Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) Public Law 107-188
1Public Health Security and Bioterrorism
Preparedness and Response Act of
2002(Bioterrorism Act)Public Law 107-188
2Presentation Outline
- Overview
- Registration
- Prior Notice (PN)
- Submitting PN
- CBP Processing
- Where Are we now
- Compliance Policy Guide
- Resources
3Bioterrorism Act (BTA)
- Purpose
- To ensure the security of food for human or
animal consumption imported or offered for import
into the United States
4BTA Key dates
- 06/12/02 Signed by President
- 02/03/03 Notice of Proposed Rule Making (NPRM)
issued (PN and Registration) - 04/04/03 Comment period ends
- 05/09/03 NPRM (Detention and Recordkeeping)
- 07/08/03 Comment period ends
- 10/10/03 Final Interim PN and Registration Rule
issued - 10/16/03 FDAs Prior Notice System Interface
(PNSI), - aka website, available for Registration
- 12/12/03 BTA Implemented - Informed Compliance
begins - 08/13/04 Full Implementation - Enforced Compliance
5FDA Process 801(a) 801(m)
- 801 (a) existing FDA Process
- Required by full range of FDA related laws and
regulations covering foods, drugs, medical
devices, and cosmetics - Currently in place
- No Change in practice
- 801 (m) BTA Requirement
- Established by BTA of 2002
- New requirement focuses on anti-terrorism
- Focus for CBP is on ensuring PN submitted and
accepted - PN not satisfied will result in refusal of
admission
6Changes in Interim Final Rule
- There have been significant changes from the NPRM
published in February 2003 - Regulations on the disposition of shipments that
fail to meet the requirements of the BTA were
modified - Language has changed from shall be refused
admission to may be subject to refusal of
admission - The regulations were published as an Interim
Final Rule - A comment period of 75 days ended on December 24,
2003 - The Scope of the Act was narrowed
- HTS numbers refined
7Changes in Interim Final Rule(cont)
- Time Frames were shortened
- ACS/ABI can be used for submission of PN
- Greater flexibility as to who can submit PN
- Reduction in data elements required for PN
- Homemade goods shipped as gifts excluded
- Phase-In requirements
- CBP Officers Commissioned to act on FDAs behalf
to enforce BTA
8 BTA Scope
- How is food defined?
- Covered under Title III, Subtitle A (Safety of
Food) - Defined in the BTA Interim Final Rule 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 U.S.
for Human or Animal Consumption - Excludes food contact surfaces and pesticide
chemicals
9 BTA Inclusions
- What Food is Covered?
- All food as defined by FDA, Being imported or
offered for import into the U.S. - Food stored or distributed in the U.S.
- Gifts, Trade, and Quality Assurance/Control
Samples - Transshipments through the U.S. to another
country (Transportation Exportations (TEs)) - Food imported for future export
- Food admitted into a U.S. Foreign Trade Zone (FTZ)
10 BTA Registration
- Who Must Register?
- Domestic and Foreign facilities that manufacture,
process, pack, or hold food subject to the BTA - Registration Deadlines
- Domestic and foreign firms that manufacture,
process, pack or hold articles subject to the BTA
began registration on October 16, 2003 - As of December 12, 2003 all firms must be
registered prior to importation
11BTA Registration Exemptions
- Which Facilities are Exempt from Registration?
- Nonprofit facilities
- Retailers
- Farms
- Restaurants
- Fishing Vessels, except those that engage in
processing as defined in FDAs seafood HACCP
regulations (21 CFR 123.3(k)) - Facilities subject to the exclusive jurisdiction
of USDA - Homemade gifts
12Registration under BTA
- How To Register
- Registration may be via
- FDA Website www.FDA.gov/FURLS
- Submitting paper copy of Form 3537 or CD/ROM to
- Mailing address (See www.FDA.gov)
- Fax Number 1-877-FDA-3882
- Form may be downloaded from the BTA page at
www.FDA.gov - Tutorial help available at www.FDA.gov/FURLS
- Toll-free number in U.S. is 1-800-216-7331
13Registration under BTA (cont.)
