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To Be Released: FSSC 22000 Version 7
Food Safety System Certification (FSSC) 22000 is a robust Global Food Safety Initiative (GFSI)-recognized food safety certification scheme based on ISO 22000 that is applicable across the food chain (i.e., food/feed manufacturing, packaging production, transport, and storage). FSSC 22000 comprises three elements:
- ISO 22000 International Standard (2018) – Specifies requirements for a food safety management system (FSMS) in alignment with the ISO Harmonized Structure.
- Sector-Specific Technical Specifications (TS) (2025) – Requires organizations to establish Prerequisite Programs (PRPs) for specific sectors:
- ISO/TS 22002-1: Food Manufacturing
- ISO/TS 22002-2: Catering
- ISO/TS 22002-3: Farming
- ISO 220002-4: Food Packaging
- ISO/TS 22002-5: Transport and Storage
- ISO/TS 220002-6: Feed and Animal Food Production
- ISO/TS 220002-100: Common/General Requirements
- FSSC 22000 Scheme Additional Requirements (2024) – Provides comprehensive additional requirements that build on ISO 22000 and sector-specific PRPs.
In early May 2026, Foundation FSSC anticipates publishing Version 7 (V7) of the FSSC 22000 Scheme Additional Requirements. Certified organizations will have a 12-month transition period to allow for effective implementation of the new version once it is published. Until V7 is released, FSSC 22000 V6 remains valid and will continue to reference the existing ISO/TS 22002-X series.
Key Updates
The updates to FSSC 22000 V7 are intended to better align the scheme with global requirements, improve clarity, and make food safety management more practical. Anticipated key changes include the following:
- Integrate with Updated ISO/TS 22002-x:2025 Series. FSSC 22000 V7 will incorporate the newly updated ISO/TS 22002-x:2025 series to ensure the FSSC scheme aligns with the most current global expectations for PRP implementation across food chain sectors. This includes a focus on taking a science-based approach to sanitation, hygiene, contamination prevention, and risk management.
- Align with GFSI Benchmarking Requirements. Aligning FSSC 22000 V7 with the latest GFSI benchmarking criteria will help to ensure FSSC certifications remain relevant and accepted across the global supply chain.
- Support United Nations Sustainable Development Goals (SDGs). FSSC 22000 V7’s strengthened requirements related to SDGs reflect growing industry-wide expectations related to sustainability, environmental responsibility, and social impacts. The scheme’s enhanced guidance is intended to help support organizations in their efforts to contribute to SDGs through responsible sourcing, reduced environmental impacts, and improved social responsibility.
- Create Clearer Food Chain Categories. FSSC V7 will implement a more defined and transparent structure for categorizing activities within the food chain to help organizations better understand which requirements apply to them, allow for more targeted implementation of food safety controls, and promote better compliance.
- Promote Continuous Improvement. Planned editorial updates will improve clarity and usability for certified organizations to make the FSMS more practical and easier to implement.
Planning for Change
For companies that are currently certified FSSC 22000 V6, now is the ideal time to assess current FSSC 22000 program elements, identify improvements that are internally desirable and required by the new standard, and implement those updates that will make the FSSC 22000 program more useful to the business and compliant with V7. This can be done through a series of phases to ensure adoption throughout the organization.
Phase 1: FSSC 22000 Assessment
An assessment should begin by reviewing the following:
- Existing FSSC 22000 programs, processes, procedures, forms, and records.
- Existing document management systems and document registers.
- Employee training tools and programs.
This documentation review and program assessment will help to identify elements of the existing FSSC 22000 program that are acceptable, those that show opportunities for improvement, and those that may be missing, including those needed for development and implementation to meet the requirements of FSSC 22000 V7.
Phase 2: FSSC 22000 Program Updates
The assessment will inform a plan for updating the FSSC 22000 certification program, including major activities, key milestones, and expected outcomes. Development/update activities included on the plan may include the following:
- Developing new or updating current FSSC 22000 programs, processes, and procedures with V7 requirements, including new procedures and PRPs to align with the ISO/TS 22002-x:2025 series.
- Updating training programs with any new and additional requirements.
- Revising document register to align with FSSC 22000 V7 numbering changes.
- Updating records and forms with any new and additional requirements.
When implementing program updates, leveraging existing management system and certification program elements and utilizing proven approaches can greatly streamline the process.
Phase 3: Training
To ensure staff are prepared to implement and sustain the updated FSSC 22000 V7 program, training is important. This includes training for affected staff on applicable requirements; specific plans, procedures, and PRPs developed to achieve compliance; and the certification roadmap to prepare for future audits.
Following this plan now will help companies ensure they maintain their FSSC 22000 certification when audits begin under FSSC 22000 V7 to demonstrate their commitment to meeting customer and regulatory requirements, protecting the company brand, and keeping consumers safe.
Tech Corner Q&A: Supplier Management System
A wider reaching global supply chain exposes the products we consume—and those companies within the supply chain—to increased risk. A robust Supplier Management Program that leverages software, standardized tools, and data management practices can help organizations to more effectively audit, monitor, and manage supplier performance and program implementation and help ensure high-quality, safe, and consistent products.
We recently sat down with KTL’s Power Platform Team to talk about how organizations can leverage Microsoft 365 and the Power Platform to effectively manage supplier data and performance to improve overall operations.
Q: What does a Supplier Management System do? What capabilities does it have?
Supplier management is about keeping vendors and suppliers organized and ensuring they meet organizational (i.e., internal), regulatory, and applicable third-party certification expectations. Supplier management may include supplier selection and approval, qualification review, contract negotiation, periodic evaluations, and documentation and records management.
KTL’s Supplier Management System is a custom tool built using Microsoft 365 and the Power Platform that streamlines how an organization approves and manages suppliers, helps control costs and reduce risk, and supports compliance with internal requirements and regulations (e.g., Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) Rule).
