Yesterday the U.S. Food and Drug Administration announced a landmark ruling that will send ripples through the food industry and may save thousands of lives.
The ruling is one of the final major pieces of the Food Safety Modernization Act and mandates that food companies in the U.S. implement digital traceability practices to help improve food safety.
In this article we’ll review what the ruling is, who’s affected, and how IBM Food Trust can help you get started on your compliance journey.
The FDA’s ask of the industry
In the US, the FDA is tasked with ensuring that the food that Americans consume is safe, which is no easy feat. The CDC estimates that 48 million Americans (one in six) get sick from food illnesses each year, of which 128,000 are hospitalized and 3,000 die from foodborne diseases. In 2011, the FDA launched the Food Safety Modernization Act to tackle some of the most prevalent food safety challenges. The major shift in focus was to specifically address and proactively prevent contamination in the food supply, rather than just responding to it.
When the act was initially released, it was missing a key piece of legislation around product traceability. Traceability provides some of the most important insights and leading indicators required to anticipate and prevent foodborne illness. When companies and governments are able to see exactly where each product came from and where it’s been throughout its supply chain, they can anticipate where issues could occur and proactively remove risky products from future shelves. Especially in the event of identified cases of foodborne illness, this traceability information can help identify where the contamination stemmed from and what products need to be removed from which store shelves in order to prevent additional people from becoming sick.
Now that FSMA Rule 204(d) has been finalized, the FDA has made their ask to the industry clear: collect and be ready to send the FDA traceability records within 24 hours of a request.
Now, this may seem like a significant amount of additional work for industry participants, however, in reality, the FDA is taking on a lot of the heavy lifting of processing all of this data and mapping out points of convergence to identify what products have most likely been contaminated. The benefit to the industry of this service is immense, as in a recall scenario, all participants in a supply chain feel the pain, and the reputational damage to a brand can impact a business for years.
Who is affected
The ruling applies to the full set of supply chain participants for certain types of food. Specifically, the ruling states that any companies that manufacture, process, pack, or hold foods (both domestic and imported) on the Food Traceability List (FTL). This includes Farms, Manufacturers, Importers, Distributors, Retailers, and Restaurants, and the note on imports means that international companies that import any foods included in the list will also have to maintain records as well.
What foods are included
In forming the ruling the FDA ran studies to assess which foods were the most important to maintain traceability records for, which led to the creation of the Food Traceability list. Any products that include foods on this list as ingredients that remain in the same form (i.e. fresh) will be included in the mandate. You can find more details here, but we’ve included an overview of the list below for your reference
- Cheese (made from pasteurized milk), fresh soft or soft unripened
- Tomatoes (fresh)
- Cheese (made from pasteurized milk), soft ripened or semi-soft
- Tropical tree fruits (fresh)
- Cheese (made from unpasteurized milk), other than hard cheese
- Fruits (fresh-cut)
- Shell eggs
- Vegetables (fresh-cut)
- Nut butters
- Finfish (histamine-producing species) (fresh and frozen)
- Cucumbers (fresh)
- Finfish (species potentially contaminated with ciguatoxin) (fresh and frozen)
- Herbs (fresh)
- Finfish, species not associated with histamine or ciguatoxin (fresh and frozen)
- Leafy greens (fresh)
- Smoked finfish (refrigerated and frozen)
- Leafy greens (fresh-cut)
- Crustaceans (fresh and frozen)
- Melons (fresh)
- Molluscan shellfish, bivalves (fresh and frozen)
- Peppers (fresh)
- Ready-to-eat deli salads (refrigerated)
- Sprouts (fresh)
What data do companies need to collect
One of the other important services provided by the FDA in this ruling is the establishment of a common standard (i.e. a shared language) with which companies can capture and share this data through the industry.
They’ve defined the essential pieces of information necessary to facilitate traceability that cover the questions of Who, What, Why, Where, and How. This is reflected by events that capture what’s happened in the real world and sets of data elements associated with each of these events to capture the essential attributes of the event.
Specifically, they’ve broken this down into a set of Critical Tracking Events (CTEs) that reflect the harvesting, cooling, initial packing, shipping, receiving, or transformation of the food. They’ve even included a CTE to capture the first land-based receiving of food obtained from a fishing vessel for sea-based products.
For each of these events, there is a defined set of Key Data Elements (KDEs) that include the essential pieces of information to trace products. Examples can be found here.
Data sharing requirements
Another key requirement of the rule that will help drive further collaboration and visibility across the industry is that companies share specific records for each lot of a product they ship with the recipient of that lot.
This means that it’s not enough to just collect your own records and act in isolation from your partners. You need to receive data from your upstream suppliers and share it with your downstream recipients. Sharing this data manually with each partner could become quite time-consuming, so it’s important that you find a solution that will take care of this aspect for you.
Many existing ERP systems are limited
Unfortunately, it’s unlikely that your existing ERP systems are storing all of the data that the FDA is requiring.
In many cases, food companies may be using Enterprise Resource Planning (ERP) systems to manage their orders and track their inventory, however, these systems are unlikely to be capturing or able to capture all of the data that the FDA is requiring.
These systems are focused on the transactional and accounting elements of your inventory and typically focus on documents like Advanced Shipping Notices and Purchase Orders rather than the events that may happen in your facilities like transformations that your products may go through.
That doesn’t mean that you have to start from scratch though. Given this new standard in the industry, some leading solution providers have designed their platforms to be able to ingest your existing systems’ data to leverage your existing data and collect the remaining pieces together.
How can IBM Food Trust help
IBM Food Trust is a purpose-built solution to help facilitate the exact traceability that the new FDA ruling is mandating. Over the past 5 years, the platform has established an ecosystem of hundreds of farms, producers, suppliers, manufacturers, retailers, and others to securely store and share data throughout the global food industry.
The solution supports GS1 standards, which align well with the CTEs and KDEs that have been defined by the FDA, and when it comes to FSMA Rule 204(d) compliance, the platform has released specific capabilities that make it simple for companies of all types to collect and store the required data. IBM Food Trust continually evaluates the data on the platform to ensure that you have the data required and are meeting your compliance obligations so that you’re not caught off guard when the FDA sends you a request.
Once you’ve onboarded your data to IBM Food Trust, the platform can help you trace your products both up and downstream throughout your supply chain to manage an investigation and can generate reports in the exact format required by the FDA with the click of a button.
Learn more about IBM Food Trust or Schedule a Consultation with an IBM Representative
Charting a new path forward
When a contaminated product makes someone sick, it’s very difficult to determine where that product came from and what other similar products might also be affected. This is especially challenging with the complexity and dynamic nature of supply chains today.
The FDA’s announcement marks a pivotal moment that will help drive the food industry to a place where it can tackle these issues and proactively prevent cases of foodborne illness.
Many companies like IBM have been working towards this goal for many years and have solutions in place to help make it easy to facilitate traceability as ultimately success in this space could very well save thousands of lives.
Together with the FDA, IBM Food Trust is creating a smarter, safer, more sustainable food system for all.
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