Tag Archives: Focus Article

Bryan Cohn, Foodlogiq

Managing Risk and Traceability in the Supply Chain

By Food Safety Tech Staff
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Bryan Cohn, Foodlogiq

Traceability and risk management go hand-in-hand. In a Q&A with Food Safety Tech, Bryan Cohn, food safety solution engineer at FoodLogiQ, shares his thoughts on risk and the critical role of communication.

Food Safety Tech: What does risk analysis mean in a complex supply chain?

Bryan Cohn: Risk analysis means the same thing it has always meant. The concept of risk is elemental; it transcends all of humanity and is rooted deep within our very DNA. Sure, we’ve added tools and technology to help us, but we still can not see into the future; thus, there will always be a risk. The best way to perceive, evaluate and comprehend risk in a complex world is faster and more accurate communications.

FST: Why is communication critical to avoid or mitigate risks within the supply chain?

Cohn: Let’s use an analogy here. Nobody likes traffic, right? In the morning when you’re getting ready for work, you might turn on the local news or check your favorite navigation app to find out the traffic conditions along your commute. You know your commute like the back of your hand, and you’re aware of every potential trouble spot along the way. But like most of us, you probably rely on fast and accurate communication from either traffic cameras, local news reports, or navigation information on your phone to give you a real-time analysis of what is happening. So aside from the usual trouble spots, you are made aware of any unexpected traffic accidents, road construction, or weather delays, which allows you to make real-time, actionable decisions about your commute.

If we think ahead – the same way we do about our work commute – and re-evaluate our communication strategy around our supply chains, we can begin to take a much stronger proactive approach to risk analysis and mitigation. If we spot a trend within our supply chain that may increase risk, we can take action before a threat materializes or intensifies.

FST: Can your risk management plan create value in the company?

Cohn: Any time a good communications strategy is integrated into your risk management program, you create value. By soliciting, evaluating and responding to feedback, you will inherently mitigate risk by addressing potential problems before they become problems and identifying new threats in a fast moving complex supply chain.

Romaine Lettuce Outbreak: We Knew It Would Get Bad Quickly

By Maria Fontanazza
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This year’s multistate outbreak of E.coli O157:H7 infections linked to romaine lettuce affected 210 people, killing five. Although the outbreak was officially declared over by the end of June, questions still remain as to the exact source. Given the widespread nature of the outbreak and the speed with which illnesses occurred, there are many lessons to be learned from the case.

During last week’s annual Food Safety Consortium, industry stakeholders from the FDA, CDC and produce associations gathered to discuss agency action upon learning of the outbreak and where there is room for improvement.

The investigation began in April 2018 when the New Jersey Department of Health contacted the CDC about a cluster of E.coli O157:H7 illnesses from people who said they ate salads at various locations of the same restaurant chain. Three days later, the agency was able to confirm eight O157 isolates from six states with the same patterns using PulseNet. And five days after that, the CDC posted a notice on its website about the investigation of 17 cases across seven states.

“We knew right away that this was going to get bad and that it would get bad quickly,” said Matthew Wise, deputy branch chief for outbreak response at the Outbreak Response and Prevention Branch of the CDC. “We saw illnesses ramp up quickly.” He added that the agency saw a lot of illness subclusters, all with romaine lettuce as the common ingredient.

The epidemiological evidence clearly indicated chopped romaine lettuce, and it appeared that all the affected romaine was coming from the Yuma, Arizona growing region, noted Stic Harris, director of the Coordinated Outbreak Response & Evaluation Network at FDA. But then things got even more confusing, as an Alaskan correctional facility was also investigating a cluster of cases. This allowed the agency to trace the source directly back to Harrison Farms as the sole supplier to the correctional facility. However, as the multi-agency investigation continued, they uncovered that the source was not just one farm. “There were three dozen farms in the Yuma region that supplied romaine lettuce,” said Harris, adding that we may never know which exact farm, and even if it was one farm, that was the source of the outbreak.

