- Food Safety Modernization Act (FSMA)
- Food Adulteration Rule
FSMA: Mitigation Strategies to Protect Food Against Intentional Adulteration Rule
The Mitigation Strategies to Protect Food Against Intentional Adulteration Rule requires food facilities to develop food defense plans that minimize and prevent large-scale, intentional food adulteration that endangers public health. These risks include terrorism targeting food supplies.
The Mitigation Strategies to Protect Food Against Intentional Adulteration Rule is part of the Food Safety Modernization Act (FSMA) and is enforceable by the U.S. Food & Drug Administration (FDA). It has been in effect since 2019.
Key requirements
The Rule establishes a flexible system allowing facilities to incorporate new information and best practices regularly.
Food defense plan
A food defense plan is a collection of documents outlining how a facility can prevent intentional harm to a food supply. Each plan must be tailored to the facility and procedures. The core elements include:
- Vulnerability assessment: Evaluate each process step for risk factors, including potential impact severity, physical access, and contamination potential
- Mitigation strategies: Reduce or eliminate the potential for harm
- Monitor and verify: After implementation, ensure the plan is functioning as intended.
- Corrective actions: Establishing necessary actions to take if mitigation strategies are not implemented.
- Conduct training: All personnel with access to vulnerable areas receive adequate training.
- Maintain records: Facilities must document these protocols and completed personnel training.
The Rule requires reanalysis every three years or sooner if a facility does not meet specific requirements, such as failing to implement a mitigation strategy properly.
How the Rule achieves its goal
Based on intelligence and industry input, the FDA adopted a systems approach similar to the Hazard Analysis and Critical Control Point (HACCP) framework used to manage food safety. The Rule creates a strategic framework for food analysis by assessing and mitigating the risk of intentional harm to the food supply during production.
Who must comply
All FDA-registered food facilities governed under the FD&C Act must comply. Covered entities include businesses exceeding $10,000,000 in inflation-adjusted sales over the previous three years.
Exemptions
- Businesses meeting the “Very small businesses” definition (less than $10,000,000 in average yearly sales) are exempt but must maintain documentation proving they meet this definition.
- Farms and any small on-farm manufacturing operations with limited reach.
- Businesses packing, repacking, or holding already-packaged foods (unless they hold food in liquid storage tanks.)
- Facilities producing alcoholic beverages.
- Facilities manufacturing, processing, packing, or holding animal food.
Noncompliance
The FDA can enact penalties including fines, increased inspections, and audits. More severe legal actions include seizure or injunction preventing selling and distributing or transporting food.
How can food manufacturers comply with the rule?
After completing vulnerability assessments, food manufacturers must determine prevention methods and mitigation strategies. Sensors, controllers, and other food and beverage automation solutions help facilitate these protocols. Some options include:
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Real-time media monitoring of multiple process parameters can alert producers to unauthorized introduction of ingredients that cause measurable changes in the product. Digital sensors for food and beverage production with increased resolution offer enhanced insight.
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Sensors with embedded IO-Link communication and field-mounted IO-Link masters enable remote monitoring and real-time notifications of changes that occur to food products during production.
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HMI controllers simplify machine control with the flexibility to program multiple screens and manage access levels easily. This feature enables permission-based data review, with both local and remote options to enhance insight into machine operations.
Reason for the Rule
The Mitigation Strategies to Protect Food Against Intentional Adulteration Rule adds preventive actions to previous food defense regulations. It also focuses on intentional harm prevention from internal actors. These elements were missing from earlier guidelines and laws.
History
Previously, FDA guidance was optional, and the Current Good Manufacturing Practices (CGMPs) addressed general contamination, but not intentional harm prevention.
Following the September 11th terrorism attack and anthrax attacks in 2001, the 2002 Bioterrorism Preparedness Act mandated enhanced FDA food traceability. It required FDA registration and threat-response recordkeeping, but omitted preventive measures.
After the FSMA became law in 2011, the FDA proposed the Food Adulteration Rule in 2016. It then provided a phased compliance period based on business size to give facilities time to adjust.
Timeline
- July 2019 – Large businesses (>500 employees)
- July 2020 – Small businesses (<500 employees)
- July 2021 – Very small businesses (limited requirements)
In the news
(Updated February 2024)
