USDA and FDA PGA requirements

This glossary covers USDA and FDA PGA requirements terms used by importers, customs brokers and trade-compliance teams.

APHIS

USDA Animal and Plant Health Inspection Service: the PGA whose plant, animal-product and Lacey data ride the ACE PGA message set as agency APH; not FSIS, AMS or CBP Agriculture.

PPQ 587

APHIS Plant Protection and Quarantine form: the application for a permit to import plants, plant products, fruits, vegetables and seeds regulated under 7 CFR 319; not a phytosanitary certificate.

PPQ 505

APHIS Plant Protection and Quarantine form: the paper Lacey Act plant and plant product declaration (with PPQ 505B); superseded for new filings by the ACE Lacey message set and LAWGS.

PPQ 585

APHIS Plant Protection and Quarantine application for a permit to import timber and timber products (logs, lumber, unmanufactured wood articles) under 7 CFR 319.40; not the ISPM 15 mark.

PPQ 526

APHIS Plant Protection and Quarantine application for a permit to move or import live plant pests, pathogens and biological control organisms; not the PPQ 525 soil permit or PPQ 587.

Lacey Act Phase VII

The seventh APHIS enforcement phase of the Lacey Act declaration, extending the duty to remaining plant-product HTS codes that are not entirely composite; not a new statute or FWS phase.

APHIS Core

The APHIS Core ACE PGA message set (agency APH; programs APQ, AVS, AAC, ABS) carrying plant, animal-product, biotech and commercial-dog admissibility data and LPCOs; not the separate Lacey (APL) set.

ACIR

APHIS Agricultural Commodity Import Requirements database: the PPQ lookup of admissibility conditions (permit, phytosanitary certificate, treatment, ports) by commodity and origin; a research tool, not an ACE filing or permit.

FAVIR

APHIS Fruits and Vegetables Import Requirements database: the legacy PPQ lookup of admissibility conditions for fruits and vegetables by commodity and origin, superseded by ACIR; not a permit or filing.

phytosanitary certificate

The exporting country's NPPO certificate that a plant or plant-product consignment meets phytosanitary requirements; reported to APHIS as LPCO A01 (paper) or AE1 (ePhyto); not a veterinary or FSIS certificate.

ISPM 15

International Standard for Phytosanitary Measures No. 15: the IPPC rule, in 7 CFR 319.40-3, that wood packaging be treated and bear the IPPC mark; not an ACE element or certificate.

VS 16-3

APHIS Veterinary Services application for a permit to import or transport controlled animal-origin materials, organisms and vectors; the issued permit is VS 16-6A (LPCO A24); not a live-animal permit.

VS 17-129

APHIS Veterinary Services application for an import or in-transit permit for live animals, semen and embryos, birds, poultry and hatching eggs (9 CFR part 93); not the VS 17-29 declaration.

AQ1 flag

ACE PGA flag AQ1, 'APHIS data may be required': the line needs an APHIS Core message set when an LPCO conditions entry, else a disclaimer; not AQ2 (required) or AQX.

AQ2 flag

ACE PGA flag AQ2, 'APHIS data is required': the line must carry an APHIS Core message set even when no LPCO exists; it cannot be disclaimed; not AQ1 or AQX.

AL1 flag

ACE PGA flag AL1, 'Lacey data may be required': the line may need a Lacey declaration or a disclaimer on formal entries; not AL2 (required) or an APHIS Core flag.

AL2 flag

ACE PGA flag AL2 (Lacey data required, program APL): the line must carry a Lacey plant declaration or a valid disclaimer on formal entries; not AL1 (may) or AQ2.

FDA prior notice

FDA advance notice, under FD&C 801(m) and 21 CFR part 1 subpart I, of every human and animal food shipment before it arrives; not the FDA entry data under 801(a).

PNSI

FDA Prior Notice System Interface: the FDA portal for filing prior notice outside ACE (mandatory for international mail; used for in-bond, FTZ, outages or by choice); not ITACS, not FURLS.

prior notice confirmation number

The 12-digit number FDA returns for a facially complete prior notice; proof of filing, reported in PG14 (LPCO type PNC) when PN was previously met; not an FDA release.

