Tag Archives: FDA

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FDA Releases Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin

By Food Safety Tech Staff
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The FDA is releasing a risk assessment that was conducted to evaluate and quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas with untreated biological soil amendments of animal origin (BSAAO), including raw manure. Results of the risk assessment will be used to inform policy decisions regarding appropriate standards for the use of raw manure and other untreated BSAAO when growing produce.

Pathogens on produce, such as Shiga toxin-producing Escherichia coli (STEC) O157:H7, Salmonella, and STEC non-O157 can cause human illness. The survival rate of pathogens from untreated BSAAO and their risk of contaminating crops are determined by various factors, including environmental conditions and agricultural practices. The FDA’s risk assessment investigated these factors and provides critical insights essential for protecting the nation’s produce supply and helping to ensure safe food for all Americans.

The untreated BSAAO risk assessment was completed in two phases. Part 1 focused on pre-harvest practices and conditions to determine the likelihood of produce being contaminated with pathogens before it is picked. It specifically analyzes how interventions, such as the waiting period between applying untreated BSAAO and harvesting the crops, affect the potential concentration of pathogens on the produce at the time of harvest. Part 2 modelled the path of potentially contaminated produce from the farm through the supply chain to the consumer. It includes processing activities, potential for cross-contamination during processing, transportation and storage, produce consumption, and the amount of pathogen exposure (STEC O157:H7, Salmonella, and STEC non-O157) required to cause illness through consumption of the produce commodity.

The main conclusion of this risk assessment is that extending the time between the application of untreated BSAAO and produce harvest significantly reduces the potential level of human pathogens on produce at the time of harvest. The effectiveness of this waiting period varied among the human pathogens analyzed and type of untreated BSAAO, as influenced by regional environmental conditions and the initial level of human pathogens in the raw manure.

The risk assessment model may also serve as a tool for stakeholders and industry in evaluating risks that may be associated with their agricultural practices and environmental conditions.

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FDA and Partners in the Central Coast Agricultural Region of California Share Findings from Multi-year Environmental Study

By Food Safety Tech Staff
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The U.S. Food and Drug Administration reported that it is sharing initial findings from a multi-year environmental study conducted in California’s Central Coast agricultural region that will inform efforts to further improve the safety of produce — an essential component of a healthy diet. The California Longitudinal Study was conducted in partnership with the Western Center for Food Safety at the University of California, Davis, the California Department of Food and Agriculture, and regional agricultural stakeholders.

The Central Coast of California is farmed year-round and supplies a large volume of produce, which includes more than 400 commodities. However, there have been periodic foodborne illness outbreaks associated with the region, including several that occurred between 2016 and 2020 caused by the same E. coli O157:H7 strain. This study sought to identify environmental factors that significantly contribute to the introduction, persistence, and spread of foodborne pathogens that could contaminate produce prior to harvest. Increasing FDA’s understanding of the ecology of this growing region as it pertains to foodborne pathogens is to the benefit of consumers, producers, academia, and food safety officials as it allows for continued improvement in best growing practices to enhance food safety.

The longitudinal study, which began in 2020, followed an adaptive research design in which sample collection matrices, sites, and frequencies were continually assessed and refined to obtain maximum useful, practical information. Through repeated sample collection, testing, measurement, and analysis, the research team observed trends in pathogen presence in this region over time, providing insightful information on prevalence, location, and potentially influencing factors such as seasonality, weather conditions, and domesticated and wild animal activities on adjacent and nearby land.

Initial findings related to E. coli O157:H7 and other Shiga toxin-producing Escherichia coli (STEC) have been posted to the FDA’s California Longitudinal Study webpage and are summarized below:

Animal Sources of Contamination: Fecal samples from rangeland beef cattle, feral pigs, deer, birds, and coyotes were frequent sources of STEC. Viable STEC was recovered from fresh and older, drier feces from livestock and wildlife found in the sampling area. These results suggest that STEC may remain viable in fecal material for extended periods.

Environmental Sources of Contamination: Surface waters and associated sediments may facilitate STEC persistence, and in the case of water, STEC movement in the region. STEC was not recovered in a substantial amount of soil or air samples, indicating that these are not likely impacting the spread of STEC in the region. However, STEC was observed in water and sediment from rivers and creeks, and to a lesser extent in irrigation tailwater and tailwater sediment (accumulations of field runoff from irrigation practices) collected at field edges.

STEC Diversity, Persistence, and Movement: Twelve different E. coli O157:H7 strains were isolated from environmental samples; however, the strain responsible for outbreaks between 2016 and 2020 was not recovered. STEC isolated from wildlife feces genetically matched strains from cattle feces, other wildlife feces, and in some cases, water, sediment, and soil. Six different highly pathogenic STEC serotypes were identified and some strains of these serotypes persisted for nearly two years.

