John Rowley, vice president of NSF International’s Global Food Division, recently discussed his views on 2022 trends in the food industry, with a focus on food safety issues. NSF specializes in food safety training, testing, consulting and other services.

Rowley said all segments of the supply chain, from producers through retailers and restaurants, continue to shift to meet challenges, even as the pandemic has led to staffing woes and exacerbated supply chain gridlock.

The major trends anticipated for the industry, according to Rowley, include:

• Rising demand for home delivery;
• Staffing crisis;
• Opportunities to cut food waste; and
• Sustainability.

Knock Knock. Who’s there? Dinner
As coronavirus variants continue to curb dining at restaurants and elevate uncertainty in the sector, home meal delivery will remain popular in 2022, Rowley said. That includes traditional restaurants, pop-ups and ghost kitchens. An NSF survey released this month highlights pandemic concerns among quick service restaurant employees and decision makers across the globe.

According to the survey of almost 700 people, 38 percent of poll respondents said they feel added pressure to prepare food faster. NSF reported 22 percent said home delivery has increased food risks.

Rowley said foodservice establishments, regardless of their business models, have an obligation to serve quality, safe food. That includes preparation and how food is treated during transportation to the consumer, or the “post-order supply chain,” as Rowley calls it.

“As an industry, we need to help these companies be successful, help them have a opportunity to be successful so the consumer can get a satisfactory product,” Rowley said.

Now Hiring
A staffing crisis in the foodservice and other industries threatens recruitment and retention, he said. 

“The staffing shortages are a fundamental issue, but what are the unintended consequences?” Rowley said, pointing out that retail and foodservice outlets are under pressure to perform with pre-pandemic hours of operation, staffing and services.

“Does that put food safety to the fore?” he said.

The issue won’t disappear once the pandemic is over — however that’s decreed — and Rowley said efforts need to focus on a campaign to promote food safety careers at the college level.

“I think as an industry we have to make sure this (food safety) is seen as an interesting job and a critical role for the industry,” he said. “We need to do a better job marketing that, working together to make it a satisfactory and enjoyable career for those who do it.”

Rowley said long-time food safety professionals are choosing to retire from the industry as the pandemic continues. Their collective institutional knowledge is critical to retain, he said.

Waste Not … Waste Not
The food industry has taken great strides in recent years to curb food waste, from “upcycling” expired but edible food to selling “ugly” produce that doesn’t fit industry standards. This year’s food waste issue will be ensuring the failing supply chain doesn’t escalate a food safety concern to food wastage, Rowley said.

“When food gets delayed in transportation, it puts pressure on the storage and distribution quality controls,” he said. “ … If the food safety standards are good, it’s not really a food safety issue. It becomes more of a food wastage issue.”

In the early days of the pandemic, some retailers and foodservice operators began sourcing from closer suppliers. One example are the Eastern U.S. retailers that bought leafy greens from nearby small hydroponic indoor farms. Switching to local growers is trend that continues, he said.

Sustainability, as a Trend, Sustains
As more corporations chart their sustainability programs and release annual reports showcasing those steps, sustainability programs are gaining steam in every food sector. Rowley said sustainability is a huge metric to measure the performance of a company, along with food safety and finances.

“As we go forward, companies need to be measured on not just traditional financial metrics, which tend to be the core measurement of a company’s performance. I think we should elevate the importance of sustainability,” he said.

Post-Pandemic View
Rowley cautions companies against reverting to pre-pandemic trends once life returns to “more normal,” without assessing the business climate first.

“I think when the crisis is over, it doesn’t mean these trends will — or should — stop. Never waste a good crisis, if there is good that can come out of it.”

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Food processors and manufacturers have a mission to supply quality and safe food to consumers.

The journey to succeed in that mission, however, is different for each company. Each ingredient, manufacturing process, facility and finished product brings unique food safety challenges and current good manufacturing practices (cGMPs) to address them.

However, there is a common enemy that thrives in most food manufacturing plants. Biofilm, a naturally-occurring mass of pathogens protected by an extracellular polymeric substance (EPS), attaches to surfaces and resists disinfection attempts.

Biofilm warning signs
When inspectors from the Food and Drug Administration — or certified third-party organizations — visit food facilities, they are not specifically looking for biofilm, which is invisible to the naked eye. Inspectors are trained to recognize conditions that would indicate a biofilm is present, such as food residue on equipment and other surfaces, as well as drains because they are notorious for harboring biofilms.

“We would look at whether the sanitation programs are effective, including whether the company conducts testing for indicator organisms where high counts could indicate inadequate sanitation and possibly biofilms,” according to an FDA spokeswoman. “We often take our own swabs if we see questionable conditions.”

If samples show high pathogen counts after sanitation, it’s likely they are protected by a biofilm and not free-floating organisms. Areas where water hasn’t drained is another red flag, she said.

It’s key that food safety plans prevent conditions that favor the establishment and growth of biofilm.

“Establish and implement good cGMPs and sanitation control programs, consider an evaluation of the cleanability of equipment when conducting the hazard analysis, and develop cleaning programs that prevent biofilm formation,” the FDA spokeswoman said.

Methods to control biofilm
If biofilm is present in a food processing facility, there are a number of ways to attack the EPS and pathogens. Bob Forner, director of marketing for Hunt Valley, MD-based Sterilex, said methods carry varying degrees of success. Sterilex manufactures microbial control products that not only attack the pathogens in biofilm, but also the EPS structure. If the protective structure remains intact, pathogens can repopulate the biofilm within two days, Forner said.

Key ways to respond to biofilm in a food facility are:

• Hand scrubbing: A soap/detergent can help break down the EPS, and elbow grease lifts the structure from the surface. This is very labor-intensive, and some areas are difficult to access for hand scrubbing, Forner said. Although the protective housing is attacked with hand scrubbing, an Environmental Protection Agency-registered sanitizer is necessary to kill the microorganisms housed in the structure.
• Heat: An autoclave-type treatment, heating a surface to at least 265 degrees Fahrenheit, is effective. This requires a significant use of energy, and many materials and equipment in a food facility cannot be heated to the necessary temperature, Forner said.
• Chemical oxidation: Oxidizing sanitizers and disinfectants fall into two categories, according to Sterilex. EPS-reactive oxidizers such as bleach, iodine and ozone are harsher on equipment and do not fully penetrate the biofilm structure, and EPS-penetrating oxidizers pass through the biofilm layers to kill pathogens. They are unable to kill both the EPS and the pathogens, he said.
• Biofilm agents: Sterilex’s PerQuat technology is EPA-approved to kill biofilm organisms and remove the biofilm from surfaces. The patented chemistry combines an oxidizer, hydrogen peroxide, and a phase transfer catalyst, quaternary ammonium, to penetrate the biofilm and release the peroxide to kill organisms inside.
• Maintenance/Prevention: Although the Food Safety Modernization Act, enacted more than 10 years ago, doesn’t address biofilms, regulations are designed to focus on preventing conditions that could lead to foodborne illness outbreaks caused by pathogens in them.

“FSMA focuses on control of hazards and biofilms that may contain pathogens would be addressed through sanitation preventive controls that are required in many food safety plans, as well as the cGMPs,” the FDA spokeswoman said.

