Tag Archives: pathogens

Robin Stombler, Auburn Health Strategies
In the Food Lab

Five Questions Food Facilities Should Ask About Testing

By Robin Stombler
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Robin Stombler, Auburn Health Strategies

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.

Salmonella outbreak linked to cucumbers

UPDATE: What is FDA Doing About Salmonella in Cucumbers?

By Food Safety Tech Staff
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Salmonella outbreak linked to cucumbers

UPDATE: September 9: According to the CDC, 341 people have been reportedly infected with Salmonella from 30 states. Since September 3, the number of cases has increased by 56. Two deaths have now been reported (California and Texas). Andrew & Williamson Fresh Produce has voluntarily recalled all cucumbers sold under the “Limited Edition” label (between August 1 through September 3, 2015).

More information has been posted on the CDC website.

Lawsuits regarding salmonella in cucumbers have already been filed.

–end update—

Across 27 states, an outbreak of Salmonella Poona linked to cucumbers grown in Mexico has led to one death and 53 reported hospitalizations, according to FDA. The agency released an update on Friday with the latest figures and information related to the outbreak and the product.

The product:

  • Cucumbers supplied by Andrew and William Fresh Produce of San Diego
  • Cucumbers grown in Baja, Mexico
  • Referred to as a “slicer” or “American” cucumber
  • Shipped in black, green, yellow cartons that read “Limited Edition Pole Grown Cucumbers”

The Salmonella outbreak (as of 9/3):

  • Where: Alaska (8), Arizona (60), Arkansas (6), California (51), Colorado (14), Idaho (8), Illinois (5), Kansas (1), Louisiana (3), Minnesota (12), Missouri (7), Montana (11), Nebraska (2), Nevada (7), New Mexico (15), New York (4), North Dakota (1), Ohio (2), Oklahoma (5), Oregon (3), South Carolina (6), Texas (9), Utah (30), Virginia (1), Washington (9), Wisconsin (2), and Wyoming (3)
  • Date range: July 3 to August 26, 2015
  • 1 death
  • 53 reported hospitalizations

Additional details are available on FDA’s website, and the agency will provide an update when new information is available.

As with any potential health hazard related to consumption of a food product, FDA is advising consumers not to eat the cucumbers. They are also urging restaurants to ask their suppliers what company supplied their cucumbers.

Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

What Should You Know About Food Safety Testing?

By Sangita Viswanathan
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Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

Food safety is in the news. Recent food industry, regulatory and consumer trends stress proactive, systematic and preventive approach to food safety by managing food hazards and risks. Testing for food safety hazards, particularly microbial hazards and allergens throughout the food production and processing chain is becoming increasingly important in assuring food safety. Food testing is also becoming important for detection of adulteration.

In next week’s Food Safety Consortium to be held in Schaumburg, IL, Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin, River Falls, and President of PCV & Associates, LLC, will discuss trends in the food safety testing market and approaches for testing of food and food plant environment, emphasizing microbial and other significant food hazards. In this article, PC, as he is popularly referred to, gives a sneak-peek into his presentation.

Food Safety Tech (FST): You will be speaking about the Food Testing Market – what are some broad trends that you are seeing?

PC: Food Microbiology testing is increasing worldwide but majority of testing is still dealing with food quality assurance and ingredient and product testing. Testing for pathogens seem to be driven by regulatory requirement. According to recent market reports, 76 percent of test volume in North America is for routine microbiology. In the EU and Asia, routine microbiology accounts for 81 percent and 72 percent of test volume, respectively.

Most pathogen testing is for Salmonella, E. Coli 057:H7 and Stex, Listeria and as L. monocytogenes. There is an increasing interest in testing for Campylobacter.

Testing of in-process and environmental samples is more common in NA and Europe. In Asia in-process/environmental testing only accounts for 9 percent of total test volume.

FST: In your presentation at the Consortium, what will you talk about FSMA and its impact on food safety testing?

PC: I plan to include a brief discussion on testing as related to monitoring and verification of Preventive Controls.

FST: Where is food safety testing headed, and what should food safety managers keep in mind?

PC: Given the emphasis on supply chain management and process control to manage identified hazards in preventive mode, food safety managers should understand testing internal and external testing requirements and complexity of sampling, testing tools and approaches not simply focus on cost aspects. Even if testing is outsourced, becoming familiar with various methods and testing tools will be necessary.

