Recall

Multi-State Listeria Outbreak Linked to Peaches, Plums and Nectarines

By Food Safety Tech Staff
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Recall

The FDA has identified peaches, plums and nectarines as the likely source of a multistate outbreak of Listeria monocytogenes, leading to a voluntary recall by HMC Farms.

The FDA and CDC, in collaboration with state and local partners, have been investigating the outbreak as new matching cases have been identified over the past several years. To date, there have been 11 reported illnesses, 10 hospitalizations and one death associated with the outbreak, spanning seven states (CA, CO, FL, IL, KS, MI, OH). Samples from sick people were collected from August 22, 2018, to August 16, 2023. According to a case-case analysis conducted by CDC, people in this outbreak were 18 times more likely to eat peaches, plums, or nectarines. This suggests that peaches, plums, and nectarines, are a likely source of this outbreak.  On October 23, 2023, FDA collected samples of 2lb bagged peaches at The HMC Group Cold Storage in Kingsburg, California, and on November 7, 2023, the samples were reported positive and a match to the outbreak strain by Whole Genome Sequencing.

In response to this investigation, HMC Farms has voluntarily recalled peaches, plums, and nectarines sold in retail stores from May 1, 2022, through November 15, 2022, and from May 1, 2023, through November 15, 2023. The recalled fruit was sold at retail stores as individual pieces of fruit bearing PLU stickers or in consumer packaging; however, the recalled fruit is no longer available for sale and any previously purchased fruit should be past shelf life. The recalled products may still be in consumer’s freezers; the FDA is directing anyone who previously purchased the recalled fresh peaches, plums and nectarines and then froze them, to throw them away.

 

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FDA Updates Online Module for Food Ingredient and Packaging Materials Submissions

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The FDA has updated the CFSAN Online Submission Module (COSM) to improve communication for industry who send regulatory submissions to FDA’s Office of Food Additive Safety (OFAS). The update to COSM introduces three new features:

  1. Users can submit documents directly to the OFAS via COSM, eliminating the need to use the FDA’s Electronic Submission Gateway (ESG)
  2. COSM allows for secure communication between the FDA and users for submissions and amendments to submissions created in COSM
  3. Dynamic user dashboard displays the status of the submissions.

Submitters use the same link to log into COSM as they have in the past and follow the same step-by-step process to assemble their submissions following the established question-and-answer form. The form then guides users through developing and organizing the documents in the appropriate order for submission directly to OFAS. Information on how to register, use COSM and send submissions is provided in the help guides on the COSM webpage.

FDA communication with submitters through COSM is available for the following OFAS submission types:

  • Biotechnology Notification File (BNF)
  • Color Additive Petition (CAP)
  • Food Additive Petition (FAP)
  • Food Contact Notification (FCN)
  • Generally Recognized as Safe Notice (GRN)
  • New Protein Consultation (NPC)
  • Pre-Notification Consultation (PNC) for a food contact substance

 

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Call For Abstracts: 2024 Food Safety Consortium

By Food Safety Tech Staff
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Share your expertise, experience and/or research with fellow food safety and quality assurance professionals at the 2024 Food Safety Consortium, taking place on October 20-22, 2024, at the Crystal Gateway Marriott, near downtown Washington, DC.

We are seeking abstracts for educational presentations, panel discussions and Posters in the following categories:

Food Safety Hazards – Detection, Mitigation, Control, Regulations

Food Safety Culture – Best Practices and Techniques to advance a positive Food Safety Culture

Food Safety Supply Chain Management – Audits, Record Keeping, Logistics, etc.

Food Integrity – Food Fraud, Economically Motivated Adulteration, etc.

Food Defense – Strategies, Best Practices and Regulations

Compliance – Regulatory, FSMA, Standards, GFSI, etc.

Abstracts are due by December 15, 2023, and will be judged based on educational value. Poster submissions are due by June 30, 2024.

Submit abstracts here.

Presented by Food Safety Tech, the Food Safety Consortium is a business-to-business conference that brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry today.

For sponsorship and exhibitor inquiries, contact RJ Palermo, Director of Sales. Stay tuned for registration and early bird specials.

