PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant...

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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

Transcript of PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant...

Page 1: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 2: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

FDA Foreign

Supplier Verification

Program (“FSVP”)

Russell K. Statman, Esq.

Executive Director, Registrar Corp

144 Research Drive

Hampton, Virginia USA 23666

+1-757-224-0177

Page 3: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 4: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

FDA Food Safety Modernization Act (FSMA)

Hazard Analysis and Risk–based Preventive Controls

(“HARPC”)

Page 5: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 6: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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.

Page 7: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

Foreign Supplier Verification Program (FSVP)

Importer identification at entry

FSV, FSX, RNE

DUNS

Page 8: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 9: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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)

Page 10: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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.

Page 11: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

Impact on the Chain of Commerce

Page 12: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 13: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 14: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 15: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 16: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

Final Advice

Page 17: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

ATF

U.S. Department of Justice, Bureau of

Alcohol, Tobacco, Firearms and Explosives.

Page 18: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

• 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.

Page 19: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

• For Imports the PGA message set has been required to be filed in

ACE since February 3rd, 2017. 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: [email protected]

Page 20: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

• 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:

https://www.cbp.gov/sites/default/files/assets/documents/2016-

Sep/ATF_Supplemental_Guidance_for_ACE_v1_15.pdf

Page 21: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

• 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.

Page 22: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

AHPIS

Animal and Plant Health Inspection Service

• AHPIS – Lacey

• APHIS - Core

Page 23: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

• 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.

Page 24: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

APHIS – Lacey

• Was the first PGA message set

• HTS numbers are flagged as:

– 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 email address:

[email protected]

Page 25: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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.

Page 26: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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.

Page 27: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 28: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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) VS17-135 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

Page 29: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

PGA Update:

Reporting

Process in ACE

EPA

NMFS

AMS

Page 30: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

EPA

• Disclaims

– 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.

Page 31: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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”

Page 32: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

EPA

• Disclaim Reason Codes

– C – data filed through other agency means

(DIS)

• Use the Correct EPA Codes for documents

– D - data filed through paper

Page 33: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

EPA • Understanding the Status

– TSCA

• Successful filing: entry accepted and May

Proceed

• Unsuccessful filing: entry rejected (bucket 1 reject)

Page 34: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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)

Page 35: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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

Page 36: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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).

Page 37: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

NMFS / SIMP • Data fields

– 3 character Species Code • http://www.fao.org/fishery/collection/asfis/en

• Subset of codes

Page 38: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

NMFS / SIMP • Data fields

– 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

Page 39: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

NMFS / SIMP • Seafood Import Monitoring Program

• More info:

• http://www.iuufishing.noaa.gov/Recommendations

andActions/RECOMMENDATION1415/FinalRuleT

raceability.aspx

Page 40: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

AMS (USDA) • Marketing Order Quality Inspection

– Requests for Inspections, Exemptions,

Testing etc…

• Import Egg Inspection

• Import Peanut Inspection

Page 41: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

AMS (USDA) • Marketing Order Quality Inspection

• UNSPSC codes - The United Nations Standard

Products and Services Codes

Page 42: PGA Update: Reporting Process in ACE (FDA, CPSC, etc.)...Application for Permit to Move Live Plant Pests or Noxious Weeds PPQ-526 PGA Application for Permit to Import Timber or Timber

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: [email protected]

www.registrarcorp.com

Tom Kuerbs, LCHB

Descartes Systems Group

Telephone: (800)419-8495

x458214

Email:

[email protected]

Twitter: @CBPWarrior

www.descartes.com

Craig Seelig

Product Manager –

Customs and Compliance

WiseTech Global Inc.

[email protected]

www.wisetechglobal.com

Moderated by: Mark Hirzel, Past President - Los Angeles Customs Brokers and Freight

Forwarders, Inc.