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The Produce Traceability Initiative and FSMA 204, Explained

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By Gordon Gerber, founder of Marapack Services. Last fact checked September 8, 2026. Regulatory dates move. Verify against FDA before making a compliance decision.

Two separate things are being asked of produce packers right now: the Produce Traceability Initiative case label and the FSMA 204 recordkeeping rule. They are constantly confused with each other, and the confusion costs money in both directions. Some packers are buying compliance they do not need. Others are missing a customer requirement because they were waiting on a federal deadline that does not apply to their crop.

This page separates them.

PTI is a voluntary industry initiative. It standardizes the case label. Your buyers enforce it.

FSMA 204 is a federal recordkeeping rule. It says nothing about your label. FDA enforces it, on a list of foods that does not include every crop.

Everything below is checked against the primary documents, and the sources are named so you can check them yourself. If you would rather have someone read your own label against what your buyer asked for, book an equipment audit and we will do it on your line.

What is the Produce Traceability Initiative?

The Produce Traceability Initiative is a voluntary, industry wide effort to standardize how a case of produce is identified as it moves through the supply chain. It is not law. It is a set of best practice documents developed by the produce industry itself, endorsed by US and Canadian buyer organizations, and enforced by those buyers through supplier requirements.

PTI works at two levels:

"Case" here is deliberately broad. It covers a corrugated box, a returnable plastic container, a bin, a bag, a crate or a tote. Anything handled as a single unit through transport and distribution.

What are the PTI label requirements?

A PTI harmonized case label must carry a GS1-128 barcode encoding the 14 digit GTIN and the batch or lot number, with both printed in human readable text beneath it, plus a 4 digit voice pick code, the brand, the commodity, the count or net weight, grown in information, and the UPC or PLU of the item inside.

Element Where it lives Notes
GTIN GS1-128 barcode, AI (01), and human readable below it PTI uses the 14 digit GTIN
Batch or lot number GS1-128 barcode, AI (10), and human readable below the GTIN Alphanumeric, variable length, up to 20 characters
Pack or harvest date GS1-128 barcode, AI (13), YYMMDD Or best-by / use-by as AI (15), depending on your buyer
Voice pick code Printed in the lower right corner 4 digit number, not encoded in the barcode
Brand and commodity Human readable
Count or net weight Human readable
Grown in Human readable State or province in the US and Canada, country elsewhere
UPC or PLU Human readable Whichever corresponds to the item inside the case

The human readable GTIN and batch or lot number go directly below the GS1-128 barcode, GTIN on one line and lot on the line underneath. PTI recommends the Swis721 Cn BT font for legibility, and includes French text where the product is distributed into Canada.

The voice pick code is worth understanding because it is the element people most often leave off. It is a 4 digit number computed from the GTIN, the lot code and, where one is used, the date, using a CRC-16 hash. It exists so that a warehouse operator on a voice picking headset can confirm they have the right case by reading four digits aloud instead of scanning. Because the GS1 lot number is case sensitive, the voice pick code is case sensitive too. Change the capitalization of your lot code and the voice pick code changes with it.

The lot code rules that catch people out

The batch or lot number is where most PTI implementations go wrong, because it is the only field the packer invents themselves.

Certain characters are not allowed. The following must not appear in a batch or lot number:

# @ $ ^ \ ~ | [ ] { } space, pound sign, currency sign, grave accent

Use upper case. GS1 lot numbers are case sensitive. PTI recommends upper case to avoid confusion, and it makes the human readable line easier to read at a distance.

Do not cross a date boundary in a shed packed lot. A lot should be scoped with the size of a potential recall in mind. If a shed packer does elect to cross a date boundary, PTI's guidance is to encode a pack date (AI 13) or a sell by date (AI 15) after the batch or lot in the barcode, and to print that date in human readable form under the barcode.

Field packed product should carry a location specific lot. Same reasoning: if something goes wrong, you want the recall to stop at one block, not one season.

Do not substitute a serial number for a GTIN. Serializing every case defeats the point of a pallet label, because a receiver then has to scan every case on the pallet instead of scanning the pallet.

Barcode size, placement and quiet zones

PTI follows the GS1 General Specifications, and the size depends on how the barcode will be scanned:

Scanning method Narrowest bar width Minimum barcode height
Attended, handheld scanner 0.00984 in (0.250 mm) to 0.0300 in (0.750 mm) 0.50 in (12.70 mm)
Unattended, fixed position scanner 0.0195 in (0.495 mm) to 0.0400 in (1.016 mm) 1.25 in (32.00 mm)

Quiet zones are 10 times the narrow bar width on each side. Maximum barcode width including quiet zones is 6.5 in (165.1 mm), and the barcode must not be compressed to fit a smaller label.

