United States of America – Export requirements for fish and seafood

Important note

  • In 2022, under the authority of Section 204 of the Food Safety Modernization Act (FSMA), the United States (U.S.) Food and Drug Administration (FDA) published the Food Traceability Final Rule, also known as "FSMA 204"
  • The original compliance date for the Food Traceability Final Rule is January 20, 2026 but FDA has announced its intention to extend the compliance date by 30 months
  • For more information, refer to United States Food Traceability Rule

On this page

Eligible/ineligible product

Eligible

All fish and seafood products except those listed as ineligible

Ineligible

Fish in the order Siluriformes ("catfish")

Pre-export approvals by the competent authority of the importing country

  • Most fish and seafood product falls under the jurisdiction of the United States Food and Drug Administration (FDA). See the Notice to Industry – United States of America – Foreign Supplier Verification Program (FSVP) for more information regarding Canadian establishments exporting FDA regulated foods to the United States
  • Importation of certain fish by-products are also subject to requirements under the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Veterinary Services

Establishments

  • Fish and seafood exporting establishments must be federally licensed to export. A full listing of approved establishments can be found on the List of Canadian fish and seafood establishments approved for export
  • If you are not on the list, contact your local CFIA office and request an Establishment ID number to be assigned to your establishment
  • Establishments that handle or export live and/or raw molluscan shellfish (including fresh and frozen in-shell or whole shucked oysters, clams, mussels, Quohogs, whole or roe-on scallops), must be listed on the Interstate Certified Shellfish Shippers List (ICSSL) and meet all applicable requirements. Refer to the list of ICSSL designations below.
    • This requirement does not apply to exporters of the adductor muscle of shucked scallops from which the roe and viscera have been removed

Certification for the Interstate Certified Shellfish Shippers List (ICSSL)

Safe Food for Canadians (SFC) licence holders wishing to be added to the ICSSL, to make amendments to a current listing, or to be removed from the list must submit the following information to their local CFIA office:

  • full legal name as it appears on the Safe Food for Canadians licence
  • Company name as it should appear on the export list. The options are
    • legal name of business as it appears on the SFC licence, or
    • legal name of business (operating name), or
    • legal name of business (vessel name)
  • facility address (street number, city, province, postal code)
  • mailing address (if different than above)
  • unique establishment identifier
  • telephone number
  • Interstate Certified Shellfish Shippers List (ICSSL) designation(s)
    • Depuration Processor (DP)
    • Repacker (RP)
    • Reshipper (RS)
    • Shucker-Packer (SP)
    • Shellstock Shipper (SS)
    • Wet Storage (WS)
  • cancellation date (if applicable)
  • reason for cancellation (if applicable)
    • decertification
    • out of business
    • other (specify)

Note: Licence holders conducting wet storage activities are required to indicate "WS" on the ICSSL in addition to any other applicable certification designation. Wet storage is defined as the temporary storage (less than 60 days) of live shellfish from approved sources, intended for marketing, in containers or floats in natural bodies of seawater or in tanks containing natural or synthetic seawater. Any applicable labels and tags must be updated with the new suffix.

An ICSSL listing for a SFCR licence holder must be renewed annually. The expiration date of Canadian licence holders on the ICSSL is November 30th of each year.

Further information on the types of ICSSL designations can be found in the National Shellfish Sanitation Program (NSSP) - Guide for the Control of Molluscan Shellfish.

Prior notice

  • The US requires prior notice to import, which includes providing information on all food for use, storage or distribution in the U.S.
  • Prior notification also applies to gifts, trade samples, quality assurance / quality control samples, transhipped products and food for future export
  • Food includes those articles intended for direct human or animal consumption and all ingredients or components of food intended for processing into food for consumption
  • For fish and seafood falling under FDA regulation, prior notice must be received and confirmed electronically by the FDA no more than five days before arrival and no fewer than:
    • 2 hours before arrival by land by road
    • 4 hours before arrival by air, or by land by rail; or
    • 8 hours before arrival by water
  • To electronically submit prior notice information, use the FDA Industry Systems interface accessible through the Prior Notice of Imported Foods web page

Production controls and inspection requirements

Salmonids

For exports of live salmonids, or non-live, uneviscerated salmonids and parts thereof (including offal), consult the CFIA's Aquatic Animal Health group.

Fish by-products

For information on instances where by-products require US import permits visit the APHIS Entry Requirements – Amphibians, Fish, Reptiles, Shellfish, and Aquatic Species webpage.

