Demand for frozen food products are on the rise. By one recent analysis, the size of the global frozen food market will reach $185.28 billion in 2027, up from $146.79 billion in 2019, representing a compound annual growth rate (CAGR) of 3.1%. The market research analysis by Fortune Business Insights, published November 10, 2020, found that an expanding workforce population, a rise in women’s employment rates, a change in lifestyles among younger generations, and increased consumer awareness of the health benefits of frozen foods are among the current and predicted drivers of increased demands for frozen food and ready-to-eat (RTE) products as people increasingly want food that requires less effort and time to make and is more convenient to consume.

Although acknowledging the downturn in demand and drop in frozen food market sales during the COVID-19 pandemic, after an initial increased demand when SARS-CoV-2 first emerged, the report highlights the recent demand for online shopping occasioned by the pandemic as increasing consumer awareness about new apps for online shopping are expected to drive growth in the frozen food market going forward. When looking at the type of product, the report predicted that frozen vegetables and fruits would lead in consumer demand, followed by frozen RTE meals.

What this report underscores, similar to several other analyses predicting similar or even higher growth in consumer demand for frozen food products, is the need for strong and secure safety measures within food processing and manufacturing facilities to ensure the safety of frozen food products.

Frozen food facilities inherently present optimal harborage environments for Listeria growth.—Sanjay Gummalla, PhD, American Frozen Food Institute

For food processors and manufacturers, a number of pathogens may pose a risk to frozen food products. Among the most concerning is Listeria monocytogenes. The seriousness of this pathogen on human health, particularly on more vulnerable populations such as pregnant women, neonates, people older than age 65, and those with chronic illnesses, is well documented. As reported in a recent review by Farber et al., published in October 2020 in the journal Food Control, the populations of people at risk of acquiring listeriosis, the foodborne illness caused by L. monocytogenes, is growing and may represent up to 30% of the general population.

Not only is the population at risk growing, so too is the incidence of listeriosis. Using data from FoodNet from 2004–2009 to estimate the rates of listeriosis by subpopulation, the study’s authors predicted that the overall listeriosis incidence rate would increase from 0.25 per 100,000 in 2010 to 0.32 per 100,000 in 2030. When looking at the specific vulnerable population of pregnant women, that number jumps to 4.0 to 4.4 per 100,000 women in the same time span.

To place that number in another context, the authors of the report estimated it would require a 48% reduction in exposure or infectivity to L. monocytogenes in the overall US population (or 89% for people >70 years old) to achieve the Healthy People 2020 goal of a one-third reduction rate of listeriosis.

The review, authored by an international expert panel commissioned by the American Frozen Food Institute (AFFI), was conducted to develop a scientific basis and rationale for regulatory policies governing L. monocytogenes. Currently, the “zero-tolerance” approach by FDA is challenged by many within the frozen food industry who do not believe it is the best approach to mitigating or preventing the presence of the pathogen, particularly in low-risk foods, given the impossibility of completely eliminating the pathogen in RTE foods, including frozen foods.

Martin Wiedmann, PhD, the Gellert Family Professor in Food Safety, in the department of food science at the College of Agricultural and Life Sciences at Cornell University in Ithaca, N.Y., an author of the report, emphasized that “total elimination” of L. monocytogenes is impossible. “There always is a residual risk of contamination even if all food safety systems work according to plan and regulation,” he says. As such, the report advances the argument and provides a number of recommendations on a risk-based approach to mitigating and preventing L. monocytogenes in low-risk foods based on a scientific and rational approach.

Dr. Wiedmann emphasized, however, that in frozen food, the vast majority of food safety issues are due to improperly designed or inconsistently or incorrectly implemented food safety systems. As such, food processors and manufacturers can and do need to have a good food safety system in place to prevent and mitigate as much as possible the potential of selling contaminated products to consumers.

For food processors and manufacturers of frozen food products, the first step is recognizing the prevalence of L. monocytogenes and understanding how this pathogen can be introduced into frozen food products.

