Chapter 11.3.

Infection with Marteilia refringens

Article 11.3.1.

For the purposes of the Aquatic Code, infection with Marteilia refringens means infection only with M. refringens.

Information on methods for diagnosis are provided in the Aquatic Manual.

Article 11.3.2.

The recommendations in this Chapter apply to: European flat oyster (Ostrea edulis), Australian mud oyster (O. angasi), Argentinean oyster (O. puelchana), Chilean flat oyster (O. chilensis), blue mussel (Mytilus edulis) and Mediterranean mussel (M. galloprovincialis). These recommendations also apply to any other susceptible species referred to in the Aquatic Manual when traded internationally.

Article 11.3.3.

1. When authorising the importation or transit of the following commodities, the Competent Authorities should not require any M. refringens related conditions, regardless of the M. refringens status of the exporting country, zone or compartment:

   1. For the species referred to in Article 11.3.2. intended for any purpose:

      1. commodities treated in a manner that inactivates the disease agent e.g. canned or pasteurised products;

      2. biological samples preserved for diagnostic applications in such a manner as to inactivate the disease agent.

   2. The following commodities destined for human consumption from the species referred to in Article 11.3.2. which have been prepared and packaged for direct retail trade:

      1. off the shell (chilled or frozen);

      2. half-shell (chilled).

   3. All commodities from Crassostrea gigas, including the live aquatic animal.

   For the commodities referred to in point 1b), OIE Members may wish to consider introducing internal measures to address the risks associated with the commodity being used for any purpose other than for human consumption.

2. When authorising the importation or transit of commodities of a species referred to in Article 11.3.2., other than commodities referred to in point 1 of Article 11.3.3., the Competent Authorities should require the conditions prescribed in Articles 11.3.7. to 11.3.11. relevant to the M. refringens status of the exporting country, zone or compartment.

3. When considering the importation/transit from an exporting country, zoning or compartment not declared free of infection with M. refringens of a commodity from bivalve species not covered in Article 11.3.2. or in point 1c) of Article 11.3.3. but which could reasonably be expected to be a potential mechanical vector for M. refringens, the Competent Authorities should conduct a risk analysis in accordance with the recommendations in the Aquatic Code. The exporting country should be informed of the outcome of this assessment.

Article 11.3.4.

A country may make a self-declaration of freedom from M. refringens if it meets the conditions in points 1, 2, 3 or 4 below.

If a country shares a zone with one or more other countries, it can only make a self-declaration of freedom from M. refringens if all the areas covered by the shared water are declared M. refringens free zones (see Article 11.3.5.).

1. A country where none of the susceptible species referred to in Article 11.3.2. is present may make a self-declaration of freedom from M. refringens when basic biosecurity conditions have been continuously met in the country for at least the past 3 years.

OR

2. A country where any susceptible species referred to in Article 11.3.2. is present but there has been no observed occurrence of the disease for at least the past 10 years despite conditions – in all areas where the species are present – that are conducive to its clinical expression, as described in the corresponding chapter of the Aquatic Manual, may make a self-declaration of freedom from M. refringens when basic biosecurity conditions have been continuously met in the country for at least the past 3 years and infection with M. refringens is not known to be established in wild populations.

OR

3. A country where the last known clinical occurrence was within the past 10 years or where the infection status prior to targeted surveillance was unknown (e.g.  because of the absence of conditions conducive to clinical expression as described in the corresponding chapter of the Aquatic Manual) may make a self-declaration of freedom from M. refringens when:

   1. basic biosecurity conditions have been continuously met for at least the past 3 years; and

   2. targeted surveillance, as described in Chapter 1.4. of the Aquatic Code, has been in place for at least the last 2  of the past 3 years without detection of M. refringens.

OR

4. A country that has previously made a self-declaration of freedom from M. refringens but in which the disease is subsequently detected may make a self-declaration of freedom from M. refringens again when the following conditions have been met:

   1. on detection of the disease, the affected area was declared an infected zone and a buffer zone was established; and

   2. infected populations have been destroyed or removed from the infected zone by means that minimise the risk of further spread of the disease, and the appropriate disinfection procedures (see Aquatic Manual) have been completed; and

   3. targeted surveillance, as described in Chapter  1.4. of the Aquatic Code, has been in place for at least the last 2  of the past 3 years without detection of M. refringens; and

   4. previously existing basic biosecurity conditions have been reviewed and modified as necessary and have continuously been in place for at least the past 3 years.

   In the meantime, part of the non-affected area may be declared a free zone provided that such part meets the conditions in point 3 of Article 11.3.5.

Article 11.3.5.

A zone or compartment free from M. refringens may be established within the territory of one or more countries of infected or unknown status for infection with M. refringens and declared free by the Competent Authority(ies) of the country(ies) concerned if the zone or compartment meets the conditions referred to in points 1, 2, 3 or 4 below.

If a zone or compartment extends over more than one country, it can only be declared a M. refringens free zone or compartment if the conditions outlined below apply to all areas of the zone or compartment.

1. In a country of unknown status for M. refringens, a zone or compartment where none of the susceptible species referred to in Article 11.3.2. is present may be declared free from M. refringens when basic biosecurity conditions have been continuously met in the zone or compartment for at least the past 3 years.

OR

2. In a country of unknown status for M. refringens, a zone or compartment where any susceptible species referred to in Article 11.3.2. is present but there has been no observed occurrence of the disease for at least the past 10 years despite conditions – in all areas where the species are present – that are conducive to its clinical expression, as described in the corresponding chapter of the Aquatic Manual, may be declared free from M. refringens when basic biosecurity conditions have been continuously met in the zone or compartment for at least the past 3 years and infection with M. refringens is not known to be established in wild populations.

