Following pressures from consumer groups and legislators, the U.S. Food and Drug Administration (FDA) has revoked its authorization for the use of red dye 3 in food and ingested drugs. Food manufacturers using the colorant have until January 15, 2027 to reformulate their products.

Despite its decision to ban red dye 3 from food and ingested drugs, FDA maintains a contrary position, stating that claims of the colorant being harmful to human health through dietary exposure are not supported by the available scientific information. Still, the agency made its decision to revoke red dye 3's authorizations based on the Delaney Clause, which says that if a substance is found to cause cancer in man or animal, then it could not be used as a food additive.

FDA made its decision in response to a 2022 color additive petition filed by the Center for Science in the Public Interest, Consumer Reports, and 22 others, which cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of red dye 3 due to a rat-specific hormonal mechanism. Although FDA granted this petition, in its decision, FDA asserted that these studies are not necessarily relevant to human health; according to the agency, harmful exposure levels for male rats are much lower than for humans, and studies in humans and in other animals did not show carcinogenic effects. In a December 2024 Senate hearing, when asked why the agency still allows potentially harmful red dye 3 in food but not cosmetics, FDA Deputy Commissioner for Human Foods Jim Jones reiterated this position, explaining that the current scientific consensus is that the additive's mode of carcinogenicity in animals is not applicable to humans.

Regardless, beliefs that red dye 3 and other artificial food colorants are harmful to human health are widely held. In October 2024, Consumer Reports delivered another petition—with 80,000 signatures—urging the agency to ban red dye 3 in foods, citing, in addition to its potential carcinogenicity, that the dye is associated with hyperactivity and other neurobehavioral effects in children. A November 2024 letter from 23 Congress members also urging FDA to ban red dye 3 echoed the same concerns, and noted that the colorant is not allowed for food use by the EU, Australia, or New Zealand.

FDA Bans Red Dye 3 in Food

USDA-FSIS Work Plans for 2025 Prioritize Regulating Salmonella in Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) has published its Annual Plan for Fiscal Year (FY) 2025, detailing activities FSIS will undertake to advance its strategic goals in the coming year. FSIS's strategic goals for FY 2025 remain unchanged: to prevent foodborne illness and protect public health; transform inspection systems, policies, and scientific approaches to improve public health; and achieve operational excellence.

To meet these goals, the agency will focus on several priorities, including:

• Preventing human cases of salmonellosis attributable to poultry consumption. Consistent with the agency's final determination declaring Salmonella an adulterant in not-ready-to-eat (not RTE), breaded and stuffed chicken products, which goes into effect in FY 2025, FSIS plans to implement verification of Salmonella control for establishments producing these products, and will continue efforts to finalize its Salmonella regulatory framework rulemaking. By May 1, FSIS will implement testing and other activities to verify that not RTE, breaded and stuffed chicken products meet adulteration standards. The agency will also continue to assess data and studies regarding regulatory requirements, sampling, and inspection tasks.
• Verifying that labels are truthful and not misleading. FSIS will implement verification activities related to the final rule on voluntary labeling of regulated products with U.S.-origin claims, continue efforts to evaluate the safe handling instructions label, and work to finalize labeling requirements for cell-cultured meat and poultry food products.
• Prioritizing effective communication strategies to share information with stakeholders, including underserved communities and tribal organizations. FSIS will focus on collaboration and communication with public health partners, consumers, and stakeholders. The agency will also continue to support State Meat and Poultry Inspection, Talmadge-Aiken, and Cooperative Interstate Shipment programs.

With the goal of ensuring agency systems and policies are scientifically up-to-date, FSIS intends to explore new or modified laboratory methods, evaluate their fitness for purpose, and plan for their implementation. Specifically, FSIS will explore new methods to detect Shiga toxin-producing Escherichia coli (STEC) using a definition based on virulence. As part of its Accredited Laboratory Program, FSIS will continue to build out its Salmonella and aerobic count proficiency analyses. Additionally, FSIS will continue to refine sampling strategies that allocate sampling tasks to establishments based on public health risk.

FDA has published a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, building upon an immediate national strategy published in March 2023, which initiated first steps and research toward a long-term strategy. The long-term strategy is informed by studies of challenges facing the U.S. infant formula market conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM).

Efforts by FDA to increase the resiliency and safety of the U.S. infant formula supply were prompted by the infant formula crisis of 2022, in which the nation faced a critical shortage of infant formula following a recall of product contaminated with Cronobacter sakazakii, resulting in the temporary shutdown of Abbott Nutrition's Sturgis, Michigan facility, a major producer of formula in the U.S. Following the crisis, FDA commissioned NASEM to evaluate the U.S. infant formula market before and during the shortage, considering FDA's response to the events. NSAEM's report, which made recommendations to federal agencies about actions required to prevent future shortages, helped inform FDA's newly released, long-term strategy.

