Is Our Food Any Safer Since the Passage of FSMA?

In just the last couple of months, we’ve been reading reports about one new food recall after another: Listeria in smoked salmon, E.coli in ground beef, and undeclared allergens in P.F. Chang’s frozen entrees – and that’s not an exhaustive list. These ongoing incidents have once more raised the question among health experts of just how safe our food is since passage of the Food Safety Modernization Act (FSMA) in 2011.

For instance, Civil Eats recently hosted a roundtable discussion with leading food safety advocates about this very topic, and with good reason. After all, the very cause of FSMA was the federal government’s response to a similar wave of foodborne illnesses, thereby encouraging Congress to grant both the FDA and the USDA unprecedented power to inspect and regulate food products and producers.

So what’s the verdict? It comes down to two points of view. One argument is popular but simplistic: FSMA will remain a “toothless” public relations program as long as the FDA and the USDA are under-funded and under-staffed. The more complex argument recognizes that the U.S. food industry has grown increasingly complicated every year as the supply chain gets longer and more intricate. Meanwhile, consumers annually raise their expectations for faster delivery and greater convenience while insisting on freshness and safety.

Rapid innovations in technology, from e-commerce to drone delivery, are creating a globally interconnected food system that is progressively more difficult to map from farm to table. In fact, experts predict more innovation in agriculture, food production, and food distribution systems over the next 10 years than we’ve seen in the past 20.

Those willing to give the FDA and the USDA the benefit of the doubt contend that these novel and evolving business models present food safety challenges at the federal, state, and local level that require more time to allow the regulations to get up to speed. In other words, eight years has hardly been long enough to eradicate the food safety problems that FSMA was designed to solve. Since massive transformations to any food system can take one or two generations to achieve, demands for full implementation in the very near future are unrealistic.

The Latest Food Safety Data from CDC

According to FoodNet preliminary data released by the Centers for Disease Control and Prevention (CDC), foodborne illness was more prevalent in 2018 than in 2017. Incidents of pathogenic infections increased in part because more infections have been diagnosed with testing procedures. Nevertheless, the CDC also suggested the possibility that the number of infections might be increasing because of the following problematic microbes:

• Campylobacter is the #1 contaminant in raw chicken or poultry juices, and causes cross-contamination impacting unwashed hands, kitchen equipment, and adjacent foods in storage.
• Salmonella tenaciously shows up in raw poultry and fresh produce.
• Cyclospora outbreaks associated with produce have also increased.
• Vibrio infections in seafood persist due to rising temperatures of coastal waters that contribute to their growth.

The CDC, responsible for protecting public health and safety through the control and prevention of disease. Source: https://www.cdc.gov/

Since these stats may indicate either better diagnosis or increased infections, the experts are now weighing in on the pros and cons of FSMA to make sense of the situation.

The Pros and Cons of FSMA

On the positive side, most health advocates recognize that FSMA is a genuinely progressive piece of legislation with many new benefits and powers. Since its passage:

• The FDA at long last has shifted its regulatory approach from reacting to food safety problems to preventing them. 
• FSMA articulates food safety objectives that were once vague, and clarifies compliance expectations through guidance and training. 
• Food safety management systems (FSMS) are now mandatory, rather than optional.
• The FDA’s ability to identify, track, and trace particular strains of pathogens back to their sources has improved due to new testing methods.
• The FDA can now suspend a facility’s registration and shut down its operations if it does not respond swiftly and effectively to a food safety concern that puts the public at risk.

On the negative side, FSMA has obvious weaknesses:

• The FDA is incapable of full enforcement for lack of funding, staffing, inspections, and education.
• The FDA must, therefore, rely on other agencies for enforcement assistance, increasingly complexity, redundancy, and gaps in communication.
• High-risk foods, such as fresh produce, still require much better requirements for product tracking.
• Many small operations are exempt from FSMA.
• FSMA is weak regarding newer, more nuanced methods of food delivery.

Getting to the Meat of the Issue

The meat industry is a good case study to measure the success of FSMA. For every step forward, it seems to take another step back. Bill Marler, managing partner of a law firm specializing in foodborne illness cases and founder of Food Safety News, had praised the meat industry in the past for following FSMA and improving its food safety procedures. But since then he’s changed his mind.

Bill Marler is an accomplished personal injury lawyer and national expert on foodborne illness litigation, and has been named America’s 50 Most Powerful People in Food. Source: https://www.marlerblog.com/lawyer-oped/the-daily-meal-americas-50-most-powerful-people-in-food-for-2017-marler-no-40/

In the Civil Eats roundtable, Marler claims that the progress made in meat safety during the early part of the 2000s has stagnated in recent years as the industry is slowly returning to its old habit of casual adherence to FSMS methods. He cites as evidence the April outbreak of E. coli reported in 10 states that caused 177 illnesses.

A large part of the problem originates within the meat industry itself. For instance, meat processing plants relentlessly push for faster line speeds and for industry oversight to replace government oversight, both of which are antithetical to FSMA objectives. The persistence of CAFOs as the leading model for livestock production is also cited as a huge source of potential infection, as they create the perfect environment in which Shiga toxin-producing E. coli can flourish. Finally, as cultured meats are introduced into the supply chain on a massive, industrial scale, no regulations are in place to ensure sterility in the laboratories producing them.

