Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

The Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration aims to prevent the intentional adulteration of food that can cause wide-scale harm to public health.

This includes acts of terrorism targeting the food supply. These acts, though not likely to occur, could cause illness, death, and economic disruption of the food supply if there aren’t any strategies in place to help prevent them from happening.

This rule does not address economic adulteration or target specific foods or hazards; rather, it focuses on risk-reducing strategies for processes in certain registered food facilities.

Who is covered?

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 are covered under this rule.

The rule targets large companies producing foods that will reach a large number of people.

Exempted facilities include, but are not limited to, farms, facilities dedicated to manufacturing, processing, packing, or holding of food for animals and very small businesses.

What are Covered Facilities required to have in place?

Covered facilities are required to develop and implement a written food defense plan.

This written plan must identify: Vulnerabilities and actionable process steps This action includes the identification of vulnerabilities and steps for each type of food manufactured, processed, packed or held at the food facility.

For each point, step, or procedure in the facility’s process, these elements must be evaluated to determine: The severity and scale of the potential impact of adulteration on public health.

The degree of physical access to the product.

The ability to successfully contaminate the product.

Mitigation strategies These strategies should be identified and implemented at each actionable process step to provide assurances that vulnerabilities will be minimized or prevented.

The mitigation strategies must be tailored to the facility and its procedures.

And procedures or management components for food defense to ensure the proper implementation of each mitigation strategy These steps include monitoring of the mitigation strategies, corrective actions, a response if mitigation strategies are not properly implemented, and verification activities that would ensure that monitoring is being conducted, and appropriate decisions are being made about corrective actions.

Additionally, the rule requires appropriate training of personnel assigned to the vulnerable areas.

The facility must document the training and keep records for food defense monitoring, corrective actions, and verification activities.

The rule also requires a reanalysis of the plan every three years or when certain criteria are met, such as mitigation strategies that are being improperly implemented.

Thank you for watching this video please follow us at www.extension.psu.edu/fsma This program was developed by Food Safety CTS, LLC for Penn State University.