Food Industry Reacts to News that FDA is Delaying FSMA 204D Compliance Date by 30 Months 

Earlier in March, The U.S. Food and Drug Administration (FDA) announced that it is delaying the compliance date for a key food traceability rule by 30 months. The 30-month delay for Food Traceability Rule 204D (FSMA 204D) compliance has been met with a mix of praise and concern in the food industry.

“Much Needed Relief” 

The delay will provide “much-needed relief” for independent grocers and should spare consumers the costs of covering implementation, the National Grocers Association said in a statement.

“Disproportionately impacting smaller grocers, the traceability rule’s original timeline was nearly impossible to meet across the vast and dynamic food system. It quickly added exorbitant costs and operational complexity, threatening grocers’ ability to serve their communities effectively,” the NGA said. 

FMI - The Food Industry Association welcomed the delay, saying that “more time is needed for compliance with the overly complex rule to ensure it does not unnecessarily increase food costs and burden the food supply chain.”

FMI added, “the food traceability rule is the most complex FDA regulation our industry has ever faced. Our member companies are spending millions of dollars every day to try to comply with its complexity.”

The FMI also argued that the rule in its current form is “unworkable” and will not achieve the traceability goals for which it was founded. 

The Global Cold Chain Alliance said “the rule’s complexity has raised concerns about the burden it places on businesses. This additional time allows for further collaboration between industry stakeholders and regulators to address outstanding challenges.”

These comments are similar to ones made in the FDA’s announcement from March 20th. In the announcement, the FDA said that the 30-month extension gives companies “the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements.”

The statement added that the delay does not change the fact that the FDA “remains committed to successful implementation of the full requirements of the final rule, as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths.” 

In an interview, Andrew Kennedy, the chief traceability officer of iFoodDS, said that the delay could mean that after the final compliance date passes, “there's probably going to be less tolerance when we get to the deadline for not being able to produce the traceability code.” 

Watchdog Groups Criticize Delay

Since March 20th, consumer watchdog groups have criticized the decision to delay FSMA 204D implementation. 

In a statement, Brian Ronholm, Director of Food Safety at Consumer Reports criticized the decision to delay FSMA 204D compliance. Ronholm said the decision “is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare.”

He added, “delaying this critical food safety rule undermines the administration’s goal of making America healthy again.”

The Consumer Federation of America said the delay “will put consumers at higher risk of getting a foodborne illness, and undermine progress towards the goals laid out in the Make America Healthy Again agenda.”

The CFA stated that the “standard recordkeeping elements prescribed in the rule would speed up foodborne illness investigations and recalls.”

The CFA blamed “a few holdouts” for causing the delay, even as much of the food and beverage industry had invested in compliance with the rule. 

“Rewarding these narrow special interests will undermine efforts across the food industry to keep better track of foods, and make it harder for responsible companies and investigators to protect consumers from contaminated food,” the CFA said.

What the Rule Requires

Under FSMA 204D, every food company operating in the U.S. that manufactures or holds foods on the FDA’s Food Traceability List must implement the recordkeeping requirements detailed in Section 204D of the FDA Food Safety Modernization Act (FSMA).

These require companies to maintain records of Key Data Elements associated with specific Critical Tracking Events (CTEs). If requested, companies must be able to provide information on a spreadsheet to the FDA within 24 hours.

The food traceability list covers a wide range of foods, including:

• Shell eggs
• Nut butters
• Crustaceans
  Molluscan shellfish
• Bivalves
• Ready-to-eat deli salads
• Fresh-cut leafy greens
• Finfish (fresh, frozen, and smoked)
• Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and vegetables
• A variety of non-hard cheeses

The FDA defines traceability as “the ability to follow the movement of a food product and its ingredients through all steps in the [food] supply chain, both backward and forward. Traceability involves documenting and linking the production, processing, and distribution chain of food products and ingredients.”

Better traceability measures mean that in the case of a foodborne illness outbreak, it is much easier to “rapidly find the source of the product and where contamination may have occurred. This enables faster removal of the affected product from the marketplace, reducing incidences of foodborne illnesses,” according to the FDA.

Thirty months can go by in a flash. To help your company get ready for FSMA 204D, download the free Rootwurks FSMA Food Traceability Chatbot, which will instruct you on the guidelines you need to meet and where to find them in the regulatory documents. You can also download the Rootwurks "Introduction to FSMA Preventive Controls" course, now available in English and Spanish.