By Timothy Ahn

If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.

Consumers and Foodborne Illness — An estimated 1 in 6 Americans fall victim to a foodborne illness annually.

While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.

We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.

In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.

In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.

Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.

Does your leadership recognize the importance of your FSMS? An effective FSMS should be established before a product incident or recall occurs.

Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.

Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.

The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.

At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.

For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.

Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.

The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.

Auditing and FSMS — A thorough auditor won’t look the other way and will find the problems. Call it as you see it–don’t be too soft when getting an assessment.

Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.

At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.

A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.

With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.

If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.

We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

October 21, 2015

From the Editor’s Desk

Listeria Puts a Spook in Halloween

By Maria Fontanazza

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It’s that time of year again: A time when Americans, both young and old, enjoy decorating pumpkins, dressing up in outrageous costumes, visiting houses haunted with ghosts and goblins, and consuming way too much sugar. And then there’s the classic favorite, the caramel apple. I’ve never been a huge fan of the sticky treat, but many Americans just can’t get enough it.

This year’s Food Safety Consortium conference features “Preventing Listeria Workshop: A Practical Workshop on Food Safety Controls” on Tuesday, November 17. REGISTER HERE. Last year caramel apples received a huge amount of negative press as a result of a deadly Listeria outbreak that was traced back to prepackaged caramel apples from Bidart Bros (Bakersfield, CA). In February of this year, the CDC closed its investigation, and provided the final stats: 7 dead and 34 hospitalizations throughout 12 states.

Now here we are, at the height of the season for apples and sweet treats, and concerns over Listeria in caramel apples are back in the media. The good news is that industry is proceeding with caution. The Wall Street Journal reports that Kroger Co. is taking unrefrigerated caramel apples off its store shelves following a recent study that cited a higher likelihood of Listeria growth on the products when at room temperature versus under refrigeration. Published by the American Society of Microbiology, the study, “Growth of Listeria monocytogenes within a Caramel-Coated Apple Microenvironment”, found that “insertion of a stick into the apple accelerates the transfer of juice from the interior of the apple to its surface, creating a microenvironment at the apple-caramel interface where L. monocytogenes can rapidly grow to levels sufficient to cause disease when stored at room temperature”. The researchers also advise that consumers purchase refrigerated apples or eat them fresh.

Although representatives from Kroger said they think the risk of Listeria contamination is minimal, they decided to take a cautionary approach. It’s reassuring to see companies step up and take proactive tactics to mitigating risks, especially when it involves protecting consumers against another potentially deadly outbreak.

Jim Hammel, vice president, customer success at Sample6

October 20, 2015

In the Food Lab

Using Software for Environmental Tracking and Data Visibility

By Jim Hammel

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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.

Dr. David Acheson is the Founder and CEO of The Acheson Group

October 16, 2015

Beltway Beat

Get Ready to Align Your Supplier Program with New FSMA Rules

By Dr. David Acheson

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FSMA’s preventive controls rule mandates a supply-chain program to “provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.” The rule defines a supply-chain-applied control as “a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.”

FDA made a few general updates in the final rule, including changing “supplier program” to “supply-chain program”, and it designated a subpart G with eight sections of regulatory text. Intended to improve clarity and readability, the language reflects its applicability to non-suppliers in a new requirement – that is, a supply-chain control can be applied and/or verified by a non-supplier (e.g., distributor, broker, aggregator). However, the receiving facility must verify the supply-chain-applied control itself or obtain documentation of the verification activity, review and assess the documentation, and document that review and assessment.

There are different compliance dates for the supply-chain program versus the entire rule, aligning compliance with the dates of FSVP rule and providing greater consistency. This also addresses comment concerns that a receiving facility would be required to comply with the supply-chain program provisions before its supplier must comply with applicable new FSMA food safety regulations.

Does your current program comply with the new rules? If not, how can you bring it in line?

The Supply Chain Program

The rule requires a supply chain program when the receiving facility has identified, through its hazard analysis, that there is a hazard requiring a supply-chain-applied control. The program should address hazards requiring a preventive control that may be intentionally introduced for purposes of economic gain, as well as those unintentionally introduced.

