FSMA 204 Shipping Requirements for Distributors

If you receive produce and send it back out, you have two critical tracking events per load, not one. Receiving is covered under § 1.1345. The outbound half is 21 CFR 1.1340, and it carries an obligation receiving doesn't: you must actively hand information to your customer, not merely keep it.

The eight shipping KDEs

For each traceability lot you ship, records must contain and link to that lot:

#	Key data element
1	The traceability lot code for the food
2	Quantity and unit of measure (6 cases, 25 RPCs, 200 pounds)
3	The product description
4	Location description for the immediate subsequent recipient, other than a transporter
5	Location description for the location you shipped from
6	The date you shipped
7	Location description for the traceability lot code source, or the TLC source reference
8	Reference document type and reference document number

Set this beside the receiving list and the symmetry is obvious — items 1, 2, 3, 7 and 8 are identical, and items 4, 5 and 6 are the mirror image. Receiving records the previous source and where it arrived; shipping records the next recipient and where it left. A distributor holding both for the same lot has a complete link in the chain, which is the whole design.

The part that's different: you must send it

Paragraph (b) is the obligation with no counterpart on the receiving side:

You must provide (in electronic, paper, or other written form) the information in paragraphs (a)(1) through (7) of this section to the immediate subsequent recipient (other than a transporter) of each traceability lot that you ship.

Items 1 through 7 go to your customer. Item 8 — your reference document type and number — stays with you.

This is why receiving works at all. Your customer's ability to populate their § 1.1345 records depends entirely on you sending yours. And your ability to populate yours depended on your supplier doing the same. The rule builds a chain where each link is fed by the previous one, which also means one non-compliant link breaks everyone downstream of it.

"Electronic, paper, or other written form" is deliberately open. An ASN, a BOL with the fields added, an invoice, or a spreadsheet all qualify. FDA's own illustration maps the shipping KDEs onto a standard bill of lading, and the rule doesn't require all required information to live in a single set of records — though your traceability plan has to state the format and location of what you keep.

What shipping is not

Paragraph (c) excludes shipment of a raw agricultural commodity before it has been initially packed. Field-run product going to a packinghouse isn't a shipping CTE, which mirrors the equivalent carve-out on the receiving side.

And shipping does not create a new traceability lot. The rule directs that you must not establish a new lot code when you conduct other activities such as shipping. The code you received is the code you ship, unless you transformed the product in between — which is a separate event with its own records.

Practical implications for a distribution operation

Your BOL is probably the cheapest place to put this. The shipping KDEs map onto fields most bills of lading already have or can accommodate, and using the document your dock already produces beats standing up a parallel system.

Item 4 excludes transporters, again. The immediate subsequent recipient is the business receiving the food, not the carrier hauling it. Cross-dock arrangements need care here.

Intracompany transfers count. Shipping between your own facilities at different street addresses is a shipping CTE with a matching receiving CTE at the other end.

Sortability matters more than format. Records have to be available to FDA within 24 hours of a request, and covered entities must be able to provide an electronic sortable spreadsheet. A stack of PDFs technically holds the data and practically fails the test.

FAQ

Do I have to send traceability data to my customer, or just keep it?

Both. You keep all eight KDEs and must provide the first seven to the immediate subsequent recipient of each lot you ship.

Does the transporter count as the recipient?

No. Items 4 on the shipping list and the equivalent on receiving both exclude transporters. The recipient is the next business to take possession, not the carrier.

Do I assign a new lot code when I ship?

No. New lot codes come from initial packing and transformation. Shipping carries the existing code forward.

What format does the information have to be in?

Electronic, paper, or other written form — the rule doesn't mandate one. Your traceability plan must describe the format and location of the records you keep.

Does shipping apply to product I haven't packed yet?

No. Shipment of a raw agricultural commodity before initial packing is outside this section.