Chelle Hartzer, Orkin
Bug Bytes

How to Prepare for an Audit at Any Time

By Chelle Hartzer
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Chelle Hartzer, Orkin

Everybody knows to prepare for the worst while hoping for the best. But being prepared for an unannounced audit isn’t something that can be done overnight, especially when it comes to pest management.

That’s why it’s important to carefully review your food safety plan and the specific pest management measures contained within it. Pest management can account for up to 20% of an audit, so it can make or break a facility’s score. There’s no room to gamble—between federal regulations, audit regulations, internal standards and customer expectations, you need to stay in compliance.

With FSMA in full effect, it’s important to become familiar with the regulations found on the FDA’s website if you haven’t yet. Reacting to problems isn’t good enough anymore, as many of these regulations emphasize a preventive strategy. The FDA has the authority to mandate recalls, shut down facilities and more. If you need help determining the rest of your facility’s food safety program, the FDA has a helpful downloadable food safety plan builder.

To make sure pest issues don’t spoil your score during an unannounced audit, remember that pest management is an ongoing partnership that requires your entire staff’s participation. It’s something you should plan for as part of regular maintenance and sanitation schedules.

The first step is to establish an integrated pest management (IPM) program. This plan should be developed with your pest management provider and should be a comprehensive look at all factors that may contribute to pest issues. It should be designed to reduce pest pressure around a facility, address all sanitation and exclusion issues, actively monitor for pests and set action levels.

The goal is to proactively deal with pests and prevent as many issues as possible. An IPM program is tailored to meet a facility’s specific needs based on a wide range of different factors. An IPM program uses pesticide treatments as a final step once all conducive conditions have been identified and addressed. The program should adapt as both the facility and the pest pressures change over time.

Implement regular training for all employees and encourage participation. Something as simple as a poster featuring the “most wanted pests” in break rooms or locker rooms can help train personnel to recognize the signs of potential pests around the facility. Make it clear that each employee is a key player in your program and empower them to speak up should they see something. Ensure you have a pest-sighting log and all personnel are aware of where it is and how to report issues. Their help will be vital to point out issues, ensure sanitation is adequate and identify problem areas on a daily basis. Your pest control professional can host a training meeting for you and your staff if needed.

When implementing an IPM program at your facility, there are numerous preventive tactics you can implement and perform on a regular basis.

  • Monitoring devices: Using devices like fly lights, rodent traps and bait stations can help reduce pest populations and keep them away from food products. These monitoring devices also offer insight as to how many and what kinds of pests are plaguing the facility, which is valuable information when determining a strategy to resolve existing pest problems and minimize pest pressure.
  • Sanitation: Any food source, including the foods you are producing and storing, can draw pests. Clean up product spills quickly. Don’t forget about food in employee areas such as break rooms and locker rooms. While it is impossible to clean up every food particle (you are producing food at your site!), you can work to limit the access pests have to food sources.
  • Take out the trash: Emptying trash daily and cleaning out the trash bins helps prevent the buildup of organic material, which can attract many different pests. Make sure dumpsters are placed away from the building if possible and always keep them closed. Don’t a smelly garbage or a full bin—when in doubt, take it out!
  • Seal cracks and crevices: Keep a constant watch around the facility for any openings big enough for a pest to fit through. Remind employees that rats only need a quarter-size hole to squeeze into a facility, while mice only need an opening the size of a dime. And that’s not the worst of it; cockroaches only need one sixteenth of an inch, making it vital to seal off any openings found. Don’t forget to look at your facility from the outside as well!
  • Install automatic doors: Often, open doorways are prime locations for pests to enter. All doors should remain closed when not in use. Especially in docking areas when loading/unloading, try to open dock doors only when needed and keep the gap from the truck to doorway sealed off if possible. Installing automatic doors can reduce the likelihood flying pests inside the facility by ensuring doors stay closed when not in use.
  • Inspect shipments: Anytime a new shipment arrives, it should be inspected closely for pests. Stored product pests could be in products and spread to others in close proximity quickly, so catching them early is key. Don’t forget to inspect shipping containers for outgoing product too, because if your product goes in an infested truck, your product will be considered infested!
  • Remove clutter: Many pests love to hide under clutter. Remove unused equipment, product and packaging—especially cardboard boxes—to avoid giving pests a convenient hiding place. Don’t forget about clutter outdoors, too.
  • Outdoor concerns: Sanitation is important outside the facility as well. Make sure to remove clutter and garbage on the ground and near the facility to help reduce pest pressure. Many pest issues start outside, so removing clutter outdoors means fewer pests to potentially get into your site. In addition, installing sodium vapor lights instead of mercury vapor lights near the building will attract fewer insects.
  • Install air curtains: The perfect complement to automatic doors, air curtains create positive airflow—or air flowing outwards from building entrances—to push pests away from the building.

Auditors are looking for a number of things when it comes to pest management. One important item they want to see is the record of past pest issues and the steps taken to resolve them. You and your pest management provider should ensure all records are up to date and accurate with pest trends that can be explained.

Documentation is perhaps the most critical part of a strong IPM program. It ensures your efforts are captured, organized and available should an unexpected auditor arrive on site.

The following are six main documents to have ready at all times.

  1. Food Safety Plan
    Perhaps the most important piece of documentation, the overarching food safety plan is absolutely necessary to have on hand. The plan should be a comprehensive document describing all activities to ensure the safety of food during manufacturing, processing, packing and holding. It should include a list of potential hazards, preventive controls and corrective actions to mitigate those risks, along with monitoring and verification procedures.
  2. List of Service Changes
    An IPM program needs to be dynamic. But when modifications are made to meet the ever-changing needs of a facility, make sure to keep careful records of how and why the plans have changed.
  3. List of Monitoring Devices/Traps
    Your plan must include a map documenting all monitoring equipment, traps and any other devices used around the facility to reduce pest pressure. Note the locations and activity levels of each. The trend report from the collected data can show important information and help make management decisions. Your pest management professionals can help with this, as they should be noting activity each time they inspect your property. Auditors will want to see the historical data of pest monitoring devices and the corrective actions associated with any issues. Monitoring devices work as a great early warning system for developing pest issues and are a great proactive approach.
  4. Annual Assessments
    Each year, you should review your food safety plan and current IPM program. These annual assessments will note problem areas and set goals for the coming year. Auditors will be looking for these yearly assessments, and if you’re able to demonstrate year-over-year improvement then you’ll give your facility a better chance at a great audit score.
  5. Sighting Reports
    If a pest is spotted within the facility, employees should document it on the pest-sighting log. The report should include information about the location of the pest within the facility, who found it and the number of pests spotted. Capturing the pest is ideal, but it’s not always feasible to do so. In that case, photo evidence helps with identification, so obtain a close-up picture of the pest(s) if possible. Ensure the pest is identified and any corrective actions documented.
  6. Proof of Training/Certification
    You know that your pest management professional is trained and certified, but an auditor doesn’t. To demonstrate your provider’s expertise, keep a valid license or certification document, written evidence of the pest management professional’s training, and documentation of internal training on IPM and Good Manufacturing Practices (GMPs).

