Deirdre Schlunegger, Stop Foodborne Illness

By Deirdre Schlunegger

Last month, I spoke in Santiago, Chile at the Inofood Conference. I spoke about the impact of foodborne illness in the lives of individuals and families.

I showed photos of little Reese who died two years ago and talked about how Stop Foodborne Illness works with the food industry to drive home the importance of food safety and the consequences of foodborne illness. Together, we work to raise awareness, create and sustain strong food safety cultures and to promote the importance of food safety.

Deirdre Schlunegger will be speaking as part of a panel of experts during the Food Safety: Past, Present & Future Plenary Session during the Food Safety Consortium, November 29th at 4:00pm.

I was in good company with Frank Yiannas as he spoke of food safety culture and his book was even translated into Spanish for this conference. Tim Jackson from Driscoll’s and DeAnn Benesh from 3M addressed technical issues related to food safety and many others spoke. Food Safety representatives from Chile and around the globe were very interested and are dedicated to the topic and practice.

I am proud that we are among the nonprofit, behavioral and scientific experts and making a difference as food safety culture, tools, data and interventions improve. I have already been contacted to see if the video, which I showed in Spanish, can be used throughout Chile in the coming months.

Just a few days following his conference, I was in Greenbelt Maryland attending the JIFSAN (Joint Institute of Food Safety and Nutrition) Conference and Advisory meeting as I serve on the Advisory Council. The topic was Risk Analysis Tools and Data and it was a fascinating two days. Again, professionals who teach and share food safety knowledge around the world gathered to share vision, tools and practices.

The 5th Annual Food Safety Consortium conference will take place November 28 through December 1st and we will be there! We continue to see a strong drive and desire to improve food safety and we need to continue to press until the estimated number of people who die each year from foodborne illness diminishes significantly from 3,000 towards zero. No one should die from nourishing their body with food.

I am ending this blog with the powerful story of Aly: http://www.stopfoodborneillness.org/stories/aly/

November 7, 2017

FST Soapbox

How the IoT Influences Restaurant Food Safety & Management

By Jordan Anderson

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The Internet of Things (IoT) is changing the way restaurants do business in 2017. Today, business owners can trace products from point-of-purchase to their doorstep using IoT devices that monitor their location and more importantly, their temperature along the way. These devices are helping keep food safe, streamlining inventory management and giving owners the real-time information they need when managing multiple locations.

Monitoring Food Safety

Nothing gets the attention of a restaurant owner quicker than a foodborne illness outbreak. When it happens, they need to know which products were involved.

IoT devices allow owners to track their food from the time they order to the time it arrives. Even in the back of a tractor-trailer rolling down the highway, owners can check to see the temperature of their food, and can obtain the data trail during its entire journey to see how it was handled, and to ensure safety standards were met.

This data is especially important since the U.S. Federal Government enacted the Food Safety Modernization Act (FSMA) in 2011, which intends to protect public health by reinforcing the U.S. food safety program. Food-based businesses are now required to establish preventative control systems modeled after HACCP (Hazard Analysis and Critical Control Points) guidelines and prove their compliance by maintaining at least two-years of documentation.

Traceability measures utilizing IoT efficiently gathers and manages this information, giving owners the peace of mind they need to ensure their food has been handled properly. Not only that, but they have the data to prove it.

Inventory Control and Management

IoT devices help manage the cost of inventory by providing the real-time data that owners need when ordering stock and forecasting needs based on their menu. The data collected by the IoT devices ensures the freshest ingredients are available for dishes, and expired products are disposed of properly.

Tracking inventory from farm-to-fork prevents food waste, deters in-house theft and helps manage the cost of inventory.

Other questions and action items that IoT devices can help manage include:

Who placed the order, authorized the purchase, and accepted the delivery?
What was ordered and what are the products’ proper temperature ranges?
When did the order take place and when did it arrive? When is its expiration date?
What is the origin of the product and how did it travel to get to you?

This can help specifically within the restaurant retail market where pick-up and deliveries are becoming more prevalent.

