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Protecting Food Imports

​IN AN ATTEMPT TO ALLAY CONFUSION about its requirements regarding prior notice of food imports, the Food and Drug Administration (FDA) has released draft guidance—in the form of a lengthy FAQ—on how to best comply with the rules, which were finalized in 2013. When an article of food, including food for animals, is being imported or offered for import into the United States, the FDA must be given notice before the food import reaches the U.S. border. This is known as a prior notice.

The prior notice requirement has its roots in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which Congress approved after the 9-11 strikes and subsequent anthrax attacks. The law directed the FDA to take more steps to protect the public from a potential terrorist attack on the U.S. food supply, as well as from other food-related emergencies. Included in the law was the prior notice requirement, under the rationale that advance notice of import shipments would allow the FDA, with the help of U.S. Customs and Border Protection (CBP), to better target import inspections.

The government’s effort to protect food was advanced further by the FDA Food Safety Modernization Act (FSMA), which was signed into law in January 2011. The FSMA aims to strengthen the government’s food protection system by shifting the focus of regulation from responding to contamination to preventing it. Thus, in May 2011, the FDA published the interim version of a new rule requiring that a person submitting prior notice of imported food must also report the name of any country to which the article has been refused entry. FDA officials say the new information will help them make more informed decisions in managing the potential risks of food imported into the United States. In 2013, the interim version of the rule was made final by the FDA.

After the FDA issues new rules, it sometimes issues guidance to assist those who are required to comply with new requirements. The FDA says that the guidance is representative of the agency’s current thinking on a topic, but it is not binding. The guidance may set out recommended practices to comply with rules, but alternate approaches may also be used as long as they satisfy the requirements of the applicable regulations.

The new guidance, which was released in early April, marks the third time that the FDA has issued guidance on its prior notice rules. The new guidance provides a list of questions that are frequently asked about the prior notice requirements and answers.

The FDA’s guidance on prior notice requirements is helpful for some members of the Specialty Food Association (SFA), says Ron Tanner, SFA’s vice president for communications, education, government, and industry relations. About 375 of SFA’s 3,000 members are importers.

“They all want to follow the proper procedures, and they need the guidelines to be set out for them,” Tanner says. “I think when it first started, because it was new, it was a little bit difficult.”

The new guidance also includes hypothetical examples designed to demonstrate how to achieve prior notice. The examples set out a scenario in which five articles of food are arriving at the border by truck. The examples included in the guidance demonstrate different aspects of the requirement, such as how registration numbers provided in different documentation must be consistent for each article and how the FDA must be given enough time after the inspection to communicate approval to CBP before the items reach the border.