Tag Archives: Focus Article

Jordan Anderson, PAR Technology Corp.
FST Soapbox

Advocate for Change to Establish a Food Safety Culture

By Jordan Anderson
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Jordan Anderson, PAR Technology Corp.

Many times food companies will simply say, “We have to change our culture” or “We’ve always done things this way”, but this attitude will not remedy potential outbreaks or help develop food safety protocols.

As author and businessman Andy Grove once said, “Success breeds complacency. Complacency breeds failure. Only the paranoid survive.” This statement could not apply more to the food service and manufacturing industry.

The first step to change is convincing your organization from the top down to buy in; getting your executive team to accept the cultural change from manual paper-based approaches to digital food safety is paramount.

Common objections will be the investment and positive record of accomplishment. Taking a proactive and preventative approach to everyday food safety compliance will have a positive ROI over time while ensuring the utmost brand protection.

Presenting the potential damages of being linked to a foodborne outbreak is a great place to start. It typically will open the eyes and slightly intimidate each audience member. After all, executives and board members do not like to hear “profit loss”, “stock plunge”, and “tainted brand image”.

While this can all seem overwhelming, it does not have to be. Preparing a strategy and evaluating the processes needed to fulfill this goal will help alleviate the red tape to get this off the ground.

However, before we prepare a strategy, it is important to understand the basic premise behind food safety and how technology can enhance it.

In essence, food safety fundamentally revolves around individual human behavior. Human behavior in turn, is largely driven by culture. In order to successfully develop a food safety culture, an operation must possess impeccable leadership and incorporate the highest standards of food safety.

Most notably, the HACCP plan and individual processes created are a reflection of the human behavior that shapes and molds the culture of an organization. In large organizations, the challenges are often compounded by an increased number of locations and stakeholders (employees, suppliers, customers, etc.) Within these operations, food safety culture and human behavior can potentially become compromised due to the nature of the organization, or attitude and work ethic of the stakeholders.

Technology can assist in the development and maintenance of larger food safety cultures through the use of extensive and dynamic procedures. Human behavior can be shaped by the resources available in today’s food safety tool box. We can now overcome the arduous “pencil whipping” of safety checklists via handheld, wireless and cloud-based technologies. Such technologies are ubiquitous today in the form of apps downloaded from the internet, cell phones, reporting platforms and omnipresent communications.

History has shown that in challenged cultures, individuals often behave as though they are not a part of the whole, and operate as one, rather than as a team that is linked together under one vision and shared effort. However, during the processing, handling and storage of food, we need all stakeholders to act as a collective operation and function as one. The growing adoption of technology is the fundamental turning point that can help drive human behavior and food safety culture in a positive direction.

The introduction of FSMA has brought both challenges and opportunities to the food safety industry—the requirement to document and record actions of a larger food safety plan is one of them. Conceptually speaking, you are only as good as your records say you are. In this context, we are faced with both the challenge of maintaining a positive and efficient food safety culture, in addition to the burden of increased regulatory compliance.

However, FSMA and the innovative technological era have guided the industry to a crossroads of sorts. I suggest embracing the FSMA mentality and implementing food safety technology into your operations. This will not only protect and preserve your organization, but perhaps more importantly, it will define your food safety culture, and implement a positive change into your brand.

Glen Ramsey, Orkin
Bug Bytes

Using Monitoring Devices to Protect Products from Pests

By Glen Ramsey
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Glen Ramsey, Orkin

They’re sneaking in through your windows, crawling through your front door when nobody is looking and squeezing through tiny openings to steal your food. They’re tough to catch, and even tougher to spot.

Naturally, we’re talking about pests. They come in all shapes and sizes, but have the same goal: To find a reliable, safe place to call home where they have abundant access to food, water and shelter. Unfortunately, food processing facilities offer pests all three of these things, making them susceptible to infestations that can compromise products and hurt the bottom line.

You probably already have an integrated pest management (IPM) program in place to mitigate the risk of pests inside your facility. While these programs are great for offering proactive, preventive solutions that use chemical solutions as a last resort, they shouldn’t be the beginning and end of your pest management efforts.

First and foremost, facility staff should always be familiar with the warning signs of pest issues and what to do if they spot something crawling around the building. Most pest management companies will offer complimentary training sessions for you and your staff, which is a great first step. Then, during your weekly/monthly staff meetings, let your employees know which pests are most likely to cause a problem and include some images of warning signs. Empower them to call out problems, explain the risks of pest damage to your products, and you’ll have a better chance of catching pest problems early.

But your staff can’t be expected to spot everything, and there are always pests that slip through the cracks.

That’s why pest management professionals frequently recommend using a variety of tools to closely watch pest activity and detect emerging hot spots around facilities. Tools like IR thermometers, moisture meters and telescoping cameras help pest management professionals identify these high-risk areas. Once these areas have been identified, your pest management professional can take the next step in advanced detection using monitoring devices to paint the picture of pest activity around your facility.

Monitoring devices make it easier to see where pests are traveling and give an idea for how many may be present. These devices capture pests for identification, assist in early detection and will help to mitigate the risk of infestation through early warning. If you’re particularly worried about an upcoming audit or the recent enforcement deadlines for FSMA, these devices will give you a better chance of scoring well and can help you demonstrate compliance by shifting your pest management plan to a more proactive approach as mandated by these new regulations.

There could be quite a few of these monitoring devices you’d like to start using around your facility today.

Fly Lights

A popular device found in many food processing facilities, fly lights attract flying pests by emitting strong UV lights that draws insects in, at which point they become trapped on a sticky glue board in the back of the light—out of sight and away from your products. They work best when placed inside near doorways and windows where pests might be able to squeeze inside, but they’re effective just about anywhere. Discuss placement with your pest management provider.

