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FDA Releases Updated Compliance Program for Infant Formula

By Food Safety Tech Staff
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The FDA has updated its infant formula compliance program for FDA investigators, laboratory analysts and compliance officers. The updates build on lessons learned over the last several years to elaborate on FDA’s approaches for inspections, sampling, laboratory analysis and imported infant formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities and instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the agency’s infant formula regulation.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.

Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, are also included in the updated compliance program.

Inspectors are directed to perform environmental sampling once a year at each domestic powder infant formula manufacturing facility during annual or compliance follow-up inspection for both Cronobacter and Salmonella analysis if there are no significant adverse supply-chain implications.

The Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination Team will prioritize the annual inspection schedule based on:

  • the facilities’ previous inspection results
  • number of consumer complaints since the last inspection
  • number of violative samples collected by FDA in the last twelve months
  • the previous environmental sampling results performed by FDA

Per the instructions, environmental sampling should focus on zone two sites near potential product exposure points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into drying system, filling lines, blending equipment, raw material handling equipment, etc.) including any areas indicating water accumulation. Additional sampling should also be done from zone three sites which may suggest a route of contamination (i.e., doorways, traffic routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites should not be swabbed as these zones can be hard to reach and may introduce contamination during swabbing of a closed system. Unless conditions observed indicate a possible route of contamination, FDA does not recommend swabbing zone four areas at a high frequency.

Inspectors are advised to collect between 100-300 environmental swabs for Cronobacter spp. and 100-300 environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility.

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FDA Releases New Draft Guidance Chapters on Food Allergens and Acidified Foods

By Food Safety Tech Staff
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The FDA has released two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and how to ensure that food products are properly labeled with respect to the major food allergens. It provides examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and provides options to consider in these scenarios, including the voluntary use of allergen advisory statements when appropriate.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers or cabbage that have an overall pH of 4.6 or below). It provides procedures, practices and processes to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Stakeholders can submit comments on the new chapters at Regulations.gov (Docket No. FDA-2016-D-2343). Comments should be submitted within 180 days of September 26, 2023, to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

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California Proposed Ban on Food Additives Moves to Governor

By Food Safety Tech Staff
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California Assembly bill AB 418, authored by Assemblymember Jesse Gabriel (D-Woodland Hills) and co-sponsored by Consumer Reports and the Environmental Working Group (EWG), has passed the state Senate and Assembly is now in the hands of Governor Gavin Newsom. If signed into law, the bill would ban the use of brominated vegetable oil, potassium bromate, propyl paraben and Red Dye No. 3 as additives in food and drink products sold in the state. The chemicals are currently banned in the European Union due to alleged links to serious health problems, including higher risk of cancer, harm to the reproductive system and hyperactivity.

“We are thrilled to move A.B. 418 to Gov. Newsom’s desk. This marks a major step forward in our effort to protect children and families in California from dangerous and toxic chemicals in our food supply,” said Gabriel, chair of the Assembly Committee on Privacy and Consumer Protection. “It’s unacceptable that the U.S. is so far behind the rest of the world when it comes to banning these dangerous additives.

The bill, if signed by Gov. Newsom, will go into effect on January 1, 2027. Violators would face a civil penalty not to exceed $5,000 for a first violation, and not to exceed $10,000 for each subsequent violation.

Some have expressed concern that passage of the bill would create a patchwork of regulations in the country. In an Opinion article, Frank Yiannas, former FDA Deputy Commissioner of Food Policy and Response, urged Newsom to think carefully about the ban, noting that three of the five original ingredients targeted by the California ban are currently under review by FDA. “In the case of brominated vegetable oil (BVO), the FDA has already initiated steps to remove BVO from the U.S. food supply, thereby making the California action unnecessary,” he argued, adding that “a state-by-state patchwork of different, emerging regulatory standards that would weaken our nation’s food system and food safety efforts. Our nation is better when each state can help feed the rest of the states with a uniform standard of safe, available food.”

 

 

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USDA FSIS Implements Quantitative Chemical Residue Testing Method

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Services (FSIS) has developed a new method to quantify chemical residues using beef muscle samples and modern chemistry instrumentation. The agency’s laboratory system plans to implement the new quantitative method for veterinary drug residue analysis in bovine muscle samples on October 1, 2023. The method, “Quantitation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS)” (CLG-MRQ1), has the ability to:

  • Quantitate multiple veterinary drug residue amounts simultaneously in a single analysis with high mass accuracy.
  • Quantitate several veterinary drugs that were previously difficult to measure.
  • Archive several single analyte or specific drug class quantitation methods that use older technology.
  • Archive traditional residue bioassay for several analytes.
  • Align detection limits with established drug residue tolerances.
  • Decrease time to result for presumptive positive residues.

In addition to this change, FSIS has recently updated three methods that will be posted to the new Chemical Laboratory Guidebook no late than September 30, 2023. They include: Quantitation of Salt (CLG-SLT); Quantitation of Fat (CLG-FAT); and Screening, Quantitation, and Confirmation of Beta-Agonists by UHPLC-MS-MS (CLG-AGON1).

