The food system and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges—and heightens some familiar ones. As we move into 2025, the Food and Drug Administration (FDA) has established priorities that will impact how food companies operate in the coming year. In addition to the FDA’s priorities, here are some of the top food safety trends KTL’s food safety experts are tracking in 2025…

FDA 2025 Priorities

On October 1, 2024, the Food and Drug Administration (FDA) began implementing its reorganization, including launching a unified Human Foods Program (HFP) to oversee all activities related to food safety and nutrition. The HFP has prioritized key deliverables for FY 2025 to strengthen regulatory oversight, advance science, and better leverage partnerships in the areas of microbiological food safety, food chemical safety, and nutrition. The FDA also restructured the Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII) to allow the Agency’s field operations unit to focus on inspections, investigations, and imports.

As with any regulatory change, FDA-regulated companies need to understand the restructuring and its potential impacts. The HFP has outlined priorities and compliance expectations that companies need to align with their internal programs, protocols, etc. It will also be important to prepare for potential changes when it comes to inspections, including more frequent and more specialized inspections.

Update: According to Food Safety Magazine, on January 21, 2025, federal public health agencies within the U.S. Department of Health and Human Services (HHS) received orders from the new Administration to temporarily pause all external communications until further notice. This includes the FDA and U.S. Center for Disease Control and Prevention (CDC), which are jointly responsible for ensuring the safety of most of the U.S. food supply and responding to foodborne illness outbreaks. All external communications must be reviewed and approved by a Presidential appointee before being issued. The directive will be in effect until February 1, 2025

Foodborne Illness

The U.S. has experienced several high-profile food recalls in 2024 that have caused illnesses and deaths—and heightened public awareness and concern. The emergence of new bacterial and viral strains and the evolution of pathogens (e.g., Listeria, E. coli, Salmonella) that are becoming resistant to traditional food safety measures are growing concerns when it comes to preventing foodborne illnesses.

The FDA’s focus on microbiological food safety (see above) is intended to advance strategies to prevent and mitigate foodborne illnesses. On July 29, 2024, U.S. Department of Agriculture (USDA) issued its proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products; final rulemaking is anticipated in 2025. The USDA Food Safety and Inspection Service (FSIS) further announced several immediate initiatives to enhance its approach to mitigating foodborne pathogens, including modernizing L. monocytogenes regulation and ready-to-eat (RTE) sampling, in response to the Boar’s Head inspection results.

Companies need to re-evaluate their food safety programs and their effectiveness. This review may necessitate changing the current level of scrutiny for current and prospective suppliers. If sourcing any products implicated in recalls, re-evaluating current suppliers’ compliance with food safety regulations is also recommended. Sanitary equipment design, robust cleaning procedures, effective traceability programs, adherence to Good Manufacturing Practices (GMPs), and adequate training will remain key to avoiding recalls.

Supply Chain Traceability

There continues to be a real need for standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response when it comes to product traceability. As such, the FDA has prioritized the advancement of traceability tools and resources to help remove contaminated products from the marketplace more quickly.

From a regulatory standpoint, companies must start meeting the requirements of the Food Traceability Rule by January 2026, though there is speculation this may be delayed due to a provision in the current draft House appropriations bill that would prohibit funding for implementation, administration or enforcement of these regulations. Regardless, organizations should be performing traceability exercises to help identify gaps, testing protocols and verifying effectiveness, implementing corrective actions, and ensuring adequate traceability processes are in place. Investing in a good technology solution that integrates with the food safety management system (FSMS) will help to further streamline the process.

Sustainability

The U.S. Environmental Protection Agency (EPA) cites that food and food packaging materials make up almost half of all municipal solid waste in the U.S. Federal and state regulatory agencies, as well as various food safety certification schemes, have begun incenting—or requiring—organizations to incorporate sustainable food management and recycling practices into their operations. For example, the New Jersey Recycled Content Law, which came into effect on January 18, 2024, is considered one of the most ambitious recycled content laws to date.

A thorough food and packaging assessment serves as the foundation for reduction efforts. Having a general understanding of operations and waste streams can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, optimize inventory management, use more recycled content, and reduce water and energy use associated with food production.

Employee Safety

Between October 2018 and September 2019, the Occupational Safety and Health Administration (OSHA) issued 1,168 citations resulting in over $7 million in fines to the food manufacturing industry, with lockout/tagout and machine guarding topping OSHA’s annual list of the most frequently cited standards in food manufacturing. Occupational safety and health risks in food manufacturing are often heightened because of the nature of the product (i.e., food or drink) being manufactured.

OSHA is watching, and facilities need to prioritize employee safety. Conduct a thorough hazard analysis of the facility, operations, and processes to identify potential safety hazards. Based on the analysis, develop, implement, and maintain the appropriate safety programs, procedures, and instructions. Provide the proper personal protective equipment (PPE) to keep employees safe. And, importantly, train employees so they understand what they need to do to protect themselves and others.

PFAS

The EPA continues to make significant contributions to confront the human health and environmental risks of per- and polyfluoroalkyl substances (PFAS). In April 2024, EPA introduced the first national drinking water standards for PFAS, and many states are introducing policies related to PFAS, including monitoring and testing for PFAS in water and banning PFAS in food packaging, clothing, and other consumer products. The FDA is further working to limit PFAS in food and food packaging. In 2024-2025, the FDA has committed to testing foods from the general food supply to more accurately estimate exposure to PFAS from foods. This includes testing total dissolved solids (TDS) samples, conducting a survey of bottled water, and conducting additional seafood testing.

