Tag Archives: inspections

Byron Reid, Bayer Digital Pest Management
Bug Bytes

Ever Drink a Dissolved Mouse?

By Byron Reid
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Byron Reid, Bayer Digital Pest Management

I know, it’s a disgusting, lazy attention-grabbing image, but if you’ve stayed with me this far it must have worked. Sadly, the story is true; it was back in the 1980s the first time that I heard of how a mouse in a bottling plant got stuck inside one of the empties ready to go onto the filling line. Unnoticed, this mouse was immersed in the beverage, was then sealed in when the bottle cap was applied, and then drowned while the bottle was packaged and palletized. While the product moved through distribution to retail, its carcass slowly dissolved and went unnoticed until an unsuspecting customer … well, you can imagine how that story ended.

After recounting this story recently, imagine my surprise to learn this is still happening today! Maybe three years ago, The Verge published a “A brief history of rodents in soda containers” and, in the present age of social media, it will surprise no one to see the video filmed by someone who spotted the mouse in their soda bottle! No surprise, there’s more than one filming of a mouse in a sealed Coca Cola bottle, the horror continues.

Let’s not pretend this is only a problem with fizzy drinks industry, every food manufacturing concern faces the risk of inadvertent contamination of their production from rodents; if not the whole animal itself, then it’s urination on raw commodity, or its fecal pellets falling into a mixer, or its hairs falling off in packaging. No wonder a well-designed and faithfully serviced pest management program and proper IPM inspections are necessary for every facility in the industry. The good news is there are digital rodent monitoring systems that can alert pest managers of a rodent capture inside a facility and rodent activity / pressure outside so they can act quickly. Perhaps the most valuable impact of this technology is that it helps automate trap checking that consumes as much as 75% of the service time. Now, that precious time can be reallocated to deeper, proactive IPM inspections to help head off infestations before they happen and root cause analysis and corrective actions if captures occur.

FDA

FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule

By Food Safety Tech Staff
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FDA

Read the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.

This is the third and final installment of the draft guidance for the IA rule.

The FDA is still on schedule to begin routine intentional adulteration inspections next month.

Megan Nichols
FST Soapbox

Machine Vision Training Tips to Improve Food Inspections

By Megan Ray Nichols
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Megan Nichols

As machines become more intelligent, every industry on earth will find abundant new applications and ways to benefit. For the food industry, which has an incredible number of moving parts and is especially risk-averse, machine vision and machine learning are especially valuable additions to the supply chain.

The following is a look at what machine vision is, how it can play a role in manufacturing and distributing foods and beverages, and how employers can train workers to get the most out of this exciting technology.

What Is Machine Vision?

Machine vision isn’t a brand-new concept. Cameras and barcode readers with machine vision have long been capable of reading barcodes and QR codes and verifying that products have correct labels. Modern machine vision takes the concept to new levels of usefulness.

Barcodes and product identifiers have a limited set of known configurations, which makes it relatively straightforward to program an automated inspection station to recognize, sort or reject products as necessary. Instead, true machine vision means handlers don’t have to account for every potential eventuality. Machine vision instead learns over time, based on known parameters, to differentiate between degrees of product damage.

Consider the problem of appraising an apple for its salability. Is it bruised or discolored? Machine vision recognizes that no two bruises look precisely alike. There’s also the matter of identifying different degrees of packaging damage. To tackle these problems, it’s not possible to program machine vision to recognize a fixed set of visual clues. Instead, its programming must interpret its surroundings and make a judgment about what it sees.

Apples, machine vision
On an apple, no two bruises are alike. Machine vision technology can help. Photo credit: Pexels.

The neural networks that power machine vision have a wide range of applications, including improving pathfinding abilities for robots. In this article, I’ll focus on how to leverage machine vision to improve the quality of edible products and the profitability of the food and beverage industry.

Applications for Machine Vision in the Food Industry

There are lots of ways to apply machine vision to a food processing environment, with new variations on the technology cropping up regularly. The following is a rundown on how different kinds of machine vision systems serve different functions in the food and beverage sector.

1. Frame Grabbing and 3-D Machine Vision
Machine vision systems require optimal lighting to carry out successful inspections. If part of the scanning environment lies in shadow, undesirable products might find their way onto shelves and into customers’ homes.

