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Public Health Security and Bioterrorism Preparedness and Response Act of 2002(Bioterrorism Act-BTA)Public Law 107-188: 

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act-BTA) Public Law 107-188

Presentation Outline: 

Presentation Outline Overview Registration Prior Notice (PN) Submitting PN CBP Processing Resources

Bioterrorism Act (BTA): 

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

BTA Key Dates: 

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 - 75 day comment period begins - Comment period closes 12/24/03 10/16/03 FDA web portal available for registration 12/12/03 BTA implementation

BTA Key Sections: 

BTA Key Sections Act contains 5 Titles FDA Responsibilities: Title III Subtitle A (Safety of Food) Section 303 Detention Section 305 Registration Section 306 Records Management Section 307 Prior Notice Subtitle B (Drug Supply)

Changes in Interim Final Rule: 

Changes in Interim Final Rule There have been significant changes from the proposed regulations published in the Federal Register in February. Regulations on the disposition of shipments that fail to meet the requirements of the BTA have been modified Language has changed from “shall be refused admission” to “is subject to refusal of admission”

Changes in Interim Final Rule (continued): 

Changes in Interim Final Rule (continued) The regulations have been published as an Interim Final Rule 75 day comment period begins with publication of the Interim Final Rule Comment period closes 12/24/03 Scope of the Act has been narrowed Time frames for PN have been shortened

Changes in Interim Final Rule (continued): 

Changes in Interim Final Rule (continued) ACS/ABI can be used for the submission of PN Flexibility as to who can submit PN Reduction in data elements required for PN Several more exclusions from PN requirements, including Immediate Export (I.E.) shipments Procedures outlined for shipments with no or inadequate PN submission

Changes in Final Rule (continued): 

Changes in Final Rule (continued) Homemade goods shipped as gifts are excluded Phase-In of requirements Another major change in implementation is the commissioning of CBP officers to act on FDA’s behalf to enforce BTA regulations

BTA Scope: 

BTA Scope How Is Food Defined? Covered under Title III, Subtitle A (Safety of Food) Food is defined in the BTA Interim Final Regulations as: (1) articles used for food or drink for man or animals (2) chewing gum, and (3) articles used for components or any such article. Food imported or offered for import into the U.S. for human or animal consumption

BTA Scope (continued): 

BTA Scope (continued) Extent of Food Coverage Approximately 2,000 HTS numbers 16% of all imports into the U.S. are food and animal feed as covered by the BTA

BTA Inclusions: 

BTA Inclusions What Food Is Covered? Food as defined by FDA, “being imported or offered for import into the United States” and not under the exclusive purview of another agency Food stored or distributed in the U.S. Gifts not homemade and not accompanying a traveler, trade, and quality assurance/control samples Transshipments through U.S. to another country(T&E) Food imported for future export

BTA Inclusions continued: 

BTA Inclusions continued Food admitted into a U.S. Foreign Trade Zone (FTZ) Household goods Ships stores (air and vessel) Unused meals

Registration: 

Registration

BTA Registration: 

BTA Registration Who Must Register? Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register with FDA. Includes, but is not limited to, secure facilities e.g., G.O. warehouses and carrier facilities who perform these functions

BTA Registration Exemptions: 

BTA Registration Exemptions Which Facilities Are Excluded from Registering? Nonprofit facilities Retailers Farms Restaurants Fishing vessels, except those that engage in processing as defined in FDA’s seafood HACCP regulations (21 CFR 123.3(k)) Facilities subject to the exclusive jurisdiction of the U.S. Department of Agriculture

BTA Registration Exemptions: 

BTA Registration Exemptions Homemade goods sent as gifts Facilities from which merchandise is sent for transit through the U.S. Transportation and Exportation shipments (T&E’s)

Registration Information: 

Registration Information Registration is one-time process and must be done using Form 3537. Information required on the form includes: Name and address of facility Parent company name (if applicable) Emergency contact information Trade names U.S. Agent (for foreign facilities) General product categories

Registration Information (continued): 

Registration Information (continued) Form may be downloaded from the Bioterrorism Act page at www.FDA.gov Registration Help: Tutorial registration available at www.FDA.gov/furls Toll-free number in U.S. is 1-800-216-7331

Registration Information (continued): 

Registration Information (continued) Outside the U.S., the number is 301-575-0156 (not toll-free) Questions may be faxed to 301-210-0247 (not toll-free) Starting 10/16/03 these numbers will be staffed from 7 AM to 11 PM U.S. Eastern Time

Registration Information (continued): 

Registration Information (continued) Changes to a facility’s registration information must be reported to the FDA within 60 days of the change FDA can be notified through the same means as initial registration was done

U.S. Agent: 

U.S. Agent Any foreign facility that registers with the FDA must appoint a U.S. agent who resides or maintains a place of business in the U.S. and be physically present in the U.S. The agent will act as the emergency contact for the FDA Only one (1) U.S. agent per facility is permitted

BTA Registration: 

BTA Registration How To Register Registration may be via: FDA web portal E-mail address: 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

FDA Notice Regarding Firms Offering Registration Services: 

FDA Notice Regarding Firms Offering Registration Services 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 the agency contracted with any firms to register facilities. Facilities must be registered with FDA by December 12, 2003. On October 16, 2003 at 6:00 P.M. EDT. you could begin to register electronically at www.fda.gov/FURLS There is no registration fee.

BTA Registration: 

BTA Registration Registration Deadlines Domestic and foreign firms that manufacture, process, pack, or hold articles or food for human or animal consumption may begin registration on October 16, 2003 As of December 12, 2003, must be registered prior to importation New facilities that commence operations after December 12, 2003 may continue to register after that date, however, they must register prior to shipping BTA regulated articles to the U.S.

Prior Notice: 

Prior Notice

Prior Notice (PN): Overview : 

Prior Notice (PN): Overview 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 Why Is PN Required on Importation of Food?

BTA Exemptions-Prior Notice: 

BTA Exemptions-Prior Notice What Food Commodities Are Excluded? Personal use food accompanying a traveler Food immediately exported (IE) (without leaving the port of arrival) Meat, poultry, and egg products (subject to the exclusive jurisdiction of the USDA) Homemade goods shipped as gifts

Prior Notice (PN): Overview (continued): 

Prior Notice (PN): Overview (continued) Who can submit a PN? Any person with knowledge of the required information may submit PN or have it transmitted on their behalf Submitter: Person submitting PN Transmitter: Individual filer submitting PN on behalf of submitter

Prior Notice (PN): Overview (continued) : 

Prior Notice (PN): Overview (continued) Article Identity FDA product code (system FDA uses to identify products), common name, trade or brand name, quantity, lot/code identifier Manufacturer, Shipper, All Growers (if known, currently provided as manufacturer) Firm name and address, e-mail address, telephone and fax numbers, registration number What Information is Provided in the PN (Data Elements)

Prior Notice (PN): Overview : 

Prior Notice (PN): Overview The country from which the article originates The country from which the article is shipped Anticipated Customs’ port of arrival Anticipated date and time of arrival Customs ACS entry type and date In the event of a hold, the information about where it is being held What Information is Provided in the PN (Data Elements) (continued)

Prior Notice (PN): Overview : 

Prior Notice (PN): Overview Submitter, Importer, Owner, Consignee Individual (for submitter) Information for submitter is currently provided by the filer as broker identity Firm name and address E-mail address Telephone and Fax numbers Registration number What Information is Provided in the PN (Data Elements) (continued)

Prior Notice (PN): Overview : 

Prior Notice (PN): Overview All carriers Firm name and address E-mail address Telephone and Fax numbers Registration number Standard carrier abbreviation code What Information is Provided in the PN (Data Elements) (continued)

Prior Notice (PN): Overview (continued): 

Prior Notice (PN): Overview (continued) When is a PN Required? A PN is required for: Merchandise covered under the BTA and imported or offered for import into the U.S. [801(m) ] Every entry item that has a separate FDA product code require a separate PN Every entry item from separate facilities requires a separate PN

Prior Notice (PN): Overview (continued): 

Prior Notice (PN): Overview (continued) Failure to Register/Provide PN FDA can bring civil and 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 Facility Exported CBP can issue penalties

Prior Notice (PN): Overview (continued): 

Prior Notice (PN): Overview (continued) Inadequate PN “No, Inadequate, or Untimely Notice…” Article may be subject to refusal and, unless immediately exported with CBP concurrence, may be held within the port of arrival or removed to a secure facility Article can not go to the importer, owner or consignees premises.

Prior Notice (PN): Overview (continued): 

Prior Notice (PN): Overview (continued) Amendments to PN No substantial amendments. Filer must cancel PN and cancel/delete entry. New PN and entry must be filed. Time frames are also restarted

PN Timeframes : 

PN Timeframes Land Border 2 hours prior to arrival at U.S. port Trucks, all vehicles, pedestrians, ferries Rail 4 hours prior to arrival at U.S. port Air 4 hours prior to arrival in the U.S. Vessel 8 hours prior to arrival at U.S. port International Mail At time of mailing FDA will not be able to process PN submissions until 12:01 am of December 12, 2003 Timeframes for Submitting PN - May not be submitted more than 5 days prior to arrival and must be submitted no later than:

Commissioning CBP Officers: 

Commissioning CBP Officers Memorandum of Understanding (MOU) between FDA and CBP Perform FDA BTA 801(m) work at locations with limited or no FDA presence Receive training in FDA examination, sampling, and document review prior to December 12, 2003 FDA to provide 24x7 hotline 800-number to assist CBP officers

Submitting PNs: 

Submitting PNs How PNs Are Submitted Via ABI/ACS Via FDA web portal Via e-mail (when web portal is unavailable) Via fax (when web portal is unavailable)

Submitting PN: 

Submitting PN ACS/ABI/OASIS Changes PN submission will be done using several new or enhanced components of FDA’s and CBP’s existing electronic systems CBP’s ACS to FDA’s OASIS system will be enhanced to support PN ABI software changes will be required to support PN information New ABI/ACS/OASIS interface, modeled after existing process, will be available to submit PN for entering the U.S. as automated in-bond or FTZ admission

Submitting PN via ABI / ACS (Entry): 

Submitting PN via ABI / ACS (Entry) How to Submit PN PN supplied along with ABI entry data 80% of BTA entries 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

Submitting PN via ACS (No Entry): “ACS 2-Step”: 

Submitting PN via ACS (No Entry): “ACS 2-Step” Known as 2 step process Electronic transmission through ACS—no consumption entry information Required information: In-bond number Complete AWB/Master Airway Bill Bill of Lading number Working on a Wanding Bar Code on FDA PN Form

BTA Entries Not Processed Via ABI/ACS: 

BTA Entries Not Processed Via ABI/ACS Any transaction involving a BTA regulated article can be input through FDA web portal Non-automated and/or paper entries Mail FTZ admissions Carnets In-bonds unable to be filed through ACS/ABI 2-step process

Submitting PN via Web Portal: 

Submitting PN via Web Portal How to Submit PN Filer submits PN request via the FDA web portal and receives PN confirmation number which filer then adds to paper entry submissions Inspectors may 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 Web Portal (www.access.FDA.gov)

Submitting PNs: Alternative Methods: 

Submitting PNs: Alternative Methods How to Submit PN When FDA Web Portal Is Unavailable Use the alternative methods listed below to submit PN: E-mail address: TBD www.access.FDA.gov Fax number: TBD (see www.FDA.gov)

FDA Process – 801(a) & 801 (m) : 

FDA Process – 801(a) & 801 (m) PN and the FDA Interface: Overview 801(a) (Normal FDA Process) Required by the full range of FDA related laws and regulations covering foods, drugs, medical devices, and cosmetics Not a new requirement Continues normal CBP/FDA processing 801(m): (BTA Requirement) Required by BTA of 2002 A new requirement that focuses on anti-terrorism Focus for CBP purposes is on Prior Notice (PN) If PN requirement not satisfied, will result in refusal of admission

FDA Process: 801 (a): Normal FDA Procedures: 

FDA Process: 801 (a): Normal FDA Procedures BTA requirements do not eliminate general FDA non-bioterrorism responsibilities under 801(a) 801(a) applies to all FDA regulated commodities (except radiation emitting electronic products) including foods, drugs, medical devices, and cosmetics

Merchandise with Inadequate or No PN is Subject to Refusal: 

Merchandise with Inadequate or No PN is Subject to Refusal At the CBP Port Director’s 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

Status of Merchandise with No PN or Inadequate PN: 

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

Procedures for Merchandise Retained at Port of Arrival: 

Procedures for Merchandise Retained at Port of Arrival Is held under “constructive G.O.” The CBP Port Director will make an operational decision if and when a G.O. number should be assigned to the shipment

Procedures for Movement of Goods to a Facility Not Within the Port of Arrival: 

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

Procedures for Merchandise Held in Secure Facility: 

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 CBP Port Director to a suitable facility; will be destroyed or sold after 3-days’ public notice Carrier will assume cost of destruction. Storage costs are between carrier and importer

Secure Facility Definition: 

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 the FDA Facilities outside the immediate vicinity of the port, suitable for the storage of food May not be the importer’s,owners or consignees facility Merchandise may be sent to a suitable facility in another port if no other options exist

Procedures for Merchandise Held in Secure Facility (continued): 

Procedures for Merchandise Held in Secure Facility (continued) What Happens to Merchandise Merchandise under “constructive G.O.” will stay at the carrier’s 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

Slide56: 

Which Facilities Must Register? All facilities that hold merchandise subject to the BTA must be registered with the FDA This includes: Terminal facilities Container freight stations (CFS) Bonded warehouses (includes duty free warehouse) Centralized examination stations (CES) G.O. warehouses Customs approved storage rooms (CASR) Registration of Facilities with FDA

Procedures for Export of Merchandise: 

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

Procedures for Abandoned Goods: 

Procedures for Abandoned Goods BTA abandoned goods will be considered G.O. merchandise and will follow normal G.O. guidelines

Procedures for Segregation of BTA Refused Foods: 

Procedures for Segregation of BTA Refused Foods What Happens to Refused Foods? Food refused under 801(m) Commingled foods within same container or truck Commingled goods, e.g., goods that are “PN satisfied” and “PN not satisfied”

Procedures for Segregation of BTA Refused Foods (continued): 

Procedures for Segregation of BTA Refused Foods (continued) What Happens to Refused Foods? Goods must be segregated, in accordance with local procedures and in coordination with the secure facility and carrier, so that “PN satisfied” foods may enter “PN not satisfied” handled as refused entry and held at port, moved to a secured facility, or exported The carrier must bear all costs

Entry Types Impacted by BTA: 

Entry Types Impacted by BTA BRASS Permit Ports Customs Form 3461 Entry/Immediate Delivery Quota Quota entries subject to the BTA cannot be processed until PN is satisfied In-bond Filing Trade Requirements FTZ admissions Express consignment Non-automated informal/walk-up International mail Carnets

BRASS: 

BRASS Entries under BRASS will no longer be permitted for goods subject to the BTA after 12/12/03 Letters have been sent to current BRASS participants informing them of this

BTA Role for Permit Ports: 

BTA Role for Permit Ports It is expected that Permit Ports will be able to run ACS/ABI selectivity by effective date of BTA, 12/12/03 for existing shippers only 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 director’s approval

ABI/ACS Customs Form 3461 Entry/Immediate Delivery: 

ABI/ACS Customs Form 3461 Entry/Immediate Delivery PN Requirements/How to Process For merchandise to be released from CBP custody and entered into the commerce of the U.S. or for export (includes warehouse entry) All BTA requirements must be satisfied prior to release

BTA In-Bond Filing Trade Requirements: 

BTA In-Bond Filing Trade Requirements PN Requirements/How to Process PN submission (through ABI/ACS or FDA web portal) must include in-bond number and bill number (if applicable) Transportation (IT) in-bond shipments may be allowed to travel to the port of entry for satisfaction of PN Transhipped merchandise (T&E) must satisfy notice requirements at port of arrival in the U.S.

BTA In-Bond Filing Trade Requirements: 

BTA In-Bond Filing Trade Requirements PN Requirements/How to Process In-bond (electronic or paper) must include indicator of PN compliance Capability to provide a 6-digit HTS on in-bonds is under development

In-Bond Processing with PN Indicator: 

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

FTZ: 

FTZ PN Requirements/How to Process No automated system for goods admitted to an FTZ PN requirements must be met prior to movement of goods to 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

FTZ: 

FTZ PN Requirements/How to Process All other movement to the FTZ done as follows: Under dray or delivery ticket with PN confirmation printout attached. By CF214 with PN confirmation printout attached FDA web portal used to submit PN. In-bond permitted if PN satisfied under in-bond guidelines.

Express Consignment: 

Express Consignment PN Requirements/How to Process PN is required for all Express Consignment Courier Facility (ECCF) BTA covered shipments This represents fundamental change in business practices Consolidated entries for BTA merchandise will not be allowed Separate entries will be required

Express Consignment: 

Express Consignment PN Requirements/How to Process No Section 321 release(on manifest) for BTA merchandise. Entry must be made for each item covered by the act.

Non-Automated Informal Entries/ Walk-ups: 

Non-Automated Informal Entries/ Walk-ups PN Requirements/How to Process All goods subject to the BTA must file PN unless specifically exempted There is no De Minimus under the BTA Household goods containing items subject to the BTA are not exempt and require PN PN must be filed on each item by product code Paper copy of PN confirmation number must accompany the shipment Failure to have PN confirmation number will result in a refusal of admission

Non-Automated Informal Entries/ Walk-ups: 

Non-Automated Informal Entries/ Walk-ups 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

International Mail: 

International Mail PN Requirements/How to Process BTA applies to food as defined in the Act imported through international mail Food shipment must have PN confirmation number on Postal Declaration Form CN22 or CN23 Home made foods sent as gifts are exempt from Registration and PN

International Mail (continued): 

International Mail (continued) PN Requirements/How to Process If there is no PN confirmation number shipment is stamped with BTA Refusal stamp and returned to sender if there is a return address If there is no return address, shipment will be destroyed Is shipment contains food covered by the act and nonfood items or items not covered by the act, the shipment will be treated as commingled goods and returned or destroyed

Carnets: 

Carnets PN Requirements/How to Process An international customs document that facilitates temporary imports into foreign countries and is valid up to 1 year Foreign facilities exporting BTA 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

Help Resources: 

Help Resources FDA registration help: U.S. Toll-free: 1-800-216-7331 Outside U.S.: 301-575-0156 Fax: 301-210-0247 Registration tutorial:www.fda.gov/furls Federal Register: www.gpoaccess.gov/fr Legislation: www.thomas.loc.gov CBP web site: www.CBP.gov

Help Resources: 

Help Resources FDA web site: www.FDA.gov FDA regional points of contacts Each CBP field office will have 2 BTA trained experts FDA Publication “What Do I Need To Know About FDA’s New Bioterrorism Rules” will available through trade associations, state agencies,U.S. embassies, and at the FDA website