Products requiring aquatic animal health attestations

If animal health or aquatic animal health statements, for example bovine spongiform encephalopathy (BSE) related attestations, are written on any import permission documentation, the exporter should provide these documents to CFIA inspection staff for review. CFIA inspectors will in turn consult with Terrestrial Animal Health group or Aquatic Animal Health group as necessary.

Import alerts (red list, yellow list, green list)

  • The FDA implements import alerts which subject certain products that may be in violation of the FDA's laws and regulations to Detention Without Physical Examination (DWPE)
  • The violations against FDA's laws and regulations may be related to the product, manufacturer, shipper and/or based upon information from other foreign competent authorities
  • The DWPE allows the FDA to detain every shipment of any product identified on an import alert at its time of entry into the US, prior to physical examination of the goods, to prevent potentially non-compliant products from being distributed
    • For each shipment which is detained at the border due to DWPE, it is the responsibility of the exporter to work with their importer to submit documentation to demonstrate that the product(s) in the shipment comply with FDA's law and regulations
    • Each shipment will be allowed entry into the US once the exporter/importer demonstrates that it complies with FDA's law and regulations
    •  An example of supporting documentation is end product sampling and testing records
  • Before importing into the United States, exporters are encouraged to review the applicable import alerts to identify if the products will be subject to DWPE
  • For more information on import alerts and how to access them, visit the FDA's Import Alerts webpage

Removal from Import Alert

  • Fish and seafood manufacturers who are not on the ICSSL and who wish to be removed from an import alert can submit a petition package directly to the FDA's Division of Import Operations (DIO)
    • It is the processor/exporter's responsibility to follow the FDA's procedure and to submit a complete petition package for FDA's consideration
    • Processors and exporters are strongly encouraged to work with their importer when preparing a petition package
    • Visit the FDA's Removal from Import Alert webpage for more information on the petition process, contact information of DIO, and a list of recommended supporting evidence to include in the petition package
  • For certified shippers on the ICSSL, the CFIA is required to submit the petition package on the company's behalf
    • The exporter must first complete the required preliminary actions as identified in the FDA's Removal from Import Alert webpage
    • The exporter must then submit, in writing, a request for CFIA to submit a petition to the FDA on your behalf
    • The following documentation and records must be forwarded to your local CFIA office in support of your request:
      • import alert #
      • description of root cause analysis and any corrective actions taken
      • description of any preventive measures that have been implemented, including verification of the effectiveness of those measures, to prevent the reoccurrence of a violative shipment
      • entry numbers and copies of import documentation of 5 consecutive non-violative commercial shipments which have successfully cleared customs and entered the US following the date that the exporter was placed on the Import Alert List. The consignments must represent typical commercial export shipments. Records which demonstrate that the shipments successfully cleared customs also need to be submitted to the CFIA
    • It is highly recommended that exporters work with their importers to prepare and collate the required documentation for submission to the CFIA

Additional requirements

Food Traceability Final Rule

Documentation requirements

For fish gelatin

  • fish gelatin, destined to the US, for further processing and then further export to the EU from the US, the shipment should be exported to the US with a certificate of Origin and Hygiene CFIA/ACIA 5003, with the added statement (below)

    "The animal products described are derived from aquatic animals and have been obtained and prepared without contact with other material which does not comply with the conditions required and it has been handled so as to avoid contamination with pathogenic agents. It consists only of the following animal by-products: Animal by-products from aquatic animals originating from establishments or plants manufacturing products for human consumption."

For other fish and seafood products

  • No known certification requirements

Additional information

United States Marine Mammal Protection Act

As requested by Fisheries and Oceans Canada, the below notifications are provided to ensure Canadian exporters of fish and seafood products to the U.S. are aware of the list of restrictions on imports of seafood maintained by the National Oceanic and Atmospheric Administration (NOAA).

For details on the specific restrictions:

If you have imported any of the items identified in the restrictions from the above links and you are planning on exporting any of those products to the U.S., you are asked to notify Fisheries and Oceans Canada at DFO.SP.ER.Trade-Commerce.RE.PS.MPO@dfo-mpo.gc.ca.

For requirements related to Product of Canada designation, refer to Country of Origin Declaration – Imported Product Exported From Canada.

United States acts and regulations

United States Food and Drug Administration (FDA)

USDA Animal and Plant Health Inspection Service (APHIS)

United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS)

Note: fish in the order of Siluriformes ("catfish") and products derived from such fish are subject to different export requirements because they fall under the jurisdiction of the FSIS under the USDA.

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