KTL’s Supplier Management Systems:
- Provide a checklist to ensure all vendors and suppliers meet required criteria (e.g., certifications, licenses, performance history).
- Manage vendor and supplier-specific requirements.
- Store and organize supplier documents and records; suppliers can upload their own documents in a secure folder (if external user access is allowed).
- Enable facilities to conduct and manage supplier evaluations.
- Provide verification procedures that close out evaluations and generate PDF reports.
- Send email notifications of supplier-related compliance deadlines.
Q: What is KTL’s approach for designing and implementing a Supplier Management System? How do you work with clients?
We design every Supplier Management System with ease of use, compliance risk, and operational impact in mind, while being mindful of the organization’s pace and budget tolerance. We understand that every company works a little differently; as such, it is important that any Supplier Management System we design reflects how the organization operates in practice. Our goal is to create a system that fits the organization, fosters user adoption once implemented, and avoids the rigidity of one‑size‑fits‑all software.
KTL’s approach to building a Supplier Management System generally follows three main phases:
- Planning: Our first step is to get a complete understanding of how the organization currently manages suppliers. We meet with key stakeholders to understand what’s working, what’s not, and what’s required to develop a robust Supplier Management System that meets organizational and compliance needs. Our team evaluates existing systems (if developed) and related processes, documents, and tools to identify gaps, understand needs, and establish priorities. Based on our initial assessment and evaluation, we work with the client to create a clear, customized roadmap for a Supplier Management System that will work within the context of the organization.
- Development, Review, and Rework: Based on the priorities identified in the planning stage, our team establishes development milestones and timelines. We then begin building the system in stages, reviewing each milestone with the client as it is completed. This helps to ensure the Supplier Management System meets defined requirements, functions as desired, effectively supports supplier processes, and delivers organizational value every step along the way (e.g., improved efficiency, reduced risks, and enhanced compliance).
- Turnover and Continued Support: Once KTL completes the development phase, we work closely with the client to coordinate the launch date and provide training to staff who will be using the system regularly to ensure they are comfortable with its functionality. We can also provide advanced user training to create internal “power users”, if desired. Importantly, our team remains available post-launch to provide ongoing support and to implement adjustments based on real‑world use. We are always available to expand the scope of development based on changing organizational needs to ensure the Supplier Management System remains a valuable tool.
Q: What are some of the most common integration challenges associated with a Supplier Management System and how do you address them?
For many companies, the biggest challenge is simply recognizing they need to develop, upgrade, or integrate a more robust Supplier Management System to meet organizational needs. Once that initial decision is made and development begins, there are several common integration challenges we encounter in the development process:
- For many companies, the biggest challenge is simply recognizing they need to develop, upgrade, or integrate a more robust Supplier Management System to meet organizational needs. Once that initial decision is made and development begins, there are several common integration challenges we encounter in the development process:
- Fragmented Inputs: The most common issue involves working with existing systems, data, and processes that are messy and don’t always align across the organization. This might include different teams in the same company using different, custom-built tools—none of which communicate with each other. These fragmented inputs create challenges figuring out how to combine various data sources and generate consolidated reports. KTL’s data management professionals help evaluate these systems and processes to ensure they can be streamlined and integrated into a Supplier Management System.
- Document and Evidence Management: Supplier Management Systems need to document, maintain, and store evidence of compliance. We find that many organizations do not have a common system for this documentation; rather, this evidence tends to “live” in different repositories without consistent version control or standards. Identifying the various repositories, determining the correct/most current versions of documents, and bringing everything together into a central repository can be challenging depending on past management practices. We support this process by helping organizations assess documentation gaps and establish structured document control frameworks within the Supplier Management System.
- Compliance and Standards Mapping: Many organizations use their Supplier Management System as part of overall compliance programs to manage regulatory (e.g., Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA)) and/or third‑party certification (e.g., International Standards Organization (ISO), Global Food Safety Initiative (GFSI)) requirements. Translating these requirements into usable data fields, workflows, and reports can be complex—and can carry significant compliance consequences if done incorrectly. The challenge becomes even greater when the system must accommodate multiple regulations or standards at once. KTL’s environmental, health, and safety (EHS); food safety; and quality professionals provide technical insights to help ensure our Supplier Management Systems effectively meet compliance and certification requirements.
Q: How do you integrate the Supplier Management System with a company’s overall management system (e.g., food safety, quality, EHS)?
One of the things that differentiates KTL as an information technology (IT) solutions provider is that we aren’t a software vendor. Rather, we are a team of consultants who use our expertise in compliance management systems to build powerful, compliance‑ready solutions using Microsoft 365 and the Power Platform. We blend deep EHS, quality, and food safety experience with practical IT know‑how to build systems that function according to our clients’ operations and regulatory/certification requirements using the software most organizations already have (i.e., Microsoft 365).
Because of our team’s broader expertise, we’re able to effectively integrate Supplier Management Systems directly into organizational food safety, quality, and EHS programs. Supplier qualification, onboarding, audits, corrective actions, and reevaluations all flow seamlessly into existing management systems. Compliance and certification requirements are incorporated into every step in the supplier management process—from initial risk scoring through ongoing monitoring. The result is a Supplier Management System that is a natural extension of the overall management system, with connected workflows, shared data, increased consistency, reduced duplication of effort, and strengthened compliance across the organization.
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FDA Human Foods Program 2026 Priorities
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. 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.
Priority Deliverables
On January 23, 2026, FDA released its priority deliverables and guidance agenda for 2026 to further advance HFP’s vision and mission within the program’s three focus areas:
- Food Chemical Safety focuses on ensuring exposure to chemicals and additives that occur in foods is safe.
- Microbiological Food Safety focuses on the oversight of industry’s efforts to ensure the safety of the foods they produce and to prevent foodborne illness.
- Nutrition promotes FDA’s Make America Health Again (MAHA) strategy and focuses on reducing chronic disease through better nutrition.
