PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)

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1 PGA Update: Reporting Process in ACE (FDA, CPSC, etc.) Russell K. Statman, Esq. Executive Director, Registrar Corp Tom Kuerbs, LCB Descartes Systems Group Craig Seelig, Product Manager Customs & Government Compliance, Americas WiseTech Global

2 FDA Foreign Supplier Verification Program ( FSVP ) Russell K. Statman, Esq. Executive Director, Registrar Corp 144 Research Drive Hampton, Virginia USA

Foreign Supplier Verification Program (FSVP) Importers must provide adequate assurances that: Foreign suppliers produce food using processes and procedures

3 Foreign Supplier Verification Program (FSVP) Importers must provide adequate assurances that: Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions -and- Food is not adulterated or misbranded as to allergen labeling

4 FDA Food Safety Modernization Act (FSMA) Hazard Analysis and Risk based Preventive Controls ( HARPC )

5 FDA Food Safety Modernization Act (FSMA) THE LAW REQUIRED FDA TO ISSUE SEVEN MAJOR SETS OF RULES Preventive Controls for Human Food Preventive Controls for Animal Food Produce Safety Foreign Supplier Verification Program Third Party Auditor Sanitary Transport Intentional Adulteration

Foreign Supplier Verification Program (FSVP) FDA will inspect FSVP importers Importer is defined as US owner or consignee of food at the time of entry. U.S. owner or consignee means the person in the United States who, at the time of U.

6 Foreign Supplier Verification Program (FSVP) FDA will inspect FSVP importers Importer is defined as US owner or consignee of food at the time of entry. U.S. owner or consignee means the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food. If there is no US owner or consignee, the Importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent.

7 Foreign Supplier Verification Program (FSVP) Importer identification at entry FSV, FSX, RNE DUNS

FOOD SAFETY MODERNIZATION ACT FOREIGN SUPPLIER VERIFICATION PROGRAM General Requirements of the FSVP A Qualified Person Must Perform the Following: Hazard Analysis Approval and compliance

8 FOOD SAFETY MODERNIZATION ACT FOREIGN SUPPLIER VERIFICATION PROGRAM General Requirements of the FSVP A Qualified Person Must Perform the Following: Hazard Analysis Approval and compliance status review of suppliers) Supplier Verification Activities, including audit if necessary Corrective Actions Periodic Reassessment of FSVP Importer Identification at Entry Record-keeping

Approval and Compliance Monitoring of Suppliers To approve suppliers, Importers must consider: Risk posed by the food (hazard analysis) Entities

9 Approval and Compliance Monitoring of Suppliers To approve suppliers, Importers must consider: Risk posed by the food (hazard analysis) Entities controlling hazards or verifying control Supplier characteristics (procedures and practices; FDA compliance history, Warning Letters, Import Alerts)

Foreign Supplier Verification Program (FSVP) Countries With

Foreign supplier is under oversight of comparable or

Food is within scope of official recognition or

10 Foreign Supplier Verification Program (FSVP) Countries With Equivalent Food Safety Systems Importer must document that: Foreign supplier is under oversight of comparable or equivalent food safety system. Food is within scope of official recognition or determination. Supplier is in good compliance standing with comparable or equivalent food safety authority.

11 Impact on the Chain of Commerce

12 Foreign Supplier Verification Program (FSVP) FSVP EXEMPTIONS Firms subject to juice or seafood HACCP regulations Food for research or evaluation Food for personal consumption Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage) Food transshipped through U.S. Food imported for processing and export U.S. food returned Meat, poultry, and egg products subject to USDA regulation at time of importation

Foreign Supplier Verification Program (FSVP) Small Businesses Very small importer (VSI) Less than $1 million/yr. in human food in sales plus imports Less than $2.5 million/yr.

13 Foreign Supplier Verification Program (FSVP) Small Businesses Very small importer (VSI) Less than $1 million/yr. in human food in sales plus imports Less than $2.5 million/yr. in animal food in sales plus imports Food from certain small suppliers Qualified facility (same $ as VSI) Produce from certain small suppliers that are not covered farms Shell egg producers with < 3,000 laying hens

14 Foreign Supplier Verification Program (FSVP) Small Businesses Annually document eligibility Verification: Written assurances from suppliers Additional requirements for food from small suppliers: Evaluate supplier compliance history Approve suppliers Ensure food is from approved suppliers Attestation

15 FSVP: When Must I Comply? Compliance is the latest of: May 30th, 2017 (18 months after publication of final rule) OR If supplier is subject to the preventive controls or produce safety regulations, 6 months after the foreign supplier of the food is required to comply with the relevant regulations

16 Final Advice

17 ATF U.S. Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives.

18 Why do I have to report ATF PGA data? The ATF will use this information to determine if a particular importation of a Firearm, Ammunition, Implement of War, or any combination thereof requires either a Federal Firearms License, Federal Explosives License, AECA Registration, and/or Permit (ATF Form 6/6A) at the point the Entry record is submitted and at the point the cargo is released.