FDA specifies the basic content of a supply-chain program, but allows for some flexibility. The rule mandates that the supply-chain program include:

Written procedures for receiving raw materials and other ingredients
Preventive control management components that include corrective actions and corrections, review of records and reanalysis
Supplier approval and use of only approved suppliers, but FDA is considering the issuance of guidance for temporary use of unapproved suppliers
Determining appropriate supplier verification activities
Conducting supplier verification activities
Documenting supplier verification activities:
- Onsite audits
- Sampling and testing of the raw material or ingredient (by the supplier or receiving facility)
- Receiving facility review of the supplier’s relevant food safety records
- Other appropriate supplier verification activities based on the risk associated with supplier performance and the raw material or other ingredient

In supplier approval and determination of supplier verification activities, the receiving facility must consider:

The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients
Where the preventive controls for hazards are applied
The supplier’s procedures, processes and practices related to the safety of the raw material and ingredients
Applicable FDA food safety regulations and the supplier’s compliance with them
The supplier’s food safety performance history relevant to the applicable raw materials, including results from testing for hazards, food-safety audit results and corrective action.
Any other relevant factors, such as storage and transportation practices

Other key points of the rule:

There must not be any financial conflicts of interests that influence the results of the verification activities. Payment must not be related to results
Domestic inspection by representatives of other federal agencies or by representatives of state, local, tribal, or territorial agencies may substitute for an audit
The definition of “supplier” has been revised so that the grower remains the supplier when the harvester is under separate management. The “supplier” is the establishment that “grows” food rather than that which “harvests” food.
Foreign suppliers may provide documentation, when applicable, of a written assurance that the supplier is producing the raw material or other ingredient in compliance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States
The provisions for supplier verification in the FSVP rule have been aligned with the provisions for a supply-chain program, so importers and receiving facilities can consider compliance with both the supplier-chain-program rule and the forthcoming FSVP regulations, as to avoid duplication of verification activities
If the receiving facility is an importer in compliance with the FSVP requirements and has documentation of verification activities under FSVP, a supply-chain program is not required even if the receiving facility’s hazard analysis determines that a supply-chain-applied control is required

Robin Stombler, Auburn Health Strategies

October 13, 2015

In the Food Lab

Five Questions Food Facilities Should Ask About Testing

By Robin Stombler

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The FDA issued the first of several final regulations aimed at modernizing the food safety system through the use of hazard analysis and risk-based preventive controls. Inherent in this system are a number of requirements that eligible food facilities must follow, such as developing a written food safety plan, monitoring, corrective actions and verification. Laboratory testing is an essential component as well.

Robin Stombler presented “Laboratory Oversight and FSMA: Why and When” at the Food Labs Conference in Atlanta, GA | March 7–8, 2016So, what should food facilities know about laboratory testing within the context of the preventive controls for human food final rule? First and foremost, the final rule states, “facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.” While a future regulation is expected to address the need for accredited laboratories and model laboratory standards, the preventive controls rule adopts other requirements pertaining to testing. Here are five questions that food facilities should ask about testing and the preventive controls rule.

1. What is the difference between pathogens and microorganisms?

The final rule defines “pathogen” to mean a microorganism that is of public health significance. A microorganism is defined as “yeasts, molds, bacteria, viruses, protozoa and microscopic parasites, and includes species that are pathogens.” Microorganisms that are of public health significance and subject food to decomposition or indicate that the food is adulterated or is contaminated with filth are considered “undesirable.”

2. How must food facilities account for pathogens?

Food facilities must prepare and implement a written food safety plan. One component of the food safety plan must include a written hazard analysis. This analysis must identify known or reasonably foreseeable hazards. These hazards may be biological, which includes parasites, environmental pathogens and other pathogens.

In another example, the food safety plan must include written verification procedures. This is to demonstrate that the facility is verifying that its preventive controls are implemented consistently and are significantly minimizing or preventing the hazards. These verification procedures are intended to be appropriate to the particular food facility, the food in question, and the nature of the preventive control and its role within the facility’s food safety system. With this in mind, facilities must conduct activities such as product testing for a pathogen or an appropriate indicator organism or other hazard, and environmental monitoring.

3. Are there written procedures specific to product testing?

Yes. Procedures for product testing must be scientifically valid and must identify the test microorganisms or other analytes. The procedures for identifying samples, including their relationship to specific lots of products, must be written and implemented. The procedures for sampling, including the number of samples and the sampling frequency, must be outlined. The facility must recognize the laboratory conducting the testing as well as describe the tests that are performed and the analytical methods used. Corrective action steps must also be included.

