Understanding the Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) is a law mandating the Food & Drug Administration (FDA) to regulate the harvesting, processing, and transporting of food products for human or animal consumption. Passed in 2011, it represents the largest food industry reform in 70 years.

Since then, food and beverage manufacturers and importers have adopted new practices to stay in compliance with new and evolving regulations. To maintain compliance, they must understand the legislation's goals, federal requirements, and how to implement cost-effective automated compliance solutions.

Drawing on decades of experience in food and beverage and other industries that already adapted to enhanced regulations, ifm helps streamline and automate food safety monitoring and documentation while minimizing labor costs and risk.

A paradigm shift for food safety practices

FSMA marks a significant shift from reactive product recalls to proactive, preventive food safety measures. The law:

Establishes comprehensive, science-based preventive measures to strengthen food safety.
Expands inspections and compliance to ensure implementation of those protocols.
Provides the FDA enforcement capabilities to force mandatory recalls.
Establishes oversight of imported food products.
Encourages collaboration between the FDA and state or local agencies to build a more integrated food safety system. (Source.)

Since 2013, the FDA has issued 10 rules to implement preventive safety measures from harvest to manufacturing to transportation across the food supply chain. It issued the final rule to establish traceability requirements for high-risk foods in 2024 with enforcement set to begin in January of 2026. Recently, the FDA announced an extension of this compliance deadline to mid-2028 to ensure all entities across the supply chain have adequate time to coordinate sharing of accurate data.

In 1938, the Federal Food, Drug, and Cosmetic Act (FD&C) empowered the FDA to enforce food safety and remove harmful products from the market. It established FDA authority and the current Good Manufacturing Practices (cGMP) requirements for food, additives, drugs, and cosmetics. The DSHEA extended cGMP coverage to dietary supplements in 1994.

How does FSMA enhance previous legislation?

FSMA gave the FDA a mandate to transition from reacting to foodborne illness outbreaks to preventing them. It covers most food production, excluding products regulated under the 1994 Dietary Health and Education Act (DSHEA).

Building on the FD&C Act, the FSMA mandates that the FDA use evidence-based practices to:

Establish preventive food safety measures
Inspect food and facilities more often
Enact mandatory recalls

The FDA established 10 new food safety rules while partnering with state and local agencies to create a nationwide food safety system. It builds on a familiar regulatory framework by using existing definitions from previous legislation to help producers understand compliance requirements.

What is the Hazard Analysis and Critical Control Points (HACCP) framework?

Originally developed by NASA, the Hazard Analysis and Critical Control Points (HACCP) framework is the leading safety protocol for food producers. The seven steps of the HACCP framework are:

Hazard analysis: identify hazards reasonably likely to cause injury or illness.
Critical Control Points (CCP): a step where a control can be applied to prevent or eliminate hazards identified in the first step.
Critical limits: defining the corresponding maximum or minimum values for each CCP to prevent or eliminate the food safety hazard.
Monitoring procedures: planned oversight of measurements on a continuous or determined frequency ensures CCPs are under control.
Corrective actions: this establishes procedures for correcting non-compliance at CCPs, how to handle non-compliant products, and record that corrective actions were taken.
Verification procedures: evaluation, review, and validation that the HACCP plan has identified all hazards and is functioning as intended.
Record-keeping and Documentation: ensures all established parts of the food safety plan are recorded and responsibilities assigned to team members.

Food producers that use this framework are implementing and establishing best practices for food safety in their production processes.

The FDA recognized its effectiveness in mitigating food safety risks and incorporated these evidence-based practices into the final rules issued under the FSMA.

FSMA Rules and key requirements

The FDA issued 10 final rules to implement the mandate established in the FSMA. These rules and the associated key requirements help food manufacturers, transporters, and importers implement best practices and foster a food safety culture. Almost all rules include some full or partial exemptions. The FDA provides guidance documents for each rule.

Food Traceability Rule

The rule establishes the Food Traceability List (FTL) of high risk foods that must comply with additional traceability requirements. It requires providing the FDA with original, untampered, searchable documentation of traceability data within 24 hours of a recall notice. While focused on high-risk foods, it establishes traceability best practices for the entire industry.

Read more about the rule and how to comply.