The table below outlines the 2026 priority deliverables for each of these areas. Several of these are also discussed in more detail in KTL’s recent article on 2026 Food Safety Trends to Watch.
| Priority Deliverable | HFP Actions |
| FOOD CHEMICAL SAFETY | |
| Generally Recognized as Safe (GRAS) Reform | Publish a proposed regulation requiring entities to submit GRAS notices for all new substances claimed to be GRAS before they are introduced into a human or animal food substance. |
| Post-Market Safety Reviews of Marketed Food Chemicals | Continue reassessing chemicals used in foods, starting with those most concerning to consumers; post a Systematic Post-Market Assessment process. |
| Microplastics | Conduct research to identify ways to accurately detect, quantify, and characterize microplastics in human food. |
| Closer to Zero | Establish action levels for cadmium and inorganic arsenic in baby and toddler foods; issue guidance on preventive controls to minimize chemical hazards in all foods. |
| Natural Color Additives | Continue phasing out petroleum-based food dyes and completing reviews of new natural alternatives. |
| Consumer Exposure to Contaminants in Food | Continue studying exposure to certain heavy metals, per- and polyfluoroalkyl substances (PFAS), and other contaminants in food. |
| Regulation of New Dietary Ingredients | Release final guidance regarding safety and identify information required for new dietary ingredient (NDI) notifications; develop methods to streamline FDA’s review of NDI notifications. |
| Dietary Supplement Oversight | Evaluate modernized approaches to support dietary supplement priorities with targeted enforcement strategies on violative products. |
| Guidelines for Caffeine Labeling | Promote best industry practices for labeling added caffeine content in both packaged foods and beverages and those in retail and restaurant settings. |
| Allergen Labeling | Develop recommendations for transparency in disclosure of ingredients that impact certain health conditions and other established food allergens. |
| MICROBIOLOGICAL FOOD SAFETY | |
| Food Inspection Coverage | Create Better Regulatory Inspections for Dynamic Government Efficiency (BRIDGE) by relying on state partners to carry out routine food safety systems inspections based on FDA’s national standards. |
| National Regulatory and Laboratory Training System | Build a sustainable training system and standards for all Integrated Food Safety System (IFSS) regulatory and laboratory professionals, including establishing the National Coordination Center to implement consistent training standards for federal and state regulatory and laboratory staff. |
| Oversight and Safety of Imported Food | Enhance the ability to identify and act on violative products and ensure imported food meets the same food safety standards as food produced domestically; expand allocation of inspectional, laboratory, and other oversight resources to the foreign arena; enforce Import Certification and Foreign Supplier Verification Program (FSVP) requirements. |
| Imported Seafood Safety | Continue emphasis on sampling shrimp supply chains for compliance to ensure the safety of imported shrimp and complete development of a seafood fraud identification program. |
| Fresh and Processed Produce Safety | Improve the safety of fruits and vegetables through numerous activities including advancing training through the Produce Safety Alliance; new training for sprout producers; new cantaloupe, leafy greens, and cucumbers initiatives; and various studies of potential hazards in produce. |
| Dairy and Egg Safety | Promote contamination through enhanced training and education for dairy and egg producers. |
| Recall Process Modernization | Explore risk communication strategies to enhance public access to critical recall information; continue to improve the speed of recall classification through process improvements. |
| Food Traceability | Work with entities to ensure they can comply with the Food Traceability Rule by the July 2028 compliance date, including facilitating tabletop exercises to test readiness and providing explanatory Q&As. |
| Food Code and Retail Program Standards | Release an updated Food Code and Retail Program Standards Manual as models for local, state, and tribal regulators to update their food safety rules and programs. |
| Tech-enabled Advances in Risk Management | Increase the information and quality of data available to establish sound risk management strategies by developing a plan to use AI predictive models to analyze large datasets and examining the application of external third-party audit data to optimize FDA resources. |
| NUTRITION | |
| Ultra-Processed Foods (UPFs) | Develop a federal government definition of UPFs and work to better identify and reduce risks associated with high consumption of UPFs. |
| Infant Formula Safety (Operation Stork Speed) | Begin implementing the plan to modernize infant formula nutrient requirements and expand options for safe, reliable, and nutritious infant formula. |
| Nutrition Regulatory Science Program | Working with the National Institute of Health (NIH), advance key research to guide food and nutrition policies to improve American’s diets and overall health (e.g., impacts of UPFs and food additives, role of maternal and infant dietary exposures on health outcomes). |
| Front-of-Package (FOP) Nutrition Labeling | Advance proposed regulation requiring food packages to display key information (e.g., added sugar, sodium levels) on the front of packages. |
| “Healthy” Claim Implementation | Implement the criteria finalized in 2025 that allows foods that meet certain standards to voluntarily use the “healthy” label claim and issue related guidance. |
| Food Standards of Identity | Complete an interim final rule, two new final rules, and several new proposed rules to continue eliminating 52 obsolete food standards of identity that describe in detail what a food must contain and what is optional in its formulation/production. |
| Added Sugar Reduction | Create an added sugar reduction strategy to encourage the food industry to lower added sugar in processed and prepared foods, including proposing a nutrient claim for added sugars and investigating ingredient and menu labeling requirements. |
| Sodium Reduction | Conduct a formal evaluation of Phase I voluntary targets under FDA’s voluntary sodium reduction initiative; encourage industry to reduce the sodium content of products. |
| Food Labeling for Online Grocery Shopping | Issue draft guidance on food labeling for online grocery shopping to increase transparency. |
| Guidelines on Direct Marketing of Certain Foods to Children | Explore development of potential industry guidelines to limit direct marketing of certain unhealthy foods to children. |
HFP also intends to develop and/or revise guidance documents on a number of topics related to food chemical safety, microbiological safety, and nutrition.
Meeting FY2026 Priorities
As we move into 2026, it is important that facilities review and understand the HBP priorities and compliance expectations for FY2026 compared to internal programs, protocols, etc.—and then make any required updates to ensure alignment. This may include the following actions:
- Educate staff to get a deeper understanding of products/operations and the associated regulatory changes and developments FDA has planned for FY2026.
