Final Rule - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (68 FR 58975)

Table of Contents

Preamble

1. Background and Legal Authority
2. Summary of Significant Changes Made to the IFR
   1. What Definitions Apply to This Subpart? (Sec. 1.276)
   2. What is the Scope of This Subpart? (Sec. 1.277)
   3. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
   4. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
   5. How Must You Submit Prior Notice? (Sec. 1.280)
   6. What Information Must Be in a Prior Notice? (Sec. 1.281)
   7. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (Sec. 1.282)
   8. What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec. 1.284)
   9. What Happens to Food That Is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Subpart H of This Part? (Sec. 1.285)
3. Comments on the IFR
   1. General Comments
   2. Comments on the Legal Authority
   3. What Definitions Apply to This Subpart? (Sec. 1.276)
      1. The Act (Sec. 1.276(a))
      2. Calendar Day (Sec. 1.276(b)(1))
      3. Country From Which the Article Originates (Sec. 1.276(b)(2))
      4. Country From Which the Article is Shipped (Sec. 1.276(b)(3))
      5. FDA Country of Production (Sec. 1.276(b)(4))
      6. Full Address (Sec. 1.276(b)(6))
      7. Grower (Sec. 1.276(b)(7))
      8. Registration Number (Sec. 1.276(b)(13))
      9. United States (Sec. 1.276(b)(15))
      10. You (Sec. 1.276(b)(16))
      11. Food (Sec. 1.276(b)(5))
      12. International Mail (Sec. 1.276 b)(8))
      13. Manufacturer (Sec. 1.276(b)(9))
      14. No Longer in Its Natural State (Sec. 1.276(b)(10))
      15. Port of Arrival (Sec. 1.276(b)(11))
      16. Shipper (Sec. 1.276(b)(14))
      17. Comments Requesting Additional Definitions
      18. Summary of the Final Rule
   4. What is the Scope of this Subpart? (Sec. 1.277)
      1. Food for an Individual's Personal Use When Accompanied at Arrival
      2. Homemade Food Sent as Personal Gift
      3. Food Imported Then Exported Without Leaving Port of Arrival Until Export
      4. Food Under the Exclusive Jurisdiction of USDA
      5. Additional Exclusions Requested--General
      6. Additional Exclusions Requested--Special Programs (C-TPAT/FAST) and Flexible Alternatives
         1. General Comments
         2. Special Programs
            1. Should food products subject to FDA's prior notice requirements be eligible for the full expedited processing and information transmission benefits allowed with C-TPAT and FAST?
            2. If the timeframe for submitting prior notice for food arriving by land via road is reduced to 1 hour consistent with the timeframe in the advance electronic information rule, would a shorter timeframe be needed for members of FAST?
            3. Should the security and verification processes in C-TPAT be modified in any way to handle food and animal feed shipments regulated by FDA?
         3. Flexible alternatives
            1. If timeframes are reduced in FDA's prior notice final rule, would other flexible alternatives for participants in FAST or for food imported by other agencies be needed?
            2. In considering flexible alternatives for food imported by other government agencies, what factors or criteria should FDA consider when examining alternatives?
            3. In considering flexible alternatives for submission of prior notice, should FDA consider additional means of ensuring that all companies subject to the Registration of Food Facilities Interim Final Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have an updated registration on file with FDA that has been verified?
            4. Are there conditions of participation that FDA should consider; e.g., inspections of companies in the supply chain from the manufacturer to those who may hold the product, or reviews of their security plans to determine what procedures are in place to prevent infiltration of their facilities?
            5. Should the food product category be considered as a criteria or element of expedited prior notice processing or other flexible alternatives?
            6. If FDA adopts reduced timeframes in the prior notice final rule, should FDA phase in the shorter timeframes as CBP phases in the advance electronic information rule?
            7. Should FDA offer a prior notice submission training program for submitters and transmitters, including brokers, to ensure the accuracy of the data being submitted?
      7. Additional Exclusions Requested--Samples
      8. Additional Exclusions Requested--Mail
      9. Additional Exclusions Requested--Gifts
      10. Additional Exclusions Requested--Low-Value
      11. Additional Exclusions Requested--Couriers
      12. Additional Exclusion Requested--Gift Packs
      13. Additional Exclusions Requested--Household Goods and Unaccompanied Baggage
      14. Additional Exclusions Requested--Noncommercial Use
      15. Additional Exclusions Requested--U.S. Goods Returned
      16. Additional Exclusions Requested--In-Transit Shipments
      17. Additional Exclusions Requested--Diplomatic Pouch
      18. Additional Exclusions Requested--Seeds for Planting
   5. Who is Authorized to Submit Prior Notice? (Sec. 1.278)
   6. When Must Prior Notice Be Submitted to FDA? (Sec. 1.279)
      1. IFR Timeframes (2, 4, and 8 hours)
      2. Integration of FDA and CBP Timeframes
      3. Table 1
      4. Phase-In of FDA and CBP Timeframes
      5. Prior Notice Confirmation Number
      6. 5-Day Maximum Pre-Arrival Limitation
      7. International Mail
   7. How Must You Submit the Prior Notice? (Sec. 1.280)
      1. General Comments
      2. English Language
      3. Technical Issues Concerning Both Systems
      4. ABI/ACS Interface
      5. PNSI
      6. Security of the Systems
      7. Contingency Plans
   8. What Information Must Be in a Prior Notice? (Sec. 1.281)
      1. General Comments
      2. The Submitter
      3. The Transmitter
      4. The CBP Entry Type
      5. The CBP Entry Identifier (e.g., The Customs ACS Entry Number or In-Bond Number)
      6. The Product Identity
         1. The complete FDA product code
         2. The common or usual or market name
         3. The estimated quantity of food
         4. The lot or code numbers or other identifier
      7. Identity of the Manufacturer
