Tag Archives: environmental monitoring

Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Listeria

How One Company Eliminated Listeria Using Chlorine Dioxide Gas

By Kevin Lorcheim
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Listeria

The previous article discussed the various decontamination options available to eliminate Listeria. It was explained why the physical properties of gaseous chlorine dioxide make it so effective. This article focuses on one company’s use of chlorine dioxide gas decontamination for both contamination response and for preventive control.

The summer of 2015 saw multiple ice cream manufacturers affected by Listeria monocytogenes. The ice cream facility detailed in this article never had a supply outage, but ceased production for a short amount of time in order to investigate and correct their contamination. After a plant-wide review of procedures, workflows, equipment design and product testing, multiple corrective actions were put into place to eliminate Listeria from the facility and help prevent it from returning. One such corrective action was to decontaminate the production area and cold storage rooms using chlorine dioxide gas. This process took place after the rest of the corrective actions, so as to decontaminate the entire facility immediately before production was set to resume.

Responsive Decontamination

The initial decontamination was in response to the Listeria monocytogenes found at various locations throughout the facility. A food safety investigation and microbiological review took place to find the source of the contamination within the facility in order to create a corrective action plan in place. Listeria was found in a number of locations including the dairy brick flooring that ran throughout the production area. A decision was made to replace the flooring, among other equipment upgrades and procedural changes in order to provide a safer food manufacturing environment once production resumed. Once the lengthy repair and upgrade list was completed, the chlorine dioxide gas decontamination was initiated.

The facility in question was approximately 620,000 cubic feet in volume, spanning multiple rooms as well as a tank alley located on a different floor. The timeline to complete the decontamination was 2.5 days. The first half-day consisted of safety training, a plant orientation tour, a meeting with plant supervisors, and the unpacking of equipment. The second day involved the setup of all equipment, which included chlorine dioxide gas generators, air distribution blowers, and a chlorine dioxide gas concentration monitor. Gas injection tubing was run from the chlorine dioxide gas generators throughout the facility to approximately 30 locations within the production area. The injection points were selected to aid its natural gaseous distribution by placing them apart from one another. Gas sample tubing was run to various points throughout the facility in locations away from the injection locations to sample gas concentrations furthest away from injection points where concentrations would be higher. Sample locations were also placed in locations known to be positive for Listeria monocytogenes to provide a more complete record of treatment for those locations. In total, 14 sample locations were selected between plant supervisors and the decontamination team. Throughout the entire decontamination, the gas concentration monitor would be used to continuously pull samples from those locations to monitor the concentration of chlorine dioxide gas and ensure that the proper dosage is reached.

As a final means of process control, 61 biological indicators were brought to validate that the decontamination process was effective at achieving a 6-log sporicidal reduction. 60 would be placed at various challenging locations within the facility, while one would be randomly selected to act as a positive control that would not be exposed to chlorine dioxide gas. Biological indicators provide a reliable method to validate decontamination, as they are produced in a laboratory to be highly consistent and contain more than a million bacterial spores impregnated on a paper substrate and wrapped in a Tyvek pouch. Bacterial spores are considered to be the hardest microorganism to kill, so validating that the process was able to kill all million spores on the biological indicator in effect also proves the process was able to eliminate Listeria from surfaces. The biological indicators were placed at locations known to be positive for Listeria, as well as other hard-to-reach locations such as the interior of production equipment, underneath equipment and inside some piping systems.

In order to prepare the facility for decontamination, all doors, air handling systems, and penetrations into the space were sealed off to keep the gas within the production area. After a safety sweep for personnel, the decontamination was performed to eliminate Listeria from all locations within the production area.

Click page 2 to continue reading.

Maria Fontanazza, Zephyr Wilson, Food Safety Consortium

Encourage Employees to Find Listeria

By Food Safety Tech Staff
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Maria Fontanazza, Zephyr Wilson, Food Safety Consortium

Building the right food safety culture around environmental monitoring requires a realistic approach to your processes. “Culture starts with understanding your process,” Zephyr Wilson, product manager at Roka Bioscience told Food Safety Tech at the 2016 Food Safety Consortium. “You need to ask questions—a lot of questions.”