According to FSMA guidelines, a strong food safety plan identifies potential hazards to food products, and focuses on a preventive, risk-based strategy instead of a reactionary one. With an IPM program in place and detailed documentation of actions taken, you’ll be prepared anytime an auditor decides to “pop in” for a “quick chat.”

Stanley Rutledge, Stop Foodborne Illness
Food Safety Culture Club

What’s the Point?

By Stanley Rutledge
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Stanley Rutledge, Stop Foodborne Illness

I’m surprised when I meet people who ask me, “What’s the point?”

What’s the point of…contacting people who’ve been impacted by foodborne illness? Sharing those peoples’ stories with industry?

Turns out, most of these people are speaking out of inexperience. For them, foodborne illness is a day or two spent home in bed, or the bathroom. They honestly aren’t aware that every year, for the families and friends of 3000 people*, foodborne illness is a destructive force much like the recent hurricane. It forces many people out of the lives they’re living into dire, and often extreme, situations where they’re required to rely on strangers and others for help. And before they reach a “new normal”—whatever that means—they face a myriad of physical, mental, financial, and social consequences. Unlike the hurricane, however, people who are victims of foodborne illness get no advance warning and are powerless to stop its effects, or even prepare for them.

At Stop Foodborne Illness we know the transforming power of story—of being able to recount an experience so powerful that it set you on a path different from where you started. For us, sharing those stories on an industry level is empowering for everyone involved. I’m always saying that everybody knows they need to wash their hands, but when that knowledge transitions from your head to your heart, then you have habits changing and behavior being modified.

Last month, a constituent from Wisconsin had the opportunity to share her story with about 120 employees of a fruit processing plant also located in Wisconsin. The following is an email we received afterwards that so clearly explains why we do what we do at Stop:

“You did an absolutely wonderful job. The impact on the group was exactly what I had hoped. Rest assured that you are making a difference by telling your story, and I know that was emotional and hard for you. Many people came up to me and said how different it makes them think of things now, having heard someone speak so close to home that almost died.

I can’t thank you enough.”

*The CDC estimates that every year in the United States, 3000 people die from foodborne disease, and that 128,000 people are hospitalized.

Gregory Siragusa, Eurofins
Food Genomics

GenomeTrakr: What Do You Know and What Should You Know?

By Gregory Siragusa, Douglas Marshall, Ph.D.
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Gregory Siragusa, Eurofins

This month we are happy to welcome our guest co-authors and interviewees Eric Brown, Ph.D. and Marc Allard, Ph.D. of CFSAN as we explore the FDA’s GenomeTrakr program in a two-part Food Genomics column. Many of our readers have heard of GenomeTrakr, but are likely to have several questions regarding its core purpose and how it will impact food producers and processors in the United States and globally. In Part I we explore some technical aspects of the topic followed by Part II dealing with practical questions.

Part I: The basics of GenomeTrakr

Greg Siragusa/Doug Marshall: Thank you Dr. Allard and Dr. Brown for joining us in our monthly series, Food Genomics, to inform our readers about GenomeTrakr. Will you begin by telling us about yourselves and your team?

Eric Brown/Marc Allard: Hello, I am Eric, the director of the Division of Microbiology at the U.S. Food and Drug Administration at the Center for Food Safety and Applied Nutrition. Our team is made up of two branches, one that specializes in developing and validating methods for getting foodborne pathogens out of many different food matrices and the other branch conducts numerous tests to subtype and characterized foodborne pathogens. The GenomeTrakr program is in the subtyping branch as Whole Genome Sequencing (WGS) is the ultimate genomic subtyping tool for characterizing a foodborne pathogen at the DNA level.

Hello, my name is Marc, I am a senior biomedical research services officer and a senior advisor in Eric’s division. We are part of the group that conceived, evaluated and deployed the GenomeTrakr database and network.

Siragusa/Marshall: Drs. Allard and Brown, imagine yourself with a group of food safety professionals ranging from vice president for food safety to director, manager and technologists. Would you please give us the ‘elevator speech’ on GenomeTrakr?

Brown/Allard: GenomeTrakr is the first of its kind distributed network for rapidly characterizing bacterial foodborne pathogens using whole genome sequences (WGS). This genomic data can help FDA with many applications, including trace-back to determine the root cause of an outbreak as well providing one work-flow for rapidly characterizing all of the pathogens for which the agency has responsibility. These same methods are also very helpful for antimicrobial resistance monitoring and characterization.

Siragusa/Marshall: From the FDA website, GenomeTrakr is described as “a distributed network of labs to utilize whole genome sequencing for pathogen identification.” We of course have very time-proven methods of microbial identification and subtyping, so why do we need GenomeTrakr for identification and subtyping of microorganisms?

Brown/Allard: If all you want to know is species identification then you are correct, there are existing methods to do this. For some applications you need full characterization through subtyping (i.e., Below the level of species to the actual strain) with WGS. WGS of pathogens provides all of the genetic information about an organism as well as any mobile elements such as phages and plasmids that may be associated with these foodborne pathogens. The GenomeTrakr network and database compiles a large amount of new genetic or DNA sequence data to more fully characterize foodborne pathogens.

GenomeTrakr and WGS are a means to track bacteria based on knowing the sequence of all DNA that comprises that specific bacterium’s genome. It can be called the “ultimate identifier” in that it will show relationships at a very deep level of accuracy.