(left to Right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Green Products Handler Marketing Agreement

During June, July and August, the FDA sent a multidisciplinary team of 16-18 people to conduct an environmental assessment of the affected area. Upon taking 111 samples, they found 13 different Shiga toxin-producing E. coli strains, but only three matched the strain of the outbreak. Water from 14 locations, including discharge, reservoir and canal water, was also tested. The environmental assessment found pervasive contamination in the water. But here was the big problem, said Harris: “There was no smoking gun. We don’t know how the E.coli got into the water, and we don’t know how the water got onto the lettuce.” He added that additional research is needed, and that government and non-government work must continue to identify the source.

There are several challenges associated with the complexity of this type of produce outbreak, said Harris and Wise:

  • The production lot information disappears at the point of service
  • Having a commingled product hinders traceback
  • Records present a challenge because agencies try to look at each company and their individual records, and every company has their own way of doing things—this takes time
  • The breadth of the impacted area—trying to do an environmental assessment for that area was staggering work
  • People who eat lettuce eat it often
  • Many people don’t remember what type of lettuce they ate
  • The product has a short shelf life
  • Communication: The packaging isn’t transparent on where it’s grown

Scott Horsfall, CEO, California Leafy Green Products Handler Marketing Agreement, chimed in on the challenges posed by the complexity of the outbreak. “If you compare these numbers with the 2016 spinach outbreak…they’re very similar [in the] total number of illnesses [and] number of states involved. But in [the spinach outbreak], it led to a specific farm. What we saw this time was very different.”

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One of the large successes in dealing with the outbreak is that the agencies issued public warnings quickly, said Wise. The produce industry also came together to form the Leafy Greens Food Safety Task Force. In addition, FDA is expanding its sampling for the coming harvests, according to Harris. “I think that in terms of the speed of the environmental assessment, we need to be quicker with that. We apparently hadn’t done one in quite a long time at FDA,” he said.

Harris and Wise also stressed that for industry to work more effectively together, they need to work with the FDA and CDC before there is an outbreak.

“This outbreak was a frustrating experience for all of us,” said Horsfall. “We have to communicate more and better when we can. And as an industry, stop these outbreaks from happening.”

FDA: 172 Ill, 1 Death, Romaine Lettuce E. Coli Outbreak Likely Over

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Food Safety Consortium

Were You There? Images from the 2018 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety Consortium

 

Images credit: amybcreative

Alert

Outbreak of Salmonella linked to Raw Turkey Products Continues, USDA Facing Pressure to Name Brands

By Food Safety Tech Staff
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Alert

Just in time for Thanksgiving, consumers are worrying about whether the turkey they are buying for the holiday is contaminated with Salmonella. A multistate outbreak of drug-resistant Salmonella linked to raw turkey products has been going on for months, but now USDA is facing increasing pressure to name any associated turkey brands. According to the CDC, “a single, common supplier of raw turkey products or of live turkeys has not been identified.”

As of the agency’s last update (November 5), 164 people across 35 states have been infected with the outbreak stream of Salmonella Reading. 63 people have been hospitalized, and one death has been reported. Three people reported living in households where raw turkey pet food was given to pets.

Thus far the CDC isn’t advising retailers to stop sell raw turkey. It is stresses that consumers should follow the basic food safety steps to prevent Salmonella infections, including proper handwashing, cooking the turkey to the proper temperature (including reheating the meat), keeping food prep areas clean, proper thawing of turkey in the refrigerator and avoiding feeding pets raw food.

CDC states that if the information becomes available, it will provide notification related to the supplier(s) related to the outbreak.

John Besser, CDC, 2018 Food Safety Consortium

CDC: Quite a Year for Outbreaks, Exciting Time in Food Safety

By Maria Fontanazza
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John Besser, CDC, 2018 Food Safety Consortium

This year Salmonella outbreaks hit chicken, shell eggs, ground beef, pre-cut melon, dried and frozen coconut, pasta salad, chicken salad, turkey, ground beef, raw sprouts and breakfast cereal. There were also significant Cyclospora infections linked to salads sold at McDonalds as well as vegetable trays. For the first time in 10 years, a Listeria outbreak was linked to an FSIS regulated product (deli ham); ground beef was affected by E. coli O26. And perhaps the most notable outbreak of the year was the E.coli O157:H7 outbreak linked to romaine lettuce from the Yuma growing region.

