–UPDATE April 19, 2021 — The FDA continues to investigate reports of acute non-viral hepatitis in Nevada associate with consumption of “Real Water” brand alkaline water. “The FDA has become aware that “Real Water” brand alkaline water is still being offered for sale through online retailers. The agency is working to locate any remaining products to ensure they are no longer available to consumers,” FDA stated in an email update. “The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale.”
–END UPDATE–
The FDA and CDC are investigating reports of acute non-viral hepatitis in consumers that has a common link to “Real Water” brand alkaline water. The agency is in the beginning stages of the investigation and notes that more products could be connected to the outbreak. The acute non-viral hepatitis cases affected infants and children, resulted in acute liver failure and occurred in November 2020, but FDA was alerted to the cases on March 13, 2021.
The manufacturer, Arizona-based Real Water, Inc., stated that the issue occurred in Las Vegas and is recalling the product. FDA pulled information from the company’s website stating that the five-gallon containers are delivered to homes in Honolulu; Orange County, Ventura and Santa Barbara, California; St. George, Utah; and Tucson, Arizona. The agency also states that Real Water is packaged and sold in various sizes including 1 gallon, 1 liter and 1.5 liter plastic bottles.
FDA is urging consumers, restaurants and retailers against drinking, cooking with, selling or serving the “Real Water” alkaline water until more information is revealed about the illnesses.
Since 2019 the FDA’s crosscutting work has implemented artificial intelligence (AI) as part of the its New Era of Smarter Food Safety initiative. This new application of available data sources can strengthen the agency’s public health mission with the goal using AI to improve capabilities to quickly and efficiently identify products that may pose a threat to public health by impeding their entry into the U.S. market.
On February 8 the FDA reported the initiation of their succeeding phase for AI activity with the Imported Seafood Pilot program. Running from February 1 through July 31, 2021, the pilot will allow FDA to study and evaluate the utility of AI in support of import targeting, ultimately assisting with the implementation of an AI model to target high-risk seafood products—a critical strategy, as the United States imports nearly 94% of its seafood, according to the FDA.
Where in the past, reliance on human intervention and/or trend analysis drove scrutiny of seafood shipments such as field exams, label exams or laboratory analysis of samples, with the use of AI technologies, FDA surveillance and regulatory efforts might be improved. The use of Artificial intelligence will allow for processing large amount of data at a faster rate and accuracy giving the capability for revamping FDA regulatory compliance and facilitate importers knowledge of compliance carrying through correct activity. FDA compliance officers would also get actionable insights faster, ensuring that operations can keep up with emerging compliance requirements.
Predictive Risk-based Evaluation for Dynamic Imports Compliance (PREDICT) is the current electronic tracking system that FDA uses to evaluate risk using a database screening system. It combs through every distribution line of imported food and ranks risk based on human inputs of historical data classifying foods as higher or lower risk. Higher-risk foods get more scrutiny at ports of entry. It is worth noting that AI is not intended to replace those noticeable PREDICT trends, but rather augment them. AI will be part of a wider toolset for regulators who want to figure out how and why certain trends happen so that they can make informed decisions.
AI’s focus in this regard is to strengthen food safety through the use of machine learning and identification of complex patterns in large data sets to order to detect and predict risk. AI combined with PREDICT has the potential to be the tool that expedites the clearance of lower risk seafood shipments, and identifies those that are higher risk.
The unleashing of data through this sophisticated mechanism can expedite sample collection, review and analysis with a focus on prevention and action-oriented information.
American consumers want safe food, whether it is domestically produced or imported from abroad. FDA needs to transform its computing and technology infrastructure to close the gap between rapid advances in product and process technology solutions to ensure that advances translate into meaningful results for these consumers.
There is a lot we humans can learn from data generated by machine learning and because of that learning curve, FDA is not expecting to see a reduction of FDA import enforcement action during the pilot program. Inputs will need to be adjusted, as well as performance and targets for violative seafood shipments, and the building of smart machines capable of performing tasks that typically require human interaction, optimizing workplans, planning and logistics will be prioritized.
In the future, AI will assist FDA in making regulatory decisions about which facilities must be inspected, what foods are most likely to make people sick, and other risk prioritization factors. As times and technologies change, FDA is changing with them, but its objective remains in protecting public health. There is much promise in AI, but developing a food safety algorithm takes time. FDA’s pilot program focusing on AI’s capabilities to strengthen the safety of U.S. seafood imports is a strong next step in predictive analytics in support of FDA’s New Era of Smarter Food Safety.