A combination of these steps is the most effective way to address biofilm in a food facility, Forner said.

“Hand scrubbing and maintenance programs are a part of just about every food processing master sanitation plan,” Forner said. “Combing these methods with the appropriate EPA registered chemistry is a powerful way to keep biofilm out of the food processing facility.”

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Food safety practices evolve as new technology and knowledge of the pathogens that spread foodborne illnesses becomes available.

In recent years, researchers have increasingly focused efforts on biofilm and its ability to thrive in nature and in food production and processing facilities. Biofilm is formed by a pathogen — or more often, a mixture of different pathogens — that builds a protective layer using extracellular polymeric substances (EPS).

A majority of foodborne illnesses can be traced to pathogens housed in biofilms, according to food safety research. Academics and food trade associations have stepped up efforts in recent years to learn more about biofilm, which naturally fights efforts to sanitize food contact surfaces in processing and manufacturing facilities.

Recent studies have looked at products and practices to eradicate or control biofilms in different segments of the food industry, from produce to meat processing and poultry farms.

A spokesman for the U.S. Department of Agriculture’s Food Safety and Inspection Service said regulators that conduct inspections aren’t specifically hunting biofilms, but recurring pathogen finds in facilities are likely from a biofilm. Biofilm-related content at industry events, such as the International Association for Food Protection’s 2021 conference in July, is increasing. The event featured more than two dozen sessions on biofilms, covering a wide range of pathogens (listeria, E. coli, salmonella and more) and segments of the food industry (lettuce, apples, dairy products, and in processing facilities).

Researchers tackle biofilm questions
The fresh produce industry has seen a rising interest in biofilms and their role in spreading E. coli and other pathogens. The Center for Produce Safety (CPS), which formed in the wake of a deadly E. coli in outbreak in 2006 linked to spinach, is largely funded by the industry.

Research supported by the CPS includes a look at biofilms containing Listeria monocytogenes and other pathogens in stone fruit packinghouses. Data from the study will be used to build an Excel-based guide to help stone fruit facility managers implement science-based schedules for sampling and sanitation programs. Paul Dawson and Claudia Ionita of Clemson University led the study.

Another recent CPS study, with co-lead investigator Boce Zhang of the University of Massachusetts, looks at different food contact substances and their ability to resist listeria biofilm. The study was a collaboration with the USDA’s Agricultural Research Service.

“It is imperative to understand the role of biofilm on the likelihood of pathogen survival and transmission,” Zhang said in an e-mail. “Addressing biofilm challenges requires a holistic approach and novel control strategies.”

A recent study by Austin B. Featherstone and Sapna Chitlapilly Dass, researchers at Texas A&M University’s Department of Animal Science, looks at the role of biofilm in protecting SARS-CoV-2 (Coronavirus) in meat processing plants.

Using samples from meat facility drains, the researchers developed a biofilm containing a surrogate (murine hepatitis virus) and pathogens often found in meat processing plants and tested it on stainless steel, PVC and tiles. They concluded that the biofilm protects the viral particles, allowing the potential spread of the virus among employees in the facility. The study did not focus on potential spread of the coronavirus to consumers from the products from the facility, and the Food and Drug Administration and Centers for Disease and Prevention say there is no evidence that food or food packaging transmits COVID-19.

Rong Wang, a research microbiologist with the USDA’s Agricultural Research Service, has led several studies on biofilms in meat processing and packing plants. In a report published in the Journal of Food Protection in January 2019, Wang outlines factors affecting biofilm cell transfer from contact surfaces to product contamination.

“A better understanding of these events would help the industry to enhance strategies to prevent contamination and improve meat safety,” according to the abstract for the report, “Biofilms and Meat Safety: A Mini-Review.”

Sterilex tackles biofilm questions
Sterilex, which offers food and beverage manufacturers products that detect and destroy biofilms and the pathogens they protect, spent a decade working with the Environmental Protection Agency (EPA) on testing methods and research into biofilm claims, according to Lise Duran, vice president of research and development and technology at Sterilex.

In 1999, Sterilex received approval from the EPA on the first label claim that its products remove biofilm for public health micro-organisms, Duran said.

Although much more is known about biofilm since the company was incorporated, Duran said continued research is vital. Different environments affect biofilms, and “there is a lot that goes on within a biofilm” that causes them to behave differently in various environments.

Most research, she said, focuses on single-species biofilms, but biofilms usually contain multiple species of pathogens.

“There’s certainly been a lot of great research and understanding, but it isn’t all solved,” she said.

The future of biofilm detection includes biosensor technology, and researchers continue to look for ways to improve the ability to remove biofilms as a food safety problem. “What can you do to improve technology so that it is more useful across a variety of different environments and applications?” Duran said.

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Biofilm, which is a cluster of pathogens encased in a protective matrix, is a common enemy across diverse food manufacturing industries.

From dairy, produce, meat, poultry, ready-to-eat deli foods and other products, biofilm is a concern at the farm level and at processing and manufacturing plants.

The protective layers generated by pathogens that create the biofilm, known as extracellular polymeric substances (EPS), resist sanitation efforts and are adept at spreading in moist environments, through a process known as “seeding dispersal.” According to Sterilex Industries, which offers products to treat biofilms and the pathogens they harbor, seeding dispersal is similar to a dandelion releasing seeds to encourage species growth.

Although forming biofilm is a natural process that pathogens — including those commonly leading to foodborne illness outbreaks, such as Shiga-toxin producing E. coli, Listeria monocytogenes and Salmonella — use to survive, industry food safety plans and government regulations don’t necessarily focus on biofilm and how to eradicate it.

Basically, Hazard Analysis and Critical Control Point (HACCP) programs, good manufacturing practices (GMPs) and other components of food safety plans target the conditions that allow biofilms to thrive. A spokesman for the Food Safety Inspection Service (FSIS), the U.S. Department of Agriculture branch tasked with inspections of meat, poultry, dairy and egg farms and facilities, said HACCP standards and procedures are not designed to specifically eradicate biofilms, but establish a system that exposes and treats them by hunting the pathogens they harbor.

Listeria monocytogenes (Lm) is of particular concern among poultry and ready-to-eat meat product companies, according to an FSIS compliance guideline on controlling it.

“Lm is known to form biofilms on food contact surfaces (FCSs) and non-food contact environmental surfaces and, as a result, persists on these surfaces despite aggressive cleaning and sanitizing,” according to the compliance guideline. “Once Lm has established a niche, it may persist in the environment for long periods of time until the niche is identified and eliminated.”

Bob Forner, director of marketing at Sterilex, said food safety plans detail steps to remove foodborne pathogens in the food supply chain. Regulations such as the Food and Drug Administration’s Food Safety Modernization Act focus on pathogens and eradicating them.

“It is required to control foodborne pathogens, like E. coli or Salmonella, but not necessarily required to have a biofilm-specific plan,” Forner said. “But biofilms are the natural state of bacteria, and (processing and production) plants really should be addressing biofilm with testing.”

Production facilities, regardless of the foods they process or manufacture, share some common areas that encourage the growth of biofilm: drains, walls and areas that are hard to reach and be scrubbed or cleaned by hand. Other areas include coils on spiral freezers at frozen food plants, and pipes that carry water to animals.