“It’s been quite a year for outbreaks,” said John Besser, Ph.D., deputy chief, enteric diseases laboratory branch, at CDC, referring to the pathogens that have plagued a variety of consumer products in 2018. “Out of this group, there are a lot of the things you’d expect, but also some brand new unexpected [products affected] like shredded coconut and Honey Smacks cereal.”

Despite the number of outbreaks that have hit the food industry in 2018, “this is a really exciting time to be in public health and food safety, because there are a lot of tools we can use to help make food safer,” said Besser. Most of the diseases that impact the food industry are preventable if their source can be identified, and using big data can have a tremendous impact on improving food safety.

Yesterday John Besser informed attendees at the 2018 Food Safety Consortium about CDC’s latest efforts in foodborne disease surveillance, which he defines as the
systematic collection, analysis and interpretation of health data. The agency is actively working to identify unrecognized gaps in the food supply chain and provide the industry with information it can use to make products safer. “The most important reason for detecting outbreaks is so we can identify the problem and fix it,” said Besser.

There are two ways that CDC detects outbreaks. The first is via the “citizen reporters” who are observant and alert the agency. (This is actually how E.coli O157 was discovered). The second is through pathogen-specific surveillance where CDC takes lab information and links cases that are geographically diverse. These cases are often widely dispersed and are the most effective way to find food production and distribution problems, and are often easier to address than local issues, according to Besser.

He went on to review the successes of PulseNet and the promise of whole genome sequencing (WGS) and metagenomics. The CDC’s PulseNet nationwide WGS implementation project is underway and will result in a “tsunami of data”, with the timeline as follows:

  • January 15, 2018: Listeria monocytogenes
  • October 15, 2018: Campylobacter jejuni/coli
  • January 15, 2019: Diarrheagenic E.coli (including STEC)
  • March 15, 2019: Salmonella enterica

Metagenomics will continue to play a large role in enabling unbiased sequencing of all nucleic acids in an environment. It will help to directly characterize sequences from samples, food and people (i.e., the gut), and could aid in pathogen discovery.

“I think within just a few years, it’s going to be the standard for tests,” said Besser. “My prediction is that you’ll be able to do this test in the production environment.”

Deadly Outbreaks and the Role of Metagenomics

magnifying glass

PCR or LAMP: Food Safety Considerations when Choosing Molecular Detection Methods

By Joy Dell’Aringa, Vikrant Dutta, Ph.D.
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magnifying glass

Food microbiology pathogen detection technology is constantly evolving and improving for fast, efficient and accurate analysis. Thanks to the wide commercialization of easy-to-use diagnostic kits, the end-user no longer needs a deep understanding of the intricacies of diagnostic chemistries to perform the analysis. However, when navigating the selection process in search of the technology that is best fit-for-purpose, it is critical to understand the key differences in principle of detection and how they can impact both operations and risk. Here, we will explore the difference between two broad categories of molecular pathogen detection: PCR and isothermal technologies such as LAMP.

PCR & LAMP Detection Chemistries: An Overview

PCR detection chemistries have come a long way from non-specific DNA-binding dyes like SYBR Green, to highly precise sequence-specific molecular probes. The efficiency of the real-time PCR reaction today allows for the use of a variety of detection probes, the most popular being Dual-Labeled Fluorescent Probes such as FRET, TaqMan probes, and Molecular Beacon probes.1 The precision of these probes is showcased in their ability to distinguish allelic single-nucleotide polymorphisms (SNPs).2,3 The most prevalent isothermal chemistry, Loop-Mediated Isothermal Amplification (LAMP), typically does not use molecular probes due to the lack of structure and formation consistency in its amplified products. As a result, LAMP mostly relies on detection through non-specific signal generation like ATP bioluminescence or non-specific dyes. In theory, this could come from specific and non-specific amplification events. This also makes LAMP inept to detect the allelic polymorphisms, which in some cases are critical to detecting crucial variations, like between close species, and within serotypes. In the end, the detection chemistries are only as good as the amplified products.