4. What are the procedures for environmental monitoring?

Similar to product testing, these procedures must be scientifically valid, identify the test microorganisms, and be put in writing. For routine environmental monitoring, the location from which the samples are collected and the number of sites that are tested must be stated. The final rule indicates that the “number and location of sampling sites must be adequate to determine whether preventive controls are effective.” Written procedures must also identify the timing and frequency for collecting and testing samples. Again, similar to product testing, the laboratory conducting the testing and the tests and analytical methods used must be divulged. Corrective action procedures must also be included.

5. How does the supply-chain program incorporate testing?

A receiving facility is required to document a written supply chain program in its records. A component of that program includes documentation of sampling and testing performed as a supplier verification activity. The documentation must include identification of the raw material or other ingredient (including, if appropriate, lot number) and the number of samples tested. It also means that the tests conducted and the analytical methods used must be identified. The date the test is conducted as well as the date of the test report must be provided, and the identity of the laboratory performing the testing must be revealed. Any corrective actions that were taken in response to a hazard detection must also be reported.

This Q&A provides a glimpse into how the preventive controls final rule for human food incorporates laboratory testing. For more details, access the final rule.

October 12, 2015

FST Soapbox

Risk in Our Supply Chain: Where Do We Start?

By Traci Slowinski

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FSMA has arrived with the launch of the first two preventive control rules – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food (or cGMP and HARPC, for short). With these new FSMA rules, the food and beverage industry will now be held accountable for being more proactive versus reactive, and will be responsible for identifying and managing risk throughout their supply chain. Of course, this emphasis on risk can also be seen in other sectors of the industry (i.e., GFSI and ISO), and risk has become the focal point for a number of compliance initiatives.

Supply chain challenges in food safety (Click to enlarge)

These days a number of supply chain challenges are driving risk. Continued global expansion of the industry is resulting in more import and export activities. We are seeing consumer food trends shift toward riskier food/preparation options. Regulatory agencies continue to work on improving their food safety requirements. And the growing population is putting more demands on our current resources. All of these factors equates to great risk within all stages of the supply chain.

Therefore, it will be important that you understand what risk management entails and have the right tools to identify, assess and control the risks that you find throughout your supply chain.

So where do we start looking for risk? Here are a few examples of where your risk assessments should be performed:

External Partners. You need to build strategic relationships with your external partners (suppliers, contract manufacturers/co-packers, service providers, carriers, etc.) across the supply chain. Building trust through good communication and collaboration is essential to ensure that you can rely on your partners to do the right thing for both parties.

Raw Materials. Many hazards can be introduced into a facility through raw materials—whether we are talking about raw ingredients, packaging materials, chemicals, or other components used to produce your product. Some hazards to assess include pathogens, allergens, chemical residues, pests and foreign material.

Storage and Handling. When looking at risk during storage and handling, it is important to address several hazards including allergen control, temperature control, foreign material control, proper segregation and product flow.

Processing. A number of areas in processing can introduce hazards and therefore should be included in your risk assessment. These include improper sanitation, cross contamination/contact potential, foreign material contamination, critical control point deviations, pre-requisite program failures and mislabeling.

Shipping and Transport. Lastly, you must safeguard your shipping and transportation procedures in order to account for any potential risk once the product has left your facility. Areas to consider during your risk assessment include temperature control, condition and sanitation of truck and storage units, loading/unloading practices, security/tampering potential, accident/emergency recovery, and traceability.

For more information on risk management within the food and beverage supply chain, register to attend the free webinar “Supply Chain Management: Does What I Eat Put Me at Risk” on October 28, 2015. Speakers will discuss risk throughout the supply chain, focusing on supplier management and some of the new FSMA requirements. They will provide an overview of risk management and some of the tools that can be used to identify and assess risk. In addition, they will discuss how technology can help companies meet FSMA requirements.

October 7, 2015

In the Food Lab

New Food Safety Technology Addresses FSMA Rules

By AJ McCardell

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In ongoing efforts to eliminate foodborne illness, the FDA recently issued the next step in rules designed for the enforcement of FSMA. The rules are aimed at modernizing food manufacturing processes after a wave of deadly outbreaks in the past decade stemming from contaminated cantaloupes, apples, spinach, lettuce, peanut butter, ice cream, cucumbers and other products. The rules require companies to draw up and implement written plans for keeping food safe. An important part of any food safety plan is the implementation of methods to verify that the controls put in place are working.

The food industry faces many challenges in meeting these new regulations. Two significant technical challenges for control verification are that the testing process takes too long and the sampling plans are often inadequate.

