Even as we began finalizing FSMA requirements five years ago, the need for change was evident. To give you an idea, here’s the roll-out: Small businesses with less than 500 employees need to comply by January 1, 2018. At a minimum, the program should be tested annually at the warehouse using their system. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). Um, what? Over the next few years, FSMA will start impacting farm and food businesses of every size. ... A recall plan is a required component of every facility having a preventative control. The law is enforced by the FDA, and is called Food Safety Modernization Act (FSMA). For full requirements, please see the appropriate FSMA rule. FSMA is the first overhaul of any such protection system since 1938. Triggers for recalls have not changed under FSMA — they’re still adulteration (Section 402) and misbranding (Section 403). By David Fairfield, Senior Vice President, Feed The U.S. Food and Drug Administration (FDA) on Aug. 3 published Federal Register notices announcing the fiscal year 2021 fees associated with reinspecting facilities and importers, overseeing mandatory recalls, and participating in the agency’s third-party certification and voluntary qualified importer programs (VQIP). Customer guidance and requirements may drive a warehouse’s trace/recall program. FSMA section 204, which covers recordkeeping and the enhanced tracking and tracing of food products, is the rule that will be defining and enacting these additional requirements. recordkeeping requirements for certain high -risk foods. FDA was given mandatory recall authority immediately, when FSMA was signed into law on January 4, 2011. These programs are usually designed at the place of manufacture and at the warehouse. Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute. Even as we began finalizing FSMA requirements five years ago, the need for change was evident. Where an identified hazard will be controlled in a facility’s supply chain (through further processing by the facility's customer) the facility is required to have a supply chain program. In the second half of Chapter 4 of the Preventive Controls Draft Guidance, FDA focuses on suggestions and recommendations for identifying, implementing, and monitoring preventive controls related to sanitation (4.4), food allergens (4.5), and the supply chain (4.6), along with recall plans (4.7). In last week's newslet Introducing the Food Safety Modernization Act (FSMA). This program must be documented to describe the procedures to perform a product recall. Home » FSMA Update: FDA Issues Draft Guidance on Recall Plans Under the Preventive Controls for Human Food Rule ... 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