Food products sometimes have unique needs when it comes to carrying out visual inspections. It’s difficult or impossible for fallible human eyeballs to perform detailed scans of thousands of peas or nuts as they pass over a conveyor belt. 3-D machine vision offers a tool called “frame grabbing,” which takes stills of — potentially — tens of thousands of tiny, moving products at once to find flaws and perform sorting.

2. Automated Sorting for Large Product Batches
Machine vision inspection systems can easily become part of a much larger automation effort. Automation is a welcome addition to the food and beverage sector, translating into improved worker safety and efficiency and better quality control across the enterprise.

Inspection stations with machine vision cameras can scan single products or whole batches of products to detect flaws. But physically separating these products must be just as efficient a process as identifying them. For this reason, machine vision is an ideal companion to compressed air systems and others, which can carefully blow away and remove even a single grain of rice from a larger batch in preparation.

3. Near-Infrared Cameras
Machine vision takes many forms, including barcode and QR code readers. A newer technology, called near-infrared (NIR) cameras, is already substantially improving the usefulness and capabilities of machine vision.

Remember that bruised apple? Sometimes physical damage to fruits and vegetables doesn’t immediately appear on the outside. NIR technology expands the light spectrum cameras can observe, giving them the ability to detect interior damage before it shows up on the exterior. It represents a distinct advantage over previous-generation technology and human inspectors, both of which can leave flaws undiscovered.

Tips on Training Workers to Use Machine Vision

Implementing machine vision into a productive environment delivers major benefits, but it also comes with a potentially disruptive learning curve. The following are some ideas on how to navigate it.

1. Take Advantage of Third-Party Training Courses
Don’t expect employees to hit the ground running with machine vision if they’re not familiar with the fundamentals of how it works. Google has a crash course on machine learning, and Amazon offers a curriculum as well to help companies get their employees up to speed on the technology and how to use it.

2. Get the Lighting Right
Having the appropriate intensity of light shining on the food product is essential for the machine vision cameras to get a clear photo or video. The most common types of lighting for machine vision are quartz halogen, LEDs, metal halide and xenon lights. Metal halide and xenon are better for larger-scale operations because of their brightness.

Train employees to check the amount and positioning of the lighting before each inspection station starts up for the day, so that no shadows obscure products from view.

3. Single Out Promising Subject Matter Leaders
Companies today don’t seem to have much confidence in how well they’re preparing their workforce for tomorrow, including future innovations. According to Deloitte, just 47% of companies in the world believe they’re doing enough to train their employees on the technologies and opportunities of Industry 4.0.

Machine vision does not involve buying a camera or two, setting them up, then slapping the “autopilot” button. As products turn over, and manufacturing and distribution environments change and grow over time, machine vision algorithms require re-training, and you might need to redesign the lighting setup.

Employers should find individuals from their ranks who show interest and aptitude in this technology and then invest in them as subject matter experts and process owners. Even if an outside vendor is the one providing libraries of algorithms and ultimately coming up with machine vision designs, every company needs a knowledgeable liaison who can align company needs with the products on the market.

Machine Vision Is the Future of Food Inspections

The market for machine vision technology is likely to reach $30.8 in value by 2021, according to BCC Research.

It is important to remember that neither machine learning nor machine vision are about creating hardware that thinks and sees like humans do. With the right approach, these systems can roundly outperform human employees.

But first, companies need to recognize the opportunities. Then, they must match the available products to their unsolved problems and make sure their culture supports ongoing learning and the discovery of new aptitudes. Machine vision might be superior to human eyesight, but it uses decidedly human judgments as it goes about its work.

Data protection, security

The Digital Transformation of Global Food Security

By Katie Evans
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Data protection, security

Modern food supply chains are inherently complex, with products typically passing through multiple suppliers and distributors, as well as countries and continents, before they end up on the supermarket shelf. While global supply chains offer consumers greater choice and convenience, they also make protecting the security of food products more challenging. With additional stakeholders between farm and fork, products are exposed to an elevated risk of biological or chemical contamination, as well as food counterfeiting and adulteration challenges—potentially putting consumer health and brand reputation in jeopardy.