The pathogen testing process for all commercially available diagnostic tests requires an upfront culture or growth step to allow any pathogens present to multiply to a level that they can be detected by the test in use. This growth step, referred to by microbiologists as enrichment, is especially challenging in heavily processed foods and environmental samples, because the bacteria present in the sample have been stressed and are not in a rapid growth phase at the time of sampling. Advances in diagnostic sensitivity and robustness have reduced the amount of time required for enrichment from three or more days with traditional methods to about 24 hours on average with rapid methods. Even with rapidly growing and low-stress organisms such as E. coli O157:H7, enrichments take more than eight hours before implementing the diagnostic. The time required for this growth step creates a bottleneck in the production and distribution process. Although diagnostic companies are continuously improving the sensitivity of their methods and new methods are constantly being developed, there are practical limitations that have thus far prevented the elimination of the upfront culture step prior to testing. Historically, improvements in the sensitivity of rapid food pathogen diagnostics have been traded for time. In other words, having a more sensitive test means that fewer bacteria are needed for detection and therefore, less time is needed for bacteria to divide during the enrichment step. Some commercially available assays require as few as 1,000 to 10,000 target cells in the sample for detection. Since the purpose of the enrichment step is to increase the number of target pathogens in the sample to a detectable limit and bacteria reproduce by cell division, further diagnostic sensitivity improvements would need to be greater than ten-fold to have a significant impact on further reducing enrichment times.

Unreliable sampling methods are an even bigger issue for industry. An example demonstrating current practice is a field of 40,000 heads of lettuce with four (.01% of the total) heads of lettuce contaminated by a pathogen. The current best practice is to go into the field and collect 60 (.15% of the total) leaves from the heads of lettuce, mash them together and test them for contamination. The probability of this sampling method finding the four contaminated heads of lettuce in the sample is much less than 1%. When the undiscovered four heads of lettuce are washed with the other 39,996 heads of lettuce, cross contamination occurs and people get sick.

Technology advances that reduce or eliminate the requirement for enrichment and make the sampling process more reliable could have a big impact on improving control verification testing. But, those advances need to be delivered in a practical and affordable manner. I recently learned about a technology that has great potential to make improvements on both of these fronts, especially for the produce industry and any process that is able to use a wash step as a control point. The recently patented OmniFresh sampling system (developed by OmniFresh, LLC) concentrates a sample from the food processing wash water, allowing immediate testing representative of the food being processed. The concentration process is performed during the entire washing cycle for a lot and is consequently representative of the entire lot.

Concentration technology has been used for many years by academic researchers and scientists to collect samples for biological testing. Ultrafiltration methods for concentrating samples have typically used smaller sample sizes in the 1-10 liter range. The OmniFresh system allows for very large samples to be concentrated, typical volumes of 400 liters are concentrated to 50 ml.

The concentration process takes about one hour to complete after the first wash cycle. During processing, a side stream of water from the first wash tank is diverted to the concentrator unit. Tens to hundreds of gallons of wash water, depending on the size of the wash tank and the type and amount of produce being washed, flows into the concentrator. Throughout the sample collection period, large particulates are removed through a course filtration. Using ultra-filtration, bacteria and other small particles are isolated from the large volume of wash water into a much smaller, concentrated final sample. This concentrated sample can then be tested directly by a diagnostic test, eliminating the need for enrichment.¹

The OmniFresh System with diagnostic platform installed at a processing facility. (Click to enlarge)

The wash water in the tank comes into contact with all of the produce being washed, the majority of bacteria is removed from the produce, and it then enters the wash water.^2-4 This process, combined with the continuous sampling of wash water, means that low levels of intermittent contamination can be detected without testing high numbers of samples. Field testing of the OmniFresh System has returned promising results. The ability to rapidly screen produce for contamination could also provide a practical lot definition instead of cumbersome field-based definitions that can impact multiple processors.

Improvements in sample preparation and sampling technologies have much to offer the industry. Improved sampling methods which are representative of entire lots identify contaminated food earlier and with high confidence. Additionally, the negative test result is of much higher quality and will result in an increase in the overall confidence of the food supply.

The OmniFresh technology is one example of the type of improvements that are needed. More research that focuses on these most challenging aspects of control verification testing is needed.

