5 Food Safety Focus Areas For 2018

By Melanie Neumann, J.D., M.S., Neumann Risk Services, a Matrix Sciences Company

I can hardly believe we’re at the end of 2017; what a year for food safety! In reflection, it was challenging to identify key food safety issues having a pivotal impact on food safety. That said, I believe the Neumann Risk Services (NRS) Top 5 Food Safety Topics identified below brought revolutionary changes to the way the food industry tackled food safety issues in 2017 and will alter how we approach food safety and how we do business in 2018 and beyond.

1. Listeria Hysteria

There’s been a notable increase in Listeria outbreaks both domestically and internationally in 2017, or at least the appearance of such due to heightened media coverage and food agency focus. Very recently, South Africa was struck with a deadly outbreak of Listeria, likely to be foodborne yet still under investigation at the time of this writing, killing 36 and rendering approximately 600 ill; the vast majority in three provinces.

Another 2017 Listeria monocytogenes outbreak involved Vulto Creamery of New York, involving raw-milk cheese, a product known to be susceptible to Lm. The raw-milk cheeses were distributed nationwide, with most being sold at retail locations in the northeastern and Mid-Atlantic states. Eight people infected with the outbreak strain of Listeria were reported from four states. All eight people were hospitalized including one illness in a newborn, as well as the two people who died from this outbreak. Epidemiologic and laboratory evidence indicates Vulto Creamery was the likely source of this outbreak. The company recalled all lots of its raw-milk cheese products.

It’s no wonder the FDA, and other regulatory agencies, are concerned about Listeria and its virulent forms, such as Listeria monocytogenes (USDA-FSIS has had what is known as the LM Rule in place preceding FDA’s Guidance). About 1,600 people are infected with listeriosis each year, and about 260 die, according to the CDC. Listeria monocytogenes causes listeriosis. Symptoms can include fever and diarrhea just like several other foodborne bugs, but Listeria can also cause headache, stiff neck, confusion, loss of balance, muscle aches and convulsions. Certain people are at greatly-increased risk for Listeria infections: the elderly, people with a weak immune system, pregnant women and their newborns.

The symptom onset time can take up to 70 days to present. However, emerging research reveals the ability of Listeria monocytogenes to enter a persistent, or dormant, state in a subset of epithelial cells, which may favor the asymptomatic carriage of this pathogen, further lengthening the incubation period of listeriosis, and even if it is diagnosed, promote bacterial survival during antibiotic therapy.

That is why the food industry must be ever vigilant in fighting this pathogen of significant concern and continue to modify its sanitation standard operating procedures, sanitization chemicals, supply chain control and verification activities, and overall food safety programs and strategies to control and eradicate Listeria.

The FDA’s 2017 publication, FDA’s Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, caused some hysteria in the FDA-regulated food sector, as it served as a distinct change to the FDA’s policy on Listeria control. While only “guidance,” and thus not carrying the full weight of regulation, those spending much time in the industry understand the weight FDA guidance documents carry. Hence it is an instrumental manual for FDA facilities who manufacture ready-to-eat (RTE) foods, and one a facility under its purview should understand and adopt.

The guidance details the FDA’s recommendations on a wide array of topics impacting Listeria control, such as physical controls, including use of foamers and footbaths; the design and construction of production facilities, and the construction and maintenance of food processing and other equipment, including recommendations on cleaning and sanitation of drains, equipment, and other related items. It also addresses crucial topics, such as employee hygiene (e.g. handwashing, gloves, clothing, footwear, etc.) and controlling Listeria in incoming raw materials, through environmental monitoring programs.It addresses the importance of corrective actions and makes corresponding recommendations on what corrective actions should be taken in the event a facility should find Listeria spp. and/or Listeria monocytogenes (Lm).

What was perhaps most striking was the agency’s change in position when it comes to the corrective action required for a Zone 1 Lm finding, and how this new position may not appear to best support an aggressive position against Lm at first blush in the microcosm of one positive. Yet, time with this Draft Guidance may reveal this new position is indeed allowing an aggressive approach to Lm control when viewed holistically through a macro-level program management lens. Allow a further explanation:

• Prior to the draft guidance, when a Zone 1 surface tested positive for Listeria spp. during production, the FDA expected the company to determine whether a Zone 1 positive was Lm or some other non-pathogenic strain of Listeria. If the positive was confirmed to be Lm, the FDA would then expect any finished products that contacted the surface to be recalled, or appropriately destroyed if in the company’s control, back to the date of the last effective clean sanitation break.
• Now, under the draft guidance, the FDA does not require food facilities to test the initial Zone 1 Listeria spp. positive for Lm, and rather allows a company to clean, sanitize, and conduct intensified sampling of the affected area during the following production run. A facility is only required to hold and test finished product for the presence of Lm if the Zone 1 food contact surface tests positive for Listeria spp. for a second time in follow-up testing. In this way, the draft guidance reflects the USDA-FSIS Listeria Rule.