- Reassess regulatory exposure, strengthen internal systems, and ensure food safety programs are resilient, auditable, and aligned with broader business objectives in light of the FY 2026 HFP priorities.
- Implement key actions, where possible, to meet impending requirements, for example:
- Perform traceability exercises and mock recalls to help identify gaps in testing protocols, verification processes, corrective action implementation, and overall adequate traceability processes.
- Inventory existing products and their ingredients to determine which products use synthetic dyes and reformulate with natural color alternatives.
- Integrate environmental contaminant testing for lead, arsenic, cadmium, and mercury into existing product testing protocols, prioritizing high-risk categories.
- Evaluate nutrition labels for required changes
- Leverage partnerships with consulting partners with deep regulatory insight and practical implementation experience to help navigate the evolving regulatory landscape, protect against emerging risks, and position your organization to manage the HFP priorities for 2026 and beyond.
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2026 Priorities: OSHA National, Regional, and Local Emphasis Programs
The Occupational Safety and Health Administration’s (OSHA) National Emphasis Programs (NEPs) are temporary programs that focus OSHA’s resources on particular hazards and/or high-hazard industries. OSHA identifies these programs by evaluating inspection data, injury and illness data, National Institute for Occupational Safety and Health (NIOSH) reports, peer-reviewed literature, inspection findings, and other available information sources.
Federal NEPs
OSHA currently has twelve active federal NEPs. In 2026, OSHA’s priorities concentrate on industries with high injury rates, severe hazards, or historically high non‑compliance. The table below highlights three NEPs that are on the top of OSHA’s list for 2026 and the most impacted industries under each.
| NEP | Description | Most Impacted Industries |
| Heat-Related Hazards | This NEP covering both indoor and outdoor heat hazards has been extended through April 8, 2026. OSHA inspectors are already evaluating heat risks and mitigation efforts (i.e., water, rest, shade, training) during site visits under existing OSHA regulations and will continue to target sites where the heat index is > 80°F. | Agriculture, construction, warehousing, manufacturing, outdoor labor. |
| Warehousing and Distribution Centers | This three-year program, which runs through mid-2026, targets high-injury rate facilities, focusing on powered industrial vehicles, material handling, walking-working surfaces, and fire protection. | Warehouses, distribution centers, logistics hubs. |
| Amputations in Manufacturing | Renewed in 2025, this program continues to focus on machine guarding and lockout/tagout (LOTO) procedures. | Iron foundries, plastics, metalworking, food manufacturing, machine‑intensive industries. |
Regional and Local Emphasis Programs (REPs/LEPs): Focus on Food Manufacturing
Much like federal NEPs, REPs and LEPs are established at the regional or local (area office) level to target hazards or industries with specific risks to workers in that area. Essentially, while REPs have a broad application across a region, LEPs focus on addressing localized hazards or industry-specific risks. Although distinct from NEPs, REPs and LEPs influence OSHA inspection priorities.
While REPs/LEPs can focus on any industry, there are currently many that target food manufacturing, primarily related to high injury/amputation rates, machine guarding failures, LOTO/hazardous energy control issues, and cleaning/sanitation hazards. Generally speaking, these REPs/LEPs involve increased inspections, outreach, and enforcement to address risks to permanent and temporary workers, particularly in the following targeted industries:
- Animal slaughtering and processing (NAICS 311611).
- Animal food manufacturing (NAICS 311111).
- Additional food processing operations, including cleaning and sanitation operations.
Preparing for NEPs/REPs/LEPs and OSHA Inspections
Companies in targeted industries (as outlined above) need to be aware of OSHA’s heightened focus areas for 2026, prepare for potential OSHA inspections, and build a solid foundation for compliance:
- Strengthen Heat Illness Prevention Programs. Conduct heat surveys in indoor and outdoor areas to evaluate and understand heat-related concerns. Update and implement a Heat Illness Prevention Plan (HIPP) before peak summer months when the heat index is likely to climb > 80°F. Develop and implement practices to ensure workers have adequate water, rest, and shade, and verify and document training and monitoring processes.
- Improve Machine Guarding and LOTO Programs. Conduct detailed reviews of machine guarding, including point‑of‑operation and interlocks, to ensure it meets requirements and adequately protects staff. Audit LOTO procedures to ensure they are compliant, documented, enforced, and understood. Regularly train all machinery operators on machine guarding and LOTO.
- Conduct Internal Warehouse & Distribution Center Audits. Internal audits of warehouses, loading docks, and storage areas can help facilities identify problems—particularly related to OSHA’s focus areas—and implement corrective actions before an OSHA inspection occurs.
- Address REP/LEP Risks. Many regions—including Wisconsin, Illinois, and Ohio—have strong LEP/REP activity around food manufacturing, machine guarding, sanitation hazards, and LOTO. Food manufacturers should conduct regular internal audits of sanitation practices, machine guarding equipment, and energy control procedures. Importantly, employees must receive adequate training on both how to safely operate equipment in the food manufacturing environment and hazards related to the chemicals used for cleaning and sanitation purposes.
- Anticipate More Unannounced Inspections. A second-party mock OSHA inspection is one of the best ways to identify hazards, areas of concern, and opportunities for improvement in operational practices and documentation requirements. A second-party auditor can provide an objective assessment of overall compliance status, so non-conformances don’t catch you off guard.
- Reinforce Worker Training and Communication. Training is a consistent requirement across all NEPs/REPs/LEPs to meet compliance requirements and, more importantly, to ensure all employees have a clear understanding of safety procedures and expectations.
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2026 Food Safety Trends to Watch
Less federal oversight is a consistent theme across the U.S. government in 2026, and the Food and Drug Administration (FDA) is no exception. Significant budget cuts are impacting federal focus—and corporate requirements, expectations, and obligations—when it comes to food safety, from inspections to rulemaking efforts. Even so, there is heightened pressure globally and from the public to elevate food safety efforts. Here are some of the things KTL’s food safety experts are watching in 2026.