Marler feels that more specific prohibitions are needed. For instance, Salmonella is not presently defined as an adulterant, which means that facilities can knowingly ship poultry, pork and eggs that contain it directly to consumers. Marler cites the USDA’s ban of E. coli in hamburger in 2011 as a precedent that more regulations should follow, since the market eventually adopted new methods to incorporate the prohibition as a standard procedure. In his own words:

“Until we set standards that are fully required across all parts of a production facility, I just don’t think we’re going to make progress, because we’re ignoring the elephant in the room, which is that under our law, we allow companies to knowingly ship contaminated meat into the marketplace.”

– Bill Marler

 

The Tester-Hagan Exemption

Another controversial aspect of FSMA is the Tester-Hagan exemption. Its purpose is to exempt small producers serving only local markets from all the preventive food safety standards that the FSMA imposes. Businesses earning less than one million dollars of annual revenue contend that the FDA requirements would be so costly that they would lose all profits and be driven from the marketplace. Therefore, Tester-Hagan provides a legal option to avoid spending already limited funds on an FSMS.

Although many health experts sympathize with cottage industries and local organic farms, they worry that the exemption provides too many loopholes that could still foster contamination of the food supply while the FDA figures out how to maintain standards at affordable scales. As Bill Marler points out, “I certainly do have clients who ate cheese and died from Listeria at a small cheese factory. I’ve had clients who purchased raw milk to support their local farmer, and their child is now a quadriplegic.”

For consumers, food safety is a universal issue regardless of company size. To avoid risk, small-scale and local operations would ideally employ the same practices and types of controls as larger operations to ensure a safe supply chain. But FSMA as of yet has no workable “scale sensitive” regulations that ensure both the health of consumers and small operators.

The Supply Chain’s “Last Mile”

In 2011 when FSMA was implemented, its designers could not have predicted the revolution that’s since taken place across the “last mile” of the supply chain. As customers demand home delivery of fresh, refrigerated, and frozen foods, a proliferation of new technologies, packaging materials, and e-commerce services have created unanticipated challenges impacting all food distribution sectors.

To make matters more complicated, the most common shipping carriers, such as UPS, FedEx, and USPS, do not assume responsibility for the handling of perishable products. Consequently, delivery services often fail to attend to basic food safety principles, such as temperature control, cross-contamination, and appropriate packaging. And given that FSMA does not yet adequately defined regulations for high-risk foods, home delivery services are very likely to create more food safety risks as they grow in popularity.

The FDA Announces a “New Era of Smarter Food Safety”

It’s probably no coincidence that the FDA had “last mile” home delivery partly in mind when the agency made the announcement on April 30 that they are developing a “Blueprint for a New Era of Smarter Food Safety” for how the agency applies new and emerging technologies to advance food safety. Traceability, digital technologies, and evolving home delivery business models are among the areas the blueprint will address:

• Traceability: The FDA plans to transition entirely to digital tracking from the paper-based systems currently in use throughout food supply chains.
• Digital technologies: The FDA is assessing how blockchain, digital sensors, the Internet of Things, and artificial intelligence can create a more transparent food safety system.
• Home delivery business models: The FDA plans to collaborate with stakeholders in the e-commerce space for food to account for the increase in home delivery of food.

Home delivery is becoming more popular, placing a strain on food safety practices.

The blueprint will also address consumer demands for quick access to information about where their foods come from, how they’re produced, and if the food is subject to an ongoing recall.

“It’s time to look to the future of food safety once again, with a view that builds on the progress we’re making with our regulatory framework, but also leverages the use of new and emerging technologies to create a more digital, traceable and safer system.”

– Acting FDA Commissioner Ned Sharpless, M.D.

New digital technologies are expected to play a pivotal role in tracing the origin of contaminated food to its source in minutes or seconds, instead of days or weeks. Rapid access to this data will help the FDA conduct more timely root cause analyses and apply their findings to prevent future incidents from occurring. In support of these objectives, the blueprint will be aligned with other traceability efforts at the FDA, such as their pilot programs focused on tracking the movement of medicines throughout the supply chain as part of the Drug Supply Chain Security Act.

Finally, to help solve the problem of under-staffed inspection teams, the FDA is implementing technologies that are much faster and more accurate, such as genome sequencing. Leading an international team effort, the agency built an innovative network of laboratories that can upload the genomic sequence of foodborne pathogens along with the geographic location from which they were gathered into a publicly accessible database. Known as the GenomeTrakr Network, this new tool is a paradigm-changing development to facilitate foodborne outbreak investigations.

A Holistic Approach

FSMA made the radical shift from a reactive to a preventative approach to food safety. The Blueprint for a New Era of Smarter Food Safety moves one progressive step further: the integration of FSMA’s currently scattershot methods and tools into a holistic digital system.

Beyond technology, the FDA’s holistic vision also means a committed collaboration between the food industry and local and federal agencies.

“We know that we cannot embark upon this journey alone and, to be successful, it’s equally important for food companies of all sizes and technology firms, as well as local and federal agencies and other stakeholders, to join us in this effort. We know it must also include the important elements of collaboration, leadership, creativity and culture… Tackling food safety is a shared responsibility, and there’s much more we can do together and in a manner that benefits people, food companies, and the planet.”

– Ned Sharpless, M.D.

The ongoing efforts at transparency and collaboration between industry and the FDA must be holistically aligned if FSMA’s promise of a truly preventive food safety network is to fulfill its potential.

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