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FSVP: 3 Key Requirements for FSMA Compliance

By John Johnson III   |   

Importers, get ready: in May 2017, FDA will start enforcing its final rule for the Foreign Supplier Verification Program (FSVP). The FSVP rule, designed to ensure the safety and compliance of imported food from foreign suppliers, requires non-exempt importers to establish written procedures for evaluating the hazards and risks associated with each foreign supplier and imported food. The multi-step task of establishing an FSVP is daunting, but it’s not impossible for those who get started now. Here are some of the challenges importers will have to tackle.


Hazard Identification and Analysis

First, importers must identify all potential hazards related to each of their food products. Hazards may be physical, biological, chemical, or radiological; examples include harmful bacteria, illegal pesticide residues, harmful chemicals, radioactive particles, unapproved additives, and glass or metal. Importers should keep in mind not only natural hazards but also harmful elements that could be intentionally added or substituted into a food product. Many factors could be the source of a hazard – importers will have to consider everything from ingredients and food storage to employee hygiene and the product’s intended use. Once the hazards are identified, the importer must assess the likelihood that a hazard will occur without a control to minimize or prevent it.


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Evaluation of Risk and Foreign Supplier Compliance

Based on the hazard analysis, the importer must determine the risk presented by a food product—how serious are the consequences of an uncontrolled hazard? As part of the risk analysis, the importer must evaluate who will control the hazard. This entity may be the importer’s customer, the foreign supplier of the food, or a supplier of a raw material or an ingredient used in the food.

The importer also has to evaluate the foreign supplier’s history of food safety and how compliant the supplier is and has been with FDA food regulations. Relevant factors include FDA warning letters issued to the supplier, the supplier’s refusal history, results of FDA inspections conducted at the supplier’s facility, food-borne illnesses traced back to the supplier, and whether the supplier successfully implemented corrective actions to any previously identified problems.

The FSVP rule requires importers to review their risk evaluations at least every three years. Based on these evaluations, importers must take appropriate steps to verify supplier compliance – for instance, by testing products, conducting on-site facility audits, or reviewing food safety records.


What this Means to Food Importers

With so many factors to consider at every step—for each foreign supplier and imported food—importers face no small task in complying with the FSVP rule. Those performing the required analyses must have expertise about the imported food as well as FDA regulations, including regulations on food adulteration and misbranding, good manufacturing practices (GMPs), preventative controls, and produce safety requirements.

The good news, however, is that importers don’t have to perform these evaluations themselves. The FSVP rule allows importers to hire a third party to perform the hazard analysis and risk evaluations, set up their food safety plan, and even monitor them. Still, the importer is ultimately responsible for ensuring that the proper evaluations are conducted and for reviewing the documentation from these tasks.

*Editor’s Note: This post was originally published by

About FDA Imports, LLC’s regulatory specialists and affiliated attorneys represent proven consulting and legal experience, integrated into a single source for solving the problems involved in bringing products to the highly-regulated United States market. The firm efficiently handles highly complex technical, regulatory, and legal issues and provides individual solutions for businesses around the world. successfully and routinely works in the intersection of complex administrative law and international regulations.


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