The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. This sweeping new law will impact the entire food supply chain, including warehouse-based third-party logistics (3PL) providers (3PLs), distributors and manufacturers, as well as transporters, importers and foreign food manufacturers. 

The Food and Drug Administration (FDA) recently held two public meetings with stakeholders to discuss two sections of the new law-the import requirements and the prevention requirements.  


 

Imports

The legislation significantly enhances FDA’s ability to oversee the millions of food products coming into the United States. The question that lies at the heart of the food import provisions of the FSMA is: When a food product enters the U.S., who is the importer? The import provisions of the new statute revolve around the “importer.” The importer will be required to verify that each foreign supplier has processes and controls in place to assure the safety of its food products. The statute says the importer may even be required by FDA to make annual on-site inspections of the supplier’s facilities or conduct lot-by-lot certifications as part of this verification.

The FSMA defines importer as the “United States owner or consignee of the article of food at the time of entry of such article into the United States”; or in the case whereif there is no United States owner or consignee, “the United States agent or representative of foreign owner or consignee of the article of food at the time of entry of such article into the United States.”

The statutory definition requires further guidance from FDA. Which consignee is the “importer” in this context? Who is the agent or representative? How does a person become an agent? FDA is currently grappling with these issues. FDA’s intent is to identify the U.S. person with the true financial interest in the product. Yet, it is difficult to rely on commercial terms, such as “consignee” or “agent,” since these words can mean different things at different times.  For example, a consignee may be the appropriate responsible party with a financial interest, but this is not always the case. A consignee may also be a 3PL warehouse. Likewise, the consignee listed on the bill of lading for a product may not be the same person listed as the consignee on the commercial invoice. 

Therefore, it will be important for the agency to understand the supply chain participants and common commercial relationships. Only then can they FDA craft a definition of “importer” that will truly capture the party in of interest.




 

Prevention

The legislation significantly enhances FDA’s ability to oversee the millions of food products coming into the United States. The question that lies at the heart of the food import provisions of the FSMA is: When a food product enters the U.S., who is the importer? The import provisions of the new statute revolve around the “importer.” The importer will be required to verify that each foreign supplier has processes and controls in place to assure the safety of its food products. The statute says the importer may even be required by FDA to make annual on-site inspections of the supplier’s facilities or conduct lot-by-lot certifications as part of this verification.

The FSMA defines importer as the “United States owner or consignee of the article of food at the time of entry of such article into the United States”; or in the case whereif there is no United States owner or consignee, “the United States agent or representative of foreign owner or consignee of the article of food at the time of entry of such article into the United States.”

The statutory definition requires further guidance from FDA. Which consignee is the “importer” in this context? Who is the agent or representative? How does a person become an agent? FDA is currently grappling with these issues. FDA’s intent is to identify the U.S. person with the true financial interest in the product. Yet, it is difficult to rely on commercial terms, such as “consignee” or “agent,” since these words can mean different things at different times.  For example, a consignee may be the appropriate responsible party with a financial interest, but this is not always the case. A consignee may also be a 3PL warehouse. Likewise, the consignee listed on the bill of lading for a product may not be the same person listed as the consignee on the commercial invoice. 

Therefore, it will be important for the agency to understand the supply chain participants and common commercial relationships. Only then can they FDA craft a definition of “importer” that will truly capture the party in of interest.