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FDA Withdraws Guidance on Enforcement of Human Food with Chlorpyrifos Residues

By Food Safety Tech Staff
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The FDA is withdrawing a 2022 guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry, following a decision by the U.S. Court of Appeals for the Eighth Circuit to vacate, or void, an Environmental Protection Agency (EPA) final rule that revoked all tolerances for the pesticide chemical chlorpyrifos.

In April 2021, the U.S. Court of Appeals for the Ninth Circuit ordered EPA to issue a final rule either revoking all chlorpyrifos tolerances or modifying the chlorpyrifos tolerances, provided EPA could make a determination that those modified tolerances met the safety standard mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA). As a result of the short timeframe, EPA found that, based on the available data and anticipated exposure from registered uses of chlorpyrifos, it could not determine that there was a reasonable certainty of no harm from aggregate exposure, including food, drinking water and residential exposure. Consequently, on August 30, 2021 EPA issued a final rule amending 40 CFR 180.342 to revoke all tolerances for residues of chlorpyrifos.

Gharda Chemicals and several grower groups challenged EPA’s revocation of the tolerances in the U.S. Court of Appeals for the Eighth Circuit. On November 2, 2023, the Eighth Circuit issued its decision, vacating EPA’s final rule and remanding the matter to EPA for further proceedings. As a result of this ruling, EPA issued the final rule to reinstate previous tolerances for chlorpyrifos; 40 CFR 180.342 reflects the current legal status of the tolerances for chlorpyrifos. The FDA guidance was intended to explain the agency’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired, per the 2021 final rule, which is now void.

 

 

 

 

 

 

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FDA Releases Foods Program Priorities

By Food Safety Tech Staff
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The FDA has launched a new webpage listing food-related regulations that it plans to publish by October 2024 as well as longer-term regulations it is prioritizing for publication at a later date. The list includes 22 Foods Program regulations ranging from Certifications Concerning Imported Foods to Nutrient Content Claims and Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation.

The three long-term action items relate to color and food additives.

The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024 to include five new guidances. They include:

  • Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
  • Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
  • The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
  • Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry

Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.

 

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TraceGains Acquires NutriCalc

By Food Safety Tech Staff
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TraceGains, a developer and provider of compliance and networked product development software, has acquired NutriCalc, a developer of product labeling and nutrition calculation software that helps professional food businesses reach their recipe nutrition targets and allergen labeling requirements.

“Since developing NutriCalc 30 years ago, it has become the industry standard in nutrition labeling across the globe at companies both large and small. Our acquisition by TraceGains fuels the development of future innovations to the product and provides an immediate benefit to customers today by linking them to a robust ingredient marketplace and streamlining their processes. The combination of these products is powerful,” said Dr. David Bartley, Founder of NutriCalc.

With this acquisition, TraceGains inherits NutriCalc’s technology and wealth of nutritional information. In turn, NutriCalc will have access to TraceGains’ network of more than 70,000 supplier locations and a database of more than 500,000 searchable ingredients and items.

Greg Heartman, VP of Product Management at TraceGains, stressed the significance of integrating NutriCalc into the TraceGains networked ecosystem. “This move enriches TraceGains’ offerings in the Food and Beverage sector, focusing on simplifying and automating processes, integrating AI solutions and enabling manufacturers and suppliers to leverage digital transformation,” he said.

“We’re excited about this acquisition because it offers a unique opportunity to drive industry advancement by merging top-tier nutritional calculation, reporting and labeling solutions with TraceGains’ established compliance and product development leadership,” said Gary Nowacki, CEO of TraceGains.

 

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USDA Launches Remote Beef Grading Pilot Program

By Food Safety Tech Staff
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On January 19, Agriculture Secretary Tom Vilsack announced a pilot program to allow more cattle producers and meat processors to access better markets through the U.S. Department of Agriculture’s (USDA) official beef quality grading and certification. The Remote Grading Pilot for Beef, developed by USDA’s Agricultural Marketing Service (AMS), matches simple technology with data management and program oversight to allow a USDA grader to assess beef carcass characteristics and assign the official quality grade from a remote location, reducing costs and location as barriers to participation in voluntary grading services.

The pilot program is part of USDA’s comprehensive approach to increase competition in agricultural markets, create a fairer playing field for small- and mid-size farmers and ranchers, and provide producers more options to market their products.