Why does it work?

The leading theory on why flying pests are attracted to lights has to do with their reliance on the sun and moon as navigational guides. In the past, insects could use the sun and moon as a guide because it stayed at a constant angle, allowing them to move in a consistent direction. However, artificial light confuses them and causes them to circle around the light source. Insects that move towards light in this way are called positively phototactic, while pests like cockroaches who move away from light are called negatively phototactic.

Mechanical Traps

Most commonly used for rodents, mechanical traps can allow for the humane capture and removal of rats and mice. These traps sound simple, and that’s because it is; the concept hasn’t changed for years. Why? Because it’s effective! Rodent curiosity or bait can draw the rodent inside one of these stations, which have a mechanical door ready to close as soon as it enters. There is also new technology on the way that will instantly notify both customer and pest management professional when this occurs, so the creature can be removed immediately. These stations are most frequently used around the interior perimeter of a facility to keep rodents from getting further than the exterior walls.

Why does it work?
Simply put, rodents will often run along walls. They’re extremely athletic and very clever, which is why it’s never recommended to try to place traps yourself. They can learn from close calls with unsuccessful trapping techniques, which is why it isn’t worth the risk to handle rodent issues alone. With proper knowledge and placement, they can be outsmarted.

Sticky Traps and Glue Boards

Perhaps the simplest tools in the pest professional’s shed, sticky traps and glue boards are meant to reduce the population of crawling insects around a facility. Because they’re not very large, they can be used just about anywhere inside a facility.

Why does it work?

These are usually used for small population control in areas where crawling pests are already present. Sticky traps and glue boards are generally coated with a substance that attract pests, which then ensnares them when they step on the surface of the trap. These are great for catching pests like cockroaches, and give you a sense of how many pests are coming through an area over a period of time. Over time, you’ll be able to see if the population is trending downwards or if the problem is getting worse based on the number of pests captured.

Pheromone Traps

Great for combating the stored product pests that pose a huge threat to food processing facilities with large inventories, pheromone traps trick pests into getting trapped. While sticky traps can be used all over, pheromone traps are more effectively used by placing them strategically around storage areas to help monitor for any stored product pests.

Why does it work?

This type of trap uses synthetically replicated versions of insect pheromones, which are secreted chemicals that insects put out to communicate with each other. In this case, the pheromone traps lure pests out from their hiding/feeding areas. There are also probe-type pheromone traps that are best used in bulk grain storage if necessary.

Now this isn’t an exclusive list of all the monitoring devices a pest management professional can recommend around your facility, but it does give you an idea of the most common, effective devices out there. Keep in mind that sanitation and exclusion must also be a big part of any IPM program, but monitoring devices (along with detailed documentation) can take your program to the next level and give you a better feel for the pest issues your facility deals with the most.

Any time you’re using these tools and devices to detect pest hot spots, it’s important to record the results over time. Your pest management professional will keep a logbook of findings on site, and you should reference that regularly. Also, consider requesting or creating a trend map of pest activity over time to help you see which pests are plaguing your facility the most. That way, it will be easy to work towards improving the pest management program you have in place, which in turn will help protect your products from contamination and protect your bottom line.

Martin Easter, Hygiena
In the Food Lab

The New Normal: Pinpointing Unusual Sources of Food Contamination

By Martin Easter, Ph.D.
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Martin Easter, Hygiena

Shiga toxin-producing E. coli in dry flour, and then romaine lettuce. E. coli O104 in fenugreek sprout seeds. Recent announcements of foodborne illness outbreaks have begun involving unusual combinations of bacteria and foods. These out-of-the-ordinary outbreaks and recalls are a small but growing part of the 600 million documented food poisonings that occur worldwide every year according to the World Health Organization. Preventing outbreaks from these new combinations of pathogen and food demand a range of accurate tests that can quickly identify these bacteria. Over the past several years, outbreaks from unusual sources included:

  • E. coli O121 (STEC) in flour: Last summer, at least 29 cases of a E. coli O121 infection were announced in six Canadian provinces. The source arose from uncooked flour, a rare source of such infections because typically flour is baked into final products. Eight people were hospitalized, and public health officials have now included raw, uncooked flour as well as raw batter and dough as a source of this type of infection.
  • E. coli O104:H4 in fenugreek sprouts: One of Europe’s biggest recent outbreaks (affecting more than 4,000 people in Germany in 2011, and killing more than 50 worldwide) was originally thought to be caused by a hemorrhagic (EHEC) E. coli strain that from cucumbers, but was but was later found to be from an enteroaggregative E. coli (EAEC) strain in imported fenugreek seeds—the strain had acquired the genes to produce Shiga toxins.
  • Mycoplasma in New Zealand dairy cows: While not unusual in cattle, the incident reported in August marks the pathogen’s first appearance in cows in New Zealand, a country known for strict standards on agricultural hygiene. The microorganism is not harmful to people, but can drastically impact livestock herds.
  • Listeria monocytogenes in food sources: Listeria monocytogenes causes fewer but more serious incidence of food poisoning due to a higher death rate compared to Salmonella and Campylobacter. Whereas Listeria has been historically associated with dairy and ready to eat cooked meat products, recent outbreaks have been associated with fruit, and the FDA, CDC and USDA are conducting a joint investigation of outbreaks in frozen as well as in fresh produce.
  • Listeria in cantaloupe: In 2011, one of the worst foodborne illnesses recorded in the United States killed 20 and sickened 147, from Listeria monocytogenes that was found in contaminated cantaloupes from a farm in Colorado. The outbreak bloomed when normal background levels of the bacteria grew to deadly concentrations in multiple locations, from transport trucks to a produce washer that was instead designed for potatoes.