Siragusa/Marshall: Is it an accurate statement that GenomeTrakr can be considered the new iteration of PulseNet and Pulse field gel electrophoresis (PFGE)? Will PulseNet and PFGE disappear, or will PulseNet and GenomeTrkr merge into a single entity?

Brown/Allard: PulseNet is a network of public health labs run by the CDC, with USDA and FDA as active participants. The network is alive and well and will continue subtyping pathogens for public health. The current and historical subtyping tool used by PulseNet for more than 20 years is PFGE. It is expected that CDC, USDA and FDA’s PFGE data collection will be replaced by WGS data and methods. That transformation has already begun. GenomeTrakr is a network of public health labs run by the FDA to support FDA public health and regulatory activities using WGS methods. Starting in 2012, this network is relatively new and is focused currently on using WGS for trace back to support outbreak investigations and FDA regulatory actions. CDC PulseNet has used WGS data on Listeria and collects draft genomes (i.e., unfinished versions of a final genome are used for quicker assembly) of other foodborne pathogens as well, and USDA’s FSIS has used WGS for the pathogens found on the foods that they regulate. All of the data from GenomeTrakr and Pulsenet are shared at the NCBI Pathogen Detection website (see Figure 1).

Sequences, GenomeTrakr
Figure 1

Siragusa/Marshall: Does an organism have to be classified to the species level before submitting to GenomeTrakr?

Brown/Allard: Yes, species-level identification is part of the minimal metadata (all of the descriptors related to a sample such as geographic origin, lot number, sources, ingredients etc.) required to deposit data in the GenomeTrakr database. This allows initial QA/QC metrics to determine if the new genome is labeled properly.

Siragusa/Marshall: After an isolate is identified to the species level, would you describe to the reader what the basic process is going from an isolated and speciated bacterial colony on an agar plate to a usable whole genome sequence deposited in the GenomeTrakr database?

Brown/Allard: The FDA has a branch of scientists who specialize in ways to isolate foodborne pathogens from food. The detailed methods used ultimately end up in the Bacteriological Analytical Manual (BAM) of approved and validated methods. Once a pathogen is in pure culture then DNA is extracted from the bacterial cells. The DNA is then put into a DNA sequencing library, which modifies the DNA to properly attach and run sequencing reactions depending on the specific sequencing vendor used. The sequence data is downloaded from the sequencing equipment and then uploaded to the National Center for Biotechnology Information (NCBI) Pathogen Detection website. The database is publicly open to allow anyone with foodborne pathogens to upload their data and compare their sequences to what is available in the database.

Siragusa/Marshall: Suppose a specific sequence type of a foodborne bacterial pathogen is found and identified from a processing plant but that the plant has never had a positive assay result for that pathogen in any of its history of product production and ultimate consumption. If an outbreak occurred somewhere in the world and that same specific sequence type were identified as the causative agent, would a company be in anyway liable? Could one even make an association between the two isolates with the same sequence type isolated at great distances from open another?

Brown/Allard: The genetic evidence from WGS supports the hypothesis that the two isolates shared a recent common ancestor. If, for example, the isolate from the processing plant and the outbreak sample where genetically identical across the entire genome, the prediction is that the two samples are connected in some way that is currently not understood. The genetic matches guide the FDA and help point investigations to study the possible connections. This might include additional inspection of the processing plant as well as linking this to the typical epidemiological exposure data. Sometimes due to the indirect nature of how pathogens circulate through the farm to fork continuum and the complex methods of trade, no connection is made. More commonly, these investigative leads from genetic matches help the FDA establish direct links between the two bacterial isolates through a shared ingredient, shared processing, distribution or packaging process. The genetic information and cluster helps the FDA discover new ways that the pathogens are moving from farm to fork. We are unaware of any example where identical genomes somehow independently arose and were unrelated. This is counter to molecular evolutionary theory anyway. Genetic identity equals genetic relatedness and the closer two isolates are genetically to each other, the more recent that they shared a common ancestor. With regard to liability, this is a topic beyond the scope of our group, but genomic data does not by itself prove a direct linkage and that is why additional investigations must follow any close matches.

Siragusa/Marshall: We know that SNPs (Single Nucleotide Polymorphisms or single base pair differences in the same location in a genome) are commonly used to distinguish clonality of bacteria with highly similar genomes. Are there criteria used by GenomeTrakr bioinformaticists that are set to help define what is similar, different or the same?

Brown/Allard: As the database grows with more examples of diverse serotypes or kinds of foodborne pathogens, the FDA WGS group is observing common patterns that can be used as guidance to define what is same or different. For example, closely related for Salmonella and E. coli are usually in the five or fewer SNPs, and closely related for Listeria is 20 or fewer SNPs using the current FDA validated bioinformatics pipeline. These values are not set in stone but should be considered more like guidance for what FDA and GenomeTrakr have observed already from earlier case studies that have already been collected and examined. Often, a greater number (e.g., 21-50) of SNP differences have been observed between strains isolated in some outbreaks. Any close match might support or direct an outbreak investigation if there is evidence that suggests that a particular outbreak looks most closely like an early case from a specific geographic location. WGS data helps investigators focus their efforts toward and international verses domestic exposure or possible country of origin. Even more divergent WGS linkages, when SNPs are greater than 50-100, often connect to different foods or different geographic locations that would lead investigators away from the source of an outbreak as the data provides both inclusivity as well as exclusivity.

When two strains have more than 50–100 SNPs, different food or geographic sources of those strains can be incorrectly linked resulting in investigators pursuing an incorrect source.

Siragusa/Marshall: Can SNPs be identified from different agar-plate clones of the same strain (i.e., Different colonies on the same plate)?

Brown/Allard: Since understanding the natural genetic variation present in foodborne pathogens is the basis to understanding relatedness, the FDA conducted validation experiments on growing then sequencing colonies from the same plate, colonies from frozen inocula, thawing and plating, as well as running the same DNAs on different instruments and with different sequencing technicians. The FDA’s work with Salmonella enterica Montevideo sequencing as well as ongoing proficiency testing among laboratories shows that the same isolate most often has no differences, although some samples have 1-2 SNP differences. Genetic differences observed in isolates collected by FDA inspectors all related to a common outbreak generally have more genetic differences, and this appears to be dependent on the nature of the facility and the length of time that the foodborne pathogen has been resident in the facility and the selective pressure to which the pathogen was exposed to in a range from 0–5 SNPs different.

