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Standard to be satisfied by test facilities, etc. conducting toxicity investigation

Chapter 6 Storage of Records, Etc. (Article 15 - Article 16)

In Japanese

(Storage)

Article 15 The data and materials as set forth in each item of Article 7 (hereinafter called the "records, etc.") shall be stored in the archives.

The records, etc. shall be stored in conformity to the following:

Any other persons than the person responsible for the archives or persons authorized by him/her shall have no access to the archives.

When samples and materials are taken in and out or transferred from the archives, this shall be recorded.

Consideration shall be given to minimize damage to records, etc. and deterioration.

Records, etc shall be put in order by a method convenient for retrieval such as providing them with indices, etc.

When test facilities, etc. suspend or discontinue their services, the records, etc. shall be transferred to the archives of the successor of the operation or the sponsor.

(Retention Period)

Article 16 Retention period of the records, etc. shall be 10 years from the date of notification made pursuant to the provisions of Paragraph 1 of Article 57-3 of the Law for the test substance.

Notwithstanding the foregoing, the retention period shall be the period during which the specimens, test substances, etc. may be retained in a stable condition, for those which are unable to be retained for 10 years.