Understanding the FDA “New Era for Smarter Food Safety Blueprint”

By now you have likely heard that the FDA is introducing some new changes that will affect how businesses in the United States will perceive, process, and demonstrate food safety compliance.

I know what you may be thinking, that this all sounds familiar and have we even finished the most recent overhaul?

It’s important to be clear on what these new changes mean and we can start by understanding that these are not designed to be a replacement of FSMA, but rather a continuation, or to use the FDA’s own terms, the ‘next step’ after FSMA.

Essentially, FSMA prepared the country’s food industry by providing much needed (and long overdue) guidance to businesses in the first major piece of federal legislation for food safety in more than 70 years.

These rules equipped businesses with the necessary tools to build scientific and risk-based protections within the food safety programs, as well as helping companies develop their supplier programs to ensure that hazards would be addressed sufficiently and that adequate controls were put in place when and where identified.

Now, the FDA has recognized that even a powerful piece of legislation like FSMA alone is not enough, and that modern problems require modern solutions.

The FDA has recognized that a powerful piece of legislation like FSMA alone is not enough, and that modern problems require modern solutions

Since FSMA was signed into law in 2011, technological solutions have advanced at a significant rate and can now be utilized to multiple means that were not possible just 10 years ago.

Not only that, but attitudes to food safety have changed with an ever-growing increase on food safety culture being required by standards such as the BRCGS.

With this in mind, it shows the FDA accepts that FSMA was only the first piece needed to reduce foodborne illnesses over the long term.

Enter: the New Era for Smarter Food Safety Blueprint.

In other words, FSMA was the foundation. The New Era is the rest of the house!

FSMA was the foundation. The New Era is the rest of the house

What is in the blueprint for the new Era?

Although the timing of the release seems coincidental with the latest challenges facing the global food industry in respect of COVID-19, these goals have been in motion from some time from the FDA, and are arguably arriving at a most crucial hour when they may be needed most.

Make no mistake, the FDA is not simply throwing this against the wall to see what might stick.

Starting in 2019, over 100 industry experts met to brainstorm what would become the 4 core elements of the New Era:

    • Tech-Enabled Traceability
    • Smarter Tools and Approaches for Prevention and Outbreak Response
    • New Business Models and Retail Modernization
    • Food Safety Culture

In order to understand what these tenets may mean it is important to understand the reason for each in isolation.

Below is an examination of each ‘Core Element’ and their future potential ramifications.

Core Element 1: Tech-Enabled Traceability

Even with all of the modern advancements in technology, a large portion of the food industry still relies on a paper-based system to manage its supply chain program.

The ability to easily trace products back to their source is cumbersome, to say the least, and during an outbreak when time is critical, a reliable and more agile system is of utmost importance.

When the veracity of data cannot be trusted or shared in real-time, the risk of erroneous data and information may compromise the ability to conduct an effective recall at worst,or introduce distrust to the system at best.

Admittedly, the FDA’s first step here will be to complete FSMA Section 204 rulemaking in order to harmonize the key data elements and critical tracking events needed for enhanced traceability.

This will lay the foundation for traceability which will allow stakeholders within the supply chain to implement digitally-enabled technologies, enable data sharing, and introduce practices all of which will reduce the time it typically takes to trace potentially contaminated foods that are associated with a recall or foodborne illness.

It is important to note that like all blueprints, this is really a plan that outlines a ‘best case’ scenario of what good looks like for the FDA.

In this Element alone the  FDA will have a considerable challenge on their hands as they acknowledge that while industry will be encouraged and incentivized to adopt new technologies, it also needs to harmonize the U.S. with regulatory counterparts.

Achieving this by seeking systems interoperability may prove to be a bridge too far as the FDA could likely face a delicate balancing act in creating a sustainable system that achieves one version of the truth while meeting the individual requirements of standard bodies, solution vendors, and end-users.

Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response

“Work smarter, not harder” was a term coined by Allan F. Morgenstern when advocating his philosophy of work simplification.

One could argue that although Morgenstern was an industrial engineer he could never foresee the amount of data that could be generated from even simple processes with the data capturing tools at our disposal that have blossomed within the century from when he first coined this phrase.

Specifically, for food safety, the SQFI already advocated for Statistical Process Controls which would allow food manufactures to deploy a suite of analytical tools to reduce waste, rework, and scrap, and ultimately cut down on their workload.

Although the requirements for Statistical Process controls were walked back to just Process Controls between SQF Edition 8 and 8.1., the principle of this vision remains in Core Element 2 of the FDA’s plan of leveraging technological solutions to do in an instant what would otherwise require significant manual labor and resources to achieve.

Core Element 2 shows the FDA’s vision of leveraging technological solutions to do in an instant what would otherwise require significant manual labor and resources

With an improved traceback program in place, it stands to reason that our ability to conduct root cause analyses (RCA) will become greater, and the results from those improved RCA’s can help drive the prevention-based framework that was established when FSMA was implemented.

As technology continues to evolve and becomes more widely available across business groups, and as more data streams and tools for rapidly analyzing data become available, it will be important to understand how the industry can utilize predictive analytical tools to identify contamination events before they occur, prevent contaminated products from entering the food supply, and remove potentially contaminated products from the market.