Organizations need to address PFAS in their operations, products, supply chains, and waste streams; stay informed about ongoing PFAS regulatory developments; and adjust compliance programs and operational practices, as needed.

Digital Transformation

According to McKinsey & Company, automation could increase productivity by up to 20% in the food manufacturing sector. More companies are employing technology solutions to improve business efficiency, and the FDA has prioritized developing AI approaches to help monitor new data and trends in FY 2025.

AI is quickly becoming a more viable solution for many food companies in automating, monitoring, and managing food safety, helping to identify contamination risks, analyze data, predict potential hazards, conduct training simulations, and even optimize cleaning schedules. While the efficiencies and other benefits of technology solutions are many, the increased reliance on AI will require an investment, not just financially but also in oversight and management, training, and cybersecurity measures. As the digital transformation continues, companies will need to determine where automation is appropriate and where the human factor is still required.

Others to Watch

• Red No. 3: On January 15, 2025, the FDA amended its color additive regulations to no longer allow for the use of Red No. 3 in food and ingested drugs. Manufacturers who use Red No. 3 will have until January 15, 2027 (food) or January 18, 2028 (ingested drugs) to reformulate products. Foods imported into the U.S. must also comply with this requirement.
• Produce Safety Rule: Pre-Harvest Agricultural Water: In May, 2024, the FDA released the updated requirements for the Produce Safety Rule, Subpart E for pre-harvest agricultural water. Facilities are now able to justify not testing agricultural water if there are no conditions (e.g., animals, human waste, or biological soil amendments of animal origin (BSAAO)) on nearby or adjacent land that pose a risk to the water source. The first compliance date for large farms is April 7, 2025.
• SQFI New Edition 10: The Safe Quality Food Institute (SQFI) is slated to release SQF Edition 10 in July 2025. Anticipated updates focus on the identification of new food safety risks, changes in the global supply chain that may impact food safety, unforeseen events (e.g., foodborne illness outbreaks), new technology, and harmonization with other internal food safety programs.
• Bird Flu (H5N1): With the rise in cases and mutations, the USDA has announced different approaches to prevent the spread of H5N1, including testing bulk raw milk. The State of California also declared a state of emergency to allocate more resources to address the continued spread of Bird Flu.
• Food Date Labeling Reform: In December 2024, the FDA and USDA announced a joint Request for Information (RFI) regarding food date labeling (e.g., ‘Sell By,’ ‘Use By’ and ‘Best By’). Open date labeling is currently not mandated or standardized by federal law. The RFI seeks information on industry practices and preferences for date labeling.

Set Your Goals for 2025

In 2025, organizations will continue to encounter workplace challenges, regulatory adjustments, food safety concerns, and rapid technology advancements—and, in most cases, fewer resources to manage it all. KTL suggests completing the following early in 2025 to prepare for whatever is on the horizon:

• Get senior leadership commitment and invest in creating a food safety culture that prioritizes food safety, quality, and employee health and safety. Focus on changing from a reactionary to a preventive mindset. And remember that your people are as important as your products.
• Conduct a comprehensive food safety and quality gap assessment. Know your operations, inventory your ingredients, understand your supply chain, quantify your food waste. This assessment should be the starting point for understanding your regulatory and certification obligations and current compliance status—and for ensuring you are prepared to meet pending regulatory developments.
• Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data. This could mean stepping into the world of AI and machine learning; it could also mean implementing a digital FSMS to help manage compliance/certification and recordkeeping requirements. Technology advancements can help create significant business efficiencies when used appropriately.
• Train your staff. Every trend discussed above requires employee understanding. Train your team routinely on requirements, responsibilities, processes, expectations, etc. Of particular note for Preventive Controls Qualified Individuals (PCQIs), the International Food Protection Training Institute (IFPTI) has released Version 2.0 of the Preventive Controls for Human Foods course. The old version will no longer be taught as of May 2025, but the training will still be recognized.

Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance. An outside expert can often provide the “big picture” view of what you have vs. what you need; how your plans, programs, and requirements intersect; and how you can best comply with changing requirements.

Every year, we see a number of environmental, health, and safety (EHS) trends rise to the surface that have the potential to impact many industries. As we enter 2025, some challenges and opportunities in EHS remain ongoing; some are just gaining traction with impacts yet to be known, particularly with a change in Administration just taking hold. Here are some of the top EHS trends KTL is keeping watch on in 2025…

Regulatory Landscape

In 2022, the Environmental Protection Agency (EPA) published its FY 2022-2026 EPA Strategic Plan to communicate the Agency’s vision, priorities, and strategies. Specifically, the Plan includes targeted objectives and outcomes in the areas of climate change; environmental justice; compliance enforcement; clean land, air, and water; and chemical safety. The Occupational Safety and Health Administration’s (OSHA’s) focus centers on National Emphasis Programs (NEPs) for 2025 related to combustible dust, fall protection/prevention, heat, silica crystalline, and warehousing and distribution center operations, as well as many regional directives.

