The Public Health Security Act and Bioterrorism Preparedness and Response Act of 2002, commonly known as the “Bioterrorism Act,” or BTA, requires that certain information be provided electronically to the U.S. Food and Drug Administration (FDA) prior to the arrival of a shipment of food in the United States. U.S. Customs and Border Protection (CBP) officers, in conjunction with the Food and Drug Administration’s authorities, are responsible for enforcing the Bioterrorism Act at all United States ports of entry. Although this law became effective on December 12, 2003, the FDA and CBP are phasing in the enforcement of the law.
Food is defined in the BTA Interim Final Regulations as:
- Articles used for food or drink for man or animals,
- Chewing gum, and
- Articles used for components or any such article.
Food imported or offered for import into the United States for human or animal consumption is covered by the Act. Also covered are:
- Food stored or distributed in the United States,
- Gifts not homemade and not accompanying a traveler, trade, and quality assurance/control samples,
- Transshipments through United States to another country (T&E),
- Food imported for future export,
- Food admitted into a U.S. Foreign Trade Zone (FTZ).
There are certain exemptions from the BTA reporting requirements, as outlined in questions 14 and 15.
The Act contains 5 titles and includes major FDA responsibilities in Title III, Subtitle A, “Safety of Food”
- Section 303 Detention
- Section 305 Registration
- Section 306 Records Management
- Section 307 Prior Notice
For CBP purposes, the most interaction with the trade community and travelers will occur regarding the Prior Notice (PN) and Registration requirements.
Under Section 305, all domestic and foreign facilities that manufacture, process, pack, or hold foods for human or animal consumption in the United States are required to register with FDA, unless exempted.
These facilities are exempt from the BTA registration requirement:
- Nonprofit facilities,
- Fishing vessels, except those that engage in processing as defined in FDA’s seafood HACCP regulations (21 CFR 123.3(k], and
- Facilities that are under the exclusive jurisdiction of the U.S. Department of Agriculture.
Any CBW that holds merchandise subject to the BTA must register with the FDA. Information on becoming a registered facility may be obtained on the FDA website.
There are various firms, which claim that they will register my facilities, domestic and foreign, for a fee. Do I have to use them?
FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has FDA contracted with any firms to register domestic and/or foreign facilities. Facilities registration with the FDA was required by December 12, 2004. Any new, or currently unregistered, facility may still register with the FDA prior to sending BTA related merchandise to the United States. You can register a facility electronically through the FDA website.
My supplier’s foreign factory produces different products that I sell to different importers based on geographic locations in the United States. Can I have different U. S. agents for my various products and territories?
No. Currently the FDA will only recognize one U.S. agent per foreign facility registration.
BTA covered merchandise sent to the United States from an unregistered, and non-exempt, facility will be refused admission.
The FDA has sole authority over registration issues. They have provided very detailed guidance regarding FDA registration.
Prior Notice consists of (but is not limited to) the following data that must be electronically provided to the FDA prior to the arrival of the article(s) at the first U.S. port:
- The country from which the article originates,
- The country from which the article is shipped,
- Anticipated CBP port of arrival,
- CBP ACS entry type and date,
- In the event of a hold, the information about where it is being held,
- All carriers,
- Firm name and address,
- E-mail address,
- Telephone and fax numbers,
- Registration number,
- Standard carrier abbreviation code
The Prior Notice information is in addition to the normal FDA admissibility information required under section 801(a) of the Food, Drug and Cosmetic Act.
PN filing is required for:
- Merchandise covered under the BTA and imported or offered for import into the United States,
- Every entry item that has a separate FDA product code requires a separate PN,
- Every entry item from separate facilities requires a separate PN,
- Every entry item for separate consignees on a consolidated entry.
Prior Notice data must be electronically submitted and confirmation issued by the FDA before the clock starts. The pre-filing times are dependent upon the mode of transportation for the goods. The minimum time limits are:
- Truck/Pedestrian/Cart/Car: 2 hours before arrival
- Air/Rail: 4 hours before arrival
- Vessel: 8 hours before arrival
Merchandise arriving by ferry carries the same time frames as the mode of transportation placed on the ferry.
The earliest that PN data can be filled is 10 days prior to the arrival of the goods into the United States. The law requires that trade must currently abide by these time limits.
There is no De Minimis value for merchandise subject to BTA, therefore, all shipments regardless of value, must meet the Prior Notice (PN) requirements of the BTA, unless specifically exempted. Please see the next question for exemption information.