A Ubiquitous and Persistent Pathogen in Frozen Foods

John Butts, PhD, founder and principal of FoodSafetyByDesign, LLC, advisor to Land O’Frost and a member of the Food Quality & Safety Editorial Advisory Board, underscored that food processors really need to understand the risks of the problem. “Just because it’s frozen doesn’t mean the organism isn’t present,” he says. He also emphasized the persistent nature of the pathogen, citing an experience in a meat plant in which L. monocytogenes contaminated a product 12 years after the same pathogen had resulted in the first fatality from a contaminated turkey frank.

Dr. Wiedmann detailed two primary ways pathogens can be introduced into frozen foods. The first is through the raw material if it does not go through a “kill step,” such as blanching, to inactivate the pathogen in vegetables and fruit. The second is through environmental exposure at the processing facility, which, he said, can lead to contamination of products after the “kill step” or heat treatment.

Drilling a bit deeper, Sanjay Gummalla, PhD, senior vice president of scientific affairs at the AFFI, emphasized the risk of repeated entry of L. monocytogenes as raw produce comes from fields into facilities, allowing for the potential spread within the production environment due to movement of personnel and vehicular traffic. “Frozen food facilities inherently present optimal harborage environments for Listeria growth,” he says, emphasizing the need for food manufacturers to continually address ways to prevent and limit the pathogen by improving sanitation practices, environmental monitoring programs, and investments in hygienically designed equipment and facility infrastructure. He underscores, however, the fact that food can still be contaminated in the post-lethality environment, making it imperative that facilities establish and implement good manufacturing practices.

Environmental Monitoring

Dr. Wiedmann also stresses that a key component of a well-designed and implemented food safety system is effective environmental monitoring and “seek and destroy” programs, as well as effective root cause analysis for every time a problem is detected. He emphasized the need to verify consistent implementation of validated safety practices, which means ensuring that these practices are followed consistently day in and day out.

Dr. Butts, who developed the seek and destroy process in the early 1990s, says that the process separates verification samples from process control samples. “A positive process control sample is an opportunity to celebrate because the plant has the opportunity to intervene before product or contact surfaces are involved,” he says. “The application of process control sampling helps eliminate “firefighting” and enables preventive and predictive pathogen control.”

Dr. Gummalla also emphasizes the need for kill steps (or lethality steps) to effectively reduce the presence of L. monocytogenes in facilities, and the requirement to validate these processes as mandated by the Food Safety Modernization Act (FSMA).

The need for environmental monitoring accompanied by verification programs as key components of a food safety plan was recently discussed and highlighted in an article published in the Journal of Food Protection, in which investigators surveyed food safety professionals working in frozen food manufacturing facilities. The survey found that floors, walls, and drains were the major areas of reported concerns in facilities for finding Listeria-positive results, and that most food safety programs within the facilities surveyed focused their attention on identifying the presence of Listeria in the processing environment and mitigating product contamination, while few focused on testing active raw material and finished products for Listeria. Along with environmental monitoring, the survey also reported the need by industry to improve and develop verification programs to reduce the prevalence of L. monocytogenes in environments in which frozen food products are processed.

To help food processors and manufacturers achieve these goals, AFFI developed ways to assist companies to validate their lethality processes, particularly for frozen foods. For example, Dr. Gummalla points to research that established a correlation of key time and temperature parameters with significant log reduction of L. monocytogenes when blanching frozen vegetables. “Blanching was originally intended to be a way to stabilize the quality of the raw materials prior to freezing, but appropriate time and temperature treatment can also serve as an effective anti-microbial step,” he says.

He cites this and other research at AFFI that is available to help food manufacturers develop and implement food safety practices for their operations. Found on its Food Safety Zone website at affifoodsafety.org, resources and downloadable tools developed by food safety professionals for food safety professionals offer manufacturers an easy way to search, access, and incorporate food safety practices. The site also includes a Listeria Control Program with more than 100 recommendations to help prevent and control L. monocytogenes.

John Rusiniak, vice president of quality and product safety at Lakeside Foods, Inc., in New Richmond, Wisc., reiterates the importance of seek-and-destroy principles as a key best practice for mitigating pathogen contamination. “We employ aggressive environmental monitoring and testing practices based on pathogen seek-and-destroy principles, supported by focused corrective actions when needed,” he says.

