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  5. FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
  1. Food Safety Modernization Act (FSMA)

FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

Federal Register Notice announcing the rule

Docket Folder FDA-2013-N-1425 provides the full text of the rule

Fact Sheet

Explanatory Diagrams
Diagram 1: Does the rule to protect against intentional adulteration apply to me?
Diagram 2: Requirements for the rule to protect against intentional adulteration

Explanatory Diagrams (Black & White)

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.

While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration is addressed in the final preventive controls rules for human and animal foods.

With some exceptions listed below, this rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.

This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities.

It does not cover farms.

 

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