Since 2022, FDA has taken several actions to improve the safety and availability of infant formula, such as entering a consent decree with Abbott Nutrition, meeting inspection targets for infant formula production facilities in 2023 and 2024, issuing warning letters to three formula manufacturers, implementing its commodity-specific prevention strategy for C. sakazakii contamination in powdered infant formula, updating the compliance program for infant formula, and participating in reviews of FDA's processes related to infant formula oversight. The agency is also working with major domestic infant formula producers to increase infant formula production, which is highly concentrated to a small number of manufacturers. For example, in 2022, four companies controlled 99 percent of the infant formula market; in 2024, the number of major manufacturers was down to three.

The long-term strategy prioritizes actions to:

• Enhance oversight of infant formula and prevent contamination
• Protect the integrity of the infant formula supply chain
• Incentivize new entrants to the U.S. market
• Support collaboration to strengthen the infant formula supply chain
• Ensure that stakeholders have the most up-to-date information on infant formula
• Improve information-sharing
• Gain additional tools and authorities to further enhance FDA's oversight of infant formula.

An area in which FDA will focus its efforts is ensuring safe production of infant formula by conducting food safety inspections of all manufacturers on an annual basis, at minimum, and setting annual sampling targets for foreign manufacturers to test for microbiological quality. FDA will also continue evaluating and improving infant formula training for inspectors and relevant staff by holding workshops.

Moreover, the agency will continue to implement its prevention strategy for C. sakazakii in powdered infant formula. This includes leveraging new information received from NACMCF on industry and public health interventions to address Cronobacter infections associated with powdered infant formula, and communicating best practices with industry based on the latest scientific information. Finally, FDA will enact structural changes and process improvements, including enhanced processes for handling consumer and whistleblower complaints throughout the agency, based on recommendations from the Office of the Inspector General (OIG). The long-term strategy also outlines how FDA intends to collaborate with other federal, state, and local partners to increase the resiliency and safety of the infant formula supply. Notably, FDA will continue to communicate and collaborate with the Council of State and Territorial Epidemiologists (CSTE), as Cronobacter has recently become a nationally notifiable disease.

While Congress has recently granted FDA additional authorities related to infant formula, the agency is still requesting resources to hire more staff and experts to increase pre-market notification review capacity, as well as more food safety inspectors. The agency also seeks the mandatory authority for remote access of records for all critical food manufacturers, and is working with Congress to require manufacturers of critical foods to give sufficient advanced notice when they decide to discontinue a critical food that is likely to lead to a meaningful disruption, as well as to encourage manufacturers to implement Redundancy Risk Management Plans and modernize manufacturing plants and equipment.

FDA Publishes Long-Term Strategy to Increase Resiliency of U.S. Infant Formula Market

USDA-FSIS has published a summary of its review of the deadly Boar's Head Listeria monocytogenes outbreak that took place in the second half of 2024. On July 12, 2024, USDA-FSIS opened an investigation into a multistate listeriosis outbreak linked to Boar's Head ready-to-eat (RTE) deli meats. By September 23, a total of 59 illnesses and ten deaths were reported in association with the outbreak. The outbreak investigation found that the products causing the illnesses were produced at Boar's Head's Jarratt, Virginia plant.

Public scrutiny of USDA and Boar's Head was heightened after FSIS inspection reports of the Jarratt facility showed a history of serious food safety and hygiene non-compliances that went unresolved in the two years leading up to the outbreak. Virginia state public health investigators, acting on behalf of FSIS, observed non-compliances like meat buildup and residues on food contact surfaces and equipment, mold, living and dead insects, condensation and pooling water, rusty pipes, improperly stored product, and other offenses. On September 13, Boar's Head announced it would indefinitely close its Jarratt plant. USDA-FSIS promised to launch an internal investigation into its handling of the outbreak, as well as its inspectional processes and regulatory oversight of L. monocytogenes, to better understand how the unsafe conditions could have been allowed to persist until they resulted in a fatal outbreak.

Findings and Short-Term Actions Resulting From USDA-FSIS' Review

As part of its review, FSIS analyzed inspection documents and establishment sampling data from January 2022 to September 2024 for the Jarratt, Virginia plant, and conducted in-person observations. The agency concluded that a large contributing factor to the outbreak was the facility's inadequate sanitation practices, underlining the issues of product residue, condensation, and structural and facility infrastructure problems.