I discussed ‘What happens when you get it wrong’ in traditional systems before, but in Safefood 360⁰, a Corrective Action could be triggered with one of the actions being a RCA performed by an authorized team member.

The results of the RCA would be fully documented in the Corrective Action, and the appropriate preventive/corrective actions could then be carried out, followed by subsequent final close out of the action.

Each streamlined Corrective Action is linked directly back to a source record enabling full traceback within a robust system.

In addition to the Corrective Action tool, predictive analytics tools provide dashboard views of the entire system in real-time.

At just a glance, you’re able to know where your compliance and risk levels are at or take action to improve them.

Core Element 2 shows a commitment from the FDA that it will pursue innovation for industry and incorporate more technology solutions, that should ultimately make life easier for food companies, but do significantly more work.

Looking back at Morgenstern’s advice, we continue to innovate our platform and enhance our services, meaning that we work smarter, so you can work harder.

 

Core Element 3: New Business Models and Retail Modernization

To say that the world has completely changed since COVID-19 is almost an understatement.

The industry has essentially been turned around, not only at the manufacturer level, but at the retail level and arguably faces its greatest challenges ever.

The food industry is arguably facing its greatest ever challenge

Prior to the COVID-19 pandemic research indicated that online grocery shopping would have a 20% share of consumer food spending over the next years.

Arguably, with the requirements of social distancing and the unexpected uptick of those that would typically not use such as service finding benefit and value in it, it’s likely that these numbers may well end up being significantly higher than originally estimated.

Sheltering in place was not necessarily conducive to shopping at brick and mortar retail, and although it is too soon to speak with clarity on the long term effects it will have on consumer behavior, online shopping and pick up services at least doubled.

In the traditional retail channel established, supermarkets have refrigeration units and are subject to routine 3rd party food safety audits.

This means applying oversight in these channels is still a relatively straight forward process as the variables can still be anticipated and controlled within reason.

However, what can the FDA do to ensure food safety when it comes to online grocery shopping as the proliferation of services increases?

Core Element 3 seeks to address this, but begins with an acknowledgment that it is an onerous task that faces the industry.

In this, the FDA claim their goal is to collaborate with regulatory partners and a “broad array of stakeholders” to “convene a new food business model summit to identify future courses of action to address potential food safety vulnerabilities”.

Modernizing traditional retail food safety will require a focused and considerable effort to ensure the FDA Food Code is uniformly adopted by local, state, tribal, and territorial or federal regulators and food protection programs to ensure a consistent national food regulatory policy.

 

Core Element 4: Food Safety Culture

Fostering a food safety culture might be last on the list, but certainly is not least.

During the COVID-19 pandemic, we saw the importance of keeping food workers safe, and we also saw how it important it was to ensure that those who were preparing food at home were safe and had an understanding of safe food handling practices.

A strong food safety culture is a prerequisite to food safety management.

This is an approach that has already been adopted and championed by the BRCGS and has grown in stature within the US.

I recall the seismic shift that rippled through the industry when the GFSI food safety benchmarked schemes hit the shores of the US.

If you were involved in food safety back then, you might recall the letters from small retailers demanding that you be certified to something called SQF.

It wasn’t until a “not to be named” large company letterhead arrived demanding you be certified to the SQF standard that anyone even decided to find out what SQF was.

Collectively as a group, we all learned pretty quickly what SQF was and today it’s probably difficult to find a food manufacturer that doesn’t know.

The food industry in the US has completely changed over the last 14 years, and with this Blueprint, the FDA is hoping to help change it even more.

In order for change to happen though, it needs to start from within the company, just as it did 14 years ago.

 

What does the future look like post-Blueprint?

The New Era promises to usher in an evolution of food safety practices within the US.

At its core, the FDA are wishing to work hand-in-glove with industry and learn from individual stakeholders and certification bodies and schemes as to what works best to create a singular utopian view of what an achievable and sustainable system will look like.

Whether or not this is a bridge too far and is a case of too many cooks spoiling the broth, it promises to be an exciting time and shows an ambition arguably not seen in the U.S. since the sweeping reforms issued in following Upton Sinclair’s ‘The Jungle’.

While I am not implying that the reforms are in any way as required now as they were then, it is an exciting time to witness an altruistic vision of what the future may hold that will bring benefit to everyone from the farmer to the final consumer.

If the FDA are successful in achieving this mandate in the years to come the benefits for the U.S. food system will have significant positive impacts on public health and the larger economy, and could well place the U.S. at the forefront of global regulation and oversight.

The Blueprint could well place the U.S. at the forefront of global regulation and oversight

If, on the other hand, it can only achieve parts of this ambition it could still achieve these goals or at least inspire other nations to build on these principles and reinforce the security of our global food system.

I used a metaphor at the start of this conversation that if FSMA was the foundation, then the Blueprint is the house, but it is perhaps more apt to say that if a rising tide raises all ships, then what the FDA are seeking to build is not just a house, but a boat that will rise and embolden all other adjacent systems with it.

As the tide rises Safefood 360° will continue to innovate and ensure we offer the best-in-class software solutions to maintain compliance with all major global and retailer technical standards.

If you would like to see what this means and how we can help you meet and maintain these FDA obligations in the years to come, whatever they may be, please leave a comment below, reach out to me directly, or simply just request a demo.

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