Subpart S. Subpart S—Additional Traceability Records for Certain Foods

• General Provisions

  • SECTION § 1.1300 - Who is subject to this subpart?
  • SECTION § 1.1305 - What foods and persons are exempt from this subpart?
  • SECTION § 1.1310 - What definitions apply to this subpart?

• Traceability Plan

  • SECTION § 1.1315 - What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
  • SECTION § 1.1320 - When must I assign traceability lot codes to foods on the Food Traceability List?

• Records of Critical Tracking Events

  • SECTION § 1.1325 - What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
  • SECTION § 1.1330 - What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
  • SECTION § 1.1335 - What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
  • SECTION § 1.1340 - What records must I keep and provide when I ship a food on the Food Traceability List?
  • SECTION § 1.1345 - What records must I keep when I receive a food on the Food Traceability List?
  • SECTION § 1.1350 - What records must I keep when I transform a food on the Food Traceability List?

• Procedures for Modified Requirements and Exemptions

  • SECTION § 1.1360 - Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
  • SECTION § 1.1365 - When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
  • SECTION § 1.1370 - What must be included in a petition requesting modified requirements or an exemption from the requirements?
  • SECTION § 1.1375 - What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?
  • SECTION § 1.1380 - What process applies to a petition requesting modified requirements or an exemption?
  • SECTION § 1.1385 - What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
  • SECTION § 1.1390 - When will modified requirements that we adopt or an exemption that we grant become effective?
  • SECTION § 1.1395 - Under what circumstances may FDA revise or revoke modified requirements or an exemption?
  • SECTION § 1.1400 - What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?

• Waivers

  • SECTION § 1.1405 - Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
  • SECTION § 1.1410 - When will FDA consider whether to waive a requirement of this subpart?
  • SECTION § 1.1415 - How may I request a waiver for an individual entity?
  • SECTION § 1.1420 - What process applies to a request for a waiver for an individual entity?
  • SECTION § 1.1425 - What must be included in a petition requesting a waiver for a type of entity?
  • SECTION § 1.1430 - What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
  • SECTION § 1.1435 - What process applies to a petition requesting a waiver for a type of entity?
  • SECTION § 1.1440 - What process will FDA follow when waiving a requirement of this subpart on our own initiative?
  • SECTION § 1.1445 - Under what circumstances may FDA modify or revoke a waiver?
  • SECTION § 1.1450 - What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?

• Records Maintenance and Availability

  • SECTION § 1.1455 - How must records required by this subpart be maintained and made available?

• Consequences of Failure To Comply

  • SECTION § 1.1460 - What consequences could result from failing to comply with the requirements of this subpart?

• Updating the Food Traceability List

  • SECTION § 1.1465 - How will FDA update the Food Traceability List?