Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food, animal feed, and pet food laws in more than 70 years, was signed into law by President Obama on January 4, 2011. The Act aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.
The U.S. Food and Drug Administration (FDA) published its final regulations mandated by FSMA to establish requirements for CGMPs; hazard analysis and risk-based preventive controls; and supply chain management programs for human food, animal feed, and pet food on September 17, 2015.
These regulations apply to domestic and foreign facilities that manufacture, process, pack or hold (store) animal feed and/or pet food, and ingredients used in such products. In general, the requirements apply to facilities that are required to register with the FDA under the agency's existing facility registration regulations implemented as part of the Bioterrorism Act. More Info - Biennial Registration Food Facility
Food Safety Modernization Act DashboardThe FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of both the human and animal food supply is a shared responsibility among many different parties at various points in the global supply chain. The FSMA rules outline specific actions the food industry must take at each of these points to prevent contamination. For each rule, the FDA has identified measures that will help to evaluate how well the rules are being implemented and where there could be room for improvement.
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Deadlines Set for FDA to Establish Reporting Requirements for “High-Risk” Foods (June 2019)As part of the FSMA regulations, FDA was to (1) designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health; and (2) publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold such foods. The FSMA also required FDA to publish the list of foods designated as high-risk on FDA’s website at the time the Agency promulgates the final rule establishing recordkeeping requirements.
- Sept. 8, 2020 – Deadline for FDA to designate the list of “high risk” foods as required by the FSMA Section 204(d)(2)(A).
- Sept. 8, 2020 – Deadline for FDA to publish a proposed rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
- Nov.7, 2022 – Deadline for FDA to issue a final rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
Link to FSMA Website
- A draft guidance on Foreign Supplier Verification Program (FSVP) rule
- A Small Entity Compliance Guide on the FSVP rule
- A draft guidance on the term “Same Level of Public Health Protection” used in both the FSVP and Produce Safety regulations
- Chapter 15 of the draft Preventive Controls for Human Food guidance regarding Supply-Chain requirements
- Enforcement Discretion guidance regarding the application of FSVP to certain importers of grain raw agUnlinkricultural commodities (RACs)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide
- Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs
- Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Current Good Manufacturing Practices (CGMPs)
- Plant and Grounds
- Sanitary Operations
- Sanitary Facilities and Controls
- Equipment and Utensils
- Processes and Controls
- Warehousing and Distribution
Hazard Analysis Risk-Based Preventive Control (HARBPC)
- Food Safety Plan
- Must be implemented by "qualified" individual.
- Must be readily available on-site and site-specific.
- Retain records for a minimum of 2 years.
- Hazard Analysis
- Preventive Controls
- Recall Plan
- Corrective Action
- Reanalysis of the plan must be conducted every three years, when significant changes are made at the facility, whenever new hazards are identified, when preventive controls are found to be ineffective or not properly implemented.