FST: Who should attend your presentation and why?

PC: Plant managers, quality assurance supervisors, marketing managers, food safety testing methods, equipment and service providers as well as anyone interested in food safety testing would find this presentation very useful and relevant to their day-to-day activities.

Are you registered for the Food Safety Consortium yet? Sign up now, and hear from over 70 experts in this area.

Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific
In the Food Lab

Molecular Diagnostics – Generation 3: 2005 to Present

By Ravi Ramadhar
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Ravi Ramadhar, Food Safety Business Director for Life Sciences Solutions, Thermo Fisher Scientific

In my previous blog, I covered the first two generations of Molecular Diagnostics: Generation one, was the advent of these tests prior to 1995, while the second generation saw the evolution of molecular diagnostics with the emergence of standardized food molecular and method workflow.

The advent of automated DNA sequencing and use of multiple fluorescent dyes by companies like Applied Biosystems and Roche led to the development of multiple fluorescent dyes and real- time quantitative PCR systems (qPCR). At first these qPCR systems were only used in the research environment, but quickly found their way to the food industry.

Applications such as quantitation of GMOs and multiple pathogen targets became common. Real-time PCR systems permitted users to visualize amplification as it happened and enabled simultaneous detection of multiple targets. With the use of newer chemistries and improved enzymes, shorter amplification cycles – sometimes as low as 40 minutes – could be achieved. The real-time systems offered faster time-to-result with additional target probes and thus higher target specificity. As with most molecular methods, the workflow was sensitive to food matrix inhibition and required alternative sample preparation methods to meet the wide variety of food matrixes.

Within this generation of solutions, alternatives were introduced, that promised faster, easier or more sensitive results. These included alternative to either the detection method or enzymes utilized Iisothermal amplification, for example without need for multiplexing capability of qPCR or internal controls, as well as targeting alternative nucleic acid such as RNA were introduced to the food market. These incremental improvements did not lead to any significant new paradigms or improvements to the food testing workflow. Their emergence instead led to an explosion of additional and alternative molecular platforms for food, without any real innovation. Within this, solutions introduced to the food industry eventually brought us to where we are today.

Directly taking systems from the clinical diagnostics workflow and introducing these platforms and systems as food solutions. While these systems automate the entire workflow or automate the PCR setup it remains to be seen if with their higher complexity and high maintenance these systems can survive the food industry. The basic molecular workflow for food has remained intact since its introduction in the late 1990s with innovation more or less stagnant. What’s needed is for someone to truly develop a platform from the ground up with the food laboratory in mind.

Today’s landscape and what’s next

Today, there are some early signals of where innovations and changes for food labs will emerge. A recent poster by Nestle, for example, highlighted the uses of next-generation sequencing (NGS) and DNA sequencing to develop a DNA method to allow the identification of coffee varieties through the value chain, from the field to the finished product. The method is applied on routine basis to guarantee the purity and authenticity of raw material used by Nespresso.

Applications of NGS in outbreak response and trace back investigations are being used in parallel with existing technologies. Finally, availability of new sequencing data enables better assay design and development of adjacent technologies.

NGS was preceded by emulsion amplification and sequencing by synthesis. These developments led to the development and introduction of digital PCR. Within a digital PCR reaction, millions of simultaneous reactions from one sample occur. The advantages of dPCR include lower and absolute, not relative gene copy number. The data has high precision and has better tolerance to inhibitors. These characteristics can lead to better and more precise molecular tests in food. , Before dPCR wide spread adoption is seen, however, the limitations of high cost and limited dynamic range must be addressed.

It’s not only in the testing labs and adjacent technologies that NGS is having an impact. In the labs driving innovation in food and food ingredient development, applications of NGS are being used to develop targeted food ingredients.

Nestle is the leader in this convergence of food, health and nutrition and over the last three years, the company has acquired and formed partnerships targeting the space. In its formation of the Nestle Institute of Health Sciences, Emmanuel Baetge, head of NHIS, emphasized NHIS expertise and research capabilities using systems biology, next generation sequencing, and human genetics.