If you missed this fall’s Food Safety Consortium, don’t miss the latest episode of the “Don’t Eat Poop” podcast featuring Food Safety Consortium founder and Food Safety Tech publisher, Rick Biros, as he discusses the conference’s history and role in improving food safety, with hosts Francine Shaw and Matt Regusci.

 

 

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FDA Moves to Revoke Use of Brominated Vegetable Oil in Food

By Food Safety Tech Staff
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On the heels of a new California law banning the use of brominated vegetable oil (BVO), potassium bromate, propyl paraben and Red Dye No. 3 as food additives, the FDA has announced its proposal to revoke the regulation authorizing the use of BVO in food. Food companies are currently allowed to use BVO, a vegetable oil that is modified with bromine, in small amounts to keep the citrus flavoring from floating to the top in some beverages.

The FDA announced that it is issuing the proposed rule now because the agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. “Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe,” the agency stated in its announcement. The studies, which were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology, showed bioaccumulation of bromine and toxic effects on the thyroid gland.

The FDA has regulated BVO as a food additive since the agency removed it from the codified list of Generally Recognized As Safe or “GRAS” substances in 1970. “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state,” the FDA wrote. “The agency is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law. In fact, the FDA is currently reviewing the color additive regulations authorizing the use of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which, in relevant part, prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested. A decision from the FDA is forthcoming.”

The agency also noted that one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance FDA’s review of food chemical safety. The proposed HFP would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation with the goal of developing a faster and more nimble process for evaluating chemicals in the food supply.

Comments about the proposed BVO rule should be submitted by January 17, 2024, using docket number FDA-2023-N-0937.

 

 

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USDA Appoints New Members to Food Safety Advisory Committee

By Food Safety Tech Staff
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The USDA has appointed 21 new members and nine returning members to the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). The purpose of the committee is to provide impartial scientific advice and recommendations to federal food safety agencies. Members of the committee are chosen based on their expertise in microbiology, risk assessment, epidemiology, public health, food science and other relevant disciplines. One individual affiliated with a consumer group is included in the membership of the committee and five members are federal government employees representing the five federal agencies involved in NACMCF—USDA FSIS, FDA, CDC, the Department of Commerce National Marine Fisheries Service, and the Department of Defense Veterinary Services.

“NACMCF members bring a wealth of expertise and dedication to the critical mission of ensuring the safety of our nation’s meat and poultry products,” said Agriculture Secretary Tom Vilsack. “Their contributions will help us continue to strengthen our nation’s food supply and protect the health and well-being of American consumers.”

The newly appointed NACMCF members, who will serve two-year terms are:

  • Dr. Bledar Bisha. University of Wyoming, Laramie, Wyoming
  • Dr. Heather Carleton. Centers for Disease Control and Prevention, Atlanta, Georgia
  • Dr. Anna Carlson. Cargill Protein, Wichita, Kansas
  • Dr. Hayriye Cetin-Karaca. Smithfield Foods, Springdale, Ohio
  • Dr. Ben Chapman. North Carolina State University, Raleigh, North Carolina
  • Dr. Vik Dutta. bioMérieux, Chicago, Illinois
  • Dr. Larry Figgs. Douglas County Health Dept., Omaha, Nebraska
  • Dr. David Goldman. Groundswell Strategy, Arlington, Virginia
  • Dr. Michael Hansen. Consumer Reports, Yonkers, New York
  • Dr. Arie Havelaar. University of Florida, Gainesville, Florida
  • Dr. Ramin Khaksar. Clear Labs, San Carlos, California
  • Lieutenant Colonel Noel Kubat. Department of Defense, U.S. Army Veterinary Corps, Fort Knox, Kentucky
  • Dr. KatieRose McCullough. North American Meat Institute, Washington, D.C.
  • Dr. Indaue Giriboni de Mello. Newman’s Own, Westport, Connecticut
  • Dr. Eric Moorman. Butterball, LLC, Garner, North Carolina
  • Dr. Abani Pradhan. University of Maryland, College Park, Maryland
  • Mr. Shivrajsinh Rana. Reckitt, Parsippany, New Jersey
  • Dr. Marcos Sanchez Plata. Texas Tech University, Lubbock, Texas
  • Dr. Kristin Schill. University of Wisconsin – Madison, Madison, Wisconsin
  • Dr. Nikki Shariat. University of Georgia, Athens, Georgia
  • Dr. Abigail Snyder. Cornell University, Ithaca, New York

