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.
Clear Safety is touted as the first NGS platform that can either match or outperform PCR systems as it relates to accuracy, turnaround time and cost. Chart courtesy of Clear Labs.
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.
Darin Detwiler will lead a plenary session titled, “Practical Use of Blockchain in Food Safety” at the 2018 Food Safety Consortium | Learn moreOn 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
Strengths
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 GL, 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.
The blockchain panel, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV GL; Simon Batters, Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.
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?
Poor architecture
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?
“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.
This week Glassdoor released its Top CEOs for 2018 list via its annual Employees’ Choice Awards. Among those who made the list are several CEOs from food and retail companies.
“You already know that having a great CEO is critical for business, but you may not realize how much of an impact it can have on your talent acquisition efforts.” – Glassdoor
The CEOs who made the list are from large companies with more than 1000 employees.
99. Preston Atkinson, Whataburger
83. Craig Jelinek, Costco Wholesale
50. Dan T. Cathy, Chick-fil-A
9. Colleen Wegman, Wegmans Food Markets
7. Charles C. Butt, H E B
4. Lynsi Snyder, In-N-Out Burger
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.
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA
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
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America
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
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.
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
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons
The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group
Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.
According to an agency news release, the draft guidance will help facilities in the following areas:
“Determine whether they need a supply-chain program;
Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
Establish frequency of supplier verification activities;
Meet documentation and recordkeeping requirements; and
Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”
In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.
The FDA is accepting public comments on the draft for the next 180 days.
An investigation of a multi-state outbreak of Salmonella Adelaide infections has been traced back to pre-cut melon distributed by Caito Foods, according to an outbreak update from FDA. The agency, along with CDC and state and local officials, are investigating the outbreak involving 60 people in five states in the Midwest, and have traced it back to fruit salad mixes that include pre-cut melon. As a result, Caito Foods has issued a voluntary recall of these products, which were distributed to Costco, Jay C, Kroger, Payless, Owen’s, Sprouts, Trader Joe’s, Walgreens, Walmart, and Whole Foods/Amazon. No deaths have been reported.
The illnesses occurred between April 30 and May 28. The FDA is advising consumers to refrain from eating the recalled cut watermelon, honeydew melon, cantaloupe and fresh-cut fruit melody products that were produced at the Caito Foods facility in Indianapolis, IN.
Following the multi-state E. coli O157:H7 outbreak linked to romaine lettuce from the Yuma, Arizona region, several groups have come together in the hopes of preventing future outbreaks. Despite the fact that the FDA announced that the outbreak was likely over weeks ago, 4 more deaths have occurred (bringing the total to 5 dead), and three more states have reported ill people.
Now the Arizona and California leafy greens industries, the Produce Marketing Association, Western Growers, United Fresh and other groups have created a special task force to improve food safety systems across the supply chain. The Leafy Greens Food Safety Task Force will consist of industry members, food safety experts, researchers and representatives from government.
“It is very difficult to identify an issue weeks or months after the fact, primarily because of the expediency with which our product is harvested and in the marketplace,” said Arizona Leafy Greens Marketing Agreement Chair Jerry Muldoon in a press release. “With our industry knowledge, scientific experts and the collaboration of state and federal agencies, we believe we can help get to the bottom of this and make changes to processes after our product leaves the farm, as well as closely examine other factors at play.”
The latest update from CDC puts the case count at 197 ill, five dead, 89 hospitalizations, with a span of illnesses across 35 states.
The Association for Food Safety Auditing Professionals (AFSAP) announces the selection of the Food Safety Supply Chain Conferenceas the site for the first Audit Stakeholders meeting on June 13 in Rockville, MD. This historic event will bring together FDA, accreditation bodies (ABs), certification bodies (CBs) and other interested parties to outline the requirements for FDA’s Accredited Certification to better understand the AB/CB roles in FSMA’s use of audits to protect the U.S. food supply.
There are two objectives for this meeting: First, the gaps in the current program must be explained so that all understand the challenges ahead. Second, and even more critical, will be to explore solutions such as creating a Voluntary Scheme Owner that will address those gaps.
Patricia Wester, AFSAP founder, will lead the groundbreaking audit panel at the 2018 Food Safety Supply Chain conference.
AFSAP’s founder, Patricia Wester, spearheaded the meeting to address critical questions regarding implementation of FDA’s Third-Party Audit program and provide a platform to discuss potential solutions.
“FDA’s program involves certification of regulatory compliance, which is an entirely new approach for CB’s currently involved in the GFSI system,” says Wester. “As currently structured, the individual CB’s responsibilities will include activities such as audit checklist development and auditor training requirements that will negatively impact audit consistency and dramatically increase audit costs. Another key concern is maintaining the audit documents, because regulations do not change on a regular cycle like GFSI, further adding costs and variability to the program.”
Supported by AFSAP’s food safety partners, NEHA and ANSI, long-time supporters of AFSAP’s efforts to raise awareness of FSMA’s use of audits, the Food Safety Supply Chain event provided the ideal venue to hold the discussion.
About AFSAP
The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.
About Food Safety Tech
Food Safety Tech is an industry-specific eMagazine and Conference series serving the global food industry. Built on the platform of the next generation model for B2B publishing, Food Safety Tech delivers top quality content in a proactive manner through a weekly eNewsletter while maintaining a website, the eMagazine that stores the content providing easy accessibility. This hybrid model provides a two way street of digital communication to the global food industry. Food Safety Tech is published by Innovative Publishing, LLC.
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