FDA Budget Cuts
As with most federal agencies, the FDA is not immune to reduced budgets for FY2026 under the Department of Health and Human Services (HHS). Cuts include significant reductions in staff, causing FDA leadership to shift focus to streamlining operations and relying on artificial intelligence (AI) tools to fill in gaps. It is anticipated that states may take on more responsibility for conducting routine food inspections due to the lack of federal capacity. In addition, federal budget cuts could slow progress on rulemaking initiatives, including traceability requirements, contaminant action levels, and artificial dye bans (see below).
Companies would be wise to continue treating proactive food safety management as a strategic investment, not a compliance cost, and maintain federal-level food safety compliance readiness, regardless of inspections and enforcement.
Tip: Strengthen internal food safety management systems (FSMS) to prepare for potentially more strict state standards. Prioritize internal audit, environmental monitoring, supplier management and verification, and corrective action programs. Maintain compliance calendars and clear records and documentation.
FDA Regulatory Updates
As noted above, budget cuts are impacting finalization and implementation of several key FDA rules, several of which have been in progress for years.
Food Traceability Final Rule: FSMA 204
FDA’s Food Traceability Rule remains on everyone’s radar. Originally passed in November 2022 with a compliance date of January 20, 2026, that date has been delayed until July 20, 2028. At this point, FDA remains committed to implementing the full requirements of the final rule but giving industry additional time to comply. Traceability remains a huge concern given the number of recent high-profile recalls. Employing robust traceability processes is vital for reducing risks, regardless of regulatory requirements.
Tip: Develop records for capturing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs). Perform traceability exercises and mock recalls to help identify gaps in testing protocols, verification processes, corrective action implementation, and overall adequate traceability processes. Invest in a good technology solution that integrates with the FSMS to streamline the traceability process.
California AB 660 “Sell by” Ban
Open date labeling (e.g., “best if used by”, “sell by”, “expires on”, “freeze by”) is not currently mandated or standardized by federal law. However, the State of California has forged ahead with standardizing the use of open date labeling on food products. Beginning July 1, 2026, California AB 660 implements the first mandatory food date labeling for companies selling food products in California. Under the new law, food products will no longer be allowed to display confusing “sell-by” or “best before” dates. Instead, food companies will use “best if used by” or “best if frozen by” to indicate peak freshness/quality and “use by” or “freeze by” to indicate when a food item is no longer safe to eat. Anticipate other states to follow California’s lead.
Tip: Understand what the various open date labeling phrases mean before applying them to products. If you currently (or intend to) sell products in California, standardize open date labeling practices to meet the new requirements by the July 2026 compliance date.
Removing Artificial Food Dyes
In April 2025, the FDA announced a series of new measures to phase out all petroleum-based synthetic dyes from the food supply by the end of 2026, including FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2. The FDA is planning to proceed without any statutory or regulatory changes, relying instead on the voluntary efforts of the food industry in complying with its mandates to remove the synthetic dyes as quickly as possible from the market.
Tip: Inventory existing products and their ingredients to determine which products use synthetic dyes. Reformulate affected products to use natural color alternatives and identify and approve new suppliers of alternative ingredients. Update label design, adjust ingredient panels, and modify any relevant nutritional claims.
Environmental Action Levels
Since 2020, the FDA has been making progress on establishing action levels for environmental contaminants (specifically arsenic, lead, cadmium, and mercury) to reduce dietary exposure as much as possible. The Closer to Zero Initiative has prioritized foods commonly eaten by babies and young children, and in 2025, the final Guidance for Lead in foods intended for babies and young children was released. Draft guidance for arsenic and cadmium was scheduled to be drafted in 2025; however, it has been delayed.
Tip: Integrate environmental contaminant testing for lead, arsenic, cadmium, and mercury into existing Environmental Monitoring Programs, prioritizing high-risk categories. Conduct risk assessments to determine which ingredients and products are most vulnerable to contamination. Review and strengthen supplier requirements to address environmental contaminants.
“Product of USA” Rule
Effective January 1, 2026, the U.S. Department of Agriculture’s (USDA) rule on how voluntary U.S. origin claims (e.g., Product of USA, Made in the USA) can be used on meat, poultry, and egg products became enforceable. Under the rule, companies may only use one of the claims if an animal is born, raised, slaughtered, and processed in the U.S. Note that these requirements differ for single-ingredient products vs. multi-ingredient products. Previously, imported animals/meats could use the claim if processed domestically. It is important to note that using these claims remain voluntary; however, establishments that choose to use them must maintain documentation proving U.S. origin.
Tip: If you choose to voluntarily make U.S. origin claims, ensure meat, poultry, and egg products meet the U.S. origin requirements; maintain documentation to substantiate claims; and include required descriptions on labels following updated USDA Food Safety and Inspection Services (FSIS) guidance.
Certification Updates
SQF Edition 10
Earlier in 2025, the Safe Quality Food Institute (SQFi) announced it would be releasing Edition 10 of its Safe Quality Food (SQF) Code to align with the latest Global Food Safety Initiative (GFSI) benchmarking criteria, updated regulatory requirements, and scientific changes. That release has been delayed until early March 2026 due to an extension in the GFSI benchmarking application timeline. The planned SQF Edition 10 changes focus on three critical areas: food safety culture, change management, and environmental monitoring. Pending completion of the review process, the first Edition 10 audits could begin as early as January 2027.
Tip: Assess current SQF program elements, identify improvements that are internally desirable and required by Edition 10, and implement those updates that will make the SQF program more useful to the business.