The returning NACMCF members are:

  • Dr. Yaohua (Betty) Feng. Purdue University, West Lafayette, Indiana
  • Ms. Janell Kause. U.S. Department of Agriculture, Food Safety and Inspection Service, Washington, D.C.
  • Dr. Elisabetta Lambertini. Global Alliance for Improved Nutrition, Washington, D.C.
  • Ms. Shannara Lynn. U.S. Department of Commerce, National Seafood Inspection Laboratory, Pascagoula, Mississippi
  • Dr. Maxim Teplitski. International Fresh Produce Association, Washington, D.C.
  • Dr. Bing Wang. University of Nebraska – Lincoln, Lincoln, Nebraska
  • Dr. Benjamin Warren. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland
  • Dr. Randy Worobo. Cornell University, Ithaca, New York
  • Dr. Teshome Yehualaeshet. Tuskegee University, Tuskegee, Alabama

NACMCF will hold a virtual public meeting of the full committee and subcommittees from November 14, 2023, to November 16, 2023. In addition to welcoming the new members, the committee will introduce a new charge from FSIS on genomic characterization of pathogens and continue working on the response to the FDA’s charge on Cronobacter spp. in Powdered Infant Formula. Register here to attend the meeting.

 

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Highlights from the 2023 Food Safety Consortium

By Food Safety Tech Staff
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Last week, hundreds of food safety professionals, members of the FDA and USDA, and leaders in academia, food safety testing and cybersecurity met in Parsippany, New Jersey, for the 2023 Food Safety Consortium.

Keynote speaker Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS, and Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, opened the Consortium to discuss their agencies’ priorities for 2024 and took part in a town hall Q&A with attendees.

Eskin and Mettler
Sandra Eskin and Erik Mettler

In April, the USDA FSIS declared salmonella an adulterant in raw breaded chicken products. The agency is now reviewing comments and finalizing a framework for other poultry products and examining how to substantiate claims, such as “Pasture Raised,” “Grass Fed” and “Raised without Antibiotics.” Cell-cultured meat is another key focus for FSIS, and it is requiring labeling of “Cell Cultivated” on the packaging of these products.

Mettler discussed the “mass reorganization” of the FDA that is currently underway following the 2022 Reagan Udall report, noting that Jim Jones, the new Deputy Commissioner for Human Foods will have full control of policy and resources of the Human Foods program. A key focus will be risk management prioritization. Expect to see full reorganization in late summer or early fall of 2024.

Reorganization of the FDA’s Human Foods program was a hot topic that was also discussed in depth during Modernizing the U.S. Food Safety System with panelists Stephen Ostroff, former FDA commission, Barbara Kowalcyk, faculty at Georgetown University, and Bill Marler, food safety attorney with Marler Clark.

Session Highlights

This year, attendees had the opportunity to take part in full-day pre-conference workshops, including Food Safety Auditor Training with Trish Wester, president of the Association for Food Safety Auditing Professionals, and the Food Safety Culture Design Workshop with Gina Nicholson Kramer, Associate Director of Partnerships, Policy, & Learning at The Ohio State University, and Richard Fleming and Austin Welch of Sage Media.

Sessions during the two-day Consortium covered everything from data analytics to risk mitigation, grassroots food safety culture and recall trends.

Steven Gendel
Steven Gendel

Attendees were able to take part in a Panel Discussion with the Producer and Food Safety Experts Behind “Poisoned: The Dirty Truth About Your Food” Documentary with producer Kristin Lazure and featured members of the film, including Dr. Darin Detwiler, CEO of Detwiler Consulting Group, and professor at Northeastern University, attorney Bill Marler, and Brian Ronholm, director of food policy at Consumer Reports.

