
Importing frozen fish into the United States means satisfying four federal agencies before a single pound clears the dock. FDA controls food safety through facility registration, HACCP verification, and the Foreign Supplier Verification Program. NOAA Fisheries enforces harvest legality via the Seafood Import Monitoring Program for 13 high-risk species groups. The Fish and Wildlife Service gates protected species under CITES and the Lacey Act. Customs and Border Protection runs the single window where every permit, bond, and data element converges.
This guide walks through the complete workflow from facility registration to cargo release. You will learn the exact sequence of registrations, the distinct roles of the FSVP importer, FDA U.S. agent, and customs broker, and how to classify your product under the correct HTS code to trigger or avoid SIMP reporting. It covers the key data elements required for NOAA Form 370, the documentation FDA expects during an FSVP inspection, and the timeline buffers that prevent demurrage on ocean and air shipments.
The import process begins with FDA facility registration for both the foreign processor and the US importer before any shipment is booked. Next the importer must designate a US-based FSVP agent who develops the Foreign Supplier Verification Program and confirms the supplier appears on FDA's seafood HACCP compliance list. NOAA requires the importer to obtain an International Fisheries Trade Permit and register for the SIMP electronic filing system if the species falls under the program. Prior Notice must be submitted to FDA within the mode-specific window before arrival. At the port CBP accepts the entry summary with the SIMP Certification of Admissibility on NOAA Form 370 and the USFWS Declaration for Importation or Exportation of Fish or Wildlife on Form 3-177. FDA may issue a detention notice if HACCP records or labeling are noncompliant. Release occurs only after all agency holds are cleared and the cargo passes any physical examination.
The FSVP agent must be identified and the verification program active before Prior Notice is filed because FDA will reject the notice if the importer of record lacks a compliant FSVP on file. The agent reviews the foreign supplier's HACCP plan monitoring records and corrective actions and confirms the facility is not on Import Alert 16-124 for seafood HACCP violations. Without this verification the Prior Notice confirmation number will not generate and the shipment cannot be legally entered. Importers often delay this step by assuming the foreign supplier's certifications are sufficient but FDA holds the US importer responsible for independent verification. A written FSVP agreement and documented hazard analysis must exist before the first shipment sails.
Air freight from Asia to Los Angeles typically moves door-to-door in 5 to 7 days including customs clearance while ocean freight from the same origin to Los Angeles requires 21 to 28 days. East Coast ports such as Newark add 7 to 10 days for ocean transit through the Panama Canal or Suez routing. Prior Notice for air shipments must be filed at least 2 hours before arrival while ocean shipments require filing at least 4 hours before arrival. FSVP verification and SIMP registration should be completed at least 30 days before the first shipment to avoid demurrage charges. Cold chain breaks during transload at intermediate hubs add 24 to 48 hours of risk that must be built into the logistics plan.
| Step | Responsible Party | Key Document | Typical Lead Time |
|---|---|---|---|
| FDA Facility Registration | Foreign Processor & US Importer | Form FDA 3537 | Immediate online |
| FSVP Agent Designation | US Importer | Written FSVP Agreement | 15-30 days |
| NOAA IFTP & SIMP Registration | US Importer | NOAA Form 370 Account | 10-15 days |
| Prior Notice Submission | US Importer or Broker | FDA Prior Notice Confirmation | 2 hrs (air) / 4 hrs (ocean) pre-arrival |
| CBP Entry & Agency Review | Customs Broker | CBP Form 7501 SIMP 370 USFWS 3-177 | 1-5 business days |
| Cargo Release | CBP | Release Notification | Same day if no exam |
The table above sequences each mandatory action with its owner document and typical lead time so a first-time importer can build a realistic project plan. Note that FSVP agent designation and NOAA registration are parallel paths that must both finish before Prior Notice filing. Ocean shipments allow more buffer for document preparation but incur higher demurrage risk if agency holds occur. Air shipments compress the timeline requiring all registrations to be complete before the cargo departs the foreign port.