Key Takeaways:

  • PCR technology has improved greatly in detection efficiencies via target specific probes
  • LAMP technology typically does not utilize specific molecular probes, but instead relies on indirect signal generation
  • Target specific probes ensures signal from specific amplification events only
  • Indirect signal can come from specific and non-specific amplification events, which can lead to a reduced specificity and inability to detect in certain cases

PCR & LAMP: Amplification Strategies

Food safety pathogen detection protocols aim to find the single cell of a target organism lurking in a relatively large sample. In order to achieve detection, molecular technologies utilize amplification strategies to increase the concentration of target DNA to a detectable level. Nucleic acid amplifications in both PCR and isothermal technologies start by making a variety of amplified products. These products include non-specific amplifications (NSA), and specific (target) amplifications.4,5,6,7 Ideally, the concentration of the desired target amplified product increases over time to levels above NSA where the detection chemistries are able to provide a detectable signal from the desired amplified product (target). Various reaction components such as: Target DNA concentration, polymerase, buffers and primers play a defining role in maintaining the progressive amplification dynamics, and thereby act as core contributors to the robustness of the reaction. However, none play a more crucial contribution to the success of a reaction than temperature. Herein lies a key difference between the fundamentals of PCR and Isothermal amplification technologies.

Key Takeaways:

  • PCR and LAMP both make a variety of amplification products: Non-Specific (NSA) and Specific (target)
  • Ideally, target products increase above the levels of NSA to reach a reliable detectable signal
  • A variety of factors contribute to the overall robustness of the reaction

What Is the Difference between PCR and Isothermal Detection Technologies?

A key foundational difference between the two technologies lies in the utilization of the thermal profiles. PCR utilizes thermocycling, while isothermal does not. This difference is the tether around how the different amplification chemistries work. In PCR, the cyclical denaturation of DNA during thermocycling separates all dimers (specific and non-specific). As the reaction progresses, this leads to frequent correction of the amplification dynamics away from the NSA and favors amplification of the desired target amplifications. Isothermal chemistries do not have the ability to correct the NSA through thermocycling, so it must rely on alternate mechanisms to achieve the same result. For example, LAMP utilizes “nested” primers where the primer sequences outside the target region are used to create early amplification products. These are subsequently used as a template for the desired target amplifications. The presence of these extra primers, along with the diverse amplified structures formed during the LAMP reaction, creates many more opportunities for NSA production.5,8,9 This causes a less controlled and inefficient amplification, and is perhaps why the preheating of the DNA prior to the LAMP has shown to increase the LAMP sensitivity.10, 11 To the end user, this inefficiency can manifest itself in various ways such as restricted multiplexing, lack of internal amplification control, complex assay design, tedious sample prep methods, and increased chance for inaccurate results (i.e., false positives and false negatives).12 Scientific literature does provide a fair amount of evidence that, under controlled conditions, the isothermal amplification reaction can provide equivalent results to PCR. Isothermal chemistries also usually require simplified instruments and thereby can present interesting opportunities in non-conventional test environments with simple and predictable matrices. This likely explains the early footing of isothermal technologies in the clinical test environment as a “point of care test” (POCT) alternative. However, it must also be noted that recently PCR has also been adapted and successfully commercialized for the POCT format.13,14

Key Takeaways:

  • PCR utilizes thermocycling, Isothermal does not
  • In PCR, thermocycling allows for the reaction to favor the target amplification over the NSA
  • LAMP must rely on alternate mechanisms to correct for NSA and these mechanisms lead to a less controlled and therefore inefficient amplification
  • Under controlled conditions, isothermal technology can provide equivalent results to PCR
  • Low instrumentation requirements make isothermal technologies interesting for non-conventional test environments (i.e. POCT); however, PCR has also been recently adapted as a POCT

