**Annex 12. Item 7.8. – Model Articles 11.X.9. – 11.X.14. for mollusc disease-specific chapters**

Model Articles 11.X.9. – 11.X.14. for mollusc disease-specific chapters 

CHAPTER 11.X.INFECTION WITH [PATHOGEN X]

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Article 11.X.9. 

Importation of aquatic animals or~~and~~ aquatic animal products from a country, zone or compartment declared free from infection with [Pathogen X]

When importing *aquatic animals*~~and *aquatic animal products*~~**of a species referred to in Article 11.X.2., or *aquatic animal products* derived thereof, from a country, *zone*or *compartment*declared free from infection with [Pathogen X], 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.*The*international aquatic animal health certificate*should state that,~~or a *certifying official*approved by the *importing country*certifying that,~~ on the basis of the procedures described in Articles 11.X.~~4~~5., 11.X.~~5~~6.  or 11.X.7. (as applicable) and 11.X.~~6~~8., the place of production of the *aquatic animals*or~~and~~*aquatic animal products*is a country, *zone*or *compartment*declared free from infection with [Pathogen X]. 

The *international aquatic animal health certificate*should be in accordance with the Model Certificate in Chapter 5.11.

This article does not apply to *aquatic animal products~~commodities~~*~~referred to~~listed in point 1 of Article 11.X.3.

Article 11.X.10.

Importation of aquatic animals for aquaculture from a country, zone or compartment not declared free from infection with [Pathogen X]

When importing, for *aquaculture*, *aquatic animals*of a species referred to in Article 11.X.2. from a country, *zone*or *compartment*not declared free from infection with [Pathogen X], the *Competent Authority*of the *importing country*should assess the *risk*in accordance with Chapter 2.1. and consider the *risk*mitigation measures in points 1 and 2 below.

1) If the intention is to grow out and harvest the imported *aquatic animals*, consider applying the following:

a) the direct delivery to and lifelong holding of the imported *aquatic animals*in a *quarantine*facility; and

b) before leaving *quarantine*(either in the original facility or following biosecure transport to another *quarantine*facility) the *aquatic animals* are killed and processed into one or more of the *aquatic animal products* referred to in point 1 of Article 11.X.3. or other products authorised by the *Competent Authority*; and

c) the treatment of all transport water, equipment, effluent and waste materials to ~~inactive~~inactivate [Pathogen X] in accordance with Chapters 4.4., 4.8. and  5.5.

OR

2) If the intention is to establish a new stock for *aquaculture*, consider applying the following:

a) In the *exporting country*:

i) identify potential source populations and evaluate their *aquatic animal*health records;

ii) test source populations in accordance with Chapter 1.4. and select a founder population (F-0) of *aquatic animals*with a high health status for infection with [Pathogen X].

b) In the *importing country*:

i) import the F-0 population into a *quarantine*facility;

ii) test the F-0 population for [Pathogen X] in accordance with Chapter 1.4. to determine their suitability as broodstock;

iii) produce a first generation (F-1) population in *quarantine*;

iv) culture F-1 population in *quarantine*for a duration sufficient for, and under conditions that are conducive to, the clinical expression of infection with [Pathogen X], ~~(as described in Chapter 2.4.X. of the *Aquatic Manual*)~~and sample and test for [Pathogen X] in accordance with Chapter 1.4. of the *Aquatic Code* and Chapter 2.4.X. of the *Aquatic Manual*;

v) if [Pathogen X] is not detected in the F-1 population, it may be defined as free from infection with [Pathogen X] and may be released from   *quarantine*;

vi) if [Pathogen X] is detected in the F-1 population, those animals should not be released from *quarantine*and should be killed and disposed of in a biosecure manner in accordance with Chapter 4.8.

Article 11.X.11.

Importation of aquatic animals or~~and~~ aquatic animal products for processing for human consumption from a country, zone or compartment not declared free from infection with [Pathogen X]

When importing, for processing for human consumption, *aquatic animals*of a species referred to in Article 11.X.2., or *aquatic animal products*derived thereof,**~~of species referred to in Article 11.X.2.~~from a country, *zone*or *compartment*not declared free from infection with [Pathogen X], the *Competent Authority*of the *importing country*should assess the *risk*and, if justified, require that:

1) the consignment is delivered directly to, and held in,*quarantine*or containment facilities until processing into one of the products referred to in point 1 of Article 11.X.3.~~,~~ or ~~products described~~ in point 1 of Article 11.X.~~12~~14., or other products authorised by the *Competent Authority*;  and

2) all water (including ice), equipment, *containers*and packaging material used in transport ~~and all effluent and waste materials from the processing~~are treated ~~in a manner that~~to ensure~~s~~ inactivation of [Pathogen X] or ~~is~~disposed of in a biosecure manner ~~that prevents contact of waste with *susceptible species*~~in accordance with Chapters 4.4., 4.8. and 5.5.; and

3)all effluent and waste materials are treated to ensure inactivation of [Pathogen X] or disposed of in a biosecure manner in accordance with Chapters 4.4. and 4.8.

