**Frequently Asked Questions & Answers Regarding CBP Procedures under
the Bioterrorism Act (BTA)**

1.  **What is the BTA?**

**A.** 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.

2.  **What "food" is covered by the BTA?**

**A.** Food is defined in the BTA Interim Final Regulations as:

-   Articles used for food or drink for man or animals,

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-   Chewing gum, and

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-   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,

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-   Gifts not homemade and not accompanying a traveler, trade, and
    quality assurance/control samples,

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-   Transshipments through United States to another country (T&E),

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-   Food imported for future export,

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-   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.

3.  **What are the major components of the BTA law?**

# A. 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.

**4. Section 305 of the BTA requires facility registration. What does
that mean?**

**A.** 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.

**5. Who is exempt from the facility registration requirement?**

5.  

**A.** These facilities are exempt from the BTA registration
requirement:

##### Nonprofit facilities,

-   Retailers,

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-   Farms,

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-   Restaurants,

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-   Fishing vessels, except those that engage in processing as defined
    in FDA's seafood HACCP regulations (21 CFR 123.3(k\].

-   Facilities that are under the exclusive jurisdiction of the U.S.
    Department of Agriculture.

**6. Are Customs Bonded Warehouses (CBWs) required to register with the
FDA?**

**A.** 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
site](http://www.cfsan.fda.gov/~furls/ovffreg.html).

**7. There are various firms, which claim that they will register my
facilities, domestic and foreign, for a fee. Do I have to use them?**

**A.** 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 site.](http://www.cfsan.fda.gov/~furls/ovffreg.html)

**8. 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?**

**A.** No. Currently the FDA will only recognize one (1) U.S. agent per
foreign facility registration.

**9. What if the manufacturer of a BTA covered product refuses to
register with the FDA?**

**A.** 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](http://www.fda.gov/).

**10. What is Prior Notice (PN)?**

**A.** 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,

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-   The country from which the article is shipped,

### Anticipated CBP port of arrival,

-   CBP ACS entry type and date,

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-   In the event of a hold, the information about where it is being
    held,

### All carriers,

-   Firm name and address,

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-   E-mail address,

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-   Telephone and fax numbers,

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-   Registration number,

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-   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.

11. **When is a PN filing required?**

**A.** PN filing is required for:

-   Merchandise covered under the BTA and imported or offered for import
    into the United States,

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-   Every entry item that has a separate FDA product code requires a
    separate PN,

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-   Every entry item from separate facilities requires a separate PN.

-   Every entry item for separate consignees on a consolidated entry

12. **What are the pre-filing time limits for Prior Notice and**

**when will they be enforced?**

**A.** 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.

**13. Is there a De Minimus (minimum) value for merchandise subject to
the BTA?**

**A.** There is no De Minimus 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.

14. **Does the Prior Notice requirement impact personal shipments?**

**A.** 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;

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-   Food purchased by a traveler and mailed or shipped to the
    traveler\'s U.S. address by the traveler;

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-   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

**15. What food commodities are excluded from PN?**

**A.** 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.

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-   Merchandise that is immediately exported (IEs).

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-   Meat, poultry, and egg products **exclusively** subject to USDA
    jurisdiction.

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-   Homemade goods shipped as gifts.

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-   Food items shipped via diplomatic pouch.

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-   Foods normally subject to the BTA that are included in shipments of
    household goods.

-   Non-consumption samples for testing only.

**16. Are alcoholic beverages and bottled water subject to the BTA?**

**A.** 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.

**17. I import various types of canned foods. What do I need to do to
satisfy PN?**

**A.** 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.

**18. 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?**

**A.** 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.

**19. What will happen to BTA covered merchandise that arrives at a U.S.
port and no Prior Notice is filed?**

**A.** 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.

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-   For seaports, airports, and courier hubs, the terminal facility of
    the arriving carrier is considered to be within the port of arrival.

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-   Directed to secure facility. This action must be done under bond.

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-   Exported (at the shippers or carriers request).

**20. Has CBP issued any BTA related penalties?**

21. 

**A.** CBP, on behalf of the FDA, has issued civil monetary penalties to
entities that have failed to file Prior Notice as required.

**21. What will happen if I mis-describe merchandise in order to avoid
the BTA requirements?**

**A.** 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.

**22. 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?**

**A.** 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.

**23. Do warehouse entries require PN?**

**A.** 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.

**24. Do warehouse withdrawals require PN?**

**A.** No, warehouse withdrawals are exempt from the PN filing
requirement.

**25.** Does a re-warehouse entry (entry type 22) require PN?

**A.** 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
12/12/03, 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.

**26.** Is PN required for merchandise subject to the BTA that are

being admitted to a Foreign-Trade Zone (FTZ)?

**A.** Yes, PN must be filed before goods are admitted into an FTZ.

**27. Is PN required for merchandise entered (withdrawn) from an FTZ?**

**A.** 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 12/12/03, in which case it was pre-BTA and as such did not
need PN. In either case, PN is not required for an FTZ entry
(withdrawal).

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

**A. 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.

**29. What Prior Notice data is required for Transportation and
Exportation (T&E) entries?**

**A.** 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.

**30. What do I do with my CBP entry if I have to cancel my PN
submission?**

**A.** You must cancel your CBP entry as well.

**31. Will CBP delete or cancel entries?**

**A.** 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 cancellation 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 cancelled. If the goods are exported, the appropriate entry
cancellation documentation must be filed with CBP. This process may also
entail filing an Immediate Export (IE) entry.

**32. Are \"Pen and Ink\" changes allowed on entries for BTA
merchandise?**

**A.** 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.

**33. Are commercial samples exempt from BTA requirements?**

**A.** 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.

**34. What if I sell my goods Free On Board (F.O.B.), are they exempt
from PN?**

**A.** 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.

**35. What does it take for someone to become a "Secure Storage"
location? We have local companies interested. One is already a Customs
Bonded Warehouse, dealing in ships stores, etc., would it need to be
registered since it would hold food, etc? Another is a Meat Inspection
Facility that is registered with the USDA Food Safety Inspection
Service.**

**A.** 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.

**36. Does a secure facility need a Customs Bond?**

**A.** 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.

**37. 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? We do that now for merchandise to be
examined at importers/broker premises (primary textiles)?**

**A.** 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.

**38. Is it true that merchandise would remain under whatever import
bond was offered under entry?**

**A.** 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.

**39. How does merchandise move to the importer's premises for
examination? Since many carriers move the types of merchandise covered
by the BTA are not bonded carriers, can the filer or the holding
facility use its type 2 bond if the truck which brought the merchandise
to the border isn't bonded? If the secure facility takes possession at
the port, can it use its own bond?**

**A.** 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.

**40. Land border carriers are not necessarily bonded. Is that an
issue?**

**A.** 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.

**41. If I need further assistance or information on the BTA, whom
should I contact?**

**A.** For FDA registration help:

-   U.S. toll-free: 1-800-216-7331

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-   Outside the United States: 301-575-0156

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-   Fax: 301-210-0247

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-   [Registration tutorial](http://www.fda.gov/furls)

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-   [Federal Register](http://www.gpoaccess.gov/fr)

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-   [Legislation](http://www.thomas.loc.gov/)

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-   [FDA web site](http://www.fda.gov/)

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-   FDA Publication "What Do I Need To Know About FDA's New Bioterrorism
    Rules" is available through trade associations, state agencies, U.S.
    Embassies and on the FDA website.