Internal Amplification Controls in Molecular Pathogen Detection Technologies: The Value & The Challenges

The purpose of an internal amplification control (IAC) is to provide an indication of the efficacy of the test reaction chemistry. The closer the IAC is to the target DNA sequence, the better view into the inner workings of each reaction. For food microbiology testing, the role of the IAC is more important now than ever. Driven by regulations, industry self-accountability and brand protection initiatives, more food laboratories are testing diverse product types with novel and innovative formulations and ingredients. IAC capability not only helps with troubleshooting, but it also allows for a more confident adoption of the technology for new and diverse food and environmental matrices.

Over the years, PCR has progressively developed into a robust and efficient technology that can provide a dynamic IAC, giving the end user a direct look into the compatibility of the test matrix within the PCR reaction. From a single reaction, we can now make a qualitative assessment of whether the crude DNA prep from a matrix undergoing testing is working with this PCR or if it is inhibiting the reaction. With legacy technologies, including the older generation PCR’s, we were limited to an “it-did-not-work” scenario, leaving the end user blind to any insights into the reason. Since isothermal chemistries typically do not have an IAC, the end user is vulnerable to false results. Even when isothermal chemistries such as nicking enzyme amplification reaction (NEAR) can provide IAC, they typically do not mimic the target reaction and, therefore, are not a direct indicator of the reaction dynamics. This limits the end user back to the “it-did-not-work” scenario. LAMP technology attempts to mitigate the absence of IAC by performing a separate and external reaction with each test matrix. This strategy leaves the final result vulnerable to a number of factors that are otherwise non-existent for IAC: Sampling variations, reagent and machine anomalies, and user error. External control approaches also have a notable impact to the end user, as the burden to demonstrate fit-for-purpose of the method for even the smallest matrix composition change increases both validation and verification activities, which can have a notable financial impact to the laboratory.

There are a few reasons why IAC incorporation is not always plausible for isothermal technologies such as LAMP. First, inefficient, less-controlled amplification reactions leave little room for reliable and meaningful supplementary reactions, like the ones required for IAC. Second, the lack of consistent amplified products make it much more difficult to pinpoint a DNA structure that can be dependably used as an IAC. Third, lack of specific detection mechanisms makes it hard to distinguish signal from the target versus the IAC reaction.

Key Takeaways:

  • Internal amplification controls (IAC) are critical for the food industry due to complex and ever-changing matrix formulations
  • IAC is useful for troubleshooting, optimizing assay performance, and adapting test for novel matrices
  • PCR has evolved to provide dynamic IAC, leading to increased confidence in results
  • LAMP is not able to utilize IAC due to the nature of the amplification products, reaction efficiency, and lack of specific detection mechanisms

Follow the link to page 2 below.

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FDA

FDA Restaurant Study Finds Employees Not Properly Washing Hands or Keeping Foods to Temp

By Food Safety Tech Staff
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FDA

Yesterday FDA released the initial phase of its findings of a 10-year nationwide study that looks at the relationship between food safety management systems, certified food protection managers, and the occurrence of risk factors and food safety behaviors/practices, and how this contributes to foodborne illness outbreaks in retail establishments. This first phase collected data from 2013–2014; subsequent data collection will be from 2017 and 2021. The entire span of the study is 2013–2023.

The data collected and used in the 84-page “Report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full Service Restaurants, 2013-2014” will be used as a baseline to evaluate trends in the occurrence of risk factors during the 2017 and 2021 data collection periods. Key findings in the report include the following:

  • Food safety management systems are important!
  • Restaurants had the most effective control over ensuring there is no bare hand contact with RTE foods as well as cooking raw animal foods (including meat, poultry and eggs) to the required temperature
  • Unsafe food behaviors in fast food and full-service restaurants. Improvement needed in:
    • Employee hand washing (knowing when and how to do it)
    • Proper temperature control of foods that require refrigeration to limit pathogen growth

Study results will be used to help advise retail food safety initiative and policies, industry partnerships and specific intervention strategies that target foodborne illness risk factors. It will also aid in providing technical assistance to state, local and other regulatory professionals. FDA put together a factsheet with highlights of the study.

