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.
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium.
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.
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?
“The growing popularity of plant-based foods has presented a new set of challenges for the supply chain,” says Joe Scioscia of VAI.
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.
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.
Food processing is a multi-trillion dollar industry that encompasses facilities such as bakeries, meat and poultry plants, bottling lines, dairies, canneries and breweries. For all of these food processing plants a commercial flooring system is essential for maintaining a hygienic environment. Few areas of a plant provide as much opportunity for the spread of bacteria, mold, fungi and dust as the floor. Hazardous materials from a contaminated floor can easily be spread from worker’s shoes and mobile equipment. Food processing plants present a unique set of challenges that require careful consideration of floor properties and installation.
Food processing plants floors are subjected to constant, high concentrations of salt, alkaline and oil compounds that substantially degrade the floor and thereby risk food contamination and facility shutdown. These compounds can come from common food production by-products like oils, fats, dairy products, sugar solutions, blood, and natural acids or from harsh cleaners and disinfectants. Even with frequent and thorough cleaning these substances can—and will—result in microbial growth and the spread of bacteria in untreated concrete or poorly installed resinous flooring.
A commercial flooring system is critical to maintaining a hygienic environment in a food processing plant. (Image courtesy of High Performance Systems)
Cleaning floors is an essential part of maintaining food processing operations to keep up with government standards. A proper floor coating is a necessity for dealing with the vigorous, harsh cleaning procedures that typically include very hot water and aggressive cleaning chemicals. Depending on the exposure to corrosive, temperature and moisture conditions a thin film coating may suffice; however, in most cases, a thick, durable floor coating is needed to endure the cleaning operations. If too thin of a coating is used the repeated barrage of high pressure, high-temperature hot water and steam will strip the floor coating. Only an experienced flooring professional can determine the proper floor coating for a facility.
In addition to the properties of the floor coating, proper installation is essential for maintaining a hygienic, safe facility. If a floor is not seamless even the best floor coatings are vulnerable to germ buildup within gaps and cracks. To prevent harmful substance accumulation, a seamless coving transition from the floor to the wall is needed. Not only does that make the floors unsanitary, but it also can spread to other parts of the facility, equipment and product. Coving also aids in the cleaning process by allowing for hosing around the sides and corners of the room where germ buildup is most common.
An often-overlooked—yet critical—aspect of floor installation is having the proper pitch to promote water drainage. Having pools of water is not only dangerous for workers but for product safety. Such an examples of this issue is the Listeria outbreak at cantaloupe producer Jensen Farms, which led to 33 fatalities, 143 hospitalized victims, and ultimately, the end of their business. In the 2011 FDA released a report that focused on “Factors Potentially Contributing to the Contamination of Fresh, Whole Cantaloupe Implicated in the Multi-State Listeria monocytogenes Foodborne Illness Outbreak”. The conclusion was reached that the leading cause of Listeria spreading was due to a poorly constructed packing facility floor that was difficult to clean and allowed water to pool. The best way to prevent a similar situation at your plant is to make sure you get an experienced flooring expert, who understands your facility’s needs, to choose a floor with the right properties and to properly install it.
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.
Going digital is a hot topic in the food industry, but making the investment can be a tough choice for organizations. Jeremy Schneider, business development director, food safety and quality assurance at Controlant, reviews some of the factors that food companies should consider when making the decision, along with the value that digital technologies can bring from the perspective of ROI and improving food safety culture.
Food Safety Tech: For businesses that have been historically paper-driven, where do they start on the technology adoption journey?
Jeremy Schneider, business development director, food safety and quality assurance at Controlant
Schneider: There are a number of questions that firms, both small and large, should consider when deciding to move to a paperless operation. Have you considered what moving away from a paper-based system would mean for your enterprise? What are the perceived challenges to making this move? Or perhaps, what are the risks of not moving to digital? How would utilizing systems provide your organization with the ability to access data in transformative ways?
For organizations that are making the transition from paper documentation to digital, it is critical to develop a roadmap with tangible milestones and objectives. Although there are a variety of reasons to make the switch to digital, what is most important for your organization will determine what those are, as they will play a critical role in developing a roadmap of priorities. We often find that organizations identify a ‘’pain-point’’ in their current process, and this is a leading driver to wanting to make a change in their process. Perhaps this is the inability to easily access information in a timely manner, or the challenges with making sense of the data that you are currently collecting. Whatever your challenges may be, begin by developing a plan, and prioritize this, as it will provide you with early positive results that will keep you working towards the goal. As you experience these early benefits from going digital, you will begin to see the value that this will bring your organization at scale.