With a new Administration taking office in January, a big unknown of the coming four years is how the EHS regulatory landscape will change. There is speculation regarding plans to reorganize the EPA and establish “pause and review” teams to assess major rules, guidance materials, grants, legal settlements, budgets, etc. How this will translate into regulatory action remains to be seen.

Update: According to InsideEPA.com, acting EPA Administrator James Payne issued a directive on January 24, 2025, ordering all EPA staff to stop all communications with external parties pending further instruction. Exemptions will allow EPA staff to continue to communicate with state and federal agencies, provided they do not discuss enforcement matters; talk to relevant partieis to facilitate imports; and continue conducting inspections. It is unclear at this time how long the directive will remain in place.

Mental Health

Companies are increasingly recognizing that traditional safety programs must evolve to prioritize mental health as much as physical health—from mental health days to employee assistance programs, to stress management training, to flexible work hours. Correspondingly, psychological safety is becoming a critical concept for building effective teams and encouraging workplace innovation and success. A psychologically safe culture allows employees to take reasonable risks in a safe environment without negative interpersonal consequences.

A related concept is safety culture, which is concerned with many cognitive aspects of safety, like norms, perceptions, beliefs, and values. Emphasizing mental health as part of the organization’s safety culture may become a priority for mature organizations. As the concept of total worker health continues to expand, the focus on mental health is also likely to be reinforced by new regulations and standards regarding psychological safety in the workplace.

Sustainability and Climate Change

Environmental, Social, and Governance (ESG) initiatives have dominated many corporate agendas for the past several years, particularly with Europe and Canada advancing standards related to sustainability and climate change data reporting and ISO’s recent Climate Change Amendments. Many organizations have worked to significantly improve their data collection efforts and have integrated climate change management and circular economy principles into their sustainability strategies.

The change in Administration may increase scrutiny regarding the value of these ESG initiatives. We have already seen the Securities and Exchange Commission’s (SEC) March 2024 Climate-Related Disclosures Rule stayed due to multiple petitions and lawsuits. This may be a sign of things to come. Many companies have invested in their ESG efforts and will continue to do so, but 2025 may present an opportunity to reassess and streamline initiatives to ensure they are practical and upholding sustainability goals, while also contributing value to the company.

PFAS

Per- and polyfluoroalkyl substances (PFAS) became a focal point for EPA in 2021 with the publication of its PFAS Strategic Roadmap, which committed to addressing concerns related to PFAS exposure. Actions have included improving reporting on PFAS, as well as adding seven additional PFAS to the Toxics Release Inventory (TRI) in January 2024 and an additional nine in January 2025. In April 2024, EPA announced three more notable actions, including introducing the first-ever national drinking water standards and designating perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as “hazardous substances” under Superfund. In addition, the updated Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS will require entities to report releases of these “forever pollutants” that exceed threshold quantities. 

Beyond federal regulations, many states are introducing policies related to PFAS, including monitoring and testing for PFAS in water and sewage sludge and banning PFAS in food packaging, clothing, and other consumer products. Organizations need to address PFAS in their operations, products, supply chains, and waste streams; stay informed about ongoing PFAS regulatory developments; and adjust compliance programs and operational practices, as needed.

Personal Protective Equipment (PPE)

Properly fitting PPE is essential for workers to complete their tasks safely. If PPE is not correctly fitted to the body, it can cause discomfort and increase the risk of workplace accidents and injuries. On December 11, 2024, the Occupational Safety and Health Administration (OSHA) announced its finalized revision to the PPE Standard for Construction, which requires PPE to properly fit any construction worker who needs it, including women and physically smaller or larger workers.

Employers must ensure that every employee not only has the right PPE, but that it also fits. Fit testing may identify the need for PPE alternatives to meet the anthropometric needs of all workers. Importantly, employees must be trained and empowered to speak up if PPE does not fit appropriately to ensure their safety.

Technology/AI

Artificial intelligence (AI) and machine learning technologies have the capacity to significantly alter how companies manage their EHS programs. While still not fully mature, these technologies are becoming more sophisticated. As AI evolves and becomes more generally accepted, more companies are likely to start adopting it to automate routine compliance tasks, conduct EHS assessments, perform training simulations, predict potential safety incidents, monitor workplace conditions in real-time, and more.

While the efficiencies and other benefits of technology solutions are many, the increased reliance on AI and machine learning will require increased oversight and management. In particular, companies will need to determine where automation is appropriate and where the human factor is still required. Not all processes lend themselves to AI. It will also be imperative to consider stronger data privacy protocols to ensure the security of the company.

Others to Watch

• OSHA Reporting: On January 1, 2024, the Department of Labor’s (DOL’s) final rule requiring employers in designated high-hazard industries to electronically submit injury and illness information to OSHA took effect. KTL inspections routinely find errors and omissions in OSHA recordkeeping. Effective solutions, particularly areas where hard copies can be replaced by digital forms, are needed.
• Hazard Communication Standard: The final Hazard Communication Standard took effect on July 19, 2024, implementing the first major updates since 2012. The first compliance date requires chemical manufacturers, importers, and distributors to update labels and Safety Data Sheets (SDSs) for chemical substances by July 19, 2026.
• Lead Levels: In January 2024, the EPA reduced the acceptable amount of lead in soil for residential exposure, stating that no level of lead is acceptable. These reduced levels may soon be translated into commercial exposures. 
• One Health: Both the Society of Environmental Toxicology and Chemistry (SETAC) and Society of Toxicology (SOT) have adopted One Health initiatives as an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals, and ecosystems (SOT). The idea is to look at the health of our environment and all aspects of our environment as a whole and not one component at a time. This idea is being translated into health impact assessments. 
• Pesticide/Herbicide Re-evaluation: The EPA has initiated re-evaluations of registered pesticides, herbicides, rodenticides, and fungicides, including the highly publicized Roundup. These reviews are expected to result in a recommendation to focus the use of these chemicals rather than using a general broadcast application. 
• Microplastics: Microplastics have been found in every ecosystem on the planet—in food, beverages, and human and animal tissue. Scientists do not fully understand the impacts of microplastics on human health and aquatic life, and industry is struggling with how to manage them due to their pervasive nature and wide variety of shapes and sizes. Ongoing research in pollution prevention will be forthcoming.