“There can be biofilm that builds up on the processing line if there are harborage niches,” Forner said. “If there’s a scratch on stainless steel (equipment), biofilm can form in the scratched surface.”

The Environmental Protection Agency, which regulates the information that companies place on labels of chemical products, has approved the use of two claims on different products that attack biofilm. One designates that a product effectively kills bacteria in the biofilm structure. The second label is for products that kill the biofilm as well.

“If the shell of the biofilm is still there, biofilm tends to repopulate relatively rapidy, within a few days likely,” Forner said. “If you remove the shell, it’ll be a much longer period.”

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In the first installment of this series with Sterilex, Food Safety News explores what biofilms are and their unique resistance to attempts to kill the pathogens they protect.

Food processors and manufacturers know the environments in which they operate are friendly to organisms that can taint their products, potentially leading to foodborne illness outbreaks.

Food safety plans and specific good manufacturing processes outlined in those documents are designed to combat common pathogens — including strains of Listeria, Salmonella and E. coli — that could lead to recalls or outbreaks.

Whether or not food safety plans specifically mention “biofilms,” in many cases they are the root cause of contamination in food facilities. Approximately 60 percent of foodborne illness outbreaks are caused by biofilms, according to food safety research.

What are biofilms?
Essentially, biofilms are communities of micro-organisms that stick to surfaces. They are naturally occurring and can be found clinging to everything from plant and animal tissue, drug devices such as implants, water system infrastructure, and of course, in manufacturing facilities.

“Biofilms are everywhere in nature. . . . (They) are the natural state of organisms and have been around since the beginning of time,” said Bob Forner, director of marketing for Sterilex Industries, which supplies products designed to detect and kill biofilms for food processing, animal health, and water treatment industries.

Biofilms can harbor clusters of specific pathogens or a combination of them. In production facilities, food contact surfaces are hotspots on which to focus biofilm sanitation efforts, because of the possibility cross-contamination will occur — repeatedly, if not properly treated.

“They are significantly more challenging to kill” than pathogens found in free-floating (known as planktonic) cells in liquids, Forner said.

Why are biofilms so hard to eradicate?
The pathogens themselves produce what is known as a matrix of extracellular polymeric substance (EPS) made up of proteins, lipids, polysaccharides, and nucleic acids. The EPS gives the pathogens a protective home that resists sanitation efforts.

“Free-floating bacteria basically form a group to help protect themselves.” Forner said. “While traditional sanitizers are effective against these free-floating bacteria, they don’t necessarily allow you to kill all of the pathogens within the biofilm.”

Fighting a biofilm with these traditional sanitizers is like peeling layers from an onion, you’re really just addressing the bacteria on the surface he said.

“Even if you succeed in killing all of the pathogens in the biofilm, you will likely still leave the EPS structure behind” Forner said. “Without removing the structure from the surface, it’s a lot easier for the microbes to repopulate the biofilm.”

Biofilm research and awareness on the rise
Tests that detect salmonella or other pathogens on food contact surfaces don’t necessarily indicate the presence of biofilms, but Forner said the food safety community is aware of the dangers they pose.

“I think recently there’s been more of a focus on them as a source of foodborne illness,” he said. “A lot of the endemic pathogens that are in food plants are housed in biofilms and that’s why they’re so hard to get rid of.”

He said organizations such as the International Association of Food Protection are targeting biofilm content at conferences and educational outreach to food companies.

“Industries are more aware of them than they have been in the past and as a result, they do put more emphasis on trying to remove those biofilms from surfaces,” Forner said.

Boce Zhang, who led a Center for Produce Safety-funded study on different food contact surfaces in processing plants and their ability to resist biofilm growth, said biofilm is a natural survival mechanism that enhances the advantage of bacteria.

“It is imperative to understand the role of biofilm on the likelihood of pathogen survival and transmission,” said Zhang, assistant professor of Biomedical and Nutritional Sciences at the University of Massachusetts. “Addressing biofilm challenges requires a holistic approach and novel control strategies.”

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Increased food safety concerns and recalls linked to wheat were addressed today at the International Association for Food Protection’s annual meeting in Phoenix, which features in-person and digital sessions.

Juliany Rivera Calo, a senior food safety microbiology specialist for Arden Mills, Denver, said treating wheat before processing is difficult because of the low water tolerance in the milling process and possibly the ability of pathogens to withstand treatment effects if they are hidden in the kernel’s crease. Treating flour can have an organoleptic effect on the product, changing the odor and flavor. Validation of non-thermal treatments require careful planning and potentially high expenses.

Another key element is consumer education. Rivera Calo said eating raw cookie dough has become fashionable and promoted on social media challenges, leading to a “it hasn’t made me sick, so I’ll keep eating it” outlook for some consumers.

Aparna Tatavarthy, a microbiologist with the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, discussed the results of FDA’s Food Safety and Nutrition Survey of almost 2,200 adults in 2019. Thirty-five percent admitted to eating something with uncooked flour in it, such as cookie dough, in the previous 12 months. In another consumer study, only 13 percent knew that consuming raw flour would “likely or highly likely” make them sick. Only a third realized raw, homemade cookie dough could have the same effect.

She provided information on foodborne illnesses linked to flour in recent years, including:

• E. coli in raw cookie dough in 2009, with 77 cases of illnesses in 30 states;
• E. coli in flour in 2016, with 63 illnesses in 21 states;
• E. coli in Canadian flour in 2016, with 30 cases in six provinces;
• E. coli in unbleached all-purpose flour in 2019, with 21 cases in nine states; and
• E. coli suspected to be linked to flour used to make crusts of frozen pizza in 2019-20, with 20 illnesses in three states.

Tatavarthy said the FDA wants to work with the grain and milling industries and the U.S. Department of Agriculture to establish best practices for grain storage, establish transportation best practices and good manufacturing practices for processing plants. Investigations of foodborne illness cases linked to flour have exposed the fact that there’s limited data about the prevalence of E. coli and other microorganisms in flour, Tatavarthy said.

The FDA is also collaborating with the North American Millers Association on food safety issues.

Alexander Gill, a research scientist with Health Canada, is an expert in shiga toxin-producing E. coli (STEC). He addressed the persistence of STEC in baking flour.

“In these outbreaks, cases were reported over periods from six to nine months, in each case ending with the recall of the implicated product from the marketplace,” Gill said. “This indicates that STEC can persist and remain infectious in flour for at least nine months.”

He said the prevalence of STEC varies greatly between studies, and more work is required to determine the variables that determine STEC variables between regions.

One model for STEC survival is that STEC is a normal part of the microbiota of wheat grains, and the E. coli cells adapt to the low-moisture environment on grains. The STEC cells also are resistant to stress and are transferred to flour during the process, Gill said.

Rivera Calo said potential contamination sources are soils, water and wildlife, and pathogens can remain viable after the drying process, remaining a food safety hazard for months in a desiccated state, she said.

The Ardent Mills approach to risk mitigation has included:

• Changing agricultural practices as needed;
• Environmental monitoring modifications;
• Wheat/product testing; and
• Consumer education.