In the following video, Wilson talks about food safety culture in the context of environmental monitoring and how companies should approach environmental monitoring. “Understand all of your processes,” she said. “Take an honest look at your metrics and make sure you’re encouraging your employees to find the Listeria.”

She also reviews the steps a company should take when undergoing self-auditing, and encourages companies to work under the direction of an attorney to ensure that all results are confidential.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Find Contamination, Reduce Pathogens, and Decrease Criminal Liability

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.

At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.

Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.

In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.

The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.

Microbiological Profiling Studies

Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.

Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege.  Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.

Pathogen Reduction Technologies

The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen  reduction  technologies  to  help  control  the  environment.

Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.

Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1

Microbial reduction, Puradigm
Microbial reductions on stainless steel associated with 24-hour treatment using Puradigm advanced oxidation cell

I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.

Criminal Protection Audits

In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.

If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.

Conclusion

The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.

Reference

  1. GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.
In the Food Lab

New Dynamics in Environmental Testing

By Erin Dreyling, Ph.D
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Recent recalls and outbreaks associated with Listeria coupled with FDA’s finalization of the FSMA preventive controls rule have heightened the industry’s need to focus on environmental testing programs. The need for a preventive control program with higher resolution is especially highlighted by the government’s increasing use of whole genome sequencing data to more rapidly link human illness to food processing establishments. I work with many customers who simply do not recognize all of the factors that influence their ability to detect Listeria in environmental samples. For many, an environmental sample is collected, shipped to a third-party lab, results are received within two to four days, and few questions asked. Most companies have not invested the time and resources needed to truly understand how each component of an environmental sample impacts their ability to detect Listeria. So what factors should be considered to maximize Listeria detection in the plant environment?

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREListeria is a True Survivor

Listeria is inherently a hearty organism that can withstand highly adverse conditions in the plant environment. It is able to survive and grow across a wide range of temperatures, including refrigeration, and it is more tolerant to heat than Salmonella and E. coli. Additionally, the organism survives across a wide pH range, including extended periods in highly acidic conditions, and can survive food processing and preservation with up to 25.5% salt. These traits may result in highly injured Listeria being collected in environmental samples, and requires optimization of the sample collection and analysis process in order for detection and culture confirmation to occur.

Sanitation Programs May Not Destroy Listeria

Sanitation practices are intended to destroy Listeria in the plant environment, but not all sanitizers will be 100% effective. In some cases, sanitizers may not fully kill Listeria, leaving highly injured Listeria that may require an extended lag phase in order for growth and detection during testing. Sub-lethally injured Listeria remains a food safety concern, as the bacteria maintain the ability to recover and flourish in a nutritive environment. Additionally, Listeria readily forms biofilms in the plant environment, which many traditional sanitizers do not effectively remove. Biofilms in the plant environment may maintain low levels of Listeria that may be challenging to detect without the use of a sensitive detection method.

Sample Collection: Choose the Right Tool for the Job

The neutralizing and nutritive capacity of the collection media used with the collection device can have a significant impact on the ability to resuscitate, detect and culture stressed Listeria. When selecting a collection media, it is important to ensure that the media will effectively neutralize the sanitizers used in the plant environment. For instance, peroxyacetic acid and quaterinary ammonia-based sanitizers will not be neutralized well by commonly used collection media such as Neutralizing Buffer or Letheen Broth. Neutralization of the sanitizer in environmental samples is important in order for resuscitation and growth of any Listeria present within the sample. Additionally, use of a collection media that contains nutrients to begin the resuscitation process for Listeria immediately upon collection is also important for detection and culture confirmation of Listeria in samples. Collection media such as Neutralizing Buffer contains monopatassium phosphate, sodium thiosulfate, and aryl sulfonate complex intended only to neutralize sanitizers. Conversely, D/E Broth and HiCap Broth have components to nourish Listeria and facilitate resuscitation in addition to neutralizing sanitizers.

Enrichment Media Determines Recovery & Growth

Enrichment media plays a major role in the speed of recovery and growth of Listeria in environmental samples. Medias that facilitate faster recovery of injured Listeria allow for shortened lag phases facilitating more rapid growth. Enrichment media that facilitate faster recovery and growth allow Listeria to reach the limit of detection for screening tools more quickly. When paired with a highly sensitive method, enrichment media, which foster greater Listeria growth and recovery, can allow for significant reductions in time to results for screening methods. Additionally, faster recovery and growth of Listeria due to enrichment media can increase the likelihood of culturally confirming Listeria found at low levels pre-enrichment.