Getting Ahead in 2025

In 2025, organizations will continue to encounter evolving workplace challenges, regulatory adjustments, societal demands, economic pressures, and rapid advancements in technology—some of which can be anticipated, some which remain to be seen. KTL suggests completing the following early in 2025 to prepare for whatever is on the horizon:

• Get senior leadership commitment. Even with the best EHS personnel, the organization and its EHS system will only be as strong as the top leadership and what they prioritize.
• Stay abreast of regulatory developments. Monitor what is going on at the federal (i.e., EPA and OSHA) and state levels, assess your regulatory applicability, and evaluate how any potential regulatory changes over the next year(s) may impact your operations.
• Conduct a comprehensive gap assessment to ensure you are efficiently meeting your EHS requirements (i.e., regulatory, management systems, internal, supply chain). Think critically about how overlapping requirements may apply (e.g., your chemical inventory may uncover requirements for air permitting, waste management, Tier II report, etc.) and how you can integrate systems to improve efficiency and compliance.
• Determine where you can integrate technology solutions into your operations. This could mean stepping into the world of AI and machine learning; it could also mean implementing compliance information management systems to help manage compliance and reporting requirements. Technology advancements can help create significant business efficiencies when used appropriately.
• Seek third-party oversight. Many EHS departments are severely understaffed. Having external experts periodically look inside your company provides an objective view of operations, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance. An outside expert can often provide the “big picture” view of what you have vs. what you need; how your plans, programs, and requirements intersect; and how you can best comply with changing requirements.

As the role of technology continues to expand at a significant pace, keeping up with advances can be challenging. Technology can offer opportunities to simplify compliance, create efficiencies, improve recordkeeping, inform better decision-making, and more if used appropriately. Here are some of the top Microsoft 365® technology advances KTL anticipates will be trends in 2025…

SharePoint® Modernization

SharePoint is constantly evolving to provide enhanced functionality to users. In 2016, Microsoft introduced the “modern” experience for SharePoint as a significant improvement, with its more modern interface that integrates better with mobile screens. When it was introduced, converting to the modern interface was optional; companies could continue operating their existing “classic” sites without necessitating significant updates. But in the past eight years, classic sites have become outdated, have limited mobile integration, and are beginning to experience performance issues resulting from limited ongoing support. Further, previous methods of creating custom forms (InfoPath) or workflows (SharePoint Designer) are slowly being phased out in favor of modern replacements, and Microsoft is removing SharePoint 2013 Workflow from existing tenants and fully retiring it in April 2026. 

Because of this, organizations are being pushed to migrate from classic to modern SharePoint to keep their sites running and usable. Beyond responding to the slow depreciation of classic sites, modern SharePoint offers significant enhancements that improve user experience and overall site performance. Transitioning from a classic SharePoint site to a modern one is not considered a “simple” process, because there is no one-to-one mapping between the functionality offered by classic web parts and what is offered on modern pages. But it is worth doing. Modern sites are less costly to create, quicker to implement, easier to manage, and much simpler to edit and update.

Digital Forms

Companies have completed inspections and assessments via paper forms for years. Many still follow this traditional process, creating mountains of paperwork and related inefficiencies. Digital forms are a simple technological advancement that more companies are embracing to improve compliance and productivity. Digital forms allow employees to quickly and easily collect data from a mobile device—from daily inspections (e.g., forklifts) to near-miss information—as it is happening in the plant/field. That data is submitted directly to the system and can then be further analyzed through dashboards to identify concerns and trends. Notifications for identified issues and program compliance can also be configured to create greater visibility.

With digital forms:

• Data can be submitted directly and immediately for review with no manual data entry required.
• Data is stored for future analysis and improvements.
• Issues can be identified quickly and assigned to relevant people for resolution.
• Program compliance is tracked in real time.

Custom Business Apps

Power Apps is Microsoft’s low-code platform for creating custom business apps. Users can create apps, add their own data sources, create custom workflows, design their own user interface—all without extensive coding experience. With its growing popularity, Microsoft is continuing to expand Power Apps’ functionality and help more organizations leverage its flexibility. Specifically in 2025, Power Apps users can look forward to the following advances:

• Deeper integration with Microsoft 365 and other emerging technologies/data sources to create smoother workflows, better collaboration between tools, and an overall simpler user interface and experience.
• Enhanced low-code/no-code capabilities, such as more drag-and-drop features, visual interfaces, and templates to allow for faster development of line-of-business apps, mobile apps, and web apps.
• Improved mobile responsiveness to ensure Power Apps functions well not only on computers, but also on smartphones and tablets.
• Integration with Power BI to allow businesses to develop comprehensive data solutions, manage workflows, and visualize key metrics through dashboards (see below).

