Prior Notice to Import

What happens to food that is imported or offered for import from unregistered facilities that are required to register?

If an article of food from a foreign (non United States [US]) manufacturer that is not registered by US Food and Drug Administration (FDA) is offered for import into the US, the food will be subject to refusal of admission for failure to provide adequate Prior Notice.

The failure to provide the correct registration number of the foreign manufacturer (where registration is required) renders the identity of that facility incomplete for purposes of Prior Notice.

Then, unless Customs and Border Protection (CBP) concurrence is obtained for export and the article is immediately exported from the port of arrival, it will be placed under hold, it must be held with the port of entry.

Food under hold must be moved under appropriate custodial bond. FDA must be notified of the location where the food has been or will be moved to within 24 hours of the hold. The food subject to hold shall not be delivered to any importer, owner or ultimate consignee and must be taken directly to the designated facility. If the food under hold is only a part of a shipment, it must be segregated from the rest of the shipment.

If an article of food is placed under hold (because of problems with registration of a manufacturer) and no registration or request for FDA review is submitted in a timely fashion or export has not occurred, the food shall be dealt with as specified in CBP regulations (sold for export or destroyed as agreed to by CBP and FDA).

Who is the 'Shipper'?

Shipper means the owner or exporter of the article of food who ships the article from a foreign country or the person who sends an article of food by international mail to the US.

Prior notice submission will also require information (the name, address and, if required, the registration number) of the shipper. A registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transhipment, storage, and export, or for further manipulation and export. If a registration number (of the shipper) is provided, the city and country may be provided instead of the full address.

What is 'PN Confirmation Number'?

After a prior notice for an article of food is submitted to the FDA, the FDA will notify you that your prior notice has been confirmed for review with a reply message that contains a Prior Notice (PN) Confirmation Number.

Your prior notice will be considered submitted and the prior notice time will start when the FDA has confirmed your prior notice for review.

The PN Confirmation Number must accompany any article of food for which the prior notice was submitted through the FDA Prior Notice Interface when the article arrives in the United States and must be provided to CBP or FDA upon arrival. The PN Confirmation Number must also accompany an article of food arriving by international mail.

Who is a 'Grower'?

Grower means a person who engages in growing and harvesting and collecting crops, raising animals, including fish/seafood. A submitter of prior notice must submit, for an article of food that is in its natural state, the name of growing location, address of the grower, if known. If the submitter does not know the identity of the grower, or (if the article has been consolidated), any of the growers, the submitter may provide the name and address of the firm that has consolidated the article of food from different growers or different locations.

FDA considers 'an article of food' to be food (in its natural state) from one grower, and therefore one prior notice must be issued for an article food from each grower. However, FDA also explained that if the submitter of prior notice for a shipment/article that has been consolidated does not know the identity of each grower, he is not required to seek out information of which he is not aware ... and in such situation one prior notice (with only the name of the firm that has consolidated the article of food from different growers) will be sufficient.

What is the 'port of entry'?

It is the port at which a US Customs officer is authorised to accept entries of merchandise (food) to collect duties, and to enforce the various provisions of the US Customs and navigation laws.

For all Food Safety Inspection Service (FSIS) US listed export meat establishments, including US listed ratite establishments:

The FDA has acknowledged that edible meat, poultry and egg products under the jurisdiction of FSIS inspection are exempt from the requirement of the Bioterrorism Act regulations. All other animal and human food products exported to the US come under the jurisdiction of the FDA and will be required to meet the Bioterrorism Act requirements.
 
This means that any products (eg offals for animal food use) or any by-products from FSIS (US) listed export establishments exported to US for animal food will need to comply with the requirements of the Bioterrorism Act regulations.

Therefore, FSIS (US) listed establishments exporting animal food to the US will need to comply with the Bioterrorism Act regulations for 'Registration' and 'Record Keeping' (when this rule is finally released), and with the 'Prior Notice to Import' requirements for only those consignment of animal food products (eg rendered products). Prior Notice to import regulations will not apply to edible products exported for human consumption.

For all meat establishments, export (eg. non US listed premises) and domestic, that export animal food products to the US

Any meat establishment (including non US listed export establishments and domestic premises) that exports animal food products or ingredients to the US will need to comply with the Bioterrorism Act regulations for 'Registration' and 'Prior Notice to Import' by 12 December 2003. These establishments will also need to comply with the 'record keeping' regulation when its (interim) final rule is published.