Final Rule on Establishment and Maintenance of Records (69 FR 71561)

Table of Contents

Preamble

1. Background and Legal Authority
2. 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
3. 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
         • Table A - Estimated Total Number of Very Small Food Establishments
      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
          • Table B - Packaging and Food Contact Substances
   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)
4. Analysis of Economic Impacts--Final Regulatory Impact Analysis
   1. Summary of the Costs and Benefits of the Final Rule
      • Table 1 - Estimated Annual and Total Recordkeeping Costs
      • Table 2 - Value of Averted Illnesses for 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
         • Table 3 - The Distribution of Illnesses by Agent from Outbreaks Monitored by FDA from 2000 to 2003
         • Table 4 - Estimated Ratio of the Total Number of Illnesses to Reported Number of Illnesses
      5. The Costs of Each Illness
         • Table 5 - The Duratation of the Illness for Mild, Moderate and Severe Cases
         • Table 6 - Lost QALDs Due to an Average Case of Foodborne Illness
         • Table 7 - Average Cost of an Illness Across Outbreaks
      6. The Stages of an Outbreak Investigation
      7. The Duration of Traceback Investigations, and Numbers of Premature Terminations
         • Table 8 - Outbreak Investigation Data
         • Table 9 - Duration of the Traceback Component of an Outbreak Investigation
      8. The Duration of Investigative Visits
         • Table 10 - Duration of the Components of an Investigative Visit
      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
             • Table 11 - The percentage of very small food establishments that make up each sector and the percentage of the total sector's food for which they are responsible
      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
         • Table 12 - Number of Transportation Establishments by NAICS Code
         • Table 13 - Mixed-Type Facilities Engage in Farming
         • Table 14 - Description of Primary Activities Performed by Warehouses by NAICS Code
      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
          • Table 15 - Estimated Annual and Total Recordkeeping Costs
          • Table 16 - Costs and Reductions in Food Safety Benefits for Changes Based on Comments
          • Table 17 - Coverage of Different Policy Options
          • Table 18 - Costs, Food Safety Benefits, and Cost Effectiveness of Alternative Coverage Options
          • Table 19 - All Averted (Reported and Unreported) Food Safety Illnesses per Year
          • Table 20 - Averted Annual Food Safety Illnesses from Faster Traceback Investigations
          • Table 21 - Averted Annual Food Safety Illnesses From More Successfully Completed Tracebacks
          • Table 22 - Value of Averted Food Safety Illnesses for the Final Rule
5. Final Regulatory Flexibility Analysis
   • Table 23 - Estimated Per Facility Recordkeeping Costs
6. Unfunded Mandates
   • Table 24 - Future Costs
7. SBREFA
8. Paperwork Reduction Act of 1995
   • Table 25 - Estimated Annual Recordkeeping Burden-First and Second Years
   • Table 26 - Estimated Annual Recordkeeping Burden-Subsequent Years
9. Analysis of Environmental Impact
10. Federalism
11. References

Requirements

PART 1--GENERAL ENFORCEMENT REGULATIONS

Subpart J--Establishment, Maintenance, and Availability of Records

General Provisions

• Sec. 1.326 Who is subject to this subpart?
• Sec. 1.327 Who is excluded from all or part of the regulations in this subpart?
• Sec. 1.328 What definitions apply to this subpart?
• Sec. 1.329 Do other statutory provisions and regulations apply?
• Sec. 1.330 Can existing records satisfy the requirements of this subpart?

Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Previous Sources of Food

• Sec. 1.337 What information must nontransporters establish and maintain 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

• Sec. 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?

Requirements for Transporters to Establish and Maintain Records

• Sec. 1.352 What information must transporters establish and maintain?

General Requirements

• Sec. 1.360 What are the record retention requirements?
• Sec. 1.361 What are the record availability requirements?
• Sec. 1.362 What records are excluded from this subpart?
• Sec. 1.363 What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?

Compliance Dates

• Sec. 1.368 What are the compliance dates for this subpart?

Part 11--Electronic Records; Electronic Signatures

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Final rule; correction Federal Register; February 23, 2005