 

Alfonso Capuchino

GFSI Specialist Capuchino Joins Kiwa-ASI

By Food Safety Tech Staff
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Alfonso Capuchino

Alfonso Capuchino, a food industry certification professional with more than 20 years’ experience, is joining the Kiwa Group as Global Technical Director for Food, Feed and Farm, and ASI, a member of the Kiwa Group, as Vice President of Certification. Capuchino specializes in management systems, HACCP, third-party auditing and GFSI certification, and has experience in developing multi-standard services. He is a certified instructor and auditor for GFSI standards in the scope of food handling, packaging, storage and distribution, and brokering.

“Alfonso’s background in GFSI benchmark standards will provide great value in increasing our already strong presence working with standards like BRC, FSSC, SQF, GlobalGAP, PrimusGFS, IFS, etc. We are happy to welcome him to the global team with open arms,” said Richard Stolk, President of the Board of Directors at ASI, and Global Business Sector Director of Food Feed Farm at Kiwa Group.

“We are excited to have Alfonso on board as a part of our growing Kiwa-ASI family. His vast industry knowledge and experience will be crucial as we work to continuously improve and expand our existing certification programs,” said Tyler Williams, CEO of ASI.

For more than 30 years, Capuchino has served multiple industries in various roles, including consulting, auditing and directing teams in quality, food safety, environmental safety, occupational safety and sustainability. He earned an industrial engineering degree from the Technological Institute of Tlalnepantla in Mexico City. Before joining the Kiwa Group, Capuchino was the Vice President of Certification Services at AIB International.

 

 

Frank Yiannas, Walmart

Frank Yiannas Joins iFoodDS Board of Directors

By Food Safety Tech Staff
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Frank Yiannas, Walmart

Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the FDA, has joined the iFoodDS Board of Directors. iFoodDS is a provider of connected traceability, quality and food safety solutions. Yiannas will advise the company on strategy.

During his time at the FDA, Yiannas was responsible for a broad range of priorities, including implementing the Food Traceability Rule under the Food Safety Modernization Act (FSMA). Prior to joining the FDA, he spent more than 30 years in food safety leadership roles with Walmart and the Walt Disney Company.

Yiannas has long been a champion of supply chain innovation and technology, making technology-enabled food traceability in the global supply chain a priority in the FDA’s New Era of Smarter Food Safety initiative.

“Frank is a visionary in the food supply chain, using his insight, knowledge and passion for innovation to enhance food safety and safeguard public health,” said Scott Mathews, CEO of iFoodDS. “We are excited to welcome him to the iFoodDS board of directors. His insights will be invaluable as we pursue our vision of a connected food value chain, enabling better collaboration between trading partners and providing insights on product safety, quality and freshness, ultimately reducing food waste and benefiting food companies and consumers alike.”

“I believe that technology will transform the food supply chain, making it safer for consumers, optimizing it, and creating shared value for all supply chain participants,” said Yiannas. “I’m excited to join the iFoodDS board of directors, and to be part of a company that has the food industry expertise, solution capabilities, and vision to not only help companies comply with FSMA 204 regulation, but to help them ensure continued business success by enabling a safer, more predictable food supply and transparency that protects brands and consumers.”

 

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FSIS Launches New Recall and Public Health Alert API Data Tool

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Service (FSIS) has launched a new feature on its website that enables software developers to access data on recalls and public health alerts through an application programming interface (API), allowing the public to access critical and timely public health information.

Currently, FSIS issues recall communications to alert consumers of potential food safety issues related to FSIS-regulated products. The API will act as a bridge, allowing software developers to leverage FSIS recall data to create new products for consumers or incorporate them into existing digital services and mobile apps. The agency’s recall and public health alert information continues to be publicly available through the FSIS website, Twitter, FoodSafety.gov, an RSS feed, and annual recall data summaries.

“Transparency, innovation, and collaboration are essential to public health,” said USDA Under Secretary for Food Safety Dr. Emilio Esteban. “By opening critical data through public APIs, third-party software developers will be able to expand the reach of our information among American consumers far beyond what FSIS could do on its own.”

Since January 2020, FSIS has migrated several applications from on-premises legacy software to cloud systems, including the FSIS public website in 2021. The cloud-based infrastructure for the website laid the foundation to build out the recall API. In addition to recall data, FSIS is working on APIs for other critical datasets.

For more information on how to use the FSIS’ recall API and other developer resources, visit the API webpage.

 

Apple Juice

Newly Discovered Fungus Helps Destroy Patulin Mycotoxin 

By Food Safety Tech Staff
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Patulin is a harmful mycotoxin produced by fungi typically found in damaged fruits, including apples, pears and grapes. Recently, researchers from Japan identified a new filamentous fungal strain that can degrade patulin by transforming it into less toxic substances, which may lead to new ways of controlling patulin toxicity in food supplies.

Patulin is produced by several types of fungi, and is toxic to humans, mammals, plants and microorganisms. Symptoms of exposure include nausea, lung congestion, ulcers, intestinal hemorrhages, and even more serious outcomes, such as DNA damage, immunosuppression, and increased cancer risk. Environments lacking proper hygienic measures during food production are more susceptible to patulin contamination as many of these fungi species tend to grow on damaged or decaying fruits, specifically apples, and can contaminate apple products, such as apple sauce, apple juice, jams and ciders.

