Food Safety

Food Safety Modernization Act

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About The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.

FDA has finalized several rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.

FAQ

Frequently Asked Questions

Frequently asked questions pertaining to the FSMA

You can find more information about the FSMA on the website https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma

It is a prohibited act to fail to meet the requirements of section 418 of the FD&C Act, related to preventive controls, and to fail to comply with the requirements under section 419, related to produce safety. Depending on the nature of the violation, and whether the food is adulterated or misbranded, FDA may consider different regulatory actions. These include:

the issuance of advisory letters;

court actions, such as seizure or injunction; and

administrative actions, such as administrative detention to gain control of adulterated or misbranded products, mandatory recall of violative food, or suspension of a facility’s food registration to prevent the shipment of food.

For imported food products, FDA may detain and refuse violative entries, or place imported food products on import alerts to inform FDA field staff that they may detain (i.e., initiate a refusal of admission) future shipments of a food without physical examination.

A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food
safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury.

It contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding.

A “preventive controls qualified individual” (PCQI) must develop (or oversee the development of) the FSP. A PCQI is a person with the education, training, or experience (or a combination of these) to develop and apply a food safety system.

A PCQI can be qualified through job experience or by completing training equivalent to the standardized curriculum recognized as adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training). The PCQI does not need to be an employee of the facility.

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