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To Drew McDonald, vice president of quality and food safety for Taylor Farms, Salinas, CA, attention to audit scores and related compliance records can be useful to gauge performance over time. But to strive for true food safety improvement, industry members need to focus on data, McDonald told in-person and virtual attendees during a July 20 session at the International Association for Food Protection’s annual meeting in Phoenix.

McDonald joined Trevor Suslow, University of California-Davis Emeritus Extension Research Specialist, and Yaguang “Sonny” Luo, a senior scientist with the Agricultural Research Service at the U.S. Department of Agriculture, for the presentation on “No Silver Bullet in Sight: How to Achieve Continuous Improvement in Fresh Produce Safety with Existing Knowledge and Tools.”

McDonald said a colleague refers to a data-driven approach to food safety as the “virtuous cycle.”

“The real trick is that as that data is generated, you’re looking back at it, you’re using it to solve problems and probably more importantly, you’re using it to ask questions,” he said. “One of the expressions we have at Taylor Farms is that ‘we’re not necessarily getting the better answers, but we’re getting really good at asking questions.’ ”

Better questions help refine and improve standards and practices, said McDonald, who presented several case studies on how looking at data has helped Taylor Farms learn and improve the company’s growing practices and those of growers who supply it.

He said Taylor Farms noticed an uptick in positive results for pathogens in product grown near Yuma, AZ., in 2010, and initial investigations didn’t pinpoint a cause. Mapping the positive testing along irrigation events, however, turned the seemingly random results into a clear issue with irrigation. After a treatment program was established, the problem was eliminated.

“The best result is not just that you find a cause or a potential source, but that you actually can identify something to do about it,” McDonald said. “That’s always challenging, especially when dealing with a wide outside growing region.”

McDonald suggested that grower-shippers find a way to clean up “messy” food safety data, whether it’s from legacy systems with limited data points, paper documents, redundant information or outdated software. Many computer programs allow for customization, and technology companies offer services to help clean up the data.

“But I will caution people on that, because they don’t know the context of your data,” McDonald said. “The great thing about the process of cleaning it up and running it is that you know your data better than anyone else, so you actually really begin to understand what you’re sitting on and what you can do with it.”

Continuous improvement
Suslow expressed concern that the produce industry needs to be more proactive in adopting practices identified in recent years as the industry, regulators and academia have undertaken research programs to address food safety issues in the supply chain. Best practices continue to evolve through the research.

“There are multiple less formal, in-practice, on-farm, boots-on-the-ground types of experiences that come from investigative research that have and continue to shape the preventive controls and mitigation measures,” Suslow said.

He presented some of that research, including a case study of how two cantaloupe fields close to each other were experiencing markedly different food safety results, how important awareness of wildlife activity in fields is, and efficacy of cover crops to help curb pathogens in soils.

Like McDonald, Suslow spoke of importance of irrigation water treatments, as well as the need to understand where specific problem spots are if pathogens are being introduced through water use. That includes possible wildlife intrusion and nearness of cattle or other livestock operations in the area of fields and irrigation canals.

Suslow said in the case of the melon fields, they were irrigated with water from the same canal, but the field with food safety issues was watered from an offshoot of the canal that passed nearby a dairy farm.

He also presented results of using short-term cover crops such as buckwheat to cut pathogens in soils. In one study, testing of a 27-acre field that was divided into a grid showed that 90 percent of the sections had positive samples of shiga-toxin producing E. coli. Suslow said a cover crop was planted and disced. After the field was flooded and left to dry, the positive tests dropped to 8 percent of the grid.

“We’re trying to understand what we can expect in terms of (pathogen) persistence and survival and what one might do about it,” he said.

One-off assessments are not likely to inform the path to effective preventive controls, and the challenge is to develop a long-term view of risk, Suslow said.

Importance of partnerships
Luo said there has been a major paradigm shift from reactive to proactive in how the fresh produce industry responds to food safety challenges, starting with an E. coli outbreak linked to fresh spinach in 2006. That event led to the establishment of the California and Arizona Leafy Greens Marketing Agreements, and the industry has donated millions for research through the Center for Produce Safety.

The USDA-ARS has collaborated with the industry and FDA and academia to develop guidelines to prevent pathogen cross-contamination during produce washing.

Luo highlighted a more recent case of food safety collaboration, triggered by an August 2019 warning from the FDA to the industry about repeated salmonella outbreaks traced to fresh papayas from Mexico. With a lack of research available on potential causes, the industry sought support from the ARS, which conducted tests on sponges and microfibers used in washing the imported fruit and use of cleaning agents in wash water. The USDA’s National Institute of Food and Agriculture also contributed to the effort.

Growers in Mexico, the FDA, United Fresh Produce Association, USDA agencies and the Texas International Produce Association worked on the issue. The first edition of the “Food Safety Best Practices Guide for the Growing & Handling of Mexican Papayas,” was released in English and Spanish in spring 2020.

It’s important when developing food safety processes to mimic real-world conditions, she said, and that means access to fields, packinghouses, fresh-cut processing plants and other facilities.

“So your facilitation of research in this area will make a big impact,” Luo said.

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Scientists whose work involves learning more about pathogens and parasites that cause such outbreaks discussed current issues today at the International Association for Food Production’s annual meeting, a hybrid event with online sessions and a conference in Phoenix.

The session, “Tracing Back to the Source: Challenges to Link Parasite and Viral Genotypes between Outbreak Clinical Samples and On-farm Environmental Sources of Contamination,” focused on hepatitus A, norovirus, cyclospora and cryptosporidium.

Lee-Ann Jaykus, of  North Carolina State University’s Department of Food, Bioprocessing and Nutrition Sciences in Raleigh, said hepatitis A transmitted via food globally often comes from frozen berries. Although those outbreaks are typically traced to an importer and country of origin fairly quickly, finding the precise source is difficult, in part because frozen berries are typically eaten after the season in which they were harvested. That’s compounded by the likelihood that the processor pooled berries from a number of growers on the production line.

Complex supply chains are often another hurdle in tracking the origins of foodborne illnesses linked to fresh and processed produce, she said.

Once a supplier-grower has been identified, investigators have a list of usual suspects to target.

“When you look at good agricultural practices associated with the production of fresh produce, we oftentimes use the ‘four Ws:’ water, waste, wildlife and workers, as the source of contamination,” Jaykus said.

She led session participants through the process of detecting enteric viruses with the commonly-used ISO (International Organization for Standardization) methodology. Researchers, however, often “play around” with different methods during outbreak investigations to increase chances of finding the target nucleic acid they’re looking for in the sample.

Jaykus discussed interpreting RT-qPCR (reverse transcription-quantitative polymerase chain reaction) results. The process is common, but Jaykus said there is a possibility of a false positive if cross contamination and other factors aren’t ruled out. Detections of a nucleic acid with this method is not proof an infectious virus is present.

“There’s a debate as to whether the reliance on PCR-based methods can result in over-estimation of public health risks,” Jaykus said. “We could have an entire symposium on that.”

Next-generation methods for foodborne illness surveillance include whole genome sequencing and meta bar-coding, she said.

Alexandre da Silva, research microbiologist at the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, discussed cyclosporiasis outbreaks, with a focus on Cyclospora cayetanensis, first classified as a human pathogen in 1994.