FDA governs food safety under the Federal Food Drug and Cosmetic Act and the Seafood HACCP regulation requiring hazard analysis critical control point plans for every processor. NOAA NMFS administers the Seafood Import Monitoring Program under the Magnuson-Stevens Act to prevent illegal unreported and unregulated fish from entering US commerce. USFWS enforces the Endangered Species Act CITES and the Lacey Act through the Declaration for Importation or Exportation of Fish or Wildlife. CBP executes the entry process collects duties and coordinates agency holds. The United States imported 6.4 billion pounds of edible seafood products in 2024 according to NOAA Fisheries (Fisheries of the United States). The total value of U.S. imported seafood in 2023 was $25.5 billion according to USDA Economic Research Service underscoring the scale of regulatory oversight across these four agencies.
| Agency | Statutory Authority | Key Program | Primary Forms | Focus Area |
|---|---|---|---|---|
| FDA | FD&C Act Seafood HACCP Reg (21 CFR 123) | Seafood HACCP FSVP Prior Notice | Form 3537 Prior Notice Confirmation FSVP Records | Food safety sanitation labeling |
| NOAA NMFS | Magnuson-Stevens Act | Seafood Import Monitoring Program (SIMP) | NOAA Form 370 International Fisheries Trade Permit | Traceability IUU prevention species verification |
| USFWS | ESA CITES Lacey Act | Wildlife Inspection Program | Form 3-177 CITES Permits | Protected species trade compliance |
| CBP | Tariff Act of 1930 | Automated Commercial Environment (ACE) | CBP Form 7501 Entry Summary | Duty collection admissibility coordination |
The table maps each agency to its legal mandate program focus and the forms an importer will encounter. FDA and NOAA requirements overlap on traceability but FDA centers on sanitation while NOAA centers on harvest legality. USFWS adds a layer for any species listed under CITES appendices. CBP is the single window where all agency data converges through ACE. An importer must satisfy every column before cargo is released.
FDA authority derives from the Federal Food Drug and Cosmetic Act which prohibits the introduction of adulterated or misbranded food into interstate commerce. The Seafood HACCP regulation at 21 CFR 123 requires every processor domestic or foreign to conduct a hazard analysis identify critical control points establish monitoring procedures corrective actions verification steps and recordkeeping. Importers must verify through FSVP that the foreign supplier's HACCP plan addresses species-specific hazards such as histamine in tuna or paralytic shellfish toxin in mollusks. FDA maintains Import Alert 16-124 for firms without an approved HACCP plan and Import Alert 16-81 for histamine violations. A facility on either alert faces detention without physical examination for every shipment.
NOAA NMFS implements the Seafood Import Monitoring Program under the Magnuson-Stevens Fishery Conservation and Management Act which authorizes the Secretary of Commerce to regulate imports to combat illegal unreported and unregulated fishing. SIMP requires the importer of record to report key data elements from the point of harvest through landing processing and export for each shipment of covered species. The data chain includes the vessel name flag state catch area gear type landing date and processor identification. NOAA Form 370 Certification of Admissibility attests that the reported data is accurate and the product was legally harvested. Failure to file complete SIMP data results in denial of entry and the shipment may be exported or destroyed at the importer's expense.
Before any frozen fish shipment departs for the United States, the importer of record must complete four mandatory registrations and secure a customs bond to avoid detention at the port of entry.
FDA Food Facility Registration is required for every foreign facility that manufactures, processes, packs, or holds frozen fish for U.S. consumption. The registration must be renewed between October 1 and December 31 of each even-numbered year. Failure to renew by the December 31 deadline results in cancellation of the registration, making it illegal to import from that facility until re-registration is complete. The facility must also designate a U.S. Agent who resides in the United States and is available to receive FDA communications at all times. This agent does not need to be a customs broker or FSVP importer but must have a physical U.S. address.
The FSVP Importer is the U.S. owner or consignee at the time of entry and bears legal responsibility for verifying that the foreign supplier produces food meeting U.S. safety standards. This role cannot be delegated to a customs broker or the FDA U.S. Agent. The FDA U.S. Agent serves only as a communication link for the foreign facility and has no FSVP verification obligations. The Customs Broker facilitates CBP entry filing and duty payment but does not assume FSVP liability. Importers must ensure the FSVP Importer named on the entry matches the entity performing supplier verification activities to avoid FDA refusal.