The outbreaks underscore the fundamental need to have a robust food safety program. Bacteria can colonize many different locations and the opportunity is created by a change in processing methods and/or consumer use or misuse of products. So robust risk assessment and preventative QA procedures need to be frequently reviewed and supported by appropriate surveillance methods.

Food safety and public health agencies like the European Food Safety Authority (EFSA) or the CDC have employed a wide range of detection and identification tests, ranging from pulse field gel electrophoresis (PFGE), traditional cell culture, enzyme immunoassay, and the polymerase chain reaction (PCR). In the case of Germany’s fenugreek-based E. coli outbreak, the CDC and EFSA used all these techniques to verify the source of the contamination.

These tests have certain advantages and disadvantages. Cell culture can be very accurate, but it depends on good technique and usually takes a long time to present results. PFGE provides an accurate DNA fingerprint of a target bacteria, but cannot identify all strains of certain microorganisms. Enzyme immunoassays are precise, but can produce false-positive results in certain circumstances and require microbiological laboratory expertise. PCR is very quick and accurate, but doesn’t preserve an isolate for physicians to test further for pathogenic properties.

Identification of the pathogens behind foodborne contamination is crucial for determining treatment of victims of the outbreak, and helps public health officials decide what tools are necessary to pinpoint the outbreak’s cause and prevent a recurrence. Rapid methods such as the polymerase chain reaction (PCR), which can quickly and accurately amplify DNA from a pathogen and make specific detection easier, are powerful tools in our efforts to maintain a safe food supply.

Recently, scientists and a third-party laboratory showed that real-time PCR assays for STEC and E. coli O157:H7 could detect E. coli O121, O26 and O157:H7 in 25-g samples of flour at levels satisfying AOAC method validation requirements. The results of the study demonstrated that real-time PCR could accurately detect stx, eae and the appropriate E. coli serotype (O121, O26 or O157:H7) with no statistical difference from the FDA’s Bacteriological Analytical Manual (BAM) cell culture method.

Agencies like the World Health Organization and CDC have repeatedly stated that historical records of food poisoning represent a very small percentage of true incidents occurring every year worldwide. Many of today’s most common food pathogens, like Listeria monocytogenes, E. coli O157:H7 or Campylobacter jejuni, were unknown 30 years ago. It’s not clear yet if unusual sources of contamination arise from increasing vigilance and food safety testing, or from an increasingly interdependent, globally complex food supply. No matter the reason, food producers, processors, manufacturers, distributors and retailers need to keep their guard up, using the optimum combination of tools to protect the public and fend off food pathogens.

Steven Burton, Icicle Technologies
FST Soapbox

Automation Is Happening—Don’t Miss The Boat

By Steven Burton
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Steven Burton, Icicle Technologies

Successful businesses move fast. They stay ahead of their competition by keeping their eye on the newest and most innovative emerging technologies. Failure to embrace the newest, fastest means of production and communication allows other businesses to muscle ahead of slow-to-change competitors, especially in the food industry. This is why embracing automation—even if it requires a commitment from you and your whole organization — is absolutely necessary for every food company.

Guarantee Growth and Compliance with the Internet of Things

The innovation at the forefront of automation technology is the Internet of Things (IoT): Multiple devices interconnected to monitor, communicate and control in real time. Today, a farmer can monitor a crop located in Australia from North America. Ingredients from anywhere in the world can be brought together in a matter of days and distributed just as quickly. Agricultural robots that reduce the risk of contamination and food safety expectations have risen as a result. As exciting as it is to be a part of a constantly innovating food industry, it’s also becoming more challenging to keep up and adapt.

It’s also becoming more necessary. Regulatory agencies are working to keep pace with technological innovations. The standards of food safety—more global than ever—have grown in complexity and will continue to grow as improved, real-time monitoring of products and facilities extends into every type and size of food production company. Properly planned and applied food safety programs are vital to ensuring that globally sourced ingredients and production facilities adhere to regulations to avoid the consequences of failed audits and expensive recalls.

Even for those on top of their regulatory requirements, IoT and other automation technologies are friends, not foes. Automation means that preparation for audits and inspections is reduced to bare minimum, eliminating the need for binders, spreadsheets and months of prep work. Furthermore, one of the greatest challenges of today’s food chain is ensuring not only your own compliance, but the compliance of your vendors. Dealing with hundreds or thousands of incoming ingredients and other materials at any given time is a massive undertaking, let alone dealing with vendor certifications. Integrated, automated systems for food production management streamlines processes and communication and reduces the risk of error and recall throughout the supply chain.

Don’t Be Paralyzed by the F-word: Fear

It is clear to see that staying competitive and staying in business in an interconnected world is possible only if the newest technology is embraced. Why are some companies reluctant to adapt, even when they know it is crucial to a successful future?

Some fear that their managers and employees may not adapt, that their functioning programs already in place may be interrupted, and that ever-present fear of a price tag.

To alleviate these fears and embrace the power of the future, it is vital that the company’s new automation and IoT utilize a software that is:

  • User-friendly so that employees, new or existing, can hit the ground running
  • Capable of building upon an existing food safety program and continue its success
  • Able to improve existing food safety programs to ensure updated compliance
  • Cost-effective and a good business decision when compared to the cost of manpower and recalls

One of the most common reasons a company chooses not to implement a new technology concerns the last point: Cost. To maximize the benefit of automation and IoT, expenses like laptops, tablets and phones are advisable in addition to software. The cost of the software itself when there is a paper or spreadsheet system that is working may seem unnecessary—after all, why buy a telephone when the telegrams are working just fine? In the high-speed world we now live in, a low-speed business approach is fatal.