         1. Does ``the manufacturer'' in section 801(m) of the act mean the place where the food was actually manufactured or can it include other entities?
         2. Does FDA have the authority to require the registration number of the manufacturer of the article of food being imported or offered for import as a data element in prior notice?
         3. Assuming FDA can require the manufacturer's registration number in a prior notice submission, should FDA continue to do so in the final rule and/or should FDA provide an alternative means for submitters to provide the identity of the manufacturer other than the registration number?
         4. Questions seeking clarification
            1. Designation of grower
            2. Manufacturer cancels registration
            3. Identity of manufacturer for samples
            4. U.S. manufacturer of product being imported
            5. Require manufacturer to reveal or conceal the registration number
            6. Exporting facility
            7. Food imported or offered for import for transshipment, storage, and export, or further manipulation and export
      8. The Grower, If Known
      9. FDA Country of Production
      10. Shipper
      11. The Country From Which the Article is Shipped
      12. Anticipated Arrival Information
      13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient
          1. Importer
          2. Owner
          3. Ultimate consignee
          4. U.S. recipient
      14. Mode of Transportation
      15. Carrier
      16. Planned Shipment Information
          1. General comments
          2. Airway bill number(s) and bill of lading number(s)--Sec. 1.281(a)(17)(i) and (c)(17)(i)
          3. Vessel name and voyage number--Sec. 1.281(a)(17)(ii) and (c)(17)(ii)
          4. Flight number--Sec. 1.281(a)(17)(iii) and (c)(17)(iii)
          5. Trip number--Sec. 1.281(a)(17)(iv) and (c)(17)(iv)
          6. Container number(s)--Sec. 1.281(a)(17)(v) and (c)(17)(v)
          7. Car number--Sec. 1.281(a)(17)(vi) and (c)(17)(vi)
          8. License plate number and State or Province--Sec. 1.281(a)(17)(vii) and (c)(17)(vii)
          9. Harmonized tariff schedule (HTS) codes--Sec. 1.281(a)(17)(viii) and (c)(17)(viii)
          10. Refused articles
      17. Table 2. Prior Notice Information Required by Category
   9. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (Sec. 1.282)
   10. What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice? (Sec. 1.283)
       1. General Comments
       2. Inadequate Prior Notice (Sec. 1.283(a)(1))
       3. Status and Movement of Refused Food (Sec. 1.283(a)(2))
       4. Segregation of Refused Foods (Sec. 1.283(a)(3))
       5. Costs (Sec. 1.283(a)(4))
       6. Export After Refusal (Sec. 1.283(a)(5))
       7. Post-Refusal Prior Notice Submissions (Sec. 1.283(c))
       8. FDA Review After Refusal (Sec. 1.283(d))
       9. International Mail (Sec. 1.283(e))
       10. Prohibitions on Delivery and Transfer (Sec. 1.283(f))
       11. Relationship to Other Admissibility Decisions (Sec. 1.283(g))
   11. What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (Sec. 1.284)
   12. What Happens to Food That is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Under Subpart H of This Part? (Sec. 1.285)
   13. Outreach and Enforcement
       1. General Outreach and Enforcement Issues
       2. Prior Notice Submission Training Program From Flexible Alternative Question 7
       3. Requests for Additional Outreach
       4. Enforcement Timeframe
       5. Enforcement Penalties
   14. The Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes
       1. Increased Integration
       2. General Comments on the Plan
4. Analysis of Economic Impacts
   1. Final Regulatory Impact Analysis
      1. Need for Regulation
      2. Final Rule Coverage
      3. Comments on the Interim Final Regualtory Impact Analysis
      4. Regulatory Options Considered (Options 1, 2 and 3)
         • Option 1
           1. Option 1-Prior Notice IFR
              1. Number of entities affected
              2. Table 3
              3. Costs to entities
              4. Table 4
           2. Updated annual costs to submit prior notice
           3. Table 5
           4. Updated costs to BRASS users
           5. Table 6
           6. Updated costs to submit prior notice by mode of transport
              1. 2-hour minimum prior notice time for food arriving by land by road
              2. Table 7
              3. 4-hour minimum prior notice time for food arriving by land by rail and by air
           7. Table 8
           8. Updated IFR costs to include the costs of manufacturer name, registration number and partial address on prior notice
           9. How some importers will be affected
           10. Table 9
           11. Table 10
           12. Table 11
           13. Benefits of Option 1
           14. Cost benefit summary table
           15. Table 12
         • Option 2 (A and B)
         • Option 2A
           1. Costs of Option 2A
              1. 1-hour or 30 minute minimum prior notice time for food arriving by land by road
              2. Table 13
              3. 2-hour minimum prior notice time for food arriving by land by rail and ``wheels-up'' or 4-hour minimum prior notice time by air
              4. Table 14
              5. Table 15
           2. Implications for the benefits of Option 2A
           3. Cost benefit summary table. Table 16 presents the costs of Options 2A annualized over 20 years
           4. Table 16
         • Option 2B
           1. Costs of Option 2B
              1. 1-hour or 30-minute minimum prior notice time for food arriving by land by road
              2. Table 17
              3. 2-hour minimum prior notice time for food arriving by land by rail and ``wheels-up'' or 4-hour minimum prior notice time by air
           2. Benefits of Option 2B
           3. Cost benefit summary table
         • Option 3
           1. Changes in to the final rule that are not quantified
           2. Table 21
           3. Benefits of Option 3
           4. Cost benefit summary table
           5. Table 22
           6. Table 23
   2. Small Entity Analysis (or Final Regulatory Flexibility Analysis)
   3. Table 24
   4. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) Major Rule
5. Paperwork Reduction Act of 1995
6. Analysis of Environmental Impact
7. Federalism
8. References

