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New Food Safety Modernization Act Update Will Increase Traceability During an Outbreak

Posted in Our Blog on February 27, 2024

One of the toughest aspects of an investigator’s job during a foodborne outbreak is determining the source. An update to an existing government regulation would potentially increase traceability during an outbreak, assisting in US Food and Drug Administration (FDA) investigations.

In a recent report to congressional committees titled FDA Should Finalize Plans to Implement Its rule to Help Trace Source of Outbreaks, the U.S. Government Accountability Office (GAO) explains the next steps of the existing Food Safety Modernization Act (FSMA) and implement a rule that would increase traceability of our food supply.

Proposed Update Would Increase Traceability During an Outbreak

This new update, designed to increase traceability during an outbreak will strengthen the existing FSMA implemented in 2021. The original FSMA, as important as it was to make food safety more consistent across the country, focused more on reacting to foodborne illness outbreaks after they occurred.

Conversely, this update is aimed at preventing outbreaks by tracking down food components before they reach the consumer in dishes served in restaurants or sold in grocery stores. Whereas most of the existing FSMA rules apply to farms and facilities that process food for human consumption, this update would expand the umbrella of other firms to which it will apply and expected to go into effect in 2026.

Covered Food Products

The proposed update to increase traceability during an outbreak focuses on six broad food categories.

  • Dairy
  • Eggs
  • Nuts and nut products
  • Prepared food
  • Produce
  • Seafood

The FDA developed this list by using a “risk-ranking model.” Several factors were taken into consideration as criteria for each category’s’ weight on the list. According to the FDA, this list will be revisited every five years or so.

Prior to the update, only the raw foods were subject to the FSMA requirements. Now, the proposed update includes foods that contain an item on the list. This takes traceability beyond the food life-cycle of the farm and drops it squarely into prepared food territory.

Who Does It Apply To?

An estimated “323,800 domestic businesses operating more than 484,100 establishments, including over 11,000 farms” will fall under this ruling.

According to the report, “fresh lettuce used in a bagged salad mix, fresh cantaloup in a commercially prepared smoothie, or a sandwich containing a fresh tomato would be covered by the rule’s requirements.”

Those not on the list, however, are not. For example, a frozen pizza topped with spinach isn’t subject to the requirements, because frozen leafy greens are not included on the list. Additionally, trail mix with dried papaya would also be exempt, as dried tropical tree fruits are also not on the list.

Additional exemptions apply, based on the size of the company.

Who is Exempt?

Certain small businesses are exempt from these updated requirements. The criteria for “small business” status is subject to change, but it often applies to companies that are independently owned and operated and are not dominant in their field. Other standards such as number of employees, volume of business, net worth, net income, or combination of some of these criteria are often factors for this status.

When it comes to the current iteration of the update, the proposed exemption threshold is $250,000 in annual sales (averaged across three years).

Stakeholders overwhelmingly responded in opposition, citing that restaurants and grocery stores, even small ones, easily surpass the exemption threshold.

In addition to the low small business benchmark, other challenges to implementation have been voiced.

Expected Challenges to Implementation and Compliance

Many businesses want to do the right thing, and most reasonable people concur that more information would assist in traceback activities. Any sane person would want to help prevent the spread of an outbreak and limit potentially harmful food products reaching public commerce. However, certain challenges are anticipated.

Identifying and Obtaining Resources to Enforce the Rule

In addition to the businesses needing to acquire resources to maintain compliance with the new recordkeeping requirements {including but not limited to sophisticated software to streamline this process), additional resources will be required to enforce the rule.

Local health department budgets are often stretched so thin you can see through the paper. These additional recordkeeping criteria will increase the workload of these inspectors. Not only will they need to significantly update inspection procedures, but these activities will also need to be monitored.

Enforcement Roles and Responsibilities Need to be Spelled Out

Details for what governmental level is responsible for each activity will need to be explicitly spelled out. Without detailed roles and responsibilities, enforcement activities will likely fall through the cracks. The update will need to explain this information in detail.

Hurdles to Non-federal Coordination with Federal Partners

Additional hurdles to cooperation between non-federal and federal partners may impact enforcement activities. Local and state jurisdictions are often left to their own oversight, with federal partners stepping in as needed for large events.

This regular coordination will likely require modifications to the command structure to accommodate federal input in these oversight activities. These hurdles will need to be addressed for seamless enforcement.

Data Management Burden

Data management will quickly become a burden. In addition to data storage for the recordkeeping needs for traceability compliance, this data must be accessible during an outbreak in a way that will allow identification of impacted food products.

This is, after all, the whole point of the update.

This data management may be a huge financial burden for a small business.

While on the topic of costs, what does the benefit look like compared to the cost?

Potential Costs and Financial Benefits to Increase Traceability During an Outbreak

According to the report’s table explaining the “Estimates of Annualized Monetary Benefits and Compliance Costs of the Food Traceability Rule,” there is an estimated $780 million health and $575 million non-health benefit to implementation at a $570 million domestic cost.

While any benefit is appreciated during an outbreak investigation, some stakeholders say that the cost vs benefit is marginally worth it. Others say the burden is too great to bear for the low threshold of sales for inclusion in these compliance activities.

Ultimately, businesses will have to find a way to maintain compliance if this new update passes intact, as it likely will.

Is this Update to Increase Traceability During an Outbreak Worth it?

The big question is, will the update to increase traceability during an outbreak be worth it? For those whose lives will be saved, and illnesses prevented, it is an overwhelming yes.

The question comes, how to do this affordably. For when food costs rise, so do the prices. Food is already expensive. Only time will tell the impact of these changes on the weekly grocery bill.

Want to Know More About Food Safety?

If you’d like to know more about food safety in the news, such as New Food Safety Modernization Act Update Will Increase Traceability During an Outbreak, check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!

By: Heather Van Tassell (contributing writer, non-lawyer)