**USA COMMENTS IN RED FONT**

**Model Articles X.X.4 to X.X.8 for disease-specific chapters to address declaration of freedom from [Pathogen X]**

**Note:** time periods in these model articles will be determined by the Aquatic Animals Commission for each disease-specific chapter based on criteria that will be included in the revised Chapter 1.4. For this reason, periods are shown as [X] to indicate that the period is yet to be determined for each specific disease. Where a period is shown (e.g. ‘the last [X] years’) this indicates an intended default period that may vary depending on the circumstances of each disease. 

Article X.X.4.

[**Note**: this is a new article that will outline general requirements for making a self-declaration of freedom for a country, zone or compartment.]

**Requirements for self-declaration of freedom from infection with [PATHOGEN X]**

A Member Country may make a self-declaration**of freedom**from infection with [PATHOGEN X] for the entire country, a *zone* or a *compartment* in accordance with the provisions of Articles X.X.5. to X.X.8., as relevant. The self-declaration of freedom must be made in accordance with other relevant requirements of the *Aquatic Code,* including that the Member Country meet the following conditions:

1)	complies with the provisions of Chapter 3.1.; and

2)	uses appropriate methods of diagnosis, as recommended in the *Aquatic Manual*; and

3)	meets all requirements of Chapter 1.4. that are relevant to the self-declaration of freedom.

Article X.X.5. 

[**Note**: this article will replace the existing Article X.X.4.]

**Country free from infection with [PATHOGEN X]**

If a country shares water bodies~~a *zone*~~with ~~one or more~~ other countries, it can only make a self-declaration  of freedom from infection with [PATHOGEN X] if ~~the~~all shared water bodies are within countries or *zones* declared free from infection with [PATHOGEN X] (see Article X.X.6.).

As described in Article 1.4.X., a Member Country may make a self-declaration of freedom from infection with [PATHOGEN X] for its entire *territory* if:

1)	none of the *susceptible species* referred to in Article X.X.2. are present and *basic biosecurity conditions* have been continuously met for at least the last ~~[two] years~~[six] months;

OR

2)	there has been no occurrence of infection with [PATHOGEN X] for at least the last [ten] years, and:

a)	the Member Country can demonstrate that conditions are conducive to the clinical expression of infection with [PATHOGEN X], as described in the corresponding chapter of the *Aquatic Manual*; and 

b)	*basic biosecurity conditions***as described in Chapter 1.4. have been continuously met for at least the last [ten] years;

OR

3)	*targeted surveillance*, as described in Chapter 1.4., has been in place for at least the last [two] years without detection of [PATHOGEN X], and: ~~a)~~*basic biosecurity conditions* have been continuously met ~~from~~for at least [one] year prior to commencement of *targeted surveillance*;

OR

4)	it previously made a self-declaration of freedom from infection with [PATHOGEN X] and subsequently lost its free status due to the detection of [PATHOGEN X] but the following conditions have been met:

a)	on detection of [PATHOGEN X], the affected area was declared an *infected zone* and a *protection zone* was established; and

b)	~~infected populations within~~pathogen has been eradicated within the *infected zone*~~have been killed and disposed of by means that minimise the likelihood of further transmission of [PATHOGEN X],~~ and the appropriate *disinfection* procedures (as described in Chapter 4.~~3~~4.) have been completed followed by fallowing as described in Chapter 4.~~6~~7.; and

**RATIONALE:**The goal is the eradication of the pathogen, which will not always require depopulation.

c)	previously existing *basic biosecurity conditions* have been reviewed and modified as necessary and have continuously been in place since eradication of infection with [PATHOGEN X]; and

d)	*targeted surveillance*, as described in Chapter 1.4., has been in place for i) at least the last [two] years in wild and farmed *susceptible species* without detection of [PATHOGEN X] or ii) at least the last [one] year without detection of [PATHOGEN X] if ~~affected farms *aquaculture establishments* were not epidemiologically connected to wild populations of *susceptible species*~~ wild susceptible species were not linked to the disease event that occurred.

**RATIONALE:** Language added to suggest a freedom claim can be made if there is biosecurity in place that documents the lack of connectivity or epidemiological link between infected farmed and wild populations. Any changes to this section should be consistent with other chapters, especially those dealing with guidance on containment zones.

In the meantime, part or all of the country, apart from the *infected*and *protection zones,* may be declared a free *zone* provided that such a part meets the conditions in point 2 of Article X.X.6.

Article X.X.6.

[**Note**: this new article for zone freedom is based on the existing Article X.X.5.]

**Zone free from infection with [PATHOGEN X]**

If a *zone* extends over the *territory* of more than one country, it can only be declared a *zone* free from infection with [PATHOGEN X] if all of the relevant *Competent Authorities* confirm that all relevant conditions have been met.