FSSC 22000 Version 7
Food Safety System Certification (FSSC) announced in October 2025 that it is commencing the development of FSSC 22000 Version 7. The new version will focus on incorporating the updated ISO 22002 prerequisite programs (PRPs), aligning with the GFSI benchmarking requirements, strengthening requirements to support UN Sustainable Development Goals (SDGs), and providing more structure for the division of food chain categories. Release of Version 7 is anticipated at the end of Q1 or beginning of Q2 2026.
Tip: Assess current FSSC 22000 program elements against potential changes. Review PRPs (e.g., sanitation, pest control, allergen management, waste handling) and update standard operating procedures (SOPs). Consider sustainability metrics, including energy, water, and waste use to ensure SDG alignment.
Others to Watch
Dietary Guidelines for Americans 2025-2030. HSS and the USDA have published new Dietary Guidelines with the underlying message to “Eat real food.” Changes include increased recommended daily protein intake, emphasis on dairy, and the avoidance of highly processed foods. Currently, “highly processed foods” or “ultra processed foods” are not clearly defined; however, there are efforts at the state and federal levels to define and regulate the category.
PFAS “Forever Chemicals”. There is currently a patchwork of federal requirements and state-level regulations and product bans in the U.S. related to per- and polyfluoroalkyl substances (PFAS). The FDA has been working to limit PFAS in food and food packaging; in 2024-2025, the agency also committed to testing foods from the general food supply to more accurately estimate exposure to PFAS from foods. While federal regulatory efforts have slowed significantly, organizations need to stay informed, especially at the state level, and address PFAS in their operations, products, supply chains, and waste streams accordingly.
Artificial Intelligence (AI). As noted above, budget cuts are prompting the FDA to accelerate the use of AI to streamline operations and improve efficiency. Many food companies are also starting to test the limits on what AI can—and can’t—do effectively and correctly. While AI may be leveraged as a tool to aggregate data, enhance traceability and recall readiness, automate routine tasks, and draft certain documents (e.g., audit reports, inspection summaries, training materials), using AI must be done thoughtfully, as it cannot replace food safety programs and human involvement. In fact, over‑automation without expert oversight can significantly increase error and legal exposure.
Looking Ahead
As we move into 2026, it will be important to monitor status of these trends and issues, as timelines may shift without warning and states may enact their own requirements. Start preparing now, even if deadlines have been pushed back—things could change. Now is the time to:
- Reassess regulatory exposure, strengthen internal systems, and ensure food safety programs are resilient, auditable, and aligned with broader business objectives.
- Implement proactive planning, disciplined data management, and thoughtful use of technology to turn uncertainty into a competitive advantage.
- Leverage partnerships with consulting partners with deep regulatory insight and practical implementation experience to help navigate the evolving regulatory landscape, protect against emerging risks, and position your organization to sustain whatever the next regulatory cycle brings.
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SQF Edition 10 Delayed
Earlier in 2025, the Safe Quality Food Institute (SQFi) announced it would be releasing Edition 10 of its Safe Quality Food (SQF) Code to align with the latest Global Food Safety Initiative (GFSI) benchmarking criteria, updated regulatory requirements, and scientific changes. The publication date was targeted for September 2025, with audits beginning in April 2026. However, SQFi recently announced that the release of SQF Edition 10 has been delayed due to an extension in the GFSI benchmarking application timeline, which now runs through March 2026.
Because of this delay, SQF Edition 9 will remain the recognized version of the SQF Code. This means that audits will continue under the requirements of Edition 9 until Edition 10 is released. At that point, sites will have a six-month transition period before audits begin under Edition 10.
As KTL reported this summer, the SQF Edition 10 changes remain focused on three critical areas: food safety culture, change management, and environmental monitoring. SQFi has reinforced that, when released, the Edition 10 changes will reflect the industry’s growing understanding that food safety is not just about compliance, but about creating a holistic, proactive approach to protecting consumers.
With the additional time before the release and implementation of Edition 10, now is an ideal time for facilities who are certified to SQF to assess current SQF program elements, identify improvements that are internally desirable and required by Edition 10, and implement those updates that will make the SQF program more useful to the business.
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Gluten Added to Major Allergen Verification
The U.S. Department of Agriculture – Food Safety Inspection Service’s (USDA-FSIS) directive, Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common (“Big 9”) Food Allergens, provides instructions to inspection program personnel (IPP) to verify that establishments are controlling and labeling the Big 9 food allergens in meat, poultry, and egg products. On September 11, 2025, USDA-FSIS reissued the directive to include gluten to be verified as an ingredient of public health concern.*
Why Gluten?
Gluten is a protein found naturally in wheat, rye, and barley. Many products contain gluten. According to the USDA, if meat, poultry, or egg products contain any of the following, they likely contain rye or barley and, subsequently, gluten:
- Malt extract
- Malt vinegar
- Rye flour
- Whiskey
- Malt flavoring
- Brewer’s yeast
- Barley flour
- Beer
- Malt syrup
- Yeast extract
- Soups
- Malted milk
- Spent grains
- Brown rice syrup
The National Institute of Health (NIH) estimates there are approximately two million Americans and one percent of the population worldwide who have celiac disease, an auto-immune disease triggered by consuming gluten-containing foods—plus many more with gluten sensitivities and intolerances. As such, the USDA considers gluten an ingredient of public health concern; however, it is not designated a Big 9 major food allergen (though wheat is). Even so, the updated USDA-FSIS directive now requires IPP to verify that establishments are accurately controlling and labeling gluten similarly to the Big 9 allergens.
Formulation Verification
The USDA-FSIS conducted analyses of voluntary recalls connected to undeclared allergens and determined the following:
- Many voluntary recalls occurred due to changes in ingredient suppliers, products in the wrong package or with misprinted labels, or changes to the product or ingredient formulation.
- Establishments failed to include allergens on the product label when product came into contact with an undeclared allergenic ingredient that was not directly added to the product (i.e., unintentional adulteration of product).
When an establishment allows product to enter commerce with undeclared allergens, it signifies that the food safety system has failed in some way to control the hazards associated with the allergens. As such, the purpose of the Big 9 Formulation Verification task is to verify that establishments are properly labeling the Big 9 major food allergens and gluten when included in the formulation of a product to avoid these issues.
