Food facilities are required to register with FDA if they manufacture/process, pack, or hold food for human or animal consumption in the United States. These registered food facilities are subject to new regulations under FSMA.
On September 17, 2015 FDA published Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF), which creates new requirements for the production of human food by registered food facilities, and revises previous requirements. The rule focuses on a written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, and associated records, and is designed to prevent biological, chemical (including radiological), and physical hazards. Compliance dates are staggered based on the size of the operation.
FDA has also published Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule), which creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration
Additionally, facilities which transport products may be subject to the Sanitary Transportation of Human and Animal Food (ST rule). The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. The goal of this rule is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. FDA has created a free online training module to help meet the requirements of this rule.
If you are a food producer covered by FDA’s regulations for seafood HACCP, FDA has published this guidance document to help you understand which parts of the FSMA rules apply to you and how the FSMA rules may affect your operations.
QCS Guidance Materials
FDA Guidance Materials
More guidance materials and full-text copies of the FSMA Final Rules can be downloaded from the FDA FSMA Rules & Guidance for Industry page.