How to comply with FSMA 204: a checklist for food packers

Executive summary 

FSMA 204 (The Food Traceability Final Rule) is a new FDA regulation that’s part of a concerted effort to rapidly trace certain high-risk foods – but how will it impact you, a food packer? 

You're busy doing what you do best – packing. You may have heard that you’ll need to comply with FSMA 204 soon, but there’s no time to read through hundreds of pages of government fine print to figure out how. TELUS Food Safety & Quality can save you the hassle and help you cut through the noise. Here’s everything you need to know about FSMA 204 and what you’ll need to do to comply.

What is FSMA 204 and where do you fit in?

Let’s start with the basics. FSMA 204 was created to combat food borne illness which is a big problem – especially in the United States where 48 million Americans (1 in 6 people) suffer from a food borne illness, 128,000 people are hospitalized for it and 3,000 people die from it each year. 

FSMA 204 is a new section of The Food Safety Modernization Act (FSMA). The broader act was first introduced way back in 2011 and was designed to prevent contamination, enhance traceability and demand transparency in the US food supply.

In 2022, FSMA 204 was included as a new regulation within the act. It will require food businesses to keep detailed traceability records for certain foods with the goal of enabling faster identification and removal of contaminated foods from the market in order to reduce foodborne illness. It requires compliance from key players across the food supply chain – especially packers like you. Let’s examine what the regulation requires and how you will need to comply.

How and when you need to comply with FSMA 204

Your role is one of the most important in the entire food supply chain. Within FSMA 204, you are the source of truth for a food product's identity and origin. You’ll need to tag the product for tracing, record where and when it was tagged and keep detailed records of your work so you can instantly share that information with your supply chain partners and the FDA.

You're almost fully compliant under FSMA 204 if you are fully meeting these specific core tasks efficiently. If you can’t, don’t fret. You have ample time to prepare your business for compliance. The original compliance date was January 20, 2026, but the FDA has proposed to kick it down the road to July 20, 2028.

If you’re ready to master FSMA 204 compliance, here’s everything you’ll need to do:

Check the list: Key foods on the FSMA Food Traceability List (FTL)

Not all foods need to be traced to comply with FSMA 204. Here are a few key examples of foods on the traceability list that you may handle and will need to trace:

Many more foods are listed in the FTL, many of which do not get handled by packers. The FDA can update the list further at their discretion, so it’s important to check back from time to time for updates and changes that may impact your business.

Record key data elements (KDEs) for critical tracking events (CTEs)

CTEs are specific points in the food supply chain where traceability data must be collected. They capture significant movements or changes to a food product.

You will need to record KDEs for CTEs. They record critical details related to a product's CTEs:

Initial Packing CTE

Initial packing involves packing a raw agricultural commodity (RAC), other than food obtained from a fishing vessel, for the first time - for example, fresh produce like cucumbers or parsley, which packers often handle. The KDEs you’ll need to record for this CTE may include things like a product description, date of harvest, harvest location and Traceability Lot Code (TLC).

So why are you capturing all this data? What does it accomplish? Let’s look at TLCs for a great example. They’re crucial to assign and record because they enable the FDA to skip steps in the supply chain, link a food to the firms that have handled it and pinpoint the source of the food during an outbreak investigation.

To help the FDA identify a food source faster, you must create and maintain documentation pertaining to your traceability lot codes and traceability lot code sources. This works because a TLC links to other KDEs, including the TLC Source, which provides the physical location where the traceability lot code for an FTL food was assigned. In short, data like this is life saving.

Shipping CTE

You already know that shipping involves arranging food for transport from one location to another. But in terms of FSMA 204, shipping is more precisely defined. It does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. It does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm. The KDEs you’ll need to capture for this CTE may include things like the previous source, the date and location and the recipient.

As you may have gathered from the nature of what’s being recorded, KDEs need to be maintained across the supply chain. They blaze the trail from farm to fork and support efficient and effective tracing while providing firms with flexibility within their existing tracing systems. 

Create a traceability plan

Perhaps most importantly, you will be required to create and maintain a written traceability plan. It should capture data that can be used to track FTL food products from supplier to recipient. The plan is critical for the rapid identification and removal of potentially contaminated items from the market. 

Your traceability plan doesn’t have to be complicated, but it must describe how you maintain your records, including record format and location; what you do to identify any FTL foods that you pack; how you assign TLCs to foods on the FTL; and contact information for the plan manager.

Adhere to the 24-hour rule

You must also comply with the “24-hour rule”. This rule ensures that the FDA can get their hands on your traceability records as quickly as possible during an outbreak, recall or other threat to public health.

You’ll need to maintain original paper or electronic records, or true copies, plus any information needed to interpret them. You may be required to submit these records and an electronic sortable spreadsheet of traceability information. In the event that the FDA requests your records and a spreadsheet, you will need to send your materials within 24 hours after a request is made, or within a reasonable timeframe that the FDA agrees to.

What to watch out for 

Record keeping will only be straightforward for you if you put adequate systems in place to streamline the process. If you currently conduct manual recordkeeping (paper logs, spreadsheets); engage in product mixing, sorting and repackaging; pack commodities that require temperature and environmental control data integration; and/or have limited visibility into supplier or downstream partner systems, you may struggle to comply with FSMA 204. 

Implementing the right digital solution today could help you to efficiently manage your record keeping tomorrow.

When to consider a digital solution

FSMA compliance will likely be challenging for your business without the right digital tools in place. Adopting food supply chain traceability software like TELUS Food Safety & Quality can help save time, reduce errors, mitigate risk, increase visibility and strengthen your partnerships and communication.

The right digital solution can help you:

The argument for adopting the right food supply chain traceability software for your packing business virtually writes itself.

How food packers can get ready for FSMA 204 in 5 steps

It’s better to be prepared than to play catch up. The sooner you reorganize your packing operations to prepare to comply with FSMA 204, the better. There may be many things that you need to organize in order to be FSMA 204 compliant, but below are 5 easy steps to help you prepare:

1. Identify all FTL products that you pack

2. Record your CTEs and KDEs

3. Invest in digital solutions, like a good food supply chain traceability software solution and onboard your team

4. Run a mock recall test

5. Document your traceability plan

Key takeaways