There is good news when it comes to automation adoption: In response to the growing need for technology and the reluctance of companies to take on the expense, new incentives are being put in place in order support businesses and keep a country’s economy competitive. For example, the U.S. Tax Cuts and Job Act of 2017 allow write-offs of new automation technology in the first year of purchase, vastly reducing the initial cost impact of implementing automation technologies. Many state and provincial governments provide grants for updating technology to improve safety and traceability.

Automation Will Feed the World

Technology and automation in agriculture and food production make a company competitive, but it is also an unavoidable requirement going forward. Looking at the big picture, it’s also necessary to meet the demands of a booming global population. Food is, in many ways, the most essential industry to human life.

In The Future of Food: Food Production, Innovation, and Technology, authors David B. Schmidt and Kimberly Reed say it clearly:

“Each U.S. farmer feeds more people worldwide than ever before, at 155 people per farmer. In 1960, that number was 25.8 people. By 2050, the same farmer will need to feed 232 people… With finite resources, it will take innovation and a variety of technologies to meet the world’s food demand. This includes using new technologies. At every step of the journey from farm to fork, technology is helping us produce a safe, abundant, sustainable, and nutritious food supply.”

It took centuries for the writing of letters to be replaced by telegrams. It took only 130 years from the invention of telegrams to the use of email. A farmer with a shovel is now a robot, with the agricultural robot market expected to increase by more than fivefold to $12.8 billion over six years. 94% of packaging operations use robotic technology today. A recent survey found that half of food companies interviewed plan to increase their use of automation in the next two years.

Where will food production be in 2020? And where will your company be in that near future?

Manik Suri, CEO and co-founder, CoInspect
Retail Food Safety Forum

Rodent Poop, the Olympics and Food Safety Inspections that Work

By Manik Suri
Manik Suri, CEO and co-founder, CoInspect

Another day, another potentially brand damaging story—just ask Little Caesars. On February 7, the health department closed down an Indianapolis-based location because customers found some rodent feces on their pizza—it was clearly a food safety violation, and pretty disgusting. Meanwhile on the other side of the planet, athletes prepared their entire lives to compete in the Olympics. More than 100 people contracted Norovirus around the Olympic sites in Pyeongchang, where the athletes were in danger of getting a violent, contagious stomach illness that would derail their dreams and prohibit them from competing.

We live in a world that eats out, and if we don’t develop new techniques to protect customers in restaurants and food service settings, more people are going to get sick (or worse) from foodborne illnesses. The current food safety process is broken, and needs to be fixed in restaurants nationwide and globally.

At Google, Larry Page has spent two decades managing the speed of a search result for the company’s core service. From 1997 forward, Page has obsessed about the right results as fast as possible. When has Google ever been slow? People use the search engine daily because it always works.

For restaurants to grow and thrive, they need habit formation from fickle consumers. Habits are formed when restaurants deliver on their value proposition slice after slice, burger after burger, and salad after salad. So what is your organization doing to make sure that every meal is extraordinary— not only delicious, but also safe? What are you doing to prevent Norovirus and other foodborne illnesses?

Well, you’re probably not studying the data to create better processes. A 2017 survey of the top 500 restaurant chains found that 85% use paper logs or spreadsheets as their core technology for safety, quality and standards management. Paper logs, line check clipboards or homemade Excel sheets on a laptop are inefficient and ineffective systems to manage something as critical as food safety.

Many restaurants have upgraded their mobile ordering software and relaunched their menus on LED screens, but still make employees use clipboards to conduct food safety line checks and QA audits. This devalues the importance of their food safety operating protocols. Restaurant teams are comprised mostly of millennials and Generation Z— the mobile generations. They expect to be trained, do work and solve problems with their phones. But when their employers train with paper manuals and complete work with paper forms, it’s a huge disconnect for them.

Moreover, how did people at Little Caesars HQ in Detroit have insight into that recent incident in their Indianapolis store? What operating data do they have to examine? What line checks happened in store on the day in question? When was their last third-party food safety audit? What corrective actions were taken? That information would be hard for them to know, if, like the vast majority of restaurant chains, they were not collecting and analyzing data with modern tools.

Upgrading your operating technology so that your people have digital tools is not expensive. Software is much more affordable today because of the software-as-a-service revolution and the extraordinary computing power and proliferation of mobile devices. An emerging ecosystem of safety and software companies is ready to take your facilities into the 21st century. But the C-Suite has to decide it wants to empower its employees to do their best work and commit to having real-time data that is actionable and accurate.

Having mobile ordering software and LED screens for menus is helpful and valuable. But food safety is the most important component of every restaurant (and other food service companies). It is imperative that the food service industry embraces digital solutions to elevate their food safety standards. Without proper food safety standards, any organization could face a crisis like Little Caesars and the Olympics recently experienced. All it takes is one tainted meal to harm your guests—and your brand.

Omar A. Oyarzabal, Ph.D.

Unraveling the Impact of FSMA On Acidified Food Regulations

By Omar A. Oyarzabal, Ph.D.
Omar A. Oyarzabal, Ph.D.

The world of acidified foods is complicated—the question of how an acidified food is distinguished from an acid food, how to measure pH of acidified foods that are not homogeneous, what kinds and how records should be maintained and finally, how FDA enforces requirements? As consultants to FDA regulated industries, we receive numerous questions, as does FDA directly, on acid and acidified foods. This Q&A, answered by EAS Independent Consultant, Omar Oyarzabal offers insight into commonly received questions and their answers.

Q: How you distinguish an acid food from an acidified food?