As described in Article 1.4.X., a Member Country may make a self-declaration of freedom from infection with [PATHOGEN X] for a *zone* within its *territory* if:

1)	none of the *susceptible species* referred to in Article X.X.2.~~10.6.2~~. are present and *basic biosecurity conditions* have been continuously met for at least the last ~~[two] years~~[six] months;

OR

2)	there has been no occurrence of infection with [PATHOGEN X] for at least the last [ten] years, and;

a)	the Member Country can demonstrate that conditions are conducive to the clinical expression of infection with [PATHOGEN X], as described in Article 1.4.8. of Chapter 1.4.~~the corresponding chapter of the~~*~~Aquatic Manual~~*; and 

b)	*basic biosecurity conditions***as described in Chapter 1.4. have been continuously met for the *zone* for at least the last [ten] years;

OR

3)	*targeted surveillance*, as described in Chapter 1.4., has been in place in the *zone* for at least the last [two] years without detection of [PATHOGEN X], and:

~~a)~~*basic biosecurity conditions* have been continuously met for at least [one] year prior to commencement of *targeted surveillance*; 

OR

4)	it previously made a self-declaration of freedom for a *zone* from infection with [PATHOGEN X] and subsequently lost its free status due to the detection of [PATHOGEN X] in the *zone* but the following conditions have been met:

a)	on detection of [PATHOGEN X], the affected area was declared an *infected zone* and a *protection zone* was established; and

b)	~~infected populations within the~~pathogen was eradicated from the*infected zone*~~have been killed and disposed of by means that minimise the likelihood of further transmission of [PATHOGEN X],~~and the appropriate *disinfection* procedures (as described in Chapter 4.4.) have been completed followed by fallowing as described in Chapter 4.7.; and

**RATIONALE:** The goal is the eradication of the pathogen, which will not always require depopulation.

c)	previously existing *basic biosecurity conditions* have been reviewed and modified as necessary and have continuously been in place since eradication of infection with [PATHOGEN X]; and

d)	*targeted surveillance*, as described in Chapter 1.4., has been in place for at least the last [two] years without detection of [PATHOGEN X].

Article X.X.7.

[**Note**: this is a new article to address free compartments].

**Compartment free from infection with [PATHOGEN X]**

As described in Article 1.4.X., a Member Country may make a self-declaration of freedom**from infection with [PATHOGEN X] for a***compartment* within its *territory* if:

1) none of the *susceptible species* referred to in Article X.X.2. are present and *basic biosecurity conditions* have been continuously met for at least the last ~~[two] years~~[six] months;

**RATIONALE:**This proposed addition is already option in Articles X.X.5. and X.X.6. regarding freedom in a country or zone, respectively. 

OR

2~~1~~)	*targeted surveillance*, as described in Chapter 1.4., has been in place in the *compartment* for at least the last [~~two~~one] year~~s~~ without detection of [PATHOGEN X], and:

**RATIONALE:**Reflects the surveillance Chapter 1.4. that states the timeframe is greater than or equal to 1 year for a compartment (Article 1.4.10. of Chapter 1.4.).

~~a)~~*basic biosecurity conditions* have been continuously met for at least [one] year prior to commencement of *targeted surveillance*;

OR

3~~2~~)	it previously made a self-declaration of freedom for a *compartment* from infection with [PATHOGEN X] and subsequently lost its free status due to the detection of [PATHOGEN X] in the *compartment**~~zone~~*~~~~but the following conditions have been met:

a)	~~all *aquatic animals* within the *compartment* have been killed and disposed of by means that minimise the likelihood of further transmission of [PATHOGEN X],~~Pathogen X has been eradicated and the appropriate *disinfection* procedures (as described in Chapter 4.3.) have been completed, and the *compartment* has been fallowed as described in Chapter 4.6.~~for at least [X] weeks~~; and

**RATIONALE:**Revision is needed because the goal is the eradication of the pathogen, which will not always require depopulation.

b)	previously existing *basic biosecurity conditions*, including the *compartment**biosecurity plan*, have been reviewed and modified as necessary and have continuously been in place from the time of restocking with animals from an approved pathogen free source in accordance with the requirements of Articles X.X.9. and X.X.10. as appropriate; and

c)	*targeted surveillance*, as described in Chapter 1.4., has been in place for at least the last [one] year without detection of [PATHOGEN X]

Article X.X.8.

[**Note**: this article is based on the current Article X.X.6.]

**Maintenance of free status**

A country, *zone* or *compartment* that is declared free from infection with [PATHOGEN X] following the provisions of Articles X.X.4. to X.X.7. (as relevant) may maintain its status as free from infection with [PATHOGEN X] provided that the requirements described in Article 1.4.15. are continuously maintained.

~~A country or~~*~~zone~~*~~that is declared free from infection with [PATHOGEN X] following the provisions of point 1 of in Articles~~~~X.X.5.~~~~or X.X.6. (as relevant) may maintain its status as free from infection with [PATHOGEN X] provided that~~*~~basic biosecurity conditions~~*~~are continuously maintained.~~

~~A country or~~*~~zone~~*~~that is declared free from infection with [PATHOGEN X] following the provisions of point 2 of in Article~~~~X.X.5.~~~~may discontinue~~*~~targeted surveillance~~*~~and maintain its free status provided that conditions are conducive to clinical expression of infection with [PATHOGEN X], as described in the corresponding chapter of the~~*~~Aquatic Manual~~*~~, and~~*~~basic biosecurity conditions~~*~~are continuously maintained.~~

~~For declared free~~*~~zones~~*~~or~~*~~compartments~~*~~within the *territory* of a country not declared free,~~*~~targeted surveillance~~*~~should be continued at a level determined by the~~*~~Aquatic Animal Health Service~~*~~on the basis of the likelihood of~~*~~infection~~**~~.~~*

~~In all cases where conditions are not conducive to clinical expression of infection with [PATHOGEN X], ongoing *targeted surveillance,* as described in Chapter~~~~1.4.~~~~, is required at a level that maintains the level of confidence in freedom from infection with [PATHOGEN X] that was required for the initial declaration of freedom.~~

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