A Continuous Customs Bond covers all entries for a 12-month period and is required for importers filing more than a few shipments annually or participating in programs like ISA. The bond amount is typically 10 percent of duties, taxes, and fees paid in the prior year with a $50,000 minimum. A Single Entry Bond covers one shipment only and equals the total entered value plus duties, taxes, and fees. For frozen fish importers with regular volume, a Continuous Bond reduces per-shipment costs and streamlines the entry process. The bond must be on file with CBP before the entry summary is filed.
Importers of SIMP-covered species must create a NOAA SIMP Importer Account within the Automated Commercial Environment (ACE) portal before filing the first SIMP entry. The account links the importer's CBP bond and IRS number to the NOAA Form 370 Certification of Admissibility. Registration requires the importer of record's legal name, address, CBP-assigned importer number, and a designated account administrator. Once approved, the account allows electronic submission of key data elements for each shipment. Without an active SIMP account, ACE will reject the entry filing for covered species.
Accurate species identification and tariff classification determine whether SIMP reporting applies and what duty rate the shipment incurs. More than 1,100 unique species, grouped into 13 species groups, are covered by the Seafood Import Monitoring Program (SIMP) according to NOAA Fisheries.
Start by identifying the scientific and common market name of the frozen fish. Check if the species falls within the 13 SIMP groups: Abalone, Atlantic Cod, Blue Crab, Dolphinfish (Mahi Mahi), Grouper, King Crab, Pacific Cod, Red Snapper, Sea Cucumber, Sharks, Shrimp, Swordfish, and Tunas (Albacore, Bigeye, Skipjack, Yellowfin, Bluefin). If the species is listed, SIMP reporting is mandatory for every shipment regardless of volume or origin. If the species is not listed, SIMP does not apply, but standard FDA HACCP and FSVP requirements remain. Use the NOAA SIMP Commodity Lookup tool in ACE to confirm the current list before each shipment as NOAA updates the groups periodically.
Classify frozen fish under Chapter 03 of the Harmonized Tariff Schedule using a three-step hierarchy. First, identify the species at the 6-digit international level (e.g., 0303.11 for frozen sockeye salmon). Second, determine the physical form: whole (heading 0303), fillets (heading 0304), or other meat (heading 0304). Third, confirm the processing state: frozen (0303 or 0304), fresh or chilled (0302 or 0304), or prepared/preserved (Chapter 16). Fillets are further split by skin-on or skin-off and whether they are blocks or individual portions. Misclassification between whole and fillet codes is the most common error and triggers CBP Form 28 requests.
| HTS Code | Description | General Duty Rate | SIMP Coverage |
|---|---|---|---|
| 0303.11.00 | Frozen sockeye salmon (red salmon) | Free | No |
| 0303.12.00 | Frozen Pacific salmon (excl. sockeye) | Free | No |
| 0303.19.01 | Frozen salmonidae nesoi | Free | No |
| 0303.23.00 | Frozen tilapia | Free | No |
| 0303.24.00 | Frozen catfish | Free | No |
| 0303.25.01 | Frozen carp | Free | No |
| 0303.26.00 | Frozen eels | Free | No |
| 0303.31.00 | Frozen albacore or longfinned tunas | Free | Yes |
| 0303.32.00 | Frozen yellowfin tunas | Free | Yes |
| 0303.33.00 | Frozen skipjack or stripe-bellied bonito | Free | Yes |
The table shows the ten most frequently used HTS codes for frozen fish imports. All listed codes currently carry a Free general duty rate under Column 1. However, the three tuna codes (0303.31, 0303.32, 0303.33) require SIMP reporting while the salmon, tilapia, catfish, carp, and eel codes do not. Importers must verify the SIMP flag for each code at the 10-digit level because some species within the same 6-digit heading may be split between SIMP and non-SIMP categories. Accurate classification avoids misdeclared entry penalties and ensures the correct NOAA Form 370 data set is filed.
An FSVP for frozen fish must identify and evaluate known or reasonably foreseeable hazards for each species and product form. Histamine formation in scombroid species such as tuna and mahi mahi requires time and temperature controls from harvest through freezing. Salmonella is a hazard in ready to eat products or those handled post freezing without a kill step. Drug residues including antibiotics and antiparasitics are a primary concern for aquaculture species such as tilapia catfish and shrimp where unapproved drugs may be used. Parasites such as Anisakis in wild caught salmon and cod require freezing to specific temperatures and durations under FDA guidance. Decomposition indicated by sensory or chemical markers must be controlled through cold chain management. The hazard analysis must be written and updated when new information emerges.
