FSMA 204 template: shipping log with key data elements (KDEs)

How to use this template

1. First confirm the food is on FDA's Food Traceability List (21 CFR 1.1310).
2. Fill in one line per traceability lot you ship and link the line to that lot (21 CFR 1.1340(a)).
3. Provide the immediate subsequent recipient (other than a transporter) with columns 1 through 7, in electronic, paper or other written form (21 CFR 1.1340(b)). The reference document type and number (column 8) is kept but does not have to be provided.
4. Record the reference document type and number (for example, bill of lading or invoice) so you can find it fast.

What the rule says

• The 8 shipping elements are: (1) traceability lot code; (2) quantity and unit of measure (for example, 6 cases or 200 pounds); (3) product description; (4) location description of the immediate subsequent recipient, other than a transporter; (5) location description of the location you shipped from; (6) date shipped; (7) location description of the traceability lot code source, or the traceability lot code source reference; and (8) reference document type and reference document number (21 CFR 1.1340(a)).
• The section does not apply to shipment of a raw agricultural commodity before it is initially packed, if not obtained from a fishing vessel (21 CFR 1.1340(c)).
• "Location description" means the business name, phone number, physical location address (or geographic coordinates), and city, state and zip code for domestic locations, and comparable information for foreign locations, including country (21 CFR 1.1310).
• "Product description" includes the product name (including, if applicable, the brand name, commodity and variety), packaging size and packaging style (21 CFR 1.1310).
• Reference document types include, but are not limited to, bills of lading, purchase orders, advance shipping notices, work orders, invoices, database records, batch logs, production logs, field tags, catch certificates and receipts (21 CFR 1.1310).
• Instead of the location description of the traceability lot code source, you can record a "traceability lot code source reference", for example the FDA Food Facility Registration Number of that source or a web address that gives FDA its location description (21 CFR 1.1310).
• Keep these records for 2 years from the date you created or obtained them. FDA can request them and you must provide them within 24 hours (or a reasonable time FDA agrees to); during an outbreak, recall or other public health threat, receiving and shipping information is provided as an electronic sortable spreadsheet, except for the rule's small-business exceptions (21 CFR 1.1455(c) and (d)).
• You do not need to duplicate records you already keep (for example, invoices or bills of lading) if they contain the required information; you may supplement them with what is missing (21 CFR 1.1455(f)). If records are kept in another language, you must provide an English translation within a reasonable time if FDA requests it (21 CFR 1.1455(c)(4)).