Strengthening the Food Supply Chain Through Education, Training, and Outreach (November 18–19, 2025)
The 2025 FSPCA Annual Conference brought together regulatory leaders, industry experts, and food safety professionals to explore emerging challenges and collaborative solutions aimed at strengthening the global food supply chain. Two dominant themes framed this year’s discussions: advancing hazard analysis practices under Hazard Analysis 2.0 and deepening industry commitment to chemical safety and contaminant reduction, particularly for vulnerable populations.
Across two days of presentations, case studies, and panel discussions, participants examined how updated FDA resources, new FSPCA teaching tools, and science-based approaches can help facilities identify hazards more accurately, assess supplier risks more effectively, and design food safety programs that anticipate chemical and process-related issues long before they reach consumers.
This information is useful to PCQIs, food safety and HACCP teams.
A New Approach to Hazard Analysis 2.0
Evolving Expectations for Hazard Identification
The speakers introduced the updated Hazard Analysis 2.0 framework, designed to align facility-level hazard identification with the most recent FDA guidance. This approach is used when teaching the FSPCA Preventive Controls for Human Food V2 course.
This approach integrates two key reference sources:
- FDA’s revised draft Food Hazards and Controls Guide – Appendix 1 (January 30, 2024)
- Updated FSPCA teaching tools, including Form 0231 and the new Teaching Example User Guide (See image below).
The overarching objective is to improve the clarity and precision of hazard identification, both for inherent ingredient hazards and for hazards that arise from supplier processes and facility operations.
The FDA’s data dashboards provide a comprehensive overview of food recalls in the USA, including details on the severity of the recall, affected products, and the number of units recalled. The dashboards are updated weekly and include only recalls classified by the FDA. Users can filter recalls at either the event or product level to find specific information.
Understanding the Two Hazard Categories
Ingredient-Related (Inherent) Hazards
These hazards originate from the ingredient itself—such as Salmonella in spices, mycotoxins in grains, or pesticide residues in produce. Appendix 1 now provides extensive biological and chemical hazard tables to guide this evaluation. Facilities must assess inherent hazards for each ingredient and document their sources, subcategories, and hazard relevance.
Note: Your food safety plan must also determine hazards for food packaging items and other inputs such as water, steam, ice and compressed air/inert gasses.
Supplier Process- and Facility-Related Hazards
These hazards occur due to how an ingredient is grown, handled, processed, packaged, or stored. Common examples include environmental contamination, allergen cross-contact, misformulation, or metal fragments from grinding equipment. Facilities use Appendix 1 (particularly section A1.7) and FSPCA Form 0231 to evaluate which hazards are reasonably foreseeable and which can be ruled out.
Enhanced FDA Appendix 1: A Central Tool for Hazard Analysis
The updated Appendix 1 is now the FDA’s primary reference for hazard identification!
Enhancements include:
- Sixteen food groups with detailed categories and subcategories
- “Most relevant” biological and chemical hazard tables
- Ingredient-specific lookups for foods without dedicated tables
- A clearer distinction that physical hazards are associated with processes, not ingredients
This shift reflects FDA’s intent to standardize hazard identification and make the rationale more transparent. The approach is guided: regulators “tell you where to look and what to consider,” while facilities must evaluate likelihood and severity.
Illustrative Case Study: Garlic Powder
A detailed garlic powder example showcased how Hazard Analysis 2.0 clarifies both inherent and supplier-related hazards.
Ingredient Hazards (Appendix 1: Table 1O / 2H)
- Biological: Salmonella; sporeformers (C. botulinum, C. perfringens, B. cereus)
- Chemical: Pesticides; Lead (relevant only for infant foods)
Supplier Process Hazards
Considerations included irradiation validation, allergen control, equipment materials, and environmental exposure. Metal fragments from grinding presented the most relevant process-related hazard.
Evaluation Outcome
- Salmonella controlled by validated irradiation
- Sporeformers not requiring control (low water activity + acidic recipe application)
- Pesticides unlikely due to U.S. sourcing
- Lead not relevant
- Metal fragments requiring a supply-chain preventive control
The example underscores the systematic risk assessment approach expected under Hazard Analysis 2.0. for the development of robust food safety plans.
Two-Step Framework for Hazard Analysis
Hazard Analysis 2.0 reinforces a structured methodology:
- Hazard Identification: Consider all potential biological, chemical (including radiological), and physical hazards from ingredients, suppliers, and facility processes. Hazards in food can be unintentional or intentional such as when considering food-fraud related risks.
- Hazard Evaluation: Determine which hazards are reasonably likely to occur and would cause severe harm—those require preventive controls.
Recognizing Exceptionally Lethal Processes
FDA has introduced the concept of “exceptionally lethal processes,” which eliminate biological hazards to such an extent that certain foods may have no remaining biological hazards requiring control. Examples include frying potato chips, baking snack crackers, popping popcorn, and producing highly refined oils. Facilities must still demonstrate that the lethality is sufficient and justified.