The world of food safety is as dynamic as the natural flora of food itself. Changing regulations, evolving organisms, technological change and consumers’ changing tastes require new solutions. The requirements of the food laboratory have not changed. They are the protectors of brands and the teams we trust to deliver safe and quality foods. However, how they do that has and will continue to change.

Next time… molecular serotyping.

References:

  1. Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP) Available at: www.genome.gov/sequencingcosts. Accessed 1/13/2014 [DOA 1/13/12014].
  2. Beilei Ge and Jianghong Meng , 2009 14: 235 Advanced Technologies for Pathogen and Toxin Detection in Foods: Current Applications and Future Journal of Laboratory Automation DOI: 10.1016/j.jala.2008.12.012.
  3. Morisset D, Sˇ tebih D, Milavec M, Gruden K, Zˇ el J (2013) Quantitative Analysis of Food and Feed Samples with Droplet Digital PCR. PLoS ONE 8(5):e62583. doi:10.1371/journal.pone.0062583.
  4. http://www.nestle-nespresso.com/asset-libraries/Related%20documents%20not%20indexed/Nespresso%20poster%20ASIC2012%20DNA%20traceability.pdf
Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Combating Norovirus Hazards in Retail Food Service – Part 3

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

In the past two weeks, this blog has covered how Norovirus is the leading cause of foodborne illness worldwide, some potential sources of outbreak, and the importance of proper handwashing, developing an employee health policy, building a comprehensive food safety program, and training of employees. One critical aspect of Norovirus management is proper attention paid to cleaning and disposal of body fluids.

Proper cleaning and disposal of body fluids

The food code requires that retail foodservice establishments have proper procedures in place for emergency body fluids clean-up. Body fluids incidents in the dining room, play areas or back of the house are arguably the single most important source of Norovirus cross contamination in the restaurant, if clean-up and disposal are not performed according to standard operating procedures. The components of an effective and compliant SOP for emergency body fluids clean-up may include the following:

  • Written step by step procedure to contain, isolate, clean and disinfect affected areas;
  • Ready and easily accessible emergency body fluid clean-up kit;
  • Use of PPEs like disposable aprons, gloves and protective eye glasses;
  • Norovirus approved disinfectant as a kill step before and after clean-up;
  • Containment of body fluids spill using absorbent yellow spill pads to reduce aerosols;
  • Affected area should be isolated to avoid accidental dispersal by guests;
  • Discard all affected open food and decontaminate all affected surfaces;
  • Stop all food prep until body fluids are contained, cleaned and affected area disinfected;
  • Perform clean-up with disposable towels and yellow spill pads for easy disposal;
  • Wear triple gloves to avoid contaminating the clean-up kit and storage area;
  • Dispose clean-up trash straight in outside dumpster without passing through kitchen; and
  • Employee must wash hands twice, first in the bathroom and then in the kitchen.

The pathogen kill-step is the most important step in the body fluid clean-up process. The preferred option is to use a disinfectant grade chemical instead of regular sanitizers.

Ecolab’s Insta-Use Multi-purpose Disinfectant Cleaner is effective against Norovirus (and other viruses), mold, mildew and bacteria. It cleans, deodorizes and disinfects in one labor saving step and packaged in an easy to use compact cartridge with less storage space requirement. Caution: Disinfectant is not approved for food contact surfaces and cannot be used as a replacement for regular sanitizers on food contact surfaces.

Proper training of team members and associates is required before use to encourage compliance.

In conclusion, Norovirus is still a major infectious pathogen associated with foodservice operations in spite of several regulatory control and technological advances to curtail its occurrence and prevalence. Until a viable vaccine or an effective drug becomes available against Norovirus, rigorous implementation of food safety procedures, behavioral changes and continuous training of both foodservice workers and customers will remain the industry’s best practices at prevention and control. Overall, it makes a lot of business sense to do all that it takes to protect your customers against the threat of Norovirus infection, and by so doing, equally protect your business brand and the entire public health.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Combating Norovirus Hazards in Retail Food Service – Part 2

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

Last week, in this blog we discussed that Norovirus is the leading cause of foodborne illness worldwide, some potential sources of outbreak, and the importance of proper handwashing and cleaning and disposal of body fluids. In this second part of the blog, we will cover developing an employee health policy, building a comprehensive food safety program, and training of employees.