Omar Oyarzabal: Acid ingredients have a natural pH of 4.6 or below, while low acid ingredients have a natural pH above 4.6. Acidified foods are comprised of low acid ingredients mixed with acid ingredient or acid to bring the finished product equilibrium pH to less than 4.6. Remember, all pH meters have a normal variation in the measurements, and therefore that variation must be understood and accounted for when measuring the equilibrium pH. For instance, if you measure a pH of 4.3, and may have a ± 0.02, the actual pH is between 4.28 and 4.32. If the variation is ± 0.05, the actual pH may be between 4.35 and 4.25. We would like to see some room for safety and therefore the highest target equilibrium pH is, in many cases, 4.4. The finished equilibrium pH is the pH of all components of the product. It can happen quickly after mixing and final preparation, or it may take hours or days.

Note: pH meters perform potentiometric measurements, meaning that the electrode measures a potential of [H+] or [OH-] in the test solution by comparison against known [H+] or [OH-] standard buffers. The numerical numbers produced by a pH meter are calculated following a scale. Therefore, we need to verify that the calculated pH scale is reliable by proper and regular calibrations.

Total Cases Reported for Previous Years
Botulism Cum 2017 Five-year weekly average  2016  2015  2014  2013  2012
Total 79  4  201 195 161 152 168
Foodborne 5  0  31 37 15 4 27
Infant 71  3  144 138 127 136 123
Other (wound and unspecified) 3  0  26 20 19 12 18
Table I. The main biological hazard of concern in acidified foods continues to be Clostridium botulinum. The latest Notifiable Diseases and Mortality Table was released by the CDC on January 5, 2018. Cases of botulism reported in the United States (Week ending December 23, 2017).

Q: Is there a formal procedure for assessing initial/raw pH? Specifically, should pH be immediately measured or should the system be given time to come to equilibrium?

Oyarzabal: There are two important pH measurements, the raw pH and the equilibrium pH. The raw pH is the pH of all the low acid food ingredients without the addition of the acid ingredients or acid to bring the finished product equilibrium pH to below 4.6. The equilibrium pH is tested in finished product after the pH has “equilibrated” and all particles and components of the finished product have the same pH. It is customary to measure the equilibrium pH after 24 hours of manufacturing, but the actual time depends on the products. If the product has particles with high buffer capacity, the product may take more than 24 hours to achieve an equilibrium pH. The shift from raw pH to equilibrium pH is called the “pH shift”.

Q: What is the basis for the 10% rule for non-acid ingredients, and is it acceptable to have more than 10% but still have acceptable shift in pH?

Oyarzabal: There is no regulation requiring less than 10%. It is a rule of thumb based on experience that has been used for some acidified products over the years. It is not part of any regulation per-se. The actual amount of acidification in a formulation is something for a process authority to evaluate and make a final recommendation.

Q: A challenge study is generally requested for an acidified food filing, however, the detail for the challenge study is not specified. Previously the three main pathogens were suggested for evaluation (pathogenic E. coli O157:H7, Salmonella and Listeria monocytogenes) and a 5-log reduction as criteria. What are current requirements?

Oyarzabal: A challenge study may be needed when developing a new product. But the microorganism of public health concern and/or spoilage concern will depend on the type of product (ingredient formulation) and process. New product should be treated on a cases-by-case basis and a processing authority should make recommendations.

Q: What is the focus of the FDA inspections of acidified foods? What are the agency recommendations for processors?

Oyarzabal: FDA has stated in the Preamble to the final Preventive Controls for Human Foods (PCHF) regulation that acidified foods would not be exempt from 21 CFR 117, Subparts C (specific preventive control requirements) and G (supplier management). Essentially, an acidified food manufacturer, during an FDA inspection, will be have to demonstrate compliance with both 21 CFR 114 (acified foods) and 21 CFR 117 (all foods). During any given FDA inspection, the FDA investigator may focus their attention on just part of the acidified food operation and the applicable regulations or on the entire acidified food operations and all applicable regulations. It is dependent upon the individual FDA investigator, the circumstances triggering the investigation, any recent illness outbreaks or deaths associated with a similar acidified foods, written FDA headquarters programs on acidified foods, etc.

Q: Is a continuous recording method required to prove compliance in meeting Critical Control Points at all times or is periodic manual check acceptable?

Oyarzabal: From a preventive controls perspective, there is no requirement for continuous monitoring. Monitoring has to be performed frequently enough to make sure there is “demonstrated” control of the hazard(s) addressed at that process or step. It may come down to what equipment is in place. But at the end of the day, the preventive control regulation provides flexibility for frequency, so long as it is appropriate to control the identified hazard. If a firm has justification that monitoring at a certain frequency is sufficient to control a hazard, it would be helpful to provide that justification if the issue came up during an inspection. Justification should be emphasized for the frequency of monitoring and verification, and must be robust enough to guarantee safety.

Q: Are salad dressings exempt from the acidified food regulations? What about cold brew coffee?

Oyarzabal: Most salad dressings may be exempt, but it would be wise for any salad dressing manufacturer to ensure that they are using a processing authority with expertise in the type of product to conduct a food safety evaluation and put their recommendations in writing, just in case there is a challenge by FDA, a customer or competitor.

All the cold brew coffees we are aware of are sold under refrigeration and therefore are exempt from low acid or acidified food product regulations.

Note: Most states have individuals that will help the industry identify the laws covering their products. The FDA also has a portal for submission of industry request related to food safety regulations that may apply to specific products.

Q: I want to produce a cold-fill beverage that will have preservatives in the recipe, do I still require a process authority to create a process schedule?

Oyarzabal: You need to have someone to review the product formulation and the process to see if it is a low-acid or acidified food, and determine the food safety regulation under which the product falls. It may be exempt from some regulations, but someone with the appropriate knowledge, such as an FDA recognized “Process Authority”, needs to make that determination. The FDA also has a portal for submission of industry questions related to food safety regulations that may provide a more direct answer to this question.

