These issues highlight how the increasingly complex supply chain further complicates problems once they arise. Ostroff emphasized the necessity of end-to-end tracing, from product origination to where the consumer can access the product, and that it needs to be efficient, standardized and rapid, especially for commodities. Regarding the E. coli O157:H7 outbreak involving romaine lettuce, FDA is still trying to determine the source and mode of the contamination. And while the recent finding of the outbreak strain in the irrigation canal water is important, it still does not answer the question of how the contamination got into the canal, said Ostroff.
The latest FDA update on the outbreak investigation stated that additional samples are being analyzed on an ongoing basis and any new matches would be publicly disclosed. As of June 28, the CDC announced that the outbreak was over.
Today FDA issued an alert after becoming aware that some retailers are still selling Kellogg’s Honey Smacks cereal, which was recalled in June following a multi-state outbreak of Salmonella Mbandaka infections linked to the product. No deaths have been reported, but 100 people in 33 states have become ill, with 30 hospitalizations, according to the CDC.
“Retailers cannot legally offer the cereal for sale and consumers should not purchase Kellogg’s Honey Smacks cereal,” FDA stated in its update about the agency’s outbreak investigation.
USDA FSIS has awarded a contract to 3M Food Safety for its pathogen detection instruments and kits. 3M’s molecular detection system will be the primary method used by the agency to detect Salmonella, Listeria monocytogenes and E. coli O157. The technology combines isothermal DNA amplification and bioluminescence detection for a fast, accurate and simple solution that also tackles some of the constraints of PCR methods. Users can concurrently run up to 96 different tests for many organisms across food and environmental samples.
Today Clear Labs announced the availability of its next-generation sequencing (NGS) platform, Clear Safety, for pathogen testing. Competing head-to-head with PCR, the product intends to bring NGS into the routine production environment. Clear Labs is launching the product at the IAFP Annual Meeting this week in Salt Lake City.
“Until the launch of Clear Safety, there was the duality between PCR and whole genome sequencing (WGS) where PCR was more applicable to routine testing and faster results,” says Mahni Ghorashi, co-founder of Clear Labs. “WGS is more expensive and slower, so the food industry has been using the technology as complementary until this time. This platform out competes PCR virtually on every level.”
Clear Safety was in the pilot phase only a couple of months ago when Ghorashi sat down with Food Safety Tech to give a brief overview of the technology. Now that the platform is officially out of pilot mode, it is accessible to all of the food industry, from third-party service labs to any food company that has an in-house lab. With less human labor involved, the platform reduces the potential for errors and does not require additional expertise. The process from sample to result has been simplified, and the bacterial enrichment and sample prep stages are identical to PCR, according to Ghorashi, who says that all a lab technician has to do is load the plates on the box and press “go”. Within 18 hours, test results are ready and can be accessed through a software platform.
In discussing the capabilities of Clear Safety versus PCR, Ghorashi named a few other key differentiators:
Molecular profiling: The ability to drill down from species-level resolution to serotype to strain-level all in a single test within 24 hours (as opposed to today’s three-to-five-day timeframe)
Better accuracy and more automation, reducing human error
Multi-target analysis: The ability to run different kinds of pathogens at the same time
Software: LIMS built specifically for food safety testing
Clear Safety’s first area of focus is Salmonella. Ghorashi estimates that 90% of the poultry market, 80% of the pet food market and half of all contract service labs have piloted the platform. Next year E.coli and Listeria testing capabilities will be rolled out.
On the heels of the deadly, widespread outbreak of E.coli O157:H7 illnesses linked to romaine lettuce—and 12 years after the infamous spinach outbreak of 2006—the food industry is struggling to find the solution to prevent these outbreaks. “I think it’s indicative that we need to do something different,” said Melanie Nuce, senior vice president, corporate development & innovation at GS1 US, during a panel discussion about blockchain at the 2018 Food Safety Supply Chain conference earlier this month. The panel, led by Darin Detwiler, assistant dean and director, regulatory affairs of food and food industry at Northeastern University, delved into the strengths and weaknesses of blockchain, along with industry readiness and acceptance.
In its most basic form, the technology would allow for the addition of information from every step of the supply chain, from manufacturing to packaging to distribution to retail, and would incorporate elements such as auditing, inspection, batch information, certification of auditors, preventive control plans, HACCP information, and allergen identification.