Prior Notice Requirements

General Provisions

1. Sec. 1.276 What definitions apply to this subpart?
2. Sec. 1.277 What is the scope of this subpart?

Requirements to Submit Prior Notice of Imported Food

1. Sec. 1.278 Who is authorized to submit prior notice?
2. Sec. 1.279 When must prior notice be submitted to FDA?
3. Sec. 1.280 How must you submit prior notice?
4. Sec. 1.281 What information must be in a prior notice?
5. Sec. 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?

Consequences

1. Sec. 1.283 What happens to food that is imported or offered for import without adequate prior notice?
   1. Consequences
      1. Inadequate Prior Notice
         1. No Prior Notice
         2. Inaccurate prior notice
         3. Untimely prior notice
      2. Status and movement of refused food
         1. An article of food that has been refused under section 801(m)(1) of the act and paragraph (a) of this section shall be considered general order merchandise as described in section 490 of the Tariff Act of 1930, as amended (19 U.S.C. 1490)
         2. Refused food must be moved under appropriate custodial bond unless immediately exported under CBP supervision
      3. Segregation of refused foods
      4. Costs
      5. Export after refusal
      6. No post-refusal submission or request for review
   2. Food carried by or otherwise accompanying an individual
   3. Post-Refusal Prior Notice Submissions
   4. FDA Review After Refusal
   5. International Mail
   6. Prohibitions on delivery and transfer
   7. Relationship to other admissibility decisions
2. Sec. 1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
3. Sec. 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part?
   1. Consequences
   2. Hold
   3. Status and movement of held food
   4. Segregation of held foods
   5. Costs
   6. Export after hold
   7. No registration or request for review
   8. Food carried by or otherwise accompanying an individual
   9. Post-hold submissions
   10. FDA review after hold
   11. International mail
   12. Prohibitions on delivery and transfer
   13. Relationship to other admissibility provisions