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

How to use this template

1. First confirm the food is on FDA's Food Traceability List; the list also covers foods that contain a listed food as an ingredient, if that ingredient stays in the same form (for example, fresh) (21 CFR 1.1310).
2. Fill in one line per traceability lot you receive and link the line to that lot (21 CFR 1.1345(a)).
3. Copy the traceability lot code and source information your supplier sent; the shipper must give you items (a)(1) through (a)(7) of 21 CFR 1.1340 (21 CFR 1.1340(b)).
4. If the supplier is not subject to the rule, you must assign a traceability lot code if none has been assigned (except retail food establishments and restaurants), and the place where you received the food becomes the traceability lot code source (21 CFR 1.1345(b)).
5. Record the reference document type and number (for example, invoice or bill of lading) so you can find it fast.

What the rule says

• The 8 receiving 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 previous source, other than a transporter; (5) location description of where the food was received; (6) date received; (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 1.1345(a)).
• The section does not apply to receipt of a raw agricultural commodity before it is initially packed (if not obtained from a fishing vessel), or to receipt by the first land-based receiver of food obtained from a fishing vessel (21 CFR 1.1345(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)).