The positive results of the draft guidance, to me, outweigh the admittedly perceived possible drawback that this guidance may appear to allow — this one “free pass” concept. It affords companies the freedom to more-aggressively look for Lm in a true “seek and destroy” fashion. Industry should be afforded the freedom to find risk on its own, as each facility knows its own risk profile the best, and implement appropriate corrective actions rather than rely on the government to do so.

Just remember: with freedom comes responsibility. It is our responsibility as a food industry to produce safe food. Using the Draft Guidance can help fulfill this responsibility.

2. Supply Chain Management

To say that the supply chain is becoming more globalized and centralized is the understatement of 2017. The industry is now working in a complex network of interconnected supply chain nodes verses the nice and neat historic linear supply chain model of days’ past. The number of interchanges our food goes through from origin to production to consumption can be staggering.

This new reality causes industry to lose visibility and traceability more easily. Which means we are at risk for not clearly understanding who in our supply chain is actually managing the hazard of concern. If we are only managing one supplier back, but they are sourcing from one or two more suppliers further back, are we adequately controlling our supply chain?  Are we adequately controlling our hazards? We should always ask ourselves “who is actually controlling my hazard, and do I have supply chain control requirements in place at the point where the hazard can actually be controlled?” If that answer is “no,” you may need to go further back in your supply chain.

How else do we mitigate this risk? We do it by creating meaningful risk-assessment tools that help identify and manage risk and then use the power of the data generated by it (addressed in more detail below). Tracking and trending key supplier performance metrics is crucial to understanding where your true supply chain-related risks are and to allocate your precious resources of time, talent, and treasure (your money). How you obtain these metrics is likely through a patchwork approach of third-party audits, first-party audits, supplier sampling and testing requirements, your own sampling and testing upon receiving, and other supplier food safety and quality expectations, often set forth in some type of Supplier Expectations Manual incorporated by reference into your supplier agreements. These strategies not only help you comply with recent regulations, such as FSMA’s Preventive Controls Rule for Human Food and Foreign Supplier Verification Program (FSVP) Rule, but also to protect your consumers, customers, and your brand reputation.

3. Environmental Monitoring

A significant risk we saw come into play in 2017 and I believe will continue into the future is the idea of companies having data under their nose but not “seeing” it for what it was — an early warning indicator something important was trending outside the guardrails it established until it was too late. Industry must be able to put procedures in place to manage for this, and better yet, leverage technology to mitigate this type of risk by turning mountains of data into usable, actionable information, such as dashboards and other meaningful analytic tools.

While turning data into actionable information is more important than ever, it is easier said than done. For example, the sheer volume of data produced in a foundational environmental monitoring program (EMP) can be overwhelming, much less an aggressive one clearly designed to find pathogens and other undesirable microorganisms. Companies should work with partners who understand food production, how microorganisms behave and thrive, data analytics, regulatory compliance and risk management, and the fundamentals of environmental monitoring, of course. It’s easy to buy an off-the-shelf system to plug data into, but like any software, what goes in, comes out. Working with experts who understand our industry and the unique risks involved will help you achieve the most robust risk management tool to effectively manage your EMP program needs in 2018 and beyond.

4. Food Safety Culture

We cannot talk about hot and emerging food safety topics of 2017 without talking about food safety culture. This topic appeared on nearly every agenda of every major food safety conference this year. I had the privilege of moderating sessions on food safety culture at a couple conferences this year and dare I say these were very-well attended with tuned-in attendees, intent with questions and a desire to learn the latest in how to enhance their respective food safety cultures.