One significant issue that many organizations face when beginning this journey is not bringing the appropriate stakeholders into a program early enough. It is critical for the success of new supply chain programs to make sure you bring in members of purchasing, logistics, quality, finance, IT, and others as early as possible so that any questions or concerns are properly vetted early in the process. In addition to this, getting buy-in from these teams at the earliest phase of a project will allow others to vet the system in their own way, potentially helping them solve challenges they have been
FST: Talk about measuring the success of a technology: How do the metrics translate into ROI?
Schneider: A question that is often raised is how to measure the success of the technology. Simply put, does the program make your life easier and solve the problem you set out to, or not? Does it meet the concise objectives that you outlined in the beginning of the process, or does it fall short in some way? If your answer to any of these questions is yes, and it does meet the objectives, then you are well on your way to defining success of your program.
Read Food Safety Tech’s previous discussion with Schneider, Using Technology for Traceability Adds Dimension to Supply Chain, Promises ROIIt is critical that programs are able to show their value through their return on investment, but how do you measure this? If you have recently implemented a real-time supply chain temperature monitoring program, for instance, you may want to consider metrics such as reduced loss, spoilage, shortages, or restaurant-level outages as metrics of success. Or perhaps you would want to translate this into a dollar figure. For instance, in the previous year, your organization counted 10 rejected shipments due to suspected temperature abuse, at a loss of $500,000. In the year following your implementation, your new system was able to help the organization intervene and minimize that loss to just one rejected shipment at a cost of $50,000, thus leading to a reduced loss rate of $450,000.
In collaboration with other stakeholders in your organization, you may be able to identify additional metrics, such as reduced freight rates from optimized shipping lanes, reduced insurance premiums from reduced losses, or reduced quantities of on-hand inventories as you are able to truly manage a just-in-time supply chain. If your organization actively measures your Cost to Serve, savings within your supply chain would likely be an important data point to consider.
Beyond the identifiable money savings, consider some of the soft ROI attributes, such as enhanced collaboration with supply chain and supplier partners, improved customer loyalty, brand protection generally, and sustainability initiatives. Does your organization have goals to reduce food waste? If so, perhaps waste minimization is an important attribute to measure. When evaluated holistically, significant savings can be realized.
FST: How does technology facilitate a more effective food safety culture?
Schneider: Building an effective food safety culture is a process that requires commitment from every level of your organization. The ways that we promote food safety culture within each organization differs, from rewarding team members when they identify an unsafe practice, to actively promoting food safety throughout the organization, to encouraging quality assurance teams to identify state-of-the-art technologies and implementing them to improve the systems, programs, and processes throughout the company.
As food safety professionals, our toolboxes are filled with a variety of tools for the job, and technology as a tool is no exception. Technology should enable our organizations to be more efficient, allowing them to focus their attention on high-priority projects while minimizing work that can be automated. An example of this is setting parameters to allow organizations to work based on exception instead of requiring a review of all documentation.
As we enter the New Era of Smarter Food Safety, and the tenants of it being people-led, technology-enabled, and FSMA-based, we have a mandate to try new technologies to help solve previously unsolvable supply chain challenges. Organizations are actively pursuing real-time supply chain temperature monitoring as a way to provide insights into their cold chain and allowing them to move from reaction to a position of prevention.
Organizations are finding that investments in food safety technologies pay dividends in customer commitment over the long term. It is no longer acceptable to only meet regulatory standards. It is now an expectation that companies do anything possible within their power to assure customer safety and, per the FDA’s new mandate, to help create a more digital, traceable, and safer food system.
In the latest FDA update about the E. coli O157:H7 outbreak involving romaine lettuce, the agency has stated that consumers should not eat romaine lettuce that has been harvested from Salinas, California. Traceback investigations related to three different E. coli outbreaks (three different strains, all of which involve romaine lettuce) have pointed to a common grower located in Salinas. Frank Yiannas, deputy commissioner for food policy and response, called the identification of a common grower a “notable development” but also stated in a press announcement, “Because of the expansive nature of these outbreaks, our investigation remains a complicated work in progress, and it is too soon to draw definitive conclusions.”
FDA, CDC and California partners have sent out a team to conduct new investigations at ranches used by the grower as part of the process in finding the contamination source, according to an FDA update.
Thus far, 102 illnesses have been reported across 23 states, with 58 hospitalizations. No deaths have been reported. The last illness onset was reported on November 18.
Thus far Swedesboro, NJ-based Missa Bay, LLC has recalled more than 75,000 pounds of salad products because of a lettuce ingredient that might be contaminated with E. coli O157:H7. This lettuce was also found to be in packaged salad that the Maryland Department of Health said contained E. coli.
FDA states that thus far lettuce grown indoors has not been indicated in the outbreak.
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