Chapter 5.3.

Criteria to assess the safety of
aquatic animal commodities

Article 5.3.1.

In all disease chapters, point 1a) of Article X.X.3. lists commodities that can be traded irrespective of country disease status. The criteria for inclusion of commodities in point 1a) of Article X.X.3. are based on the absence of the disease agent in the traded commodity or inactivation of the disease agent by treatment or processing.

The assessment of the safety of the commodity using the criteria relating to treatment or processing can only be undertaken where treatments or processing are well defined. It may not be necessary to provide details of the entire treatment or process undertaken. However, the steps considered critical in the inactivation of the disease agent of concern should be detailed.

It is assumed that treatment or processing (i) uses standardised protocols, which include the steps considered critical in the inactivation of the disease agent of concern; (ii) is conducted according to Good Manufacturing Practices; and (iii) that any other steps in the treatment, processing and subsequent handling of the commodity do not jeopardise the safety of the traded commodity.

For a commodity to be considered safe for international trade under the provisions of point 1a) of Article X.X.3., it should comply with the following criteria:

1. Absence of disease agent in the traded commodity:

   1. There is strong evidence that the disease agent is not present in the tissues from which the commodity is derived.

   AND

   2. The water (including ice) used to process or transport the commodity is not contaminated with the disease agent and the processing prevents cross contamination of the commodity to be traded.

OR

2. Even if the disease agent is present in, or contaminates the tissues from which the commodity is derived, the treatment or processing to produce the commodity to be traded inactivates the disease agent:

   1. physical (e.g. temperature, drying, smoking);

   AND/OR

   2. chemical (e.g. iodine, pH, salt, smoke);

   AND/OR

   3. biological (e.g. fermentation).

Article 5.3.2.

In all disease chapters, point 1b) of Article X.X.3. lists aquatic animal products destined for human consumption. The criteria for inclusion of aquatic animal products in point 1b) of Article X.X.3. include consideration of the form and presentation of the product, the expected volume of waste tissues generated by the consumer and the likely quantity of viable disease agent in the waste.

For the purpose of this criterion retail means the selling or provision of aquatic animal products directly to the consumer with the intended purpose of human consumption. The retail pathway may also include wholesale distribution of the products provided they are not further processed by the wholesale distributor or the retailer, i.e. are not subjected to actions such as gutting, cleaning, filleting, freezing, thawing, cooking, unpacking, packing or repackaging.

It is assumed that the aquatic animal product is used for human consumption. It is assumed that treatment or processing prior to importation (i) uses standardised protocols, which include the steps considered critical in the inactivation of the disease agent of concern; and (ii) is conducted according to Good Manufacturing Practices; and (iii) that any other steps in the treatment, processing and subsequent handling of the aquatic animal products do not jeopardise the safety of the traded aquatic animal products.

For aquatic animal products to be considered safe for international trade under the provisions of point 1b) of Article X.X.3., it should comply with the following criteria:

1. the aquatic animal product is prepared and packaged for retail trade for human consumption; AND

EITHER

2. it includes only a small amount of waste tissues;

OR

3. viable disease agent is unlikely to be present in the waste tissues, because:

   1. the disease agent is not normally found in the waste tissues;

      OR

   2. the disease agent may be present in the waste tissues but the processing prior to importation involves processes known to inactivate and/or reduce the load of disease agent:

      1. physical (e.g. temperature, drying, smoking);

      OR

      2. chemical (e.g. pH, salt, smoke);

      OR

      3. biological (e.g. fermentation).