That said, Rusiniak, who is a member of AFFI’s Scientific and Regulatory Affairs Committee, underscored the idea that the challenge faced by frozen food manufacturers to ensure safe food products is the same for all food manufacturers and is based on the essential principle of “Safe Food Always.”

“How we get there differs in terms of managing the four Ms: methods, materials, machines, and manpower,” he says. “I would also add a fifth M for “money,” because food safety only happens with commitment during the budgeting process to financially support all aspects of food safety.”

Food Safety Culture

Basically, what Rusiniak is describing is the need for food manufacturers to invest in and adhere to a food safety culture. “The bottom line is that manufacturers must build a food safety culture, which boils down to awareness, education, and commitment,” he says.

Dr. Wiedmann also stresses the need for food processors to take seriously the risk of pathogen contamination of their frozen food products and not adopt a “we never had a problem so everything must be fine” attitude. “There is a need for continuous improvement and regular re-assessment of food safety systems,” he says, citing, for example, the need to continually monitor sanitation procedures. “Often, problems can be traced back to sanitation procedures that do not include sufficient disassembly before cleaning and sanitation, which is essential to make sure cleaning agents and sanitizers reach all spots where L. monocytogenes may ‘hide,’” he adds.

Talking about food safety culture in terms of the level of cultural maturity of an organization, Dr. Butts underscores questions that companies can ask themselves about their commitment to food safety: What are our values? Are we going to apply our values to our production process? “The culture of an organization drives what they are going to do,” he says.

An article recently published in the journal Comprehensive Reviews in Food Science and Food Safety describes in detail how organizations can look at food safety culture in terms of moving from a compliance-oriented organization to one that is more integrity oriented, and the ways to determine the cultural maturity of an organization (see “Determining Cultural Maturity,” p. TK).

One outgrowth of organizations moving to a food safety culture built less on compliance and more on integrity (or a higher maturity level) may arguably be a more risk-based regulatory approach, moving away from the more stringent FDA “zero tolerance” approach. Some argue that this will, in turn, actually improve food safety more than a “zero tolerance” approach, in which a food product is recalled if it is found to have any trace of L. monocytogenes regardless of the product’s risk profile, by reducing the disincentive to companies to regularly sample foods in fear of a recall.

Calling the “zero tolerance” approach a “significant impasse confronting the food industry,” Dr. Gumalla says that a more risk-based approach to regulating L. monocytogenes as laid out by the expert panel in a review published in October 2020 in the journal Food Control will “enhance food safety management and improve public health.” Among the risk-based approach recommendations are the use of alternate sampling approaches for foods that are at low risk of L. monocytogenes contamination and the use of big data to improve microbial risk assessments. Among the other recommendations is the need for clear communication to consumers on safe food handling and avoidance of high-risk foods for at-risk populations.

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The FDA is collecting samples of frozen berries from processors, distribution centers, warehouses, and retail locations throughout the year to test for hepatitis A virus and norovirus.

The sampling assignment began in November and is estimated to last approximately 18 months. FDA is collecting domestic samples of frozen berries. It is also collecting import samples from ports of entry, importer warehouses, or other storage facilities where foreign goods are cleared for entry into the country. The agency plans to collect and test 2,000 samples in all.

Some consumers use frozen berries as ingredients in foods without first cooking them, increasing their risk of exposure to harmful viruses, says FDA. The agency reported three hepatitis A virus outbreaks and one norovirus outbreak linked to frozen berries in the U.S. from 1997 to 2016.

Strawberries, raspberries, and blackberries are delicate and may become contaminated with bacteria or viruses if handled by an infected worker who does not use appropriate hand hygiene, or if exposed to contaminated agricultural water or a contaminated surface, like a harvesting tote. Freezing preserves berries but generally does not kill viruses, which can survive at low temperatures.

If FDA detects hepatitis A virus or norovirus in a sample, the agency will notify the firm of the finding(s) and work with the firm to take appropriate action. Upon detecting a positive test result, FDA may also take actions such as placing a firm on an import alert, overseeing a recall, or issuing public warnings.

The FDA will post the sampling results on its FY 19-20 Frozen Berries Assignment page on a quarterly basis and will publish an analytical report once the assignment is complete.

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