Not All Detection Methods are the Same

The ability of a detection method to find Listeria in an environmental sample is impacted by two factors: 1) method sensitivity and 2) method robustness in the presence of sanitizers. The more sensitive a rapid test method, the greater the chance of finding low levels of Listeria in an environmental sample. Low levels of Listeria in environmental samples are likely due to the injured state of Listeria in the plant environment post sanitization. Immuno-based rapid methods have a sensitivity of 105–106, DNA-based methods have a sensitivity of 104–105 and RNA based methods have a sensitivity of 102–103. Using an RNA-based method offers 1 to 2 logs greater sensitivity and greatly increases the chance of finding low-level Listeria.1 This can be particularly true when sampling conditions such as collection media or enrichment media are less than optimal for the neutralization of sanitizers and growth and recovery of Listeria.

Another important factor that influences a test method’s ability to detect Listeria in an environmental sample is the method’s ability to amplify and detect the organism in the presence of sanitizers. Most molecular-based methods do not include a sample clean up step resulting in sanitizer being present during the amplification step. For some methods, sanitizers may inhibit amplification, resulting in indeterminate or false negative results.

Confirmation Requires Optimization of the Sampling Process

The ability to culturally confirm a Listeria sample that screens positive is influenced by the entire environmental sampling process. In order to culture confirm samples with highly injured, low-level Listeria, it is necessary to optimize the sample collection media, enrichment media, and confirmation process to provide the greatest likelihood of culture recovery. If Listeria is not adequately resuscitated and able to achieve sufficient growth, the level of Listeria present in the sample post-enrichment may be below the limit of detection for culture. The likelihood of culture confirmation can be increased by incorporating steps such as a secondary enrichment or concentration via IMS capture. Culture confirmation for samples that screen positive on a rapid method can be especially challenging if a highly sensitive test method is used for screening that may detect Listeria at lower levels than culture. Thus, optimizing the environmental sample program is especially important if confirmation of screening results for highly sensitive methods is desired.

Method Sensitivity and Increased Positivity

Employing a highly sensitive screening tool for environmental samples provides a better lens to view risk within the food safety processing environment. Many companies fear that a more sensitive method will result in significant increases in positivity and cost for increased sanitation. In working with customers who have moved from immune-based methods to a highly sensitivity molecular method, I’ve observed an initial increase in positivity followed by a leveling off of low-level positivity after enhanced interventions are taken in the plant. Companies that proactively seek out and destroy Listeria in their plants are then able to maintain low level rates of positivity with routine cleaning measures, while also maintaining the confidence that they are using the best tool available for Listeria monitoring.

Understand Your Risk & Establish a Culture of Food Safety

It is important for food safety professionals to fully consider the hidden risks that may exist in their plant environment due to the environmental sample process masking the true presence of Listeria. Each component of the environmental monitoring process, sanitizer, collection media, enrichment media, detection method and culture process plays an important role in a company’s ability to be able to detect and culture confirm Listeria in the plant environment. Optimizing each step within the environmental sample process allows a company to be proactive instead of reactive. This approach creates a company culture of food safety that can seek out, detect and destroy Listeria in the plant environment, can significantly mitigate risk. The good news is that by incorporating the right food safety culture and making data-driven choices, today’s manufacturer can achieve both short-term dividends of risk reduction as well as a long-term elevation of control of its process.

Reference

  1. Culture Shift: The New Dynamics of Listeria Environmental Control and Testing. Roka Bioscience, Webinar.

Safe Food: A Product of a Clean Environment

By Gina R. Nicholson-Kramer
1 Comment

Most recently we have seen an increase in foodborne illness outbreaks from Listeria to Salmonella to Norovirus to E.coli, many of which are a result of post-lethal contamination of processed foods. This is often a direct result of a gap in the sanitation programs that were in place at the processing facilities. Every facility should conduct a sanitation gap analysis on an annual basis. In order to receive unbiased feedback, this activity is best performed by a third party that is not a chemical provider.

