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Guidance & Regulation

Federal Register Final Rule (Recordkeeping) - 69 FR 71561 - Table of Contents

Final Rule on Establishment and Maintenance of Records (69 FR 71561) December 9, 2004

Establishment and Maintenance of Records Under the Public Health Security and and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Rule


Table of Contents

Preamble

  1. Highlights of the Final Rule and Summary of the Significant Changes Made to the Proposed Rule
    1. Highlights of This Final Rule
    2. Significant Changes FDA Made to the Proposed Rule
  2. Comments on the Proposed Rule
    1. General Comments
    2. Foreign Trade Issues
    3. Comments on Who is Subject to This Subpart? (Proposed Sec. 1.326)
      1. General
      2. Intrastate
      3. Foreign Facilities
    4. Comments on Who is Excluded From All or Part of the Regulations in this Subpart? (Proposed Sec. 1.327)
      1. General
      2. Farms
      3. Restaurants
      4. Fishing Vessels
      5. Retail Facilities
      6. Retail Facility/Roadside Stands
      7. Persons Under the Exclusive Jurisdiction of USDA
      8. Retail Facility/Roadside Stands
      9. Pet Food
      10. Food Contact Materials
    5. Comments on What Definitions Apply to this Subpart? (Proposed Sec. 1.328)
      1. General Comments
      2. The FD&C Act
      3. Domestic Person
      4. Farm
      5. Food
      6. Foreign Facility
      7. Manufacturing/Processing
      8. Nontransporter
      9. Nontransporter Immediate Previous Source
      10. Nontransporter Immediate Subsequent Recipient
      11. Perishable Food
      12. Pet Food
      13. Recipe
      14. Restaurant
      15. Retail Facility
      16. Transporter
      17. Transporter's Immediate Previous Source
      18. Transporter's Immediate Subsequent Recipient
      19. You
    6. Comments on Do Other Statutory Provisions and Regulations Apply? (Proposed Sec. 1.329)
    7. Comments on Can Existing Records Satisfy the Requirements of this Subpart? (Proposed Sec. 1.330)
    8. Comments on What Information is Required in the Records You Must Establish and Maintain to Identify the Nontransporter and Transporter Immediate Previous Source and Immediate Subsequent Recipients? (Proposed Sec. Sec. 1.337 and 1.345)
      1. General Comments
      2. Information Reasonably Available to Identify the Specific Source of Each Ingredient
      3. Requirement to Record Responsible Individual
      4. Adequate Description of Type of Food
      5. Date Food Received or Released
      6. Lot or Code Number/Other Identifier
      7. Quantity and How the Food is Packaged
      8. Name. Responsible Individual. Address, Telephone Number, Fax Number, E-mail Address of Transporters Who Transported the Food To You and From You
    9. Comments on Who is Required to Establish and Maintain Records for Tracing the Transportation of All Food? (Proposed Sec. 1.351)
    10. Comments on What Information is Required in the Transportation records? (Proposed Sec. 1.352)
    11. Comments on What Are the Record Retention Requirements? (Proposed Sec. 1.360)
    12. Comments on What Are the Record Availability Requirements? (Proposed Sec. 1.361)
    13. Comments on What Records Are Excluded From this Subpart? (Proposed Sec. 1.362)
    14. Comments on What Are the Consequences of Failing to Establish and Maintain Records or Make Them Available to FDA as Required By This Subpart? (Proposed Sec. 1.363)
    15. Comments on What Are the Compliance Dates for This Subpart? (Proposed Sec. 1.368)
  3. Analysis of Economic Impacts--Final Regulatory Impact Analysis
    1. Summary of the Costs and Benefits of the Final Rule
    2. Description of Proposed Rule
    3. General Comments
    4. The Tradeoff Between Costs and Risk Reduction
    5. Estimating the Benefits
      1. Bioterroism Considerations
      2. Benefits: Model Framework
        • Figure 1: The Distributions of the Onsets of New Illnesses Over the Time During and Outbreak, and the Duration of an Outbreak Investigation
      3. Data on Outbreak Sizes, Durations, and Contaminating Agents
        • Chart 1: Distribution of numbers of known illnesses from outbreaks reported in internal investigation data from 2000 - 2003
        • Chart 2: Durations of outbreaks from internal investigation data for 2000 - 20003
        • Figure 2: Cumulative Distribution of the Fraction of Total Illnesses by Outbreak Duration (2000-2003)
      4. The Total Number of Illnesses
      5. The Costs of Each Illness
      6. The Stages of an Outbreak Investigation
      7. The Duration of Traceback Investigations, and Numbers of Premature Terminations
      8. The Duration of Investigative Visits
      9. Adjustments to Account for Records Requests Made on the Weekends
      10. Estimate of the Time Required Before Preventive Action
      11. Estimating the Impact on Traceback Performance for Options With Different Coverage
        1. Adjustments to traceback performance for the grocery sector
        2. Adjustments to traceback performance for transportation and warehouse facilities
        3. Adjustments to traceback performance for large and very small facilities
      12. Estimating the Benefits When Selected Sectors are Excluded
        1. Excluding foreign facilities
        2. Excluding persons that manufacture, process, pack, hold, transport, distribute, receive, or import food contact substances
        3. Excluding transporters
      13. Options With Different Acces and Retention Requirements and With Different Compliance Dates
        1. 24-hour and 4- and 8-hour records access requirements
        2. Records retention requirements of 6 months, 12 months, and 24 months based on three NIST definitions
        3. Extending the compliance dates.
        4. Exemption of all very small entities.
    6. Costs
      1. Estimates of the Number of Facilities Affected By the Final Rule
      2. High Cost of Tracking by Lot Code
      3. Records Retention Costs
      4. Records Access Costs
      5. Additional Records Maintenance and Redesign Costs
      6. Estimates of Additional Records Maintenance Costs Too Low
      7. Labor Cost Estimates
      8. Learning Costs
      9. Specific Sector Cost Estimates
        1. Transportation and warehouse sector
        2. Interstate conveyance and catering services sector
        3. Pet foods sector
        4. Food contact subtances and the packaging sector
        5. Foreign facilities and related impacts
      10. Compliance Dates
      11. Summary of the Costs and Benefits of the Final Rule and Policy
  4. Final Regulatory Flexibility Analysis
  5. Unfunded Mandates
  6. SBREFA
  7. Paperwork Reduction Act of 1995
  8. Analysis of Environmental Impact
  9. Federalism
  10. References

Requirements

PART 1--GENERAL ENFORCEMENT REGULATIONS

Subpart J--Establishment, Maintenance, and Availability of Records
General Provisions
Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Previous Sources of Food
Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food
Requirements for Transporters to Establish and Maintain Records
General Requirements
Compliance Dates

Part 11--Electronic Records; Electronic Signatures


Final rule; correction Federal Register; February 23, 2005