Given the importance of maintaining the safety, quality and provenance of food products, global regulatory bodies are placing the integrity of supply chains under increased scrutiny. In the United States, for example, the adoption of FSMA moved the focus from responding to foodborne illnesses to preventing them by prioritizing comprehensive food testing measures, enforcing inspections and checks, and enabling authorities to react appropriately to safety issues through fines, recalls or permit suspensions.1 Similarly, China’s revised Food Safety Law (known as FSL 2015) is widely considered to be the strictest in the country’s history, and seeks to drive up quality standards by empowering regulators, and enhancing traceability and accountability through robust record-keeping. 2 The European Union continues to closely regulate and monitor food safety through its General Food Law, which is independently overseen by the European Food Safety Authority from a scientific perspective.

Achieving the Highest Standards of Food Security, Integrity and Traceability

For producers, manufacturers and distributors, the heightened regulatory focus on the security and integrity of the food supply chain has placed additional emphasis on accurate record-keeping, transparent accountability and end-to-end traceability. To meet the needs of the modern regulatory landscape, food chain stakeholders require robust systems and tools to manage their quality control (QC), environmental monitoring and chain of custody data. Despite this, many businesses still handle this information using paper-based approaches or localized spreadsheets, which can compromise operational efficiency and regulatory compliance.

The fundamental flaw of these traditional data management approaches is their reliance on manual data entry and transcription steps, leaving information vulnerable to human error. To ensure the accuracy of data, some companies implement resource-intensive verification or review checks. However, these steps inevitably extend workflows and delay decision-making, ultimately holding up the release of products at a high cost to businesses. Moreover, as paper and spreadsheet-based data management systems must be updated by hand, they often serve merely as a record of past events and are unable to provide insight into ongoing activities. The time lag associated with recording and accessing supply chain information means that vital insight is typically unavailable until the end of a process, and data cannot be used to optimize operations in real-time.

Furthermore, using traditional data management approaches, gathering information in the event of an audit or food safety incident can be extremely challenging. Trawling through paperwork or requesting information contained in spreadsheets saved on local computers is time-consuming and resource-intensive. When it comes to establishing accountability for actions, these systems are often unable to provide a complete audit trail of events.

Digital Solutions Transform Food Security and Compliance

Given the limitations of traditional workflows, food supply chain stakeholders are increasingly seeking more robust data management solutions that will allow them to drive efficiency, while meeting the latest regulatory expectations. For many businesses, laboratory information management systems (LIMS) are proving to be a highly effective solution for collecting, storing and sharing their QC, environmental monitoring and chain of custody data.

One of the most significant advantages of managing data using LIMS is the way in which they bring together people, instruments, workflows and data in a single integrated system. When it comes to managing the receipt of raw materials, for example, LIMS can improve overall workflow visibility, and help to make processes faster and more efficient. By using barcodes, radiofrequency identification (RFID) tags or near-field communication, samples can be tracked by the system throughout various laboratory and storage locations. With LIMS tracking samples at every stage, ingredients and other materials can be automatically released into production as soon as the QC results have been authorized, streamlining processes and eliminating costly delays.

By storing the standard operating procedures (SOPs) used for raw material testing or QC centrally in a LIMS, worklists, protocols and instrument methods can be automatically downloaded directly to equipment. In this way, LIMS are able to eliminate time-consuming data entry steps, reducing the potential for human error and improving data integrity. When integrated with laboratory execution systems (LES), these solutions can even guide operators step-by-step through procedures, ensuring SOPs are executed consistently, and in a regulatory compliant manner. Not only can these integrated solutions improve the reliability and consistency of data by making sure tests are performed in a standardized way across multiple sites and testing teams, they can also boost operational efficiency by simplifying set-up procedures and accelerating the delivery of results. What’s more, because LIMS can provide a detailed audit trail of all user interactions within the system, this centralized approach to data management is a robust way of ensuring full traceability and accountability.