“Blockchain could be the death of the document.” Simon Batters, Lloyd’s Register
The increased demand for transparency and traceability could be one of the biggest drivers for the adoption of blockchain. “[Blockchain] offers us the technology for traceability,” said Simon Batters, vice president of technology solutions at Lloyd’s Register. “It allows us to have an immutable record of a transaction; it won’t solve the food safety conundrum overnight—it’s part of the tool kit that we need.”
The fact that the food supply chain consists of millions of transactions, which could not be tampered with under blockchain, while the data could be used as reference points and for verification—those are strengths. However, Batters pointed out, there should be restrictions on who has permission to write the code and who has access to putting the information into a chain.
The technology would also enable smart contracts whereby shipments wouldn’t be finalized if they didn’t meet the conditions of a supplier, for example. “All parties to a transaction have a view to the entire chain at the same time,” said Nuce. “You have real time visibility. This democratizes that.”
Kathleen Wybourn, director, food safety solutions at DNV Business Assurance, calls blockchain “the birth certificate for food.” From a consumer standpoint, it would provide information on a product’s origin—and these days, consumers—especially millennials—are very interested in the story of food from farm to fork.
Weaknesses and Threats
The panel pointed out several areas of improvement (and unknowns that must be answered) before blockchain can be taken to the next level in the food industry.
Although the technology could aid in faster transaction times, as the size of the ledger gets larger, and it will become more difficult to manage.
Industry involvement: “If you don’t get 100% participation, it’s not going to be successful,” Nuce said. “To have true trace back, everyone has to participate.”
Blockchain platforms: Will they be able to interact and share data? What type of blockchain architecture is necessary for this?
Need a better grasp on the type of data being used and how it delivers value
What impact will it have on the role of certification bodies?
Politics and the competitive element: Will certain parties seek to control this space?
Will the culture shift be a roadblock?
Final Thoughts from the Panel
“Nobody can really tell where this is going to go in the future. I think it’s going to be part of food safety in their roles in one shape or form…I think we’ll see more of where this is headed within the next 12–18 months.” – Kathy Wybourn
“I think it’s going to be a fast-moving dynamic area.”– Simon Batters, who suggested that the organizations that embrace blockchain early may be the ones who show the way
“From an information/standards perspective, you have to have foundational business processes to support any type of technology. That’s what we’ve learned through the pilots.” – Melanie Nuce
“It’s not going to make a company any more ethical… a lot of what we need already exists out there; blockchain is just a tool out there. I keep warning people that this is not the only solution.” – Darin Detwiler
Today Decernis announced that it has acquired USP’s Food Fraud Database. The database was launched in 2012 to assist food manufacturers, retailers and other stakeholders make informed decisions of ingredient vulnerability, food fraud and economically motivated adulteration. It contains information about thousands of ingredients from scientific literature, media publications, regulatory reports, judicial records and trade associations worldwide. Users can use the database to search for information and generate reports.
Decernis and USP will collaborate during the transition process to ensure a seamless integration. Like USP, Decernis is committed to the mission of product safety and we believe the Food Fraud Database has significant runway for expansion through Decernis’ existing platforms, allowing us to scale this important capability and help combat intentional food adulteration,” said Pat Waldo, Decernis CEO.
Kellogg Company announced a voluntary recall of Honey Smacks cereal (15.3 oz and 23 oz) after it was uncovered there may be a presence of Salmonella. The products were distributed national wide as well as in Costa Rica, Guatamala, Mexico, the Caribbean, Guam, Tahiti and Saipan. The issue was uncovered after FDA and CDC were contacted regarding reported illnesses—at that point Kellogg initiated an investigation with the third-party manufacturer of Honey Smacks. The products have a Best If Used by Date of June 14, 2018 through June 14, 2019.
Following a potential link to a cluster of illnesses related to Cyclospora contamination, Del Monte Fresh Produce N.A., Inc. initiated a voluntary recall of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to certain retailers in the Midwest (Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin).
The products were distributed to Kwik Trip, Kwik Star, Demond’s, Sentry, Potash, Meehan’s, Country Market, Food Max Supermarket and Peapod, and have a “Best By” date of June 17 or earlier.
How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.
“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.
Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL
It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America
“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register
Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International
The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group
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