During the Big 9 Formulation Verification task, IPP verify the following:
- The establishment has developed and implemented preventive or control measures in its Hazard Analysis and Critical Control Points (HACCP) Plan, Sanitation Standard Operating Procedures (SSOPs), and/or other prerequisite programs (PRPs) to address allergens.
- All ingredients used in the production of the product are present on the product formulation record.
- All ingredients in the product formulation are declared in the ingredient statement on the product label by common name in descending order of predominance.
- All ingredients listed on the labels of incoming food and food ingredients are also listed on the labels of the products in which they are used.
- All ingredients listed in a “may contain” or “produced in a facility” statement on incoming food and food ingredients are also listed on the final product label, except when the establishment contacts the supplier for further clarification and addresses the statement in the hazard analysis.
- The appropriate label is applied to the product.
- The applied label is consistent with the establishment’s label approval on file.
If IPP find that a product contains one of the Big 9 allergens or gluten that is not declared on the final label, they document a food safety labeling noncompliance in a Noncompliance Record (NR).
The Big 9 Formulation Verification task is conducted monthly; however, frequency may increase if there are indicators of an increased risk related to the Big 9 allergens, gluten, ingredients of public health concern, or other undeclared ingredients linked to the establishment, including the following:
- Public Health Alert (PHA) or recall.
- Consumer complaints.
- History of sanitation and/or HACCP NRs.
- History of labeling NRs.
- Recent product formulation changes, adjustments to ingredients, supplier changes, or new products added by the establishment.
Questions to Ask
The USDA-FSIS cautions that these updates do not change the fact that all ingredients, other than processing aids, whether allergens or not, must be declared on the label.
If you produce meat, poultry, and/or egg products, it is important to understand what allergens—and now gluten—you have at your facility, how you use them in product formulation, and how you label them as ingredients in your products. The USDA-FSIS outlines the following questions for the Big 9 Formulation Verification task that you can ask internally to ensure your products comply with labeling requirements:
- Which of the Big 9 allergens and/or gluten are included in products you produce at your facility?
- Does your facility use any components that have multiple ingredients that you do not produce or mix onsite?
- For the selected product, do you have any labels that claim the absence of one or more of the Big 9 allergens and/or gluten?
- For the selected product, do you implement control measures within your HACCP Plan, SSOPs, PRPs, or other programs to prevent misbranding (e.g., mistakes on labeling)?
- For the selected product, do you implement control measures within your HACCP Plan, SSOPs, PRPs, or other programs to prevent allergen cross-contact (e.g., food allergens from one product getting into another product that doesn’t contain the allergen)?
* Note: USDA-FSIS is also removing certain tree nuts that are no longer considered major food allergens from the directive, updating the milk category to include milk from other ruminant animals (e.g., sheep, goats), and updating the eggs category to include eggs from other fowl (e.g., duck, quail), in accordance with the Food and Drug Administration’s (FDA) January 2025 updates to food allergen labeling requirements.
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FSIS Publishes New HACCP Models
The U.S. Department of Agriculture (USDA) published the Pathogen Reduction; Hazard Analysis Critical Control Point (HACCP) Systems Final Rule (9 CFR 417.2(b)(1)) in July 1996, mandating all USDA-inspected meat and poultry establishments implement a system of controls to improve the safety of their products (i.e., a HACCP Plan). To assist in developing these HACCP Plans, the USDA Food Safety and Inspection Service (FSIS) developed a guidebook, accompanied by a generic HACCP model for each food processing category defined in the regulation. Recently, the FSIS published revised models for three different processing categories.
New Models
In June 2025, the FSIS released the two new generic HACCP models for egg products:
- HACCP Model for Pasteurized Liquid Egg Products (Fully Cooked – Not Shelf Stable Category), which includes pasteurized liquid whole egg, pasteurized liquid egg white, pasteurized liquid egg yolk, pasteurized scrambled egg mix products.
- HACCP Model for Dried Egg Products (Heat Treated Shelf Stable Processing Category), which includes spray-dried whole egg, spray-dried egg white, spray-dried egg yolk, spray-dried yolk, and whole egg blends products. This HACCP model illustrates the Heat-Treated Shelf Stable processing category with a dried egg product.
Published in August 2025, the HACCP Model for Ready to Eat (RTE) Fermented, Salt-Cured, and Dried Products (Not Heat Treated – Shelf Stable) applies to products that are cured, dried, or fermented as the sole means to achieve food safety and uses RTE dried fermented sausage as the example product. Products in this category are shelf stable and may be produced as RTE, including:
- Dried sausage, such as salami and pepperoni (if not heat-treated).
- Semi-dry sausages, depending on the process steps.
- Dried whole muscle products that are mostly dry cured, including dried hams (e.g., prosciutto, parma, and country ham) and dried intact pieces of meat (e.g., dried pork bellies (Pancetta), dried pork shoulders (coppa), and dried beef rounds (bresaola, beef prosciutto, and basturma)).
How HACCP Models Help
The generic HACCP models are written to help small and very small federal- and state-inspected establishments (SMEs) that produce meat, poultry and egg products develop their HACCP Plans. In essence, they help to:
- Translate FSIS rules and regulations into plain language and daily operational practices.
- Provide useful examples of how to meet the regulatory requirements.
Each HACCP model represents a food processing category, such as those outlined above. Each processing category may contain numerous products. The models include a product description, ingredients list, production flow diagram, hazard analysis, and HACCP Plan, as well as details regarding regulations and best practices to meet regulatory requirements.
Importantly, generic HACCP models are not intended to be used “as is”. Rather, they serve as examples that establishments must customize to fit the SME’s operations. For example, the model may lend ideas about which critical control points (CCPs) might be effective, offer guidance on the selection of critical limits, or help Food Safety Teams think more creatively about their processes and HACCP system.