Automated Workflows

Microsoft Power Platform® allows businesses to automate workflows and streamline and standardize processes. For example, a document approval workflow can be set up to automatically route documents, assign review tasks, track progress, and send reminders and notifications when needed. It takes documents from development through final approval, ensuring documents are reviewed at the appropriate time by the appropriate party.

Automated workflows can be developed for virtually any business process, and the benefits of doing so are many, including:

• Standardized and streamlined approach for approving and completing tasks.
• Improved accuracy with less opportunity for human error.
• Business efficiencies from automated and streamlined practices.
• Version control and history to create a reliable audit trail.
• Improved access/security for sensitive information.

Data Visualization and Insights

A dashboard is a tool used to quickly display and visualize data, typically using charts, tables, and other graphic elements. Dashboards provide a quick and simplified way for users to understand complex data sets, review key performance indicators (KPIs), and identify trends or patterns.

The data collected in most business processes—ranging from the outputs of an inspection form to the inputs into a companywide sales program—can be displayed in a dashboard. Centralizing and visualizing this data can have significant business benefits, including the following:

• Dashboards provide an integrated view of data pulled from multiple sources into an easy-to-read display.
• Simplified data visualization allows for improved and more efficient decision-making.
• Dashboard metrics provide for monitoring of data that has been collected.
• The collaboration, customization, and transparency provided through dashboards help support organizational objectives.

Getting Ahead in 2025

Traditional processes tend to produce traditional results. Integrating technology can help companies to stretch and empower every limited resource. The key is identifying those traditional processes that will realize benefit from technological integration, such as those outlined above.

The right technology can enhance traditional business practices to create greater efficiencies and enhanced business value. Integrating technology with current business practices not only allows for continual improvement, it also helps create the next level of competitive advantage. Doing so requires businesses to start thinking strategically about these trends now. It also requires working with someone with the technology expertise to design and build scalable systems that allow the organization to more efficiently and effectively manage compliance and business processes. Technology solutions should be designed with the end in mind. That means considering the company’s immediate issues/needs within the context of the overall business need, and then formulating platforms/systems, as required, into an aligned system.

KTL is pleased to welcome the following new Consultants to our team!

Margaret Roy, Senior Consultant

Margaret is an expert risk assessor who specializes in conducting ecological and health-based risk assessments ranging from screening level to complex baseline assessments under a variety of state and EPA programs. She has been providing risk assessment subject matter expertise to KTL for years as an LTE, and we are thrilled to have her join the team as a Senior Consultant. Margaret applies her experience to help clients design sampling plans, identify technical data gaps, and develop overall project strategy. Margaret is a Diplomate in the International Board of Environmental Risk Assessors (IBERA), as well as a member of the Society of Environmental Toxicology and Chemistry (SETAC) and Association for Environmental Health and Science (AEHS). She is based in Austin, TX. Read her full bio…

mroy@goktl.com | 512.913.5142

Connor Odekirk, Consultant

Connor is a food safety and quality assurance (FSQA) professional with five years of experience working in various capacities in the food industry, including restaurants, cattle ranches, farming operations, and U.S. Department of Agriculture (USDA)-inspected meat processing plants. Connor excels at managing sanitation and maintenance programs to maintain corporate and regulatory standards. He further has experience developing training and educational curriculum. He is based in Charleston, WV. Read his full bio…

codekirk@goktl.com | 304.545.5555

Access to treatment for opioid use disorder (OUD) is a challenge in rural settings and communities of color due, in part, to the limited availability of healthcare providers equipped and willing to provide medications for opioid use disorder (MOUD). Recent discussion has explored the role of pharmacies in enhancing access to MOUD within underserved areas. However, pharmacies face multiple obstacles related to expanded responsibilities in dispensing MOUD, especially in rural and other communities.

To address this issue, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded a study (CTN-0124) to examine the practicality of expanding pharmacy roles in treating OUD in underserved communities.

KTL helped to lead the nine-month engineering systems analysis, assessing the existing system, envisioning an ideal future state, identifying gaps, and highlighting improvement opportunities. The study, Delivering MOUD to the Underserved: How Can Pharmacies Really Helped?, was recently published in the October 15, 2024 edition of the Journal of Studies on Alcohol and Drugs.

On October 1, 2024, the Food and Drug Administration (FDA) began implementing the largest reorganization in the Agency’s recent history, including launching a unified Human Foods Program (HFP) to oversee all activities related to food safety and nutrition and transforming the Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII), amongst other modernizations. This reorganization is intended to enhance the FDA’s ability to protect the human food supply and make the Agency more efficient and prepared to respond to changes in industries, food and medical product technologies, and the impacts of globalization and climate change.

HFP: Priorities for 2025

The FDA regulates 80% of the U.S. food supply. The HFP was designed to help ensure that the FDA-regulated food supply is safe by taking a systematic, risk management approach to implementing the preventive measures outlined in the Food Safety Modernization Act (FSMA) and responding to food-related emergencies. Specifically, the HFP’s mission is to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.