Siragusa/Marshall: Regarding the use of WGS to track strains in a particular processing plant, is it possible that within that closed microenvironment that strains will evolve sufficiently so that it becomes unique to that source?

Brown/Allard: Yes, we have discovered multiple examples of strains that have evolved in a unique way that they appear to be specific to that source. Hospitals use the same practice to understand hospital-acquired infections and the routes of transmission within a hospitals intensive care unit or surgery. Food industry laboratories as well as FDA investigators could use WGS data in a similar way to determine the root cause of the contamination by combining WGS data with inspection and surveillance. The FDA Office of Compliance uses WGS as one piece of evidence to ask the question: Have we seen this pathogen before?

Siragusa/Marshall: The number of sequences in the GenomeTrakr database is approaching 120,000 (~4,000 per month are added). Are the sequences in the GenomeTrakr database all generated by GenomeTrakr Network labs?

Brown/Allard: The sequences labeled as GenomeTrakr isolates at the NCBI biosample and bioproject databases are the WGS efforts supported by the U.S. FDA and USDA FSIS. GenomeTrakr is a label identifying the FDA, USDA FSIS and collaborative partner’s efforts to sequence food and environmental isolates. Additional laboratories, independent and beyond formal membership in the GT network, upload WGS data to the NCBI pathogen detection website of which GenomeTrakr is one part. CDC shares WGS data on primarily clinical PulseNet isolates and USDA FSIS shares WGS foodborne pathogens for foods that they regulate. Numerous international public health laboratories also upload WGS data to NCBI. The NCBI pathogen detection website includes all publicly released WGS data for the species that they are analyzing, and this might include additional research or public health data. The point of contact for who submitted the data is listed in the biosample data sheet, an example of which can be seen here.

Siragusa/Marshall: Once sequences are deposited into the GenomeTrakr database, are they also part of GenBank?

Brown/Allard: The majority of the GenomeTrakr database is part of the NCBI SRA (sequence read archive) database, which is a less finished version of the data in GenBank. GenBank data is assembled and annotated, which takes more time and analysis to complete. Once automated software is optimized and validated, NCBI likely will place all of the GenomeTrakr data into GenBank. Currently, only the published WGS data from GenomeTrakr is available in GenBank. All of the GenomeTrakr data is available in SRA both at GenomeTrakr bioprojects and in the NCBI pathogen detection website.

Readers, look for the Part II of this column where we continue our exploration with Drs. Brown and Allard and ask some general questions about the logistics surrounding GenomeTrakr. As always, please contact either Greg Siragusa or Doug Marshall with comments, questions or ideas for future Food Genomics columns.

About the Interviewees

Marc W. Allard, Ph.D.

Marc Allard, FDAMarc Allard, Ph.D. is a senior biomedical research services officer specializing in both phylogenetic analysis as well as the biochemical laboratory methods that generate the genetic information in the GenomeTrakr database, which is part of the NCBI Pathogen Detection website. Allard joined the Division of Microbiology in FDA’s Office of Regulatory Science in 2008 where he uses Whole Genome Sequencing of foodborne pathogens to identify and characterize outbreaks of bacterial strains, particularly Salmonella, E. coli, and Listeria. He obtained a B.A. from the University of Vermont, an M.S. from Texas A&M University and his Ph.D. in biology in from Harvard University. Allard was the Louis Weintraub Associate Professor of Biology at George Washington University for 14 years from 1994 to 2008. He is a Fellow of the American Academy of Microbiology.

Eric W. Brown, Ph.D.

Eric Brown, FDAEric W. Brown, Ph.D. currently serves as director of the Division of Microbiology in the Office of Regulatory Science. He oversees a group of 50 researchers and support scientists engaged in a multi-parameter research program to develop and apply microbiological and molecular genetic strategies for detecting, identifying, and differentiating bacterial foodborne pathogens such as Salmonella and shiga-toxin producing E. coli. Brown received his Ph.D. in microbial genetics from The Genetics Program in the Department of Biological Sciences at The George Washington University. He has conducted research in microbial evolution and microbial ecology as a research fellow in the National Cancer Institute, the U.S. Department of Agriculture, and as a tenure-track Professor of Microbiology at Loyola University of Chicago. Brown came to the Food and Drug Administration in 1999 and has since carried out numerous experiments relating to the detection, identification, and discrimination of foodborne pathogens.

Thomas Tarantelli
In the Food Lab

Lead Found in Recalled Ground Cumin

By Thomas Tarantelli
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Thomas Tarantelli

Laboratory reports recently acquired by the Freedom of Information Law from the New York State Department of Agriculture and Markets show the Sol Andino brand ground cumin to contain 1090 ppm lead as well as 259 ppm chromium. The spice was also analyzed by IS:2446, 1980 method, “Detection of Lead Chromate in Chillies, Curry Powder and Turmeric by diphenyl carbizide.” A positive result was given, indicating the presence of hexavalent chromium, which is a component of lead chromate. Lead chromate is a yellow pigment, not allowed in food anywhere in the world as it is toxic, containing both lead and hexavalent chromium. The New York State Department of Agriculture and Markets posted a Class I recall of the Sol Andino ground cumin on July 10, 2017, without mention of the extremely high concentration of lead in the product.

Sol Andino, ground cumin
Sol Andino ground cumin recalled

The author could find no record of an FDA recall for the Sol Andino brand cumin powder containing excessive lead.

Some of us remember the four FDA Class I recalls of Pran brand turmeric for excessive lead in October 2013. These recalls were initiated by the New York State Health Department due to an illness complaint—most likely a child with high blood lead levels. The recalled Pran brand turmeric contained 28–53 ppm lead.

Also worthy of mention is the FDA/Illinois Class I recall of Nabelsi brand Thyme (actually a spice mix containing Thyme) on March 17, 2017.

“There have been two cases of high blood levels of lead associated with this product to date. Both cases have been reported through the Illinois Department of Public Health, Environmental Health Protection.”

According to the recall, the “Thyme” was found to contain 422 ppm lead.

Wondering if the 422 ppm lead was caused by adulteration of the “Thyme” with lead chromate or another lead pigment, a food chemist at the New York State Food Laboratory (a Division of NYS Dept. of Agriculture and Markets) requested from Illinois a sub-sample of the “Thyme” for analysis. Lab analysis of the spice found 323 ppm lead, 109 ppm chromium and a positive result for the chromate test. Thus, this recalled “Thyme” contains lead chromate.

