United States Of America (US)

 

The following should be considered prior to updating establishment details:

  • When an establishment notifies the Department of an administrative change (that is, a change of occupier, company name, address, or in some instances product specific changes), the Department will amend the establishment record in the system.
  • The establishment's amended details will appear on applicable export documentation including health certification from the date that the Department amends the establishment record
  • When relevant changes are made to an establishment's details, the Department will advise trading partners that maintain establishment lists of the change of details; however, the Department is unable to guarantee a timeframe as to when trading partners will update the establishment's overseas listing details they maintain. This means that there may be a period in which export certification issued by the Department does not match the trading partner's official published listing, which may result in clearance issues at the port of entry.
  • Establishments should be aware that their ability to export to some countries may be impacted during this transition period and may include issues with goods in transit.
  • Exporters and manufacturers are encouraged to check that their establishment's details are recorded accurately where they appear on trading partners' lists and to contact the Department if errors are found.


 

Fish products for human consumption

1.1 Establishment registration

The Department of Agriculture, Fisheries and Forestry (the Department) is the Australian government authority responsible for export registration, inspection and certification of Australian food and agricultural exports.

All premises involved in the production of fish and fish products for export, including fishing vessels where fish is prepared for export must be registered with the Department.

For more information or assistance with the export registration process contact the departments Dairy, Eggs and Fish Program at dairyeggsfish@aff.gov.au.

Exceptions to establishment registration

Preparation of goods at an export registered establishment and an export permit is not required if you are exporting the following as these goods are not prescribed under the Export Control (Fish & Fish products) Rules 2021;

  1. liquid fish and liquid fish products exported in a consignment of not more than 10 litres;
  2. dried fish and dried fish products (other than dried abalone) exported in a consignment of not more than 2 kilograms;
  3. fish products where fish or fish products are not the major component;
  4. fish or fish products that are animal food or pharmaceutical material;
  5. fish or fish products not covered by paragraphs (a) to (d) (other than dried abalone) exported in a consignment of not more than 10 kilograms;
  6. fish or fish products in the form of a tablet or capsule;

Note

However, if the importing country requires a government certificate for the entry of the above goods, a certificate can be issued by the department – provided that the goods have been prepared in an export registered establishment.

1.2 Overseas listing

Initial listing procedure for fish products for human consumptionRequired?

*Note
 

Establishments must be registered with the United States Food and Drug Administration (US FDA) under the Bioterrorism Act. Establishments should organise this registration directing with the US FDA.

Establishment listing for USNo*

1.3 Prohibited products

Australia does not currently have market access for bivalve molluscs into US. It is prohibited to import, transport, or possess all live species of Haliotis genus in California except for the native species: H. rufescens, H. sorenseni, H. corrugate, H. fulgens, H. cracherodii, H. kamtschatkana, H. walallensis, and H. assimilis.

With the exception of roe-off scallop adductor muscle meat, to export bivalve molluscs to US, Australia must demonstrate full compliance with the US National Shellfish Sanitation Program (NSSP) and must sign a Memorandum of Understanding with the US Food and Drug Administration.
 

1.4 Access for fish products for human consumption

ProductAccess?

Note
 

Refer to Section 1.3 for further information bivalve mollusc access.

*It is prohibited to import, transport, or possess all live species of Haliotis genus in California except for the native species: H. rufescens, H. sorenseni, H. corrugate, H. fulgens, H. cracherodii, H. kamtschatkana, H. walallensis, and H. assimilis.

** The United States of America (US) has implemented a Seafood Import Monitoring Program (SIM) for prawn and abalone to be administered by NOAA Fisheries to curb Illegal, Unreported and Unregulated (IUU) fishing practices and identify misrepresented seafood imports before they enter the US Market.
 

