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FDA Issues Two New Guidances on Food Allergen Labeling Requirements

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The FDA has issued two new guidance documents on food allergen labeling requirements.

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

The draft guidance includes:

  • New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.
  • Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.
  • Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Stakeholders can submit comments about the draft guidance within 60 days of the November 30 publication of the notice in the Federal Register. Submit comments electronically on www.regulations.gov or by mail:

Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s Docket ID: FDA-2022-D-0099.

Kiwa Group Acquires ASI Food Safety

By Food Safety Tech Staff
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Global Testing, Inspection and Certification (TIC) company Kiwa has acquired St. Louis-based ASI. ASI has provided farm-to-fork food safety solutions since the 1940s. The company offers a full suite of safety and quality services to the food and beverage, dietary supplements and cannabis industries. The merger will strengthen Kiwa’s U.S. footprint in providing Food, Feed & Farm certifications.

“Kiwa and ASI share similar customer-first business values and follow the same business model when it comes to testing, inspection and certification. By joining the Kiwa family, we’re combining their wide portfolio of accreditations and services (BRC, IFS, FSSC, PrimusGFS, GLOBALG.A.P., Rainforest Alliance, MSC/ASC, Organic/USDA and many others), global business network and expertise with our client network in farm-to-fork food safety to assist our growing client base in North America even better,” said Charray Williams, CEO of ASI.

On January 1, 2023, 29-year-old Tyler Williams, CTO of ASI, will take the reigns as CEO of ASI. He is the youngest CEO in the history of the company. He will succeed current CEO Charray Williams and lead the expansion of Kiwa and ASI in the Food, Feed & Farm sector in North America. Richard Stolk, Kiwa’s global Director for the Food, Feed & Farm sector will serve as President of the Board of ASI and will be directly involved in the further growth of ASI.

“Kiwa already has a strong footprint in the global Food, Feed & Farm sector. With ASI, we significantly expand our reach, expertise and footprint, particularly in the U.S. but certainly with a global perspective. Now that we have welcomed ASI to the Kiwa family, we can better provide our customers with a one-stop shop for food- and feed-related certification services on all continents,” said Stolk.

 

X5 SideShoot

New X-Ray Inspection System Accommodates Taller Products

By Food Safety Tech Staff
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Loma Systems has launched a new addition to its X5 X-ray inspection series: the X5 SideShoot, designed specifically for the inspection of taller products.

Using dynamic detection, the X5 SideShoot carries out a series of product inspections looking for unwanted contaminants; it can also be used to estimate fill level, check for missing content and determine whether a package is damaged. It can inspect product packaging up to 265mm in height, including plastic bottles, glass jars with metal lids, aluminum cans, plastic tubs and pots, tetra pack cartons, cardboard cans and tubes.

The X-ray device features a line speed of up to 50m/min, and can detect a broad range of contaminants, including ferrous, non-ferrous and stainless steel (~1.5-2.0mm St/St) metal, glass, bone, ceramic/stone, dense plastics and product clumps.

IP66-rated for low-pressure washdown, the X5 SideShoot includes a 15″ color touchscreen, multilevel password access to store data-logged events for traceability, improved digital detection to reduce electrical interference for image optimization, and energy-saving automatic idle capabilities.

“The New X5 SideShoot has been specifically designed and engineered to help our customers deliver new packaging technologies, successfully inspect products that are taller versus width, promote sustainability and enhance food safety,” said Toby Kemp, LOMA’s Director of Marketing & Innovation.

 

 

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WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight

By Food Safety Tech Staff
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The World Health Organization (WHO) announced that it is launching a global scientific process to update the list of priority pathogens to guide global investment, research and development of vaccines, tests and treatments.

The process began on November 18 with a meeting of more than 300 scientists who will consider the evidence on over 25 virus families and bacteria, as well as “Disease X.” Disease X is included to indicate an unknown pathogen that could cause a serious international epidemic. The experts will recommend a list of priority pathogens that need further research and investment. The process will include both scientific and public health criteria, as well as criteria related to socioeconomic impact, access, and equity.

The first priority pathogen list was published in 2017 and the last prioritization exercise was done in 2018. The current list includes COVID-19, Crimean-Cong hemorrhagic fever, Ebola virus disease and Marburg virus disease, Lassa fever, Middle East respiratory syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), Nipah and henipaviral diseases, Rift Valley fever, Zika and Disease X.