FSVP requires the importer to verify that the foreign supplier produces food in compliance with applicable FDA requirements. Onsite audits are the most robust option and are appropriate when the hazard analysis identifies significant hazards controlled by the supplier such as histamine or drug residues. Audits must be conducted by a qualified individual and cover HACCP plan implementation GMP compliance and sanitation. Sampling and testing of incoming lots for histamine drug residues or microbiological indicators provides verification when audit frequency is limited. Record review of the supplier HACCP records monitoring records and corrective actions can supplement audits or testing. The verification method and frequency must be documented and justified based on risk.
FSVP records must be kept for two years and made available to FDA within 24 hours of request. Required records include the written hazard analysis the list of approved suppliers the verification activities performed and their results and any corrective actions taken. Records must be legible and stored in English or be translatable upon request. Electronic records are acceptable if they meet FDA requirements for authenticity and accessibility. During an FDA inspection the agency will review the FSVP for each product and supplier combination. Common findings include missing hazard analyses for specific species inadequate verification frequency for high risk suppliers and failure to reassess the FSVP when supplier performance changes. Importers should conduct internal mock inspections quarterly.
| KDE Category | Data Element | Source | Format Notes |
|---|---|---|---|
| Harvest | Vessel name flag state and registration number | Harvesting vessel logbook or flag state registry | Must match RFMO records if applicable |
| Harvest | Catch area FAO major fishing area code | Vessel logbook or catch certificate | Required for all SIMP species |
| Harvest | Date or date range of harvest | Vessel logbook or landing declaration | Range allowed for multi day trips |
| Harvest | Gear type FAO gear code | Vessel logbook or license | Must be specific not generic |
| Landing | Port of landing and date | Port state landing declaration | First point of landing only |
| Processing | Processor name address and establishment number | Processing plant records | Must be approved for US export |
| Processing | Product form species scientific name and weight | Processing plant production records | Matches commercial invoice |
| Chain of Custody | Importer of record name and address | Entry documentation | Must match CBP entry |
| Chain of Custody | Container number and seal number | Bill of lading | Required for containerized shipments |
| Chain of Custody | Bill of lading number | Carrier documentation | Master or house bill acceptable |
The table lists the Key Data Elements required to complete the NOAA Form 370 Certification of Admissibility for SIMP covered species. Each element must be traceable to a verifiable record from the point of harvest through entry. Harvest data including vessel identity catch area dates and gear type are typically captured in vessel logbooks and flag state registries. Landing data comes from port state declarations. Processing data requires the establishment number of the facility approved for US export. Chain of custody data links the shipment to the CBP entry. Missing or mismatched KDEs are the leading cause of SIMP entry holds. Importers should collect these elements from the foreign supplier before the shipment departs.
Filing the Certification of Admissibility occurs through the Automated Commercial Environment using the International Trade Data System. First the importer or customs broker creates an entry in ACE and selects the SIMP program code. Next the filer enters the NOAA Form 370 data set which maps to the KDEs in the previous table. The system validates mandatory fields and checks for format compliance. After submission ACE generates a certification number. NOAA reviews the data and may issue a message requesting clarification or additional documentation. The entry cannot be released until NOAA returns an admissible status. Filers should submit the certification at least 24 hours before vessel arrival to allow time for NOAA review. Errors in vessel identification or catch area codes are the most common rejection reasons.
Collecting accurate harvesting entity data from foreign suppliers is often the most difficult part of SIMP compliance. Small scale or artisanal fisheries may lack formal vessel registration numbers or electronic logbooks. Some flag states do not publish vessel registries accessible to importers. Language barriers and inconsistent record keeping at the landing site can result in missing catch area codes or gear type codes. Importers should require suppliers to provide a harvest declaration template aligned with the KDE table before the first shipment. For high volume suppliers a traceability audit of the supply chain from vessel to processor can identify gaps early. When primary harvest data is unavailable NOAA may accept alternative documentation but this requires a pre entry consultation and is not guaranteed.