Placement on the case: the target position for the bottom of the barcode is 1.25 in (32 mm) from the natural base of the case, which with a 1.25 in barcode height puts the centerline at 1.875 in (47.6 mm) from the base. Keep the symbol, including its quiet zones, at least 0.75 in (19 mm) from any vertical edge so it does not get damaged in handling.

If the case or tray is under 2 in (50 mm) tall and a full height barcode with the human readable text below will not fit, the first fallback is to move the human readable text to the left of the symbol, outside the quiet zones. If the unit is under 1.25 in (32 mm) tall, the symbol can go on the top of the pack, bars perpendicular to the shortest side, no closer than 0.75 in (19 mm) to any edge.

The print quality grade nobody checks until a load is rejected

A GS1-128 barcode has to reach a minimum print quality of an ISO/IEC 15416 overall grade of 1.5. Below that, it does not conform to the GS1 standards, and a receiver is within their rights to say so. The verifier used to measure it must itself conform to ISO/IEC 15426-1.

ISO/IEC grade ANSI letter Conforms?
3.5 and above A Yes
2.5 to below 3.5 B Yes
1.5 to below 2.5 C Yes
0.5 to below 1.5 D No
Below 0.5 F No

A scanner is not a verifier. A scanner tells you whether one particular scanner could read the code once. A verifier grades the symbol against nine measured parameters and tells you whether it will read reliably across the supply chain. If a customer is complaining about scan failures and your own handheld reads the label fine, the answer is almost always in the grade.

The Application Identifiers, the data order rule and the SSCC pallet level are covered in detail on our GS1-128 label structure page.

What does FSMA 204 require?

FSMA 204, the FDA Food Traceability Rule, requires firms that handle a food on the Food Traceability List to record Key Data Elements at seven Critical Tracking Events, assign traceability lot codes, maintain a traceability plan, keep the records for two years, and produce them to FDA within 24 hours of a request.

Section 204 of the FDA Food Safety Modernization Act required FDA to designate foods needing additional traceability records. The resulting rule, formally Requirements for Additional Traceability Records for Certain Foods and commonly called the Food Traceability Rule or FSMA 204, requires firms that handle a listed food to keep specific records and hand them to FDA on request.

It is built from four ideas:

You also have to create and maintain a traceability plan, keep required records for two years, and be able to give them to FDA within 24 hours of a request, or within some other reasonable time FDA agrees to. In certain circumstances FDA can require the records as an electronic sortable spreadsheet.

The rule does not tell you what to print

This is the single most useful fact on this page, and almost nobody selling traceability leads with it.

FDA does not require a specific technology for keeping records, and FDA does not require the traceability lot code to appear on the product label or packaging at all.

FDA has also said the traceability lot code "may include a product identifier such as a GTIN and/or an internal lot code", provided it meets the rule's own definition.

So the label is not a compliance artifact. It is the mechanism the industry chose because moving the data physically with the product is the only version that survives contact with a warehouse.

Is your crop even on the list?

FSMA 204 applies to foods on the FDA Food Traceability List (FTL). The produce categories on it are:

Whole fresh cherries, blueberries, raspberries, blackberries, apples and pears are not on the Food Traceability List. Fresh-cut fruit is. So a packer running whole sweet cherries into a clamshell is outside FSMA 204 for that product, while the same packer running a fresh-cut fruit line is inside it.

That does not mean the label is optional for them. It means the requirement is arriving from their retail and foodservice buyers rather than from FDA, and buyer deadlines are usually the earlier of the two.

The compliance date, stated precisely

This is worth getting exactly right, because it has moved and the wording matters.

Two things follow from that, and they are not the same thing.

The compliance date itself has not legally moved. FDA's 30 month extension is still a proposed rule, so January 20, 2026 remains the compliance date on the books, and it has passed. The recordkeeping obligation exists now for a covered firm handling a listed food.

What has moved is enforcement. Congress barred FDA from using appropriated funds to administer or enforce the rule before July 20, 2028, and FDA has said it intends to comply.

So plan to July 20, 2028, but understand you are planning against an enforcement pause rather than a changed requirement. Verify the current status with FDA before you make a spending decision on the strength of it, because a final rule would change this paragraph.