- Outside the U.S. the number is 301-575-0156
- Questions may be Faxed to 301-210-0247 (not
Toll-free) - These numbers are staffed from 7 AM to 11 PM U.S.
Eastern Time
14 U.S. Agent
- Any facility that registers with the FDA must
appoint a U.S. agent who resides and maintains a
place of business in the U.S. and must be
physically present in the U.S - The agent will act as the emergency contact for
the FDA
15 Prior Notice - Overview
- Why is Prior Notice (PN) Required on Importation
of Food? - The intent is to provide FDA with advance
information to target potentially high risk
shipments that could threaten Public Health and
the Security of the food chain by an act of
Bioterrorism
16Prior Notice - Overview (cont.)
- Who Submits PN?
- Any person with knowledge of the required
information may submit PN or have it transmitted
on their behalf - Submitter Person submitting the PN
- Transmitter Individual filer submitting PN on
behalf of submitter
17Prior Notice - Overview (cont.)
- When is PN Required?
- PN is required when
- Merchandise covered by the BTA is imported or
offered for import into the U.S. 801(m) - Each item covered under the BTA that has a
separate FDA product code requires a separate PN
18Prior Notice - Overview (cont.)
- Failure to Register/Provide PN
- FDA can bring civil and/or criminal action
against a party that is not registered - FDA can bring about debarment (prohibits further
trade activity) of any person convicted of a
felony violation of the BTA - Merchandise can be
- Held at Port
- Sent to a Secure Storage
- Exported
- CBP can issue penalties
19Prior Notice - Overview (cont.)
- PN requirements not met
- Failure to submit, Inadequate, Untimely or
Inaccurate PN - Article may be subject to refusal and unless
immediately exported with CBP concurrence, may be
held at the port or removed to a secure facility - Refused merchandise CAN NOT Go to the importer,
owner, or consignees premises
20Prior Notice - Overview (cont.)
- What Food imports are Exempted from PN?
- Food accompanying a traveler for his/her personal
use - Food imported for Immediate Export (IE)
- Can not leave port of arrival except for export
- Meat, Poultry, and Egg products
- Subject to USDA
- Homemade gifts shipped as gifts
21Prior Notice Time Frames
- Land Border
- 2 Hours prior to arrival at U.S. port
- Trucks, Cars, Pedestrians, Carts, all types of
vehicles - Any of the above arriving by ferry must meet the
Land Border time frames - Rail and Air
- 4 hours prior to arrival at U.S. port
- Vessel
- 8 hours prior to arrival at U.S. port
- International Mail
- At time of mailing
22Commissioning CBP Officers
- Memorandum of Understanding (MOU) between FDA and
CBP signed December 3, 2003 - In the absence of FDA, perform PN initiated exams
and/or sampling under the BTA - FDA has provided a 24x7 toll free to assist both
the trade and CBP, 866-521-2297
23Submitting Prior Notices
- How Prior Notices Are Submitted
- Via ABI/ACS
- Includes the (WP) for automated in-bond
- Via FDA Prior Notice System Interface (PNSI)
(www.access.FDA.gov) - A paper copy of the PN will be required for
release - Via E-Mail (when PNSI is unavailable)
- E-Mail address to be announced
- Via FAX (when PNSI is unavailable)
- Fax Number to be announced
- See www.FDA.gov
24Submitting Prior Notice
- ACS/ABI/OASIS Changes
- PN submission can be done using several new or
enhanced components of FDAs and CBPs existing
electronic systems - CBPs ACS to FDAs OASIS system has been enhanced
to support PN - ABI software changes were required to support PN
information - New ABI/ACS/OASIS interface (known as WP),
modeled after existing process, is available to
submit PN for entering the U.S. as automated
in-bond
25Submitting Prior Notice via ABI / ACS (Entry)
- How to Submit PN
- PN information supplied along with ABI entry data
