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.

KTL will be joining the technical program of the Society of Environmental Toxicology and Chemistry (SETAC) North America 46th Annual Meeting November 16-20, 2025 in Portland, Oregon. SETAC is dedicated to advancing environmental science and science-informed decision-making through collaboration, communication, eductaion, and leadership.

KTL Senior Associate Margaret Roy will be presenting Representation of the Homeless in Human Health Risk Assessment on Monday, November 17 at 10:00 am as part of Session 5.08: Beyond Direct Contact: Non-Traditional Exposure Scenarios in Human Health Risk Assessment.

Human Health Risk Assessments (HHRAs) are used to assess contaminant exposure and risk to defined populations, such as residents, commercial workers, and construction workers. HHRAs can also be used to assess risk for the homeless population. This presentation will discuss some of the challenges associated with developing an exposure model to represent the homeless sheltering and living on a contaminated site. For example, interviews with individuals may be necessary to develop an accurate exposure model. The presentation will also discuss the importance of the field sampling crew, from observing field conditions to safety concerns.

Functionality: What does it do?

Many organizations rely on external contractors to help deliver products and services. However, using these contractors comes with inherent risks, especially when it comes to safety. Contractor safety management is vital in reducing operational risks, meeting regulatory requirements, and keeping contractors and employees safe. KTL’s Contractor Safety Management Tool supports multiple layers of compliance (e.g., site-level, contractor-level, and employee-level requirements) to help efficiently manage contractor safety requirements—from training, to document management, to proof of qualifications.

Benefits: Why do you need it?

A Contractor Safety Management Tool helps to streamline compliance by keeping all safety-related records in one web-based system, creating the following benefits:

• Maintains proof of qualifications and reduces associated risk by tracking expiration dates and sending reminders before certifications, insurance, or permits lapse (both at the company and individual levels).
• Improves operational safety by providing a centralized location for important safety documents and procedures, such as lockout/tagout (LOTO) procedures and access points.
• Simplifies audits and inspections by organizing safety records in a secure and easily accessible format.
• Efficiently tracks and manages pending, completed, and upcoming training and associated records to help ensure role-specific competency and demonstrate training compliance during audits.
• Increases transparency, enhances accountability, and promotes continual improvement regarding contractor safety performance.
• Maintains a consistent, structured process for completing contractor approvals, including sending notifications.

Technology Used

• SharePoint
• Power Apps (for custom forms)
• Power Automate (for email notifications)

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

Betzy Colon, Senior Associate

Betzy is a senior environmental and social safeguards specialist with nearly 20 years of experience managing multi-sector investment projects, with a focus on project planning, safeguards implementation, strategic monitoring, and regulatory compliance. She has technical expertise in environmental management systems, environmental compliance audits and inspections, human health and ecological risk assessments, site investigations and remediation under CERCLA and RCRA, environmental permitting, and spill prevention and response. Betzy is based in Washington, D.C. Read her full bio…

Jeff Ploetz, Senior Associate

Jeff is an interdisciplinary environmental specialist with over 25 years of experience in environmental, social, and climate risk management. He has a proven track record of strengthening international development programs, environmental regulations, environmental impact assessment procedures, and knowledge management systems. He further has expertise in circular economy; climate mitigation/resiliency; energy efficiency; sustainable development; environmental, social, governance (ESG); strategic planning; and training and technical support.Jeff is based in Arlington, VA. Read his full bio…

Jordan Szynal, Associate

Jordan is an experienced quality and food safety professional with a background working in the chemical manufacturing and construction industries. She is well versed in developing and managing programs, standard operating procedures (SOPs), and work instructions to comply with quality and food safety regulatory compliance and certification requirements. Jordan is based out of the Chicagoland area. Read her full bio…

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.

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!

KTL is excited to be joining the 2025 Midwest Environmental Compliance Conference (MECC) in Overland Park, Kansas, September 15-16, 2025, as a sponsor, presenter, and exhibitor. MECC takes a fresh, regional approach to the increasingly difficult task of environmental compliance, permitting, enforcement, and other critical environmental issues that impact Midwest facilities and institutions.

KTL will be leading the following sessions as part of the workshop’s technical agenda:

OSHA Fundamentals for Advancing Environmental Professionals
September 15, 2025 | 8:45 am | Presenter: April Greene, CSP, CHMM, Senior Consultant

Moving from environmental specialist to EHS leader means you suddenly need to know about fall protection, lockout/tagout, confined spaces, and more. This session gives environmental professionals the strategic safety overview on critical safety programs.

IT Tools for EHS Compliance: Demo
September 15, 2025 | 11:15 am | Presenter: Joseph Kunes, Consultant

Building an EHS IT system doesn’t have to be complicated or expensive. Most companies already
have the software they need. Learn how to build data management tools to collect, track, & report EHS
compliance information using the latest Microsoft 365 and Power Platform apps. See examples and
hear from EHS/IT experts on how you can benefit from this approach.