For example: If a customer changes their scheduled pick-up, or drop-off times, retailers must have technology in place that will monitor food safety best practices. Deli, produce and dairy related products could use pre-determined checklists that will verify items were picked correctly, bagged properly and temperatures are checked to FDA regulated standards. While FDA regulations pertaining to FSMA are stricter than ever, it has never been more important for food safety technology to be integrated within the adoption of omnichannel restaurant practices. The likes of digitalized checklist management, temperature control and traceability will have a tremendous impact on continued growth and service within the marketplace.

IoT Devices and Temperature Control

Utilizing the IoT is a critical aspect of quality control. These devices are equipped with a temperature probe, barcode scanner and RFID infrared temperature reader that monitors and tracks your food throughout its journey in the supply chain.

Here’s how it works:

The probe, infrared and RFID scanner track and measure the temperature of each product.
The IoT software prompts employees to complete checklists, including temperature checks on a regular basis.
Each time the data is collected, it is immediately uploaded to a secure cloud and is accessible anytime, from anywhere.
While in the cloud, you can customize, store, filter and analyze the information.
Users are alerted immediately if any steps are overlooked, like non-observed items, missed checklists and violations, in addition to any corrective actions that address temperature concerns.
Should an issue arise, you have the detailed, automated audit trail to prove your company followed proper food safety protocol.

IoT Devices Can Create Modern Dining Experiences

Aside from helping to streamline and manage day-to-day operations, IoT devices can create a unique dining experience for your customers.

For example, if you love seafood – some restaurants are using IoT devices to track where and when seafood is harvested. One example of this kind of initiative is the Boat-to-Plate project funded by a grant from the Mid-Coast Fishermen’s Association. This project developed an app for anglers to upload information regarding their catch. Restaurant owners are using IoT information like this to create unique dining experiences.

IoT and You

How do you plan to use IoT technology in 2017? Integrating IoT practices gives your business the food safety solution needed to help keep food safe, improve supply chain traceability, manage your inventory and gain better control over your bottom-line.

Erin Mann, Food Protection and Defense Institute

November 7, 2017

FST Soapbox

Improving Food Supply Chain Resilience Through Proactive Identification Of Risks

By Erin Mann, MPH

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There was a time not long ago when most of the food Americans ate came from close to home. Consumers primarily ate what was in season and there were less processed and manufactured foods in general. That has all changed. Our world is more accessible, people are traveling more frequently, and as they do, they are also expanding their palates. Consumers can have Thai food for lunch, Ecuadorian for dinner, and enjoy fresh produce year round regardless of the growing season near home. Similar changes in diet and consumption patterns can be observed across the world. This global “shrinking” (globalization) demands longer and more complex food supply chains to move product and provide ingredients.

Attend the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MD | Learn moreTo support changes in consumer demands, food supply chains that support movement of ingredients and products from farm to fork are becoming increasingly global, dynamic and complex. These supply chains are comprised of complicated networks of farms, production or processing facilities, and storage and distribution channels with product moving via road, rail, ship and air across the globe. These supply chains provide the global food and agriculture sector with efficient access to suppliers and consumers around the world. Unfortunately, however, food supply chains are vulnerable to disruptions such as natural disasters, transportation hazards, cyber attacks, product contamination, theft and unexpected shutdowns of key supply chain nodes. Any of these disruptions could lead to significant public health and economic consequences.

Many supply chain risks and vulnerabilities are directly related to the way a supply chain is constructed. First, there are often several degrees of separation between the point of production and the source of raw ingredients with limited visibility of the pathways in between. Spices are an illustrative example of this supply chain challenge. Spice supply chains are notoriously long with product moving through a complex web of farmers, brokers, processors, wholesalers and exporters. By the time a spice reaches a manufacturer for use in a processed food product, the manufacturer may have adequate visibility and information only about the supplier from whom the spice was most immediately purchased. The manufacturer may not have good visibility of supply chain components further upstream. Depending on the nature of the manufacturer’s customers and distribution channels, the same manufacturer may also have limited visibility of downstream supply chain components. This limited visibility up and downstream could be true for every step of the chain. Without end-to-end supply chain visibility, stakeholders cannot adequately assess risks related to supplier quality and reliability. Tracing product forward and backwards becomes a very difficult task. In the event of a supply chain disruption or contamination event, limited supply chain visibility not only impedes mitigation and response efforts, but also exacerbates the event.