This high level of operational efficiency and usability also extends to the way in which data is processed, analyzed and reported. LIMS platforms can support multi-level parameter review and can rapidly perform calculations and check results against specifications for relevant customers. In this way, LIMS can ensure pathogens, pesticides and veterinary drug residues are within specifications for specific markets. With all data stored centrally, certificates of analysis can be automatically delivered to enterprise resource planning (ERP) software or process information management systems (PIMS) to facilitate rapid decision-making and batch release. Furthermore, the sophisticated data analysis tools built into the most advanced LIMS software enable users to monitor the way in which instruments are used and how they are performing, helping businesses to manage their assets more efficiently. Using predictive algorithms to warn users when principal QC instruments are showing early signs of deterioration, the latest LIMS can help companies take preventative action before small issues turn into much bigger problems. As a result, these powerful tools can help to reduce unplanned maintenance, keep supply chains moving, and better maintain the quality and integrity of goods.

While LIMS are very effective at building more resilient supply chains and preventing food security issues, they also make responding to potential threats much faster, easier and more efficient. With real-time access to QC, environmental monitoring and chain of custody data, food contamination or adulteration issues can be detected early, triggering the prompt isolation of affected batches before they are released. And in the event of a recall or audit, batch traceability in modern LIMS enables the rapid retrieval of relevant results and metadata associated with suspect products through all stages of production. This allows the determination of affected batches and swift action to be taken, which can be instrumental in protecting consumer safety as well as brand value.

Using LIMS to Protect Security and Integrity of the Food Supply Chain

Increasingly, LIMS are helping businesses transform food security by bringing people, instruments and workflows into a single integrated system. By simplifying and automating processes, providing end-to-end visibility across the food supply chain, and protecting the integrity of data at every stage, these robust digital solutions are not only helping food supply chain stakeholders to ensure full compliance with the latest regulations; they are enabling businesses to operate more efficiently, too.

References

  1. FDA. (2011). FDA Food Safety Modernization Act. Accessed October 3, 2019. Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma.
  2. Balzano, J. (2015). “Revised Food Safety Law In China Signals Many Changes And Some Surprises”. Forbes. Accessed October 3, 2019. Retrieved from https://www.forbes.com/sites/johnbalzano/2015/05/03/revised-food-safety-law-in-china-signals-many-changes-and-some-surprises/#624b72db6e59.
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Failure to Have Foreign Supplier Verification Plan a Common Inspection Observation

By Maria Fontanazza
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Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.

Thus far, common citations include:

  • No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
  • No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food

Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:

  • Approval of a foreign supplier
  • Evaluating foreign supplier performance, along with related risks
  • Establishing written procedures to ensure foreign supplier verification activities are performed
  • Review and assessment of another party’s evaluation of foreign supplier performance
  • Ensuring food was produced in compliance with low acid canned foods regulations
  • Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food FY 2017 285
Risk-based (hazards, importers and suppliers) FY 2018 792
Align with PC supply chain provisions FY 2019 (as of 5/28/19) 458 (FDA is planning for 880)
FDA oversees compliance via importer inspection
Foreign suppliers can help importers comply

 

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about food fraud  at the Food Labs Conference | June 2–4, 2020 | Rockville, MDThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Shawna Wagner, DNV GL
FST Soapbox

How to Strengthen Your Audit Score

By Shawna Wagner
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Shawna Wagner, DNV GL

It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!

Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.

Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.

Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!

Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.

Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!

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Food Safety Tech’s Best of 2018

By Food Safety Tech Staff
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The end of the year is always a time of reflection. At Food Safety Tech, it is also a time when we like to share with you, our readers, the most popular articles over the last 12 months. Enjoy, and thank you to our loyal and new readers, as well as our contributors!

10. Three Practices for Supply Chain Management in the Food Industry

By Kevin Hill, Quality Scales Unlimited

9. Food Investigations: Microanalytical Methods Find Foreign Matter in Granular Food Products

By Mary Stellmack, McCrone Associates, Inc,

8. Stephen Ostroff to Retire from FDA, Walmart’s Frank Yiannas to Take the Reins

By Food Safety Tech Staff

7. FDA Inspections: Top Five Violations for FY2017

By Food Safety Tech Staff

6. Is There Any End in Sight for the E.Coli Outbreak in Romaine Lettuce?

By Food Safety Tech Staff

5. CDC Alert: Do Not Eat Romaine Lettuce, Throw It Out

By Food Safety Tech Staff

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

By Melody Ge, Kestrel Management

3. 5 Problems Facing the Global Supply Chain

By Sean Crossey, arc-net

2. FDA: 172 Ill, 1 Death, Romaine Lettuce E. Coli Outbreak Likely Over

By Food Safety Tech Staff

1. Romaine Lettuce Outbreak: We Knew It Would Get Bad Quickly

By Maria Fontanazza, Food Safety Tech

Stephen Ostroff, 2016 Food Safety Consortium

Blockchain Transformational, Says Ostroff. FDA Updates on Pathogens, FSMA, WGS and More