A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.
In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.
“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”
The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:
“Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
Focused compliance and enforcement activities, including inspections.
Providing guidance to industry on how to meet their obligations under current regulations.”
The agency will also continue its surveillance sampling assignment that focuses on these products.
This year’s Food Safety Consortium Virtual Conference Serieskicks off on Thursday, May 6 with a keynote presentation from Frank Yiannas, FDA deputy commissioner for food policy and response. This year we are extending the Q&A period with Yiannas to 30 minutes, and we are providing attendees the opportunity to bring their questions to the top of the list by filling out the below form. We had a lot of questions during last year’s FDA Town Hall, and we’d love to be able to get to more of them this year.
The Spring Program will run every Thursday in May, with each episode starting at 12 pm ET. The weekly episodes will tackle a range of critical topics in foods safety, including FSMA and traceability, food protection strategies, COVID-19’s lasting impact on the food industry by segment, audits and supply chain management.Registration is open now.
The Food Safety Consortium 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 sessions that are critical for advancing careers and organizations alike. Over the past 9 years the Food Safety Consortium has built a reputation for delivering the most knowledgeable and influential perspectives in food safety. The speaker line-up has driven key food safety decision-makers to the event (both in-person and virtually)—facilitating an environment for vendors, suppliers, food industry professionals, and consultants to network and build long-lasting business relationships.
Due to COVID-19, the 2020 Food Safety Consortium was converted to a virtual conference series that featured specific topics in a weekly episode series. The 2021 Food Safety Consortium Virtual Conference Series will feature a Spring and Fall program, running in May and October, respectively.
Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.
“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”
FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).
The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.
Phase one of the pilot looked at using machine learning to find violative seafood shipments. “The pilot program will help the agency not only gain valuable experience with new powerful AI-enabled technology but also add to the tools used to determine compliance with regulatory requirements and speed up detection of public health threats,” FDA stated in a news release. “Following completion of the pilot, FDA will communicate on our findings to promote transparency and facilitate dialogue on how new and emerging technologies can be harnessed to solve complex public health challenges.”
Last week a report released by Congress cited dangerous levels of toxic heavy metals in several brands of baby food. Back in November 2019, the Subcommittee on Economic and Consumer Policy asked for internal documents and test results from baby food manufacturers Nurture, Inc. (Happy Family Organics), Beech-Nut Nutrition Company, Hain Celestial Group, Inc., Gerber, Campbell Soup Company, Walmart, Inc., and Sprout Foods. According to the staff report, Nurture, Beech-Nut, Hain and Gerber responded to the requests, while Walmart, Campbell and Sprout Organic Foods did not.
The findings indicate that significant levels of arsenic, lead, cadmium and mercury were found in the baby foods of the four manufacturers who responded to the Subcommittee’s requests (Nurture, Beech-Nut, Hain and Gerber). It also stated the alarming point that, “Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”
The Subcommittee voiced “grave concerns” that the baby food made by Walmart, Sprout Organic Foods and Campbell was “obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products” due to their lack of cooperation.
In addition, the report states that the Trump administration “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods” in August 2019.
“To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report stated (infant rice cereal is the only baby food held to a stringent standard regarding the presence of inorganic arsenic).
As a result of the findings, the Subcommittee has made several recommendations:
FDA should require baby food manufacturers to test their finished products for toxic heavy metals.
FDA should require manufacturers to report toxic heavy metals on food labels.
Manufacturers should find substitutes for ingredients that are high in toxic heavy metals or phase out the ingredients that are high in toxic heavy metals.
FDA should set maximum levels of toxic heavy metals allowed in baby foods.
Parents should avoid baby foods that contain ingredients that test high in toxic heavy metals.
Today the FDA announced a new plan to collect samples of romaine lettuce as part of its ongoing surveillance after the spring 2018 multistate outbreak of E. coli O157:H7. The samples, which will be tested for Shiga toxin-producing Escherichia coli (STEC) and Salmonella, will be collected from commercial coolers in Yuma County, Arizona during the current harvest season.
FDA plans to collect and test about 500 samples (each of which will consist of 10 subsamples), beginning in February and continuing through the end of the harvest season. In order to reduce the time between sample collection and reporting results, an independent lab close to the collection sites in Arizona will be testing the samples. FDA expects to receive test results within 24 hours.