The agency also looked at its own processes and procedures. In December, even before its internal review was completed, USDA-FSIS announced several new steps to strengthen its oversight of RTE facilities, including expanded Listeria Rule requirements and stricter state-federal cooperative inspection agreements. The agency announced a number of improvements and initiatives to be implemented quickly—which can be read in detail here—focusing on enhancing its science-based approach to mitigating foodborne pathogens, improving training and tools for its inspection workforce, and evolving its oversight of regulated facilities.

Newly Announced Long-Term Measures to Modernize L. Monocytogenes Regulation, RTE Sampling

With the publication of the summary of its internal review, FSIS has announced for the first time several actions it will take in the long term to modernize its approach to regulating L. monocytogenes. First, USDA announced in December that it is seeking new members for the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), creating a new committee that will be given the charge of reviewing FSIS' regulatory approach to L. monocytogenes. The committee should produce science-based recommendations by 2026 on how FSIS can make its regulatory approach more effective.

In its review of the Listeria Rule and existing policies, the agency will address a wide range of topics, including whether FSIS should:

1. Determine whether to require establishments to perform additional testing for Listeria and take corrective actions in response to positive results
2. Determine whether to require RTE establishments to routinely submit to FSIS through the External Lab Results System all microbial data used to support their Hazard Analysis and Critical Control Points (HACCP) system
3. Strengthen the documentation requirements for RTE food producers regarding the steps they are taking to prevent product adulteration by L. monocytogenes, including testing.

FSIS will also consider any additional revisions to the regulations that may be needed, including to sanitation model Alternatives 1–3 (Boar's Head employed Alternative 3, called the "weakest" of all available options by Congress members).

The agency will also review and consider enhancing its RTE sampling programs to more effectively identify potential Listeria contamination or harborage at the facilities it regulates. Pointing to the need for this reevaluation, in its routine RTE sampling program during 2023, Boar's Head's Jarratt plant was sampled by FSIS at the highest frequency (monthly), yet this sampling did not identify the establishment's Listeria problem.

Additionally, FSIS is exploring establishing a new routine sampling program for inspectors to collect swabs from food contact surfaces and non-food contact surfaces from the RTE processing environment based on production volume, L. monocytogenes control alternatives, and other risk factors. These samples would be analyzed for L. monocytogenes and Listeria using the new method FSIS will implement in January 2025.

Finally, FSIS will evaluate incorporation of agency Listeria results, certain types of noncompliance records, and additional relevant data into FSIS' routine sampling algorithm, which will ensure that adequate samples are collected at the highest-risk establishments. After FSIS has implemented any of the potential changes to the RTE sampling program that it is exploring, the agency will evaluate all RTE sampling programs to determine their effectiveness.

USDA Considering More Changes to Listeria Rule, RTE Sampling After Boar's Head Outbreak Review

The presence of Salmonella in raw, frozen and breaded chicken products in Canada, as well as associated human salmonellosis cases, decreased significantly after the Canadian Food Inspection Agency (CFIA) enhanced its regulation of these products in 2019, according to a study by experts at the Public Health Agency of Canada's Center for Foodborne, Environmental, and Zoonotic Infectious Diseases.

In Canada, nontyphoidal S. enterica is a leading cause of foodborne illness, and epidemiological investigations of foodborne salmonellosis cases between 2000 and 2010 identified raw, frozen and breaded chicken products as a significant source of illness. Recent estimates show these types of chicken product to be responsible for approximately 12.9 percent of Canadian salmonellosis cases from 2000–2010. Between April 2017 and April 2019 alone, whole genome sequencing (WGS) directly linked 12 outbreaks comprising 285 cases of salmonellosis to raw, frozen and breaded chicken products. This issue could partly be due to the fact that consumers believe these raw products to be ready-to-eat (RTE); a 2018 study found that 35 percent of Canadians mistakenly believed raw, frozen and breaded chicken products to be pre-cooked for reheating.

To address the issue of salmonellosis linked to raw, frozen and breaded chicken products, in April 2019, CFIA implemented a requirement for industry to implement control measures at manufacturing/processing to reduce the presence of Salmonella to undetectable levels in certain types of these products (i.e., non-intact, raw, and breaded par-fried products like chicken nuggets and popcorn chicken, sold at retail). Such control measures could include a validated cooking process resulting in an RTE frozen product, implementation of a testing program to demonstrate undetectable levels of Salmonella, or a combination of both. Industry could also implement a Salmonella test-and-hold program for finished products.

