According to the Food and Agriculture Organization (FAO), value-added agricultural products went up 84% between 2000 and 2021, reaching 3.7 trillion dollars in value.¹ Amongst the 193 member countries of the United Nations, the USA is the largest food importer. The country imported $171 billion worth of food in 2021. This is an increase of 17% from previous year.² The USA is not only known for its enormous food market, but also for their complex import regulations. The food import activities are regulated across different agencies, which makes it difficult for foreign businesses to navigate import requirements and stay compliant. To help companies with importing food into the USA, we will introduce the different US departments that are involved in food importing activities as well as their roles and responsibilities.

CBP: The safeguard of the US border.

The U.S. Customs and Border Protection (CBP) is the agency responsible for screening imported food shipments and is the first agency that food importers will encounter when bringing products to the United States. The CBP verifies the Harmonized System (HS) codes and the country of origin of the products. It determines the tariffs in effect and performs inspections on the incoming shipments to fight trafficking and other illegal activities.

Importing food into the USA requires that a food business hold an importer number and a custom bond (for import value of $2500 USD or more). For US businesses, the importer number is the IRS number, while for foreign importers, the business shall request the CBP to assign an importer number prior to products entering the US.

It is important to ensure that the correct HS codes are provided to the CBP when declaring the product. It is recommended to work with an experienced customs broker to help determine the HS code of each imported product. The customs broker will also assist with the importer number and custom bond application.

In the case where the HS code classification or the country of origin of a product is less clear, the CBP provides advanced rulings to determine the proper information to submit. The advanced ruling can be requested through the CBP electronic ruling requests system. Note that it can take many weeks for CBP to respond and to complete a ruling.

FDA: The agency with “Food” in the name.

The US Food & Drug Administration is responsible for regulating most food importing activities, except for meat excluding venison, processed eggs and catfish products that fall under USDA jurisdiction.

For products under FDA jurisdiction, there are three major aspects of the importing regulations:

• Facility registration
• Prior notice and point of entry inspection.
• Foreign supplier verification program (FSVP)

All foreign food processors, who produce, pack or store food products to be consumed in the USA, are required to have a valid FDA facility registration. The registration can be acquired through the FDA food import system and must be renewed every 2 years.

To register a facility, the facility must have a unique facility identifier (UFI). The FDA currently accepts the DUNS number as the UFI. Facilities can apply for a DUNS number free of charge through Duns & Bradstreet (D&B).

Besides the DUNS number, it is also mandatory to have a US agent for foreign facility registration. The US agent can be either a company or an individual who has a valid address in the USA. Any companies or individuals can accept the role as the US agent and register in the FDA food import system. Alternatively, importers can contract companies offering US agent services for an annual fee.

Prior notice and import alert process.

For products under FDA jurisdiction, prior notice is required for each shipment, including samples, before the shipment arrives at the US border. The prior notice can be filed either by the importer, exporter or a third-party submitter through the FDA food import system. After filing the prior notice, an entry number will be assigned to the shipment and will be used by the FDA to refer to a specific shipment.

Once the products arrive at the US border, FDA will decide if a detention or inspection is required based on current import alerts (Also referred to “the red list”) and random inspection requirements. Detained products must be kept intact until release. The FDA may decide to sample the products. Note that samples can be reimbursed if the test results are found compliant.

Failed inspections can lead to either the importer, the processor or both being added to the red import alert list. For products, importers and processors on the import alert list, all future shipments are subject to detention and inspection until they are removed from the list. A minimum number of consecutive passes and a written proposal for removal with details of corrective actions taken are required to grant the removal of detained food.

Unless exempted, such as seafood products, importers, who bring in FDA regulated food products, must establish and maintain a written FSVP plan to ensure the compliance of imported products. An effective FSVP shall include:

• Supplier approval procedure
• Prior shipment inspection
• Post shipment inspection.
• Label approval.
• Traceability and recall plan.
• Record keeping.

FDA conducts regular audits of the US food importer to ensure FSVP compliance. To learn more about the FSVP rule, consult the FSPCA FSVP curriculum.³

USDA: From Farm to Fork.

The US Department of Agriculture is responsible for regulating most of meat, processed egg products and catfish imports. For products falling under the USDA’s jurisdiction, the prior notice and FSVP requirements are not applicable. However, it is important to mention that some products, for example, a product that contains both meat and fish ingredients, can be regulated by both the FDA and the USDA. For those products, they must be compliant with the requirements of both agencies.

Products under the USDA’s jurisdiction are controlled through the list of eligible foreign establishments. Only listed establishments from an eligible export country are allowed to conduct trade with the United States.

Food Safety and Inspection Services (FSIS) perform point of entry inspections for all USDA-regulated food items. The agency verifies the validity of the official import certificates and product compliance, including food labelling requirements. For some products, such as meat products with claims, labels must be submitted to the FSIS and receive approval prior to importing food into the USA.

Besides FSIS, the Animal and Plant Health Inspection Service (APHIS) also plays a role re: regulating food products from animal and plant origin. For animal derivatives, the importer may be required to obtain an import permit. The permit and documentation requirements for a specific category of products can be obtained through APHIS’s Veterinary Service Permitting Assistant (VSPA) system. It is crucial to keep in mind that, even for foods that are exempted from FSIS requirements (such as products containing insignificant amount of meat), food products can still be subject to APHIS regulations.

NOAA: When things get fishy.

For new seafood importers, National Oceanic and Atmospheric Administration (NOAA) requirements can be easily overlooked, which can turn into expensive food rejections at the border.

NOAA imposes regulations and restrictions over international trade of seafood species that are susceptible to illegal harvest and illegal trade activities. The current Seafood Import Monitoring Program (SIMP) covers 13 species groups, namely shrimp, abalone, Atlantic cod, blue crab, dolphinfish, Grouper, King crab, Pacific cod, red snapper, sea cucumber, sharks, swordfish and tuna.

Importers of regulated species of fish / seafood are required to have an International Fisheries Trade Permit (IFTP) issued by the NOAA. They must also provide traceability documents proving legal and compliant harvesting and processing of fish and seafood.

Summary

Importing food into the USA is not an easy task. Food safety and food import regulations are complex and enforced by different agencies. It is the responsibility of US food importers to confirm the scope of their import activities (what food products are to be imported and what food safety and import regulations will apply). Once the scope is known, US importers must document the regulatory compliance of the foreign facility (the food exporter) and that of the imported food. It is important to review the regulations, consult with an import specialist and the regulatory bodies before importing food to the USA. It is always more cost-effective and more efficient to be thorough and get things done right the first time.

References

• FAO – Value Added Agricultural Products
• Yahoo Finance – Food Imports in Value (USA – 2021)
• FSVP Curriculum (2017)

Authored by Sean Xia, Edited by Karine Lawrence.

Sirocco Food + Wine Consulting specializes in food safety compliance for food products to be consumed in the USA and Canada. We support Canadian and US importers with PCP importer plans and FSVP plans. We also help domestic manufacturers with PCP manufacturing plans (SFCR – Canada) and Preventive Control Plans for Human & Animal Food (US-FDA under FSMA). We are HACCP plan writers too and can develop HACCP plans for meat, fish/seafood and juice products as mandated by the US FDA’s food safety standards. Contact us to schedule a free consultation.