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Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Bioterrorism Act Publi


1
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002(Bioterrorism Act)Public Law 107-188
2
Presentation Outline
  • Overview
  • Registration
  • Prior Notice (PN)
  • Submitting PN
  • CBP Processing
  • Where Are we now
  • Compliance Policy Guide
  • Resources

3
Bioterrorism Act (BTA)
  • Purpose
  • To ensure the security of food for human or
    animal consumption imported or offered for import
    into the United States

4
BTA 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

5
FDA 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

6
Changes 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

7
Changes 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

11
BTA 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

12
Registration 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

13
Registration 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

16
Prior 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

17
Prior 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

18
Prior 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

19
Prior 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

20
Prior 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

21
Prior 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

22
Commissioning 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

23
Submitting 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

24
Submitting 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

25
Submitting 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

26
Submitting 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

27
Entries 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)

28
Submitting 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)

29
Merchandise 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

30
Status 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

31
Procedures 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

32
Procedures 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

33
Secure 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

34
Procedures 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)

36
Procedures 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

37
Procedures 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

38
Procedures 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

39
Entry 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

40
BRASS
  • As of 12/12/03 Releases under BRASS are no longer
    be permitted for foods subject to prior notice.

41
Role 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

42
ABI/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.

43
In-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

44
In-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

45
Foreign 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

46
Foreign 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

47
Express 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


48
Non-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

49
Non-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

50
International 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


51
Carnets
  • 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


52
Compliance 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

53
Compliance 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.

54
Compliance 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.

55
CBP 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

56
Harmonization 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.

57
Help 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

58
Help 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
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