To support this mission, FDA is implementing several operational changes, including developing enhanced risk modeling, advancing inspectorate training, establishing a Human Foods Advisory Committee, developing a performance management framework, improving recall communications, and integrating food laboratories to advance science.

The HFP has also prioritized key deliverables for FY2025 to strengthen regulatory oversight, advance science, and better leverage partnerships in the following risk management areas:

Microbiological Food Safety

Advancing strategies to prevent foodborne illness. Specific deliverables include:

• Finalizing an implementation plan for the FSMA Final Rule on Pre-harvest Agricultural Water.
• Advancing traceability tools and resources to remove contaminated products from the marketplace more quickly.
• Issuing final guidance for the Produce Safety Rule and developing associated compliance resources.
• Initiating a study to better understand Salmonella outbreaks linked to melons.
• Enhancing the use of GenomeTrakr to help identify and respond to outbreaks.
• Working with various stakeholder groups to develop strategies to prevent and mitigate microbiological foodborne risks.
• Enhancing communication and transparency, including publishing a new public outbreak report and facilitating information sharing related to fresh produce and seafood.
• Implementing regulatory partnerships with Ecuador, India, and Indonesia for imported seafood.

Food Chemical Safety

Ensuring exposure to chemicals in food is safe. Planned actions include:

• Reviewing inefficiencies in the current premarket review process for food or color additives to help prevent unsafe uses of chemicals.
• Updating the framework for post-market assessments of chemicals in food and publishing an updated list of substances prioritized for re-assessment.
• Establishing action levels and associated guidance for environmental contaminants in food intended for infants and young children.
• Releasing additional guidance on submitting new dietary ingredient notifications (NDINs).
• Issuing draft guidance for Preventive Controls for Human Food specific to chemical hazards.
• Completing external review and validation of the Expanded Decision Tree, which sorts chemicals into classes of toxic potential.
• Developing AI approaches to help monitor new data and trends.
• Evaluating and characterizing potential effects of PFAS exposure from selected foods.
• Partnering with international organizations on food chemicals and innovation to strengthen the global food safety system.

Nutrition

Elevating nutrition to improve health equity. Deliverables include:

• Issuing a final rule to update the definition of the claim “healthy” and educating the public.
• Proposing a rule to establish mandatory front-of-package nutrition labeling.
• Publishing a long-term national strategy to help facilitate the entry of new infant formula manufacturers and continuing education on safe handling of powdered infant formula.
• Advancing nutrition research to better inform food-related policy and regulatory decision making.

OII’s Focus on Inspections

Restructuring the ORA into the new OII is intended to allow the Agency’s field operations unit to focus on inspections, investigations, and imports to support its core mission to conduct rigorous, transparent, and science-based inspections and investigations, providing real-time evidence and insight essential in empowering fact-based regulatory decisions to protect public health. OII is charged with inspecting regulated products and manufacturers, as well as reviewing imported products.

This restructuring will enable the FDA to put more focus directly on inspections and investigations and, subsequently, create a more efficient compliance and enforcement process, clearer communication, and faster decision-making. As a result of this transformation, inspections have the potential to become more efficient—and more frequent. In addition, increased inspection resources may allow inspectors to specialize in specific product areas, which could lead to more thorough and knowledgeable inspections.

Keeping Up

As with any regulatory change, FDA-regulated companies need to get up to speed on FDA’s recent restructuring and its potential impacts:

• Educate staff on FDA’s reorganization and potential implications for your organization.
• Identify any new points of contact for your organization within the FDA (i.e., HFP, OII), anticipate how your interactions may change, and start building new relationships, where necessary.
• Review the HBP priorities and compliance expectations for FY2025 compared to internal programs, protocols, etc. and make any required updates to ensure alignment.
• Prepare for potential changes when it comes to inspections, including more frequent and more specialized inspections. This may include educating staff to get a deeper understanding of products/operations and the associated regulatory requirements and/or stepping up compliance efforts, where necessary.

KTL uses the Microsoft Power Platform®—including SharePoint®—as a suite of dynamic information management tools that can be customized to provide streamlined, centralized information management and consolidated reporting to all levels of the organization.

SharePoint is constantly evolving to provide enhanced functionality to users. In 2016, Microsoft introduced the “modern” experience for SharePoint as a significant improvement, with its more modern interface that integrates better with mobile screens. When it was introduced, converting to the modern interface was optional; companies could continue operating their existing “classic” sites without necessitating significant updates. But in the past eight years, classic sites have become outdated, have limited mobile integration, and are beginning to experience performance issues resulting from limited ongoing support. Further, previous methods of creating custom forms (InfoPath) or workflows (SharePoint Designer) are slowly being phased out in favor of modern replacements. Because of this, organizations are being pushed to migrate from classic to modern SharePoint to keep their sites running and usable.

Benefits

Beyond responding to the slow depreciation of classic sites, modern SharePoint offers significant enhancements that improve user experience and overall site performance, including the following:

• Modern, Intuitive Interface: The user-friendly interface offers streamlined navigation, improved layouts, and mobile responsiveness for optimal viewing on different screen sizes (e.g., phone, laptop, desktop, tablet). This provides easier user interaction and enhanced accessibility in the office, plant, field, etc.
• Performance Optimization: Modern SharePoint sites are optimized for performance. The search functionality is more powerful and produces more relevant search results that are easier to filter and find. Optimization also creates faster page load times to improve efficiency for users.
• Flexible Modern Web Parts: Modern’s wide range of configurable web parts can be simply added or modified to update site content.
• Custom Workflows and Automation: Modern SharePoint can be more easily tailored to specific business needs by integrating Power Automate, Power Apps, and other apps to build custom workflows, forms, and automations that support changing business processes.
• Seamless Microsoft 365 Integration: Modern SharePoint integrates deeply with other Microsoft 365 tools, including Microsoft Teams, OneDrive, and Planner. This makes collaboration more efficient, as employees can work together in real-time using familiar tools.