Advances such as those in bacteriology haven’t been seen in the methodology used to detect and trace cyclospora, da Silva said, but available methods have been successful, he said.

Da Silva’s presentation included information on cyclospora’s life cycle, and he touched on specific outbreaks, from almost 1,000 lab-confirmed cases linked to imported raspberries in 1996, basil grown in Missouri in 1999, romaine lettuce in 2013 and bagged salads in 2020.

While developing methods to detect cyclospora in produce is needed, he said lab capacity is also critical.

“We also need to make sure there are laboratories capable of using all this methodology they’re developing,” he said. “Otherwise, all those efforts are not going to produce the outcomes that we want.”

He said FDA has established a number of labs that can specialize in cyclospora and the agency was in the process of training researchers, but the COVID-19 pandemic put the program on hold.

Rachel Chalmers, a cryptosporidium expert with Public Health Wales, said a 2014 global ranking of foodborne illness caused by parasites by the Food and Agriculture Organization and World Health Organization placed Cryptosporidium spp. linked to fresh produce, fruit juice and milk at No. 5. Twelve of the top 20 foodborne illness outbreaks from parasites were from on-farm environmental contamination of fresh produce.

Genotyping parasites  helps shed light on the extent of an outbreak, what the route of transmission is and precise interventions that are needed. Genotyping can help strengthen the association with the implicated food, she said.

“The genotyping data can help refine the epidemiological analysis, and also make better use of surveillance data to identify further cases and to identify outbreaks themselves,” Chalmers said.

Challenges faced in a typical foodborne illness outbreak investigation, she said, include:

• Obtaining relevant samples, whether from the farm or other locations in the supply chain, to clinical isolates;
• Coping with a high number of tests and the rapid feedback, especially during the escalation phase of the outbreak;
• Good communication between labs, epidemiological investigators, on-site inspectors/samplers and others;
• Clear external communications with business owners, suppliers, media and the public; and
• Having the right tools to prepare samples and put them through the genotyping process.

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That’s the consensus of panelists discussing crisis plans during a virtual Food Safety Summit education workshop today, May 13.

Mary Lynn Walsh, a regional director of food safety for Sysco Corp., detailed steps to consider when crafting a crisis plan, starting with knowing what terms to use and a company-wide knowledge of what constitutes a crisis, incident or emergency.

Walsh said employees might not know about the plan or make common assumptions about it, including if it’s accessible to employees, whether co-workers know what’s in the plan, and if everyone has the same end goal.

“Everybody ultimately wants the business to be up and running, everybody ultimately wants the associates to be safe,” Walsh said, but a safety manager, facilities manager and the president of the company will have different priorities.

Companies working though crises and incidents, whether a recall, hurricane or other weather event, must revisit the issue to evaluate the response.

“We’re not going to improve for the next event unless we acknowledge what went well and what didn’t go well,” Walsh said.

The discussion outlined numerous scenarios companies have had to deal with in crisis situations, from natural disasters to the current pandemic.

“The intent here is to really create a system that could react to or manage any incident or crisis that comes at you, regardless if you’ve thought about it or not,” said Will Daniels, president of the produce division at IEH Laboratories. “It is important to be sure that you are ready to go.”

In 2006, Daniels was in charge of food safety/quality at organic salad processor Earthbound Farm when an E. coli outbreak was traced to fresh spinach processed and bagged by the company. The deadly outbreak led to the establishment of the Arizona and California Leafy Greens Marketing Agreements, which have set standards for growing and harvesting leafy greens for their members.

He said the company recalled spinach products and followed internal plans to address the outbreak.

“We had intense pressure from all of our stakeholders — the media, customers, the industry, consumers and even internally we had a lot of pressure to identify the root cause, correct things and get back to business as usual,” Daniels said. “I truly believe that without our incident management plan in place, it would have been a lot harder to get through the crisis.”

Daniels said the plans must identify the experts who can deal with specific issues, whether they are in-house or trusted partners outside of the company. The media component is a critical part of crisis management, and companies must interact with the media to tell their story, he said.

If the incident continues for several days, Daniels said it’s important to revisit communication plans to see if messaging needs to be altered or updated. The evolution of social media has created the biggest changes in crisis communications, he said, even changing what constitutes a crisis. A single consumer can amplify a bad experience into national headlines via social media.

The speed of information has increased, Daniels said, and that not only includes the truth, but rumors and speculation as well.

Glenn Stolowski, manager of retail quality assurance for Texas-based retailer H-E-B, said technology opened new avenues for communication during the pandemic.

“It’s made a big difference in how we approach training and drills during a pandemic,” he said, “because crisis situations still happen during a pandemic. We still had a hurricane hit last year in the middle of the pandemic, and we still had to work through that.”

Stolowski said it’s currently hurricane training season for H-E-B employees, an annual spring process. He said training for various crisis responses is important, and that records be kept on what training employees have completed.

“The training really helps bring home the written plan,” Stolowski said. “The written plan sometimes can be long, but the training needs to break it down into bite-size pieces for your employees. What are the top three or four things they can take away from a training, so they can apply it when a situation happens?”

Panel moderator Gary Ades, president of G&L Consulting Group LLC, noted the importance of all levels of leadership embracing crisis and incident management plans. Panelists said executives and even boards of directors are becoming more supportive of the proactive stance of having plans to respond to crises.

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Representatives of foodservice, retail and an industry association talked about their pandemic experiences and the difficulty in responding to the crisis during a Food Safety Summit 2021 virtual panel this afternoon. Participants agreed that early communications from government and health officials were sometimes conflicting and late in coming as companies were forced to fill knowledge gaps with experts from their own industry.

“The fact is, at the beginning of the pandemic, we knew very little, to nothing, about the virus and we weren’t quite sure if the virus could be transmitted through food,” said panel moderator Jorge Hernandez, vice president of quality assurance for Wendy’s.

“. . . In addition, all of us had to separate between multiple and often contradictory messages and information that came to us from all over the place to be able to help our companies and agencies guide the communications and the actions we needed to take to ensure the safety of our employees and customers and the compliance with multiple orders that came about from the pandemic.”

Daily web conferences and constant communications with local health and government officials, as well as contact with both clients and other industry groups helped food companies navigate the early days of the pandemic.

Tom Ford, vice president of food safety and quality assurance for foodservice provider Compass Group, said the company relied on the “three Cs” for steps to take: community (local health departments), customers and Compass, for in-house policies on responding to the pandemic.

Mahipal Kunduru, vice president of quality assurance for retailer Topco Associates LLC, said most organizations have business continuity plans, but they’re geared for short-term crises.

“All of a sudden, it required the entire operation to work effectively and efficiently in a remote perspective,” Kunduru said.

Steve Mandernach, the executive director for the Association of Food and Drug Officials (AFDO), said trade associations and industry partners were critical in navigating information in the early weeks of the COVID-19 pandemic. A lack of outreach by public health officials to food safety experts in different industries fueled early confusion on how to follow prescribed protocols, but communication improved as the pandemic continued, he said.

New business models
Panelists agreed that the pandemic is altering the way food companies will do business, following the prolonged period of change it has forced on consumers. The scenario has shifted from finding crisis solutions to meeting new expectations, Ford said.