In both cases, Pran turmeric and Nabelsi Thyme, illness complaints led to the recall of lead adulterated spices.

The New York State Department of Agriculture and Markets has a proactive program. Random samples of spices are sampled from retail markets and subsequently analyzed for unallowed colorants, undeclared allergens and heavy metals. In 2016 this resulted in the Oriental Packing Class I recall of 377,000 lb. of turmeric containing spices for excessive lead. (A typo in the FDA recall attributes the recall to the New York State Health Department, instead of the New York State Dept. of Agriculture and Markets.)

Still, it’s even better to analyze spices being imported into the country at receiving warehouses before the product reaches retail markets. Lead concentrations above 10 ppm can be determined instantaneously with a handheld XRF analyzer.

Adulteration with Sudan Dye Has Triggered Several Spice Recalls

Food Safety Tech
FST Soapbox

3 Ways to Ensure Food Safety for Packaged Foods

By Erica Montes
No Comments
Food Safety Tech

Food safety and hygiene are very important aspects of food production, processing and consumption. In the absence of proper hygiene and safety protocols, the entire food chain right from the farmer who grows the food till the consumer who eats it is compromised. Food safety lapses like contamination and spoiling of food pose major health risks.

There are many ways in which a perfectly safe food product can turn hazardous. Cross contamination from animal matter, lack of hygiene among workers in processing plants, poor sanitation procedures, inadequate preservation techniques and low-quality packaging can all adversely affect the shelf life of a food product. Raw food spoils much faster than processed food, so fresh vegetables and fruits used in food processing must be washed properly and stored at optimal temperatures before they are processed.

The following are a few critical factors that affect the safety, shelf life and hygiene of food products.

1. Hygiene in Processing Plants

Personal hygiene and excellent sanitation policies are essential to maintaining food safety. Processing facilities potentially have several points of food contact equipment and food contact surfaces. There must be well developed and written standard cleaning practices or sanitation procedures for all such high-touch areas in a food processing plant. All equipment, vessels and surfaces must be monitored for bioburden or presence of microbial matter.

The workers must also be aware of good personal hygiene practices. This will help prevent cross contamination and possible spread of foodborne diseases from humans. Workers suffering from contagious diseases should refrain from coming to work and regular employee health checkups must be carried out by doctors. All staff must be trained in food and personal hygiene, and strictly follow recommended methods of hand washing and drying. Proper usage of hygiene gear including masks, caps, gloves, overalls and footwear must be ensured.

Floors, walls, drainage facilities, narrow cat-walks and all surfaces in the processing area must be cleaned thoroughly using high quality cleaning materials. The standard cleaning practices must be diligently met each time and the supervisors should ensure that the crew is doing their job properly. Quality and consistent employee training, and effective instant monitoring methods like ATP testing will help achieve these goals.

2. Good Packaging Is Crucial

The quality and suitability of packaging are also very important in determining the safety, longevity and hygiene of food products.

Evolving consumer habits, growth of online marketplaces, increased consumption of high-protein foods, popular demand for smaller portions due to shrinking family size and the rise in new global distribution channels have all impacted packaging requirements.

Sustainable and responsibly sourced packaging materials are the hallmark of advanced packaging technology. They are environmentally friendly and do not deplete natural resources. Clean label packaging focuses on using recycled materials, high-pressure packaging technology, digital packaging and 3-D printing techniques, and outsourcing of more activities to save money, time and resources.

The need for reducing food waste has been an important objective of all recent packaging innovations. According to a recent report by The Guardian, almost half of all U.S. food produce is thrown away. Global food waste can be reduced by extending the shelf life of packaged foods, thereby avoiding early disposal and excessive purchasing. Latest innovations include in-built freshness sensors in packaging that alert customers when food goes bad, vacuum skin innovations, barrier bags and modified-atmosphere packaging.

3. Consumer Awareness Is Key

The end user or the customer who buys the food product for consumption also needs to be aware of good food use, preparation and storage methods.

Fresh veggies and fruits should be washed thoroughly, chopped, diced, and sliced, and stored in clear, airtight containers in the fridge. Prepare and cook raw foods like fish, poultry and meat to extend their storage life. Cooked food can be safely frozen for a long time. In addition, many food items like casseroles, soups, sauces, stir-fries and baked foods stay safe for cooking and consumption even beyond their typically assumed use-by date.

As responsible consumers, we must be aware of the difference between use-by, sell-by, best-before and expiration dates. This will prevent us from throwing away a whole lot of perfectly edible food items from our pantries.

Conclusion

Food safety is a matter of global concern and affects the well being of billions of people all over the world. Ensuring safety, hygiene, freshness and long shelf life of food items will help reduce food waste, hunger and starvation in the world. It will also reduce the burden on limited natural resources and will help ensure a sustainable and efficient food chain.

Erin Mann, Food Protection and Defense Institute
FST Soapbox

Targeting Agent Detection with Horizon Scanning of Food System Disruptions

By Erin Mann, MPH
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Erin Mann, Food Protection and Defense Institute

Agent detection to identify contamination of food products is required in food safety and defense programs. Detection typically involves laboratory methods or technologies, such as biosensors, that are used in close physical contact with food products. While the field of food protection has benefited from the development of novel agent detection methods in recent years, the challenge of determining which food products to test remains. The sheer volume of food produced within and traded across U.S. borders makes agent detection a daunting, time-consuming and expensive task. The decision of when to utilize detection methods depends on the risk of a particular product being contaminated. Contamination may be unintentional or intentional, including economically motivated adulteration (EMA).

The risk of contamination fluctuates over time and is a function of several factors. Risk depends on the biochemical makeup of the product, supply chain characteristics such as complexity and transport distance, and a wide range of natural or manmade events that may disrupt supply and potentially incentivize intentional adulteration. This is particularly true in the case of EMA. Events include but are not limited to natural disasters that destroy or reduce the usual supply of an ingredient, political instability that disrupts usual trade patterns, interruptions of routine food safety inspections, and market fluctuations that impact global prices. While data exists to monitor these risk factors of contamination, optimal use of this information by government and private industry is hindered by several challenges. For example, valuable data often exists across multiple data systems with data across systems appearing in inconsistent formats. In addition, the amount of data that must be reviewed to find a signal within the noise is frequently overwhelming.