Get Modernizing

Microsoft suggests taking a four-step approach to transitioning from a classic SharePoint site to a modern one:

1. Assess. Inventory your existing site, determine priorities for modernization, and establish a clear scope of work.
2. Strategize. Develop a strategy for how the classic site will be transformed into a modern site, considering the various impacts of the transition on different elements of your system.
3. Execute. Create an implementation plan to outline what needs to happen to update each site and associated roles, responsibilities, tasks, and timelines.
4. Enhance. Consider the many opportunities for integrations and enhancements to address business needs once sites have been converted.

Transitioning from a classic SharePoint site to a modern one is not considered a “simple” process, because there is no one-to-one mapping between the functionality offered by classic web parts and what is offered on modern pages. But it is worth doing. Modern sites are less costly to create, quicker to implement, easier to manage, and much simpler to edit and update.

If you currently have a classic SharePoint site, KTL can walk you through the modernization process to help ensure your sites deliver improved functionality, enhanced user experience, and better overall performance. Please reach out and set up a no-obligation demo.

“Best if Used by”, “Sell by”, “Expires on”, “Freeze by”…

Consumers see various versions of these phrases on food product labels all the time. But do they understand what these labels mean? Does industry? According to the Food and Drug Administration (FDA), it is estimated that the confusion over date labeling terms on food products accounts for about 20% of the food waste in the home. This is significant given that the U.S. Department of Agriculture (USDA) estimates nearly one-third of available food in the U.S. (i.e., 133 billion pounds) goes uneaten due to food loss or waste.

Why the confusion? Because open date labeling is still not mandated or standardized by federal law. In fact, the State of California just recently passed the first legislation of its kind in September 2024 to standardize the use of open date labeling on food products.

Nutrition Labeling vs. Open Date Labeling

The Nutrition Labeling and Education Act (NLEA) of 1990 requires that food manufacturers provide standardized nutritional information on their products. It also requires that food labels comply with certain requirements if they make nutritional or health claims. The FDA developed the Nutrition Facts Label to comply with the requirements of the NLEA.

The phrases mentioned above are considered open date labeling and are not part of the NLEA. Any open date labeling on food products is applied voluntarily by manufacturers or retailers to tell consumers when food is of best quality. With the exception of infant formula, these dates are not required and are not related to a product’s safety.

The USDA gives the following definitions of common phrases on open date labels:

• “Best if Used by/before” indicates when a product will be of best flavor or quality. It is not a purchase or safety date.
• “Sell by” tells the store how long to display the product for sale. This phase is for inventory management; it is not a safety date.
• “Use by” provides the latest date recommended for the use of the product while at peak quality. It is not a safety date (except on infant formula).
• “Freeze by” indicates when a product should be frozen to maintain peak quality. It is not a purchase or safety date.

A Question of Quality

For most, the confusion lies in understanding the status of a food product once the open date passes. While the quality of perishable products may deteriorate after a “Best if Used by” date, most products remain safe to eat, sell, or donate as long as they are handled properly (e.g., correct temperature and storage conditions) and show no signs of spoilage. In fact, the USDA suggests that food handling conditions are a greater predictor of spoilage than time (i.e., open date).

Sources including FDA, USDA, and a number if industry associations believe that food waste is due, in part, to fears about food safety and consumers not understanding that date labels refer to the quality of a product versus its safety to consume.

Call for Standardization

Despite this confusion and the associated ramifications (i.e., wasted food, economic loss), no mandatory federal labeling standard has been enacted, though attempts at standardization have been made:

• The Food Recovery Act of 2015 introduced the first language to standardize date labels, but it did not pass Congress. 
• In December 2016, the USDA Food Safety and Inspection Service (FSIS) updated its guidance on product date labeling, recommending that manufacturers and retailers use the phrase “Best if Used by” to indicate when a product is at peak quality.
• In 2017, industry stepped in, as the Food Manufacturing Institute (FMI) and the Consumer Brands Association (CBA) adopted joint industry guidelines to standardize open dates.
• The FDA issued a letter supporting industry’s efforts to standardize date labeling in May 2019. Consistent with the USDA, the FDA recommended using the “Best if Used by” date for manufacturers choosing to apply a quality date label.
• In 2019, the first Food Date Labeling Act (FDLA) was introduced in Congress and failed to pass. The FDLA was introduced again in 2021 and, most recently, in 2023.

California Leads the Way

In the meantime, the State of California has forged ahead, passing legislation in September 2024 to standardize the use of open date labeling on food products. Beginning July 1, 2026, the law implements the first mandatory food date labeling for companies selling food products in California by instituting the following changes:

• “Best if Used by” must be used to indicate the date when a product reaches peak quality.
• “Use by” must be used to indicate the date when a product’s safety can no longer be guaranteed.
• Retailers will be authorized to display “Packed on” labels on prepared food items, but they must also display the “Best by” or “Best if Used by” dates.
• Consumer-facing “Sell by” dates are prohibited and may only be used for inventory management.
• The phrases “Expires on” and “Freshest by”, which have inconsistent definitions, are prohibited.