“I kept saying at the time that the food experience is changing; we can’t do it the same way,” he said. “Food safety rules can’t change, the food quality rules can’t change. But how we’re getting food to people had to change.”

The food industry is fast-paced and flexible, Ford said, and companies must evaluate how best to serve customers post-pandemic, including food safety solutions, delivery methods and where meals are eaten.

“The industry will forever be changed by this, and we don’t know what the end of it will look like,” Ford said. “Flexibility and being open-minded are two traits this industry will come out of this with.”

Kunduru said it’s important to have an outcomes-based approach to evaluate processes, instead of trying to use existing plans to achieve different goals.

What won’t change, he said, is that consumers expect that food will be safe and available.

“The format in which they might engage with you might look different, in terms of making the purchase or preparing the food,” Kunduru said. “. . . Peoples’ interest in wanting to experience types of foods has changed and evolved because menu options have changed quite a bit in terms of how consumers are eating at home.”

Mandernach said disruptions of on-site visits forced his organization to offer daily web training by the third week of March 2020. Within a month, he said, the association had offered 96 hours of training to state and local officials.

The Food and Drug Administration shuttered some inspections as personnel were pulled from exporting countries, but the agency continued “mission critical” inspections and introduced off-site inspections via the web. Mandernach said these remote inspections likely will continue in some situations, as well as more “non-regulatory” inspections to take advantage of technology to evaluate processes.

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Norovirus experts detailed best practices for restaurants today during an online panel, “Restaurant Policies and Practices Related to Norovirus Outbreak Size and Duration,” at the 2021 Food Safety Summit.

Lee Ann Jaykus, William Neal Reynolds Distinguished Professor in the Department of Food, Bioprocessing and Nutrition Sciences at North Carolina State University, said norovirus has been referred to as the “perfect foodborne pathogen” because of its sanitizer resistance, evolution of strains and ability to infect someone even when small numbers of the virus particles are present.

Although norovirus doesn’t grow in foods like some other pathogens, it is able to remain stable in environments for weeks and possibly months, said Jaykus, scientific director of the Food Virology Collaborative (NoroCORE), a five-year project at the U.S. Department of Agriculture’s National Institute of Food and Agriculture.

Anita Kambhampati, an epidemiologist for the Center for Disease Control and Prevention’s National Center for Immunization and Respiratory Disease, said norovirus is the leading cause of foodborne illness outbreaks and overall cases in the U.S. From 2009-12, nearly half of those outbreaks were from norovirus, she said.

Research on foodborne norovirus outbreaks from 2009-15 showed that 76 percent of the cases with a known contributing factor implicated food workers as a source of the virus, and bare hands in contact with ready-to-eat foods transmitted the virus in more than half of those cases.

Kambhampati said following the Food and Drug Administration’s Food Code model and guidelines from the CDC have been shown to greatly reduce norovirus cases.

Five recommendations for foodservice operators have been shown to reduce norovirus transmission,  she said. Those are:

• Hand washing requirements
• Preventing bare-hand contact with RTE foods
• Keeping employees who have vomiting and diarrhea out of the workplace (regardless if they’ve tested positive for norovirus)
• Employing a certified food protection manager
• Having a response plan for contamination events.

Kambhampati also said employee and manager training has been linked to a reduction in the number of norovirus cases in outbreaks.

Glenda Lewis, director of the Retail Food Protection staff in FDA’s Center for Food Safety and Applied Nutrition, said states have adopted varying degrees of the FDA’s Food Code. She said the agency’s goal is full adoption in every state, which “establishes really practical science-based guidance for mitigating risk factors that are known to cause foodborne illness.”

“It’s an important part of strengthening the national food safety system,” Lewis said.

Guideline compliance and behavior change is key, said Lewis, who highlighted results of a 2017 review of food safety management systems at foodservice establishments and how they affected norovirus outbreaks. Again, removing ill employees from restaurants was found to be a significant step in reducing the size of the outbreak, she said, and having a strong food safety management system leads to better compliance.

Hal King, president and CEO of Public Health Innovations LLC, said the science is clear: to reduce the number of people who become ill from norovirus, restaurants must have specific food safety controls defined.

King and other panelists touched on lower norovirus numbers in 2020, and the COVID-19 pandemic’s likely contribution to the drop in cases, with social distancing and shutdown or curtailed business at restaurants. Panelists said the issue needs to be studied more, and King said there’s a case to be made that some of the pandemic safety procedures could be helpful in limiting norovirus cases in the future.

That includes temperature and wellness screening before employee shifts, and using hand sanitizers and personal protective equipment.

But those steps are just one part of an overall food safety plan at a restaurant, King said, and protocols must be set for everything from food cooking temperatures to proper cleaning procedures.

“You really can’t manage food safety if you don’t know that controls are in place on a daily basis,” he said. “So you need a food safety management system in place that your manager can check every day.”

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How food and beverage companies achieve that goal, however, is as varied as the products they ship to customers. A patchwork of programs and regulations guide manufacturers and grower-shippers on food safety processes in plants and packinghouses. That includes the Food Safety Modernization Act, California/Arizona Leafy Greens Marketing Agreements, Global Food Safety Initiative (GFSI), British Retail Consortium, and Good Agricultural Practice standards.

A food or beverage company might even have different in-house food safety procedures depending on the variety of what they produce. The Food and Drug Administration’s FSMA, for example, proposes stricter traceability rules on certain fish and cheeses, chicken eggs, fresh-cut produce, leafy greens and other fruits and vegetables.

As food safety regulations — and requests from customers to follow various programs — have increased, so has the need to collect, retain and share information with regulators and partners in the supply chain.

More companies are turning to plant management software to address food safety oversight, as well as collect data used to enhance the overall efficiency of manufacturing plants and packinghouses.

The same, yet different
SafetyChain Software, a plant management software provider, works directly with company executives and plant personnel to tailor platforms that meet the needs of food, beverage and consumer packaged goods manufacturers.

Barry Maxon, SafetyChain CEO and co-founder, said a vice president of quality at a customer once said something years ago that underscores the SafetyChain process and configurability for new clients: Food and beverage companies all do the same thing — differently.

That’s where SafetyChain solutions architect Brandon Wright comes in.

“I’ll walk through their facility with them and try to understand how their process works, how that process of making things engages with humans, and how those two pieces engage with data,” Wright said. “How do we capture that data, whether it be for food safety, or process management or compliance?”

The process, which SafetyChain refers to as “blueprinting,” configures the platform’s backbone with forms that address everything from receiving to tracking temperatures, finished product, maintenance and sanitation checks, and corrective actions taken when parameters aren’t being met on the line.

“(Companies) can build their forms to capture data and trend data they way they want to and need to, because someone making a specialized olive oil blend is going to be measuring it differently than someone who’s harvesting blueberries out in the field,” Maxon said.

By the time the plant management platform goes live, according to Maxon, “we’ve already figured out the huge base of infrastructure that you need to have to support a real-time operation, we’ve thought about compliance, we’ve thought about data redundancy, about how to handle if WiFi isn’t available, about security, about operational demands, and ease-of-use for production line workers.”

During a recent SafetyChain web seminar featuring Blue Bell Creameries’ use of plant management software, the dairy products manufacturer outlined the blueprinting process involved in adopting the platform.