FinfishYes, with the exception of fish from the order of Siluriformes
Bivalves (for example, oysters, scallops, mussels, oysters, clams, cockles)No, with the exception of roe-off scallop adductor muscle meat
Crustaceans (for example, crab, prawn, lobster, scampi, crayfish)Yes**
Echinoderms (for example, sea urchins, sea cucumber)Yes
Gastropods (for example, abalone, periwinkles)Yes*&**
Cephalopods (for example, squid, cuttlefish, octopus)Yes
Tunicates (for example, sea squirts)Yes
Crocodile
 		No agreed certification
 

The SIM program requires importers to provide information and maintain records about the harvest, landing and chain of custody of imported fish and fish products for certain priority species identified as especially vulnerable to IUU fishing and seafood fraud.
 

As of 1 January 2018, exports of some species of fish to US need to be accompanied by additional information to enable importers to report and maintain the required records.

  • The priority species included in the SIM program has been expanded to include species of prawn and abalone. As of 31 December 2018 additional information will be required to gain entry of product to US:
     
    • Prawns (all species)
    • Abalone (all species)
    • Tunas: Albacore, Bigeye, Skipjack, Yellowfin and Bluefin
    • Sea Cucumbers (all species)
    • Swordfish Xiphias gladius
    • Dolphinfish (Mahi Mahi) Coryphaena spp.
    • Groupers (Rockcods and Coral Trouts)
    • Snappers (Lutjanidae)
    • Sharks (all species)
  • The species listed are not fished from Australian waters and additional information will only be required if imported into and used in Australia to prepare chilled, frozen dried, salted or smoked fish products for export to US:
     
    • Atlantic Cod / Pacific Cod / Northern Cods (Gadus spp. including G. morhua, G. ogac, G. microcephalus)
    • Atlantic Blue Crabs (Callinectes spp. including C. apidus)
    • Red King Crabs (Paralithodes spp. including P. camtschaticus)
    • Red Snapper (Lutjanus campechanus)

This additional information is required for some but not all products prepared from prawn and abalone species and includes live, chilled, frozen and some highly processed products but not all (i.e. products containing prawn meat are included but not fish oil, sauces, sticks, balls or fish cakes prepared from prawn).

2.1 Harvest

Sourcing of fish and fish products

US has no known specific requirements for sourcing of fish and fish products that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

Sourcing, slaughter and post-mortem inspection of crocodiles

There is no agreed certification to import crocodile into US.

2.2 Microbial and residue sampling

US has no known additional requirements for microbial sampling of fish and fish products that differ from those required in the Export Control (Fish and Fish Products) Rules 2021.

US residue standards

Maximum residue limits (MRLs) or import tolerances for residues of specific agricultural and veterinary chemicals approved for use in Australia may not exist in US or may be established at levels lower than those established in Australia. Maximum Limits (MLs) for contaminants may also vary between US and Australia.

Food business operators should note that:

  • These differences can be interrogated case-by-case by considering the US standards and the Australian standards.
  • Any detection of a residue above the US MRLs/MLs (as applicable) at the border may result in rejection of the consignment.

Note

Importing country residue standards can usually be found via the official webpages of their competent authority. Links to a limited number of export markets and Australia are provided on the DAFF website.

2.3 Operational requirements additional to Australia's export legislation

US has no known specific operational hygiene requirements that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

2.4 Premises and equipment

US has no known specific premises and equipment requirements that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

3.1 Live fish

US has no known specific requirements for the preparation of live fish that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

3.2 Non-viable fish

US has no known specific requirements for the preparation of non-viable fish that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

3.3 Crocodile

There is no agreed certification to import of crocodiles into US.
 

3.4 Packaging

US has no known specific requirements for packaging that differ from the Export Control (Fish and Fish Products) Rules 2021.