Erin Mann, Food Protection and Defense Institute
Read our recent Q&A with Erin Mann, “As Food Fraud Grows, More Comprehensive Tools Emerge”

To address finding signals within vast quantities of data sources and systems, the Food Protection and Defense Institute (FPDI) developed technology to curate and help make sense of this data. With support from both the FDA and the Department of Homeland Security, FPDI developed FIDES or Focused Integration of Data for Early Signals to perform “horizon scanning” of food system disruptions in support of food protection efforts, including agent detection. FIDES was designed to help users forecast, monitor and identify food system risk factors and adverse food events. The FIDES web application fuses multiple streams of data from disparate sources and displays information in the form of an online dashboard where users browse, search and layer both dynamic and reference data sets related to food system disruption events. Examples of data currently included in FIDES are import refusals, global disasters, animal health alerts, food defense incidents, historical food safety incidents, import data, price alerts and reference data on food production worldwide.

Events in recent years illustrate the value of gathering intelligence and utilizing data related to food system risks to inform decisions regarding product targeting. Tsunamis, crop failures and disease outbreaks in humans and animals around the globe have threatened supply of products such as shrimp, spices, cocoa and eggs. When supply is disrupted, companies are often forced to quickly identify new and sometimes previously unvetted suppliers, including spot market purchasing. Likewise, supply disruptions often lead to price increases. As prices increase in the absence of adequate supply, concerns about EMA also increase. In both of these instances, the risk of product contamination—both unintentional and intentional—may rise and an increase in product screening or a change in agent detection methods may be appropriate.

For example, the 2014–2016 Ebola outbreak had a significant impact on West Africa, the primary production region for the world’s cocoa supply. Disruptions from the outbreak, including border closures and other trade interference, led to uncertainty about supply availability and prices. This raised concern for EMA, particularly given that many cocoa products are sold as powders, butters and liquors— forms that are more vulnerable to EMA than raw ingredients. As a test case, FPDI reviewed FIDES data streams during the peak of the outbreak. Real-time data on the outbreak was layered with data on global cocoa production and import patterns. Import refusal data from multiple global systems was assessed to identify any concerning patterns. Historical food defense and food safety incidents were also reviewed to determine which cocoa products had been previously contaminated. A similar approach could be used by the food and agriculture sector to guide decisions about targeted inspections—which product(s) and region(s) to monitor, which method(s) to use and which contaminant(s) to test. FIDES could support targeted screening and enhanced awareness of product risk profile that would allow the food industry to assure continued supply of authentic and quality products.

Jordan Anderson, PAR Technology Corp.
FST Soapbox

How Proper Record Keeping Can Help Reduce Food Waste in the Supply Chain

By Jordan Anderson
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Jordan Anderson, PAR Technology Corp.

One stringent component of FSMA and the Final Rule on Sanitary Transportation of Human and Animal Food is record keeping. Depending on the type and size of business, the FDA can demand proof of record anywhere from under one year and upwards to two years, all while needing to address their inquiry within 24 hours. Failure to do so will be considered a “prohibited act” and violators can be tried for civil and criminal penalties.
This new rule, put in place by the FDA, will put immense pressure on the food transportation industry, not only to make food safety a priority, but also to ensure that proper food safety practices and measures are being properly implemented, by way of record keeping.

While the litany of rules and regulations pertaining to record keeping best practices is intense, let us break down the basic requirements applying to records in layman’s terms:

  • If HACCP procedures aren’t documented, it didn’t happen
  • Records must be verbatim accounts of what happened
    • The need for real-time recording is paramount
  • Corrective actions must be executed immediately if an issue occurs
    • If not, liability risk increases exponentially

Companies must determine the most efficient and plausible manner by which they will comply. Traditional storage of records in filing cabinets and input of data in spreadsheets is antiquated, and leads to errors and the potential for misplaced records. Now, more than ever, is the time for businesses along the food chain to deliver value to their organization via digital technologies and automated data gathering solutions. This will ensure constant visibility and ensure quality control throughout the process from farm to fork.

Where Does Waste Happen?

While covering a lettuce farm in central California, National Geographic discovered that numerous loads were dumped each day due to procedural mistakes , including improperly filled, labeled and sealed containers.1 Due to the mishaps, the loads were then dumped. Between April and November that year, the local Waste Authority landfilled 4–8 million pounds of fresh vegetables from those fields.

The Food and Agriculture Organization (FAO) estimates that:

  • 54% of world food waste occurs during production, handling and storage
  • 46% occurs during processing & distribution

These numbers are not only staggering, but they illustrate the seriousness of this issue.

Many of these mishaps occur when standard recording procedures are done manually, which leads to improper documentation that invalidates the integrity of shipments—to which the above figures illustrate and corroborate.

But can shippers, loaders, receivers and the like secure their procedures and eliminate wasted product by implementing stricter digital HACCP solutions?

Lost Food

While improper execution of best practices can lead to FDA imposed sanctions and profit loss, it also perpetuates the problem of food waste globally. This issue has become an epidemic and one that greatly affects the lives of many.

In a recent National Geographic article, The Food and Agriculture Organization (FAO) suggests the following:1

  • One-third of food produced for global human consumption is annually lost or wasted along the supply chain
  • Food waste equates to 2.8 trillion pounds each year, which is enough to feed 3 billion people per year

Consider this: The World Food Programme estimates that nearly 795 million people in the world do not have access to the proper amount of food needed to live a healthy, active life, which equates to roughly one in nine people on earth.

The amount of waste created along the supply chain each year is enough to feed the hungry and malnourished people of the world three-times over. While waste is inevitable, even a 50% improvement would be able to feed those most in need.
We understand the nature of business is overcoming competition while expending the least capital possible, ultimately leading to profit. However, food-related businesses along the supply chain must ask themselves whether or not they are their own competition. Are best practices being properly executed? How can they ensure this in order to mitigate waste?

Ultimately, however, it becomes a human issue. Companies must be responsible and possess the empathy to understand this. While domestically we may not feel the effects of global hunger as much as other third-world countries, these businesses must be aware of the epidemic in order to elucidate this topic while simultaneously maximizing its businesses potential.