The FDA and CBP have issued a revised Compliance Policy Guide regarding our enforcement of various provisions of the BTA. The policy guide explains that our two agencies will exercise enforcement discretion on BTA issues until such time as the FDA publishes a final BTA rule for foods imported or offered for import for non-commercial purposes. It also defines that a "non-commercial purpose" generally exists when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (i.e., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use).
Examples of foods imported or offered for import that may be covered by this non-commercial category are:
- Food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
- Food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler;
- Gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment,
- Food contained in diplomatic pouches.
The revised guidance also clarifies that an individual is a sole human being, not a corporation. The guide also expands upon the difference under the BTA between a shipper (most likely an individual) and a carrier (most likely a commercial entity). This revised guidance applies to non-commercial shipments with non-commercial shippers, irrespective of the carrier, which could be a foreign mail service, a courier, or a common carrier.
The following commodities are excluded from the PN requirements of the BTA:
- Personal food and/or gifts (non-commercial purpose) accompanying or shipped by an individual.
- Merchandise that is immediately exported (IEs).
- Meat, poultry, and egg products exclusively subject to USDA jurisdiction.
- Homemade goods shipped as gifts.
- Food items shipped via diplomatic pouch.
- Foods normally subject to the BTA that are included in shipments of household goods.
- Non-consumption samples for testing only.
Yes, both alcoholic beverages and bottled water are subject to the BTA, and as such, the production facility must be registered with FDA and Prior Notice is required for all importations, unless exempted.
Unless exempted by FDA, each facility that you import your various food products from, must be registered with the FDA. Second, each item that you import that has a different FDA Product Code Number and/or is from a different supplier requires a separate PN.
What happens if someone does not follow the Prior Notice pre-filing time limits and attempts to obtain release of their BTA covered merchandise from CBP prematurely?
For BTA covered merchandise, the FDA must authorize release or some other action prior to CBP processing. CBP Officers may not release BTA covered merchandise without FDA approval. Anyone attempting to gain premature release (termed “untimely filing ” by the FDA) of goods that have not been processed by the FDA for BTA purposes, will find their merchandise held at the port until the FDA completes their BTA review. The act of “untimely filing” may also subject violators to significant civil monetary penalties issued by CBP.
What will happen to BTA covered merchandise that arrives at a U.S. port and no Prior Notice is filed?
The merchandise will be refused admission by the FDA. At the CBP Port Director’s discretion in consultation with FDA, and based on availability of storage and resources, the refused merchandise may be:
- Held at the port.
- For seaports, airports, and courier hubs, the terminal facility of the arriving carrier is considered to be within the port of arrival.
- Directed to secure facility. This action must be done under bond.
- Exported (at the shippers or carriers request).
CBP, on behalf of the FDA, has issued civil monetary penalties to entities that have failed to file Prior Notice as required.
When CBP detects this sort of violation, the consequences for smuggling can be substantial. CBP has existing and sufficient enforcement authority in this type of matter. All of the merchandise involved may be seized, and subject to forfeiture. The violators may face significant penalty or liquidated damage claims. In certain cases, the violators may be criminally prosecuted. Upon conviction, the FDA may disbar someone from ever importing food items into the United States. CBP may also apply significant civil monetary penalties to anyone who had knowledge, assisted, or aided in the unlawful importation of these violative goods.
What happens to the quota status of merchandise subject to BTA if PN is not satisfied but all other entry data would be acceptable? Is quota denied until PN is satisfied?
No importation of quota merchandise can be made until PN is satisfied. Release cannot occur; entry and/or entry/summary cannot be properly filed. The fact that the merchandise might be subject to a quota must be dealt with after PN is satisfied, as a condition precedent to entry being made. However, CBP will allow some very specific HTS number changes be made in the case of tariff rate quota merchandise, even after Prior Notice has been satisfied.
Warehouse entries are not excluded from PN requirements. Any merchandise covered by the BTA for which a warehouse entry has been filed must have PN properly filed before the merchandise enters the warehouse.
No, warehouse withdrawals are exempt from the PN filing requirement.
No, PN was required and had to be submitted at the time of the original warehouse entry unless the warehouse entry was made prior to December 12, 2003, in which case it was pre-BTA and as such did not need PN. In either case, PN is not required for the re-warehousing.
Is PN required for merchandise subject to the BTA that are being admitted to a Foreign-Trade Zone (FTZ)?
Yes, PN must be filed before goods are admitted into an FTZ.
No, PN was required and had to be submitted at the time of the original admission to the FTZ, unless the zone admission application was made prior to December 12, 2003, in which case it was pre-BTA and as such do not need PN. In either case, PN is not required for an FTZ entry (withdrawal).
