Logistics Challenges The New Dimensions ITDS Are the

Logistics Challenges The New Dimensions

ITDS: Are the PGA Data Sets bringing Efficiency to the Entry Process? • What additional work is being required from the Trade?

AMS Agricultural Marketing Service – Order Quality Inspection and Imported Egg Inspection APHIS Animal and Plant Health Inspection Service – Core - Lacey ATF Alcohol Tobacco and Firearms DDTC Directorate of Defense Trade Controls Environmental Protection Agency- Vehicles, Engines, Pesticides, TSCA and Ozone Depleting EPA FWS FDA Fish and Wildlife Service Food and Drug - Drugs, Cosmetics, Animal drugs and Devices, Tobacco, Biologics, Radiation Emitting, Medical Devices, Prior Notice NHTSA National Highway Safety Administration - Vehicles, Parts, and Engines NMFS National Marine Fisheries Service TTB Alcohol and Tobacco Tax and Trade Bureau FSIS Food Safety Inspection Service CPSC e-filing Alpha Pilot

Executive Summary …Aphis requires that importers file specific information with DHS… Electronic collections, processing, sharing, and analysis of trade data from many of the supporting documents required during the cargo import process will significantly increase efficiency and reduce costs over the current manual, paperbased processing, while also allowing APHIS to leverage electronic data in risk based analysis directly supporting expedited and/or low risk release programs. CBP and Trade Automated Interface Requirements – APHIS ACE PGA Message Set Adapted Data Element Record Layout – March 1, 2016 V 4. 7 – 386 pages

The following forms have been mapped to date; APHIS 7040 B, APHIS Form 2000, APHIS Form 2006, APHIS Form 7041, APHIS Form 7042, PPQ 203, PPQ 368, PPQ 505 B, PPQ 525, PPQ 526, PPQ 546, PPQ 585, PPQ 586, PPQ 587, PPQ 588, PPQ 621, VS 10 -13, VS 16 -6 A, VS 17 -129, VS 17 -135, VS 17135 A, VS 17 -29, VS 17 -32, VS 17 -8. Page 368

The Bad news There were a total of 133 data elements within the various forms amongst APHIS programs that were not converted as they did not map directly to the data element requirements within the ACE ABI Customs and Trade Automated Interface Requirements (CATAIR) document. Page 370

The Good News – For APHIS There were a total of 1392 data elements within the various forms amongst APHIS programs that were converted as they did map directly to the data element requirements within the ACE ABI Customs and Trade Automated Interface Requirements (CATAIR) document. Page 371

http: //www. cbp. gov/sites/default/files/assets/documents/2016 Mar/PGA%20 Forms%20 Document%20 March%2030%202016. pdf

Caution Form does not translate to data.

Certifying Individual CB Customs Broker - Agent, representative, or a professional Customs clearing agent who deals directly with Customs on behalf of the importer or exporter. A Customs Broker with power of attorney to act on behalf of the importer who is knowledgeable about the importer’s vehicle or equipment item and is willing to personally take responsibility for filing the HS-7 28 declaration certifying to the government the lawful basis for the commodity’s importation may do so.

FDA – DUNS and FEI http: //www. accessdata. fda. gov/scripts/cdrh/cfdocs/cf. RL/rl. cfm https: //fdadunslookup. com

Customs Brokerage | Transportation | Warehousing & Distribution NCBFAA National Conference April 2016 Tucson, AZ Michael Lahar Corporate Compliance Manager A. N. Deringer, Inc. For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 Efficiency is the (often measurable) ability to avoid wasting materials, energy, efforts, money, and time in doing something or in producing a desired result. For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 Who • U. S. Customs & Border Protection • PGA’s • Importers & Exporters • Customs Brokers What Which PGA’s are involved at time of entry? For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 http: //www. cbp. gov/document/guidance/ace-november-1 -pga-forms COMING SOON - SUMMER 2016 AMS ATF APHIS Core CDC CPSC DCMA DDTC OTEXA TTB USTR For internal use only DEA E&C EPA FWS FSIS FAS NMFS NRC OMC www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 Where – Air Vessel Train Truck Pipeline For internal use only When Data Prep by Client/Partner Entry Processing Time of Release/Entry Time of Summary www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 Wins/Losses FSIS – Takes longer to process but shipments given priority over non-ITDS filers. FDA - Takes longer to process but shipments given priority over non-ITDS filers – proper, accurate and complete data filing will expedite release. NHTSA – Substantial new data requirements EPA – Pesticides & TSCA FCC – No data requirement as of July 1 st DDTC – Electronic filing of licenses For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

ITDS: Are the PGA data sets bringing efficiency to the entry process? Heritage of Trust since 1919 How May Efficiencies be Gained – • Working with vendors to understand new systems • Working with internal IT departments to develop new solutions • Development and training of staff • Exchange of information to populate databases • Move towards EDI solutions • Educate clients/partners about expectations and responsibilities For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

Contact Heritage of Trust since 1919 Michael Lahar Corporate Compliance Manager A. N. Deringer, Inc. 173 West Service Rd Champlain, NY 12979 Tel (518) 298 -8281 E-mail mlahar@anderinger. com For internal use only www. anderinger. com © 2012 A. N. Deringer, Inc.

