On Friday FDA announced the approval of a drug to mitigate allergic reactions to accidental peanut exposure in children. Manufactured by Aimmune Therapeutics, Palforzia is intended for use in children who are four years through 17 years old. FDA points out that there is no cure for a peanut allergy and so peanuts must continue to be avoided.
Palforzia is a powder made from peanuts and administered in capsule and sachet form via three phases, the first of which occurs under the supervision of a healthcare professional. This first phase, called “initial dose escalation”, involves administration of a single capsule. The second phase, “up-dosing”, is a phase of 11 increasing dose levels over a period of several months (the first dose of this phase is also administered under watch by a healthcare professional, while the remaining doses can be taken daily at home). Following completion of the second phase, a patient begins the “maintenance” treatment, which is delivered via a sachet (the powder can be mixed with foods such as applesauce and yogurt).
“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in an agency press release.
Palforzia is available through healthcare providers, healthcare settings and pharmacies that receive special certification and are educated on the risk of anaphylaxis in using the drug. Patients interested in receiving the drug must be part of FDA’s risk evaluation and mitigation strategy program.
EDGARTOWN, MA, January 22, 2020 – Innovative Publishing Company Inc., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker for the 2020 Food Safety Consortium Conference & Expo on October 21. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 21–23 in Schaumburg, IL (just outside Chicago).
“At last year’s Food Safety Consortium, Frank Yiannas spoke about the ‘sea change’ happening at FDA and the increased efforts on the part of the agency to drive more transparency and traceability. We look forward to his insights, as well as learning more about FDA’s progress on its initiatives, especially the New Era of Smarter Food Safety,” says Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference & Expo.
This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Food Safety, chaired by Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation; Food Integrity, chaired by Steven Sklare, president of The Food Safety Academy; and Food Defense, chaired by Jason Bashura, senior manager, global food defense at PepsiCo.
Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
About the Food Safety Consortium Conference and Expo
Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy. The Food Safety Consortium Conference and Expo is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.
With the passage of the Farm Bill, there has been a great deal of interest from the food industry in cannabis-infused foods and beverages, which includes hemp and CBD. The Food Safety Consortium is co-located with The Cannabis Quality Conference & Expo, an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the Cannabis Quality Conference enables attendees to engage in conversations that are critical in finding solutions to improve regulatory compliance, quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace. Both conference programs run concurrently, thus, Food Safety Consortium registrants can attend any of the Cannabis Quality Conference presentations and vice versa. This year’s event takes place October 21–23 in Schaumburg, IL and is co-located with the Cannabis Quality Conference & Expo.
The plant-based meat market is anticipated to be worth more than $320 millionin the next five years, according to a report released last summer by Global Market Insights. As the popularity of meat-alternative products continues to rise, new challenges are being introduced to supply chain management. Joe Scioscia, vice president of sales at VAI explains some of these hurdles and proposes how technology can help.
Food Safety Tech: Is the growing popularity of plant-based foods introducing hazards or challenges to the supply chain?
Joe Scioscia: The growing popularity of plant-based foods has presented a new set of challenges for the supply chain, especially considering many of these organic items are being introduced by traditionally non-organic retailers. Impossible Foods received FDA approval for its plant-based burger in 2019, showing just how new the plant-based movement is to the industry.
Obviously, the organic supply chain and produce suppliers have long followed regulations for handling produce, such as temperature controls, cargo tracking, and supply and demand planning software, so the produce could be tracked from farm to table and in the case of a recall, be traced back to the source. But for meat alternatives that are combining multiple plant-based ingredients, organizations in the supply chain who are handling these products
have new food safety concerns. Considerations on how to store and process meat alternatives, how to treat each ingredient in the product and, most importantly, how to determine temperature controls or the source of contamination are all discussions the food industry is currently having.
FST: How are plant-based foods changing the dynamic of the supply chain from a food safety perspective?