Navigating EHS Challenges in the Food Industry: Panel
September 16, 2025 | 9:40 am | Moderator: Joe Tell, Principal

In the fast-paced and highly regulated world of food production, EHS professionals play a critical role in maintaining operational excellence while protecting workers, consumers, and the environment. This panel brings together experienced EHS managers from across the food industry to share real-world insights, lessons learned, and practical strategies for overcoming today’s pressing EHS challenges. The session will offer takeaways to strengthen your EHS programs and drive continuous improvement.

And be sure to stop by and visit our booth in the exhibit hall. We look forward to seeing you at MECC!

Functionality: What does it do?

A Safety Document Management System provides a company-wide framework for central, secure storage and organization of safety-related documents and records. This includes policies, procedures, training records, inspection reports, and regulatory documentation to comply with Occupational Safety and Health Administration (OSHA) requirements.

Safety records often have strict retention and security requirements and must be accessible for an audit at any time. A structured Safety Document Management System can help ensure that these critical files are not only retained according to OSHA requirements, but also are standardized, easily searchable, and available to the right people when they need them.

Benefits: Why do you need it?

Implementing a Microsoft SharePoint-based Safety Document Management System provides the following:

• Centralized access to safety policies, procedures, checklists, inspection logs, and training records – whether onsite or remote.
• Document version control to promote consistency and reduce errors associated with outdated versions being used.
• Quick document retrieval, version history, and clear audit trails to demonstrate compliance during audits.
• Improved operational collaboration through real-time share, review, and update capabilities.
• Enhanced workflows configured for notifications, document retention/archive processes, and document approvals (e.g., new procedures, corrective actions) with clear accountability.
• Increased visibility into safety performance by linking documents with incident reports, risk assessments, and corrective and preventive actions (CAPAs).
• Ease in uploading documents (like a shared network drive) and adding/updating metadata to improve searchability.
• Reduced physical paperwork.
• Option to include digital signatures on required documents.
• Better security and access permissions/control to protect sensitive safety data (e.g., incident investigations or medical information).

Together, these capabilities lead to safer workplaces, stronger compliance performance, and reduced risk during audits or inspections.

Technology Used

• SharePoint
• Power Automate

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:

1. 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.
2. 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.
3. 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.

Safe + Sound Week

Maintaining Occupational Safety and Health Administration (OSHA) compliance is not just about avoiding fines—it’s about creating a safe and productive environment where workers can thrive. And it’s about moving beyond paperwork and policy development to implementing practical strategies and creating a culture that makes safety a daily priority.

Practical Strategies

Implementing effective safety protocols and maintaining OSHA compliance requires a combination of diligence, training, regular monitoring, and engagement.

1. Diligence. To create an effective Safety Program, you need to understand your regulatory requirements. Equally important, you need a thorough understanding of your operations, your workforce, and your hazards and risks to develop a Safety Program that meets your specific needs. Diligence requires staying informed about changes to OSHA regulations and industry best practices to ensure your facility remains compliant and workers stay protected according to the law. A comprehensive hazard assessment can help identify areas where specific safety improvements—sometimes beyond the law—are needed at your facility. Use this assessment, as well as your understanding of your operations and your employees, to develop or update your Safety Plan and procedures. Procedures should be customized to address specific risks within your facility, while still meeting regulatory compliance requirements.
2. Training. A hallmark of any best-in-class organization is its ability to continually look for opportunities to improve. Safety is no exception. OSHA has significant training requirements for employees for good reason. If employees don’t know how to do their job safely, there are real risks of noncompliance, poor employee morale, injury, or worse. Ensure all employees are trained in relevant OSHA standards, understand their responsibilities related to job tasks and safe behaviors, and know how to identify and report potential safety issues. Ongoing education and engagement are key to retention. Safety training shouldn’t be a one-time event; rather, it should be a continuous process that evolves as the facility and industry standards change. Effective training will incorporate interactive learning approaches, real-world scenarios, peer-to-peer learning and mentorships, and continual feedback to create a culture where employees understand and value the importance of safety.   
3. Regular Monitoring. Regular audits and inspections of your operations, equipment, and practices provide a valuable means of supporting ongoing safety performance and compliance. Every Safety Program needs to be continually reviewed and assessed to ensure it is meeting organizational goals and compliance requirements. Internal audits and inspections can help identify problems so corrective/preventive actions can be put into place and then sustained and improved over time. Many organizations conduct internal audits with their own staff to assess conformance and identify opportunities for improvement. It can be beneficial to bring in a second party at least annually to provide a fresh set of eyes and an objective assessment of overall compliance status.  
4. Engagement. Engaging workers in safety initiatives, encouraging them to voice concerns, and creating an open dialogue about safety will create buy-in and foster a strong safety culture. Every employee can bring something to the table when it comes to safety. New employees offer a fresh set of eyes; long-term employees have valuable lessons learned to share. Organizations need to continually provide opportunities to get all employees involved in safety in meaningful and appropriate ways, such as creating employee safety committees, involving employees in procedure development, and engaging employees in incident investigations.

Prioritizing Employee Safety

It takes practical strategies to maintain ongoing compliance and create a workplace culture that truly values employee safety. You can make health and safety compliance a daily priority by implementing clear strategies, staying informed on regulations, and actively involving your team. Prioritizing employee safety is about more than just addressing regulatory compliance, it is about safeguarding your employees and the future of your business.