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Peas, UV light

Controlling and Mitigating Pathogens Throughout Production

By Troy Smith
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Peas, UV light
Sampling
Product sampling

As the enforcement of rules, regulations and inspections get underway at food production facilities, we are faced with maintaining production rates while looking for infinitesimal pathogens and cleaning to non-detectible levels. This clearly sets demand on the plant for new and creative methods to control and mitigate pathogens pre-production, during production and post production.

As this occurs, the term clean takes on new meaning: What is clean, and how clean is clean? Swab and plate counts are now critically important. What method is used at the plant, who is testing, what sampling procedure is used, and how do we use the results? As we look at the process from start to finish, we must keep several key questions in mind: What are harboring points in the process, and what are the touch-point considerations to the product? Let’s review the overall processing progression through the factory (see Figure 1).

Figure 1.
Figure 1. The progression of processing of a food product through a facility.

Now consider micro pathogen contamination to the product, as we look deeper in the process for contamination or critical control points as used in successful HACCP plans. Consider contamination and how it may travel or contact food product. It is understood through study and research of both pathogens and plant operations that contamination may be introduced to the plant by the front door, back door, pallet, product, or by a person. In many cases, each of these considerations leads to uncontrolled environments that create uncontrolled measurements throughout, which lead to cleaning procedures based on time rather than science. This is certainly not to say that creating a preventive maintenance schedule based on a calendar is a bad thing. Rather, the message is to consider a deeper look at the pathogens and how they live and replicate. From the regulatory and control measures this should be a clear message of what food-to-pathogen considerations should be taken at the plant level as well as measurement methods and acceptable levels (which is not an easy answer, as each product and environment can change this answer). A good example to consider is public schools and children. Health organizations work to help the schooling system understand what immunizations children should have based on the current health risk tolerance levels. In food production, the consideration is similar in an everchanging environment. As we see contamination levels change the methods, techniques and solutions to proper food production must account for the pathogens of concern.

Contamination, Risk tolerance, Opportunity for Growth

Contamination, risk tolerance, and opportunity for growth are the considerations when looking at a plant design or a plant modification. Modification to modernization should be a top-of-mind critical quality control measure. If there are a few things we know, it is how to produce food at high rates of speed, measure and value production rates, and delays or failures can be measured by equipment and personnel performance. In the case of quality control, we must review, comprehend, and protect process risk. From a management or non-technical viewpoint, quality control can be very difficult to understand. When discussing pathogens, our concerns are not visible to the human eye—we are beyond a dirty surface, weare looking at risk tolerance based on pathogen growth in logarithmic measurement. When combining quality control and production, the measurement control and mitigation measures complement the effort. The use of quality control is expected and should coordinate with production to ensure the product is produced at the expected quality level.

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
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FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.

Changing Landscape for Selecting a Food Safety Contract Laboratory

By Bob Ferguson, Thomas R. Weschler
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A recent study of more than 100 food processing customers of food contract laboratories examined the key factors that make a commercial food laboratory competitive in the eyes of their customers. The details of this study, which was conducted by Strategic Consulting, will be presented at the Food Safety Consortium in December.

The 2016 Food Safety Consortium takes place December 5–9 in Schaumburg, IL | LEARN MOREThe volume of microbiology testing worldwide is growing annually at 6%. The study data, however, shows that the growth of microbiology testing at food contract labs is growing at twice that rate—12%—annually. This means that every year food contract labs are taking a larger share of the micro-testing market. Specific to pathogen testing, the situation is more pronounced. Two-thirds of the food processors surveyed conduct routine microbiology testing at their in-house lab, but the number willing to conduct pathogen analysis in-house has dropped to one-third. With more and more companies becoming wary about the risks and costs of analyzing pathogens in a plant lab, outsourcing continues to grow and the volume of total pathogen tests conducted at food contract labs is growing at more than 13% per year. Based on the data generated from the study, it can be deduced that, for the first time in the United States, the number of pathogen tests conducted at food contract labs now exceeds 50% of all pathogen tests conducted in the country. This is not only changing the face of microbiology testing, but it is also creating a very competitive market for laboratory services.

With this test volume now going to food contract laboratories, anyone who needs microbiology analysis has already (at least once) checked the qualifications of a food contract laboratory and validated that it has the right scope of accreditations, specific experience with product type, and proof that they can reliably meet test specifications and detection limits.

These basic qualifications, however, are “table stakes” in today’s highly competitive food safety contract laboratory market.

In the study, the most common answers to the question of the top decision criteria used when selecting a food contract laboratory for microbiology testing were, in order of importance, price, turnaround time, and dependability. When asked about testing of pathogens, most respondents reported that “accreditations” was their number one decision criteria, followed in order by the three previous factors of price, turnaround time and dependability.

A key distinction to understand in this analysis is the term “accreditations” was certainly used to describe formal lab accreditations, but it was also commonly used interchangeably with “expertise.”  In detailed conversations with buyers, it was clear that specialization and competence in pathogen testing was of primary importance and, in many cases, specific experience with the specific pathogen in which they were interested, and in most cases, experience with their specific product type (e.g., meat, dairy, processed foods, etc.).

