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.
“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.
One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.
Assemble a HACCP team
Describe the finished product
Define intended use and consumer
Create process and flow diagram
Verify process and flow diagrams
This is followed by the seven principles of HACCP.
Conduct the hazard analysis
Identify critical control points
Establish critical limits
Establish monitoring requirements
Establish corrective actions for deviations
Procedures for verification of the HACCP plan
Record keeping documenting the HACCP system
HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.
When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.
HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.
Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.
For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.
Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:
Assemble a food safety team
Describe the product and its distribution
Describe the intended use and consumers of the food
Develop a flow diagram and describe the process
Verify the flow diagram on-site
Their recommended plan also requires a number of additional steps, including:
A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
A written recall plan if a facility identified a Preventive Control.
Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.
While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.
Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.
“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”
Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne
Food fraud can have a substantial impact on a consumer’s health, like in this case of fruit juice that was sold (including to school lunch programs) in spite of contamination with arsenic and mycotoxins. The fruit used for the juice was decomposing, and also processed in a facility that unacceptably violated hygiene and food safety standards. The FDA filed a lawsuit against the company, which in the meantime has ceased operations.
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