This is also an area ripe with opportunity to establish quantifiable metrics around which to build meaningful, continuous-improvement programs. Put another way, this is not a fluff topic; there is much science around food safety culture. Granted, it is social science rather than microbiological science — which many readers, including myself, may have come up through the ranks to know, but legit and important science nonetheless.  And perhaps it is even more important because social science analyzes behavior — the “why” behind the reasons people do what they do, or do not do what we want them to do. Isn’t that what we try to accomplish in training — to communicate the “why?” The best programs do this on the largest scale and highest levels and set measurable, objective metrics to ensure each facility and the company as a whole is on a path of continuous improvement, to ultimately build a mature food safety culture. A key to success however, is the metrics. Per Dr. Lone Jespersen, a leading expert and researcher in the field of food safety culture and founder of Cultivate, a company focusing on helping the industry on this topic, summed up this importance so well: “We must measure what we treasure.”

5. Leveraging Big Data

From the topics discussed above, the many more, not-able-to-be-discussed-due-to-article-space constraints, and the obvious realities we face in our day-to-day operations, one thing is clear — all roads lead to Big Data.

2017 brought laser focus on the need for 24/7, on-demand access to food safety and quality data, including supplier performance, key food safety tasks, such as monitoring preventive controls, and most importantly turning that data into information and intelligence. Real-time monitoring and trending of key food safety, quality and operational data, and process controls across multiple facilities is no longer a luxury; one historically reserved for larger companies with sizable capex budgets. Rather, it is a necessity.

2017 ushered in a new era where this level of data-management sophistication has become an expectation. For example, the new SQF Edition 8 Quality Code (effective January 2018) requires statistical process control monitoring to be used to control for process variation and optimize production processes to improve process efficiency, product quality, and reduce waste. Control charts (aka visual trend analysis) must also be used to control key processes and have defined upper and lower (process) control limits.  Moreover, both food agencies expect companies to be managing and trending complaints. So why wouldn’t industry leverage data trending and analytics to mitigate risk to its fullest extent possible?

What are other drivers pushing industry towards big data and what are the risks? As mentioned earlier, one driver is industry identifying a clear need to turn mountains of data points into not just information, but intelligence. We need tools to help industry shape decisions and drive actions that ensure it is on a never-ending road of continuous improvement.

However, over-reliance on metrics and data points comes at a risk, so a delicate balance must be achieved. Focusing solely, or placing great weight on, one metric — like an annual third-party audit score — likely will not drive the kind of behavior you seek on an ongoing basis. There is too much risk that a facility will focus on that one day and that one audit, which we all know is a snapshot in time. But, who can blame the plant manager and QA manager if that is how they are incentivized and how their bonus structure is based? We get the results for which we reward. Consider building in additional metrics and measures that must be met on a daily-, weekly-, and monthly-basis and place equal weight on these expectations and behaviors as you do that one audit score that happens on one day out of 365 in a year. Establish incentives, rewards and — dare I say it — consequences if the expectations are not met. Consequences are a sensitive topic and many companies are uneasy to dole them out; but note that consequences are easier to issue when you have the power of data to back you up.

Conclusion
This year was a whirlwind — of change, of managing emerging risks and of implementing new regulations, such as certain FSMA rules. Readers may note that I (of all people) did not mention FSMA at all in this Top 5 list. There is a reason for that omission and it is certainly not because regulatory implementation and compliance is not important; of course it is. Building your programs to only regulatory compliance requirements however, is not advised, can lead to complacency, and does not provide a safety net if you have a bad day. Rather the topics in the Top 5 list primarily focus on programs and initiatives aimed at exceeding regulatory compliance standards, such as building an EMP program to reward people to find undesirable pathogens and to enhance your programs to achieve the most mature food safety culture possible. Neither of these measures are required by regulation, but both can provide you with stronger consumer, customer and brand protection, and risk mitigation if you have a bad day and hopefully prevent you from having to pull the trigger on a recall or other public level market action.

So, make 2018 your best year yet. Review your food safety programs and commit to a year of continuous improvement and programs that go beyond mere compliance. Aim for the most mature, best in class, program that protects your brand, customers and consumers.

About The Author
Melanie Neumann, J. D., M.S. is the President of Neumann Risk Services, a Matrix Sciences Company. Matrix Sciences recently acquired NRS. Melanie also assumed the role of Executive Vice President and General Counsel for Matrix Sciences and she will be maintaining a separate but allied legal practice called Neumann Legal Services where legal work will be performed. In addition to further growing the NRS consulting business, Melanie will be developing an exexpanded set of services that are targeted at helping companies reap the benefits of their investments in food safety risk management for Matrix.