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The FDA Food Safety Modernization Act (FSMA) regulations are the most comprehensive overhaul of the FDA food safety regulations in over 70 years. They were approved in 2011, and the effective dates began in 2015, as the rules were finalized and published.
FSMA is broken into 7 different rules, with the intent to protect the U.S. food supply during all points of the supply and distribution chains. Each rule covers a specific part of domestic food production, processing and transportation of human and animal food, as well as the importation of food for humans and animals, and strategies to mitigate intentional adulteration.
The FSMA Rules are a science-and risk-based approach to the management of food safety. This is a major shift instead reacting to an outbreak after it happens.
Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), which covers fruits, vegetables and tree nuts that are likely to be consumed raw.
Below is an overview of the FSMA rules for processed foods, and summarizes the requirements for food entering the U.S. supply and distribution chains. For full requirements, please see the appropriate FSMA rule.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventative Controls for Human Food)
Very similar to the Preventative Controls for Human Food, this rule ensures the safety of food used for livestock as well as pets.
Assures foreign food suppliers are providing human and animal food meeting FSMA level compliance at the time of importation.
Protecting the U.S. food supply from economically motivated adulteration.
Through this discussion of the seven FSMA rules for processed foods, you may have noticed the mention of several food safety systems. All are based on prevention, but they each have a different focus. Below is a very brief overview:
HARPC (Hazard Analysis and Risk-Based Preventative Controls)
FDA mandated through FSMA, this food safety plan has a broader scope than HACCP, in that is looks at all risk points, known or reasonably foreseeable hazards, with the intent of proactively taking steps to significantly minimize or prevent the hazard. Chemical, biological and physical hazards, as well as naturally occurring, intentionally and unintentionally introduced hazards are all part of HARPC.
HACCP (Hazard Analysis and Critical Control Points)
A globally recognized, voluntary, food safety standard primarily driven by retailers, auditors, and inspectors. An exception is where the FDA or USDA requires a HACCP plan for meat, seafood and juice production. HACCP looks at critical points in the food process system and applies controls to prevent, eliminate or reduce the hazard to a safe level. Minimum temperature and time requirements when cooking meat, is one example.Food Defense Plan
An FDA mandated food safety system that is vulnerability based. Developing a Food Defense Plan is similar to developing a HACCP plan. Each step in the production of a food is evaluated for several criteria and actionable steps put in place to mitigate the vulnerability. This is a new type of food safety plan, introduced with the Food Defense rule.
Compliance dates for each rule are dependent on the published date of the finalized rule and the size of the covered company. For a comprehensive list of compliance dates for all rules, click here. To learn more about the FSMA Rules, click here.
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