3.5 Labelling

  • On 15 November 2022, FDA has published its new Requirements for Additional Traceability Records for Certain Foods (the Food Traceability Final Rule).
  • The new requirements are scheduled to come into force from 20 January 2026.
  • Foods subject to the Food Traceability Final Rule appear on the Food Traceability List (FTL) and include fresh (chilled and frozen) finfish and crustaceans.
  • While the Food Traceability Final Rule applies to US importers of food, importers may request information from Australian exporters to meet their traceability requirements.
  • Under the Food Traceability Final Rule, establishments involved in manufacture, processing, packing, or holding foods on the FTL, must maintain records containing Key Data Elements (KDEs).
  • KDEs are specific information for certain critical tracking events in the food’s supply chain. Establishments are required to keep and send forward the information along the supply chain.
  • The KDEs required for each establishment will depend on the type of supply chain activities. Examples of KDE include, but not limited to, description of the commodity location, quantity and traceability lot code.
  • The department encourages exporters to work with their importers in preparation for the commencement of new traceability requirements and ensure they are keeping records of information that may be required by their importers.
     

3.6 Shelf life

US has no known specific requirements for Shelf life that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

4.1 Shipping marks

US has no known specific requirements for shipping marks, that differ from of the Export Control (Fish and Fish Products) Rules 2021.
 

4.2 Refrigeration, transfer and loadout

US has no known specific requirements for refrigeration, transfer and loadout, that differ from the Export Control (Fish and Fish Products) Rules 2021.
 

5.1 Import permit

Exporters should confirm with their importer if an import permit is required for their product.
 

5.2 Port of entry inspection and testing

The department has no specific knowledge of port-of-entry inspection and testing for imports into US. Exporters should confirm requirements with their importer or agent.
 

6.1 Live fish

Finfish, crustaceans, echinoderms, gastropods, cephalopods and tunicates

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to US. A Prior Notice should be organised directly with the US FDA.

For finfish, crustaceans, echinoderms, gastropods, cephalopods and tunicates, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.
 

6.2 Non-viable fish

The United States of America (US) has implemented a Seafood Import Monitoring Program (SIM) for prawn and abalone to be administered by NOAA Fisheries to curb Illegal, Unreported and Unregulated (IUU) fishing practices and identify misrepresented seafood imports before they enter the US Market.

The SIM program requires importers to provide information and maintain records about the harvest, landing and chain of custody of imported fish and fish products for certain priority species identified as especially vulnerable to IUU fishing and seafood fraud.

As of 1 January 2018, exports of some species of fish to US need to be accompanied by additional information to enable importers to report and maintain the required records.

  • The priority species included in the SIM program has been expanded to include species of prawn and abalone. As of 31 December 2018 additional information will be required to gain entry of product to the US:
     
    • Prawns (all species)
    • Abalone (all species)
    • Tunas: Albacore, Bigeye, Skipjack, Yellowfin and Bluefin
    • Sea Cucumbers (all species)
    • Swordfish Xiphias gladius
    • Dolphinfish (Mahi Mahi) Coryphaena spp.
    • Groupers (Rockcods and Coral Trouts)
    • Snappers (Lutjanidae)
    • Sharks (all species)
  • The species listed are not fished from Australian waters and additional information will only be required if imported into and used in Australia to prepare chilled, frozen dried, salted or smoked fish products for export to the US:
     
    • Atlantic Cod / Pacific Cod / Northern Cods (Gadus spp. including G. morhua, G. ogac, G. microcephalus)
    • Atlantic Blue Crabs (Callinectes spp. including C. apidus)
    • Red King Crabs (Paralithodes spp. including P. camtschaticus)
    • Red Snapper (Lutjanus campechanus)

This additional information is required for some but not all products prepared from prawn and abalone species and includes live, chilled, frozen and some highly processed products but not all (i.e. products containing prawn meat are included but not fish oil, sauces, sticks, balls or fish cakes prepared from prawn).

Bivalves
Roe-off scallop adductor muscle meat

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US. A Prior Notice should be organised directly with the US FDA.

For roe-off scallop adductor muscle meat, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.