The FDA will engage with stakeholders to further discuss the data and findings from this study and assist stakeholder efforts to develop practices to manage the risks posed by the potential sources of contamination. Additional information and publications will be added to FDA’s California Longitudinal Study webpage as they become available.

Beltway Beat

Regulators in the Spotlight: FDA & USDA’s Vision for Safer Food

By Food Safety Tech Staff
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Dr. Mindy Brashears, Under Secretary for Food Safety, USDA and Dr. Donald A. Prater, Principal Deputy Director for Human Foods, FDA will present at the Food Safety Hazards Conference, April 20-22 in St. Louis MO. The format is a fireside chat with a town hall Q&A, moderated by Brian Ronholm, Director of Food Policy, Consumer Reports.

The Food Safety Hazards Conference will take place April 20-22 in St. Louis MO. The Program starts on Monday April 20 at 12 pm which leads into two full days of high-level panel discussions and educational presentations concluding Wednesday, April 22 at 12 noon CST. Presentations include:

* Regulators in the Spotlight: FDA & USDA’s Vision for Safer Food
* Practical Pathogen Control Strategies for Complex Food Operations: Lessons from Real-World Implementation
* Food Allergen Safety – On the Other Side of the Threshold
* Assessing Heavy Metal Risks in Food Systems: A Preventive Food Safety Approach to Protect Public Health
* Forecasting Microbial Behavior: Predictive Tools for Smarter Hazard Analysis
* Transforming Pest Control Through FMEA: A Predictive, Risk-Based Framework for Preventing Food Safety Hazards
* Cybersecurity and Food Safety: HACCP Meets Hacking
* End to End Foreign Material Control: A Practical Guide for Manufactures
* Less Chemicals, More Microbes? The Use of Clean-Label Ingredients to Formulate Processed Meats
* Sanitary Transportation – Bulk Tankers – cross contamination?
* From Known to Reasonably Foreseeable: Rethinking Biological Hazard Identification in Food Safety Programs
* Food Safe Facility Drainage Design

Organized by Food Safety Tech, who also runs the Food Safety Consortium Conference since 2012, the Food Safety Hazards Conference will focus on the detection, mitigation, control and regulations of food safety hazards through technology, best practices and data analytics. The Hazards addresses in the program include Listeria, e-Coli, Salmonella, Allergens, Chemicals and Foreign Matter. The conference scope includes both human and pet foods. The complete agenda, speakers and registration information is on the Food Safety Hazards Conference website.

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FDA Takes Several Actions Related to the Food Traceability Rule

By Food Safety Tech Staff
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On February 19, the FDA issued guidance addressing stakeholder questions regarding implementation of the Food Traceability Rule and a notice exempting certain cottage cheese products from the requirements of the Food Traceability Rule. FDA is also announcing a series of engagements with stakeholders to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026.

The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List. The final rule requires such entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help FDA rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

Questions and Answers Guidance on the Food Traceability Rule

The guidance issued includes questions and answers to assist industry with understanding the scope of the Food Traceability Rule and meeting the requirements of the rule. The guidance addresses several topics, including:

  • Applicability of the rule to entities such as farms, farmers’ market stalls, fishing vessels, first land-based receivers, retail food establishments, and restaurants;
  • Applicability of the rule to activities such as intracompany shipments, commingling, initial packing, and transformation, including answers to questions about breaking pallets and culling produce;
  • Details about the exemption for raw molluscan shellfish;
  • Determining if a product is “fresh-cut” for the purpose of identifying whether it is on the Food Traceability List; and
  • Additional information on the food traceability plan and recordkeeping requirements.

Finalizing Exemption for Certain Cottage Cheese Products from the Requirements of the Food Traceability Rule

In the preamble to the final Food Traceability Rule, FDA announced its intention to consider initiating a process to exempt certain cottage cheese products from the rule. In 2024, FDA published a notice proposing to exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers (IMS) List (“IMS listed Grade “A” cottage cheese”) from the rule. FDA published a notice announcing that they are finalizing that exemption.

Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS). FDA and NCIMS have together developed a cooperative, Federal-State program (the IMS Program) to ensure the sanitary quality of milk and milk products shipped interstate. The IMS program relies on the Pasteurized Milk Ordinance (PMO), which represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese.

After considering the comments on the proposal, FDA has concluded that the exemption is warranted because the processing requirements specified in the PMO for IMS listed Grade “A” cottage cheese address the risk factors that resulted in cottage cheese being included on the Food Traceability List, and because of the enhanced oversight of the manufacturing of IMS listed Grade “A” cottage cheese through the IMS program. In keeping with the statutory and regulatory provisions that allow for this type of exemption, facilities required to register with FDA that manufacture, process, pack, or hold IMS listed Grade “A” cottage cheese will still be required to maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food.