“As we were building these forms and doing the training and getting more people involved, (employees) actually bought into this and were coming to me, and saying, ‘Hey, we could do it this way or change it up this way, make it easier and more efficient,’ so we received a lot more buy-in from that,” Josh Kalich, Blue Bell food safety and projects manager, said during the March 23 web seminar.

Kalich suggests that companies involve employees who are excited about the data potential during the blueprinting process. Feedback on tailoring the forms to meet the needs of specific facilities is important, he said.

“I picked an individual that knew the forms very well, and was very energetic about it, very positive,” he said. “. . . The biggest thing is getting people involved. Find your strongest people, people that want to work with it.”

The plant management platform is engineered to be updated or added to as manufacturers’ needs change, which is critical as technology allows improvements to be introduced faster, Wright said.

“The days of ‘This is the way we’ve always done it’ are no more,” he said. “Now it’s, ‘How do we want to do it?’”

Sustainability
As consumer interest in how food, beverage and consumer packaged goods companies grow and process products, manufacturers are tracking everything from their carbon footprint, use of resources and how much waste they generate.

Sustainability reports are more common in providing the transparency sought by customers and consumers. Wright said plant management platforms can also capture sustainability information to support ESG initiatives if a manufacturer builds it into the blueprinting process.

“We’re really here to empower these businesses to use the information that is happening,” Wright said. “If they can figure out how to capture it, we can do it.”

For example, Maxon said, dairies can monitor resources in real time.

“If you’re a dairy and running a (clean-in-place) process, you’re putting a tremendous amount of water and electricity into that process,” he said. “Just by being able to measure data in real time, you can help the operator fine-tune that process to reduce your use of water and reduce your spend on electricity.”

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Overall Equipment Effectiveness (OEE) and Statistical Process Control (SPC) programs are not new concepts in manufacturing. For decades, they’ve been helping companies gauge efficiency and address issues that decrease efficiency.

How that data is being collected and connected, however, is being revolutionized by technology, giving manufacturing plant managers access to data that can be manipulated into unlocking better ways to track trends, detect factors leading to slowdowns on the line, and break down the walls that have historically existed between company departments to make them work better as a unit.

OEE essentially measures asset availability and performance, and production quality. SPC uses statistical techniques to reduce variations in the manufacturing process to increase quality and lower costs.

Tools to facilitate OEE and SPC programs — digital and paper-based — have long supported everything from tracking food safety programs in the lab, quality assurance testing, production quotas, out-of-spec products and more.

With plant management software, food, beverage and consumer packaged goods manufacturers are bringing that data together in a single platform.

“There have been tools around for a while, but they were only doing one piece of the overall problem, only solving one portion,” said Barry Maxon, CEO and co-founder of SafetyChain Software. “The evolution here is having a platform that puts it all together, and does it in a way that actually yields better results for the company.”

From a food safety perspective, plant management software helps oversee testing results, record and pull up data for proof of compliance to regulations, and can enhance product traceability.

“There’s a ‘Program View’ that’s really important, that allows a company to see the connection between a regulatory code or a GFSI (Global Food Safety Initiative) code and how that flows through their SOP and to their forms and to their records,” Maxon said. “It’s a very unique and novel view and yet it supports the fundamental goal of being audit-ready all of the time, of being able to demonstrate compliance all of the time.”

Maxon said there’s another food safety benefit to plant management software, keeping in mind that compliance isn’t a point-in-time view, but a continuous effort to maintain food safety standards.

“The plant management platform really helps reinforce a food safety culture in real time,” he said. “Through the ‘program view,’ you can see that your food safety programs are being properly implemented on the plant floor.”

Audits and Inspections
The necessary checks to follow Food Safety Modernization Act (FSMA) and related regulations generate a lot of data. Traditionally, that has reduced food safety managers to paper pushers and document seekers as part of their daily duties. That process is amplified leading up to inspections and audits from the Food and Drug Administration, the U.S. Department of Agriculture and other agencies.

“You hire people in food safety that are well educated, they’re super smart,” Maxon said. “If you look at a resume for a food safety person, or look at a job description, nowhere on there do we put ‘filing paper, managing mounds of papers on your desk.’ And yet that’s what they wind up spending hours a day doing.”

Despite the preparation, there’s no way to predict what extra information an auditor might request while on site, and retrieving paper documents or digital-based spreadsheets for specific timeframes might not be immediately possible.

Blue Bell Creameries, which now uses the SafetyChain platform at its three plants, tracks and documents compliance to FSMA, British Retail Consortium (BRC) and other programs. Easy access to data during audits is a plus, Josh Kalich, Blue Bell food safety and projects manager, said during a March 23 SafetyChain sponsored web seminar.

“We would have to ask the departments to find the paperwork and provide it to us,” Kalich said. “Now we can just pull it up on the screen and show the auditors whatever date range they need, whatever check they want to look at.”

Kalich said Blue Bell Creameries used to collect data through paper and digital documents, but the various sources made comparing that data across all three of the company’s plants difficult. Plant management software has made that “a lot easier and eye-opening,” he said.

“The dashboard intelligence for tracking and trending data has definitely helped and it’s going to definitely help us in the future as we continue to learn more and continue to see what other information we can gather from the software.”

Management by exception
Manufacturers live and die by hitting specifications set by customers, regulators, and their own internal quality measures. Plant management software can be customized to meet needs of different companies serving diverse industries. Equipment on the line and throughout a plant can track everything from temperatures during cooking to how many ounces are in a bottle or pounds are in a box.

As plant management software logs data, it gives users the ability to update dashboards for SPC checks, and also alerts managers to exceptions when specifications are missed, such as a temperature being too high or too low.

That oversight allows food safety managers to shift a focus from seeking out an exception to finding the root of the exception.

“In the past, it’s interesting that with the overwhelming volume of compliance, the programs were managing the people,” Maxon said. “Now the people can manage the program, so they can focus on the exceptions.”

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The chaos that the COVID-19 pandemic inflicted on the manufacturing sector and those who keep it running underscores the need to keep the supply chain operating effectively and rapidly.

In the early weeks of the pandemic in spring 2020, shopping habits changed drastically and tested the ability of food, beverage and consumer packaged goods companies to keep customers supplied with high-demand items. From demand for toilet paper and hand sanitizers to certain produce at grocery stores, consumers showed their concerns about health and the need to cook more at home.

At the same time, companies that supply foodservice operations saw orders plummet as restaurant, institutional cafeterias and similar customers closed or shifted to takeout or reduced outdoor seating models.

Food, beverage, and CPG manufacturers have responded to the pandemic with the backdrop of changing and increasing regulations that were already complicating in-plant and packinghouse processes.

Those industries are turning to Plant Management Software to track everything from the performance of new supply channels and customers to worker safety in facilities and fields. That includes changing work schedules, tracking COVID-19 quarantined employees, and new policies for social distancing and basic screening before shifts.

SafetyChain Software has seen pandemic-related interest from food, beverage, and CPG companies and from customers adapting their platforms to meet COVID-19 challenges to potential customers hampered by piecemeal paper and digital systems that fail to give an overview of operations.