Are the PGA Data sets Bringing Efficiency to the Entry Process Domenic J. Veneziano CAPT U. S. Public Health Service Food and Drug Administration Director, Division of Import Operations

ACE CARGO RELEASE FDA PILOT PARTICIPATION Summary Stats ENTRIES Total processed by ACE as of 3/27/2016: 162, 142 (including disclaims) Disclaimed Entries: 121, 533; Non-disclaimed Entries: 40, 609 Weekly Total since 3/20/2016: 25, 907 LINES Total processed by ACE as of 3/27/2016: 415, 299 (including disclaims) Disclaimed Lines: 291, 627; Non-disclaimed Lines: 123, 672 Weekly Total since 3/20/2016: 67, 985 FILERS Total Participating in ACE as of 3/27/2016: 1067 Weekly Total participating since 3/20/2016: 41 March 27, 2016

ACE CARGO RELEASE FDA PILOT PARTICIPATION

ACE CARGO RELEASE FDA PILOT PARTICIPATION

ACE CARGO RELEASE FDA PILOT PARTICIPATION

*FDA will continue to use ITACS at this time

*CBP sends a 1 USG Release message once all PGAs have may proceeded the articles

Five-Day Window Lockdown • • • CBP will send entries to FDA once an entry is within five (5) days of (prior to) arrival at the port of entry Ø If an entry is transmitted more than five days prior to arrival, CBP will not send the data to FDA until five days prior to arrival and trade is allowed to make corrections or edits to the entry Once CBP sends the entry to FDA, FDA will process in real time and no corrections or edits are allowed to be made, unless FDA rejects the entry If the filers needs to update information, he/she must cancel the entry and re-file with correct information **Same process as in ACS**

Why is ACE/ITDS more efficient? Throughout the cargo lifecycle: Coordinated, consolidated status messaging capability across the Partner Government Agencies (PGAs) ensures a consistent understanding across stakeholders in the trade community.

Why is ACE/ITDS more efficient? Before cargo arrives at the border: • A single, harmonized data set is collected electronically by CBP, on behalf of all PGAs utilizing the single window reduces duplication of efforts for the filer. • Early validation and rejection of entry filings that do not meet the PGA business rules: Ø Allow more time for trade to correct any issues. Ø Result in better data quality and shorter overall initial admissibility decision times for the FDA.

Why is ACE/ITDS more efficient? When cargo arrives at the border: (Future FDA and other PGA Functionality) • The single window will provide for communication and coordination of: Ø Examination/sampling across PGAs. Ø Enforcement actions/final disposition across PGAs.

FDA Operational Changes • Minimal changes to field operations Ø Modifications made to entry review systems ü accommodates changes to the new data elements submitted through ACE; and, ü highlights entries submitted thru ACE Ø Elimination of FD 0 Ø Prioritization of ACE entries during the decommissioning of ACS

Elimination of FD 0 • CBP and FDA agreed to eliminate the FD 0 construct in ACE. ØFD 0 previously indicated that FDA has determined the article, even though subject to FDA's laws and regulations, is acceptable for CBP release without further presentation of prior notice or other entry information to FDA. ØElimination of FD 0 does not affect products that can be disclaimed, because they are not FDA regulated.

Facilitation of ACE Entries in Support of ACS Decommissioning Starting in late February, FDA has been actively increasing the facilitation of ACE commerce as FDA and PGAs move away from ACS. Ø Focus more resources on ACE projects and ACErelated commerce. Ø ACE entries are generally reviewed before entries transmitted through ACS.

Resources • • • FDA Supplemental Guide: http: //www. cbp. gov/document/guidance/fdasupplemental-guide-release-16 DUNS Portal: www. fdadunslookup. com FDA Commodity-specific Webinars for Trade: http: //www. cbp. gov/tradecommunity/border-interagency-executivecouncil-biec/biec-webinars

References • For inquiries, including questions on requirements, filing in ACE cargo release, or ACE-related technical assistance (internal or external), email: ACE_Support@fda. hhs. gov • For operational concerns, email: orahqoeioace@fda. hhs. gov

Questions?