Annex 12. Item 6.7. – Draft new Chapter 4.Z. Control of pathogenic agents in traded milt and fertilised eggs of fish

SECTION 4

DISEASE PREVENTION AND CONTROL

CHAPTER 4.Z.

CONTROL OF PATHOGENIC AGENTS IN TRADED MILT AND FERTILISED EGGS OF FISH

Article 4.Z.1.

Purpose

To provide recommendations for trade of milt and fertilised eggs of fish for aquaculture and to define risk mitigation for import to a *free country*, *free zone* or *free compartment*when: 

1)	the intention is to grow out and harvest the imported *aquatic animals*; or 

2)	the intention is to establish a new stock for aquaculture.

For disease-specific recommendations, refer to Section 10. 

Article 4.Z.2.

Scope 

This chapter describes general recommendations for safe trade in milt and fertilised eggs of fish from an area other than a *free country*, *free zone* or *free compartment*.  These recommendations cumulatively reduce the *risk*of transfer of infection to *aquatic animal* populations in a *free country, free zone*or*free compartment*.

Trade of milt and fertilised eggs of fish from a *free country*, *free zone* or *free compartment* should meet the requirements in Articles 10.X.9. (and Article 10.4.14. for infection with ISAV) of the fish disease-specific chapters, and is not addressed in this chapter.

Article 4.Z.3.

Specific measures required for trade of milt and fertilised eggs of fish 

Trade of milt and fertilised eggs of fish from a country, *zone* or *compartment* not declared free from infection with the listed diseases of concern should meet the following requirements: 

1)	the health status of the broodstock**at**the*aquaculture establishment* of origin should be determined. Only populations of broodstock which test free from the *pathogenic agents* of concern are suitable for supply to *collection and incubation centres*, as described in article 4.Z.4.;

2) 	milt and fertilised eggs should come from a collection and incubation centre approved by the Competent Authority of the place of origin, which operates in compliance with the conditions described in Articles 4.Z.5.,  4.Z.6. and 4.Z.7.*;*

3)	the fertilised eggs should have been surface disinfected prior to the export using a method proven to inactivate pathogenic agents, for salmonid eggs as described in Chapter 4.5. and in accordance with the recommendations in the fish disease-specific chapters (Articles 10.X.15. for infection with SAV, infection with IHNV, and infection with VHSV; Article 10.4.20. for infection with ISAV); 

4)	when intended for *international trade*, the consignment should be accompanied by an *international aquatic animal health certificate* issued by the *Competent Authority* of the exporting country which**should state that the milt and the fertilised eggs come from parents which have tested free from the relevant *disease*, and meet the requirements in points 1 and 2. 

Application of the measures recommended in this chapter should comply with the requirements of Chapters 5.1., 5.2 and 5.3.

Article 4.Z.4.

Health status of broodstock at the place of origin 

*Aquaculture establishments* keeping broodstock for the production and milt and fertilised eggs of fish from a country, *zone* or *compartment* not declared free from infection with a *listed disease*, should meet the following requirements: 

1)	be approved by the *Competent Authority*; 

2)	have in place a biosecurity plan in accordance with Chapter 4.1.;

3)	the broodstock should be tested for the pathogenic agents of concern prior to entry to the collection and incubation centre to demonstrate with 95% confidence that the pathogenic agent would be detected if present above a prevalence of 2%, using the diagnostic methods provided in the *Aquatic Manual*. If the results of this testing produce a positive result, the broodstock should not be moved to the *collection and incubation centre*;

4)	broodstock intended for movement to a collection and incubation centre should be clinically healthy at the time of movement, should not be from a population experiencing recent or ongoing mortality, and should not be exposed to animals of a lower health status following the testing at point 3.

Article 4.Z.5.

Collection and incubation centres 

Collection and incubation centres should be approved by the Competent Authority on the basis that the collection and incubation centre should:

1)	be under the supervision of an *Aquatic Animal Health Professional*or *veterinarian*;

2)	have a biosecurity plan in accordance with Chapter 4.1.;

3)	be structured to contain epidemiologically separate groups of broodstock;

4)	have in place a valid traceability system to ensure that each batch of gametes or fertilised eggs can be traced back to an epidemiologically separate group, and include documentation and auditing of testing results, *disease* history and movements of *aquatic animals*;

5)	be separated into:

a)	a collection room for eggs and milt; 

b)	an incubation centre for fertilised eggs;

c)	a milt laboratory and milt storage area;

d)	administration offices.

6)	be subject to and pass audits by the *Competent Authority* or an approved third party at least once per year against the requirements of this chapter.

Article 4.Z.6.

Testing of broodstock at the collection and incubation centre

Broodstock for the production and milt and fertilised eggs of fish, should meet the following requirements at the *collection and incubation centre*: 

1)	at stripping the broodstock should be individually sampled, and tested for the *listed diseases* of concern, in accordance with the methods for diagnosis provided in the *Aquatic Manual,*in a laboratory that has been approved by the *Competent Authority*;

2)	fish that test positive, and any milt or eggs derived from them should not be traded and all gametes and fish from that epidemiological group should be disposed of in a biosecure manner. Affected facilities should be disinfected to  ensure that cross-contamination of other batches of milt or eggs does not occur. 

Article 4.Z.7.

Conditions applicable to the collection and storage of milt and preparation of milt samples in the laboratory 

The following conditions should be in place at the laboratory for milt collection and storage:  

1)	the integrity of the traceability system as described in Article 4.Z.5. should be maintained at all times;

2)	receptacles used to freeze milt should be sterilized before use;

3)	diluents should be produced in a way to protect against contamination with *pathogenic agents*;

4)	frozen milt should be stored in hermetically sealed containers in a separate room.

____________