FDA Shares Australia Certificate Requirements for Bivalve Molluscs and Related Products

WASHINGTON, D.C. – The Australia Department of Agriculture, Fisheries and Forestry (DAFF) will require an official certificate for imports of bivalve molluscs and bivalve molluscs products effective Feb. 16, announced the U.S. Food and Drug Administration (FDA). 

DAFF has agreed to accept an FDA-issued "Certificate to a Foreign Government" (CFG) for U.S. exports of FDA-regulated bivalve molluscs and bivalve molluscs products.

To meet Australian biosecurity conditions for bivalve molluscs, only non-viable (dead) molluscs are permitted entry. Non-viable bivalve molluscs are those that have undergone processing such as shucking, chilling, freezing, cooking, marinating and smoking. Oysters must be flesh only (no shell) and other bivalve molluscs can only include shell if they are frozen. Details on biosecurity conditions for bivalve molluscs can be found in the department’s BICON system under seafood (excluding finfish) for human consumption (BICONExternal Link Disclaimer).

Bivalve molluscs and bivalve molluscs products that are covered by the certification requirement include:

• Bivalve molluscs — clams, cockles, mussels, oysters, pipi and scallops. 
• Bivalve mollusc products — foods containing any bivalve molluscs; for example, seafood mixes (such as marinara mix) that contain bivalve molluscs as an ingredient.
• Products that are excluded include bivalve molluscs that are both retorted and shelf stable, or dried.

Industry may request a CFG for these covered products by submitting an online application in the HFP Export Certification Application and Tracking System (HFP eCATS). Visit Online Applications for Export Certificates for Food for a link to HFP eCATS and general instructions for submitting an application. U.S. applicants should select “Seafood” as the product type. See below for information required by DAFF for these products and instructions on how to provide this information in HFP eCATS.

Additional Certification Statements for Bivalve Molluscs and Bivalve Molluscs Products

For a list of certification data elements required by DAFF and additional information, people can refer to FDA’s Food Export Library webpage. It should be noted that DAFF also requires an additional certification statement for bivalve molluscs and bivalve molluscs products, based on an applicant’s attestation that the products were harvested from an area meeting U.S. shellfish standards. Applicants should copy and paste the following statement into the “Additional Information for Certificate” free-text field box in the “Additional Information” section of the application. 

“The product(s) described above, have been harvested from an area classified as suitable and open at the time of harvest, in accordance with U.S. shellfish sanitation controls.”

Applicants will be required to attest that the above statement they requested to print on the certificate is factual when they electronically sign the HFP eCATS application.

Additional Information

• Food Export Library
• Online Applications for Export Certificates for Food