FFR

FDA food facility registration (21 CFR part 1 subpart H): the biennially renewed registration of every facility that manufactures, processes, packs or holds food; not FSIS or MoCRA registration.

FSVP

FDA Foreign Supplier Verification Program (21 CFR part 1 subpart L): the US owner or consignee's duty to verify foreign suppliers and be identified by DUNS at entry; not HACCP.

DUNS

Dun and Bradstreet Data Universal Numbering System number: the 9-digit identifier FDA accepts for food facility registration and requires for the FSVP importer at entry; not the CBP importer number.

UNII

FDA Unique Ingredient Identifier: the code from FDA's Global Substance Registration System used in drug and cosmetic listings to name ingredients; not an ACE data element or FDA product code.

FDA product code builder

FDA's online tool for building the 5 to 7 character FDA product code transmitted in PG02 on each FDA-regulated entry line; not the HTS, not the CDRH device classification code.

AofC codes

FDA Affirmations of Compliance: the 3-character PG23 codes by which the filer affirms registrations, listings, approvals, exemptions and certificates for an FDA-regulated line; not APHIS or CBP codes.

PREDICT

FDA's Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting: the screen that scores FDA lines after ACE acceptance, routing them to May Proceed, review or exam; not a CBP system.

DWPE

FDA detention without physical examination: detaining a listed firm's or importer's products on arrival on prior evidence, without sampling, under an Import Alert; not a CBP hold or a refusal.

Import Alert 99-xx

FDA Import Alerts carrying the 99 prefix: detention-without-physical-examination alerts that cut across product types (FSVP importers, canned-food process filings) rather than one commodity or country; not CBP notices.

FDA 766

Form FDA 766: the owner's or consignee's application for FDA authorization to relabel or otherwise recondition a detained or noncompliant article under bond instead of refusal; not a CBP form.

FDA 2877

Form FDA 2877: the importer's declaration for electronic products subject to radiation performance standards, transmitted in ACE as declaration A, B, C or D; not a device listing or 510(k).

FD1 flag

ACE flag FD1, 'FDA data may be required 801(a)': product may or may not be FDA-regulated; if regulated, transmit FDA entry data, if not, disclaim A; not FD3 (prior notice).

FD2 flag

ACE flag FD2, 'FDA data Required 801(a)': the product is FDA-regulated but not food, so FDA entry data (program, product code, intended use, affirmations) must be transmitted; not FD4.

FD3 flag

ACE flag FD3, 'FDA Prior Notice Data may be required 801(m)': article may or may not be food; if food, file prior notice plus FDA data, else disclaim; not FD1.

FD4 flag

ACE flag FD4, 'FDA Prior Notice Data is required 801(m)': the article is food: prior notice and FDA entry data (program FOO) must be transmitted, no disclaimer; not FD2.

FDA may proceed

The FDA line status sent through ACE when FDA takes no further action, clearing the FDA condition for release; not CBP's release, not a bar to later FDA action.

device listing number

The FDA number identifying a device listed in FURLS under a registered establishment (21 CFR 807), transmitted as PG23 affirmation LST; not the 510(k) number, UDI or FDA product code.

510(k)

Premarket notification under FD&C Act section 510(k): FDA clearance that a device is substantially equivalent to a marketed device; its number is the PG23 PM# affirmation; not PMA or listing.

FSIS 9540-1

FSIS Form 9540-1: the import inspection application for meat, poultry, egg products and Siluriformes, filed on paper or electronically (PHIS or ACE FSIS message set); not the foreign inspection certificate.

PHIS

FSIS Public Health Information System: the FSIS system that receives the import inspection application (electronic 9540-1) from the ACE FSIS message set, schedules reinspection and records results; not FDA's PREDICT.

FSIS eligible establishments

The FSIS lists of countries found equivalent and foreign establishments they certify to export meat, poultry, egg products or Siluriformes to the US; a condition of entry, not FDA registration.