Reasons for Proposal

According to the current Act, the Minister of Food and Drug Safety shall prepare and publish a report on the current status of animal testing each year, but there are no regulations in the current Act requiring operators of animal testing facilities and laboratory animal suppliers to submit data related to animal testing.

Therefore, this amendment aims to establish appropriate laboratory animal policies based on accurate laboratory animal-related data by obligating operators of animal testing facilities and laboratory animal suppliers to report relevant data, such as the type and number of laboratory animals used in animal testing and the current status of production and import of laboratory animals, to the Minister of Food and Drug Safety to ensure the reliability of the animal testing report and by imposing administrative fines on those who fail to report or report falsely.

This amendment also aims to reduce the burden on the industry and to improve and supplement matters necessary for the efficient operation of the current system and some deficiencies, such as providing a basis for reporting a minor change (currently, when there is a change in the registration of animal testing facilities and laboratory animal suppliers, the change must be registered) and acknowledging the experience before obtaining a degree for experience in the field of animal testing, which is a requirement for appointment as a member of the laboratory animal management committee.

Major Provisions

A. Clarify the relationship between education and career, which are the requirements for the appointment of members of a laboratory animal management committee, so that experience before obtaining a degree in the field of animal testing is recognized (Article 7).

B. Establish a new provision to report rather than register minor changes in animal testing facilities and laboratory animal suppliers (Articles 8 and 12).

C. Obligate laboratory animal suppliers to report to the Minister of Food and Drug Safety on the current status of production, import, etc., of laboratory animals, and establish new sanctions (administrative fines) for non-compliance or false reporting (Articles 13 and 33).

D. Remove “A person who conducts animal testing” from the training subjects so that operators of animal testing facilities may conduct training on the use, management, etc., of laboratory animals on their own (Article 17).

E. Obligate operators of animal testing facilities to report to the Minister of Food and Drug Safety on the current status of the use of laboratory animals, such as the type and number of laboratory animals used in animal testing, and establish new sanctions (administrative fines) for non-compliance or false reporting (Articles 21 and 33).

F. Establish a basis for administrative disposition in cases of a loss of registered facilities, non-compliance with the responsibilities of operators of animal testing facilities, and a failure to comply with the requirements for operators of animal testing facilities or laboratory animal suppliers (Article 24).