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Fish

United States Of America (US)

Considerations prior to updating of establishment details (added 3 June 2021)

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1. Preconditions for market access

1.1 Establishment listing

Initial listing procedure for edible productsRequired?
Export registrationYes
Establishment listing for the US (fish of the order Siluriformes)Yes*
Establishment listing for the USNo

* Establishment listing required by 1 September 2017

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.

1.2 Access for products for human consumption

ProductAccess?
FinfishYes, with the exception of fish from the order of Siluriformes, after 1 September 2017
BivalvesNo; with the exception of roe-off scallop adductor muscle meat.
CrustaceansYes
EchinodermsYes
GastropodsYes*
CephalopodsYes
TunicatesYes
CrocodileNo agreed certification

Refer to Section 1.4 for further information bivalve mollusc access.

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

US Bioterrorism Act

The US Bioterrorism Act requires establishment registration and prior notification for each shipment to the US. Exporters should organise these directly with US FDA (Food and Drug Administration).

1.3 Access for non-prescribed goods

ProductAccess?
Technical products and pharmaceutical materialRefer to comment below
Rendered productsRefer to comment below
Crocodile skins and hidesRefer to comment below
ShellsRefer to comment below

These products are non-prescribed goods and are not regulated by the Export Control (Fish and Fish Products) Rules 2021. Furthermore, the Rules do not apply to:

  • liquid fish products exported in a consignment of no more than 10 litres
  • dried fish and dried fish products (other than dried abalone) exported in a consignment of no more than 2 kilograms
  • fish and fish products (other than liquid fish and dried abalone) exported in a consignment of no more than 10 kilograms.
However, the Department may provide an export certificate if one is required by the United States of America competent authority.

1.4 Australian products that do not meet American official requirements

Bivalve molluscs

With the exception of roe-off scallop adductor muscle meat, to export bivalve molluscs to the 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.

Currently, bivalve molluscs intended for export from Australia are managed in accordance with the Australian Shellfish Quality Assurance Program (ASQAP) which does not completely align with the NSSP.

These requirements do not apply to roe-off scallop adductor muscle meat.

1.5 Premises and equipment

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known additional requirements for premises and equipment that differ from those required in the Export Control (Fish and Fish Products) Rules 2021.

2. Operational requirements

2.1 General operational Requirements

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known additional requirements for specific operations that differ from those required in the Export Control (Fish and Fish Products) Rules 2021.

2.2 Microbial and residue sampling, and maximum acceptable limits

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA 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.

3. Harvesting and processing

3.1 Sourcing of fish and fish products

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known additional requirements for sourcing of fish and fish products that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

3.2 Sourcing, slaughter and post-mortem inspection of crocodiles

The USA has no agreed requirements for the slaughter and post-mortem inspection of crocodiles.

3.3 Refrigeration, transfer and loadout

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known additional requirements for refrigeration, transfer and loadout that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

4. Production for human consumption

4.1 Fish and fish products

Cephalopods

The USA has no known additional requirements for the production of cephalopods that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

Finfish

The USA has no known additional requirements for the production of finfish that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

Crustaceans

The USA has no known additional requirements for the production of crustaceans that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

Echinoderms

The USA has no known additional requirements for the production of echinoderms that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

Crocodile

There is no agreed certification to import crocodiles to the USA.

Bivalves

With the exception of roe-off scallop adductor muscle meat, Australia does not currently have access for bivalve molluscs. Refer to Section 1.4 for information.

Tunicates

The USA has no known additional requirements for the production of tunicates that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

Gastropods

The USA has no known additional requirements for the production of gastropods that differ from those required by the Export Control (Fish and Fish Products) Rules 2021.

5. Production of non-prescribed goods

5.1 Non-prescribed goods

Crocodile skins and hides

Crocodile skins and hides are non-prescribed goods and are not regulated by the Export Control (Fish and Fish Products) Rules 2021.

Technical products and pharmaceutical material

Technical products and pharmaceutical material are non-prescribed goods and are not regulated by the Export Control (Fish and Fish Products) Rules 2021.

Shells

Shells are non-prescribed goods and are not regulated by the Export Control (Fish and Fish Products) Rules 2021.

Rendered products

Rendered products are non-prescribed goods and are not regulated by the Export Control (Fish and Fish Products) Rules 2021.

6. Labelling, use-by date, trade description and shipping marks (port marks)

6.1 Labelling and trade description

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known specific requirements for labelling and trade description in addition to those provided in the Export Control (Fish and Fish Products) Rules 2021.

6.2 Use-by date and/or shelf life restrictions

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no known specific requirements for use-by dates and/or shelf life restrictions in addition to Departmental-administered legislation.

6.3 Shipping marks (port marks)

Bivalve molluscs cannot be exported to the US. Refer to Section 1.4 for information.

The USA has no other known specific requirements for shipping marks (port marks).

7. Documentation requirements for products for human consumption

7.1 Live seafood

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 the 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.

7.2 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 1.4 for information.

7.3 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.

7.4 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.

7.5 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.

7.6 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.

7.7 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.

7.8 Crocodiles

There is no agreed certification to import of crocodiles into the USA.

8. Documentation requirements for non-prescribed goods

8.1 Technical products and pharmaceutical material

There is no agreed certification for import of technical products and pharmaceutical material into the USA. The Department may not be able to intervene in the event of a detained consignment.

Exporters should check import requirements with their importer or the importing country competent authority prior to shipping any technical products or pharmaceutical material.

8.2 Rendered products

There is no agreed certification for import of rendered products into the USA. The Department may not be able to intervene in the event of a detained consignment.

Exporters should check import requirements with their importer or the importing country competent authority prior to shipping any rendered products.

8.3 Crocodile skins and hides

8.4 Shells

9. Shipping and air freight requirements

10. Port-of-entry clearance inspection and testing

11. Definitions

Latest updates

17/06/2021 - References to export legislation have been updated.
3072|17/06/2021|20211119|4096
Last updated: 19/11/2021 5:49 PMCreated: 15/01/2015 12:11 PM