Join Gina Kramer at the Listeria Detection & Control Workshop, May 31–June 1 in St. Paul, MN | LEARN MOREDeveloping and implementing a sound environmental hygiene program at a food processing facility is essential to its success in producing safe food for consumer consumption. There are fundamental basics of sanitation that every plant must follow in developing a strong program. The fundamental basics include: Developing sanitation standard operating procedures (SSOPs) for; Floors and drains, walls, ceilings, equipment and utensils, and employees. SSOPs must also contain perimeter control, foot traffic control into food preparation areas, zoning, and environmental sampling procedures.

Jeff Mitchell, Gina Kramer, Listeria
VIDEO: Jeff Mitchell and Gina Kramer discuss the increase in Listeria recalls. | WATCH NOW

When developing SSOPs, using the proper risk reduction formula will lead to sanitation success. To determine the best risk reduction formula, I sought the advice of sanitation expert, Jeff Mitchell, vice president of food safety at Chemstar. Before working for Chemstar, Mitchell was the Command Food Safety Officer for the United States Department of Defense (DOD). Serving more than 20 years for the DOD has given him the opportunity to visit thousands of processing facilities all over the world, seeing the best and the worst, and assisting in finding the root cause of contamination issues and negative environmental sampling results. In this article, I share Mitchell’s risk reduction formula for sanitation success and how to use the formula to build a solid and successful sanitation program.

Foundational Science

“An understanding of the difference between transient and persistent (or resident) pathogens is a key part in the foundational science of sanitation solutions,” explained Mitchell as we discussed the details of the risk reduction formula. Transient pathogens are those that are introduced to the processing facility from the external environment. Entrance occurs from deliveries on transportation vehicles and pallets, food, and non-food products and its packaging, employees and visitors, pests and rodents, along with leaks in the roof or improper cleaning of drains, which are known reservoirs.

Kramer_FoundationalScience“Persistent pathogens are those pathogens that establish residency within the processing facility. Most bacteria will aggregate within a biofilm, allowing them to live in communities. A biofilm is a survival mode for the bacteria; it protects it from sanitizer penetration. The biofilm layers actually masks it from sampling detection. You could swab a surface or an area and not get a positive pathogen test result, because the biofilm is masking it,” Mitchell stated. He continued to explain that most contamination risks are likely from established populations. Four things need to exist for resident populations to form: Pathogen introduction, water, trace organics and niche area for attachment and growth. Food processing facilities should be most concerned about these populations, as they’re being traced to many recent outbreaks and recalls.

In his experience, Mitchell shared that sanitation efforts should focus on areas within the processing facility where moisture and nutrients are collected; both are needed for biofilm formation. Disruption of these niche areas containing biofilm can result in direct (food contact) and indirect (non-food contact) contamination if the biofilm is not completely penetrated or removed. This can occur through active and passive dispersal of pathogens. Active dispersal refers to mechanisms that are initiated by the bacteria themselves where they naturally eject from the biofilm and land on other surfaces. Passive dispersal refers to biofilm cell detachment that is mediated by external forces that shear the biofilm, causing it to move and further spread. This can be caused through fluid shear, abrasion and/or vibration due to power washing, equipment vibration, or deep cleaning/scrubbing that does not penetrate and remove all the aggregate layers of biofilm. In other words, the biofilm and pathogens are just smeared around the facility like cleaning a mirror with a greasy wiping cloth.

Chemistry and Application

Kramer_CleaningMatrixThe cleaning matrix must be considered to properly remove soils that house both transient and persistent pathogens. This is done by combining proper cleaning and sanitizing agent concentration (PPM), adequate exposure time, proper temperature and mechanical action (agitation) or good old elbow grease. If there is a decrease in one area of the matrix, then an increase in the other areas needs to be made as an accommodation to the cleaning process. My years working in industry have taught me that the most expensive quadrant of the cleaning matrix is agitation, because it requires manual labor. Reduction of labor is one of the first ways companies build in efficiencies to increase profit margins. That means a solution must be built that focuses on temperature, concentration and proper contact time to produce the sanitation results necessary to prevent persistent pathogens from establishing residency within processing facilities.

Temperature should be regulated by the type of soils that need to be removed. High fat soils need a higher temperature of about 140⁰ F. However, when removing high protein soils, the temperature needs to be reduced so that the protein is not baked onto the surface. Baked proteins that are not removed become nutrients for bacteria to aggregate and reside. High temperature is does not work in every food processing plant, Jeff explained.