Second, supply chains are often constructed in such a way that certain components of the supply chain are more critical than others. For example, a supply chain may rely upon a single manufacturing plant through which all ingredients and all finished product are routed; a shutdown or failure at that point in the supply chain would greatly impact normal operations. Likewise, a supply chain may rely exclusively on a particular transportation route; a disruption to that route from a disaster could significantly delay delivery of product to consumers. A supply chain may also source the majority of a raw ingredient from a single supplier; a disruption to that supplier could force a producer to scramble to identify and vet alternative suppliers.

CRISTAL (Criticality Spatial Analysis). Photo: Food Protection and Defense Institute

Forward-thinking approaches are needed to address supply chain challenges related to supply chain complexity and poor visibility. While some supply chain risks cannot be avoided entirely, understanding supply chain structure and proactively identifying supply chain hazards based on the structure of the supply chain will ultimately improve supply chain resilience. For example, end-to-end, geo-spatial mapping of the supply chain of a particular product line would allow stakeholders to identify risks such as exclusive reliance upon a single supply chain node. However, such an approach is not easy. End-to-end geo-spatial mapping of a supply chain requires data and information from multiple stakeholders. Sharing information across organizations is both culturally and logistically difficult.

To address these challenges, the Food Protection and Defense Institute (FPDI) has developed technology that allows private food companies and the government to document, visualize and compare supply chains in support of risk and criticality assessments, mitigation efforts and event response. With support from the Department of Homeland Security, FPDI developed CRISTAL or Criticality Spatial Analysis. CRISTAL is a geo-spatial web application that allows organizations to document supply chains from end-to-end, including supply chain components owned by other entities such as suppliers or distributors. Additionally, CRISTAL allows users to visualize the geo-spatial structure of a supply chain alongside hazard layer data, including cargo theft and natural disaster hazards. By increasing supply chain visibility, CRISTAL ultimately facilitates supply chain documentation, product tracing, and event response. Finally, CRISTAL supports efforts to identify where mitigation resources are most needed during potentially catastrophic supply-chain failures.

More information about the CRISTAL technology is available on the FPDI website. Organizations interested in using the technology may contact FPDI at fpdi@umn.edu.

October 25, 2017

FST Soapbox

How Your Approved Supplier Program Can Reduce Your Risk

By Randy Fields

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Editor’s note:
Randy Fields, Chairman & CEO of Park City Group and CEO of ReposiTrak, will be featured in the keynote panel on the past, present and future of food safety journey at the upcoming Food Safety Consortium November 29, 2017 in Schaumburg, Il. He will discuss how to leverage technology and an approved supplier program to reduce a company’s risk. Here’s a preview of some of that content.

Everyone in the extended food supply chain, from ingredient and packaging suppliers through manufacturers and ultimately to the retailers or foodservice operators work hard to ensure the safety of the consumer. It’s why they’re in business. These companies also work to understand the various risks inherent in the supply chain and deploy comprehensive and repeatable processes designed to reduce the potential impact of those issues.

Selecting suppliers has inherent risks, so a comprehensive process is needed to mitigate any threats. Without properly vetting potential suppliers, companies may encounter existential challenges without the right tools needed to survive.

One of the most important areas for this risk mitigation is the approved supplier program which helps to ensure product quality standards are met. These programs are also required under the Preventive Controls portion of the Food Safety Modernization Act.

A best-in-class supplier approval process includes certifying suppliers, monitoring external and internal risk levers, continual and repetitive analysis to determine how programs are affecting the business and mitigating risk by planning for potential disruptions. It needs to be proactive and predictive to address the ever-changing consumer and business environments.

A successful supplier approval program attempts to address every foreseeable risk concern, from product recalls to supply chain disruptions. It is typically based on a standardized checklist that includes a comprehensive list of questions to assess a supplier’s food safety and quality systems. Sample questions focus on items like food safety certificates, compliance documentation, quality assurance programs, HACCP plans and third-party audits.

