Signed into law by President Obama on January 4, 2011, the Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
The US Food and Drug Administration (FDA) has proposed seven rules to implement the FSMA. One of these is the Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, which was issued on November 13, 2015.
Americans eat a lot of imported foods and the FDA FSMA mandates that foods imported from other countries be held to the same high standards required of domestic food. The FSVP rule is about minimizing the risk of consumers becoming ill or injured from contaminated food.
The regulation requires that importers identify the hazards for each type of food they import and conduct foreign supplier verification activities that take into account the risks posed by these hazards in order to provide assurances that suppliers are following procedures to ensure food safety consistent with U.S. standards.
X-ray inspection can play a key role in helping importers achieve compliance with the FSVP rule by securing the food supply chain through precise physical contamination detection and rejection while providing essential reports to ensure food safety and traceability.
This article explains what the FSVP rule is, who is subject to it and how product inspection equipment can aid compliance.
1. What is the FSVP Rule?
Imported food accounts for about 19 percent of the U.S. food supply, including approximately 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans ¹.
The FSVP rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets U.S. safety standards and is not adulterated or misbranded with respect to allergen labelling.
The regulation is designed to be flexible based on risk and the requirements vary based on the type of food product and category of importer. The FDA is responsible for ensuring that importers meet the FSVP requirements.
2. Who Does the FSVP Apply to?
The rule focuses on the responsibilities of the importer who is defined as the U.S. owner or consignee of a food offered for import into the U.S. If there’s no U.S. owner or consignee, the importer is the U.S. agent or representative of a foreign owner or consignee of the food offered for import at the time of entry, as confirmed in a signed statement of consent.
FSVP requirements apply to most imported food under the FDA’s jurisdiction, but certain categories of food are not covered, such as fish products, juice, certain alcoholic beverages and some meats because they are already subject to verification on FDA’s hazard analysis and critical control point (HACCP) regulations.
For a list of exemptions, please visit:
Importers are required to develop, maintain and follow a FSVP for each food brought into the United States and the foreign supplier of that food.
3. What is Required Under FSVP?
Under the FSVP regulation, importers are responsible for:
- Determining known or reasonably foreseeable hazards likely to cause illness or injury for each type of food they import. These include biological hazards, chemical hazards and physical hazards, such as glass. Importers can conduct their own hazard analysis or review and assess one conducted by another entity.
- Evaluating the risk posed by a food, using the results of the hazard analysis, and evaluating the foreign supplier’s performance. This evaluation informs the approval of foreign suppliers and the determination of appropriate supplier verification activities.
- Conducting supplier verification activities for each foreign supplier before importing a food. Importers must establish and follow written procedures to ensure they only import foods from foreign suppliers they have approved. Importers are responsible for determining and documenting foreign supplier verification activities that are appropriate to provide assurance that hazards requiring a control in food are significantly minimized or prevented. The appropriate verification activities and their frequency will vary depending on the food, the foreign supplier, and the nature of the control. Appropriate verification activities could include onsite auditing, sampling and testing of a food, or a review of the supplier’s relevant food safety records.
- Conducting corrective actions if a supplier doesn’t produce the food in compliance with the processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations. The appropriate action will depend on the circumstances, but could include discontinuing use of the foreign supplier until the problem is resolved.
- Reaccessing the FSVP within three years after establishing the FSVP and within three years of the last assessment.
- Retaining records of FSVP activities including compliance status reviews, hazard analyses, investigations and corrective actions.
- Obtaining a DUNS number for their company as well as providing their name and DUNS number electronically when filing for entry of food with Customs and Border Protection (CBP).
4. When Must Importers Comply?
The date by which importers must comply with the FSVP regulation is the latest of the following dates:
- May 2017 (18 months after publication of the final rule).
- For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations.
- For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions. A range of compliance dates were established in the preventive controls rules for the supply-chain program provisions, which vary based on the size of the receiving facility and when the receiving facility’s supplier is required to comply with the new FSMA regulations.
5. How Can Product Inspection Equipment Aid Compliance?
Eagle’s product inspection systems have been developed with FSMA regulations and compliance in mind and are fully capable of performing the documentation, monitoring and verification required to help importers comply with the FSVP rule.
For example, if a hazard analysis has been conducted and the results identify the risk of physical contamination, x-ray inspection equipment can be used at a critical control point (CCP) to significantly minimize or prevent the risk of contamination. For more information, read our whitepaper, How to Select Critical Control Points for X-ray Systems, X-ray inspection machines can detect foreign contaminants in food such as metal, glass, dense plastics and rubber.
Eagle’s TraceServer™ program collects valuable production data and consolidates it into a centralized database that is easily accessible by Operations, Quality and Maintenance personnel. By allowing easy access to reports and statistics on all inspected products, x-ray systems enable swift traceability of physical contamination, and can help importers verify that their suppliers are producing food in a manner that provides the same level of public health protection as required under the other FSMA regulations on preventive controls and produce safety.
¹ 2013 statistics, according to the USDA, Economic Research Servic