Q: What are FDA’s expectations on cold-filled acidified foods? Do we need to hold the products till the product formulation ensures 5-log reduction of relevant pathogens?

Oyarzabal: This is a product-related question and without the full understanding of the formulation and process, it is hard to provide any recommendation. The cold-filled process can be managed for acidified foods in a manner that would maintain the safety of the food and not impact the pH requirements or result in recontamination.

Q: Does FDA consider “water” ingredient as a “low-acid” ingredient? What about under the FSMA Rule?

Oyarzabal: Yes, traditionally water has been considered a low acid ingredient as it has the ability to modify the pH of the food. In some recipes water is added in such a low amount that it doesn’t change the rest of the formulation. The addition of water in those cases doesn’t change the rest.

Q: Are inspectors using the Acidified Guidance Document that was pulled a couple of years ago for inspections?

Oyarzabal: The 2010 draft received lots of comments, and ultimately was never finalized from draft form. Investigators inspecting acidified foods are aware of the 2010 guidance, but they should not be enforcing the provisions in this draft guidance. A guidance document is not binding on FDA or industry, but provides recommendations to consider as it contains the agency’s thinking at a given time in relation to a given piece of regulation. That being said, based on observations and comments from the acidified food manufacturing industry, FDA investigators are using the draft guidance as a reference source.

Q: Are electronic records permitted for process controls (e.g., electronic record of temperature instead of chart recorders)?

Oyarzabal: Yes. The Preventive Controls rule speaks to the acceptability, in theory, of electronic records as long as they are in compliance with 21 CFR 11 (Electronic Records; Electronic Signatures), and are accessible and retrievable as appropriate in a reasonable time frame for review by an FDA investigatory.

Matthew Botos, ConnectFood
FST Soapbox

Innovation Fundamentals Start With A Food Safety Foundation

By Matthew Botos
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Matthew Botos, ConnectFood

Food Safety. Two powerful words that hold the key to growth for food and beverage in the Chicago region (Chicagoland) in 2018. And when said differently, they can mean so many different things.

Everyone eats. Is your food safe? Do you want to consume safe food? How do you manage the safety of your food? How long is my food safe (my mom calls and asks this all the time)? All good questions and something that can be terrifying to the thousands of local companies and millions of consumers in any given area. The Chicagoland community understands that availability of proper meals and nutrition can be an issue for certain areas, and we are tackling that as a community in other efforts.

Food safety is impactful to the farmers (growers), manufacturers, and especially consumers. Think about when you walk into a grocery store. Every product you look at is mandated to have some type of food safety risk management plan. The consumers of today and tomorrow are demanding healthier, clean label, safe items. Farm-to-table is more than a trend; it’s a way of life. My belief is that food safety is “basics done well” and there are tens of thousands of professionals in Industry, academia and government working to make this happen. I try to draw the analogy that the food and beverage industry is a like an iceberg—we only really see the tip of that iceberg being the large national names that everyone recognizes. FDA has an estimated 125,000 registered facilities. This does not include facilities regulated by USDA and other unregistered facilities. Therefore, the food and beverage industry iceberg is actually mostly below the water line. It is estimated that 80% of all food companies have less than 100 employees. In my experience, I believe that number is closer to less than 50 employees.

Chicagoland is filled with high-growth companies that are rapidly changing the industry. They have a unique product, it tastes great, and the packaging is amazing. They believe we should all buy their products! When working with these companies, I ask them: What is your pH? What is your water activity? What temperature do you heat your product to and for how long? Do you use preservatives? What is your shelf life? How are you keeping your records? Do you know if your suppliers have safe food? DO YOU have a food safety plan? I have seen plenty of these talented people start to cry.

There should be no fear of food safety, and once you sit down with companies and talk about a step-by-step “basics-done-well” plan, they realize that they can do this. We have strong innovative large, medium and small companies in the region. And the way they come together, through organizations like Chicagoland Food and Beverage Network, gives Chicagoland the competitive edge at being the food and beverage hub for the United States. But none of this can happen without food safety.

For companies, it is simply a matter of telling your story and how you safely make your products. Sometimes companies have to make some changes and they must prepare proper paperwork. These steps are necessary to inform the regulators and the retail outlets who want to know that there are food safety plans in place and the products are safe.

Many companies are moving toward innovative technologies to make food safer. We have companies using high pressure processing to help with shelf life and inactivation of pathogenic bacteria. Some are using chemistry. Some are using unique packaging. The great thing about the Chicagoland community is that we have access to experts in all of these fields that will help companies continue to grow safely. This includes incubators, marketing firms, scientists and international organizations like the IIT’s Institute for Food Safety and Health.

Chicagoland food and beverage companies are world leaders and will continue to be so as long as they start with food safety.

Tim Birmingham, Almond Board of California
In the Food Lab

10 Years, 0 Salmonella Outbreaks

By Tim Birmingham
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Tim Birmingham, Almond Board of California

Almond Board of California (ABC) tackled food safety head-on in the wake of emerging Salmonella concerns in the early 2000s. Conventional wisdom of the time suggested that low-moisture foods like almonds presented a minimal threat, but rather than simply accepting this, ABC engaged in research to better understand the risks. The resulting best practices and groundbreaking mandatory pasteurization program developed by ABC remain the gold standard for other sectors—and drive continued food safety and quality efforts for California Almonds.

