What is FSMA? Key requirements food exporters to the US need to know

FSMA is one of the key legal foundations for food safety in the United States, with a strong emphasis on preventing risks before food safety incidents occur. For food manufacturers supplying the U.S. market, understanding the applicable FSMA regulations helps clarify responsibilities related to food safety, facility conditions and pest management throughout production.

1. What is FSMA?

FSMA stands for the Food Safety Modernization Act, the U.S. Food Safety Modernization Act. The Act was signed into law on January 4, 2011, and gave the FDA additional authority to build a food safety system with a stronger focus on prevention.

The FDA has implemented FSMA through a number of different rules, including Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, and Foreign Supplier Verification Programs. Businesses need to determine which specific rules apply to their operations and products.

This distinction is important when discussing FSMA: it is a law and regulatory framework, not a certification scheme like BRCGS, IFS Food or SQF.

2. What is distinctive about FSMA’s preventive approach?

FSMA shifts the focus of food safety management towards preventing hazards before they result in food safety incidents. Under the Preventive Controls for Human Food rule, covered facilities must have a written food safety plan that includes hazard analysis and risk-based preventive controls where required. For pest management, the same preventive thinking means that businesses need to manage attractant sources, entry routes and abnormal pest activity before pest issues develop into incidents that affect products.

Businesses also need to verify that hazards are being controlled and implement corrective actions when the system does not achieve the intended outcome. The frequency of many verification activities is determined based on risk.

The same principle is useful when designing a pest management programme: inspection and treatment frequencies should not be applied uniformly across all areas or all facilities.

This approach shares many similarities with the risk-management principles of Integrated Pest Management (IPM), where pest risks are prevented and monitored continuously rather than addressed only after pests appear.

3. What does FSMA require for pest control?

The Current Good Manufacturing Practice requirements in 21 CFR Part 117 include specific provisions on pest control. Under 21 CFR 117.35(c), pests are not permitted in any area of a food plant. Effective measures must be taken to exclude pests from manufacturing, processing, packing and holding areas and to protect food against contamination. In practice, this requirement needs to be translated into a structured pest control process for food manufacturing facilities , covering prevention, monitoring, documentation and corrective action.

The use of pesticides is permitted, but precautions and restrictions must be followed to prevent contamination of food, food-contact surfaces and food-packaging materials.

The regulation also links pest control with conditions on the facility grounds. Under 21 CFR 117.20, facilities need to manage waste, weeds, stored equipment and other conditions around the plant that may provide pest harbourage or attract pests.

4. Which areas should facilities control to meet applicable FSMA requirements?

External areas need to be managed to reduce the risk of pests approaching and entering the facility. Overgrown vegetation, stored materials, waste and drainage systems can become attractant sources or harbourage if they are not properly managed.

Inside the facility, doors, drains, utility penetrations, raw material receiving areas, storage areas and production zones need to be assessed for potential pest entry.

Technical exclusion measures—such as sealing gaps beneath doors, installing insect screens and sealing wall penetrations—should be combined with pest monitoring devices and adapted to the actual conditions of each area.

When pest activity is detected, the facility needs to take action to protect products and address the underlying cause. FDA inspection history shows that facilities have received official Warning Letters for violations of 21 CFR 117.35(c) involving pest activity in production areas. Such violations can contribute to regulatory actions that may affect the entry of products into the U.S. market.

5. How can IPM support FSMA compliance?

IPM helps businesses translate facility-condition and pest-prevention requirements into a structured management programme. The process begins with risk assessment, structural controls and management of attractant sources, followed by the installation of monitoring devices to track pest activity.

Monitoring data help businesses identify areas requiring action and evaluate effectiveness after corrective measures are implemented. This approach is consistent with the principle of risk-based prevention reflected in FDA regulations implementing FSMA.

For these data to support effective management, businesses need to understand how to read pest control reports, from activity levels and trends to preventive and corrective actions.

In particular, reducing reliance on broad-area pesticide treatment can also help businesses manage product-contamination risks more effectively.

6. How does FSMA differ from BRCGS, IFS Food and SQF?

BRCGS, IFS Food and SQF are certification programmes or standards against which businesses can be assessed by certification bodies within the relevant scope. FSMA is part of the U.S. legal framework and is implemented by the FDA through mandatory regulations for entities that fall within their scope. If a facility also applies certification systems, businesses can review common pest control requirements across major manufacturing standards and systems to distinguish the requirements of BRCGS, IFS, FSSC, HACCP, GMP, AIB and related systems.

Businesses should therefore not refer to themselves as being “FSMA certified” in the same way they might refer to BRCGS or SQF certification. A more appropriate expression is compliance with the FSMA requirements applicable to the business.

For Vietnamese businesses exporting food to the United States, it is important to clearly identify the responsibilities of the facility, importer and supply-chain parties under each applicable FSMA rule rather than treating FSMA as a single checklist.

7. How VFC PestMan supports pest management under FSMA-related requirements

VFC PestMan develops IPM programmes based on risk assessment and the operating conditions of each facility. Entry points, external areas, drainage systems, storage areas, loading docks and production zones are assessed to determine appropriate preventive measures.

The monitoring system enables businesses to track pest activity using data and take action when abnormal activity is detected. Inspection records, device maps, treatment history and CAPA provide a stronger foundation for QA/QC teams to manage the programme transparently.

For businesses supplying food to the U.S. market, a structured IPM programme can support the maintenance of appropriate facility conditions and the management of pest risks under relevant FDA CGMP requirements.

FSMA places strong emphasis on prevention and risk management throughout the food safety system. For pest control, FDA CGMP regulations require food facilities to actively prevent pest entry and protect products from contamination risks.

An IPM programme built around structural controls, sanitation, monitoring and data can help businesses manage pest risks more systematically while supporting compliance with applicable food safety requirements for the U.S. market.