19 For Imports the PGA message set has been required to be filed in ACE since February 3 rd, Use information supplied on ATF forms 6 and 6A to complete PGA filing data in ACE As an alternative original paper ATF Forms 6 and 6A may also be submitted to the ports of entry, but could result in delays in release of cargo. ATF no longer support DIS documents At this time, the ATF does not Flag any HTS codes. The importer/filer is responsible for knowing what to file, regardless of whether a tariff code has been flagged. When the PGA message set is filed correctly, the filer will receive an automatic May Proceed from ATF, and if there are no further issues, the shipment will be released. Any ATF import related questions and/or comments regarding the requirements to: Imports-Helpdesk@atf.gov

20 Different weapon types require different types of LCPOs (Licenses Certificates, Permits & Other) or exemption codes Possible LCPOs for ATF are AT2 ATF Federal Firearms License Number - FFL AT3 Federal Explosive License Number - FEL AT4 ATF Import Permit Number AT5 ATF Importer s Registration Number AECA (Arms Control Export Act) Requirements for the LCPO s by weapon type are available in the ATF PGA guide beginning on page 26: Sep/ATF_Supplemental_Guidance_for_ACE_v1_15.pdf

21 Most Common ATF Errors/Rejections [PDY] INVALID CATEGORY CODE FOR PERMIT PER PGA The Category submitted does not match what is on the ATF Permit [PDP, PDQ, PDN, PDO] MISSING <PG14 / LPCO> PER PGA A required LCPO is not being submitted in the ATF PGA data [PDZ, PEA, PEB] <PG14 / LPCO> MUST MATCH IMP PRMT PER PGA After a AECA was renewed, use the original AECA from the ATF permit [PDR, PDT, PDW, PEC] INVALID <PG14 / LPCO> NUMBER PER PGA Incorrectly entered LCPO (FFL, FEL, Permit or AECA) number, or The License/Permit is new and has not been uploaded by ATF to ACE yet.

22 AHPIS Animal and Plant Health Inspection Service AHPIS Lacey APHIS - Core

23 Why do I have to report APHIS PGA data? Previously, much of the information needed to correctly regulate and safeguard agriculture products and related products are provided via paper Licenses, Permits, Certificates and other documents (LPCO s). Utilizing the PGA Message Set to automate the filing of much of the data found on paper LPCO s will allow both CBP and APHIS to process cargo release more expeditiously and to identify unsafe, dangerous, or prohibited shipments. Paper filing of documents is still available, but could delay release of cargo.

24 Was the first PGA message set HTS numbers are flagged as: APHIS Lacey AL1 (Lacey Act specific data may be required) AL2 (Lacey Act specific data is required) Lacey can be filed via ACE PGA message set, Paper or APHIS s Lacey Act Web Governance System Lacey Disclaims are: A - Product not regulated by this agency (AL1 only) B - data is not required per agency guidance (AL1 only) C - data filed through other agency means (if Lacey is filed thru LAWGS) D - data filed through paper (if the physical PPQ 505 is mailed to APHIS) USDA APHIS Lacey Act contact address: ace.itds@aphis.usda.gov

25 APHIS Core APHIS and CBP Agriculture will also utilize a Document Imaging System (DIS) to supplement the data submitted via the PGA Message Set Additionally certain documents may still require physical documentation. Most commonly these are documents issued by foreign governments.

26 APHIS Core One of the most complex PGAs message sets APHIS has four Core program codes: Veterinary Services (AVS), Animal Care (ACC), ABS (Biotech Regulatory Services) and Plant Protection and Quarantine (APQ) APHIS Core optional to participate (you can still do paper), but is open to all filers. APHIS intends to utilize the PGA Message set to receive electronic data found on many of the paper import documents required to accompany agriculture shipments. LPCOs are currently utilized to further identify commodities, certifying their health, provide import conditions, and instructions for proper inspection. It is expected that this conversion will eventually eliminate much of the need for paper documents in hopes of increasing the speed of clearance.