“On average, a beef carcass that grades as USDA Prime is valued at hundreds of dollars more than an ungraded carcass, but costs for this voluntary USDA service often prevents smaller scale processors and the farmers and ranchers they serve from using this valuable marketing tool,” said Secretary Vilsack. “This remote grading pilot opens the door for additional packers and processors to receive grading and certification services allowing them to access new, better, and more diverse marketing opportunities.”

While more than 90% of America’s fed beef supply is officially graded by USDA, most users are large beef packing operations. USDA’s meat grading and certification services are significantly underutilized by small, independent processors, in large part due to the expense of paying for a highly trained USDA grader to travel to their facility to perform service in-person for a relatively small number of cattle that may not require a full day of the graders’ work. Experience with remote grading so far has shown it dramatically reduces travel-related expenses, which makes the service more accessible to smaller processors.

In this pilot, trained plant employees capture specific images of the live animal and beef carcass. These images are submitted electronically to a USDA grader already stationed elsewhere in the U.S., who reviews the images and accompanying plant records and product data, assigns the USDA Quality Grade and applicable carcass certification programs, and communicates the official grade back to the plant to be applied to the carcass. Plants can then use this information in their retail marketing and transmit carcass performance information back to producers.

The pilot will build on lessons-learned during AMS’ feasibility study of a “remote grading” process conducted during the second half of 2023. AMS will expand its testing by engaging a larger and more diverse number of beef packers to participate in the development of this procedure. Through the pilot, AMS will gather additional information on actual cost and the level of in-person surveillance needed to ensure program consistency and integrity to formalize this service option as part of the USDA Quality Grading Service.

The Remote Grading Pilot for Beef is limited to domestic beef slaughter facilities operating under federal inspection and producing product that meets the eligibility criteria for the USDA grading program.

For more information about the Remote Grading Pilot for Beef, visit www.ams.usda.gov/remote-beef-grading. The USDA will host a webinar this Thursday, January 25 at 3:00 pm Eastern Time to provide additional information about the program. To register, visit the signup webpage. A recording will be made available following the live broadcast.

 

Laurent Vernerey

Novolyze Appoints New Board Member, Nabs Most Innovative Food Safety and Quality Software Award

By Food Safety Tech Staff
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Laurent Vernerey

Novolyze, developer of food safety and quality digitalization technology and solutions, was recognized as the Most Innovative Food Safety and Quality Software Company of 2023 by New World Report’s Software and Technology Awards.

The Software and Technology Awards, now in their fourth year, recognize companies across North and South America that demonstrate excellence, innovation, and a commitment to advancing technology. Novolyze’s patented technologies provide a comprehensive view of environmental monitoring, process control, sanitation, and other critical aspects of food safety and quality.

New World Report’s award affirms Novolyze’s mission to revolutionize the food industry,” said Novolyze CEO Karim-Franck Khinouche. “Our SMART Food Safety & Quality platform of solutions ensures product safety without the need for costly testing, empowering efficient and waste-minimized food production, transforming our customers processes so consumers can enjoy safe, high-quality products with confidence.”

Novolyze recently appointed Laurent Vernerey to its Board of Directors. Vernerey brings more than 25 years of experience in industrial software to the board. He is currently an investor and board member of Tulip.co, a leading provider of no-code software for the industrial workforce. Prior to that, he held executive positions at Acuity Brands, where he oversaw its Technology Group, and Schneider Electric, as CEO for North America with an extensive software portfolio including Wonderware and Foxboro.

“Novolyze is at a pivotal time in the company’s growth, which makes it an exciting time to join their Board of Directors,” said Vernerey. “Novolyze has developed a truly innovative platform that is transforming the way food and beverage companies collect, analyze and leverage data. I am confident that my experience will help Novolyze achieve its ambitious goals.”

Image: Laurent Vernerey

Jim Jones, FDA

Jim Jones to Keynote 2024 Food Safety Consortium in October

By Food Safety Tech Staff
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Jim Jones, FDA

Food Safety Tech is thrilled to announce that James (Jim) Jones, Deputy Commissioner for Human Foods at FDA, will be the keynote speaker for the 2024 Food Safety Consortium, which will be held October 20-22 at the Crystal Gateway Marriot in Arlington, Virginia. Jones joined the FDA in September 2023 as the agency’s first Deputy Commissioner for Human Foods.

Now in its 12th year, the Food Safety Consortium brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry. In addition to two days of educational presentations and panel discussions, the Consortium will offer full-day pre-conference workshops, focused on topics including auditor training and food safety culture design, on Sunday, October 20.