- 80 of entries that require prior notice
processed via ABI/ACS - FDA provides PN confirmation number
electronically to CBP and CBP advises filer - PN results matched to the ABI entry and
electronically provided to CBP officers
26Submitting PN via ACS (No Entry)Known as WP
- Estimated to be roughly 10 of submissions
- Electronic transmission through ACSno
consumption entry information. - Required information
- In-bond number
- Complete AWB/Master Airway Bill
- Bill of Lading number
- Working on Bar Coding on FDA PN Form
27Entries Not Processed Via ABI/ACS
- Any transaction involving a human or animal food
subject to prior notice requirements can be input
through FDA Prior Notice System Interface (PNSI) - Non-automated and/or paper entries
- Mail
- FTZ admissions
- In-bonds unable to be filed through ACS/ABI (WP)
28Submitting PN via FDA Prior Notice System
Interface
- How to Submit PN
- Filer submits PN information via the FDA PN
System Interface and receives PN confirmation
number which filer then adds to paper entry
submissions - CBP Officers will need to query new database file
for PN results - A paper copy of the PN will be required for
release, if requested by CBP - FDA PN System Interface (www.access.FDA.gov)
29Merchandise with Inadequate or No PN is Subject
to Refusal
- At the CBP Port Directors discretion in
consultation with FDA, based on availability of
storage and resources merchandise subject to
refusal 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 (must be done under
bond) - Exported
30Status of Merchandise with No PN or Inadequate PN
- Legal status is G.O. merchandise
- If carrier has a terminal facility, it will be
held in constructive G.O. at the terminal
facility until final disposition (entry, export,
sale for export only, or destruction) - If no terminal facility available, Port Director
may send it to nearest G.O. warehouse or suitable
facility, which may be inside or outside the port
limits - The Port Director will make an operational
decision if and when a G.O. number should be
assigned to the shipment
31Procedures for Movement of Goods to a Facility
Not Within the Port of Arrival
- Documentation Required
- Requires the appropriate CBP control
documentation - CBP 6043 Permit to Transfer for movements
within CBP limits - CBP 7512 Restricted in-bond for movements
outside of port entities - No documents needed for movement of merchandise
to terminal facility of carrier within the port
of arrival
32Procedures for Merchandise Held in Secure Facility
- Merchandise held under G.O. procedures for each
port - Perishable shipments, or where no suitable G.O.
facility exists, will be held under constructive
G.O. or directed by the Port Director to a
suitable facility will be destroyed or sold for
export after 3-days public notice - Carrier will assume cost of destruction. Storage
costs are between carrier and importer
33Secure Facility Definition
- What Is a Secure Facility?
- A bonded facility designated by the CBP Port
Director (may include G.O. warehouses or other
suitable facilities) - Facilities must be registered with FDA
- Facilities may be outside the immediate vicinity
of the port, if suitable for the storage of food - May not be the importers,owners, or consignees
facility - Merchandise may be sent to a suitable facility in
another port if no other options exist
34Procedures for Merchandise Held in Secure
Facility (continued)
- What Happens to Merchandise
- Merchandise under constructive G.O. will stay
at the carriers facility until final disposition
of the merchandise - If eventually sold, it will be for
- Export only (PN not required) and shipped
directly (Immediate Export) out of the port in
which it is being held
35 Registration of Facilities with FDA
- Which Facilities Must Register?