Supplier and product risk assessment is a critical element of the supplier approval program. Companies need to examine hazards that could contaminate products or create issues related to allergies. The risk assessment is usually a scorecard that establishes a series of levels and a baseline under which a supplier is not acceptable.

To ensure accuracy and consistency throughout the onboarding and subsequent procurement processes, companies should have a single repository of supplier information. Having a centrally located database of supplier information and required documentation will not only increase efficiency, it can help maintain compliance and give your organization the visibility it needs to take action. This database should include details on the approved primary suppliers and any potential risks associated with the supplier or its products. The system should have a process to conduct ongoing monitoring of suppliers to ensure that agreed upon standards are maintained.

Once the supplier approval program is up and running, it needs to be monitored constantly or the risks companies are trying to mitigate will return. Managing risk is not a one-time event., nor is managing supplier information. Implementing a process where established suppliers will update their information annually will help ensure companies are working with the most current information.

The bottom line is that a company’s reputation may be tarnished if there is a product recall or worse. Ensuring approved procedures and processes are followed every time a new supplier or product is considered will greatly help to mitigate the risks involved.

October 24, 2017

FST Soapbox

Food Safety Issues Don’t Occur In The QA Manager’s Office

By Vicky Waskiewicz

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Just like many jobs, a quality assurance manager starts out with high hopes of creating a real difference in their day-to-day work. But that vision quickly gets blocked by stacks of paperwork and other to-dos taking top priority. Soon, QA managers find themselves far from the floor and far from where the real work is happening, usually stuck behind a desk in an office.

While this may have become standard practice, that doesn’t mean that there’s nothing you can do to change this reality. And, the sooner you are able to do so the better, because we all know that the job of a QA manager, especially when it comes to food safety, is important, both to the company and to the public.

Why Food Safety Should Be At The Top Of A QA Manager’s Priority List

The roles and responsibilities of a QA manager are vast, which is why it’s so easy to get caught-up in tasks that keep you holed up in your office. But of all the duties you have, the one that shouldn’t get overlooked is food safety. Because food is consumed, and has the potential to endanger consumers if it’s not produced properly, it is capable of destroying a company’s reputation and their margins, not to mention people’s lives.

As a QA manager, you know this, but you might not be doing everything in your power to make sure the food your company is producing is safe.

How To Improve Food Safety

While you can do a lot from your office, you can’t know what’s happening on the floor without actually spending time there. You have to work closely with your employees to make sure they understand the importance of food safety and therefore the importance of their job.

Here are five ways you can begin to improve the level of food safety in your company.

Work directly with the production floor. Make it a priority to get out of your office regularly to observe the practices that are being used. The more you talk directly with employees about food safety, the more they will understand why it’s important and the safety precautions they can take to ensure they are creating food that is safe.
Demonstrate the importance of food safety. Consider setting up a meeting or talk that gives real life examples of people who have gotten sick or hurt from food that is produced with improper practices. Demonstrating the importance of things, like proper sanitation, can make individuals on the floor aware of the repercussions if they don’t follow the safety guidelines.
Get employees involved in food safety. Spend time educating your employees on measures they can take to assure that the food they are producing is safe. Letting them hold each other accountable is a powerful way to make sure there are eyes on the floor even when you’re not there.
Lead by example. When management walks out onto the production floor, all eyes are on them. Be sure that senior management is aware of the rules, handwashing, hair restraints, etc. and that they follow them every time they enter the production area. Teach employees to kindly remind them if they see them bypass one of the good manufacturing practices.
Regularly change signage throughout the facility. The same old signage over time becomes part of the landscape and eventually the worker is blind to it. Take the time to change the signs, using different sizes, bold colors and positive messaging.

Becoming A Food Safety Hero

QA managers play crucial roles in companies, but without putting food safety at the top of their list, they’re overlooking one of their most important jobs. By learning about steps you can take to improve food safety, like the five mentioned above, you can become a food safety hero, protecting your company and its consumers.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

October 23, 2017

FST Soapbox

FSMA Checklist: Sanitary Transportation of Human and Animal Food Rule

By Bill Bremer

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The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. Sanitary Transportation is one of seven foundational rules proposed under FSMA since January 2011 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

How much do you know about the Sanitary Transportation Rule? Test your smarts by taking the FSMA IQ Test hereSpecifically, the Sanitary Transportation rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers. It applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicles. Additionally, it impacts shippers in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico) or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the United States, if that food will be consumed or distributed in the United States. These requirements took effect April 2017 for shippers, carriers and receivers subject to the rule.