This year’s session highlights include:

Navigating Global Food Systems: Insights and Strategies for Compliance with FDA’s Food Traceability Rule

Presenters: John Crabill, Director of Food Safety & Quality, Chipotle; Adam Friedlander, Policy Analyst, Coordinated Outbreak Response and Evaluation (CORE) Network, FDA; Julie McGill, VP of Supply Chain Strategy & Insights, Trustwell; and Sara Bratager, Sr. Food Safety & Traceability Scientist, Global Food Traceability Center at IFT

Are you the weakest link in the supply chain? Steps for bulletproofing your facility to become a major supplier

Presenters: Jorge Hernandez, VP of Quality Assurance, The Wendy’s Company; Tyler Williams, President, ASI

Next Level Preventive Controls

Presenter: Cathy Crawford, President, HACCP Consulting Group

Understanding Corrective Actions, Nonconformities and Root Cause Analysis

Presenter: Heather McLemore, Senior Accreditation Officer, A2LA

View the full agenda here.

Demonstrating Food Safety Culture

Presenters: Tia Glave and Jill Stuber, Co-Founders, Catalyst, LLC

The Internal Audit: Going Beyond the Certificate

Presenter: Cameron Prince, Executive VP, Regulatory Affairs, The Acheson Group (TAG)

Millions of Chemicals…But Which are Reasonably Likely to Occur?

Presenter: Tracie Sheehan, Technical Services, Mérieux NutriSciences

In-person and virtual registration available. Learn more about registration options.

Event Hours

Sunday, October 20: 8:30 am – 5:00 pm (Pre-conference Workshops)

Monday, October 21: 8:00 am – 6:30 pm

Tuesday, October 22: 8:30 am – 3:45 pm

Register now.

For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales.

About the Food Safety Consortium

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 its educational content. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore high-level educational tracks, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

 

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FDA Releases 2022 Annual Report on Investigations of Foodborne Outbreaks

By Food Safety Tech Staff
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On January 8, the FDA Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

In 2022, CORE evaluated 65 incidents, responded to 28 and issued advisories for 11. These numbers show a slight increase from 2021 when 59 incidents were evaluated with 19 responses and 10 advisories. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy and fish.

CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert and a Consent Decree. Outbreak advisories were issued for:

  • E. coli O157:H7 linked to packaged salads
  • Cronobacter linked to infant formula
  • Salmonella Senftenberg linked to peanut butter
  • Hepatitis A Virus linked to strawberries
  • Unknown contaminant linked to French Lentil and Leek Crumbles
  • Listeria monocytogenes linked to ice cream
  • Listeria monocytogenes linked to Brie and Camembert soft cheese products
  • E. coli O121 linked to frozen falafel
  • Salmonella Litchfield linked to seafood
  • Listeria monocytogenes linked to enoki mushrooms
  • Salmonella Typhimurium linked to sprouts

The 2022 annual report highlights noteworthy outbreaks from 2022, including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe and Salmonella linked to peanut butter.

Read the full report here.

 

Trish Wester

Food Safety Consortium Launches Virtual Food Safety Training Series

By Food Safety Tech Staff
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Trish Wester

The Food Safety Consortium Conference has announced a new online Food Safety Training Series, developed to explore critical food safety and quality topics in depth and offer timely information on emerging issues.

The first series is Food Safety Testing – Above and Beyond PCQI Principles, which will include three 90-minute online classes on February 1, 15 and 29. Building on the core PCQI principles, this training covers the key elements of effective food safety testing programs. The course will be led by Trish Wester, President of the Association for Food Safety Auditing Professionals (AFSAP).

Drawing on the extensive training portfolio of AFSAP, the first class includes an overview of general testing principles and the regulatory framework used to enforce compliance. Anticipating an increased focus on chemical testing under the new FDA leadership, a complete class session will be devoted to what, how and when to test for chemical contaminants, with the third and final class of the series devoted to the complexities of microbial testing.

“I am excited about the brand expansion of the Food Safety Consortium moving into training. Last year, we introduced two highly successful training programs, one on site and the other as a hybrid of three online classes followed by an onsite class. The Food Safety Testing Above & Beyond PCQI Principles Series is the first of several new and innovative programs we’ll offer this year,” said Rick Biros, founder of the Food Safety Consortium and publisher of Food Safety Tech.