Stakeholder Engagement Sessions

The FDA is also announcing a series of engagements with stakeholders, organized by the Partnership for Food Traceability (PFT), to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA will engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to better understand concerns and explore options for assisting regulated entities with complying with the Food Traceability Rule. The PFT and FDA will hold a series of listening sessions on these topics. The sessions will include opportunities for public input as well as smaller group discussions. The listening sessions will provide an opportunity to engage with FDA on Food Traceability Rule implementation of lot-level tracking, challenges facing regulated entities, and potential solutions. The first session will take place March 6, 2026, for PFT members, with a public session the following quarter. Additional sessions will be announced as they are scheduled.

Additional Information

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FDA’s 3rd Food Safety Culture Webinar – February 18, 2026

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FDA announced in a press release the third webinar in FDA and Alliance to Stop Foodborne Illness co-hosted Food Safety Culture Webinar Series.

Webinar #3: Live Your Values Day by Day Wednesday, February 18, 2026; noon ET

Register here!

The webinar will discuss how to avoid complacency through proactive, ongoing reinforcement of organizational values. Webinar participants will include Sean Leighton, Global Vice President of Food Safety, Quality and Regulatory at Cargill and Sarah Nayani, Director of Compliance with Arctic Storm Management, as well as speakers from FDA and the Alliance to Stop Foodborne Illness.

This is the third in the ongoing series of interactive, hour-long webinars throughout the year designed to deepen your knowledge and strengthen your commitment to food safety. Each session will feature industry experts who will share valuable insights, real-world tools and actionable strategies to enhance food safety culture across your organization.

Click this link to view the complete list of webinars and reserve your spot for the rest of the series.

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Beltway Beat

FDA Releases Human Food Program (HFP) 2026 Priority Deliverables

By Food Safety Tech Staff
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FDA’s Human Foods Program (HFP) released its priority deliverables for 2026. As part of HFP’s comprehensive plan, these targeted deliverables represent more than incremental progress; they signal a transformation in how HFP fulfills its mission to protect and enhance public health.

According to a press release, in 2026, HFP will build on accomplishments in 2025, guided by the three risk pillars, to strengthen and shape the next phase of FDA’s efforts. Throughout this year, FDA intends to provide periodic updates on their progress.

The planned activities include:

  • Food Chemical Safety: Improving the safety of food ingredients by systematically reviewing and, where appropriate, banning additives from the food supply.
  • Nutrition: Helping to reduce the prevalence of diet-related chronic disease by increasing transparency and empowering consumers to make informed choices through enhanced food labeling, such as front-of-package nutrition labeling; and expanding options for safe, reliable, and nutritious infant formula for American families through Operation Stork Speed initiatives.
  • Microbiological Food Safety: Enhancing food safety by advancing strategies and best practices for preventing contamination in human foods, strengthening protection by leveraging state oversight to complement FDA’s resources, and improving transparency of FDA’s regulatory and enforcement decisions.

In line with these 2026 priorities, HFP is also publishing its proposed 2026 guidance agenda to increase transparency of their work and processes, enhance food safety, and empower consumer nutrition choices, including the following impactful public health actions:

  • Establishing action levels for cadmium and inorganic arsenic in infant and young children’s foods, plus issuing guidance on preventive controls for chemical hazards.
  • Issuing guidance to assist industry in implementing effective sanitation controls consistent with the Preventive Controls for Human Food rule.
  • Issuing guidance to assist with food labeling for online grocery store platforms to give consumers access to nutrition information wherever they shop.

FDA states its goals for 2026 are ambitious, but claims HFP has the dedication, knowledge, and experience to tackle them.

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FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

By Food Safety Tech Staff
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The U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

The agency is seeking information on adverse reactions due to “ingredients of interest” (i.e., non-wheat gluten containing grains (GCGs) which are rye and barley, and oats due to cross-contact with GCGs) and on labeling issues or concerns with identifying these “ingredients of interest” on packaged food products in the U.S.

The agency has received a citizen petition on this matter and has reviewed available data and reports including the most recent reports by the Food and Agriculture Organization of the United Nations expert consultation. The FDA’s review of this information indicates that there are several serious data gaps limiting the agency’s ability to fully evaluate the public health importance of these ingredients which includes limited U.S. data on adverse reactions to the “ingredients of interest.”

The FDA seeks detailed information such as the prevalence of products where rye or barley are not currently disclosed; information on the severity of and potency of immunoglobulin E-mediated food allergy to rye and barley; concerns around the gluten content of oats due to cross-contact and other questions related to these issues.