As the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and to develop programs for compliance, including Sanitary Transportation. This requires companies to document specific verification steps to satisfy regulations and meet food safety transportation requirements.

Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing Sanitary Transportation Requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA Sanitary Transportation rule — Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Sanitary Transportation of Human and Animal Foods programs, as required under FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA Sanitary Transportation of Human and Animal Food requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their Sanitary Transportation programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

October 18, 2017

FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers

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The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

Put in place preventive controls to address those hazards,
Monitor those preventive controls to ensure their effectiveness &
Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

October 16, 2017

Food Safety Culture Club

The Food Safety Culture Conversation

By Deirdre Schlunegger

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I learn and remember visually and I was recently thinking about the food safety world and culture; how the fabric of the culture is woven together with people who care about people. After all, that is what it comes down to, people who cultivate, grow, harvest, produce, distribute, deliver, store, prepare, serve and eat safe food. When there is a breakdown of the weave, people become ill and some die, families are devastated, business fails and trust is broken. The system fails.

It really comes down to each weaver, regardless of the level of responsibility performing their duty, knowing that they are the link between health and illness, success and failure, life and death. So, the question is how do we make sure that each person who comes in contact with food products is thoroughly educated, truly understands the impact and has a breadth of awareness of the importance of food safety?

Many companies are admirably deeply invested in food safety training. Organizations share food safety tips about safe food practices, including Stop Foodborne Illness. Stop Foodborne Illness employees and volunteers bring the stories of foodborne illness to light each time we speak, are present at conferences, participate in food safety trainings, deliver video messages and send out newsletters. We work with those impacted and pair them with others who have experienced the same thing and offer them an outlet to share their stories.

What more can we do? 3000 people in the US die each year, 128,000 are hospitalized and 48 million become ill. The numbers are much too high. Let’s keep the food safety culture conversation going and improvement in training and practices and ideas flowing. Here is one such story to start the conversation.

Tressa, Chloe, and Luke

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

October 4, 2017

Food Genomics

Part II: Logistics of GenomeTrakr

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

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Last month in Food Genomics we asked FDA scientists Drs. Marc Allard and Eric Brown to help the readers of Food Safety Tech understand the process used by GenomeTrakr. In part two we cover some logistical and more general questions.

Greg Siragusa/Douglas Marshall: Why should a food producer or processor submit its own pathogen isolates to GenomeTrakr? Are there any legal liabilities incurred by doing so?

Eric Brown/Marc Allard: The database is available publicly for any outside laboratory to be able to rapidly compare their new WGS data to all of the data in the database. The data is all publicly available so food industry members should carefully consider the strengths and weaknesses of sharing data. The main reason for sharing data is that if any matches arise then this would be immediately known for an investigation and corrective action. With knowledge, companies can better understand their risk and exposure to occasional contamination events.

Siragusa/Marshall: Are there private third-party providers who will perform the same method of sequence analysis for private companies that GenomeTrakr uses in the FDA?

Brown/Allard: Yes, as all of the FDA methods of data collection and analysis are fully transparent and publicly available, any expert third-party provider could easily set up and reproduce the GenomeTrakr methods. Third-party support may be an excellent mechanism for food industry partners that wish to examine the pathogens they have found connected to their products but do not wish to maintain an active WGS laboratory. An internet and reference search will uncover these private third-party providers, as this is a growing market with a diversity of services provided. The FDA works closely with the Institute for Food Safety and Health (IFSH) to share information that may be valuable to their industry partners.

Siragusa/Marshall: Will the FDA perform analysis of isolates for private parties and the sequence not made publicly available?