The classes will feature a two-way virtual training format. All webcams will be on so the instructor can see each trainee and each trainee can see the instructor. This allows the instructor to monitor the class progress throughout, encouraging group discussion and live questions, replicating an in-person training experience without the need for travel. Space is limited, as class size is limited to 20 participants per series.

“I’m thrilled to bring food safety training to a new level. Working with the Consortium, we developed the Virtual Live concept that blends the best attributes of instructor led in-person training with the cost effectiveness of web-based programs. This should provide increased access to training for all food safety employees, which will have a positive impact on food safety,” said Wester.

Who should attend?

  • All levels of QA/QC personnel interested in advancing their food safety career into food safety program management and plan development in a wide range of product categories.
  • Entry level food personnel would also benefit from the course format.
  • Food Safety Auditors of all levels will increase their understanding of the food safety principles used in the area of product and environmental testing.

4.5 CE Hours and Certificate of Attendance: The Food Safety Consortium Conference’s Training, developed by AFSAP, is recognized by NEHA (National Environmental Health Association) for Continuing Education (CE) Hours. Upon completion of the training, each trainee will receive a Certificate of Attendance.

Learn more and register here.

 

 

Michelle Catlin

USDA FSIS Appoints New Chief Scientist

By Food Safety Tech Staff
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Michelle Catlin

The USDA Food Safety and Inspection Service (FSIS) has announced that Michelle Catlin, Ph.D., will serve as Chief Scientist of FSIS, effective December 31, 2023. In this role, Dr. Catlin will serve as the primary scientific advisor on matters of public health and food safety that affect the mission of the agency, with primary responsibility for scientific initiatives within the Office of Public Health Science (OPHS).

Dr. Catlin has more than 20 years of experience in the public health field. From 1999 through 2004 she worked for National Academy of Sciences. In 2004, Dr. Catlin joined FSIS as a senior scientist. She most recently served the agency as the International Coordination Executive, overseeing all of FSIS’ international activities. Dr. Catlin holds a Bachelor of Science (Honors) in life sciences and a Master of Science in pharmacology from Queen’s University at Kingston, Ontario, Canada, and a Ph.D. in toxicology from the Department of Environmental Health of the University of Washington at Seattle.

 

Recalled WanaBana Pouches

FDA Investigation of Elevated Lead Levels in Cinnamon Applesauce Pouches Identifies Source and Potential Adulteration

By Food Safety Tech Staff
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Recalled WanaBana Pouches

The FDA has determined that cinnamon used in multiple recalled cinnamon applesauce pouches is the most likely culprit behind at least 65 and potentially as many as 205 cases of lead poisoning reported between October and December 15, 2023, and that the lead contamination may have been the result of intentional adulteration.

The investigation led to an October recall of Wanabana USA apple cinnamon fruit puree pouches. In November, the recall was expanded to include Schnucks-brand cinnamon-flavored applesauce pouches and variety packs, and Weis-brand cinnamon applesauce pouches.

During their inspection of the Austrofoods facility in Ecuador, FDA investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. The samples showed extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, Codex Alimentarius Commission (Codex) is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024.

The FDA announced that, working with state partners, it tested at least 136 samples of non-cinnamon containing products, and all have been negative for elevated lead levels. On Friday, an FDA spokesperson said that one of the agency’s current theories is that the cinnamon contamination was the result of “economically motivated adulteration.”

FDA stated that it has confirmed that Negasmart does not ship product directly to the U.S. and that, of Negasmart’s direct customers, only Austrofoods ships product to the U.S. Further, Ecuadorian officials from ARCSA report that Negasmart does not ship product outside Ecuador. ARCSA also reports that in their testing thus far, raw/unprocessed cinnamon from all cinnamon importers in Ecuador do not appear to be contaminated with lead, whereas the ground or powdered cinnamon from Negasmart is contaminated. The Ecuadorian processor used by Negasmart is not currently operating.

“While our information at this time indicates that in the U.S. the contaminated cinnamon is limited to only the applesauce products that have already been recalled, the FDA is still investigating whether the cinnamon in the recalled products was used in other products exported to the U.S.,” the FDA shared in its statement. “To date, increased screening for imported cinnamon from certain countries remains in place and FDA has no indication that this issue extends beyond these recalled products.”

While the FDA investigation into the lead contamination will continue, the agency noted that it has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. Hence, the FDA cannot take direct action with Negasmart. “However, we are continuing to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination,” said the FDA.