Scioscia: The food supply chain has changed dramatically in recent years to become more complex, with food items traveling farther than ever before, containing more ingredients and required to follow stricter regulations. Many of the changes to the supply chain are for the better—organic and plant-based alternatives offer health benefits for consumers and are a move towards a more sustainable future. But the reality is that the supply chain isn’t quite there yet. Suppliers, retailers and producers at every part of the supply chain need to work together to ensure transparency and food safety compliance—including for plant-based products. Foodborne illnesses are still a real threat to the safety of consumers, and these same consumers are demanding transparency into the source of their food and sustainable practices from brands. All of these considerations are what’s making this next era of the food industry more complicated than ever before.
Because food safety compliance is always top of mind in the food industry to keep consumers safe, this new and complex supply chain has required companies to rely heavily on technology solutions to ensure plant-based products are equally as safe to consume as non-organic alternatives. These same solutions are also helping supply chains become more transparent for customers and streamline food processes to build a more sustainable future.
FST: What technologies can food companies and retailers use to better manage the supply chain risk while supporting the increased consumer demand for meat alternatives?
Scioscia: Utilizing a centralized software system is one tool many food suppliers and distributors can use to better visualize, trace and process products in the supply chain—including for plant-based alternatives. Having access to a central platform for business data to track assets and ensure food safety regulations are being met allows for companies to optimize processes and cut unnecessary costs along the way.
Heading into 2020, many organizations in the food supply chain are also looking at new applications like IoT, automation, and blockchain as ways to curb food safety issues. The FDA has taken steps to pilot blockchain and AI programs to better track drugs and food products, in conjunction with major food brands and technology companies. Other organizations are following suit with their own programs and many are looking at these solutions to improve their food tracking efforts. It’s clear technology has the most potential to make it easier on the industry to comply with food safety regulations while meeting customer demands for plant-based alternatives and organic options—all the while building a sustainable supply chain for the future.
— UPDATE — March 9, 2020 – IPC and the Food Labs/Cannabis Labs Conference want to reassure you, that in case of any disruption that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. Please note that if you initially register as a virtual participant (meaning you have no intentions of traveling to the event regardless) and the on-site event is not cancelled, you will ONLY be able to listen to the General Sessions and the Cannabis Sessions. You will have not have access to the Food Labs Sessions and there will be NO recording of these sessions. If you have any questions, please contact Veronica Allen, Event Manager.
–END UPDATE —
EDGARTOWN, MA, Jan. 22, 2020 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo is announcing the launch of the Food Labs Conference. The event will address regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. It will take place on June 3–4 in Rockville, MD.
Some of the critical topics include discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.
The event is co-located with the Cannabis Labs Conference, which will focus on science, technology, regulatory compliance and quality management. More information about this event is available on Cannabis Industry Journal.
“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Labs Conference.
The agenda and speakers will be announced in early March.
About Food Safety Tech Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.
Yesterday the CDC reported that the E.coli outbreak linked to romaine lettucegrown in the Salinas, CA growing region is over. The contaminated lettuce should no longer be available, and FDA states that consumers do not need to avoid romaine lettuce from Salinas. The agency will continue its investigation into the potential factors and sources that led to the outbreak.
The FDA did identify a common grower link to the E.coli O157:H7 contamination as a result of its traceback investigation. However, a statement released yesterday by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas points out that “this grower does not explain all of the illnesses seen in these outbreaks.”
To be specific, the FDA, CDC and other public health agencies were tracking three outbreaks involving three separate strains of E.coli O157:H7 linked to romaine lettuce. During the course of the investigation FDA, CDC, the California Department of Food and Agriculture and the California Department of Public Health conducted sampling of the water, soil and compost of several of the fields in the lower Salinas Valley that were connected to the outbreak. “So far, sample results have come back negative for all of the three outbreak strains of E. coli O157:H7. However, we did find a strain of E. coli that is unrelated to any illnesses in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze,” Yiannas said in the agency statement. “This could be an important clue that will be further examined as our investigation continues. However, this clue does not explain the illnesses seen in these outbreaks.”
