Fed Foot-Dragging on Food Regs Highlights Company Role

Should companies step up to the plate, or take a cue from the Feds and adopt a laissez-faire approach to food safety?

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Editor’s Note: Dr. Alexis Bateman ([email protected]) is a Research Scientist at the MIT Center for Transportation & Logistics (MIT CTL) and Director of MIT CTL's Sustainable Supply Chains initiative.


Consumers are deeply concerned about food safety issues at a time when Federal regulators appear to be pulling back from stricter oversight of food supply chains. Should companies step up to the plate, or take a cue from the Feds and adopt a laissez-faire approach to food safety?

The frequency and scale of food risks and recalls has increased significantly in the last few years. One out of six Americans get sick from eating contaminated foods every year, according to the Centers for Disease Control (CDC). Recently, six million pounds of ground beef contaminated with salmonella bacteria sickened 246 people across 25 states. On November 20, 2018 the CDC warned consumers not to eat romaine lettuce and retailers not to serve or sell the product owing to contamination issues.

High profile cases like these have heightened concerns over food safety. Stories of recalls appear to capture news headlines on a daily basis, involving various types of products from cake mixes allegedly tainted with salmonella to listeria-infected chicken salad. News groups such as CNN commonly summarize the numerous recent recalls, highlighting the frequency of such events.

Slack oversight?

There are various reasons for the increasing frequency and scale of these incidents.

In some cases, companies are becoming more aggressive in issuing voluntary recalls. Also, oversight from physicians and public health officials is improving.

Another reason is that the US Food and Drug Administration (FDA) has relaxed enforcement across the board, and maintained a gradual approach to adoption of regulations such as the Food Safety Modernization Act (FSMA).

The FSMA's ultimate goal is to increase safety across the entire food chain from farm to fork.

The Act affects all actors in the food supply chain and requires a more rigorous commitment to food safety, inspection procedures, data collection, and responses to contaminations. The FSMA became law in 2011, but allowed for a phased-in adoption over a multi-year period with enforcement of certain provisions beginning in 2016.

In January 2018, the agency issued an enforcement discretion policy for certain FSMA provisions. This means that the FDA has no plans to enforce the listed provisions. FDA Commissioner Scott Gottlieb said the intent of the discretion policy is to ensure that the agency works with farmers and other producers to achieve shared goals around food safety to an appropriate timeline.

Some praised the move because there continues to be confusion around how the regulation defines “farm” and “facility” with major implications for how the rules will be enacted.

However, others suggest that the guidance is an attempt by the Trump Administration to undermine landmark legislation and reduce the cost burden on businesses. The exemption creates a gap by not enforcing rules for all relevant actors.

In October this year, two watchdog groups filed a complaint against the FDA in the US District Court for Northern California. The groups claimed that the agency has failed to meet deadlines for classifying and designating high-risk foods, and to create record-keeping requirements for facilities handling the foods.

Failure to comply with FMSA requirements can have real-world consequences. This was highlighted in the June 2018 outbreak of E.coli in romaine lettuce, which stemmed from contaminated water. The outbreak was the largest since 2006, and resulted in 210 illnesses from 36 states and five deaths. During the crisis, the price of romaine fell 50% and many farmers were forced to leave their crops to rot as demand plummeted. As a result of poor information management, the outbreak stretched on for weeks before the CDC could identify the source of the issue. The investigation into the incident showed that documentation of processes was poor, and much of it was paper or handwritten.

Toxic fallout

The government's lax approach to enforcing full FSMA compliance will surely accelerate the rise in foodborne illness outbreaks and large-scale recalls.

Furthermore, on the heels of a historic midterm election, the U.S. government will remain in gridlock with a divided House and Senate for the next two years. In all likelihood, this means that there will be limited regulatory progress and oversight during this period.

It is possible that with Democrat House majority, regulatory oversight in some of these primary cases will come back into focus. However, in the near term the confluence of relatively limited government enforcement of stricter regulation and rising consumer demand for improved food safety, increases the pressure on companies to act.

To win consumer trust, businesses need to embed processes and technologies that achieve safe handling practices and better information management, and reduce or eliminate outbreak of foodborne illnesses. Companies need to voluntarily promote higher safety standards in the food supply chain, and improve visibility to pave the way for more effective handling verification and trace-back protocols.

Business stepping in

The business community has started to act. For instance, Walmart is pushing suppliers of leafy greens to trace their products back to the farm using blockchain technology. Other such initiatives include IBM's Food Trust, that utilizes a blockchain-based cloud network to enable food traceability, transparency, and efficiency.

Companies are looking to employ other technologies including remote sensing, digital auditing and mobile solutions to raise safety standards, increase consumer trust, and bring enterprises into full compliance with the FSMA.

However, scaling these innovations remains a challenge; as does aligning all the players across the supply chain to create a system that delivers thoroughly documented safe handling practices – especially in recall situations.

The cost of these efforts is high – but so is the potential rewards. In the absence of a strong lead from government regulators, companies that act and even strive to exceed the regulatory requirements can reap the benefits of more efficient supply chains, enhanced customer trust and loyalty, and fewer damaging product recalls.


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