The FDA is taking this action to help enhance transparency for consumers and inform the agency’s gluten-related labeling priorities and next steps. The FDA intends to use the information to support a determination on what type(s) of future regulatory actions we should take to better protect consumers with celiac disease.

How to Submit Comments

Electronic Submissions Comments can be submitted via the Federal eRulemaking Portal to Docket No FDA-2023-P-3942 (open for 60 days). Follow the instructions for submitting comments.

Written Submissions Written comments may be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Ensure that all comments include Docket No. FDA-2023-P-3942. Confidential submissions should be appropriately marked.

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Beltway Beat

DeLauro, Durbin Reintroduce the Federal Food Administration Act

By Food Safety Tech Staff
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On December 10, 2025, Congresswoman Rosa DeLauro (CT-03) and Senate Democratic Whip Dick Durbin (D-IL) reintroduced the Federal Food Administration Act, legislation that would streamline our food safety system by consolidating food oversight into a single agency dedicated to keeping the foods Americans eat safe.

“We need a single food safety agency to ensure the food Americans eat is safe,” said DeLauro. “Currently, food safety oversight is scattered across multiple agencies with the bulk of the responsibility falling to the Food and Drug Administration – where food safety has often been treated like a second-class citizen. This legislation would put one agency clearly in charge with the singular mission of protecting our food supply with the resources, staff, and focus to achieve that goal. I am proud to partner with Senator Durbin in this effort, because Americans deserve peace of mind that the government is keeping companies accountable with clear, consistent safety standards.”

“The sad reality is that FDA has failed to protect Americans from preventable foodborne illnesses and death. In recent years, the FDA has failed to protect babies from bacterial infections in their infant formula and lead-tainted applesauce pouches,” said Durbin. “This is why Congresswoman DeLauro and I are introducing legislation to create a Federal Food Administration.  With the Federal Food Administration Act, we hope our nation will have greater success in protecting the foods in our kids’ lunch boxes and on our dining room tables.”

FDA regulates approximately 80 percent of our food supply. Consumers and companies depend on FDA to perform its regulatory role effectively.  Yet, despite increased authorities included in the Food Safety Modernization Act (FSMA) and the creation of the Human Foods Program at FDA, the agency has failed to make significant inroads in reducing rates of foodborne illness and death in the U.S.

About one in six Americans—or 48 million people—get sick from a foodborne illness each year.  According to the Centers for Disease Control and Prevention (CDC), 128,000 Americans also are hospitalized and 3,000 Americans die of foodborne diseases each year.

A single food safety agency, with a Senate-confirmed Commissioner, will strengthen oversight of the food supply, improve the health and well-being of Americans, and ensure companies that cut corners on food safety are properly held accountable.

Joining Durbin and DeLauro as original cosponsors of this legislation is Sen. Richard Blumenthal (D-CT) and U.S. Representative Sara Jacobs.

The legislation is endorsed by Consumer Reports, Consumer Federation of America, Environmental Working Group, and STOP Foodborne Illness.

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FDA Opens VQIP Application Portal for FY2027

By Food Safety Tech Staff
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The FDA’s Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2027 opens on January 1, 2026, providing food importers with an opportunity to streamline their import processes through expedited review and importation benefits.

VQIP is a voluntary, fee-based program that offers expedited review and importation benefits for human and animal foods when importers demonstrate control over their supply chain safety and security. To participate, importers must ensure their foreign supplier facilities are certified through FDA’s Accredited Third-Party Certification Program.

Key Application Details:

• Application Window: January 1 – September 1, 2026

• Program Year: FY2027 benefits

Getting Started:

• Create an account on the FDA Industry Systems website (https://www.access.fda.gov/)

• Contact FSMAVQIP@fda.hhs.gov for an informational meeting

• Review eligibility requirements and certification needs, as foreign supplier facilities must be certified by FDA-accredited third-party certification bodies.

VQIP supports FDA’s Strategy for the Safety of Imported Food by incentivizing importers to use certified suppliers and maintain robust processes to help ensure imported food meets U.S. food safety requirements.

Resources and Support:

For questions or assistance, contact the VQIP Importers Help Desk:

• Email: FSMAVQIP@fda.hhs.gov

• Phone: 301-796-8745

• Program Information: https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip

Beltway Beat

FDA and CDC Leading Multistate Outbreak Investigation of Infant Botulism from Infant Formula

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The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states. Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.

The company posted a letter on the company’s website. https://byheart.com/ that stated It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority. Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. 

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had consumed ByHeart Whole Nutrition infant formula.

This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing, but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism.  Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

FDA contacted the firm and requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.

FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula.

Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

According to the Times article, FDA inspection reports detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, the findings raise concerns about the company’s safety record.

For example, in July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant. When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.

Months later, FDA inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The FDA classified the inspection at its highest tier of concern.