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

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

2. 2 Presentation Outline Overview Registration Prior Notice (PN) Submitting PN CBP Processing Where Are we now Compliance Policy Guide Resources

3. 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. 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 FDA�s 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. 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. 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. 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 FDA�s behalf to enforce BTA

8. 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. 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 (T&E�s)) Food imported for future export Food admitted into a U.S. Foreign Trade Zone (FTZ)

10. 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. 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 FDA�s seafood HACCP regulations (21 CFR 123.3(k)) Facilities subject to the exclusive jurisdiction of USDA Homemade gifts

12. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 NOTESNOTES

23. 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 NOTESNOTES

24. 24 Submitting Prior Notice ACS/ABI/OASIS Changes PN submission can 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 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 NOTESNOTES

25. 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 NOTES For information changes to the PN after FDA confirmation, the PN must be cancelled and resubmitted. NOTES For information changes to the PN after FDA confirmation, the PN must be cancelled and resubmitted.

26. 26 Submitting PN via ACS (No Entry)Known as WP: Estimated to be roughly 10% of submissions Electronic transmission through ACS�no 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. 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) NOTESNOTES

28. 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) NOTESNOTES

29. 29 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 NOTESNOTES

30. 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 NOTESNOTES

31. 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 NOTESNOTES

32. 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 NOTESNOTES

33. 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 importer�s,owner�s, or consignee�s facility Merchandise may be sent to a suitable facility in another port if no other options exist NOTESNOTES

34. 34 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 NOTESNOTES

35. 35 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) NOTESNOTES

36. 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 NOTESNOTES

37. 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 NOTESNOTES

38. 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 NOTESNOTES

39. 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 NOTESNOTES

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

41. 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 Director�s approval NOTESNOTES

42. 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. 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 (T&E) entry processed. This will allow merchandise to be transshipped through the U.S. In-bond (electronic or paper) includes indicator of PN compliance

44. 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. 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 NOTESNOTES

46. 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 NOTESNOTES

47. 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 NOTESNOTES

48. 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 NOTESNOTES

49. 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 NOTESNOTES

50. 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 NOTESNOTES

51. 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 NOTESNOTES

52. 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. 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. 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. 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. 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. NOTESNOTES

57. 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 tutorial:www.fda.gov/furls Federal Register: www.gpoaccess.gov/fr Legislation: www.thomas.loc.gov CBP web site: www.CBP.gov NOTESNOTES

58. 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 FDA�s New Bioterrorism Rules� will available through trade associations, state agencies,U.S. embassies, and at the FDA website