References

Dyer, M.A. (2009). “New biosensors for food safety screening solutions.” SPIE.
Beuchat, L. R., and Ryu, J.-H. (1997). “Produce Processing Practices,” Emerg. Infect. Dis 3 (4), 459-465.
Sapers, G. M, (2001). “Efficacy of washing and sanitizing methods for disinfection of fresh fruit and vegetable products,” Food Technol. Biotechnol. 39 (4), 305-311.
U.S. Food and Drug Administration. (1998). “Water: Control of Potential Hazards: Wash Water.” Chap. II.B.2.3 in Guide to minimize microbial food safety hazards for fresh fruits and vegetables, by US FDA.

Deirdre Schlunegger, CEO of STOP Foodborne Illness

October 1, 2015

Food Safety Culture Club

2015 Food Safety Heroes Announced

By Deirdre Schlunegger

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Many of you are committed to doing everything possible to prevent people from becoming ill or dying from foodborne illness, and you whole-heartedly embrace a strong food safety culture. On November 17, 2015, STOP Foodborne Illness is pleased to be hosting Food Safety Heroes, an interactive fundraising event sponsored by Chemstar Corp. and Food Safety Tech.

We are excited that Food Safety Heroes will take place during, and in conjunction with, the Food Safety Consortium Conference, which is a summit meeting for Food Safety and Quality Assurance (FSQA) industry experts and government officials. In our eyes, every guest coming to this event is a food safety hero! Each day these people contribute to the overall health of our nation, and we couldn’t be more proud to be working alongside such outstanding men and women. To be a part of efforts to increase public awareness and collaboratively seek solutions is a great honor for us.

In addition to raising much-needed funds for the important, life-saving work of STOP Foodborne Illness, we also have the great pleasure of honoring two individuals who have seen the national conversation about safe food grow from its infancy, born from tragedy, to an increasingly aware industry of food safety professionals and consumers. Their efforts have been instrumental in cultivating the food safety culture that we see today.

The 2015 Food Safety Heroes award will honor:

Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness. Donley will be presented with the 2015 Legacy Tribute in recognition of her four-year-old son Alex, who died from an E. coli infection in 1993. From the time of her son’s death until her recent retirement from STOP, Donley has worked tirelessly to raise public awareness of foodborne illnesses by providing information and support for the millions of people who get sick from eating each year.

Frank Yiannas, vice president of food safety at Walmart Corp. A pioneering force in advancing the concept of a strong food safety culture, Yiannas is being celebrated as our 2015 Industry Advocate Hero. Going far beyond his role in overseeing the safety of the world’s largest food retailer, Yiannas is recognized for his commitment and dedication to building unique partnerships and participating in innovative approaches to food safety.

Please join us on November 17!

Food Safety Heroes

Time: 7–9 pm

Where: Renaissance Convention Center in Schaumburg, IL

Guests will enjoy cocktails and hors d’oeuvres, lively entertainment, a silent auction and more

(Follow the Food Safety Consortium link to the STOP Foodborne Illness Fundraiser)

September 24, 2015

FST Soapbox

Tackling the “Why” of Food Safety

By Timothy Ahn

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Food safety training has traditionally focused on foundational topics such as Hazard Analysis Critical Control Points (HACCP) and Good Manufacturing Practices (GMPs). While these topics are essential in defining and implementing Food Safety Prerequisite Programs, they define the What and How, but not the Why of Food Safety. In order to address the Why of Food Safety, training programs need to address food safety culture, and the role of a food safety management system in establishing that culture.

A session during the 2015 Food Safety Consortium Conference will discuss advancing food safety and harmonization through educating employees. | November 17-20, Schaumburg, IL| REGISTER NOWCreating a food safety culture needs to start at the top. It must be known that food safety is a top priority to upper management. In order for training programs to support a food safety culture, they need to be delivered in a format that enables employees to contribute to the organization’s business strategy and food safety objectives while simultaneously reinforcing employee skills, attitudes and behaviors. Studies have shown that during training, one should consider manufacturing as a whole—not bits and pieces—and that the correct and most effective approach to training should look at collective knowledge requirements rather than any single requirement. A good starting point is to understand how a well-planned management system can help bring focus on a holistic approach that transforms the culture. A company’s ability to adopt a culture of food safety is dependent on its ability to take a holistic approach to manage food safety risk and incorporate all components of a food safety culture.

The second area of focus is having an effective FSMS in place. The International Organization for Standardization (ISO) defines a system as “a set of interrelated or interactive elements” and a management system as “a system to establish policy and objectives and to achieve these objectives.” In order for the FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the whole organization. A food management system is most effective when it benchmarked against a proven standard and independently verified. Having an effective FSMS in place provides a vote of confidence in your organization—a statement that your organization takes safety and quality seriously and has made the right moves to help protect your brand reputation and consumers by addressing the complexity of risks, up and down your supply chain, and assuring food safety and sustainability.

