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FDA announced the release of new draft guidance on requirements for prior notice of imported food, in a March 31 Federal Register notice. Some of the draft guidance responds to provisions in section 304 of the Food Safety Modernization Act (FSMA). The new draft includes several new questions and answers that help throw light on how the agency would deal with particular scenarios.

The prior notice requirement for imported food originated in the Bioterrorism Act of 2002. The current guidance, the second edition, was issued in May 2004. So the new draft will become the third edition when finalized. The agency issued a final rule on prior notice of food, including animal feed, on November 7, 2008 (73 FR 66294). In May 30, 2013, implementing a provision in section 304 of FSMA, the agency issued a final rule requiring the name of any country to which an article has been refused entry be reported in prior notices (78 FR 32359).

In the draft guidance, the agency says it received many questions about the definition of the term “ultimate consignee” for an imported food. “A significant number of people have asked this question, and there has been a lot of variation in what people have been submitting as the ultimate consignee,” the draft guidance states. “FDA considers the location where the imported food is to be delivered as the ultimate consignee for the purposes of prior notice,” it says.

If the imported food is delivered to the owner, the name and full address of the owner should be given as the ultimate consignee. If the food is owned by a foreign shipping firm and is being delivered to a public storage warehouse in the U.S., FDA considers the public storage warehouse to be the ultimate consignee and its name and address should be submitted in the prior notice, the agency says.

Another new question in the draft deals with the FSMA-related requirement to report the name of any country that has refused entry of the article of food. Specifically, the agency says it is necessary to report refusals of entry of food, including food for animals, based on food safety reasons given by the government of the country that refused entry. This includes a refusal by another U.S. port.

Another new question in the draft guidance deals with the definition of the word “article” and whether it refers only to the food in the specific shipment, or if it also includes food from the same batch or lot numbers that was shipped to other countries. The agency says the term “article” does not refer to food from the same batch or lot numbers that is not being imported or offered for import into the U.S. and for which prior notice will not be submitted at the time of the specific shipment, or food of a similar type that was previously refused entry by a country.

The new draft also clarifies that prior notice is required for meat intended for food for animals, including pet food and treats. “Meat intended for food for animals, such as that fed to zoo animals or meat products intended to be incorporated into food for animals, is not under the jurisdiction of USDA/FSIS and is subject to the prior notice requirements. These meats include meat derived from cattle, swine, goats, sheep, horses, and mules that are destined for food for animals,” the agency says.

As always with such agency guidance, it represents FDA’s current thinking on the subject, but it is not binding upon the agency or the regulated community, so alternative approaches may be used if they satisfy the requirements. The 60-day comment period began March 31, 2014.


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