Immediate Transportation (IT) in-bond movements of merchandise are subject to the BTA regardless of mode and legally require Prior Notice (PN) to be filed before arrival at the first U.S. port of entry. However, such shipments will not be held up by CBP or the FDA for lack of PN alone, barring any other targeting results or extenuating circumstances. Failure to submit PN, inadequate PN, and untimely PN will legally result in an FDA refusal of the shipment, however, CBP and FDA will allow movement to the port of entry where PN must be satisfied, along with all other import requirements, before release of the shipment into the commerce.
Transportation and Exportation (T&E) in-bond movements are subject to the BTA regardless of mode and as such require the filing of PN data prior to arrival at the first U.S. port of entry.
Immediate Exportation (IE) movements are exempt from BTA requirements.
The importing 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 either ABI or the FDA Prior Notice System Interface (PNSI), before the goods arrive. For T&Es, PN must be satisfied at the port of arrival; however, registration information is not required.
You must cancel your CBP entry as well.
CBP will delete entries only when appropriate. Situations may arise when neither the FDA nor CBP will require entry records to be maintained, such as when the covered merchandise never arrives. CBP will utilize the entry cancelation procedure when there are concerns with maintaining historical records and other actions taken by the agencies. If Prior Notice is not satisfied, the entry cannot be processed by CBP, and must be canceled. If the goods are exported, the appropriate entry cancelation documentation must be filed with CBP. This process may also entail filing an Immediate Export (IE) entry.
Yes, but only for carrier and bill of lading data that was transmitted with an entry that has not had a "hold" placed on it because of CBP concerns over compliance with the BTA. CBP will also allow some minor changes to occur for BTA covered tariff rate quota merchandise. All other changes will require the original entry to be cancelled and a new entry filed. This may also require new PN information depending upon the nature of the change being made. CBP will track the workload generated by this requirement and re-examine the procedure if necessary.
Prior Notice (PN) is required. If the samples are for purely scientific analysis (other than human or animal consumption and not for resale) then, facility registration may not be required. Please consult the FDA website for further clarification on this topic.
No, the manner of sale, or commercial terms of sale, (i.e. F.O.B., CIF, Landed, Consignment, Duty Paid, etc.) has no bearing on the BTA reporting requirements.
What does it take to become a “Secure Storage” location? We have companies interested - one is a customs bonded warehouse that would hold food, etc. - another is a meat inspection facility that is registered w/USDA Food Inspection Service.
Both facilities must be registered with FDA to become Secure Storage Facilities. While the meat inspection facility is ordinarily exempted from the registration requirements of the BTA, to be a secure facility for other products subject to the BTA, it must be registered. The criteria to be a secure facility for CBP purposes has three elements: The facility must be bonded, registered with FDA, and may not hold merchandise for which it is the importer, owner, consignee or any other parties with a financial interest in the instant shipment. Additionally, bonded warehouse entries cannot be filed on merchandise unless PN has been satisfied.
Yes, for within-port movements, a CBP 6043 will be used. A bonded cartman or facility owner transporting merchandise under bond directly to their facility, as described in 19 CFR 112.2 (b), may perform the movement of BTA merchandise. Movement outside port limits to a secure facility must be performed by a bonded carrier that uses a CBP 7512. Bond liability is transferred to the party moving and subsequently storing the merchandise pending satisfactory PN and entry of the merchandise.
Could we move the offending shipment on a CBP 6043 as long as the secure facility is within or reasonably close to the port limits as defined in the regulations?
Yes, for within-port movements. A CBP 7512 will be needed for movements outside the port limits, but in no case can merchandise lacking adequate prior notice be moved to an importer's, owner's, or consignee's premises.
No, if prior notice is not provided and the merchandise must be moved to secured storage, it could not move there under the import bond. The merchandise may only move to secured storage under a Type 2 custodial bond.
How does merchandise move to the importer’s premises for examination? Can the filer or holding facility use its type 2 bond if the truck which brought the merchandise to the border isn’t bonded?
Under the provisions of the Act, merchandise for which adequate PN has not been provided cannot move to the importer's premises. While the use of the import bond for CBP-directed examinations under its own legal authority does occur, it cannot be used for movement of merchandise with inadequate PN to the importer’s premises. A type 2 custodial bond must be used to guarantee the movement of the cargo to a secure facility. The secure facility's bond would be acceptable.
It is only an issue if the merchandise being carried does not meet PN requirements and the goods must be moved to a secure facility. Only a carrier with a Class 2 custodial bond (bonded carrier or cartman) can move the goods to a secure facility.
For FDA registration help:
U.S. toll-free: 1-800-216-7331
Outside the United States: 301-575-0156