1. Reason for Revision
In order to improve efficiency when managing pathogens of aquatic organism diseases, the proposed revision aims to improve and supplement certain insufficiencies in the current notice, such as the pathogen distribution period, rejection of distribution and cancellation of approval, and subdivision of application forms.
2. Main Contents
A. Method of disclosing information on the disposal of stored/managed pathogens (Article 5 of the draft)
B. Revision of pathogen distribution methods (Article 6 of the draft)
1) The revision increases the notification of distribution review results from 14 days to 30 days in order to ensure sufficient time for the cultivation and testing of the pathogens designated for distribution.
2) The revision stipulates prior consultation with the aquatic organism quarantine institutions when pathogens are used for purposes such as publications, research papers, patents, manufacture of preventive medicines, and production of diagnostic solutions, and specifies the types of supporting documents to be submitted after utilization.
C. Establishment of provisions on refusal and cancellation of approval of distribution (Article 8 of the draft)
1) The revision establishes the grounds for refusing or restricting distribution despite a distribution request and establishes the obligation to notify of a refusal.
2) The revision moves the provision on the cancellation of distribution approval from Article 6 to Article 8 and establishes the notification procedure for cancellation and disposal orders.
D. Revision of application form for distribution and documents to be submitted (Attached Forms 1 to 4)
1) The revision adds various items such as the list of pathogens to be requested for distribution, their storage location, and method of disposing of them, etc.
2) The revision adds list of documents to be attached (Specifications of facilities and research plan, etc.).