Tag Archives: FDA

U.S. House of Representatives Seap

House Subcommittee Releases Report on Dangerous Levels of Toxic Heavy Metals in Baby Food

By Food Safety Tech Staff
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U.S. House of Representatives Seap

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.

The 59-page report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, is available on the U.S. House of Representatives’ website.

FDA

FDA to Test Yuma-Grown Romaine Lettuce for E. Coli and Salmonella

By Food Safety Tech Staff
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FDA

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.

2021 Food Safety Consortium

2021 Food Safety Consortium Virtual Conference Spring and Fall Series Announced

By Food Safety Tech Staff
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2021 Food Safety Consortium

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.

Read the Top 10 from the 2020 Food Safety Consortium Virtual Conference Series

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.

Registration for the 2021 Food Safety Consortium Spring and Fall Virtual Conference Series is open now.

TechTalk Sponsorship

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

FDA Issues Update on E. Coli Outbreak Involving Leafy Greens

By Food Safety Tech Staff
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FDA

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.

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“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.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. 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:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. 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.
  2. 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.
  3. 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.
  4. A written recall plan if a facility identified a Preventive Control.
  5. 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.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. 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.

FDA

In a Year of ‘Unprecedented Challenges’ FDA’s Food Program Achieved So Much

By Food Safety Tech Staff
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FDA

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.
  • Release of the New Era of Smarter Food Safety Blueprint
  • Release of the 2020 Leafy Greens STEC Action Plan with a focus on prevention, response and research gaps
  • Artificial Intelligence pilot program to strengthen the screening of imported foods
  • Proposed Food Traceability Rule issued in an effort to create more recordkeeping requirements for specific foods
  • 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
Susanne Kuehne, Decernis
Food Fraud Quick Bites

Many Bad Apples Spoil the Bunch

By Susanne Kuehne
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Susanne Kuehne, Decernis
Rotten apples
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.

Resource

  1. Vigdor, N. (November 10, 2020) “School Lunch Program Supplier Sold Juice With High Arsenic Levels, U.S. Says in Lawsuit”. The New York Times.

 

Recall

Q3 Food and Beverage FDA Recalls Up 34% Over Q2, USDA Recalls at Record Low

By Food Safety Tech Staff
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Recall

It is being speculated that the short-term decline in the number of food and beverage recalls this year is due to less regulatory oversight as a result of the COVID-19 pandemic. During Q3, FDA food recall activity was up 34% compared to last quarter, but this increase is actually a sign of things returning to normal on the side of regulatory oversight activities, according to the latest Q3 Recall Index from Stericycle.

FDA Food Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: 56 recalls, accounting for nearly 53% of all recalls; the top cause of an FDA food recalls for the 13th consecutive quarter
  • Bacterial contamination: Accounting for 62% of recalled units, this was the top cause of recalled units with Salmonella being the most common contaminant (the pathogen was responsible for 17 out of 24 recalls)
  • Foreign materials, quality and mislabeling were the other reasons for recalls

USDA Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: Top cause of recalls; 6 recalls accounted of nearly 70% of all recalled pounds
    • A single meat and poultry recall affected more than 242,000 pounds (63%) of all recalled pounds
  • The average recall affected 38,000 pounds
  • Over the last three quarters, recalls have been at record low levels
    • Quarterly recall activity is averaging 8.3 recalls a quarter versus an average quarterly volume of more than 30 recalls over the last five years
FDA

FDA’s New Outbreak Table an Effort Toward Earlier Transparency about Outbreaks

By Food Safety Tech Staff
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FDA

FDA has released an outbreak investigation table that aims to disseminate information about foodborne illness outbreaks right when the agency begins an investigation. The table, published by the FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, will be updated with important information before a public health advisory or food recall is issued.

“The outbreak investigation table is a demonstration of our continued commitment to more frequent and transparent communication with stakeholders and consumers about outbreaks we’re investigating,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency statement. “We have already taken steps to release information early, in some cases prior to a specific food being linked to an outbreak, including in our recent communications on investigations into three ongoing E. coli O157:H7 outbreaks.”

As of November 18, the table listed seven outbreak investigations, only one of which identified a product linked to illnesses. Yiannas pointed out that during the early stages of an investigation, there may not be any action that a consumer can take—however, the tool is in line with the New Era of Smarter Food Safety initiative, which commits to releasing outbreak information in the “earliest stages of an investigation”.

The FDA’s outbreak investigation table is available on the agency’s website.