21 CFR Part 1, Subpart S — Additional Traceability Records for Certain Foods
Subpart S contains the controlling definitions, Food Traceability List record requirements, CTE and KDE provisions, traceability-plan duties, record availability, exemptions, modified requirements, waivers, and enforcement provisions.
What the authority record establishes
Subpart S contains the controlling definitions, Food Traceability List record requirements, CTE and KDE provisions, traceability-plan duties, record availability, exemptions, modified requirements, waivers, and enforcement provisions.
Binding federal regulation within scope
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
Systems and implementation claims should be mapped to the codified sections and actual activities rather than to an undifferentiated FSMA 204 checklist.
Affected operating stages
- Definitions
- Applicability
- Event Records
- Plan Governance
- Record Provision
- Exemptions And Waivers
Capabilities to examine
Critical Tracking Event And Key Data Element Capture
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for critical tracking event and key data element capture.
Electronic Sortable Spreadsheet And Authority Response
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for electronic sortable spreadsheet and authority response.
Supplier Facility And Trading-Partner Master Data
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for supplier facility and trading-partner master data.
Item Product Location And Party Identification
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for item product location and party identification.
Traceability Lot Code And Lot Genealogy
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for traceability lot code and lot genealogy.
Affected buyer audiences
- U.S. regulatory and food-safety teams
- traceability program owners
- technology and data teams
- legal and audit teams
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
The eCFR is the codified legal text. Technology labels and editorial mappings do not establish coverage or compliance.