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Risk and Responsibility for Importers

The new ‘Sanitary Transportation of Food’ rule

Food importers in the United States are typically not directly involved in the transportation of food, but rely on foreign suppliers to deliver food to the border that is safe and sanitary, and then rely on domestic agents to deliver product to destination in the same manner. While transporting food creates relatively low safety and sanitary risks, proposed U.S. Food and Drug Administration (FDA) rules will create new requirements for the transportation of food, along with additional responsibilities for food importers.

Food importers already face safety and sanitary risks in relying on others to transport food into the United States. Risks related to the conditions under which food is transported arise from an importer’s own safety standards and expectations, those of its customers, and those enforced by the regulatory requirements of U.S. government agencies.

The risks for government regulatory action regarding food imports at the border are significant. Through U.S. Customs and Border Protection (CBP), two U.S. government agencies have primary responsibility for ensuring food entering the United States is safe and sanitary: the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), which has the authority to deny entry of most meat, poultry and processed egg products for food safety reasons; and the Animal and Plant Health Inspection Service (APHIS), which governs the entry of agricultural food products for sanitary and phytosanitary reasons. The FDA regulates the importation of most other foods, and may detain or refuse entry when any product is not in compliance with its regulatory requirements.

Even if a load is granted entry into the United States, it may still fail to meet the standards of the importer or its customer(s), which may lead to rejection, a reconditioning requirement, or exportation of the food. Depending on the contractual arrangements between the importer and foreign supplier, the importer may be liable for some or all of the costs associated with detention or refusal of goods by the government, or for the disposition of goods which does not meet the importer’s standards.

In a worst case scenario, if imported unsafe or insanitary food crosses the border and enters the food supply chain and reaches consumers, the risk of liability to the importer and/or its customer(s) may lead to a voluntary recall or a mandatory recall issued by the FDA if the food is proven to be adulterated and poses an imminent danger to health. Producers of the same types of food item often suffer the consequences as well, as consumers tend to stop purchasing any variety of a recalled food out of fear, thereby damaging the class of commodity and nearly every company involved in its growing, shipping, and marketing.

Even if imported food is safe and sanitary at the time it is produced or when it leaves the production facility or enters the United States, new risks can be created during shipping by unsafe and insanitary transportation practices, which FDA’s proposed rule on the Sanitary Transportation of Food (STF) intends to control.

The FDA acquired the responsibility for regulating food transportation from the U.S. Department of Transportation in 2005. Since the FDA had not finalized its initial proposed rule regarding the safe transport of food, this contributed to the Food Safety Modernization Act (FSMA) directive that the FDA issue its final STF regulations.