For these *aquatic animals* or *aquatic animal products**~~commodities~~*Member Countries may wish to consider introducing internal measures to address the *risks*associated with the *aquatic animal* or *aquatic animal product**~~commodity~~*being used for any purpose other than for human consumption.

Article 11.X.12.

Importation of aquatic animals or aquatic animal products intended for usesother than human consumption, including~~in~~animal feed~~,~~and~~or for~~ agricultural, industrial, research or pharmaceutical use, from a country, zone or compartment not declared free from infection with [Pathogen X]

When importing *aquatic animals* of a species referred to in Article 11.X.2., or *aquatic animal products* derived thereof,intended for usesother than human consumption, including ~~in~~ animal *feed*~~or for~~ and agricultural, industrial, research or pharmaceutical use, *~~aquatic animals~~*~~of species referred to in Article 11.X.2.~~from a country, *zone*or *compartment*not declared free from infection with [Pathogen X], the *Competent Authority*of the *importing country*should require that:

1)	the consignment is delivered directly to and held in *quarantine*or containment facilities ~~for slaughter and processing~~until processed into one of the products referred to in point 1 of Article 11.X.3. or other products authorised by the *Competent Authority*;  and

2)	all water (including ice), equipment*, containers,*and packaging material used in transport ~~and all effluent and waste materials from the processing~~ are treated ~~in a manner~~to~~that~~ ensure~~s~~ inactivation of [Pathogen X] or disposed of in a biosecure manner in accordance with Chapters 4.4., 4.8. and 5.5.; and

3)all effluent and waste materials are treated to ensure inactivation of [Pathogen X] or disposed of in a biosecure manner in accordance with Chapters 4.4. and 4.8.

~~This article does not apply to *commodities*referred to in point 1 of Article 11.X.3.~~

Article 11.X.13.

[**Note**: this is a new article to align with other disease-specific chapters within the *Aquatic Code*.]

Importation of aquatic animals intended for use in laboratories or zoos from a country, zone or compartment not declared free from infection with [Pathogen X]

When importing, for use in laboratories or zoos, *aquatic animals*of a species referred to in Article ~~10.2.2.~~11.X.2. from a country, *zone*or *compartment*not declared free from infection with [Pathogen X], the *Competent Authority*of the *importing country*should ensure:

1) the consignment is delivered directly to, and held in, *quarantine*facilities authorised by the *Competent Authority*; and

2) all water (including ice), equipment, *containers*and packaging material used in transport are treated to ensure inactivation of [Pathogen X]**or disposed of in a biosecure manner in accordance with Chapters 4.4., 4.8. and 5.5.; and

3) all effluent and waste materials from the *quarantine*facilities in the laboratories or zoos are treated to ensure inactivation of [Pathogen X]**or disposed of in a biosecure manner in accordance with Chapters 4.4. and 4.8.; and

4) the carcasses are disposed of in accordance with Chapter 4.8.

Article 11.X.~~13~~14.

Importation ~~(~~or transit~~)~~ of ~~aquatic animals and~~ aquatic animal products for retail trade for human consumption regardless of the infection with [Pathogen X] status of the exporting country, zone or compartment~~from a country, zone or compartment not declared free from infection with [Pathogen X]~~

1) *Competent Authorities*should not require any conditions related to ~~infection with~~[Pathogen X], regardless of the infection with [Pathogen X] status of the *exporting country*, *zone*or *compartment*, when authorising the importation or transit of the following*aquatic animal products~~commodities~~*that~~which~~ have been prepared and packaged for retail trade and which comply with Article 5.4.2.

a)	[...] 

Certain assumptions have been made in assessing the safety of the *aquatic animal products*mentioned above. Member Countries should refer to these assumptions at Article 5.4.2. and consider whether the assumptions apply to their conditions.

For these *aquatic animal products**~~commodities~~*Member Countries may wish to consider introducing internal measures to address the *risks*associated with the *aquatic animal products**~~commodity~~*being used for any purpose other than for human consumption.

2) When importing *~~aquatic animals~~*~~or~~*aquatic animal products*, other than those referred to in point 1 above, derived from a~~of~~species referred to in Article 11.X.2. from a country, *zone*or *compartment*not declared free from infection with [Pathogen X], the *Competent Authority*of the *importing country*should assess the *risk*and apply appropriate *risk*mitigation measures.

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