Proper balance of detergent and sanitizer is necessary to remove and destroy both transient and persistent pathogens. The detergent needs to be the right formulation and contact time to break down soils and biofilms with application of the right concentration and contact time of sanitizer to kill the exposed pathogens. Without the right balance in place it can create the perfect storm for spread and contamination within the processing facility.

Validation

Do your homework. Research is the most valuable tool when validating the effectiveness of a cleaning process. Private research is good but not the only form of validation on which to base a business decision. I have found that peer reviewed published research is best to use in validating all quadrants of the cleaning matrix. Academic research based on sound science that has practical application results is worth the investment to make sound business decisions.

Many products have been developed to penetrate and destroy the biofilm layers that bacteria aggregate. Again, do your homework. Choose a product that also provides a pathogen kill once the biofilm has been penetrated. I cannot stress enough to make sure that the SSOPs follow the manufacturer’s validated processes and the sanitation team follows the SSOPs’ directions.

Solution

Applying the desired solution requires dividing the processing facility into zones to designate specific sanitation requirements. This will assist in the development of specific SSOPs that apply the right solution in the right zone throughout the site.

Kramer_ZoneMitchell also gave great advice about cleaning tools and cleaning chemical basics. He explained that a facility should color code the cleaning tools according to zone and only use them in the designated zone area. This prevents cross contamination from occurring, because cleaning tools can be vehicles of contamination transfer. Utilize foam detergents and foam sanitizers as they are more forgiving and increase contact time, and sanitation crew can see where they have applied the chemicals. Use the Ross-Miles foam test for stability: Foam should last more than three minutes before breaking and turning into a liquid solution that runs down the drain, costing a site money and opening up the potential for introducing pathogens into production rooms.

Mitchell advised the development of sanitation procedures that focus on daily thorough cleaning of everything from the knees down in Zones 1-3. “You want to knock everything down and keep it down. The objective is to keep bacterial creep from occurring,” he said. “Creep is where bacteria are moved by processes like water spray, splash and aerosolization, causing the bacteria to move from one area (it usually develops on the floor) to then move up walls and the legs of equipment, etc.— eventually causing contamination of food during food production and packaging.” Obviously, all food contact surfaces in Zone 1 need to have specialized SSOPs according to the equipment, food processing shifts per day, and type of foods that are being processed.

Mitchell stressed that perimeter and foot traffic control entry programs should incorporate a good foam sanitizer that stands up to the Ross-Miles test with optimal duration of five minutes. The distribution of the foam should cover a large enough area that the employees’ foot path and equipment must travel through the foam to achieve contact to control transient pathogen entrance into Zones 1–3. Concentration levels of these areas should be at least double what the food contact area strength is for effectiveness of log kill needed for control.

Environmental monitoring procedures should follow the zoning process set up for sanitation. “Swabbing for Adenosine Triphosphate (ATP) and/or Aerobic plate count (APC) are tools that can be used to help identify biofilm locations. One thing to note is that the bacteria located under the biofilm are in a modified dormant state requiring less energy and making less ATP available for detection.  With that said, ATP and APC swabbing are still both viable tools to use in sanitation verification,” said Mitchell. If you only test for general risk pathogens in your facility you may receive false negatives due to biofilm masking the pathogen from showing up as a positive in environmental testing. Utilizing both general pathogen, ATP and APC in concert, is the best combination in a facility’s environmental monitoring program. The goal is to seek and find then destroy and verify.

I recently discovered a great biofilm visual detection test from Realzyme that is wonderful to use to verify whether the sanitation system in place is working. It can also differentiate between protein build-up and biofilm formation. In my professional opinion, this visual detection test is essential to incorporate in a robust environmental testing system.

Safe Food: The End Product

Our responsibility as food safety/quality professionals is to provide the safest, most delicious food for our customers to enjoy. To ensure safe food in our end product, we need to develop a robust sanitation and environmental testing program that follows the risk reduction formula (Foundational Science + Chemistry & Application + Validation = Solution) and conduct an annual sanitation gap analysis by a third-party expert for continuous improvements.