“Helping to ensure the safety of leafy greens continues to be a priority of the FDA. This assignment adds to other work underway in collaboration with stakeholders in the Yuma agricultural region to implement actions identified in the Leafy Greens Action Plan, including a multi-year study to assess the environmental factors that impact the presence of foodborne pathogens in this region. Consistent with the action plan, the agency will engage with industry on conducting root cause analyses for any positive samples found during this assignment. Root cause analyses are important in that they seek to identify potential sources and routes of contamination, inform what preventive measures are needed, and help prevent outbreaks of foodborne illness,” FDA stated in a release.
COVID-19 precautions will be taken during the sampling plan. Agency investigators will preannounce visits and wear PPE while conducting the work.
Over the past 9 years, the Food Safety Consortium Conference & Expo has built a reputation for delivering perspectives and insights from the most knowledgeable and influential experts in food safety. As a result of the COVID-19 pandemic, last year’s event was converted from an in-person event into a 14-week series of virtual themed-episodes during the fall. Continuing the momentum from 2020, the 2021 Food Safety Consortium Virtual Conference Series will take place as a four-week Spring and five-week Fall program. Both the Spring and Fall programs will feature critical thinking topics that are for industry veterans and knowledgeable newcomers.
“As you know, the online experience is very different than in-person, so last year we deconstructed our in-person program and re-engineered it for virtual. Instead of having a virtual conference for three straight days, we set up our program in short 2.5-hour themed episodes that ran every Thursday in the fall. We received great feedback from attendees, speakers and sponsors. I think we were one of the few conferences that successfully pulled off the pivot to virtual,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium.
Building on the strong success of the 2020 Food Safety Virtual Conference Series, the 2021 Consortium will be presented into two seasonal programs. “This will allow us to continue the conversation throughout the year, while also taking into consideration the busy lives of food safety professionals,” Biros adds.
Food Safety Tech is the media sponsor and will feature exclusive content from the event.
The Spring Program will run every Thursday in May, with each episode starting at 12 pm ET. The weekly episodes will tackle a range of critical topics in foods safety, including FSMA and traceability, food protection strategies, COVID-19’s lasting impact on the food industry by segment, audits and supply chain management. Frank Yiannas, FDA deputy commissioner for food policy and response, is the confirmed keynote speaker for Thursday, May 6.
The Fall Program will run every Thursday beginning on October 7 at 12 pm ET through November 4. Episode topics include food safety hazards (emerging threats and new technologies), food defense strategies, an FDA update, and personal development, training and mentorship.
Companies that are interested in sponsoring a 10-minute technical presentation during the series can contact Sales Director RJ Palermo for more details.
About Food Safety Tech
Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.
Since 2012, Food Safety Tech audiences have learned to respect and expect our high-quality content—via FoodSafetyTech.com, our weekly newsletter and by attending our educational programs. Food Safety Tech keeps professionals current with the latest information about technology, best practices and regulations, and how innovative solutions and approaches can be leveraged to further advance food safety across the globe.
About the Food Safety Consortium Conference
The Food Safety Consortium 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 sessions that are critical for advancing careers and organizations alike. Over the past 9 years the Food Safety Consortium has built a reputation for delivering the most knowledgeable and influential perspectives in food safety. The speaker line-up has driven key food safety decision-makers to the event (both in-person and virtually)—facilitating an environment for vendors, suppliers, food industry professionals, and consultants to network and build long-lasting business relationships.
Due to COVID-19, the 2020 Food Safety Consortium was converted to a virtual conference series that featured specific topics in a weekly episode series. The 2021 Food Safety Consortium Virtual Conference Series will feature a Spring and Fall program, running in May and October, respectively.
FDA has completed its investigation of the multistate outbreak of E. coli 0151:H7 that occurred last fall and was linked to leafy greens. The FDA and CDC found the outbreak was caused by an E. coli strain that was genetically related to the strain found in the fall 2019 outbreak involving romaine lettuce (Salinas, California). Despite conducting environmental sampling at dozens of ranches in the area, the FDA was unable to identify a single site as the source of the outbreak. However, the analysis did confirm “a positive match to the outbreak strain in a sample of cattle feces,” which was located uphill from where the leafy greens identified in the agency’s traceback investigation were grown, according to an FDA release.
Although the FDA’s investigation has ended, the agency will be reviewing the findings and release a report in the “near future” with recommendations. “In the meantime, as recommended in our Leafy Greens Action Plan, the FDA continues to recommend growers assess and mitigate risk associated with adjacent and nearby land use practices, particularly as it relates to the presence of livestock, which are a persistent reservoir of E. coli O157:H7 and other STEC,” FDA stated in the update.
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