E-Book22 chapters # FDA Food Safety Compliance Handbook (FSMA) A US food safety handbook: FDA and USDA roles, facility registration, FSMA rules, HACCP vs HARPC, food safety plans, FSMA 204 traceability and labels. US food safety compliance runs on a genuine split system: the FDA governs most of the food supply, while USDA's Food Safety and Inspection Service governs meat, poultry, and egg products under an entirely separate statutory framework, with its own continuous in-plant inspection model. Layered on top of that split sits the Food Safety Modernization Act of 2011, which rewrote FDA's authority around prevention rather than reaction through seven foundational rules most operators have only partially internalized. This book is a complete, standalone reference for US food safety compliance — from facility registration and HARPC-based food safety plans, through the Produce Safety Rule, FSMA 204's Food Traceability Rule, the full FALCPA and FASTER Act labeling and Big 9 allergen framework, the 2026 regulatory shift already underway, USDA/FSIS jurisdiction, and recalls and enforcement across both agencies. Written for food business owners, manufacturers, and quality assurance leads, this book takes the same first-principles-to-practical approach as the companion course, organized so you can read it start to finish before launching a business, or use it as a working reference once your own compliance project is already underway. Eight appendices document the downloadable tools that accompany this material, and a full ninety-day action plan closes the book with a concrete starting sequence for your own compliance work. ## What you'll learn * Understand exactly how the FDA and USDA/FSIS divide jurisdiction over US food, and which agency governs your product * Register your facility correctly and build a genuine HARPC-based food safety plan under FSMA's Preventive Controls rule * Determine which of FSMA's seven foundational rules actually apply to your specific business * Build a real traceability program ahead of FSMA 204's Food Traceability Rule, now delayed to July 2028 * Apply FALCPA and the FASTER Act correctly to the Big 9 major food allergens, including labeling edge cases * Navigate the Produce Safety Rule if you grow, harvest, or handle produce, including qualified exemptions * Understand FDA's mandatory recall authority versus USDA/FSIS's still-voluntary recall process * Stay ahead of the 2026 regulatory shift: GRAS reform, ultra-processed food definitions, and the synthetic dye phase-out $34.99 One-time purchase · Read in browser · No subscription * Understand exactly how the FDA and USDA/FSIS divide jurisdiction over US food, and which agency governs your product * Register your facility correctly and build a genuine HARPC-based food safety plan under FSMA's Preventive Controls rule * Determine which of FSMA's seven foundational rules actually apply to your specific business Buy for $34.99 Secure checkout via Paddle Not what you expected? Contact us within 14 days. This book is included free when you enroll in the full course — [$149.00 for the complete video curriculum plus this book](/courses/61-us-market-food-safety-compliance-guide). Built from a regulatory graph already at work 2,191 users this week 658 guides 323 product types 9 markets ## Chapters Read Chapter 1 free → 1 The Big Picture: Why US Food Safety Runs on a Split System US food safety law can look deceptively unified to a first-time operator — one country, one food supply — but it runs on a genuine split between two federal … 2 Legal Foundations: FDA, USDA/FSIS, and the FD&C Act Every rule in this book traces back to a specific statutory source. 3 FSMA and the Seven Foundational Rules FSMA rebuilt FDA's food safety authority around seven foundational rules, and this chapter maps all seven — Preventive Controls for Human Food, Preventive Co… 4 Facility Registration and the Preventive Controls Rule This chapter covers facility registration in full detail — who must register, the biennial renewal cycle, Unique Facility Identifiers, and genuine exemptions… 5 HACCP, HARPC, and Building a Food Safety Plan This chapter builds a genuine, working HARPC-based food safety plan from first principles: hazard analysis, the four categories of preventive controls, monit… 6 The FSMA Produce Safety Rule This chapter covers the Produce Safety Rule's scope, the qualified exemption under the Tester-Stemmer amendment, agricultural water requirements, biological … 7 FSMA 204: The Food Traceability Rule This chapter covers the Food Traceability List, Critical Tracking Events, Key Data Elements, the traceability lot code system, and the compliance date extens… 8 Food Labeling Under FALCPA and the FASTER Act This chapter covers the Big 9 major food allergens in full, contains-statements versus ingredient-list declarations, precautionary "may contain" labeling don… 9 Nutrition Labeling, Health Claims, and the 2026 Regulatory Shift This chapter covers the current, actively developing 2026 regulatory landscape: GRAS standard reform, the push toward a federal ultra-processed food definiti… 10 USDA/FSIS Jurisdiction: Meat, Poultry, and Egg Products This chapter covers USDA/FSIS's continuous in-plant inspection model, the mark of inspection and establishment numbers, HACCP under 9 CFR Part 417 versus FDA… 11 Recalls, Reportable Food Registry, and Enforcement This chapter covers the Reportable Food Registry's 24-hour reporting requirement, recall classification, the complete recall process, FDA's mandatory recall … 12 Common Mistakes That Sink US Food Safety Compliance This chapter pulls together the recurring mistake patterns from every earlier chapter into one place, organized for use as a genuine periodic self-audit rath… 13 Full Walkthrough and Your Action Plan This closing chapter traces one realistic specialty sauce and condiment manufacturer from registration through its first FDA inspection, applying every princ… 14 Knowledge Checks Every module in this book includes a short knowledge check in the course itself. 15 Appendix A: Facility Registration & PCQI Readiness Worksheet 16 Appendix B: FSMA Rule Applicability Router 17 Appendix C: HARPC Food Safety Plan Builder 18 Appendix D: FSMA 204 Traceability Plan Builder 19 Appendix E: Big 9 Allergen Matrix & Label Compliance Checklist 20 Appendix F: FDA vs. USDA/FSIS Jurisdiction Router 21 Appendix G: Recall & Reportable Food Registry Response Plan 22 Appendix H: Due Diligence & Inspection Readiness Log Buy for $34.99 ## Want the full video course? This book's companion course covers the same material with video lessons and downloadable resources — and includes this book free. [ ![FDA Food Safety Compliance Course (FSMA)](/posters/61-us-market-food-safety-compliance-guide.svg) ](/courses/61-us-market-food-safety-compliance-guide) Intermediate2h 19m [ ### FDA Food Safety Compliance Course (FSMA) ](/courses/61-us-market-food-safety-compliance-guide) US food safety compliance: FDA facility registration, FSMA's foundational rules, HARPC, FSMA 204 traceability, allergens and the FDA/USDA split. Includes the ebook, free $149.00[View course →](/courses/61-us-market-food-safety-compliance-guide) Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. [See services](/services)