Duncan Hines cake mix, recall

Duncan Hines Recalls Cake Mixes After Finding Salmonella

By Food Safety Tech Staff
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Duncan Hines cake mix, recall
Duncan Hines cake mix, recall
The following Duncan Hines cake mixes were recalled by Conagra Brands over concerns of Salmonella. (Click to enlarge)

–UPDATE–

“FDA and the CDC informed Conagra Brands that a sample of Duncan Hines Classic White Cake Mix that contained Salmonella Agbeni matched the Salmonella collected from ill persons reported to the CDC. This was determined through Whole Genome Sequencing, a type of DNA analysis. The sample was collected by Oregon health officials. Based on this information, Conagra Brands is working with FDA to proactively conduct a voluntary recall of Duncan Hines cake mixes from the market. The FDA is conducting an inspection at the Conagra Brands-owned manufacturing facility that produced the cake mixes. The FDA is also collecting environmental and product samples.” – FDA, November 7, 2018

 

–END UPDATE–

After a retail sample tested positive for Salmonella, Duncan Hines issued a recall of four varieties of its cake mixes. The sample that tested positive for the pathogen was the Classic White cake mix, but out of an “abundance of caution”, the company recalled its Classic Butter Golden, Signature Confetti and Classic Yellow cake mixes that were manufactured during the same period of time.

According to a Conagra Brands press release, the FDA and CDC are investigating five occurrences of Salmonella that may be linked to the Duncan Hines cake mix.

“Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling.” – Conagra Brands

The recalled products have a “Best If Used By Date” ranging from March 7 to March 13, 2019 and were distributed to U.S. retailers as well as exported internationally (on a limited basis). Consumers are advised to return the recalled products to the store in which they were purchased.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Five Steps to Creating a Successful Validation Study

By Gabriela Lopez-Velasco, Ph.D.
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Gabriela Lopez, 3M Food Safety

Manufacturing large volumes of food product that must be safe for human consumption with finite resources is, simply put, a demanding responsibility. For many food brands, having dedicated production lines is not always an option, so lines are often shared amongst a variety of food products. A potential problem arises when products containing allergenic foods are manufactured on the same equipment as other products, and those allergenic foods are not meant to be declared in the product label. As a result, residues of the first product manufactured may move to the next product. Known as direct cross-contact contamination, this issue can have a severe adverse impact on allergic consumers.

Cross-contact contamination can occur at various stages of production, but it’s direct food cross-contact in shared production lines that is often found as a particularly significant food safety hazard. Addressing cross-contact through effective cleaning procedures is one of the most critical allergen management activities in establishing preventive controls and minimizing the potential of unintentional presence of food allergens. Allergen cleaning validation enables food manufacturers to evaluate that their cleaning procedure is adequate when it comes to removing ingredients from direct food contact surfaces.

Cleaning validation consists of generating data to demonstrate that allergenic foods are removed from direct food contact areas to a pre-defined acceptable level. A basic cleaning validation design consists of determining the residual level or presence of allergenic food before cleaning (baseline), and then assessing the level of the allergenic food after cleaning.

If the cleaning procedure exists in several steps (i.e., more than one rinse or purge, as with dry cleaning) additional testing to assess the level of allergens between cleaning stages and in the final product can also be incorporated. It is important to remember that a single validation study may not be applicable for an entire site operation. Different production lines within a food production site may require an individualized validation analysis. This determination will depend on the cleaning process as well as the formulation of the products being manufactured.