Apply these steps to protect your food, protect your brand and protect your customers so that they Savor Safe Food in every bite!

Rod Wheeler, The Global Food Defense Institute

Are Food Companies Prepared for Intentional Contamination?

By Maria Fontanazza
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Rod Wheeler, The Global Food Defense Institute

Unfortunately, quite often we are reminded of the vulnerabilities throughout the food supply chain. The latest E. coli outbreak linked to Chipotle restaurants in Oregon and Washington once again has consumers and the food safety industry on edge about traceability and a company’s ability to quickly identify the source of a serious outbreak. According to the CDC’s most recent update, laboratory testing is ongoing to find the DNA fingerprint of the bacteria. Concerning as this may be, no deaths have been reported thus far, but 42 people have been reported ill and 14 have been hospitalized in Washington and Oregon. In the most recent statement released on Chipotle’s website, the company said it is “aggressively” taking steps to address the problem, including by conducting deep cleaning and sanitization of its restaurants as well as environmental testing in its restaurants, and replacing all food items in the establishments that it closed “out of an abundance of caution”.

What if this were a situation of intentional contamination? Would Chipotle or any other company in this type of scenario really be prepared? These questions were posed by Rod Wheeler, CEO of The Global Food Defense Institute during a recent conversation with Food Safety Tech about food defense, and food tampering and intentional adulteration. Wheeler and Bruce Lesniak, president of Lesniak & Associates, shared their views on the threats that the food industry is facing and why companies need to have a strong plan in place to prepare for an attack on the food supply.

During next week’s Food Safety Consortium conference, Rod Wheeler will moderate the Ask the Experts session, “Engaging Food Tampering Discussion Surrounding Food Defense” on Wednesday, November 18.  LEARN MOREFood Safety Tech: What challenges do you see companies facing in the area of food tampering and adulteration?

Rod Wheeler: Our food supply is wide open. It accounts for 13% of the overall U.S. GDP. One thing we know about terrorists is that they want to affect our financial markets. What’s the best way to do that? You attack the 13% GDP – and what infrastructure is that? It’s our wireless systems, airline systems, transportation systems, medical supply, or our food and agricultural supply. Those are the top areas in which we need to focus, and we have to make sure the food & agriculture supply remains safe and secure in the United States.

On 9/11 the world changed, and the challenge for us becomes, within all of our 18 infrastructures, but how have we changed? Do we continue to do business the same way we always have, even prior to 9/11? Over the past few years, we’ve seen a significant increase in terroristic activity around the world—from France to Syria to Yemen to Pakistan. Here in the United States, we have to be mindful of what is happening.

Rod Wheeler, The Global Food Defense Institute
Rod Wheeler, CEO of The Global Food Defense Institute

We’ve always had food safety programs: HACCP, HARPC, GFSI, SQF, etc.—those are good for unintentional contamination. But what happens if someone wants to intentionally place a deadly contaminant into a product?

In this country, on a daily basis we see contaminations occurring.  We were recently notified of a massive outbreak of E. coli that has occurred throughout the Chipotle system: 47 Chipotle stores have been closed. What does that mean? Is that just a food safety issue? What if that E. coli could have been intentionally grown in a test tube and placed into the food supply? Going forward, we have a duty and an obligation to look at these things, not just at face value but think about whether they are intentional events.  

FST: Where are the biggest holes within food defense plans?

Wheeler: With more than 15 years of visiting food processing facilities, agricultural farms, dairy farms, and dairy processing facilities, the biggest concern that resonates with me is the fact that the culture of security is not there. The culture of security is simply security awareness—not planning. People in food plants are being taught to be mindful not vigilant. The largest of food companies have well thought out and active safety and defense plans, and their employees are educated, trained and empowered. We find that this falls off sharply with the mid-sized and small manufacturers and suppliers.  All food providers must have a comprehensive and strategic security plan that is active and measureable.

For example, let’s say a contractor is walking though a food plant. You have worked in that plant for five years but have never seen this person before. Would you question that person about their credentials? Are people thinking about the things they can personally do to reduce or mitigate the risk… are they empowered?

Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry. Watch the video

So, the question is “what do you do when/if”: This is one of the topics we will be discussing at the [Food Safety Consortium] conference. It’s interesting that when we present this scenario to the management of a food company, many answer back with a blank stare. We ask, do you shut down your facility? Do you notify your customers? Do you notify the national media? This question goes to the root of the company’s security culture and the strength of its strategic planning. Until we develop the necessary plans, processes and protocols to respond proactively, we will continue to remain vulnerable.  

FST: Do you think many food companies assume something catastrophic won’t happen to them?

Wheeler: I always ask why it is that we don’t anticipate these things in advance. People are complacent. “It’s not going to have happen here,” they say. “What terrorist would come to our small town and do this? We’re just a small mom and pop [business].”

Recently, I received a call from a 17-employee company in Tennessee. This particular company processes honey for 100 large box retail stores. I received a call from the CEO who said, “My client wants us to have one of those vulnerability things.” He was referencing the vulnerability assessment. He said, “I don’t know why they’d want us to have one of those. We’re a small company down here in Tennessee, why does my client think some terrorist would come here?” The fact is, attackers will find the weakest link to attack: The small honey company is not the target; they are the vessel by which the attackers get to the primary target, and in this case, the big box retailer. The big box retailer/supplier is the target and the simplest, most effective way to get to them is through the hundreds of small, low to no protection suppliers.

These are the issues we need to enlighten and educate companies about; we need to get them thinking differently, because this way of thinking is completely different. If you ask someone who’s been in this industry for years, they’ll say, we never had to worry about locking our doors, or use biometrics to gain access to certain areas. We never had to think about these things in the Food & Ag supply before.

During our front line training course, we place a significant amount of focus on the food plant blending areas and why it is the number one threat area for intentional/unintentional contamination of our food supply in the United States. The blending area is exposed to a number of vulnerabilities and once attacked, the tainted ingredients are spread among numerous products that once distributed, are not necessarily quickly traced once they are blended into the final product.

Bruce Lesniak: The consequences of such an emergency are multifaceted; they affect the consumer and their product confidence, the manufacturer through recall and the retailer through recall, brand damage and loss of consumer loyalty. Often, this ripple effect begins with the small supplier and works its way upstream to affect the entire process.

We are seeing this scenario unfold in real time with Chipotle—this is huge in the food industry. FDA has not been able to determine exactly where that genetic fingerprint has originated resulting in location closures, shaken consumer confidence and brand damage. –Rod Wheeler

FST: What will it take the industry to wake up to what could become a serious reality?

Wheeler: Unfortunately it’s probably going to take a major incident for people to wake up and smell the coffee. With that said, we firmly believe that it is critical to awaken the sleeping giants before something happens. We must increase the awareness and provide education to heighten the reality of what can potentially happen and promote proactive engagement of risk mitigation.

FST: In the context of FSMA, are companies prepared for the compliance stage?

Wheeler: Over the years, I’ve seen a number of companies begin to ramp up security at their facilities. But a number of them are doing it because they realize they need to comply with the food defense elements of FSMA; the larger companies are driving compliance and are requiring that their suppliers comply. But I think convincing companies about “Why” this is important, is the challenge. Often times companies will say, “we’re doing this training”, or “we’re doing this vulnerability assessment because it’s a requirement of FSMA.”

We feel that if being compliant is your “Why “reason, then you are spending time and money for the entirely wrong reason. You don’t do vulnerability assessment or training in food defense because you want to comply with the law. You do it because you want to protect your company and the consumer from the reality of what can happen and proactively work to avoid a threat.

Lesniak: We see the adoption trend take hold as it has traditionally, in three phases. First are the early adopters—they understand the importance of compliance for the right reasons and the need for food defense, Second are those who feel the urgency to comply due to a compelling issues (an incident or have been instructed to do so by larger suppliers in order to retain contracts), and third are those who will come kicking and screaming.

Wheeler: A lot of the requirements of FSMA were generated as a result of the PCA event in 2009. The prosecution and subsequent conviction of the Parnell brothers isn’t the last prosecution we’re going to see for someone violating a food safety protocol. This is the first, and it’s a wake up call.

Jim Hammel, vice president, customer success at Sample6
In the Food Lab

Using Software for Environmental Tracking and Data Visibility

By Jim Hammel
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Jim Hammel, vice president, customer success at Sample6

There is growing evidence that a strong environmental program is critical to identifying potential issues before they threaten product. This data must be captured regularly based on a robust environmental sampling plan and then analyzed in order to take advantage of the results. However, without the proper tools, this is challenging, time consuming and ineffective.