OR

3. A zone or compartment where the last known clinical occurrence was within the past 10 years or where the infection status prior to targeted surveillance was unknown (e.g.  because of the absence of conditions conducive to clinical expression as described in the corresponding chapter of the Aquatic Manual) may be declared free from M. refringens when:

   1. basic biosecurity conditions have been continuously met for at least the past 3 years; and

   2. targeted surveillance, as described in Chapter  1.4. of the Aquatic Code, has been in place for at least the last 2  of the past 3 years without detection of M. refringens.

OR

4. A zone previously declared free from M. refringens but in which the disease is detected may be declared free from M. refringens again when the following conditions have been met:

   1. on detection of the disease, the affected area was declared an infected zone and a buffer zone was established; and

   2. infected populations have been destroyed or removed from the infected zone by means that minimise the risk of further spread of the disease, and the appropriate disinfection procedures (see Aquatic Manual) have been completed; and

   3. targeted surveillance, as described in Chapter  1.4. of the Aquatic Code, has been in place for at least the last 2 of the past 3 years without detection of M. refringens; and

   4. previously existing basic biosecurity conditions have been reviewed and modified as necessary and have continuously been in place for at least the past 3 years.

Article 11.3.6.

A country, zone or compartment that is declared free from M. refringens following the provisions of points 1 or 2 of Articles 11.3.4. or 11.3.5. (as relevant) may maintain its status as M. refringens free provided that basic biosecurity conditions are continuously maintained.

A country, zone or compartment that is declared free from M. refringens following the provisions of point 3 of Articles 11.3.4. or 11.3.5. (as relevant) may discontinue targeted surveillance and maintain its status as M. refringens free provided that conditions that are conducive to clinical expression of infection with M. refringens, as described in the corresponding chapter of the Aquatic Manual, exist and basic biosecurity conditions are continuously maintained.

However, for declared free zones or compartments in infected countries and in all cases where conditions are not conducive to clinical expression of infection with M. refringens, targeted surveillance needs to be continued at a level determined by the Competent Authority on the basis of the likelihood of infection.

Article 11.3.7.

When importing live aquatic animals of species referred to in Article 11.3.2. from a country, zone or compartment declared free from M. refringens, the Competent Authority of the importing country should require an international aquatic animal health certificate issued by the Competent Authority of the exporting country or a certifying official approved by the importing country.

This certificate must certify, on the basis of the procedures described in Articles 11.3.4. or 11.3.5. (as applicable), whether the place of production of the aquatic animal is a country, zone or compartment declared free from M. refringens.

The certificate should be in accordance with the Model Certificate in Chapter 5.10.

This Article does not apply to commodities referred to in point 1 of Article 11.3.3.

Article 11.3.8.

1. When importing, for aquaculture, live aquatic animals of species referred to in Article 11.3.2. from a country, zone or compartment not declared free from M. refringens, the Competent Authority of the importing country should assess the risk and, if justified, apply the following risk mitigation measures:

   1. the direct delivery to and lifelong holding of the consignment in biosecure facilities for continuous isolation from the local environment; and

   2. the treatment of all effluent and waste material in a manner that ensures inactivation of M. refringens.

2. If the intention of the introduction is the establishment of a new stock, the Code of Practice on the Introductions and Transfers of Marine Organisms of the International Council for the Exploration of the Seas (ICES) should be followed.

3. For the purposes of the Aquatic Code, the ICES Code (full version see: http://www.ices.dk/indexfla.asp) may be summarised to the following main points:

   1. identify stock of interest (cultured or wild) in its current location;

   2. evaluate stock health/disease history;

   3. take and test samples for M. refringens, pests and general health/disease status;

   4. import and quarantine in a secure facility a founder (F-0) population;

   5. produce F-1 generation from the F-0 stock in quarantine;

   6. culture F-1 stock and at critical times in its development (life cycle) sample and test for M. refringens and perform general examinations for pests and general health/disease status;

   7. if M. refringens is not detected, pests are not present, and the general health/disease status of the stock is considered to meet the basic biosecurity conditions of the importing country, zone or compartment, the F-1 stock may be defined as free of infection with M. refringens or specific pathogen free (SPF) for M. refringens;

   8. release SPF F-1 stock from quarantine for aquaculture or stocking purposes in the country, zone or compartment.

This Article does not apply to commodities referred to in point 1 of Article 11.3.3.

Article 11.3.9.

When importing, for processing for human consumption, live aquatic animals of species referred to in Article 11.3.2. from a country, zone or compartment not declared free from M. refringens, the Competent Authority of the importing country assess the risk and, if justified, require that:

1. the consignment be delivered directly to and held in quarantine facilities until processing and/or consumption; and

2. all effluent and waste material from the processing be treated in a manner that ensures inactivation of M. refringens.

This Article does not apply to commodities referred to in point 1 of Article 11.3.3.

Article 11.3.10.

When importing aquatic animal products of species referred to in Article 11.3.2. from a country, zone or compartment declared free from M. refringens, the Competent Authority of the importing country should require that the consignment be accompanied by an international aquatic animal health certificate issued by the Competent Authority of the exporting country or a certifying official approved by the importing country.

This certificate must certify, on the basis of the procedures described in Articles 11.3.4. or 11.3.5. (as applicable), whether or not the place of production of the consignment is a country, zone or compartment declared free from M. refringens.

The certificate should be in accordance with the Model Certificate in Chapter 5.10.

This Article does not apply to commodities referred to in point 1 of Article 11.3.3.

Article 11.3.11.

When importing aquatic animal products of species referred to in Article 11.3.2. from a country, zone or compartment not declared free from M. refringens, the Competent Authority of the importing country should assess the risk and apply appropriate risk mitigation measures.

This Article does not apply to commodities referred to in point 1 of Article 11.3.3.