“Targeting priority pathogens and virus families for research and development of countermeasures is essential for a fast and effective epidemic and pandemic response. Without significant R&D investments prior to the COVID-19 pandemic, it would not have been possible to have safe and effective vaccines developed in record time,” said Dr. Michael Ryan, Executive Director of WHO’s Health Emergencies Programme.

For those pathogens identified as priority, the WHO R&D Blueprint for epidemics develops R&D roadmaps, which lay out knowledge gaps and research priorities. Efforts are also made to map, compile and facilitate clinical trials to develop vaccines, treatments and diagnostic tests. Complimentary efforts—such as to strengthen regulatory and ethics oversight—are also considered.

“This list of priority pathogens has become a reference point for the research community on where to focus energies to manage the next threat,” said Dr. Soumya Swaminathan, WHO Chief Scientist. “It is developed together with experts in the field and is the agreed direction for where we—as a global research community—need to invest energy and funds to develop tests, treatments and vaccines. We thank our donors like the U.S. government, our partners, and the scientists who work with WHO to make this possible.”

The revised list is expected to be published in the first quarter of 2023.

Upside Foods Chicken

Lab Grown Meat Passes Key Safety Hurdle on Path to Approval

By Food Safety Tech Staff
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Upside Foods Chicken

On November 16, the FDA announced that it had completed its first pre-market consultation for a human food made from cultured animal cells. After evaluating the information submitted by UPSIDE Foods, a company that uses animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food, the agency stated that it had no further questions at this time about the firm’s safety conclusion.

In a statement from Commissioner Robert M. Califf, M.D., and Susan Mayne, Ph.D., director of the FDA Center for Food Safety and Applied Nutrition, the regulators explained that before this food can enter the market, the facility in which it is made also needs to meet applicable U.S. Department of Agriculture (USDA) and FDA requirements. In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from the USDA Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions as well as a USDA mark of inspection the product itself.

Cultivation Room Upside
UPSIDE Foods Cultivation Room

UPSIDE Foods’ CEO Uma Valeti, M.D., celebrated the news with a mock letter to the chickens of the world. “So what does getting a ‘No Questions Letter’ mean, exactly? It means that the FDA accepts our safety conclusion and UPSIDE’s cultivated chicken will be available following USDA inspection and label approval. It’s an important step on the road to bringing cultivated chicken to the market in the U.S., and gets UPSIDE closer to being on tables everywhere,” said Valeti. “And what does that mean? It means a whole new future is around the corner. And in that future, we might be eating just as much meat as we always have. But a lot fewer animals are going to have to suffer for it.”

Now that the pre-market consultation is completed, the approval process will transition from the FDA to USDA FSIS oversight. USDA FSIS will oversee the post-harvest processing and labeling.

“The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their products are safe and lawful under the Federal Food, Drug, and Cosmetic Act,” said Drs. Cardiff and Mayne. “We also plan to issue guidance to assist firms that intend to produce human foods from cultured animal cells to prepare for pre-market consultations. The published draft of this guidance will provide a formal opportunity to the public for comment.”

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FDA Announces Publication of Final Traceability Rule and Informational Webinar

By Food Safety Tech Staff
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The FSMA Final Rule on Traceability was published in the Federal Register on November 21, meaning the rule will go into effect on January 20, 2023 (60 days after the publication date). The FDA will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm – 5:00 pm (ET) to provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and to discuss the recordkeeping requirements of the rule.  The FDA will answer pre-submitted questions and take questions during the webinar.

The final rule establishes additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables and ready-to-eat deli salads. In collaboration with industry, the FDA will be able to more rapidly and effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.

“This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future.”

Foods subject to the final rule requirements appear on the Food Traceability List (FTL). To determine which foods should be included on the FTL, the FDA developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act (FSMA). These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, and tropical tree fruits, as well as shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish and crustaceans.

The FDA released a proposed rule in 2020 and held a public comment period where comments were received from food producers and other stakeholders through early 2021. In response, the agency has made several changes to the final rule so that it better aligns with current industry approaches to food traceability and harmonizes points in the supply chain where records must be maintained.