Interestingly, although proximity to the plant ranked last of the six most common selection criteria, greater than 70% of the plant personnel interviewed reported that they use a food contract lab for pathogen testing that is within 100 miles of their production location. Based on the interviews it was clear that proximity was very important (and linked to turnaround time), but it also revealed that all of the major customers reported that all of the labs they would even consider had locations within a 100-mile radius of their plant. Of these labs, 60% offered a courier service to collect samples at the plant and deliver them to the lab. It is clear that proximity and a sample collection service, while once a point of differentiation, is now seen less as key selection criteria and more of a “table stake” for being considered at all.

Food processors, of course, run samples for testing for parameters other than microbiology. In this study, 78% of the companies surveyed ran tests for nutritional chemistry and, of those, 42% used an in-plant lab. In addition, 81% of the companies test for contaminants (e.g., pesticides, drug residues, metals) and of those, 55% run the tests in an in-plant lab. Of the companies that use a food contract lab for either types of tests, 60–65% (depending on the parameter) report sending samples to a lab that is more than 100 miles from their plant.

It is clear from this data that food processors are far more comfortable analyzing samples for nutritional parameters, contaminants and routine microbiology in an in-plant lab, but fewer are comfortable running pathogen tests in-plant. And while proximity is important for pathogen tests, it was not a top qualifier for nutritional or contaminant testing. As more and more pathogen samples are outsourced to food contract labs, however, it remains to be seen if the samples will “drag” samples for these other parameters along with them to the closer proximate labs. But it is clear that the contract labs with a network of locations that place them close to their customer’s locations and who have expertise in pathogens as well as a full range of other analyses will likely have an advantage.

The role of food contract laboratories will continue to grow, creating great business opportunities. The dynamics of this market, however, are clearly changing the ground rules and presenting companies with new risks and opportunities. Understanding this changing landscape will be of paramount importance to food contract labs, and their  success or failure will depend on their strategic decisions and how well they navigate these changing conditions.

These business environment changes are also essential for food processors to understand. As market conditions change, pricing, turnaround times, and add-on services available from food contract labs will also change, presenting risks and opportunities for processors. Food processors that understand these changes will also be able to take advantage and improve their testing programs.

Gina Kramer, Savour Food Safety International

Industry’s Responsibility to Protect Consumers from Listeria

By Maria Fontanazza
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Gina Kramer, Savour Food Safety International

The ubiquitous nature of Listeria has made it a difficult pathogen to detect, control, and find its root cause. Led by Gina Kramer, executive director of Savour Food Safety International, attendees of last week’s Listeria Detection & Control Workshop learned everything from the cost of Listeria ($1.4 million per case and $2.3–$22 billion in the United States annually) to the challenges of breaking down biofilms to the steps a company should be taking to do sanitation right and get rid of resident Listeria in their facility. Here’s a snapshot of what experts said as they addressed industry’s obligation to ensure that their facilities are constantly monitored for contamination to ensure that safe product comes out of their plants.

People equate local and organic with safer, safer, safer. That’s not true, because pathogens are agnostic. ­– Gina Kramer, executive director, Savour Food Safety International Gina Kramer, Savour Food Safety International
John Besser, CDC Whole genome-based outbreak detection allows us to detect more quickly, with greater precision in identifying source — John Besser, Ph.D., Deputy Chief, Enteric Diseases Laboratory Branch, CDC
 What’s happening in your plants? What are you taking into your processing plant? What time of year is it coming in? What is your environment—is it more urban or rural? The presence of Listeria isn’t any greater in an urban or rural environment. You might find it in different places, but there isn’t a difference in incidence.  – Janet Buffer, corporate food safety manager, The Kroger Co.  Janet Buffer, Kroeger Company
Dominique Blackman, Realzyme  Biofilm erupts like a volcano. But once it has erupted, your volcano goes dormant. And for how long? Nobody knows. That’s the problem. The biofilm can release two days later, a week, or a month later.  – Dominique Blackman, general manager, Realzyme
 Listeria testing is the ugly duckling in preventive controls. Companies need to ask themselves whether the method they use is able to detect potential positives in the environment. – Ted Andrews, senior director, product marketing, Roka Bioscience  Ted Andrews, Roka Bioscience
 Jeff Mitchell, Chemstar Sanitation is not one size fits all. You need to have specific controls in place that look at controlling Listeria not just for equipment but periodic infrastructure and equipment and routines. Validate that they work. Train employees so they properly execute.  – Jeff Mitchell, vice president of food safety, Chemstar
 You’ve identified Listeria in your facility.  Now what? Review touch points: This includes the air, surfaces, transportation and packaging areas. – Troy Smith, CEO, Radiant Industrial Solutions, LLC  Troy Smith, Radiant
 11_FSTListeria_DougMarshall If you get everything mostly right, what are the odds that you’ll find a pathogen in end product testing? Getting the proper data point is a big deal. – Douglas Marshall, Ph.D., chief scientific officer, Eurofins

 

Recent Developments in Pesticide Analysis

Evaluation of Q Exactive LC-MS for Pesticide Residues in Fruits and Vegetables – Plenary Lecture: Abstract: The Thermo Scientific™ Q Exactive™ LC-MS has been evaluated for detection, identification and quantitation of pesticide residues included in the European Union Monitoring Program. Pesticides were analyzed in four matrices representing wide range of difficulty (tomato, pepper, orange and green tea). Read more and watch the lecture here.