By following these pragmatic guidelines your organization can raise the level of food safety around the world by creating more effective food safety solutions not only for today, but also tomorrow.

September 23, 2015

Beltway Beat

Final Preventive Controls Rules – Devil in the Details?

By Dr. David Acheson, Melanie J. Neumann

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As we review the general applications and requirements for the first two final rules of FSMA (Preventive Controls for Human Food and Preventive Controls for Animal Food), we’re not seeing a big departure from the proposed preventive controls. But with nearly 1,600 pages of reading, we may not have found all the changes yet. Areas of note include: For the first time in history, training is now a regulatory requirement; and a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule. With further analysis of the rule to come, we fully anticipate the devil to be in the details.

In this first article on the final rules, we are pulling out the key points, providing a general perspective of the Preventive Controls for Human Food, and main elements and compliance dates for both Preventive Controls rules.

The Human Food Rule

FDA has emphasized that it has built more flexibility into key requirements of the Human Food rule, including giving facilities the flexibility to consider the nature of the preventive control, the facility, and the its food safety system when establishing the appropriate preventive control management strategies (e.g. monitoring, verification, validation, corrective action). In addition, the definition of farms, which are exempt from these regulations, has significantly changed to reflect modern farming practices.

The agency views the rule as better protecting public health by adopting a modern, preventive, and risk-based approach to food safety regulation for the future in three key ways:

It creates new requirements for facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
It modernizes FDA’s long-standing CGMP regulations, updating, revising, and otherwise clarifying certain CGMP requirements, which were last updated in 1986.
It clarifies the scope of the exemption for “farms” and makes corresponding revisions to regulations for the establishment, maintenance and availability of records.

The rules generally apply to establishments that are required to register with FDA. Key elements of the rule are as follows:

Facilities must implement a food safety system that includes an analysis of hazards and risk-based preventive controls, including a written food safety plan that integrates hazard analysis of known or reasonably foreseeable biological, chemical, and physical hazards; preventive controls for processes, food allergens, and sanitation, supply-chain controls and a recall plan; and oversight and management of preventive controls to include monitoring, corrective actions/corrections, and verification.
The definition of a “farm” is clarified to cover two types of farm operations not subject to the preventive controls rule (however, farms that conduct activities covered by the Produce Safety rule are subject to that rule):
- Primary Production Farm. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing or harvesting of crops, the raising of animals (including seafood), or both. The final rule expands the definition to include facilities that pack or hold raw agricultural commodities grown on a farm under different ownership, and to those that solely harvest crops from farms.
- Secondary Activities Farm. The operation is majority owned by the primary production farm but located separately and is devoted to harvesting, packing and/or holding raw agricultural commodities.
A flexible supply-chain program with separate compliance dates. In general, a manufacturing/processing facility must implement a risk-based supply chain program for raw materials/ingredients for which it has identified a hazard requiring a supply-chain applied control – unless it or its customer controls the hazard using preventive controls according to the preventive controls rules.
Updated and clarified Current Good Manufacturing Practices (CGMPs). In addition, some previously nonbinding provisions have become binding rules.
A new “Qualified Individual” aka the “preventive controls qualified Individual.” This is a more highly qualified position/level in the organization with responsibility to perform the hazard analysis and assign preventive controls, defined under the rule as “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system.” The qualified individual is based on education/training as applied to the individual’s assigned job duties—with the assumption that each individual will be a “qualified individual” for his/her assigned role.
Training is a requirement. Foremost is the training required for the preventive controls qualified individual and qualified individuals. Further training may be required under Proposed §117.135(c)(6)–Other Controls, which proposes that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of §117.135(a).

The Animal Food Rule

In addition to key elements similar to #1–3 of Human Food (above), this rule:

Establishes CGMPs for animal food production by which facilities that further process a by-product for use as animal food must do so in compliance with CGMPs, but can follow either the human food or animal food CGMPs.
Does not apply to feed mills associated with fully vertically integrated farming operations that generally meet the definition of a farm. However, because FDA expressed concern that this leaves a food safety gap, it plans to publish a proposed rule in the future to require that some feed mill operations implement the CGMPs established by the Preventive Controls for Animal Food rule.

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