See also the Final Rule, published on November 7, 2008, effective on May 6, 2009.

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

Table of Contents

Interim Final Rule October 10, 2003
Corrections to Interim Final Rule February 2, 2004
Reopening of Comment Period on Interim Final Rule April 14, 2004
Extension of Comment Period on Interim Final Rule to July 13, 2004 May 18, 2004

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Preamble

1. Background
   1. Current Process--Admissibility Determinations Under Section 801(a) of the FD&C Act
   2. Process After December 12, 2003--Prior Notice Determination Followed by Admissibility Determination
2. Overview of the Interim Final Rule and Significant Changes Made to the Proposed Rule
   1. "What Definitions Apply to This Subpart?" (Section 1.276 Proposed as Sec. 1.277)
   2. "What is the Scope of This Subpart?" (Section 1.277 Proposed as Sec. 1.276)
   3. "Who Is Authorized to Submit Prior Notice?" (Section 1.278 Proposed as Sec. 1.285)
   4. "When Must Prior Notice Be Submitted to FDA?" (Section 1.279 Proposed as Sec. 1.286)
   5. "How Must You Submit Prior Notice?" (Section 1.280 Proposed as Sec. 1.287)
   6. "What Information Must Be in a Prior Notice?" (Section 1.281 Proposed as Sec. 1.288)
   7. "What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA?" (Section 1.282 Proposed Sec. Sec. 1.289 to 1.294)
   8. "What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice?" (Section 1.283 Proposed as Sec. 1.278)
      1. Inadequate Prior Notice
      2. Status and Movement of Refused Food
      3. Segregation of Refused Foods
      4. Costs
      5. Export After Refusal
      6. No Post Refusal Submission or Request for Review
      7. Food Carried by or Otherwise Accompanying an Individual
      8. Post-Refusal Prior Notice Submissions
      9. FDA Review After Refusal
      10. International Mail
      11. Prohibitions on Delivery and Transfer
      12. Relationship to Other Admissibility Provisions
   9. "What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart?" (Section 1.284 Proposed as Sec. 1.278)
   10. "What Happens to Food That Is Imported or Offered for Import from Unregistered Facilities That Are Required to Register Under 21 CFR Part 1, Subpart H?" (Section 1.285)
   11. Table 1A - Prior Notice Information Required by Category
3. Comments on the Proposed Rule
   1. General Comments and Outreach
   2. Foreign Trade Issues
   3. "What Definitions Apply to This Subpart?" (Section 1.276 Proposed as Sec. 1.277)
      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 and Originating Country (Sec. 1.276(b) (4))
      6. Food (Sec. 1.276(b) (5))
         1. Food Packaging and other food contact substances
         2. Food processing aids
         3. Antimicrobial pesticides
         4. Chemicals
         5. Live animals
         6. Articles for further processing or capable of multiple uses
      7. Grower (Sec. 1.276 (b) (6))
      8. International Mail (Sec. 1.276 (b) (6))
      9. No Longer In Its Natural State (Sec. 1.276(b) (8))
      10. Port of Arrival (Sec. 1.276(b) (9)) and Port of Entry (Sec. 1.276(b) (10))
      11. Registration Number (Sec. 1.276(b) (11))
      12. Shipper (Sec 1.276(b) (12))
      13. United States (Sec. 1.267(b) (13))
      14. You (Sec 1.276(b) (14))
      15. Summary of the Interim Final Rule
   4. "What Is the Scope of This Subpart?" (Section 1.277 Proposed as Sec. 1.276)
   5. "Who Is Authorized to Submit Prior Notice?" (Section 1.278 Proposed as Sec. 1.285)
   6. "When Must Prior Notice Be Submitted to FDA?" (Section 1.279 Proposed as Sec. 1.286)
   7. "How Must You Submit Prior Notice?" (Section 1.280 Proposed as Sec. 1.287)
      1. 1a. Work With Other Agencies To Eliminate Redundancies
      2. 1b. CBP AMS
      3. 2a. Viability of a Web-Based System
      4. 2b. Contingency System
      5. 2c. Alternate Methods
      6. 2d. Security of System
      7. 3a. Prior Notice Form
      8. 3b. Form Processing
      9. 3c. Clarification of Fields
      10. 4. Existing System Adequate
      11. 5-11. Description of the Prior Notice Submission Systems
      12. 11a. ABI/ACS Interface
      13. 11b. FDA PN System Interface
      14. 12. FDA Review
      15. 13. Summary of the Interim Final Rule
   8. "What Information Must Be in a Prior Notice?"(Section 1.281 Proposed as Sec. 1.288)
   9. "What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA?" (Section 1.282 Proposed as Sec. Sec. 1.289 to 1.294)
   10. "What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice?" (Section 1.283) and "What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart?" (Sec. 1.284 Proposed as Sec. 1.278)
       1. Inadequate Prior Notice
          1. Status and movement of refused foods
             1. General order status
             2. Locations for holding refused foods
             3. Movement of refused foods
          2. Segregation of refused foods
          3. Costs
          4. Post-refusal submissions and resubmissions
          5. Export after refusal
          6. Abandoned merchandise
       2. International Mail
       3. Food Carried by or Otherwise Accompanying an Individual
       4. FDA Review After Refusal
       5. Prohibition on Delivery Outside of the Port
       6. Relationship to Admissibility
          1. Inadequate Prior Notice
          2. Status and movement of refused
          3. Segregation
          4. Costs