Key features of the final rule include:

  • Critical Tracking Events: at specific points in the supply chain—such as harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods—records containing Key Data Elements are required.
  • Traceability Plan: information essential to help regulators understand an entity’s traceability program. These include a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan and a farm map for those that grow or raise a food on the FTL.
  • Additional Requirements: maintenance of records as original paper or electronic records, or true copies; providing requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist the FDA during an outbreak, recall or other threat to public health.
chicken, beef, dairy, lettuce

Foodborne Illness Report Highlights High-Risk Food Categories

By Food Safety Tech Staff
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chicken, beef, dairy, lettuce

This month, the Interagency Food Safety Analytics Collaboration’s (IFSAC) released it newest annual report , “Foodborne illness source attribution estimates for 2020 for SalmonellaEscherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States.” IFSAC is a collaboration between the CDC, FDA and USDA Food Safety and Inspection Service (FSIS).

The report was developed to help shape the priorities of the FDA, inform the creation of targeted interventions to reduce foodborne illnesses caused by these pathogens, inform stakeholders and improve regulatory agency’s to assess whether prevention measures are working.

The report identified 3,749 outbreaks that occurred from 1998 through 2020 and were confirmed or suspected to be caused by Salmonella, E. coli O157, or Listeria, including 192 outbreaks that were confirmed or suspected to be caused by multiple pathogens or serotypes.

The IFSAC excluded 96 of these outbreaks according to its pathogen-exclusion criteria, leaving 3,653 outbreaks. The agency further excluded 1,524 outbreaks without a confirmed or suspected implicated food, 836 outbreaks for which the food vehicle could not be assigned to one of the 17 food categories, and six that occurred in a U.S. territory.

The resulting dataset for the report included 1,287 outbreaks in which the confirmed or suspected implicated food or foods could be assigned to a single food category. These included 960 caused or suspected to be caused by Salmonella, 272 by E. coli O157 and 55 by Listeria. Outbreaks from 2016 through 2020 provide 71% of model-estimated illnesses used to calculate attribution for Salmonella, 67% for E. coli O157 and 62% for Listeria.

Salmonella illnesses came from a wide variety of foods, with more than 75% of illnesses attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef and Turkey.

More than 80% of E. coli O157 illnesses were linked to Vegetable Row Crops (such as leafy greens) and Beef.

More than 75% of Listeria monocytogenes illnesses were linked to Dairy products, Fruits and Vegetable Row Crops, though the IFSAC noted that “the rarity of Listeria monocytogenes outbreaks makes these estimates less reliable than those for other pathogens.”

Attribution estimates for Campylobacter outbreaks were not included in this year’s report, though they have been included in the past. IFSAC said that this was “due to continued concerns about the limitations of using outbreak data to attribute Campylobacter illnesses to sources … these concerns are largely due to the outsized influence of outbreaks in certain foods that pose a high individual risk for Campylobacter infection but do not represent the risk to the general population.” For example, 91% of reported Campylobacter outbreaks related to dairy products were associated with unpasteurized milk, while 57% majority of chicken-related outbreaks were due to chicken liver products, which are not widely consumed.

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FDA Commits $41M to Support the Joint Institute for Food Safety and Applied Nutrition

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The University of Maryland has announced a five-year, $41 million cooperative agreement with the FDA to expand the University’s Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

Established in 1996, JIFSAN is an FDA Center of Excellence combining the expertise of the federal agency with UMD researchers. It promotes research, education and outreach in food safety, security and applied nutrition and has developed partnerships across industry, government and other stakeholders in support of the 2011 Food Safety Modernization Act (FSMA).

“This enduring partnership and funding will allow us to continue our collaborative research efforts between UMD and the FDA,” said Jianghong Meng, professor of nutrition and food science and JIFSAN director. “We are in a new era of food safety where better protections and preventative measures are more important than ever. The last few years have shown that as a community we must all work together to eradicate illness and disease.”

The new award will be used to grow several programs, including a congressional mandate on imported aquacultured shrimp, which supports the FDA in regulating the sourcing and importing of shrimp to the United States.

JIFSAN will continue to provide graduate and undergraduate internship opportunities to UMD students who work with and are mentored by FDA scientists. In its first quarter century, the institute has provided more than 300 undergraduate internships, graduate assistantships and postdoctoral research appointments that have contributed to a variety of food safety initiatives and programs.