How do PTI and FSMA 204 line up?

PTI and FSMA 204 line up through the barcode. PTI's own guidance treats the GTIN plus the batch or lot as the industry standard FSMA 204 traceability lot code, and that is exactly what the PTI case label's GS1-128 barcode already carries. One properly implemented case label serves both, and records can be built by scanning.

PTI's own guidance states the alignment directly:

Which is the practical answer to "do we need two systems": no. If you implement the PTI case label properly, the barcode on the case carries the traceability lot code, and your receiving and shipping records can be built by scanning rather than by typing. For the recommended data order in the barcode and the pallet level, see the GS1-128 page linked above.

What does PTI mean for the equipment on your line?

PTI turns a data specification into a mechanical job. Meeting it on a packing line usually comes down to four questions: whether you can print a variable lot code at line speed, whether the label lands within the placement rules, whether a bad code is caught before the load ships, and whether pallets get labeled as well as cases.

1. Can you print a variable lot code at line speed? A preprinted label cannot carry a lot code that changes during a shift. Variable data means printing at the moment of application, which means a print engine in a print and apply head rather than a labeling head running a preprinted roll. The heads that do this are covered on our print and apply label applicators hub. Where a date or lot only needs to appear as printed text on a tray or pack, outside the barcode, date and lot coding equipment prints it directly.

2. Can the label be placed accurately enough to satisfy the placement rules? The 1.25 in from the base and 0.75 in from the vertical edge rules are not decoration. They exist because labels near an edge get damaged and unreadable labels are rejected loads. Placement accuracy is an applicator and product handling question.

3. Can you catch a bad code before the load ships? Altech's over print camera is a line item on a print and apply head. It reads the code after printing, in line, and can trigger a reject. On a line producing thousands of cases an hour this is the difference between finding a printhead problem in the first minute and finding it at your customer's receiving dock. It is a production control rather than a graded measurement, which is a separate thing and a separate instrument.

4. Can you print and apply a pallet label as well as a case label? Case labeling and pallet labeling are different machines. The SSCC on a pallet label is a different identifier with different rules, and the PTI hybrid pallet label goes on two adjacent sides of every unit load.

Marapack Services specifies, installs, commissions and services all four on produce lines, from a base in the Pacific Northwest. The equipment side in detail is on our PTI labeling systems hub, and how case, clamshell and tray lines are laid out is on our packing shed labeling page.

Frequently asked questions

Is PTI mandatory? No. PTI is a voluntary industry initiative. In practice it is enforced by buyers as a supplier requirement, which for most packers makes it functionally mandatory even though it is not law.

Does FSMA 204 require a barcode on my case? No. FDA does not require the traceability lot code to be on the label or packaging, and does not require any specific technology for recordkeeping. The barcode is how the industry chose to make the recordkeeping practical.

Do cherries and blueberries fall under FSMA 204? Not as whole fresh fruit. Neither appears on the FDA Food Traceability List. Fresh-cut fruit does appear. If you run both a whole fruit line and a fresh-cut line, only one of them is covered. Check the current list before relying on this, because FDA can revise it.

What is the difference between a lot code and a traceability lot code? Your lot code is a number you assign. A traceability lot code is the identifier that uniquely identifies a traceability lot within your records under the rule. The industry standard way to express it is GTIN plus lot, which is exactly what the PTI case label barcode already carries.

Can we just add a lot number to the label we already print? Sometimes, if your existing system can take variable data and your barcode still grades 1.5 or better at the size you are printing. Often the constraint is that the existing label was designed before anyone needed a GS1-128 on it and there is no longer room for a compliant symbol with its quiet zones. That is a five minute check on an actual case.

What is a voice pick code and do we have to print it? It is a 4 digit hash of your GTIN, your lot and, where one is used, the date, printed in the lower right of the PTI label so warehouse staff on voice picking systems can confirm a case without scanning. PTI recommends including it. Some buyers ask for it specifically.

How long do we have to keep the records? Two years, and you must be able to produce them within 24 hours of an FDA request, or within some other reasonable time FDA agrees.

Get a straight answer about your own line

If you are trying to work out whether you need to change anything, the fastest route is not a compliance consultant. It is somebody walking your line with a case in their hand, reading what your label actually carries against what your buyer actually asked for.

We will tell you whether your line can carry a variable lot code, whether the label can be placed where the rules require it, and what it would take. Including when the answer is that it already can and you do not need to buy anything. Request a packing line assessment, or call 253-709-5566.

Sources

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