FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
horizontal rule

October 10, 2003

horizontal rule

Interim Final Rule on Registration of Food Facilities (68 FR 58894)

Table of Contents

Preamble

  1. Background and Legal Authority
  2. Highlights of the Interim Final Rule and Summary of the Significant Changes Made to the Proposed Rule
  3. Comments on the Proposed Rule
    1. General Comments
    2. Foreign Trade Issues
    3. Comments on "Who Must Register Under This Subpart?"(Proposed Sec. 1.225)
    4. Comments on "Who is Exempt from This Subpart?" (Proposed Sec. 1.226)
      1. Foreign Facilities
      2. Farms
      3. Retail Facilities
      4. Restaurants
      5. Nonprofit Food Facilities
      6. Fishing Vessels
      7. Facilities Regulated Exclusively, Throughout the Entire Facility, by USDA
    5. Comments on "What Definitions Apply to This Subpart?" (Proposed Sec. 1.227)
      1. The Act
      2. Calendar Day
      3. Facility
      4. Domestic Facility
      5. Foreign Facility
      6. Farm
      7. Food
      8. Holding
      9. Manufacturing/Processing
      10. Nonprofit Food Establishment
      11. Packing
      12. Port of Entry
      13. Restaurants
      14. Retail Food Establishment
      15. U.S. Agent
      16. Other Definitions Included in the Interim Final Rule
    6. Comments on "When Must You Register?" (Proposed Sec. 1.230)
    7. Comments on "How and Where Do You Register?" (Proposed Sec. 1.231)
    8. Comments on "What Information is Required in the Registration?" (Proposed Sec. 1.232)
      1. General Comments
      2. Name, Full Address, Phone Number, Fax Number, and E-mail Address
      3. Name and Address of the Parent Company
      4. Emergency Contact Information
      5. Trade Names
      6. Product Categories Under Sec. 170.3
      7. U.S. Agent
      8. Certification Statement
    9. Comments on "What Optional Items are Included in the Registration Form?" (Proposed Sec. 1.233)
      1. General Comments
      2. Type of Activity Conducted at the Facility
      3. Type of Storage, if the Facility Is Solely a Holding Facility
      4. Food Categories Not Included Under Sec. 170.3
    10. Comments on "How and When Do You Update Your Registration Information?" (Proposed Sec. 1.234)
    11. Comments on "What Other Registration Requirements Apply?" (Proposed Sec. 1.240)
    12. Comments on "What Happens if You Fail to Register?" (Proposed Sec. 1.241)
      1. Revocation of Registration
      2. Prohibited Act for Domestic or Foreign Facility
      3. Food Held at the Port
    13. Comments on "What Does Assignment of a Registration Number Mean?" (Proposed Sec. 1.242)
    14. Comments on "Is Food Registration Information Available to the Public?" (Proposed Sec. 1.243)
  4. Analysis of Economic Impacts
    1. Final Regulatory Impact Analysis
      1. Description of Interim Final Rule
      2. General Comments
      3. Number of Facilities Affected
      4. Costs
      5. Alternative Options
      6. Benefits
  5. Final Regulatory Flexibility Analysis
  6. Unfunded Mandates
  7. Small Business Regulatory Enforcement Fairness Act (SBREFA) Major Rule
  8. Paperwork Reduction Act of 1995
  9. Request for Comments
  10. Analysis of Environmental Impact
  11. Federalism
  12. References

Registration Requirements

General Provisions

  1. Sec. 1.225 Who must register under this subpart?
  2. Sec. 1.226 Who does not have to register under this subpart?
  3. Sec. 1.227 What definitions apply to this subpart?
    1. (a) The act
    2. (b) for this subpart:
      1. (1) Calendar day
      2. (2) Facility
        1. (i) Domestic facility
        2. (ii) Foreign facility
      3. (3) Farm
        1. (i) [Farm] Facilities that pack or hold food
        2. (ii) [Farm] Facilities that manufacture/process food
      4. (4) Food
        1. (i) Except for purposes of this subpart, it does not include:
          1. (A) Food contact stubstances
          2. (B) Pesticides
        2. (ii) Examples of food
      5. (5) Holding
      6. (6) Manufacturing/processing
      7. (7) Nonprofit
      8. (8) Packaging (when used as a verb)
      9. (9) Packing
      10. (10) Restaurant
        1. (i) Entities in which food is provided to humans
        2. (ii) Pet shelters, kennels, and veterinary facilities
      11. (11) Retail food establishment
      12. (12) Trade name
      13. (13) U. S. agent
        1. (i) [acts as] communications link
        2. (ii) representations by [treated as]
        3. (iii) [does not preclude] having multiple agents
      14. (14) You

Procedures for Registration of Food Facilities

  1. Sec. 1.230 When must you register?
  2. Sec. 1.231 How and where do you register?
  3. Sec. 1.232 What information is required in the registration?
  4. Sec. 1.233 What optional items are included in the registration form?
  5. Sec. 1.234 How and when do you update your facility's registration information?
  6. Sec. 1.235 How and when do you cancel your facility's registration information?

Additional Provisions

  1. Sec. 1.240 What other registration requirements apply?
  2. Sec. 1.241 What are the consequences of failing to register, update, or cancel your registration?
  3. Sec. 1.242 What does assignment of a registration number mean?
  4. Sec. 1.243 Is food registration information available to the public?
horizontal rule
horizontal rule