27 APHIS Core Document/Form Description Form # PGA DIS Paper Animal Care - Health Certificate 7041 PGA Continuation Sheet for Application for Import Permit for Dogs 7040A PGA Continuation Sheet for Veterinary Treatment Agreement 7043A PGA Animal Care - Veterinary Treatment Agreement 7043 PGA Application for Import Permit for Dogs 7040 PGA Import Permit for Dogs 7040B PGA Rabies Vaccination Certificate 7042 PGA Interstate Movement, Importation or Courtesy Permit 2000 PGA Foreign Site Certificate of Inspection and/or Treatment PPQ-203 PGA Notice of Arrival PPQ-368 PGA Permit to Import Soil PPQ-525B PGA Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber Products (SDS) PPQ-585 PGA Permit to Transit Plants and/or Plant Products, Plant Pests, and/or Associated Soil through the United States PPQ-586 PGA Permit to Import Plant or Plant Products PPQ-587 PGA

28 APHIS Core Document/Form Description Form # PGA DIS Paper Controlled Import Permit PPQ-588 PGA General Permit to Engage in the Business of Import, Export, or Re-Exporting Terrestrial Plants PPQ-622 PGA Foreign Government Sanitary Certificate (Veterinary Health Certificates) N/A PAPER U. S. Veterinary Biological Product Permit 2006 DIS U. S. Veterinary Permit for Importation & Transportation of Controlled Materials and Organisms and Vectors VS16-6A PGA U.S. Permit to Import (Includes Transit) VS PAPER Declaration of Importation (Required to Accompany Animal) VS17-29 PGA DIS Application for Inspection and Dipping VS17-32 PGA DIS Agreement of Pet Bird Owner (U.S. Origin Returning) VS17-8 PAPER Foreign Meat Certificate N/A PAPER STAT Supporting Statement N/A DIS Phytosanitary Certificate (Issued by Country of Origin) N/A PAPER Foreign Government Health Certificates (including dip certificates, spay certificates, test charts, etc.) N/A PAPER Various import documents (invoices, packing list, etc.) N/A DIS

29 PGA Update: Reporting Process in ACE EPA NMFS AMS

30 Disclaims EPA All tariffs now have the May be required EPA flag. EP1 (ODS) EP3 (VNE) EP5 (PST) EP7 (TSCA) The importer is responsible to file EPA when needed regardless of the flag or lack thereof.

31 EPA Disclaim Reason Codes A product not regulated by agency B data not required per agency guidance Example: Original Equipment Manufacturers (OEMs) who are importing on-road and/or non-road vehicles and engines with certificates of conformity, are not required to file V&E Declarations but must disclaim with B

32 EPA Disclaim Reason Codes C data filed through other agency means (DIS) Use the Correct EPA Codes for documents D - data filed through paper

33 EPA Understanding the Status TSCA Successful filing: entry accepted and May Proceed Unsuccessful filing: entry rejected (bucket 1 reject)

34 EPA Understanding the Status Pesticides Successful filing: entry accepted and May Proceed Unsuccessful filing: entry rejected (bucket 1 reject) Unsuccessful filing: entry accepted and Hold Intact (bucket 2 failure)

35 EPA Understanding the Status VNE Successful filing: entry accepted and May Proceed Unsuccessful filing: entry rejected (bucket 1 reject) Unsuccessful filing: entry accepted and Data under PGA Review It s not really under review! Bucket 2 failure

36 NMFS / SIMP Seafood Import Monitoring Program Affected Priority Seafood Species *Abalone, Atlantic Cod, Blue Crab (Atlantic), Dolphinfish (Mahi Mahi), Grouper, King Crab (red), Pacific Cod, Red Snapper, Sea Cucumber, Sharks, *Shrimp, Swordfish and Tunas (Albacore, Bigeye, Skipjack, Yellowfin, and Bluefin).

37 NMFS / SIMP Data fields 3 character Species Code Subset of codes

38 Data fields NMFS / SIMP NMFS IFTP Permit number or Other authorization to Fish Harvest Description Code HCF = Harvest Capture Fisheries / Wild Caught HBA = Hatchery based aquaculture Country Location Parties and Vessel Info

39 NMFS / SIMP Seafood Import Monitoring Program More info: andactions/recommendation1415/finalrulet raceability.aspx

40 AMS (USDA) Marketing Order Quality Inspection Requests for Inspections, Exemptions, Testing etc Import Egg Inspection Import Peanut Inspection

41 AMS (USDA) Marketing Order Quality Inspection UNSPSC codes - The United Nations Standard Products and Services Codes

Thank You! Questions? Russell Statman, Esq. Executive Director Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: info@registrarcorp.

42 Thank You! Questions? Russell Statman, Esq. Executive Director Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA P: F: E: Tom Kuerbs, LCHB Descartes Systems Group Telephone: (800) x Craig Seelig Product Manager Customs and Compliance WiseTech Global Inc. Moderated by: Mark Hirzel, Past President - Los Angeles Customs Brokers and Freight Forwarders, Inc.

Food Safety Modernization Act (FSMA) & Imports of Food Products. August 9 th, 2016 Russell Statman, Registrar Corp

Food Safety Modernization Act (FSMA) & Imports of Food Products August 9 th, 2016 Russell Statman, Registrar Corp Background TIMELINE OF U.S. FOOD REGULATION Until 1906 The Jungle Background TIMELINE OF