By leveraging new food safety solutions such as mobile devices, the cloud, IoT, sensors and more, you can better protect your customers while also gaining a tangible ROI. Wherever consumers purchase and shop for food today, they are likely to find a larger selection than ever before. From the bread aisle to the cheese counter to the produce section, food options and manufacturing processes today are more diverse than ever. While variety is positive on a consumer and cultural level, it can create challenges for food safety from farm to fork.

Reference

  1.  Royte, E. (October 13, 2014). “One-Third of Food Is Lost or Wasted: What Can Be Done”. National Geographic. Retrieved from http://news.nationalgeographic.com/news/2014/10/141013-food-waste-national-security-environment-science-ngfood/.
Melody Ge, InstantLabs
FST Soapbox

Five Tips to Add Food Fraud Prevention To Your Food Defense Program

By Melody Ge
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Melody Ge, InstantLabs

Food defense is the protection of food products from intentional contamination or adulteration, as well as biological, chemical, physical or radiological agents. It addresses additional concerns including physical, personnel and operational security. A traditional food defense program is generally perceived as a program that includes site security, visitors control or even on-site personnel monitoring. However, with the new FSMA Preventive Controls Rules and GFSI Guidance for all the recognized schemes, additional to consumer demand on product transparency, we must now take food fraud into consideration within our food defense program.

What is food fraud? According to the study from Michigan State University, food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false misleading statements made about a product, for economic gain. It becomes not just a potential for food safety issues, but also a severe issue that could potentially damage your brand reputation. It is hence critical to have appropriate protection and prevention, as the umbrella encompasses both food defense and food safety.

What does this mean to food manufacturers? The awareness of traceability and transparency certainly should rise. Most facilities should have a food defense program in place to comply with any GMP or GFSI requirements. To make it more competent for food fraud, what could we do? Here are some quick tips to strengthen your food defense program with food fraud prevention:

  • Tip 1: Review your entire supply chain one more time, considering fraud risks
  • Tip 2: Use the HACCP concept for food fraud risk analysis
  • Tip 3: Double-check incoming goods
  • Tip 4: Make the entire supply chain transparent
  • Tip 5: Document all records

Tip 1: Review your entire supply chain one more time, considering fraud risks

The unknown could potentially hurt you or your program. You would prefer to be aware of what might go wrong before it goes wrong, which is why a review should be one of the key steps in your food safety program. It might be a familiar terminology in the industry; however, we could not eliminate its importance to your entire food safety management system. To maintain product authenticity, understanding where your ingredients come from and who your business partners and suppliers are become the first step to success. It also gives you an excellent opportunity to analyze the risks and potential risk sources. A thorough review should include all the approved suppliers and vendor information. Knowing the source of your product provides you with a good foundation for your food defense program. How can we efficiently review our own supply chain?

  • List all approved suppliers and contract vendors
  • Make sure all ingredients are used accordingly and as intended
  • Keep the supplier registration list up to date

The more you understand your own supply chain, the more helpful it will be to your food defense program.

Tip 2: Use HACCP concept for food fraud risk analysis within supply chain

Hazard Analysis Critical Control Point (HACCP), as defined by FDA, is a management system in which food safety is ensured by addressing through the analysis and control of biological, chemical and physical hazards throughout the entire supply chain. This mentality of HACCP could be used and very helpful to analyze the potential fraud risks. Its seven principles and 12 steps could be implemented to identify your own fraud risks. And it is important for us to identify the hazards from potentially adulterated ingredients to determine the next step for what needs to be controlled. Utilizing the 12 steps, we can list all the key points and steps that could potentially impact your products’ authenticity. The risks can come from personnel, visitors or the ingredients themselves. There are many resources out there; for example, US Pharmacopeia (USP) has developed a global food fraud database that is a good resource for all ingredients that have been falsely used in food products.

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Tip 3: Double-check incoming goods

Many articles address the importance of vulnerability assessments to prevent food fraud plus any documentation your suppliers have provided. Yes, it is critical; however, as one of the important steps in the HACCP program, verification is also important to make sure what goes into your finished products is safe and guaranteed. This could be addressed and monitored by implementing genetic testing. Each product and ingredient has its own DNA, just like our fingerprints. Nowadays, there are many methodologies developed for this type of test. The DNA testing could be a helpful tool to help your facility verify the authenticity of your incoming raw materials. Genetic testing using techniques like polymerase chain reaction (PCR) technology to detect the DNA of the product upon receiving the incoming goods. Moreover, as fast as it can be, facilities can now receive the test results within one to two hours. The testing itself might seem like an extra step with more effort and labor. However, the return is a huge saving on damages caused by food fraud. You can now start to verify and control your supply chain from the beginning to avoid any potential adulteration.

Tip 4: Make the entire supply chain transparent

This transparency not only applies to internal employees but also outward to your customers and vendors. That way you can familiarize yourself with your own supply chain, while at the same time establish brand reputation and confidence to your customers.

Tip 5: Keep all records documented

The records you should keep, besides a registration list of all your ingredients and vendors, should include the inventory list, how ingredients are used, whether it is used outside of its intended use and authorized personnel signatures. The following are some tips for an efficient document control:

  • Make it clear and straightforward
  • Categorize it based on your own facility operations
  • Keep the records in the same order of your supply chain from ingredients to end consumers

After all, with the newly released requirements, as QA professionals, we need to start developing a mindset that considers food fraud as a type of hazard, and develop monitor and control strategies for mitigating it. Just like we are now so familiar with the physical, chemical and biological hazards within our production facilities compared to decades ago, food fraud will no longer be a scary term once it is proficiently understood and properly controlled.

Judy Black, Rentokil
Bug Bytes

How the Internet of Things Helps Pest Management in Food Processing

By Judy Black
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Judy Black, Rentokil

As the applications of connected devices continues to drive innovation and create exciting possibilities throughout the food processing industry, the impact of the Internet of Things (IoT) on pest management in the food supply chain is already easy to recognize. An ecosystem of connected devices streamlines several processes that are integral to an effective integrated pest management plan, providing convenience and saving time for both food manufacturers and their pest management partners. From creating a smart network of devices that detect changes and track movement in the pest population to seamless reporting procedures that cut down on paperwork, we’re already seeing the benefits of a more connected world on a very important aspect of food safety.