In 2017, ABC marked the 10-year anniversary of its mandatory almond pasteurization program – and, most importantly, 10 years free of Salmonella recalls and outbreaks attributed to California Almonds. The almond industry is proud of its unified efforts over the last decade, as well as the food safety record we’ve been able to achieve. However, the work to protect and improve food safety and quality continues. Looking back at our initiatives and successes reminds us of how important this work is and drives our exploration of what’s next.

Understanding and Addressing the Risk

Outbreaks of Salmonella in 2001 and 2004 raised questions and concerns about food safety and quality across industries. For California Almonds, one of the biggest challenges was determining the true level of risk. The easy answer seemed to be that risk should be low, that, based on accepted conventions of the time, pathogens should not be able to grow in almonds and other low-moisture foods. However, ABC investigated further and quickly realized that the pathogen could present a problem. The organization decided to take action and tackle Salmonella and other potential threats.

In collaboration with food safety experts and research partners, ABC began research in 2001 to better understand the prevalence and concentration of contamination in almonds, conducted in tandem with efforts to develop strategies for contamination control. ABC was able to gather enough survey data over the course of several years to show that Salmonella was indeed present in about 1% of the almonds tested at very low concentrations. This data was fed into ABC’s risk assessment work, which enabled identification of appropriate performance criteria for ensuring consumer safety (>4-log reduction).

At the same time, ABC also worked to identify effective processing technologies and the best means of validating them. A technical expert review panel was assembled to help ABC develop a plan, assess research needs, establish standards and create guidelines for the industry. Extensive work went into determining how to validate equipment, including the determination of an appropriate surrogate (non-pathogenic microorganisms) that could be used in lieu of Salmonella in the plant. Concurrently, researchers worked to determine the specific time and temperature combinations needed for a >4-log (and 5-log) reduction for a range of pasteurization processes, including oil roasting, blanching and dry roasting, some steam processes and PPO processing. ABC and partners invested significant time and effort into this research, which culminated in the development of the groundbreaking mandatory pasteurization program for Salmonella reduction, and validation guidelines.

Process Implementation and Ongoing Education

Voluntary compliance with the pasteurization program began in 2004, well in advance of September 2007, when it became mandatory. By that time, pasteurization was established as the industry norm and laying the groundwork for ongoing food quality and safety efforts. Today, ABC has more than 1 billion pounds of validated pasteurization capacity for processes that maintain the raw characteristics of almonds, including steam, moist heat and propylene oxide (PPO). It also has close to 1 billion pounds of validated capacity for processes such as dry roasting, oil roasting and blanching. All reduce the level of potential contamination in almonds without diminishing the product’s quality, nutritional value or sensory qualities (taste and crunch).

ABC also developed a comprehensive round of updates to recommended food safety practices, creating a powerful program with tools that help growers and processors achieve their desired results. These tools include Good Agricultural Practices, Good Manufacturing Practices, HACCP guidelines and Pathogen Environmental Monitoring resources.

In total, ABC has made a $5 million investment in food quality and safety research and validated more than 200 treatment processes, to date. It remains committed to this mission, maintaining close connections with the scientific and regulatory communities to stay current on food safety in the broader context as well as issues specific to California Almonds. All relevant insights and information are disseminated to growers and processors in the form of clear, practical resources, including print publications and digital communications, and workshops and one-on-one field trainings.

What’s Next: Research, Tech and Regulatory Practices

The mandatory pasteurization program is now well established, but it isn’t static – ABC continues to stay on top of the latest methods, regulations and needs impacting California Almonds. Industry investment continues to increase, particularly in processes that maintain the raw characteristics of the product. And, while much information regarding processes and technologies are company-specific and confidential, equipment manufacturers continue evolving and growing their offerings, with a particular focus on maximizing almond quality and throughput.

On the regulatory side, FSMA continues to roll out for growers and processors. ABC helps growers and other stakeholders understand which rules apply, what actions to take to ensure compliance and when specific requirements come into effect for different operations, with FSMA-related resources, Preventative Controls and Produce Safety trainings and timely information available online. Many processors and non-farm huller/shellers started 2018 already meeting FSMA Preventive Control requirements, but the number of impacted orchards and huller/shellers expanded in January as the Produce Safety rule came into effect. At this point, the almond industry and the larger community of food and beverage industries have had time to assess the impact on their stakeholders and take action to ensure FSMA compliance.

FSMA reflects the evolving role of FDA in ensuring food safety. Traditionally, FDA has taken a reactive approach to food safety. The agency now has the authority to investigate farms and facilities regularly to ensure food safety regulations are followed. For the first time, growers and huller/shellers falling under the farm definition may be audited by FDA or FDA-designated agencies. While some growers may choose the exemption option, ABC encourages almond growers to understand the rule’s requirements and develop food safety plans appropriate to their farms. It will be new and uncertain territory for some, but with the FDA’s proactive approach, staying ahead of the curve on food safety and quality will be beneficial.

Currently, almonds are the only tree nut with a mandatory pasteurization program and defined performance criteria accepted by FDA. They have paved the way for validation of other tree nuts, and those industries should also consider implementing appropriate preventive controls for Salmonella. ABC’s work can be considered a road map for other nuts and low-moisture foods, but what works for almonds will not always work for other foods. Research specific to each type of nut needs to be conducted to uncover pathogen prevalence and concentration, as well as pathogen/surrogate resistance to various processes. We will continue to be proactive, as well, evaluating current practices and engaging in research to improve how we understand and control microbial contamination in almonds.

Even with a track record to take pride in, the responsibility and work of food quality and safety never end. We will continue to update and evolve programs, not only as a function of compliance, but to protect the almond customers who support us every day.

Steven Burton, Icicle Technologies
FST Soapbox

Could Blockchain Technology Drive FSVP Compliance?