The USFWS Form 3-177 Declaration for Importation or Exportation of Fish or Wildlife must be filed electronically through the eDecs system before the shipment arrives at a US port. The declaration requires the scientific name, common name, quantity, weight, country of origin, and the port of entry for every species in the shipment. Importers must also provide the HTS code, container numbers, and the bill of lading or air waybill number. Filing typically occurs 24 to 48 hours prior to arrival to allow USFWS inspectors to schedule examinations. A confirmation number generated by eDecs must be referenced on the CBP entry filing in ACE. Incomplete declarations trigger holds that can delay cold chain cargo for days.
CITES permits are required for any frozen fish species listed in Appendix I, II, or III of the Convention. Common frozen seafood items triggering CITES include sturgeon caviar (Acipenseriformes spp. Appendix II), seahorses (Hippocampus spp. Appendix II), and certain shark fins such as hammerhead (Sphyrnidae Appendix II). The exporter must obtain a CITES export permit from the CITES Management Authority of the country of origin before shipment. The US importer must hold a valid CITES import permit issued by USFWS for Appendix I species. Both original permits must accompany the shipment and be presented to USFWS at the designated port. Species identification using the scientific name on the commercial invoice must match the permit exactly.
USFWS charges inspection fees for commercial wildlife shipments under the current fee schedule. Overtime inspections outside normal business hours incur additional costs billed directly to the importer. Frozen fish shipments must enter through a USFWS designated port unless a port exception permit is obtained in advance. Major designated ports for seafood include Los Angeles, New York, Miami, Chicago, and Seattle. Importers must coordinate the arrival window with the port wildlife inspector to ensure the cargo is examined while the cold chain is maintained. Failure to use a designated port without a permit results in seizure of the shipment and potential civil penalties.
| Mode of Transport | Minimum Prior Notice Deadline | Maximum Prior Notice Window | Submission System | Confirmation Required |
|---|---|---|---|---|
| Truck | 2 hours before arrival | 15 calendar days | PNSI / ACE | Yes |
| Air | 4 hours before arrival | 15 calendar days | PNSI / ACE | Yes |
| Rail | 4 hours before arrival | 15 calendar days | PNSI / ACE | Yes |
| Vessel (Sea) | 8 hours before arrival | 15 calendar days | PNSI / ACE | Yes |
| International Mail | Before shipment mailed | 15 calendar days | PNSI | Yes |
| Express Courier | Before shipment dispatched | 15 calendar days | PNSI | Yes |
The table above outlines the FDA Prior Notice submission deadlines for frozen fish shipments by transport mode. Vessel shipments require the longest lead time at eight hours before arrival while truck shipments need only two hours. All modes allow filing up to 15 calendar days in advance which is useful for scheduled sailings. The Prior Notice System Interface (PNSI) or the Automated Commercial Environment (ACE) accepts filings for formal entries. Express courier and international mail shipments must file before the goods are dispatched from the foreign country. A Prior Notice confirmation number is mandatory for the subsequent CBP entry filing. According to NOAA Fisheries (Fisheries of the United States) 82 percent of the seafood Americans ate in 2024 came from foreign imports highlighting the volume of traffic moving through these notice windows NOAA Fisheries.
Shipments valued at $800 or less entering via express courier or international mail may qualify for Section 321 de minimis clearance which exempts them from formal entry requirements. However FDA Prior Notice is still required for all food articles regardless of value. For de minimis shipments the carrier typically files Prior Notice on behalf of the importer using the tracking number as the shipment identifier. Formal entries above $800 require the importer or broker to file Prior Notice and obtain a confirmation number before the CBP entry is submitted. Express carriers such as FedEx UPS and DHL have proprietary systems that transmit Prior Notice data to FDA but the legal responsibility for accuracy remains with the importer of record.
The Prior Notice confirmation number issued by FDA must be entered on the CBP entry summary (CBP Form 7501) or the ACE entry filing for the shipment to be released. Without a valid confirmation number CBP will reject the entry or place the shipment on hold. The confirmation number is specific to the shipment description quantity and arrival information submitted in the Prior Notice. If the vessel name container number or estimated arrival date changes after Prior Notice submission the filer must update or resubmit the Prior Notice to obtain a new confirmation number. Discrepancies between the Prior Notice data and the actual arrival details are a leading cause of exams and cold chain delays for frozen fish.