Develop an employee health policy

It is important to develop an employee health policy with detailed guidelines for sick employees. Sick foodservice workers are required to stay off work until fully recovered and cleared by their Doctor. When an employee becomes sick at work, such an employee must report to the immediate supervisor, and be allowed to leave work to attend to the ill-health. Reportable diseases must be reported upon diagnosis to enable the Local Health Department and affected foodservice establishment take necessary actions to protect the public health. There should be a crisis management plan in case the media gets involved in any such reportable infectious disease situations. To enable ill-health reporting compliance by employees, foodservice establishments are encouraged to adopt an employee health policy that is not punitive in nature.

Managers and supervisors should also be trained to recognize abnormal behaviors and tell-tale signs of ill-health in employees who may choose not to report due to the potential of losing hourly wages. Employee health policy training should be mandatory – to report injuries, ill-health and to follow the exclusion policy from food prep until fully certified and cleared to return to work by the Doctor.

For more resources on employee health policy, please see FDA’s Employee Health and Personal Hygiene Handbook for practices and behaviors of food service workers that can help reduce the spread of infectious diseases in retail food operations.

Self-auditing of food safety procedures

Active managerial control will enable verification of the food safety program for potential corrective actions that may be required including retraining of staff. A self-auditing system will ensure that risk mitigation is applied at every stage of foodservice operations with HACCP plans implemented and verified. In addition, a third party auditing will identify the weak links in the system and help prepare the establishment for Local Health inspections. Proper cleaning and sanitation of contact surfaces, observing the temperature rule – keeping cold food cold and hot food hot or routine cleaning and sanitizing of high touch points surfaces are examples of food safety procedures that managers can evaluate and verify on daily basis to continue serving safe quality food to customers. Effective implementation of these food safety standard will have a direct correlation with reduction in cross-contamination including Norovirus prevention.

Comprehensive supplier food safety program

Food can get contaminated at any point during the farm to fork journey. A robust supplier food safety program will ensure better control of potential risk transfer in retail food operations. A system that ensures that approved certified suppliers are continuously verified will capture any potential system failure and implement corrective action both at the supplier and retail levels. The use of approved suppliers is an important risk mitigation step that should be mandatory and verified to ensure that all deliveries are of the highest food safety and quality standard. Since risk burden may be accentuated at retail foodservice due to multiple operational processes in the kitchen, it is important to assess the risk burden at the supplier level, to enable effective mitigation. Thus, a dedicated supplier food safety monitoring, evaluation and verification is absolutely required at retail foodservice to assist in eliminating any food safety weak link in the supply chain. The safe quality food outcome will remain complementary and supportive of the supply chain’s mission of “never run out”.

Training of employees on standard operating procedures

Proper and continuous training of employees is fundamental to a successful food safety program in retail food operations. We may have the best food safety program in place but if these important SOPs are not properly implemented at every operational step as a result of training gap, it may in fact introduce a greater risk into the system. Since most hourly foodservice workers are young adults with a higher than normal turn-over rate, effective communication and continuous training will help keep a good handle on the food safety know-how of each batch of employees. Consequently, it is absolutely necessary to have a certified food safety manager as the person-in-charge to oversee foodservice operations. Training the trainers, managers and training directors will assist in meeting the training needs of all employees including hourly and temporary workers and for compliance with food code requirements.

Online food safety courses and training is the preferred method of instruction for most large retail foodservice chains. These training materials can be accessed anywhere in handheld devices and can be updated in real time. Online training however should not be a replacement for personalized one-on-one onsite training on the job. Hand washing compliance, no bare hands contact with RTE foods, clean-up of body fluids, separating high risk raw chicken, beef and sea foods from RTE foods using a color coded system, and observing critical control points in the food prep process are some of the SOPs that require continuous training and verification to ensure compliance.

In conclusion, Norovirus is still a major infectious pathogen associated with foodservice operations in spite of several regulatory control and technological advances to curtail its occurrence and prevalence. Until a viable vaccine or an effective drug becomes available against Norovirus, rigorous implementation of food safety procedures, behavioral changes and continuous training of both foodservice workers and customers will remain the industry’s best practices at prevention and control. Overall, it makes a lot of business sense to do all that it takes to protect your customers against the threat of Norovirus infection, and by so doing, equally protect your business brand and the entire public health.