On May 29, 2013, the Food and Drug Administration (FDA) published a Final Rule that adopts, without change, the Interim Final Rule entitled “Information Required in Prior Notices of Imported Food”, which was issued on May 5, 2011.1 The Final Rule now requires, in addition to the other information already mandated, that prior notices of any imported article of human or animal food, identify any country (including the United States) where the article has been refused entry by a country’s agency or representative.
FDA uses prior notices to determine which imported food shipments to inspect. Currently, the agency targets foods which, based on information submitted in the prior notice, may pose a significant risk to public health. FDA now considers the fact that another country has refused admission when deciding whether to admit the food; the refusal could indicate that the food might also violate U.S. law. The Final Rule is based on § 304 of the Food Safety Modernization Act (FSMA) (Pub. L. 111–353), signed into law by President Obama on January 4, 2011, which amended § 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)). 21 C.F.R. § 1.281 sets forth the information that must be submitted in a prior notice, and the Final Rule is codified in this section.
Brief History of Prior Notices
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) was signed into law on June 12, 2002, and among other things, required FDA to receive certain information about imported foods prior to their arrival in the United States, or otherwise be refused at the port of entry2 In accordance with the Bioterrorism Act, on February 3, 2003, the Department of Health and Human Services (HHS) and the Department of Treasury3 issued a proposed rule about requirements for prior notices for food imported into the United States4, and HHS later published, with the Department of Homeland Security (DHS), an Interim Final Rule on the matter on October 10, 2003.5 On November 7, 2008, HHS and DHS published a Final Rule, making several changes to the 2003 Interim Final Rule.6 That Final Rule became effective May 6, 2009, and prior notice regulations are codified at 21 C.F.R. §§ 1.0276-1.285.
The 2013 Final Rule
The Final Rule answers a few questions:
- Which refusals of entry must be reported? The final rule states that “only refusals for food safety reasons should be reported”, e.g., intentional or unintentional contamination of an article of food. The agency stated that it will further clarify what it means by “refused entry” in a future guidance.
- What information specifically needs to be included? Only the country that refused entry needs to be listed. The reason for refusal of entry and documentation of the information submitted do not need to be included. That being said, during its review of the prior notice, FDA may contact the submitter or other parties to obtain further information to assist its review.
- What is the scope of the rule? Countries must be listed only for “the specific food item for which prior notice is being submitted.” FDA provides an example where some of the food from a batch is shipped to the United States and at the same time the rest of the food is shipped to Country A. “If Country A refuses entry, this fact is not submitted as part of prior notice for the portion that has been shipped to the United States. However, if the food that was originally shipped to Country A is subsequently shipped to the United States, then the prior notice for this shipment must include Country A as the country to which the article has been refused entry.”7 Also, if a similar type of food to the food being imported was previously refused entry by a country, this country does not need to be listed either.
The final rule took effect May 30, 2013.