Complete FDA facility registration for both the foreign processor and the U.S. importer before booking any shipment. Designate a qualified FSVP agent who develops a written verification program and confirms the supplier is absent from Import Alert 16-124. Secure the NOAA International Fisheries Trade Permit and SIMP Importer Account in ACE for covered species. File Prior Notice within the mode-specific window and ensure the Continuous Customs Bond is active on file with CBP. Align the HTS classification to trigger correct SIMP and USFWS Form 3-177 requirements.
Retain FSVP records including the hazard analysis and verification results for two years and be prepared to produce them within 24 hours of an FDA request. Build a project plan that finishes FSVP designation and NOAA registration at least 30 days before the first sailing to prevent demurrage. Start the compliance setup now at globaltradeplaza.com/blog/how-to-import-frozen-fish-to-usa-fda-and-noaa-steps.
Register the Chinese processor and U.S. importer with FDA via Form 3537, designate a qualified FSVP importer to verify the supplier's HACCP plan, obtain a NOAA International Fisheries Trade Permit, and file Prior Notice before arrival. Ensure the species is not subject to SIMP traceability gaps or Import Alert 16-124 for HACCP non-compliance.
Follow the same federal framework as other origins: FDA facility registration, FSVP verification, NOAA IFTP, and Prior Notice filing. European suppliers often hold EU health certificates that support but do not replace FDA HACCP verification; confirm the facility is not on Import Alert 16-124 and secure a Continuous Customs Bond for CBP entry.
Core costs include a Continuous Customs Bond minimum of $50,000, customs broker fees, FDA facility registration (free), FSVP program development, cold-chain freight, and potential demurrage during agency exams. Duties vary by HTS code; many frozen fish enter duty-free but require accurate classification to avoid penalties.
Costco acts as the importer of record and FSVP importer, so your facility must pass their supplier approval audit and meet FDA HACCP, FSVP, and SIMP requirements before they issue a purchase order. You must provide a written FSVP agreement, HACCP plan, and traceability data for SIMP species to their compliance team.
It is NOAA Form 370, filed electronically in ACE, where the importer certifies that the shipment's harvest-to-import traceability data is accurate and the fish was legally caught. CBP will not release SIMP-covered species without a valid Form 370 linked to the entry summary.
Every foreign facility that manufactures, processes, packs, or holds frozen fish for U.S. consumption and the U.S. importer of record must register via Form 3537. Registration must be renewed every two years during the period set by FDA regulation.
Prior Notice is an advance notification to FDA of an incoming food shipment submitted through the Prior Notice System Interface. It must be filed at least 2 hours before arrival for air shipments and 4 hours before arrival for ocean shipments.
The foreign processor must have a written HACCP plan per 21 CFR 123 addressing species-specific hazards such as histamine or parasites, with monitoring records, corrective actions, and verification steps. The U.S. FSVP importer must verify the plan's adequacy and ongoing compliance before entry.
FSVP is a written program the U.S. importer must develop to verify that each foreign supplier produces frozen fish meeting U.S. safety standards, including hazard analysis review, supplier approval, and corrective action records. The importer retains liability and must produce records to FDA within 24 hours of request.
Form 3-177 Declaration for Importation or Exportation of Fish or Wildlife is required for every frozen fish shipment. It identifies species, quantity, value, country of origin, and CITES permit numbers if applicable, and must be filed in ACE or presented to a USFWS inspector at the port.
SIMP covers 13 species groups including tunas, swordfish, sharks, shrimp, abalone, Atlantic cod, blue crab, dolphinfish, grouper, king crab, Pacific cod, red snapper, and sea cucumber. Each shipment of these species requires harvest-to-import traceability data reported on NOAA Form 370.
Engage a customs broker and FDA regulatory counsel immediately to request the detention notice details, then compile HACCP records, labeling proofs, FSVP verification documents, or SIMP data corrections to support a petition for release or re-export. Do not move or destroy the cargo without FDA written authorization.