- All facilities that hold food for consumption in
the United States must be registered with the FDA - This includes
- Terminal facilities (unless holding in the course
of transportation) - Container freight stations (CFS)
- Bonded warehouses (includes duty free warehouse)
- Centralized examination stations (CES)
- G.O. warehouses
- Customs approved storage rooms (CASR)
36Procedures for Export of Merchandise
- Shipper, importer, or carrier may decide to
export with CBP concurrence - Should be under physical control and custody of
CBP - May be documented using an Immediate Export (IE)
in-bond
37Procedures for Abandoned Goods
- Foods that are, abandoned, refused for no or
inadequate prior notice (treated same as if no
prior notice), will be considered G.O.
merchandise and will follow normal G.O. guidelines
38Procedures for Segregation of BTA Refused Foods
- For foods refused under 801(m) that are
commingled shipments either within same container
or truck where you have foods that are PN
satisfied and PN not satisfied - Goods may be segregated, in accordance with local
procedures and in coordination with the secure
facility and carrier, so that PN satisfied
foods may enter - Food that is PN not satisfied is treated as
refused and subject to being held at port, moved
to a secured facility, or exported - The carrier must bear all costs
39Entry Types Impacted by BTA
- BRASS
- Permit Ports
- Customs Form 3461 Entry/Immediate Delivery
- In-bond Filing Trade Requirements
- FTZ admissions
- Express consignment
- Non-automated informal/walk-up
- International mail
- Carnets
40BRASS
- As of 12/12/03 Releases under BRASS are no longer
be permitted for foods subject to prior notice.
41Role of Permit Ports
- As of 12/12/03 Permit Ports are able to run
ACS/ABI selectivity - This does not extend permit rights to new
shippers through permit ports. New shippers
wishing to cross at permit ports must still
obtain the Port Directors approval
42ABI/ACS Customs Form 3461 Entry/Immediate Delivery
- Prior notice requirements must be satisfied for
merchandise to be released from CBP custody and
entered into the commerce of the U.S.
43In-Bond Filing Trade Requirements
- PN submission (through ABI/ACS or FDA PN System
Interface) must include in-bond number and bill
number (if applicable) - PN must be submitted for Immediate Transportation
(IT) in-bond shipments, however, absent an
identified threat, they will be allowed to travel
to the port of entry for satisfaction of PN - Prior notice requirements must be satisfied at
the port of arrival for merchandise to be
released from CBP custody and have a
Transportation and Export (TE) entry processed.
This will allow merchandise to be transshipped
through the U.S. - In-bond (electronic or paper) includes indicator
of PN compliance
44In-Bond Processing with PN Indicator
- PN Requirements/How to Process
- Automated in-bonds will query ACS PN database and
return status messages to AMS/ABI - Paper in-bonds will require manual input by CBP
of PN indicator ACS PN database will be queried
automatically and return status messages to CBP
officer
45Foreign Trade Zones
- PN Requirements/How to Process
- No automated system for goods admitted to an FTZ
- PN requirements must be met prior to admission of
goods into the FTZ - Paper copy of PN confirmation number shall be
submitted with admission document - Direct delivery only permitted if PN
requirements, including time frames are satisfied - 48-hour post arrival reporting time disallowed
46Foreign Trade Zones (continued)
- PN Requirements/How to Process
- All other movement to the FTZ done as follows
- Under dray or delivery ticket
- By CF214
- FDA PN System Interface used to submit PN
- In-bond permitted if PN satisfied
47Express Consignment
- PN Requirements/How to Process
- PN is required for all Express Consignment
Courier Facility (ECCF) food shipments subject to
prior notice requirements - Consolidated entries for foods subject to prior
notice requirements will not be allowed unless PN
is satisfied for all. - If not, then separate entries will be required.
