Questions and Answers

The following questions and answers have been developed to assist food importers in understanding the new regulations, PBB’s services, and how we can help ensure your compliance with the new FDA regulations.

Q. Why did the FDA issue these regulations?

A. As the primary authority over food in the U.S., the FDA intends to strengthen its ability to protect the nation’s food supply from potential bio-terrorism threats. These new responsibilities were mandated by Congress in 2002

Q. What do the FDA regulations entail?

A. There are four major components to the regulations:

1. Registration of foreign and domestic food facilities with the FDA. And in order for foreign facilities to register, they must indicate a U.S.-based agent.
2. Prior notice to the FDA before importing any food shipment into the U.S.
3. New recordkeeping requirements.
4. Detention of shipments at the border for non-compliance with the new regulations.

Q. Is there a minimum value for merchandise subject to the BTA?

A. There is no minimum value for merchandise subject to BTA. All shipments, regardless of value, must meet the Prior Notice (PN) requirement. This includes samples, mail, household goods, gifts and etc. However, there are certain very limited exemptions for PN requirements described below.

Q. What authority does CBP have to deny Section 321, if necessary, and require entry for BTA merchandise?

A . CBP’s authority resides in 19 CFR 143.22 and 143.23 in which entry may be required for import admissibility enforcement purposes .

Q. What food is excluded from PN?

A. Personal food accompanying a traveler, food that is immediately exported (IE’s), meat, poultry, and egg products exclusively subject to USDA jurisdiction, and homemade goods shipped as gifts.

Q. Are alcoholic beverages subject to the BTA?

A. Yes, Prior Notification is required for all non-excluded food importations.

Q. Is bottled water subject to the BTA?

A. Yes, Prior Notification is required for all non-excluded food importations.

Q. Does an individual who buys food and brings it to his or her private residence outside the United States and then sends that food, as personal gifts to someone in the United States need a registration number, and is PN required?

A. A PN is required, for goods sent as gifts.

• Either the registration number of the retail establishment, or
• That retail establishments name and address must be provided.

Q. If I make food in my home and ship it as a gift to an individual in the United States, is PN and registration necessary?

A. No PN or Registration is required provided the items were not purchased and were made in an individual’s home.

Q. Are samples exempt for BTA PN requirements?

A. No. Prior notice must be satisfied.

Q. Is there an impact on in-bond movements of merchandise subject to BTA?

A. Yes.

Transportation and Exportation (T&E) are subject to BTA, regardless of mode.

• The carrier must indicate that the shipment contains “merchandise subject to BTA.” A party involved with the shipment (e.g. shipper, importer, broker, etc.) must file PN using ABI or the FDA’s Prior Notice System Interface (PNSI), before the goods arrive. For T&E’s, PN must be satisfied at portal of arrival, however, registration information is not required.

Immediate Transportation (IT) is subject to BTA, regardless of mode.

• If PN is filed and there is no FDA or CBP hold, the merchandise will be allowed to move from the port of arrival to the port of entry. If PN is not filed, movement to the port if entry will not be allowed.

Immediate Exportation (IE) movements are exempt from BTA requirements.

Q. Who should I contact at PBB regarding this initiative?

A. The point of contact for sales support and implementation of this new service is Trade & Regulatory Services.

Q. Is there a cost for this service?

A. Yes, there is an annual flat rate to set-up the agency agreement and a per hour fee for support. Please contact PBB Trade & Regulatory Services for more information.

For further information please contact:

PBB Trade & Regulatory Services Offices

U.S.A. Telephone: 716-692-3100
e-mail: trs@pbb.com

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