How Software Strengthens a Sampling Program

The most critical component of an environmental sampling plan is zone coverage. Many sampling plans exclude zone 1, direct food contact, because this implicates the finished product and may lead to a test-and-hold situation. However, at minimum, zones 2-4 should be covered in a sampling plan. In addition, it is important to randomize test points and schedules. Sanitation crews are held to rigorous standards, but it is human nature to complete repetitive tasks in the same manner. By randomizing which test points are tested—by day, time and operator—quality teams are more likely to identify potential areas of concern. Randomization is a challenging task to complete manually but a routine task for software.

Using Software for Environmental Tracking and Data Visibility
Using software enables environmental tracking and provides and data visibility. Image courtesy of Dietz & Watson

In addition, ensuring test-point coverage is a key component to sampling plans. An interval for test-point coverage is typically included in environmental sampling plans. It is up to quality teams to ensure that their sampling programs are consistent with these business rules. When this is tracked in an Excel spreadsheet, randomization is typically sacrificed to ensure test-point coverage. This is tracked in a large table with dates on one axis and test points on the other. The challenges to this approach include randomization, analysis and management of more than one test-point coverage interval. Business rules of this nature can be easily managed through software algorithms. In fact, the task of creating a schedule according to a series of business rules is not unlike a macro.

Lastly, robust sampling programs include detailed remediation and response plans in the event of a positive or presumed positive test result. The details on these plans are reviewed internally to ensure that the issues have been adequately addressed. Documentation that each step has been completed in a timely manner is absolutely essential in today’s regulated food production environment. Remediation records may be requested in a government or supplier food safety audit. Emails, meeting notes, pictures and cleaning records can certainly be kept in file drawers, but the more accessible this information is, the more likely it will be used. Approval processes and business workflows have been automated in a variety of software tools. Everything from sales to expense reports has sought support from software to ensure that their workflows are executed consistently and with traceability. Software can support food safety efforts in this way as well.

Dos and Don’ts of Data Analysis

The next challenge in environmental monitoring is the volume of data generated and the tools required for effective analysis. A robust environmental sampling program for Listeria can range from 10 to 15 samples per week per line—often much more. Each test result includes metadata such as sample location, day and time, sample collector and result. In a plant with 10 lines, there are 150 test results per week, or 7,800 test results per year. When compiling results for the past three years, the numbers reach nearly a quarter of million just for pathogen testing. Routine testing such as yeast, mold and Enterobacteriaceae should also be considered in the analysis. The sheer volume of the data can be challenging in a spreadsheet but routine in a database.

Don’t rely on unmanageable spreadsheets. Analysis should look for trends in the data as well as compliance to the program. Completing this task in spreadsheets requires that the data be properly formatted. Further, the database-like structure that would enable analysis is often inconsistent with the table format used for sample schedule generation. In addition, this task is time consuming, manual and error prone; therefore, the frequency of analysis may be reduced.

Don’t take an analog approach to floor plans and risk it being outdated. Particularly for environmental data, it is important to understand the proximity of test points and their results. This allows managers to look for patterns or workflow trends that may be impacting results. This task typically requires mapping the test points and their results to a floor plan. Many plants keep a copy of the floor plan and recent findings posted on the wall.

Do use the tools available. In today’s data-rich food production environment, successful data analysis must be automated.

Answering the Call for Communication

Lastly, for an environmental monitoring program to be effective, communication is critical. The members of the quality team need to know what specific tasks are expected of each of them and when. Sanitation workers need to know what areas require their timely response. Executives need visibility into the results and actions underway so that they can support their teams and make critical food safety decisions. While these tasks can be completed manually, it is ripe for automation and new tools are streamlining the communication process.

Food safety managers and quality teams are working diligently with their sanitation teams to keep their plants and product safe.  However, they need to leverage the available tools needed to do their jobs efficiently and effectively. New software tools designed for the food safety industry are changing the way the industry handles safety initiatives. In particular, sampling program, data analysis and communication tools are ripe for automation. Take advantage of technologies and tools already in use in business today so you are prepared to manage the food safety challenges of tomorrow.