By Steven Burton
Steven Burton, Icicle Technologies

From farm to fork, food produced today goes through more hands than ever before. A greater number of players in the production of even a single product could increase that the risk for foodborne illness. Not only do companies need to check incoming and outgoing products from their own facilities, but they also need to consider whether products that they are importing from other countries are compliant with local regulations, and whether the products that they are exporting are compliant with the regulations of the destination country.

The current traceability standard of “one step forward, one step back’”is less and less suited for the current global marketplace, and governments are demanding more. Handling all this information is a challenge for food producers of all sizes, around the world.

Taking Traceability Global with FSVP

Needless to say, with 600 million people contracting foodborne illnesses every year, there is a dire need for food traceability and transparency in the food supply chain. If and when something goes wrong, traceability gives oversight agencies greater visibility investigating the root causes of an outbreak to prevent further risk to the public. It also allows companies to minimize the financial impact of a recall if they are able to pinpoint exactly which lot numbers of their products are affected.

In response to the changes in the food industry, in 2011 the USFDA introduced FSMA to implement a more proactive food safety regulatory system. With FSMA came the Foreign Supplier Verification Program (FSVP), which basically extends FSMA regulations to companies supplying food to the United States. All U.S. importers are now required to monitor and manage their foreign suppliers through six steps of hazard analysis, record keeping and more. Given the complexity of the global food supply chain, this is by no means an easy undertaking and it is clear that technology is crucial to achieving this granular level of data management alone. Blockchain technology, however, might be the answer to this problem—and many other related ones.

What is Blockchain Technology?

Evolving from the digital financial world, blockchains are distributed databases that build a growing chain of ordered records, called blocks. This means that any type of information can be stored in a chronological, consistent and secure way; even if multiple users are involved, it is extremely difficult to alter a blockchain.

Since any information on the blockchain is shared with all of its users, they can view any transactions made historically and in real-time. Theoretically, this could allow authorities to pinpoint food problems within minutes, when previously it would take days, potentially saving many lives in the process.

Blockchain in Action in the Food Industry

In 2016, retail giant Walmart started using a pilot version of the technology in its stores, tracking two products using blockchain: A packaged produce item in the United States and pork in China. Walmart announced that the results were “very encouraging,” noting that using blockchain technology could dramatically increase the speed of traceability from days to minutes. In fact, Walmart is now taking it to the next level with a collaboration with one of China’s largest retailers, JD.com, and their suppliers, to bring a higher level of food safety to China.

Other major food suppliers and retailers—Dole, Driscoll’s, Golden State Foods, Kroger, McCormick and Company, McLane Company, Nestlé, Tyson Foods and Unilever—have also signalled their intention to work with IBM to create blockchain-based solutions. Blockchain technology is even being used to track the movement of tuna through the ocean and all the way to the consumer.

At the same time, implementing blockchain technology throughout the industry is a mammoth task. As of now, blockchain technology has a problem with scaling up and can only process a limited number of transactions per second, which would not be sufficient given the needs of the global supply chain. According to Coindesk, each transaction costs about $0.20, and can only store 80 bytes of data, so the bill might become quite hefty as well.

There’s also the fact that the food industry is traditionally slow to adopt new technologies. It’s not just about big players like Walmart—small, medium, and large businesses alike need to come onboard in order for this to become an industry-wide standard.

Can FSVP Unlock the Potential for Blockchain Technology?

There are several reasons why blockchain technology could be the key to tackling the complex challenge that is tracking and verifying foreign suppliers. Blockchains can help increase transparency and communication across the food supply chain, ensuring that there are no gaps and that records are widely available and up to date. When all the information about suppliers and products is easily accessible, the potential to increase the speed of recall response is very high.

Blockchain technology is also suited to FSVP’s goals, specifically. One of the main goals of FSVP and FSMA generally is to tackle the issues of food fraud, intentional adulteration and bioterrorism that are unique problems of our time, in terms of scale if nothing else. Such a modern problem requires modern solutions. Because the blockchain, forming the basis of cryptocurrencies like Bitcoin, focuses on security, it could mean that blockchains can help close the gaps that would be exploited by food companies employees, or other actors who harbor ill intent.

The reality, however, is that the level of industry-wide coordination—and voluntary transparency—that would be necessary to deliver real benefits is extremely high. The theoretical possibilities are exciting and hugely impactful; the practical reality is more complex. For blockchain to reach its full potential, it has to be universally mandated, which is highly unlikely given the current circumstances. It seems more likely that adoption in this area could be driven by industry organizations and/or government, but unfortunately, the recently proposed budget cuts for the FDA might block progress in the latter area.

Still, with major food suppliers and retailers leading the charge and taking blockchain technology for a test run, the rest of the industry is waiting with bated breath to see what happens next.


FDA Collaborates with AMA on Foodborne Illness Education

By Food Safety Tech Staff
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FDA and the American Medical Association (AMA) have joined forces to release continuing medical education videos for doctors about foodborne illness. FDA and AMA felt that the globalization of the food supply as well as the growth of foodborne pathogens necessitated more medical education and patient counseling on foodborne illness.

“These changes create a need for physicians to guide patients in protecting themselves from foodborne illness, especially those who are among the most vulnerable to serious consequences and who are most likely to be in a physician’s care: the very young whose immune systems are not yet fully developed; individuals whose immune systems are weakened by pregnancy, age, chronic conditions like diabetes, cancer and HIV/AIDS; and persons with organ transplants taking immuno-suppressive medications,” according to an FDA release.

The two videos, “What Physicians Need to Know About Foodborne Illness: Suspect, Identify, Treat, and Report” and “Preventing Foodborne Illness: Talking to Patients About Food Safety” are available on FDA’s Food Safety and Nutrition Resources for Healthcare Professionals webpage.