There are five important considerations for establishing a successful validation study:

  1. Set up a team and assign a leader to carry out the design of the validation. Involving relevant personnel with knowledge in the product formulation, manufacturing process, equipment design and cleaning and sanitation regimes may provide valuable insight to identify processes that should be included in the validation. It may also bring to light critical sampling points in the equipment that should be considered.
  2. Determine the scope of the study. This is where you describe and justify which equipment, utensils, cleaning regime and production processes will be validated. It may be wise to group different processes or select the worst-case scenario. For example, you might choose to focus on food production equipment regarded as hard to clean or equipment that contains the highest concentration of the allergenic food.
  3. Design a sampling plan. This is a critical prerequisite before starting a validation study. The plan should be clearly defined, with critical sampling points and locations prescribed to challenge the effectiveness of the cleaning regime and to find evidence of allergenic food presence. In both open equipment and equipment that will be dismantled as part of the cleaning regime, it is important to select sites where food can get trapped, as well as other sites that are hard to clean. Also consider other surfaces that can be a source of direct cross-contact like protective clothing and utensils. For clean-in-place (CIP) systems, wash water should be collected from the onset of cleaning and then at intervals leading up to the final rinse water. This helps to demonstrate that allergen food levels are diminishing, thereby validating the use of CIP analysis as a verification method. Note that it is important to consider that the sampling plan for the validation should also reflect the sampling plan that will be used during routine verification. Support from a statistician may facilitate the decision to define how many samples and type of samples (swabs, CIP or final product) should be collected for the validation and how many cleaning runs should be performed to demonstrate validity.
  4. Select a method of analysis. Validation and verification involve the use of a specific method to detect allergenic foods. The selected method should be validated as well, an undertaking most often done by the commercial supplier. Then it should be verified by the food processor that the method is fit for purpose, such that the allergenic food will be recovered and detected under the conditions in which samples are routinely collected. This ensures there will not be interference due to the food itself or due to cleaning chemicals. There are a variety of different analytical methods; most are based in technologies designed to detect proteins. Enzyme-linked immunosorbent assays (ELISA) and immune-based lateral flow devices (LFDs) offer detection of specific protein targets (i.e., egg proteins, milk proteins, peanut proteins) and are ideal for a validation study. ELISA can provide quantitative data from pre-cleaning, at various intervals during the cleaning process, at post-cleaning and at final product, offering a measurable level of the allergenic food during the cleaning process. Rapid detection through LFDs also allows food processors to assess the presence or absence of a specific protein or group of proteins, but different from ELISA, the result is only qualitative. In either case, these rapid tests may be used for both validation and routine verification. In addition, there are non-specific tests that can detect total protein that may be selected for a cleaning validation study. These tests do not provide specific information about the allergen to be managed, and thus may be more suitable for routine verification. During a cleaning validation study, it is important to include the test that will be utilized for verification and ensure it is also fit for purpose and detects the allergenic food to an appropriate pre-defined sensitivity. This is particularly important if the test is different from the analytical method chosen for cleaning validation.
  5. Establish acceptance criteria. Proteins from allergenic foods may cause an adverse reaction at very low levels. To date, there are very few regions in the world in which threshold or permitted levels for allergens in food are established. Each individual food manufacturer should define a criterion to establish when a surface is clean from allergens after routine cleaning. The limits that are set up should be practical but also measurable and verifiable, thus it is important to define a level with knowledge of the sampling and analytical method selected. The sensitivity of the analytical methods currently available may be used as a criterion to verify that levels of an allergen are under control if they fall below the limit of detection of the analytical method.

Once a cleaning regime has been validated and documented, routine allergen cleaning verification should be performed as part of a monitoring program to demonstrate that the cleaning process in place is effective and that the risk of direct cross-contact is consequently being controlled. The validation should be repeated at defined intervals, often once a year. However, it is expected that a cleaning verification will be performed after each production run and cleaning procedure in order to reflect that the validated cleaning process is still effective. Cleaning verification, along with other allergen management activities, strengthens implemented food safety programs and helps to protect consumers.

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements