Implementation of Prior Notice

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act-BTA) Public Law Customs and Border Protection

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 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 Shipments thus targeted would be held for examination Shipments thus targeted would be held for examination Why Is PN Required on Importation of Food?

BTA Exemptions: Prior Notice Personal use food accompanying a traveler Personal use food accompanying a traveler Food immediately exported (IE) [directly leaving the port of arrival] Food immediately exported (IE) [directly leaving the port of arrival] Meat, poultry, and egg products Meat, poultry, and egg products (Subject to the exclusive jurisdiction of the USDA) (Subject to the exclusive jurisdiction of the USDA) Homemade goods shipped as gifts Homemade goods shipped as gifts What Food Commodities Are Excluded ?

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

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

Prior Notice (PN): Overview The country from which the article originates The country from which the article originates The country from which the article is shipped The country from which the article is shipped Anticipated Customs’ port of arrival Anticipated Customs’ port of arrival Anticipated date and time of arrival Anticipated date and time of arrival Customs ACS entry type and date Customs ACS entry type and date In the event of a hold, the information about where it is being held 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 Submitter, Importer, Owner, Consignee Submitter, Importer, Owner, Consignee Individual (for submitter) Individual (for submitter) –Information for submitter is currently provided by the filer as broker identity Firm name and address Firm name and address address address Telephone and Fax numbers Telephone and Fax numbers Registration number Registration number What Information is Provided in the PN (Data Elements) (continued)

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

Prior Notice (PN): Overview (continued) When is a PN Required? 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) ] 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 requires a separate PN Every entry item that has a separate FDA product code requires a separate PN Every entry item from separate facilities requires a separate PN Every entry item from separate facilities requires a separate PN

Prior Notice (PN): Overview (continued) Failure to Register/Provide PN Failure to Register/Provide PN FDA can bring civil and criminal action against a party that is not registered 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 FDA can bring about debarment (prohibits further trade activity) of any person convicted of a felony violation of the BTA Merchandise can be: Merchandise can be: Held at port Held at port Sent to a secure facility Sent to a secure facility Exported Exported CBP can issue penalties CBP can issue penalties

Prior Notice (PN): Overview (continued) Inadequate PN Inadequate PN “No, Inadequate, or Untimely Notice…” “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 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 be released to or held at the importers, owners, or consignees premises Article can not be released to or held at the importers, owners, or consignees premises

Questions What’s next? What’s next? CBP Process for Submitting Prior Notice (PN) CBP Process for Submitting Prior Notice (PN)

CBP Process for Submitting PNs How Are PNs Submitted? How Are PNs Submitted? Via ABI/ACS Via ABI/ACS Via FDA Prior Notice System Interface (PNSI) Via FDA Prior Notice System Interface (PNSI) Via (when PNSI is unavailable) Via (when PNSI is unavailable) Via fax (when PNSI is unavailable) Via fax (when PNSI is unavailable)

Timeframes for Submitting PNs Land Border2 hours prior to arrival at U.S. port Land Border2 hours prior to arrival at U.S. port Trucks, all vehicles, pedestrians Trucks, all vehicles, pedestrians Rail4 hours prior to arrival at U.S. port Rail4 hours prior to arrival at U.S. port Air4 hours prior to arrival in the U.S. Air4 hours prior to arrival in the U.S. Vessel8 hours prior to arrival at U.S. port Vessel8 hours prior to arrival at U.S. port International MailAt time of mailing International MailAt time of mailing

Submitting PN via ABI / ACS (Entry) How to Submit PN How to Submit PN PN supplied along with ABI entry data PN supplied along with ABI entry data 80% of BTA entries processed via ABI/ACS 80% of BTA entries processed via ABI/ACS FDA provides PN confirmation number electronically to CBP and CBP advises filer 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. PN results matched to the ABI entry and electronically provided to CBP officers.

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

BTA Entries Not Processed Via ABI/ACS that may use “2 Step” FTZ admissions FTZ admissions In-bond In-bond Non-automated and/or paper entries Non-automated and/or paper entries Carnets Carnets

Submitting PN via FDA PNSI How to Submit PN How to Submit PN Any transaction involving a BTA regulated article can be input through FDA PNSI Any transaction involving a BTA regulated article can be input through FDA PNSI Filer submits PN request via the FDA PNSI and receives PN confirmation number which filer then adds to paper entry submissions Filer submits PN request via the FDA PNSI and receives PN confirmation number which filer then adds to paper entry submissions Bar coded PN number will print on FDA PN Form Bar coded PN number will print on FDA PN Form Inspectors may need to query new database file for PN results Inspectors may need to query new database file for PN results A paper copy of the PNSI issued PN’s may be required for release A paper copy of the PNSI issued PN’s may be required for release

Submitting PNs: Alternative Methods How to Submit PN When FDA PNSI Is Unavailable How to Submit PN When FDA PNSI Is Unavailable Use the alternative methods listed below to submit PN: Use the alternative methods listed below to submit PN: address: address: Fax number: TBD (see Fax number: TBD (see Filer can submit paperwork in person to the local FDA office. Filer can submit paperwork in person to the local FDA office.