Supplier Knowledge as a Critical Control Point
Speakers emphasized that the ability to evaluate supplier-related hazards relies on understanding supplier processes in detail. Recommended industry practices include:
- Conducting site visits
- Using pre-assessment questionnaires
- Requesting safety plans, flow diagrams, environmental data, pesticide usage records, and FSVP documentation
Hazard Analysis 2.0 demands greater supplier transparency and more robust verification of how ingredients are produced.
Chemical Safety and the “Closer to Zero” Imperative
The conference’s chemical safety panel focused on how regulators and industry are working together to minimize chemical contaminants in the food supply.
FDA’s “Closer to Zero” Framework
Panelists highlighted FDA’s multi-stage initiative aimed at reducing children’s exposure to arsenic, lead, cadmium, and mercury. These metals pose heightened risks for infants and children due to their developmental sensitivity. FDA’s structured process—scientific review, proposed action levels, stakeholder engagement, and finalization—reflects a commitment to transparency, feasibility, and health protection.
The Value of Data Sharing and Collaboration
A recurring message was that “food safety is not proprietary.”
Shared contaminant data enables better surveillance and helps industry move toward ALARA (As Low As Reasonably Achievable) levels for toxic elements. Companies are encouraged to provide contamination data, participate in research, and help shape realistic action levels that reflect achievable manufacturing practices.
Food Safety by Design (FSbD): A Proactive Chemical Safety Model
FSbD integrates chemical safety directly into product development and hazard analysis. This structured approach involves cross-functional expertise, global regulatory review, ingredient and component testing, and evaluation of processing-induced toxins. By assessing more than 100 potential hazards per project, FSbD promotes consistency, conservatism, and continuous improvement in chemical safety management.
Current Chemical Hazard Trends
Panelists noted emerging patterns in global ingredient sourcing:
- Chlorates and perchlorates appear more frequently in U.S. and South East Asian products than in European equivalents.
- Lead levels can be higher in certain U.S.-sourced materials compared to imports.
These trends highlight the need for targeted sourcing decisions and improved sanitation and water controls.
In addition to Appendix 1, additional resources included:
FDA Chemical Contaminants & Pesticides page – overview and links to programs and limits:
FDA Chemical Contaminants Transparency Tool – searchable database of contaminant tolerances, action levels, and guidance levels by chemical and commodity:
Industry Actions to Strengthen Chemical Safety
Recommended next steps for manufacturers included:
- Enhancing chemical hazard mapping and team training
- Reviewing sanitation chemical classes linked to endocrine or thyroid impacts
- Monitoring heat-induced toxins such as acrylamide and furan
- Applying multi-hurdle strategies to reduce chemical hazards across the production chain
Overall Takeaway
The FSPCA 2025 Annual Conference underscored the industry’s transition toward more sophisticated, science-based hazard identification and chemical risk management. Whether through leveraging the FDA PCHF guidance 2024 (Appendix 1), strengthening supplier verification, embracing Food Safety by Design, or advancing collaborative chemical safety initiatives, the message was clear: continuous improvement, data sharing, and proactive evaluation are essential to protecting consumers and reinforcing the food supply chain.
Summary: Chemical Safety Panel (FSPCA 2025)
- FDA’s “Closer to Zero” initiative aims to reduce children’s exposure to key toxic elements (arsenic, lead, cadmium, mercury) through a transparent, multi-stage regulatory process.
- Industry collaboration is essential—data sharing helps drive ALARA contaminant reductions and supports realistic regulatory action levels.
Food Safety by Design (FSbD) offers a disciplined framework for evaluating over 100 chemical hazards, integrating global regulations, and preventing processing-induced toxins. - Emerging chemical hazard trends include elevated chlorates, perchlorates, and lead in certain domestic ingredients.
Action steps for industry include expanded chemical hazard training, sanitation chemical review, toxin monitoring, and applying hurdle technology. - Core message: A proactive, science-driven, collaborative approach is critical to reducing chemical hazards, especially for foods intended for infants and children.
Sirocco Food + Wine Consulting Inc. offers the FSPCA Preventive Controls for Human Food V2 course. Course is offered in a 3-day format and hybrid format (9 hours + breaks, Part 2). The PCQI course is the only “standardized curriculum” recognized by U.S. Food and Drug Administration. The FSPCA provides training programs to assist the food industry to achieve compliance with the U.S. Food and Drug Administration (FDA) Hazard Analysis and Risk-based Preventive Controls for human food regulation. Successful completion of the FSPCA course is one way to meet the requirements for a “preventive controls qualified individual or PCQI.” Under the rule, the PCQI, which can be a company employee or a consultant, prepares or oversees the preparation of the food safety plan, validates preventive controls, performs a review of food safety documents and reassesses the plan a minimum of every 3 years or when changes are required.