Brown/Allard: No. While we will sequence relevant strains from many different sources, as a matter of protocol we will submit all of these data to the GenomeTrakr database. That is, currently, the FDA sequences and uploads all available genomic strain data. All data are made publicly available through the GenomeTrakr and NCBI pathogen detection website. The metadata describing each isolate only includes species, date, state location and a general food description which could include the type of food (e.g., an egg) and/or the type of sample (e.g., environmental swab, surface water, sediment, etc.) as well as production date, pH, fat content and water activity. No trade or industry brand names are made publicly available, and the location is ambiguous down to the state level to allow for anonymity of specific farm names or processing centers. An example of metadata in the GenomeTrakr database might include Salmonella, from Washington State in spinach from 2015.

Siragusa/Marshall: Is the CDC tied into GenomeTrakr and if so, how?

Brown/Allard: CDC labels their clinical WGS data as PulseNet with the data uploaded to the NCBI Pathogen Detection website. USDA FSIS also uploads the isolates that they have collected and sequenced from foods that they regulate. All of this WGS data is housed in a centralized repository at NCBI Pathogen Detection website where NCBI conducts rapid analysis for QA/QC. The NCBI posts a daily tree for all species that recently have been uploaded. This way all of the data collected by these federal laboratories and their state and international partners are made publicly available for direct comparison. Numerous other international and academic laboratories also provide data to the NCBI centralized database. When isolates cluster together and appear to be closely related, the FDA works with CDC and USDA FSIS through the normal channels. The great benefit of combining food, environmental and clinical isolate genomes in a common database cannot be overstated.

Siragusa/Marshall: In the event of an outbreak, is it possible to obtain WGS’s from using a shotgun metagenome (a microbial and organismic profile obtain by sequencing all of the DNA in a sample, not just bacterial analysis of an enrichment thereby precluding isolation? (Refer to glossary; see Table 1)

Brown/Allard: Yes, preliminary research has documented the potential to obtain WGS data from cultural enrichments, saving the time it takes for full pure culture isolation, which potentially could provide time savings of two to five days depending on the pathogen. Having well characterized draft genomes such as those in the GenomeTrakr database will support rapid characterization from metagenomes after cultural enrichment. A future goal for the FDA is to transform and expand GenomeTrakr into metaGenomeTrakr to support either pure culture or enriched shotgun metagenomic samples.

Siragusa/Marshall: Is there any way that associated metadata tied to a strain (and hence its sequence) can be unmasked through legal action?

Brown/Allard: FDA protects confidential metadata collected during inspection just as it has always done with PFGE data. WGS data is protected at the same level as other types of subtyping information.

Siragusa/Marshall: Is the GenomeTrakr database associated with the GMI (Global Microbial Identifier)?

Brown/Allard: The GMI is a consortium of like-minded public health scientists who wish to collaborate to create a harmonized global system of DNA genome databases that is publicly available to promote a one-health approach. The GenomeTrakr is one of the databases that make up this larger effort that includes some data from members of the GMI.

Siragusa/Marshall: This column is meant to keep food safety professionals abreast of the latest knowledge, technology and uses of genomics for food safety and quality. Tell us your vision of how or which changes in technology (sequencing chemistry, bioinformatics, etc.) will be coming down the pike and how it might impact GenomeTrakr?

Brown/Allard: New technology has been constantly improving in WGS and in sequencing for the last 20 years, and there is no sign of this slowing down. Improvements continue to accrue in chemistry, equipment and software analysis. Likely future improvements will include more turnkey solutions for WGS from sample to report. This includes both DNA extraction and library preparation for sequencing, as well as data analysis pipelines (the system of analyzing the actual sequence data) that provide rapid, accurate and simple language results. Smaller mobile WGS devices are starting to show feasibility that would bring the lab to the samples and decrease the time to an answer (See: https://nanoporetech.com/products/minion) Metagenomics approaches appear to be maturing so that technology improvements are moving this out of a research phase and into direct applications. Currently MISeq (a commonly used workhorse nucleic acid sequencer made by the Illumina Co.) outputs are on the order of 300 base pair read lengths of nucleotides (i.e. A’s, T’s. C’s G’s), long read sequencing technologies, upwards of 1,500 base pairs may make analysis much easier so that more assembled and completed finished genomes are available in the databases. Cloud-based solutions of data analysis pipelines may provide simple solutions, giving wider access to rapid, validated data analysis and results. FDA researchers are working on all of these aspects of improvements in WGS technology as well as expanding the network to more global partners.