          5. Post-refusal submissions and resubmissions
          6. Export after refusal
          7. No post refusal submission or request for review
          8. International mail
          9. Food carried by or otherwise accompanying an individual
          10. FDA review after refusal
          11. Prohibition on delivery outside of the port
          12. Relationship to admissibility
       7. What Are the Other Consequences of Failing To Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart?
   11. "What Happens to Food That Is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Under Section 415 of the FD&C Act, 21 U.S.C. 350d and 21 CFR Part 1, Subpart H?" (Section 1.285)
4. Issuance of an Interim Final Rule and Effective Date; Comments
5. Analysis of Economic Impacts
   1. Final Regulatory Impact Analysis
      1. Need for Regulation
      2. Interim Final Rule Coverage
         1. Number of establishments affected
            1. New and closing importer establishments
            2. Baseline
         2. Current state of the world
      3. Regulatory Options Considered
         1. Option 1. Current state of the world, pre-Bioterrorism Act (baseline)
         2. Option 2. Prior notice time of 1 hour (constrained by shipments arriving by land modes of transport); electronic submission of information. This option would require the persons responsible for all food imported or offered for import into the United States to notify FDA of their intent to import articles of food through an importer, customs broker, purchaser, or other agent. This option applies to all imported foods subject to the interim final rule. Submission of prior notice information must be electronic. Any change in prior notice information requires resubmission of corrected or new information.
         3. Option 3. Require all components of option 2, but lengthen the minimum prior notice time to 2 hours (constrained by shipments arriving by land transportation modes).
         4. Option 4. Require all components of option 2, but lengthen the minimum prior notice time to 4 hours (constrained by shipments arriving by air and land modes of transport); electronic submission of information.
         5. Option 5. Require all components of option 2, including a 1-hour minimum prior notice time for vehicles, but lengthen the minimum prior notice time to 4 hours for articles of food arriving by train and by air, and 8 hours for articles of food arriving by vessel; electronic submission of information.
         6. Option 6. Require all components of option 2, but lengthen the minimum prior notice time to 2 hours for articles of food arriving by vehicle, 4 hours for articles of food arriving by train and by air, and 8 hours for articles of food arriving by vessel; electronic submission of information (interim final rule).
         7. Option 7. Require all components of option 4, but allow some prior notice information to be revised 1 hour before arrival at a U.S. port.
         8. Option 8. Require all components of option 2, but lengthen the minimum prior notice time to 8 hours (statutory self-executing provision).
         9. Option 9. Require all components of option 7, but allow some prior notice information to be revised 1 hour before arrival at a U.S. port.
         10. Option 10. Require all components of option 2, but lengthen the prior notice time to 12 noon of the calendar day before crossing the U.S. border.
         11. Option 11. Require all components of option 9, but allow some prior notice information to be revised 1 hour before arrival at a U.S. port.
         12. Option 12. Require all components of option 9, but allow some prior notice information to be revised 2 hours before arrival at a U.S. port (proposed rule).
      4. Summary of Options
      5. Benefits
   2. Small Entity Analysis (or Final Regulatory Flexibility Analysis)
      1. Number of Establishments Affected
      2. Costs per Entity
      3. Additional Flexibility Considered
   3. Unfunded Mandates
   4. Small Business Regulatory Enforcement Fairness Act (SBREFA) Major Rule
6. Paperwork Reduction Act of 1995
   1. Description
      1. Comments on the Burden of Information Collection
      2. Information Collection Burden Estimate
   2. Hour Burden Estimate
      1. Number of Establishments Affected
      2. New and Closing Importers
      3. Hour Burden Estimate Researching the Prior Notice Requirement
         1. Learning the Interim Final Rule
         2. Coordinating the information
      4. Submitting Prior Notice
      5. Changes to a Confirmed Prior Notice
      6. Refused Admission
      7. Correction and Resubmission of Prior Notice
      8. Exportation of Products Refused Admission
      9. FDA Review Request
   3. Capital Cost and Operating and Maintenance Cost Burden
7. Analysis of Environmental Impact
8. Federalism
9. 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
      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 21 CFR part 1, subpart H?
   1. Subject to Refusal
   2. Held at Port of Entry
   3. Status and movement of held foods
   4. Segregation of refused foods
   5. Costs
   6. Export after refusal
   7. No Registration or Request for Review
   8. Food carried by or otherwise accompanying an individual
   9. Post-refusal and post-hold submissions
   10. FDA review after hold
   11. International mail
   12. Prohibitions on delivery and transfer
   13. Relationship to other admissibility provisions