Support from Industry

According to the Zero Waste Food Coalition, over 25 industry supporters have signed the Zero Food Waste Coalition’s open letter urging Congress to support the bipartisan Food Date Labeling Act of 2023…  Major food industry businesses, including Kroger, Walmart, and Nestlé USA, have signed the letter, which cites that standardizing and streamlining date labels is one of the most cost-effective methods to prevent the wasting of surplus, wholesome food.

Currently, it is at the food manufacturer’s/retailer’s discretion to use open date labeling as they see fit. As such, it is important for manufacturers and retailers to understand what the various open date labeling phrases mean before applying them to products. The available USDA, FDA, and industry guidance is meant to alleviate consumer confusion and should be used as best practice in absence of a federal standard. Using this guidance to standardize open date labeling practices to the extent possible may help manufacturers extend the shelf-lives of their products, prevent the corresponding economic loss of removing inventory from the supply chain, and reduce the amount of wholesome food being wasted.

KTL will be joining the technical program of the Society of Environmental Toxicology and Chemistry (SETAC) North America 45th Annual Meeting October 20-24, 2024 in Forth Worth, TX. SETAC is dedicated to advancing environmental science and science-informed decision-making through collaboration, communication, eductaion, and leadership.

KTL Senior Consultant Margaret Roy will be co-chairing Session 6.04.T – Risk Assessment, Remediation, and Restoration: Applying Interdisciplinary Approaches to Creating Successful Remediation and Restoration Projects on Wednesday, October 23 from 10:00am – 12:00pm.

In addition, KTL is co-author to the following poster, which will be on exhibit all day on Monday, October 21:

Human Health and Ecological Risk Assessment of the Herbicide Flumioxazin for the U.S. Forest Service
5.12.P-Mo-160 | Presenters: Julie Rothrock, SRC, Inc.; Margaret Roy, KTL; and Dan Tekiela, U.S. Forest Service

The United States Department of Agriculture (USDA) Forest Service (FS) is responsible for protecting and managing natural resources on National Forest System lands. Pesticides are one tool used by the FS to prevent, control, or manage forest insects, diseases, and invasive plants. When considering the use of a pesticide on forest lands, the FS conducts a human health and ecological risk assessment (HHERA) to evaluate risk to FS personnel, the public, and the environment, and to then make decisions regarding specific applications of pesticides on forest lands throughout the U.S. This poster presentation outlines the process for conducting theHHERA for the herbicide flumioxazin to estimate the nature and degree of potential risks, both human health and environmental, associated with its use in FS vegetation management programs. 

Location: Chicago, Illinois or St. Lous, Missouri

KTL is seeking an experienced Safety Consultant based in the Chicago, IL or St. Louis, MO metropolitan area with a strong safety compliance background working as a consultant or in industry to join our team. This individual will have knowledge of general industry safety procedures and Occupational Safety and Health (OSHA) requirements. The Safety Consultant will have experience auditing, developing, and implementing OSHA safety programs in an industrial setting, and expertise helping organizations proactively manage their operational safety-related risks.

Responsibilities and tasks include the following:

• Conducting OSHA compliance audits in general industrial settings.
• Researching federal, state, and local regulatory requirements and helping maintain standards.
• Effectively managing and building client relationships, leading to repeat business.
• Developing and delivering training and coaching on safety.
• Performing site safety assessments, conducting incident investigation/root cause analysis, and implementing follow-up corrective actions.
• Working with a team to assess, design, implement, and audit safety management systems and related programs.
• Designing safety performance metrics to drive continual improvement.
• Applying quality and process improvement methods and tools.
• Writing technical reports, work plans, and proposals.
• Supporting other KTL professionals to effectively manage and deliver projects.
• Managing tasks remotely and at client sites.

Requirements

• B.S. degree in Environmental Science, Engineering, or Occupational Safety preferred.
• 5-10 years of consulting or relevant experience working in safety for industry/manufacturing.
• Associate Safety Professional (ASP) or Certified Safety Professional (CSP) preferred.
• Recent experience conducting safety audits.
• Strong knowledge of OSHA safety standards and programs.
• Experience with environmental compliance preferred.
• Experience in healthcare preferred.
• Previous project management experience and ability to manage multiple projects and clients.
• Excellent verbal and written communication, interpersonal, and presentation skills.
• Excellent research, analytical, writing, and organizational skills.
• Ability to work independently and as a part of a team.
• Proficient in Microsoft 365 software.
• Valid driver’s license.
• Ability to travel up to 50%.

How to Apply

Forward a resume to recruiting@goktl.com.

Company Description

KTL is a multidisciplinary consulting firm that specializes in providing environmental, health, and safety (EHS); food safety; and quality management and compliance consulting services to industry and government clients. Our primary focus is to build strong, long-term client partnerships and provide tailored solutions to address regulatory compliance requirements. KTL’s services include auditing and assessments, management system development and implementation, certification support, regulatory compliance assistance, information management solutions, and training. Our headquarters are in Madison, WI and Atlanta, GA, with satellite offices throughout the U.S.