“There’s a whole new element of Plant Management Software that now begins to expose the whole EHS (environmental health and safety) side of the plant,” said Barry Maxon, SafetyChain CEO and co-founder. “COVID showed the industry how a platform like this can very easily adapt to a whole new way of doing business because the (software) infrastructure was already in place.”

Companies are tracking personal protection equipment inventories, reviewing plant specs to configure social distancing policies on the production line and in warehouses, and even considering ventilation needs with the spread of the virus in mind.

Maxon said he spoke to a senior vice president of quality at a company that uses SafetyChain’s platform who was forced to quarantine.

He told me he was blown away by the fact that when he was quarantined at home, he could see what was going on in real-time in all 18 plants across the country from his mobile phone, Maxon said.

Regulatory compliance
The Centers for Disease Control and Prevention and Food and Drug Administration have stressed that the pandemic is a worker safety concern, not a food safety concern. But the virus has dramatically influenced how food and beverage companies conduct business in their plants, including food safety audits mandated by the Food Safety Modernization Act.

In March 2020, the FDA halted in-person inspections of foreign food facilities, citing travel restrictions. Inspections at borders continued, but “mission-critical” in-person audits became the norm when audits in the United States became problematic as travel restrictions increased.

In November 2020, the California Leafy Greens Marketing Agreement and Western Growers, which represent produce growers, unveiled a virtual audit program to help the industry maintain FSMA compliance. The FDA also announced an interest in virtual audits as an option even beyond the outbreak.

Plant Management Software can facilitate that offsite oversight, Maxon said.

“You couldn’t travel anymore, but you still had to continue operations, you had to continue running your plant,” he said. “How do you audit your suppliers? You can’t go see them. How do we conduct a GFSI audit, but we cant have an auditor in our space? . . . We suddenly had to learn to operate differently because we had these constraints on travel and  physical presence that upended how we think about the business.”

The pandemic highlights the need to share data with suppliers and customers easily. Plant Management Software is SaaS-based (Software as a System), which gives users flexibility.

“We have customers that have used it to conduct audits. We have customers that now have co-manufacturers supplying their data right through the system,” Maxon said. “They don’t have to manually review records or visit facilities and can see quality and compliance in real-time.”

Food safety
The pandemic delayed the rollout of the FDA’s “New Era of Smarter Food Safety” from spring 2020 to summer. The initiative stresses the need for food companies, particularly leafy greens grower-shippers, to ditch paper records in favor of digital tools. When the FDA unveiled the long-awaited traceability rule covering leafy greens and other produce and food items this past fall, it didn’t necessarily mandate digital record-keeping.

The FDA has faced hurdles in past E. coli outbreaks traced to leafy greens because investigations included poring over paper documents and hand-written information in some cases. Through the traceability rule, the FDA says companies should submit an electronic spreadsheet with traceability information to the agency within 24 hours of a request.

Maxon said companies that use Plant Management Software solutions for food safety oversight can satisfy the FDA’s reporting requirements and share the data with retail and other customers with their own set of requirements for suppliers.

“Our customers are winning business and expanding their footprint with retail customers because they have access to data where they can prove a higher degree of compliance,” he said.

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In the era of the Internet of Things, machine learning and technology that drives innovation and growth for industries, there’s no dispute that data is king.

How that data can be harnessed and made more useful by companies, from smaller manufacturers to corporations with plants across the globe, is advancing to provide real-time information that can tackle hurdles to productivity faster – and even clue plant managers in on problems they didn’t know existed.

To achieve those results, companies must say goodbye to outdated tools of the trade, from legacy enterprise resource planning platforms, limited point solutions, spreadsheets and paper documents.

Enter Plant Management Software, a newer concept that ties together oversight and data collection from the mundane, such as plant cleanup schedules and tasks, to the all-important tracking of production statistics and inventory.

Barry Maxon, CEO and co-founder of SafetyChain Software, which focuses on plant management software for the food, beverage and consumer packaged goods industries, said the software is a relatively new concept for process manufacturing. Companies have relied on unconnected data points, whether digital or on paper, to focus on the many parts of manufacturing, from food safety and Hazard Analysis and Critical Control Point programs to management of suppliers, line starts, OEE and yield.

“Plant management software is starting to put together a broader footprint that traditionally in the past you would have had to go out and buy three or four different point solutions to try to do a portion of what plant management software is doing,” he said.

At its core, plant management software is about maximizing the productive profitability of a plant. 

“There’s a lot that goes into that,” Maxon said. “There’s no one thing; it’s everything, it’s a whole coordination of activities.”

Plant management software is designed to target inefficiencies that lead to a drag on the bottom line, from out-of-spec products, wasted raw materials, bottlenecks on the production line, and unplanned stoppages that eat into productive use of labor.

“On top of all of that, the next big dimension (provided via plant management software) is continuous improvement and how you use data to drive continuous improvement,” Maxon said. “In today’s technology-driven world, data is king, one of the most valuable resources in an organization.”

While the underlying value of the data provided through plant management software is universal to all  manufacturing environments, there are specific examples for food/beverage and CPG industries:

Food and beverage manufacturing: Perishable foods and beverages demand a tighter control on inventory and shipping than durable goods. Increasing regulations such as the Food Safety Modernization Act and traceability mandates for produce shippers from the Food and Drug Administration are placing a greater emphasis on companies to demonstrate compliance.

As competition and complex regulations place a greater need on in-plant efficiencies and communication with others in the supply chain, whether upstream or downstream, plant management software eases the ability to do so.

CPG manufacturing: With online purchasing rapidly escalating, especially as consumers curtailed in-store shopping during the global pandemic, the need for real-time overview of manufacturing and inventory has also ramped up. Traditional management of production and all of its moving pieces doesn’t allow for the necessary control over and visibility into manufacturing processes.

“It’s interesting – food and beverage companies invest huge amounts of money in collecting data on paper that gets locked in filing cabinets in binders,” Maxon said. “It’s like burying money in your backyard. It does you no good.”

By ditching those binders in favor of a digital solution, plant managers have the ability to oversee what’s going on in facilities without needing to travel. Mobile devices allow remote oversight, increasing the ability to make decisions based on current data. That’s a significant plus for managers, Maxon said.

Return On Investment
Maxon is big on return on investment, and said it is “fundamentally super-critical” in measuring success for customers.

“We’re really big on how plant management software can deliver a hard dollar ROI,” he  said. “There’s a lot of ways you can look at that, and uptime is a big one. If you can improve your on-time starts, and have a faster line start-up, you can reduce your change-over times, that’s increasing your overall ability in uptime to produce products.”

The data uncovered by plant management software allows executives and plant managers to make decisions based on real-time projections and trend data.

“Yields can put millions of dollars to the bottom line of a company, just by simply getting more value out of the goods that you’re buying,” Maxon said. “One of the largest expense items, after labor and equipment, is all your ingredients. Maximizing raw material yields is of huge value in ROI.”

With a comprehensive plant management software platform, data is immediately available to chart trends, test the metrics of new processes or evaluate the effectiveness of separate parts of the manufacturing process.

“With food and beverage industries, we’re dealing with a very fast-paced environment where you want to be able to identify an issue as soon as possible,” Maxon said. “The sooner you can correct an issue, the smaller the cost to fix it is going to be.”

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