To understand the impact of CFIA's April 2019 requirements for industry to control Salmonella levels in certain raw, frozen and breaded chicken products, researchers estimated the proportion of salmonellosis cases attributable to these products prior to and after the implementation of the regulation. The researchers used data from two Canadian enteric disease surveillance systems, the National Enteric Surveillance Program and FoodNet Canada. The data included human cases of salmonellosis, and surveillance for Salmonella in retail foods.

Analysis of the surveillance data for retail samples showed the prevalence of Salmonella in raw, frozen and breaded chicken products fell from 28 percent to 2.9 percent after April 2019. The researchers found that the remaining presence of Salmonella in these products after April 2019 was largely due to those products not covered in the new requirement, but still included in FoodNet Canada retail sampling activities.

Moreover, there was a 23 percent decline in salmonellosis incidence after April 2019, estimating that 26 percent of salmonellosis cases in the pre-intervention period were attributed to raw, frozen and breaded chicken products. Overall, the researchers concluded that CFIA's 2019 requirement for raw, frozen and breaded chicken products was successful at substantially reducing Salmonella in these products at retail, and significantly contributed to a reduction in human salmonellosis incidence.

Canadian Rule for Frozen, Breaded Chicken Products Slashed Salmonella Illnesses by 23 Percent

FDA has released several new guidance documents to help industry comply with food labeling regulations; food safety regulations for ready-to-eat (RTE), low-moisture foods; and action levels for lead in certain foods.

Regarding allergens, FDA released two new guidance documents. The first is the fifth edition of a question-and-answer document about the food allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act (FFDC). The guidance replaces the draft and final guidance documents on food allergen labeling that were issued in November 2022, and has been updated based on comments to include answers to additional questions.

FDA also released a final guidance for FDA staff and interested stakeholders on the evaluation of the public health importance of food allergens other than the nine major allergens defined in U.S. law.

Concerning low-moisture RTE foods, FDA released a draft guidance for industry to inform sanitation programs and corrective actions following a pathogen contamination event. It is intended to help manufacturers and processors of low-moisture RTE foods comply with current Good Manufacturing Practices (GMPs), hazards analysis, and risk-based preventive controls.

Additionally, FDA published a draft industry guidance on the labeling of plant-based alternatives to animal foods. It outlines best practices for naming and labeling plant-based alternatives to eggs, seafood, poultry, meat, and dairy (excluding plant-based milk alternatives). If finalized, the guidance will help industry develop labels that allow consumers to understand the nature of plant-based alternative foods, including differences among these products, so they can make informed decisions.

FDA also issued a new final guidance for industry on the action levels for lead in processed food intended for babies and young children, reflecting the levels of lead at which the agency may consider the food to be adulterated under the FFDC. The final guidance covers packaged, processed foods that are marketed for babies and young children less than two years of age, including foods in jars, pouches, tubs, or boxes. These may include RTE foods such as purees, as well as semi-prepared foods such as dry infant cereals.

The action levels for processed foods described in the guidance are as follows:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
• 20 ppb for single-ingredient root vegetables
• 20 ppb for dry infant cereals.

FDA Releases New Food Safety Guidances

On December 19, 2024, the European Commission officially adopted a ban on the use of bisphenol A (BPA) in food contact materials due to its potential harms to human health. The ban also includes other bisphenols that are harmful to the reproductive and endocrine systems. Following an 18-month phase-out period, BPA will no longer be allowed in any products that come into contact with food or drink, such as the coating on metal cans, reusable plastic drink bottles, water distribution coolers, kitchenware, and food processing equipment. A few, very limited exceptions will be made to the 18-month transition period in cases where no BPA alternatives exist, to avoid supply chain disruption and give industry more time to adapt.

The Commission's decision to ban BPA is based on an April 2023 reassessment of the health risks posed by dietary exposure to BPA, which underlined harmful effects to the immune system and established a tolerable daily intake (TDI) for the chemical that is 20,000 times lower than what was previously established. According to experts, EFSA's most recent risk assessment for BPA included nonstandard studies that are not traditionally considered for assessments of this type—an approach that the scientific community non-unanimously lauded as more modern and comprehensive.

Recognizing that a ban on BPA will lead to a rise in the use of alternative chemicals, the European Food Safety Authority (EFSA) is investigating methods for assessing the risk of BPA alternatives. EFSA has published a study that advances genotoxicity assessment methods for chemicals used as BPA alternatives in combination with developing new advanced models, laying the groundwork for potential Organization for Economic Cooperation and Development (OECD) Test Guideline development and regulatory readiness.

EU Officially Adopts Ban on BPA in All Food Contact Materials

The Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Joint Expert Meeting on Microbiological Risk Assessment (JEMRA) has published a report ranking the most important foodborne viruses and virus-food commodity pairings.