Finding the contamination source(s) is critical, as it will aid romaine growers in putting safeguards in place to help prevent future contamination.
As for the final case count (with last illness onset on December 21, 2019) of this outbreak, there were 167 total illnesses and 85 hospitalizations across the United States. No deaths were reported.
Technical writing is not as simple as it sounds—especially as it relates to writing non-conformances and CAPAs. Innovative Publishing is offering a Technical Writing Virtual Workshop that takes place over two two-hour sessions on March 3 and 10. The event is being hosted by Food Safety Tech’s sister publication, MedTech Intelligence, but the content is applicable to the food industry as well.
The course will be instructed by world-class, international quality and regulatory consultant Mark Proulx, president of MLB Consulting Services. Proulx has more than 25 years of direct manufacturing, auditing, and FDA experience and is a certified quality auditor and Six Sigma Black Belt.
The workshop was developed for the following industry professionals:
Engineers responsible for writing up investigations and reports
Tech writers who must communicate the results of testing in reports, write up papers, produce arguments for or against an issue
Middle-level managers who are attempting to make arguments or show results
Laboratory staff who document results and write reports
Technicians who must write up test protocols, non-conformance reports, corrective actions, reports to upper management, etc.
Quality Assurance/Quality Control and Regulatory Compliance people who must document clearly the purpose of investigations and produce final reports that clearly state actions to be performed or the results of testing
2018 and 2019 were the years of the “blockchain buzz”. As we enter the new decade, we can expect a stronger focus on how technology and data advances will generate more actionable use for the food industry. Food Safety Tech has highlighted many perspectives from subject matter experts in the industry, and 2020 will be no different. Our first Q&A of the year features Sasan Amini, CEO of Clear Labs, as he shares his thoughts on tech improvements and the continued rise consumer expectations for transparency.
Food Safety Tech: As we look to the year ahead, where do you see artificial intelligence, machine learning and blockchain advancing in the food industry?
Sasan Amini: AI, ML, and blockchain are making headway in the food industry through advances in supply chain management, food sorting and anomaly detection, and tracing the origin of foodborne outbreaks. On the regulatory side, FDA’s focus on its New Era of Smarter Food Safety will most likely catalyze the adoption of the above mentioned technologies. On the private side, a few of the companies leading the charge on these advancements are IBM and Google, working in partnership with food manufacturers and retailers across the world.
Along those same lines, another area that we expect to grow is the use of AI and ML in tandem with robotics—and the value of new troves of data that they collect, analyze and distribute. For example, robotics for the use of environmental monitoring of potential contaminants, sorting techniques and sterilization are valuable because they ensure that end products have been through thorough testing—and they give us even more information about the lifecycle of that food than ever before.
At the end of the day, data is only valuable when you can transform it into actionable insights in real-time with real-world applications, and we expect to see more and more of this type of data usage in the year ahead.
FST: Where do you think food safety testing technologies will stand out? What advancements can the industry expect?
Amini: In 2020, technology is going to begin to connect itself along the entire supply chain, bringing together disparate pieces and equipping supply chain professionals with action-oriented data. From testing advances that improve speed, accuracy and depth of information to modular software solutions to promote transparency, the food safety industry is finally finding its footing in a data-driven sea of technological and regulatory advances.
Right now, legacy testing solutions are limited in their ability to lead food safety and quality professionals to the source of problems, providing insights on tracking recurring issues, hence having a faster response time, and being able to anticipate problems before they occur based on a more data heavy and objective risk assessment tools. This leaves the industry in a reactive position for managing and controlling their pathogen problems.
Availability of higher resolution food safety technologies that provide deeper and more accurate information and puts them in context for food safety and quality professionals provides the food industry a unique opportunity to resolve the incidents in a timely fashion with higher rigour and confidence. This is very in-line with the “Smarter Tools and Approaches” that FDA described in their new approach to food safety.
FST: How are evolving consumer preferences changing how food companies must do business from a strategic as well as transparency perspective?
