FDA Import Regulations

Background:
In 2002, Congress passed the Bioterrorism Act (BTA) which mandated the U.S. Food & Drug Administration (FDA) to require all foreign and domestic growers, manufacturers, producers and handlers of food, food products and animal feed to register with the FDA.

The first phases of implementation of the BTA began over a year ago with informational meetings. The next phases of gradual enforcement through informed compliance started with Phase 2 and Phase 3. On November 1, 2004 U.S. Customs & Border Protection (CBP) and the Food & Drug Administration will begin Phase 4, the enforcement of the Act through the issuance of monetary penalties.

Registration:
Registration is free on the FDA’s web site at FDA's Website under Food Industry, register a facility. To register, the applicant needs to first obtain a user name and password on the FDA’s site and then start the registration process by getting another user name and password. Again, registration is free. All foreign registrants must have a “U.S. Agent” to act as a contact between the FDA and the registrant. An importer, customs broker or other party who agrees to be the agent can act as agent for foreign entities.

Prior Notice:
A Prior Notice (PN) must be filed on each import shipment prior to its arrival at the first U.S. port, airport or border crossing. The Prior Notice is required to be filed 4 hours prior to the arrival of international airfreight and rail shipments, 8 hours prior to the arrival of ocean freight shipments and 2 hours prior to arrival of truck shipments. The prior notice rules apply to shipments arriving after hours, on week ends and holidays. The Prior Notice can be filed by the manufacturer, shipper, foreign freight forwarder, importer, Airport Brokers Corporation or other party having knowledge of the shipment. The Prior Notice can be filed through the Prior Notice System Interface (PNSI) at FDA’s web site.

Failure to have a prior notice filed and accepted prior to the guidelines listed above subject the consignee to FDA penalties. If PNSI is down, the FDA expects the PN information to be emailed or faxed to them prior to the arrival of the shipment.

Gallagher Transport International expects each importer of food, food products and other products covered by the BTA to furnish Gallagher Transport International with copies of all commercial invoices, packing lists, bills of lading and other documents far enough in advance of arrival of the shipment to allow Gallagher Transport International time to properly classify and entry the shipment through PNSI. Again, reporting must be done and accepted in proper format Prior to the arrival of the shipment. PNSI reporting is complicated. The imported products must be classified in terms of FDA’s classification manual. Product coding not only requires what the product is, it also requires classification of the inner packaging, outer packaging, the weight and measurement of each inner package and each outer package. Questions can arise that require answers from importers and exporters. Plus, we have other shipments for other clients that also require handling. While we will make every effort to make sure that PNs are sent to FDA in a timely manner, we will not be responsible for information and documents received late. And, overtime, weekend and holiday charges may apply when needed.

Penalties:
Starting November 1, 2004, U.S. Customs & Border Protection and the U.S. Food & Drug Administration (FDA) will start the enforcement provisions of the BTA. Penalties will be issued by U.S. Customs & Border Protection on behalf, and with consultation, of the FDA.

For failure to file a Prior Notice, for the untimely filing of a PN and/or for filing inaccurate information in a PN, CBP and the FDA may issue a penalty for the U.S. domestic value of the shipment. There are guidelines for mitigation of these penalties.

For a first violation for failure to file a Prior Notice, CBP may mitigate the penalty to $750.00. For a first violation of filing a timely PN, CBP may mitigate the penalty to $250.00. For the first violation of filing accurate information in a PN, CBP may mitigate the penalty to $500.00. Second, third and additional violations allow for less and less mitigation.

Because the filer of late (untimely) Prior Notices may be subject to penalties, Gallagher Transport International may require importers to file their own PNs through PNSI. And, again, since PNs are complicated, Gallagher Transport International is not responsible for the timeliness or accuracy of the information presented when documents are received late, are in accurate or incomplete.

The penalty guidelines can be found at FDA's Import Regulations.

Additional Information:
Additional information, registration and PNSI reporting are available at FDA's Website. The web site contains several publications of Questions & Answers (Q&As) that should be helpful to both importers and their foreign shippers. Importers are advised to make the foreign shippers aware of the program, make sure they are registered and make sure that a Prior Notice is timely filed prior to each importation.