By Maria Fontanazza
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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. deputy commissioner for foods and veterinary medicine, sounds excited about the promise of blockchain. He also continues to enthusiastically wave the flag for whole genome sequencing (WGS) in solving foodborne illness cases. At the recent GMA Science Forum, Ostroff shared his usual update on incidents involving pathogens, agency progress in inspections and FSMA, and what the future holds.

The 2018 Food Safety Supply Chain conference features a Blockchain panel discussion | June 12–13 | Learn morePathogens

“There’s been essentially zero change in incidents of pathogens, and in some [cases there have been] increases—despite the fact that we’ve been doing quite a bit to improve the profile of food safety in the United States,” said Ostroff. This isn’t the first time that Ostroff pointed to the fact that foodborne illness is resistant to change, but he still emphasized the disappointment that industry is “way off” from the Healthy People 2020 target rate for pathogens established by the government. “None of these are close to where we thought we would be,” he said, referring to the government’s established target rates for Campylobacter, E.coli O157, Listeria, Salmonella, Vibrio and Yersinia.

Ostroff has previously pointed to improved diagnostics and surveillance systems as being partially responsible for a lack of improvement in the number of foodborne illness cases (due to higher detection rates), but during this particular presentation he brought attention to culture independent diagnostic tests (CIDTs)—which he said are having a “major impact on data collected in FoodNet.” CIDT is relatively new and is more rapid than the culture method, but it doesn’t allow for subtyping or antimicrobial resistance testing.

According to Ostroff, CIDTs have major implications for folks who work in food safety. The overall incidence of infection with foodborne pathogens is not decreasing, and the use of CIDTs makes assessment of trends difficult. CIDTs appear to be finding infections previously undiagnosed or unrecognized. In addition, they could affect the agency’s ability to monitor FSMA impact measures.

Inspections

The agency continues to look at inspection data from both the perspective of the number of inspections and their outcomes. During FY 2017, there were 1253 domestic and 146 foreign inspections. For FY 2018, there have already been 1610 domestic inspections to date.

Enforcement Discretion

In January, FDA issued new enforcement discretion for certain provisions in four FSMA rules. This included resolving issues related to the “farm” definition, requirements for food contact substances under FSVP, and certain written assurances in place for the Preventive Controls (human and animal) rule until FDA comes up with a practical solution to issues raised by stakeholders, Ostroff said.

Oversight of Food Imports

FDA continues to take a risk-based approach to FSVP and overseas inspections. Part of these efforts includes the agency’s systems recognition program where it looks at other mature food safety systems around the world to recognize countries that have programs similar to the United States. Thus far FDA has recognized Australia, Canada and New Zealand food safety systems; It is currently in the process of evaluating European Union members.

Intentional Adulteration Rule

The International Adulteration rule continues to be a hot topic of discussion, especially as it relates to associated costs. FDA is actively working on putting out a draft guidance that will discuss how to conduct vulnerability assessments, along with its interpretation of the rule, according to Ostroff. Part one of the draft should be out “in the very near future”, he said. He added that the agency is trying to be flexible with the rule and although food defense is an important component of food safety, companies should never do anything in the context of food defense that could pose a food safety risk.

Whole Genome Sequencing

WGS provides more precise identification at a genetic level and helps expedite recognition and response time for nearly all current foodborne illness and outbreak investigations. “It’s the new normal—it’s here and it’s here big time,” said Ostroff, adding that the GenomeTrakr network has more than 167,000 isolates sequences in the database and is becoming more and more powerful. “It’s amazing what this tool can do,” he said, citing two recent cases involving strains of Salmonella in papayas and kratom.

Blockchain

“I think blockchain can be really transformational in the world of food safety,” said Ostroff, calling it “traceability on steroids without question”. He thinks the technology could also be useful in addressing food fraud and economically motivated adulteration, and provide more consumer transparency. Right now the FDA is looking very closely at blockchain in context of traceability and FSMA.