Amini: Consumers are continuing to get savvier about what’s in their food and where it comes from. Research suggests that about one in five U.S. adults believe they are food allergic, while only 1 in 20 are estimated to have physician-diagnosed food allergies. This discrepancy is important for food companies to consider when making decisions about transparency into their products. Although the research on food allergies continues to evolve, what’s important to note today is that consumers want to know the details. Radical transparency can be a differentiator in a competitive market, especially for consumers looking for answers to improve their health and nutrition.
Consumers are also increasingly interested in personalization, due in part to the rise in new digital health and testing companies looking to deliver on the promise of personalized nutrition and wellness. Again, more transparency will be key.
FST: Additional comments are welcome.
Amini: Looking ahead, we expect that smaller, multi-use, and hyper-efficient tools with reduced physical footprints will gain market share. NGS is a great example of this, as it allows any lab to gather millions of data points about a single sample without needing to run it multiple times. It moves beyond the binary yes-no response of traditional testing, and lets you get much more done, with far less. Such wealth of information not only increases the confidence about the result, but can also be mined to generate more actionable insights for interventions and root cause analysis.
This “multi-tool” will be driven by a combination of advanced software, robotics, and testing capabilities, creating a food safety system that is entirely connected, driven by data, and powerfully accurate.
Using whole genome sequencing (WGS), FDA has confirmed 96 illnesses in 11 states that were caused by Salmonella Javiana. Thus far, traceback evidence indicates that a fruit mix from New Jersey-based Tailor Cut Produce is the possible source of the outbreak.
FDA provided its latest update about the ongoing investigation today: Of the 96 illnesses, 27 have been hospitalized, and no deaths have been reported. The highest number of illnesses have been reported in Delaware (39), Pennsylvania (34) and New Jersey (12). The agency stated its inspection at Tailor Cut Produce continues and it is collecting records to support a traceback investigation.
Today FDA provided an update about its outbreak investigation of Listeria monocytogenes linked to hard-boiled eggs manufactured by Almark Foods’ facility in Gainesville, Georgia. On December 23, Almark expanded its recall to include all eggs manufactured at the Gainesville plant. In addition, the company is not producing products at this facility.
Thus far, four companies have recalled products containing the eggs from Almark Foods, as they have the potential to be contaminated with Listeria monocytogenes:
Bakkavor Foods (Trader Joe’s Egg Salad and Potato Salad)
As of December 17, seven infections were reported, with four hospitalizations and one death across five states. The hard-boiled eggs were sold both in bulk pails to food processors, restaurants and retailers, as well as directly to consumers at the retail level, and have “Best If Used By Dates” through March 2, 2020.
FDA used whole genome sequencing to find a genetic match in the outbreak strain from samples collected at Almark’s facility during agency inspections in February and December of this year.
In a Q&A with Food Safety Tech, Eddie Hall, business development director and food safety expert at Vital Vio looks ahead to 2020 and how technology will be impacting food safety, the additional measures that the industry will be taking to protect consumers, and the critical emphasis on sanitation.
Food Safety Tech: What are some of the touch points for food safety innovation in the supply chain in 2020?
Eddie Hall: When we think of the supply chain, we often imagine food traveling during transportation—by road, rail and air. During transit, our food comes into contact with countless surfaces, hands, tools and bacteria that travels from the farm to the table. However, transit isn’t the only place for germ spread and bacteria growth. When food reaches the factory for processing and packaging, there are opportunities for contact with debris, mold and dust, along with un-sanitized machinery and employees. Not only does this negatively affect the health of our workers, but also the cleanliness and safety of the food that consumers are buying off the shelves. In food manufacturing plants, Zones 1 and 2 are the most obvious for safety innovation in the supply chain, given food is bound to come into contact with tools, conveyor belts, etc. However, processors must consider the touch points in Zones 3 and 4 as well—such as employee break rooms, bathrooms and offices around the plant that foster bacteria. If these areas are not cleaned, food manufacturers have a significantly higher chance of breeding bacteria in food production areas, even if the right protocols are put in place in those zones.