Judy Black will host a free webinar, along with her colleague Jeff Robbins, director of commercial pest marketing, on the applications of IoT in pest management throughout the food supply chain on Wednesday, Aug. 9 at 1:00 pm ET/10:00 am PT. Register hereAt the ground level—often quite literally—we have networked traps for pests ranging from stored product insects to rodents. Each trap tracks the pests it captures and reports its readings to a central hub in real time, providing an instant snapshot of changes in the pest population and triggering notifications when that population exceeds pre-set parameters—well before the pests create an issue. Beyond knowing when a pest population increases in a facility, this network of connected monitoring devices can pinpoint where those pests are congregating, allowing the facility’s pest management partner to identify and eliminate the source of the issue quickly.

Beyond those devices on the front lines, the IoT also has a major impact on the behind-the-scenes management of pest management processes. With the increase in reporting requirements brought on by the adoption of FSMA earlier in the decade came a lot of new paperwork for food manufacturers. On the pest management front, the paper trail required to track the steps taken to reduce the risk of pest infestation represents a significant commitment of time and effort on the part of facility managers. Working with a pest management partner that understands the opportunities connected devices provide means less paperwork; a centralized online hub allows facility managers to review their partner’s recommendations, indicate the steps they’ve taken to address issues and close the loop without having to touch a file cabinet.

The availability of this pest-tracking data allows forward-thinking pest management companies to be more efficient and better informed. By compiling and analyzing this data, they can identify regional trends in pest populations, allowing them to be better prepared to recognize and resolve pest issues early and to stay ahead of cyclical fluctuations in the pest population.

We often talk about technology in terms of the impact it will have in the future, but in the pest management business, we’re already seeing the benefits of a connected ecosystem of devices. While the technology will continue to evolve and improve, it’s important for food manufacturers to recognize the benefits of working with a pest management partner that embraces the IoT. By streamlining and centralizing the processes of monitoring and reporting on pest management practices, this technology saves time and reduces the risks pests pose throughout the food supply chain.

Katy Jones, Foodlogiq
FST Soapbox

3 Ways to Make Transparency a Successful Business Strategy

By Katy Jones
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Katy Jones, Foodlogiq

Transparency. It’s been top of mind for years. But because of the shift in public’s interest in healthy ingredients and where they come from, businesses are responding by making transparency part of their strategic business initiatives. This includes providing a complete list of ingredients, known allergens and their nutritional information. They also want to know where and how products are sourced and handled. If this information isn’t available, it creates an air of distrust with today’s savvy consumers.

FoodLogiQ, FoodSafety Tech
EXCLUSIVE VIDEO: Food Safety Tech recently spoke with Katy Jones about consumer preferences and their expectations during a product recall. Watch the video

This information is becoming increasingly mandatory, not just because of FSMA and other regulations but because customers are demanding it. With globalization and increased imports from foreign suppliers, regulations as well as consumer expectations for food quality and safety has dramatically risen in the past few years. It is now one of the most critical ways you can earn consumer trust and loyalty. Here are three ways to incorporate transparency into your business plan.

1. Supplier Engagement Makes Good Business Sense

To offer transparency to customers, you must engage with your suppliers. You can’t offer your consumers the transparency they are demanding if you are not getting the information from your suppliers. Plus, it is critical to know who your suppliers’ suppliers are to mitigate risk.

Leveraging a supplier management technology solution will save you time by automating processes such as supplier onboarding and will help you keep track of documents, certificates and audits that you require.

It also helps support supplier communications so you can establish an open dialogue, which is critical when problems arise. You can’t expect a supplier to fulfill your requirements around safety and brand promise if you aren’t open about your expectations. It’s a two-way relationship that can make a huge difference in your business.

FoodLogiQ’s recent survey, “A Food Company’s Guide to What Consumers Care About in the Age of Transparency” (click to enlarge)

2. Label Transparency

FoodLogiQ recently published a survey that revealed supply chain transparency by food companies is a critical driver in consumer purchasing decisions and brand loyalty. Fifty-four percent of respondents want as much information as possible on the label, and nearly 40% want country of origin, allergen alerts and GMOs all identified on the label.

In this survey, those who identify as “caring deeply about the quality of food they eat,” are overwhelmingly in favor of more transparent labeling, with 86% of that demographic expecting country of origin, allergen alerts and genetically modified ingredients to be noted, and they ask that “as much information as possible” be included on the label (or menu) itself.

If a brand doesn’t provide this information, consumers will look elsewhere for it. This puts companies in a vulnerable position.

3. Building a Transparent Culture and Backing Marketing Claims

Food safety professionals and the marketing department are now working together to communicate their transparent farm-to-fork story. This cross-departmental collaboration will not only meet business goals but the teamwork strengthens the overall business.

To maintain a positive reputation, it starts with being open and honest, and engaging your customers in an authentic way. And once a brand establishes itself as being transparent, consumers are more open to trying other products from that company. Building a culture of transparency that is focused on safety and quality can be an incredible marketing advantage and give food companies an edge over competitors.

A recall, stock withdrawal or a report of a foodborne illness can wreak havoc on a business. But the worst thing you can do is hide it. If a brand has ever been under fire for false information, low-quality ingredients or a major recall, consumers know. They are more informed about your products through their online research and social media. It is better for consumers to receive this information directly from the brand than through a third-party site.

If a company is faced with a recall, it is important to involve multiple business units that each have a stake in resolving the issues as quickly as possible. Include the marketing department in your food safety plan and preventative controls so if you are faced with a recall, you have a communication plan in place.

How to Meet Transparency Business Goals

For food companies to provide this transparency, protect their brand image and earn their customers’ trust, they need full end-to-end supply chain traceability technology to modernize their processes and access real-time data. Centralizing your data creates a single source of truth to make data-informed decisions and remain compliant, all while empowering consumers to make safer, more informed decisions about the food they eat.

The good news is that food companies making transparency a priority are being rewarded by customer loyalty, as consumers are willing to pay more for those products. The previously mentioned survey revealed that 88% of respondents—from all demographics, Millennials to Boomers—were willing to pay more for healthier foods including those that are GMO-free, have no artificial coloring/flavors and are deemed all natural.

Transparency transcends all categories: From restaurant menus to labels on consumer package goods. So no matter what business you are in, implement these strategies to systematically impact on your bottom line and keep your food chain safe.