Transporters
  31. Records Transporters Have To Establish And Maintain to Identify the IPR and ISR
  32. What Records Would Transporters Have To Establish And Maintain?
  33. Example 3: Various Transportation Companies
  34. Example 4: Purple Transportation Company
  35. Frequently Asked Questions . . .
  36. Do other recordkeeping requirements in statutes and regulations still apply?
  37. When do I have to create the records?
  1. Can I Use Existing Records?
  2. In what format must I establish and maintain these records?
  3. How long must the records be retained?
  4. What are the record availability requirements?
  5. What are the record availability requirements (cont.)?
  6. What records are excluded?
  7. What if records aren't established, maintained, or provided to FDA upon request?
  8. When would compliance with the recordkeeping rules be required?
  9. Some Significant Areas For Which FDA Specifically Is Seeking Comment
  10. Some Significant Areas For Which FDA Specifically Is Seeking Comment (cont.)
  11. Proposed Administrative Detention Requirements 68 FR 25242 (May 9, 2003)
  12. What are the criteria for detaining food?
  13. Administrative Detention
  14. What Food is Subject to FDA's Jurisdiction?
  15. Examples of FDA-Regulated Food
  16. What Food is Not Subject to Administrative Detention?
  17. Labeling or Marking of Detained Food
  18. Proposed Expedited Procedures for Detained Perishable Foods
  19. Proposed Expedited Procedures for Detained Perishable Foods (cont.)
  20. FDA'S Administrative Detention: Proposed Definitions
  21. What Information Must Be Included in An Administrative Detention Order?
  22. What Information Must Be Included in An Administrative Detention Order (cont.)?
  23. What Information Must Be Included in An Administrative Detention Order (cont.)?
  24. Who would receive a copy of the detention order?
  25. When does a detention order terminate?
  26. Administrative Detention Right to Appeal
  27. Appeals
  28. Detention Appeal Timelines
  29. Detention Appeal Timelines (cont.)
  30. Use of Classified Information in Hearings
  31. Use of Classified Information (cont.)
  32. Next Steps
  33. Next Steps (cont.)
  34. How Do I Get a Copy of the Proposed Rules?
  35. How To Comment (Deadline July 8, 2003)
  36. For Further Information . . .
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PROTECTING THE FOOD SUPPLY: FDA Actions on New Bioterrorism Legislation
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