FST: How will the retail sector step up to the consumer demand for safer food?
Hall: Consumers are increasingly demanding transparency around how food ends up on their plate, and prioritizing purchasing from brands that they trust to be safe. Food suppliers are being careful to remove harmful chemicals from the manufacturing process, along with displaying ingredients and supply chain information. For example, Bumble Bee Foods is using blockchain technology for its tuna fish, allowing consumers to access detailed information around the tuna’s origin, authenticity, freshness and sustainability by scanning the QR code on its packaging. Panera Bread has been consistent in offering customers ingredient transparency [by] providing calorie counts on menu items and removing antibiotic-treated animal proteins, as well as vocalizing recent efforts to perform safety audits throughout its supply chain. Not only does tracking technology and clarity meet consumers’ demands, but [it] also helps retailers pinpoint locations of outbreaks, foodborne illness and mislabeling. We’re already seeing retailers step up to meet the growing demand for safer food, but in 2020 we will see an uptick in brand transparency around supply chain information, safety programs and ingredient clarity within restaurants, fast food chains, processing companies and grocery stores.
FST: How will automation play a role in advancing food safety?
Hall: Food processing companies and retailers are implementing remote monitoring technologies that track data and help measure protocol, temperature controls, sanitation, record-keeping and food traceability. Automation can also help advance food safety through methods such as enhance sanitation and sterilization efforts. It is critical for food industry employees to maintain clean environments, but continuously cleaning every hour of every day can become labor-intensive, and sometimes fall off the to-do list. Automated technologies can take on some of these tedious tasks and work in our favor to heighten food safety. For example, Stop and Shop’s new robot, Marty, patrols the aisles to detect food on the floor, torn packaging, empty shelves and more. However, robots aren’t the only place we’re seeing automation in action. Vital Vio has found a way to automate killing bacteria through antimicrobial LED lighting technology, which continuously kills pathogens with the flick of a switch. Automated tech isn’t meant to replace workers, but to enhance their work around cleaning, sanitizing and meeting safety requirements. In 2020, automation is expected to explode and it’s important for leaders in the food and beverage industry to take advantage of safety tech innovations to advance food safety in 2020 and beyond.
FST: How will food companies continue to work towards reducing contamination issues and recalls?
Hall: The U.S. government has stepped in to tackle issues in the food industry by implementing new regulations, such as FSMA. This regulation urges food companies to shift from reactively responding to safety and contamination issues, to proactively working to prevent them. In an effort to reduce recalls, retail giant Walmart recently employed blockchain to track its lettuce supply chains all the way back to the grower. For food companies to reduce contamination, they must also implement more automated sanitation technologies along the supply chain. The most common food contaminants are usually invisible to the naked eye, such as mold, Listeria, Salmonella and E. coli. Sanitation automation tech—such as antimicrobial LED lighting—can continuously kill microscopic bacteria and prevent regrowth, ensuring clean food and equipment. Not only will food companies begin implementing more sanitization technologies, but also focus on other ways, like blockchain traceability, to prevent food recalls and bacteria growth that pose serious health risks to their customers.
FST: Any additional comments?
Hall: Our Dirty Truth report reveals disturbing stats around Americans’ cleaning habits, such as 1 in 4 (27%) do not sanitize their hands after traveling on public transportation. This means that factory or grocery employees that commute to work via bus, train, etc. are bringing bacteria and other germs with them. What’s worse, 1 in 6 Americans get sick and 3,000 die each year from consuming contaminated foods or beverages. This alarming rate can only be improved if we see effort from all sides of the industry—including food processors, manufacturers, workers throughout the supply chain and retailers. Continuous cleaning and sanitation measures can be labor-intensive and sometimes impossible to tackle throughout the day. Luckily, automated technology exists and is expected to address this growing issue of contamination, the spread of bacteria, recalls, and consumer demand for safety and transparency.
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