The institute will also conduct multi-institutional, multidisciplinary research projects and develop mechanisms for the exchange of technical information and scientific concepts. Additionally, it will continue to advance the development of educational and outreach programs designed to enhance the FDA’s efforts with other nations to improve U.S. and global health.

The funding will also help support JIFSAN as it prepares to move its offices to a new location at 5825 University Research Court in UMD’s Discovery District. The new facility includes a microbiology laboratory for research and training in whole genome sequencing as well as other advanced technologies for detecting and tracing the source of foodborne pathogens.

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USDA FSIS Seeks Input on Exploratory and Special Program Poultry Sampling

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The USDA Food Safety and Inspection Service (FSIS) announced that it is preparing to publish the next establishment-specific dataset on exploratory and special program poultry sampling in January 2023.

Prior to publishing the dataset, FSIS is seeking comments on a sample dataset and data documentation. Comments can be submitted until December 22, 2022. The sample dataset and corresponding data documentation include sampling results of FSIS’ non-regulatory poultry microbiological sampling projects, including poultry establishments with a very low volume of production (≤ 1,000 lbs/day), religious-exempt chicken carcasses, comminuted or mechanically separated poultry and chicken quarter or half-carcasses and chicken parts. This dataset also includes data associated with special programs, such as a response to an outbreak or testing a new sampling methodology.

Establishment-specific datasets were first released in 2016 as announced in the July 14, 2016, Federal Register

Six weeks before the first publication, FSIS will share the data via email with establishments. After the first publication, product type information from the Exploratory Sampling for Chicken Parts – Quarter and Half Carcasses project will continue to be emailed to applicable establishments six weeks before each publication. Except for results from the Exploratory Sampling for Chicken Parts – Quarter and Half Carcasses project, establishments can access their data using the “Industry Sampling Results for Primary Establishment Number Detailed” report within the Public Health Information System (PHIS).

To remain consistent with the other establishment-specific datasets, the first datasets will be posted with an archive and current file. The archive file will contain data through fiscal year (FY) 2021; the current file will contain FY2022 data. Both the archive and current files are planned to publish on January 27, 2023. Subsequent postings will follow the regular posting schedule for establishment-specific datasets. New datasets are released the first Friday of the next quarter with a quarter lag, meaning data for FY2023 Q1 (December 2022) are scheduled to be released on April 7, 2023, data for FY2023 Q2 (March 2023) are scheduled to be released July 7, 2023, and so forth. Existing datasets will be updated quarterly.

To comment on sample dataset and data documentation, visit Regulations.gov and use Docket FSIS-2014-0032.

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FoodChain ID Acquires Lexagri

By Food Safety Tech Staff
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FoodChain ID, a provider of technology-enabled food safety quality and sustainability solutions, has acquired Lexagri International, a company that focuses on verifying, harmonizing, structuring and distributing global agricultural data.

“Lexagri’s services are focused on data enhancement, and their data harmonization processes transform raw, untreated agricultural data into standardized, validated and accessible data sets,” said Brad Riemenapp, CEO of FoodChain ID. “This expands FoodChain ID’s scope of regulatory and compliance content into crop protection and brand registration data, allowing us to serve our food customers even more effectively and to strengthen our reputation as a trusted source of data-driven, actionable insights from farm to fork.”

Lexagri’s Homologa is the largest pesticide database in the market with over 33 million entries including Good Agricultural Practices (GAP) data, logistics data and Maximum Residue Levels (MRLs). The company’s PhytoScan mobile app offers an integrated label scanner for on-farm use that provides immediate access to up-to-date product regulatory and safety information to enhance compliance at the farm level.

Other products include Basagri and Phytodata, which are reference data sources for crop protection information in France that compare and contrast registered and certified data, and Agrowin, a service package for top tier chemical companies allowing them to analyze crop protection and seed market data providing access to harmonized and consolidated global agricultural market data.

“Lexagri’s aim has always been, and continues to be, to become the global harmonized reference provider of regulatory crop protection data for the industry, digital farming and the food chain,” said Fritz Schuster, CEO of Lexagri. “The upcoming integration of Lexagri with FoodChain ID will be another step in this direction. We will be able to enhance the link between ‘farm and fork’ through an easier data flow and more transparency.”