In the recent study, the research team from Tokyo University of Science (TUS) in Japan, screened soil for microorganisms that can potentially help keep patulin toxicity in check. The team cultured microorganisms from 510 soil samples in a patulin-rich environment, looking for those that would thrive in presence of the toxin. Next, in a second screening experiment, they used high-performance liquid chromatography (HPLC) to determine the survivors that were most effective in degrading patulin into other less harmful chemical substances. They identified a filamentous fungal (mold) strain, Acremonium sp. or “TUS-MM1,” belonging to the genera Acremonium, that fit the bill.

Patulin graphic
The mold TUS-MM1 can degrade the patulin mycotoxin.

The team then performed various experiments to shed light on the mechanisms by which TUS-MM1 degraded patulin. This involved incubating the mold strain in a patulin-rich solution and focusing on the substances that gradually appeared both inside and outside its cells in response to patulin over time.

One important finding was that TUS-MM1 cells transformed any absorbed patulin into desoxypatulinic acid, a compound much less toxic than patulin, by adding hydrogen atoms to it. Moreover, the team found that some of the compounds secreted by TUS-MM1 cells can also transform patulin into other molecules. By mixing patulin with the extracellular secretions of TUS-MM1 cells and using HPLC, they observed various degradation products generated from patulin. Experiments on E. coli bacterium cells revealed that these products are significantly less toxic than patulin itself. Through further chemical analyses, the team showed that the main agent responsible for patulin transformation outside the cells was a thermally stable but highly reactive compound with a low molecular weight.

“Elucidating the pathways via which microorganisms can degrade patulin would be helpful not only for increasing our understanding of the underlying mechanisms in nature but also for facilitating the application of these organisms in biocontrol efforts,” said Dr. Toshiki Furuya, Associate Professor at the Faculty of Science and Technology of the Department of Applied Biological Science at TUS and co-author of the study.

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Federal Food Safety Analytics Collaborative Releases 2024-2028 Priorities

By Food Safety Tech Staff
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The Interagency Food Safety Analytics Collaboration (IFSAC)—a collaboration between the Centers for Disease Control and Prevention (CDC), the FDA and the USDA Food Safety and Inspection Service (FSIS)—has published its upcoming priorities for calendar years 2024 – 2028.

IFSAC was established in 2011 to improve coordination of federal food safety analytics efforts and address cross-cutting priorities for food safety data collection, analysis and use. The collaborative’s focus is foodborne illness source attribution, with an emphasis on four priority pathogens: Campylobacter, E. coli O157, Listeria monocytogenes, and Salmonella.

In addition to its continued work generating and publishing annual estimates of foods contributing to foodborne illness, the following four priorities will guide IFSAC’s work for the next five years:

Priority 1. Improve foodborne illness source attribution estimates for Campylobacter by exploring additional data sources and alternative methods to better estimate the sources of foodborne illnesses caused by Campylobacter and harmonize estimates across different approaches and data sources.

Priority 2. Develop foodborne illness source attribution estimates for non-O157 Shiga toxin-producing Escherichia coli (STEC). IFSAC will be adding STEC to its list of priority pathogens and provide source attribution estimates in its annual Foodborne Illness Source Attribution reports.

Priority 3. Refine foodborne illness source attribution estimates using data from non-foodborne sources of pathogens. Although the priority pathogens included in IFSAC’s analyses are spread predominantly through foodborne transmission, these pathogens also spread through contact with water, human, animal, and environmental sources. To generate more accurate estimates for foodborne illness source attribution, IFSAC analysts will explore available data for non-foodborne sources of the priority pathogens and consider methods to incorporate this information in communications.

Priority 4. Finalize existing analyses and disseminate findings to multiple audiences. IFSAC plans to review the status of all projects, determine which are close to completion, and identify which should be finalized and by when. During the final stages of each project, IFSAC will implement appropriate communication vehicles for each project, such as peer-reviewed publications, public reports, webinars, conference presentations or updates to the IFSAC website to disseminate findings to the appropriate audiences.

 

STOP Foodborne Illness

FDA and Stop Foodborne Illness to Co-Host Webinar on Facing Food Safety Challenges

By Food Safety Tech Staff
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The FDA and Stop Foodborne Illness are hosting the eighth webinar in the ongoing series of webinars exploring food safety culture on September 13, 2023, from 12pm to 1:00pm ET. “Facing Food Safety Challenges through Culture and Persistence” will focus on the importance of a strong food safety culture and how it can help organizations address food safety challenges they may face.

Guest speakers include:

  • Kerry Bridges, Vice President of Food Safety, Chipotle Mexican Grill
  • Al Almanza, Global Head of Food Safety and Quality Assurance, JBS Foods
  • Lone Jespersen, Principal and Founder, Cultivate SA
  • Conrad Choiniere, PhD, Director, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, FDA

Those interested in attending the free webinar can register here.

To learn more about the webinar series and listen to recordings of past webinars, visit Collaborating on Culture in the New Era of Smarter Food Safety.