Human norovirus was identified as the leading cause of foodborne illness. Hepatitis A virus and hepatitis E virus were ranked equally below norovirus in terms of frequency, but higher than norovirus in terms of clinical severity. When considering both frequency and severity, the ranking for foodborne viruses fell into three groups as follows:

1. Norovirus
2. Hepatitis A and hepatitis E, ranked in order
3. Rotavirus, sapovirus, enterovirus, astrovirus, and enteric adenovirus, ranked in order.

Virus-food commodity pairs with the highest global public health burden were also ranked for norovirus, hepatitis A, and hepatitis E:

• For norovirus: Prepared foods, frozen berries, and shellfish, ranked in order
• For hepatitis A: Shellfish, frozen berries, and prepared foods, ranked in order
• For hepatitis E: Pork and wild game, ranked in order.

Every year, norovirus is estimated to cause 125 million cases of foodborne illness and 35,000 deaths globally. Hepatitis A is estimated to cause 14 million cases of foodborne illness and 28,000 deaths around the world, annually. Hepatitis E is unique in that it is a zoonotic pathogen with many asymptomatic animal reservoirs, notably swine. Although there is no global estimation of foodborne cases of hepatitis E infection, countries that have explored the issue have concluded that their prior estimates are significantly too low.

The report highlighted international and national standard methods for detection and quantification of human norovirus and hepatitis A virus in foods since the last JEMRA report on foodborne viruses in 2008. These methods include International Organization for Standardization (ISO) methods ISO-15216-1:2017 and ISO-15216-2:2019, which are likely to become benchmarks for validation of new methods. ISO methods for hepatitis E virus detection in meats and meat products are also in development.

Aside from ISO, national methods have been validated and are being used by some laboratories. Existing methods can be limited by factors like food composition complexity and low contamination levels, and come with challenges in interpretation, applicability, integration with sequencing technologies, and implementation in low-resource countries.

JEMRA underlines the need for infectivity assays for wild-type viruses, relative to detection. The expert committee also recommends that member countries consider capacity-building to support training for and adoption of detection methods for foodborne viruses.

FAO/WHO Experts Rank Foodborne Viruses of Greatest Public Health Significance

FDA has issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key elements of an effective retail food regulatory program for state, local, tribal, and territorial (SLTT) food regulatory agencies. The Retail Program Standards include recommendations for designing and managing retail initiatives, as well as recognizing programs that effectively implement the standards, providing a foundation upon which all regulatory programs can build through a continuous improvement process.

The 2024 edition incorporates changes recommended from the 2023 Conference for Food Protection Biennial Meeting. These changes include:

• Re-standardization frequency updates
• Newly added courses
• Audit procedures updates
• New terminology.

FDA Issues 2024 Edition of Voluntary Retail Program Standards

Chipotle Mexican Grill promoted Scott Boatwright from interim CEO to permanent CEO and a board member. Boatwright was named interim CEO in August and previously was COO since 2017.

Nestlé USA appointed Martin Thompson as CEO.

Krispy Krunchy Chicken announced the appointment of Matt Testa as its new COO.

MycoTechnology named Jordi Ferre as its new CEO.

Sprague Pest Solutions hired Angela Treleven as its new CFO.

Fresh-Lock^® Closures promoted Todd Meussling to Director of Business Development and Sustainability.

USDA's Food Safety and Inspection Service (FSIS) announced leadership changes. Dr. Denise Eblen, previously FSIS's assistant administrator for the Office of Public Health Science, was named agency Administrator, and Paul Kiecker is taking on the role of Assistant Administrator in the Office of Investigation, Enforcement, and Audit.

The National Association of State Departments of Agriculture (NASDA) hired Patrick Wade as Director of Public Policy.

Arjoon Bose was appointed as Bel Group's Chief Marketing and Digital Officer.

RESOURCES

The Peanut and Tree Nut Processors Association (PTNPA) has released the Fifth Edition of the Handbook for the Safe Handling and Processing of Nuts, featuring updated chapters on Allergen Preventive Controls and Traceability, as well as a new chapter focusing on Best Practices for Importers and Exporters.

The handbook serves as a comprehensive food safety reference for the nut industry, covering onboarding, training, and implementation to aid compliance and industry advancement. The Fifth Edition was made possible by the 2024 Handbook Task Force and members' affiliated PTNPA organizations.

In a recent Food Safety Matters podcast episode, PTNPA CEO Jeannie Shaughnessy discusses how the Handbook for Safe Processing of Nuts serves the nut industry, among other topics. Listen to the episode here.

Fifth Edition of the Handbook for the Safe Handling and Processing of Nuts Released