This represents fundamental change in business
practices - No Section 321 release(on manifest) for foods
subject to prior notice requirements unless PN
requirements have been met
48Non-Automated Informal Entries/ Walk-ups
- PN Requirements/How to Process
- All foods subject to the prior notice and food
facility registration requirements must file PN
unless specifically exempted - There is no De Minimus under the prior notice
rule - Household goods containing items subject to prior
notice requirements are not exempt and require PN - PN must be filed on each item by FDA product code
- Paper copy of PN confirmation number must
accompany the shipment - Failure to have PN confirmation number may result
in a refusal of admission
49Non-Automated Informal Entries/ Walk-ups
(continued)
- PN Requirements/How to Process
- Inspector will query PN database to determine
status - Most of these will not have a bond and as a
result will not be able to move their goods to a
secure facility - Many may not be able to meet PN requirements and
shipment will most likely be exported or abandoned
50International Mail
- PN Requirements/How to Process
- PN requirements apply to food as defined in the
interim final regulations imported through
international mail - A Food shipment must have PN confirmation number
on Postal Declaration Form CN22 or CN23 - Home-made foods sent as gifts are not subject to
prior notice requirements - If there is no PN confirmation number CBP will
hold shipment for 72 hours for FDA inspection and
disposition - If there is no return address, shipment will be
destroyed - If shipment contains food subject to PN and items
not subject to PN, the shipment will be treated
as commingled, where the items not subject to PN
or if in compliance with PN, will be segregated
and processed and the non-compliant food items
will either be returned or destroyed
51Carnets
- PN Requirements/How to Process
- Definition
- An international customs document that
facilitates temporary imports into foreign
countries and is valid up to 1 year - Foreign facilities exporting food products to the
U.S. using carnets must register with the FDA PN
requirements also apply - Process normally except CBP inspectors must query
PN documents (PN confirmation) and database. - Paper copy of PN confirmation number shall be
submitted with carnet
52Compliance Policy Guide
- Prior Notice (PN) Enforcement Guidelines
Although the BTA was implemented on December 12,
2003, enforcement of the PN reporting
requirements of the BTA will be phased in over
eight months. Unless a threat is identified and
FDA working in conjunction with CBP at the
National Targeting Center (NTC) orders a hold,
enforcement actions will be taken based on the
following schedule
53Compliance Policy Guide (continued)
- Phase 1 December 12, 2003 March 12, 2004 No
shipments will be stopped for administrative
failure. Only the National Targeting Center
(NTC) will be able to place a hold on any
shipment subject to the BTA and that would only
be for a perceived threat. All other shipments
will be processed under informed compliance with
educational materials e.g., flyers and pamphlets,
and outreach, letters and meetings with the
trade. - Phase 2 March 13, 2004-May 12, 2004 No
shipments will be stopped for administrative
failure. Penalties against egregious violators
who have been counseled begin.
54Compliance Policy Guide (continued)
- Phase 3 May 13, 2004 August 12, 2004 Failure
to provide Prior Notice will result in refusal of
the shipment and/or penalty. Refusal results in
merchandise being held at port of arrival, sent
to a secure facility as determined by the CBP
port director or exported under CBP supervision. - Phase 4 August 13, 2004 and thereafter Full
enforcement. Failure to provide Prior Notice
will result in refusal of shipment and/or
penalty. FDA determination that Prior Notice
data is either incomplete or inadequate will also
result in refusal of merchandise.
55CBP Processing - Identified problems
- Ability to disclaim PN for goods subject to FDA
- HTS 9801 ability to disclaim BTA
- System flags FD 1-3 being modified to allow FDA
and/or PN submission or FDA disclaim
56Harmonization of Advance Notice Time Frames
- CBP and FDA have agreed to harmonize advance
notice (Prior Notice) time frames to the extent
possible. - FDA and CBP will publish a document in the
Federal Register on or before March 12, 2004
laying out any changes to the time frames.
57Help Resources
- FDA registration help
- U.S. Toll-free 1-800-216-7331
- Outside U.S. 301-575-0156
- Fax 301-210-0247
- Registration tutorialwww.fda.gov/furls
- Federal Register www.gpoaccess.gov/fr
- Legislation www.thomas.loc.gov
- CBP web site www.CBP.gov
58Help Resources (continued)
- FDA web site www.FDA.gov
- FDA regional points of contacts
- Each CBP field office will have 2 BTA trained
experts - FDA Compliance Policy Guide
- FDA Publication What Do I Need To Know About
FDAs New Bioterrorism Rules will available
through trade associations, state agencies,U.S.
embassies, and at the FDA website -