Steven Gendel spoke on regulatory guidance, thresholds and best practices for Allergen Advisory Labeling, followed by Tracie Sheehan of Mérieux Nutrisciences who presented Protecting Allergic Consumers through Audited and Validated Allergen Control Plans.

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Food Safety and Cybersecurity panel discussion

Two sessions highlighted the growing threat of cyber attacks. Attendees gained valuable insights from Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security, in Re-Imagining Food Protection as a National Security Issue – DHS Perspective, and Scott Algeier of the Food-Ag ISAC, who led a panel discussion on Food Safety and Cybersecurity.

“We’d like to thank all of our attendees, speakers and sponsors for helping make this year’s Food Safety Consortium a success. Through discussion, sharing of knowledge and building industry connections, the food industry will be better prepared to tackle the biggest challenges facing food safety, ensuring a safer and more resilient food supply for consumers,” said Rick Biros, founder and program director of the Consortium and publisher of Food Safety Tech. “We look forward to welcoming everyone to next year’s program in Washington, DC.”

Save the Date: The 2024 Food Safety Consortium will take place October 20-22 in Washington, DC. The call for abstracts is now open.

Reception at 2023 Consortium

About the Food Safety Consortium: ​Organized by Food Safety Tech, the Food Safety Consortium Conference, launched in 2012, is an educational and networking event that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology, best practices and compliance, the “Consortium” features critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers.

 

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Nature’s Touch Acquires Sunrise Growers Frozen Fruit Operations

Nature's Touch Acquisition Logo image

Nature’s Touch has acquired the frozen fruit operations of SunOpta Inc., a subsidiary of Sunrise Growers. Nature’s Touch, founded in 2004, is a leading retail supplier of frozen organic and conventional fruits worldwide. The company operates freezing and packaging facilities in both Canada and the U.S. and recently invested in a new facility in Virginia. Sunrise Growers frozen fruit operations are located in Edwardsville, Kansas, and Jacona, Mexico.

In a release announcing the acquisition, Nature’s Touch stated that the acquisition will help create value for consumers through synergies in scale, product diversity, innovation, geographic reach and growth prospects. “This acquisition is more than just a business transaction—it marks a deliberate step towards a future that is more integrated, innovative and impactful. By welcoming the Sunrise Growers’ frozen fruit operations into our family, we are bolstering our unwavering commitment to offering unparalleled value to our customers and stakeholders,” said John Tentomas, CEO of Nature’s Touch. “This acquisition puts us in the unique position of providing North American consumers with the most expansive network of freezing and distribution on the continent. Together, our combined strengths will propel us to new heights, quicker and with renewed vigor.”

CA State flag

With Newsom’s Signature, California Bans Four Food Additives

By Food Safety Tech Staff
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CA State flag

On October 7, California Governor Gavin Newsom signed California Assembly bill AB 418 into law. The bill, which was authored by Assemblymember Jesse Gabriel (D-Woodland Hills) and co-sponsored by Consumer Reports and the Environmental Working Group (EWG) bans 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.

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

In a statement following the signing of the bill, Governor Newsom acknowledged concerns relates to the state’s actions as well as his reasons for supporting the legislation, stating:

“Californians trust that the food products they consume are safe. I appreciate the author and stakeholders for working on amendments, which advance our shared public health objectives while maintaining consumer choice. The additives addressed in this bill are already banned in various other countries.

Signing this into law is a positive step forward on these four food additives until the United States Food and Drug Administration (FDA) reviews and establishes national updated safety levels for these additives.

There have been many misconceptions about this bill and its impacts. For example, attached to this message is a bag of the popular candy “Skittles,” which became the face of this proposal. This particular bag of candy comes from the European Union – a place that already bans a number of chemical additives and colorants. This is demonstrable proof that the food industry is capable of maintaining product lines while complying with different public health laws, country-to-country.

Further, this bill’s implementation is delayed until 2027 – significant time for brands to revise their recipes to avoid these harmful chemicals. Californians will still be able to access and enjoy their favorite food products, with greater confidence in the safety of such products.”

 

 

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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.