While the generic HACCP models cannot guarantee a facility will meet all the regulatory requirements, they are an excellent resource and provide a solid foundation for developing a HACCP system that is focused on producing safe and wholesome products.
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KTL Returns to the 2025 Food Safety Consortium
KTL will be joining the 2025 Food Safety Consortium in Arlington, VA, October 19-21, 2025, as a featured panelist and exhibitor. The 14th Annual Food Safety Consortium provides food safety and quality assurance professionals with cutting-edge knowledge, practical skills, and a collaborative network to enhance their professional development as champions of food safety.
KTL will be a panelist on the following breakout session as part of the workshop’s technical agenda:
Beyond the Checklist: Strengthening Supplier Verification for Transparency and Compliance
October 21, 2025 | 9:30-10:30 am | Panelist: Roberto Bellavia, Senior Consultant and Partner
In today’s dynamic regulatory environment, supplier verification is no longer just a documentation exercise—it’s a critical component of a resilient and transparent supply chain. This session will explore how food manufacturers, retailers, and foodservice operators are leveraging digital platforms, risk-based strategies, and FSMA-aligned best practices to ensure supplier compliance and mitigate potential disruptions. Learn how to build verification programs that go beyond minimum requirements to proactively manage risk, foster trust with trading partners, and adapt to evolving traceability expectations. Whether you’re preparing for FDA inspections or looking to streamline supplier onboarding and oversight, this session will equip you with actionable strategies to enhance both transparency and performance across your supply network.
And be sure to stop by and visit us at Booth #21. We look forward to seeing you at the Food Safety Consortium!
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FSSC Development Program
Every company has an obligation to its customers to provide safe, quality, and legal food. Certification under a Global Food Safety Initiative (GFSI)-recognized food safety management program is a growing requirement within key food product supply chains—one that is driven by customer/market demands. The GFSI system provides a high degree of confidence that food safety management systems (FSMS) are adequately designed, implemented, and maintained.
The requirements of the GFSI-benchmarked certification schemes can be complex, and the certification process can be long, especially for small and medium-sized enterprises (SMEs). Initiatives such as the FSSC Development Program can serve as an entry point for organizations to help implement a conforming FSMS without the additional challenge of achieving full certification.
What Is the FSSC Development Program?
The FSSC Development Program provides a flexible approach to food safety conformity, allowing SMEs to demonstrate to the food supply chain and their customers that food safety is a priority. The FSSC Development Program is aligned with Hazard Analysis and Critical Control Points (HACCP) according to CODEX Alimentarius, GFSI Global Markets, and the food safety elements of ISO 22000 and the related sector technical specifications.
The Program offers a series of clear steps to help organizations develop an effective FSMS and provides a pathway to achieve full FSSC 22000 certification, while building the maturity of the FSMS. The Program applies to SMEs in the following sectors:
- Food and feed manufacturing
- Catering and food service
- Retail, wholesale, and e-commerce
- Transport and storage
- Packaging (new as of May 2025 – see below)
How Does It Work?
FSSC outlines the following proposed steps for achieving conformity under the FSSC Development Program:
- Reflect: SMEs review the Program requirements and then complete a self-evaluation using the free Self-Assessment Checklists. Each sector listed above has its own checklist to assess sector-specific requirements. The self-assessment requires SMEs to consider their operations, focusing primarily on existing FSMS elements and prerequisite programs. A second-party auditor may provide additional value conducting this initial assessment.
- Prepare: Once the SME has completed the self-assessment and made appropriate changes, the organization will work with an FSSC Development Program Conformity Assessment Body (CAB) to schedule a complete assessment of the FSMS. The CAB will work with the SME to identify and help to address any nonconformities identified.
- Conform: After a successful assessment, the CAB will issue a Conformity Statement, including any corrective actions needed. This statement serves as evidence of improvements the SME has made toward achieving full certification. At this point, the organization will be listed on FSSC’s List of Conforming Organizations. To maintain conforming status, an annual assessment is required. Once the SME reaches this level, it can continue conforming to the Development Program or proceed toward attaining full FSSC 22000 certification.
What Are the Version 2.0 Updates?
For companies interested or already involved in the FSSC Development Program, Foundation FSSC released a series of improvements (Version 2.0) on May 20, 2025 to better support conformance. Based on the results of a global survey, FSSC updated the Program for the following reasons:
- Include Category I: Packaging in the Program’s scope.
- Adjust the duration of the conformity assessment to better suit SMEs.
- Provide enhanced support to participants, including guidance documents, training, and webinars.
- Increase the Program’s awareness and visibility throughout the marketplace and, correspondingly, strengthen acceptance of the Program throughout the supply chain (i.e., specifying organizations and large buyers).
The primary changes in Version 2.0 include the following:
- Transition to a single conformity level—versus two different levels—aligned with the current Level 2 in Version 1.1.
- Implementation of a full HACCP system aligned with ISO 22000, including critical control points (CCPs) and operational prerequisite programs (OPRPs).
- Shift from a question-based structure to a requirements-based structure in the self-assessment.
Assessments against Version 2.0 went into effect on June 1, 2025; however, conformity assessments against Version 1.1 may still be conducted until May 31, 2026, when everything will transition to Version 2.
Why Participate in the Program?
The FSSC Development Program is ideal for smaller organizations that want to develop and improve their FSMS but might not have the resources to achieve GFSI-recognized certification in one step.
- The Program provides SMEs with a flexible solution that aligns their conformity status to their food safety and business goals (e.g., meeting their clients’ food safety requirements or expanding their market access).
- Integrating the Development Program into vendor assurance programs helps larger food organizations ensure the food safety of their non-GFSI certified SME suppliers through an internationally recognized program.
- Conforming organizations are listed on the FSSC website, making it easy to share conformance status; this global recognition can support expansion into new markets.
- Alignment with the FSSC Development Program supports progression to GFSI certification, if desired, while building the maturity of the FSMS.