Siragusa/Marshall: Sequences deposited into GenBank (as part of GenomeTrakr) are accessible to anyone anywhere. Does this essentially usher in a whole new chapter in food microbiology especially at the pre-harvest level?

Brown/Allard: Yes, having well characterized reference genomes provided by GenomeTrakr partners will support microbial ecology and metagenomics studies. Metagenomics or microbiomes describing which species are present and what they may be doing in the ecology is providing new knowledge in all aspects of the farm to fork continuum. As the costs for these services decrease, we are seeing an increase in use to answer questions that have been impossible or extremely difficult in the past.

Siragusa/Marshall: GenomeTrakr is not a project per se; rather it is a program. How is it funded and will it continue on stable fiscal footing for the foreseeable future?

Brown/Allard: GenomeTrakr started as a research project in the Office of Regulatory Science in CFSAN, but much of this data collection is no longer research. Today, and for some time in the future, WGS at the FDA is collected as fully validated regulatory data to support outbreak and compliance investigations. As such, the FDA is in transition of moving WGS into a phase for more stable regulatory support. Research and development for future applications and technology exploration will always be a part of the FDA portfolio, although typically at lower funding levels than the regulatory offices. Public health funding is generally protected as everyone wants safe food.

Siragusa/Marshall: Are there any restrictions of isolate source? For instance, can isolates from poultry flocks or even wild birds be deposited?

Brown/Allard: The GenomeTrakr and NCBI pathogen detection databases are open to the public and thus there are no restrictions as long as the minimal metadata and QA and QC metrics are met. Current GenomeTrakr WGS foodborne pathogen data includes samples from both poultry and wild birds, as well as turtles, snakes and frogs. Members interested in what is in the database can go to the NCBI Pathogen Detection website and filter on simple words like avian, bird, gull, chicken, wheat, avocado, etc. An example is as follows for a snake.

Siragusa/Marshall: If a company deposits an isolate, will it have access to the GenomeTrakr derived sequence exclusively or at least initially for some period before that information becomes public?

Brown/Allard: No, currently the FDA does not hold WGS data. All data collected by the FDA is uploaded and released publicly at the GenomeTrakr bioprojects and at NCBI pathogen detection website with no delays. If companies wish to hold data then they need to look to third-party solutions for their needs. The reason that GenomeTrakr has been so successful is due to the real-time nature of the released information and that it is globally available.

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September 25, 2017

FST Soapbox

FSMA Checklist: Foreign Supplier Verification Program Requirements

By Bill Bremer

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As all the FSMA rules move to enforcement status, food companies must prepare to best respond to requirements and, correspondingly, to develop required programs such as the Foreign Supplier Verification Program (FSVP) rule. The FSVP requires impacted companies to document specific verification steps to satisfy regulations and meet foreign-supplied shipment information requirements. These requirements took effect on May 30, 2017 for companies importing certain food products to the United States.

How much do you know about FSVP? Test your smarts by taking the FSMA FSVP IQ Test here Ultimately, the purpose of the FSVP is to document the shipping paperwork necessary to provide evidence and verification that a foreign supplier’s food-grade product shipped to a U.S. customer meets the requirements of FSMA. A company’s FSVP may include providing an additional level of evidence that the foreign company distributes safe foreign-supplied food products to the United States, the qualification of these suppliers, verification of supplier and shipment information, and records to verify the shipment of all imported food under FSMA and food safety plans. This information provides the U.S. customer receiving the product necessary proof of compliance and a record that the foreign-supplied material meets imported food product requirements.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing FSMA FSVP requirements. To complete your own assessment, review and compare your programs to the questions in Table I.

FSMA, Foreign Supplier Verification Program — Table I. Kestrel Management’s self-diagnostic tool can help a company assess its Foreign Supplier Verification Program (FSVP) for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate systems in place to comply with FSMA FSVP requirements or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions above will help companies identify areas to consider regarding their FSVP programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all your food safety requirements, and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

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