Bivalve molluscs (excluding roe-off scallop adductor muscle meat)

Australia does not currently have access for bivalve molluscs (excluding roe-off scallop adductor muscle meat). Refer to Section 1.6 for information.

Crustaceans

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US. A Prior Notice should be organised directly with the US FDA.

For crustaceans, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.

Echinoderms

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US. A Prior Notice should be organised directly with the US FDA.

For echinoderms, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.

Gastropods

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US. A Prior Notice should be organised directly with the US FDA.

For gastropods, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.

Cephalopods

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US.A Prior Notice should be organised directly with the US FDA.

For cephalopods, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.

Tunicates

Exporters should ensure that a Prior Notice recognised under the US Bioterrorism Act is provided for each shipment to the US. A Prior Notice should be organised directly with the US FDA.

For tunicates, use an FX46A Certificate with endorsement 2011.

Embedded endorsement

I hereby certify that to the best of my knowledge the conditions or restrictions applicable under the particular inspection system prescribed under the Export Control Act have been complied with in respect of the prescribed goods described above, being goods that are;

  1. In sound condition
  2. Fit for human consumption
  3. Of Australian origin
Additional Endorsement 2011

The fish &/or fishery products listed above have been prepared using HACCP to control food safety hazards & are considered by the Department to be processed in accordance with the requirements of United States Food & Drug Administration Regulations 21 CFR Part 123.
 

6.3 Crocodiles

There is no agreed certification to import of crocodiles into US.
 

Fish products not for human consumption

1.1 Establishment registration

The Export Control (Fish and Fish Products) Rules 2021 does not regulate fish and fish products not for human consumption. Establishments processing such products are not required to be export registered with the Department unless it is a requirement of the importing country. Exporters are encouraged to confirm the eligibility and import requirements of their product with their importer, or directly with the importing country competent authority prior to export.

Importing countries may require a health certificate be provided for fish and fish products not for human consumption. If a health certificate is required, contact the department’s non-prescribed goods program at NPGExports@aff.gov.au for further information.

1.2 Overseas listing

Initial listing procedure for fish products not for human consumptionRequired?
Establishment listing for United States
 		No

1.3 Prohibited products

The Department is not aware of any prohibited fish products. Additional information relating to fish and fish products not for human consumption may also be found on the corresponding Meat Micor page. Exporters should check with their importers to determine if the products are permitted for import to US.
 

1.4 Access for fish products not for human consumption

ProductAccess?
Aquaculture feedNo agreed certification
Animal feedNo agreed certification
Crocodile skins and hidesNo agreed certification
Technical products and pharmaceutical material (for example, fish oil capsule)No agreed certification
Rendered productsNo agreed certification
 
ShellsNo agreed certification

The Department is not aware of the requirements for animal feed. Additional information relating to fish and fish products not for human consumption may also be found on the corresponding Meat Micor page. Exporters should check requirements with their importer or US competent authority prior to shipping any animal feed to US.
 

The Department is not aware of the requirements for crocodile skins and hides. Additional information relating to fish and fish products not for human consumption may also be found on the corresponding Meat Micor page. Exporters should check requirements with their importer or US competent authority prior to shipping any crocodile skins and hides to US.
 

The Department is not aware of the production requirements for Rendered products. Additional information relating to fish and fish products not for human consumption may also be found on the corresponding Meat Micor page. Exporters should check production requirements with their importer or US competent authority prior to shipping any Rendered products to US.
 

The Department is not aware of the production requirements for technical grade and pharmaceutical products. Additional information relating to fish and fish products not for human consumption may also be found on the corresponding Meat Micor page. Exporters should check production requirements with their importer or US competent authority prior to shipping any technical products or pharmaceutical material to US.

29/08/2023 - Updated residue statement to refer to importing country standards (section 2.2).
04/04/2023 - Content on this page may have changed location to conform to standard Fish headings.