Assessment and Accreditation Project for Laboratory Animal Care and Use

Project outline

In Japan, “The Act Concerning Humane Treatment and Management of Animals” (Act No.105 of October 1, 1973) stipulates basic consideration for care and management of laboratory animals, and the principle of 3 Rs for animal research is clearly set forth in the Article 41 of the Act. “The Standard for Care and Management of Laboratory Animals and Alleviation of Pain” (Notice No.88 of Ministry of the Environment, 2006) was established under the Act, and the Standard stipulates voluntary management of animal care and use at research institutions where animal experiments are performed. In addition, the Ministry of Education, Culture, Sports, Science and Technology (MEXT), the Ministry of Health, Labor and Welfare (MHLW), and the Ministry of Agriculture, Forestry and Fisheries (MAFF) have established “The Basic Policy on Animal Experimentation Performed at Research Institutions” (Notice No.71, June 1, 2006), “the Basic Policy on Animal Experimentation Performed at the Institutions under the Jurisdiction of MHLW” (Notification of the Director of the Health Science Division of the Minister's Office of Health, Labor and Welfare, June 1, 2006.), and “the Basic Policy on Animal Experimentation at Research Institutions under the Jurisdiction of MAFF” (Notice of Secretary-General of Agriculture, Forestry and Fisheries Technology Committee, MAFF, June 1, 2006), respectively.

In this project, we evaluate, verify, and certify the animal care and use program of institutions where animal experiments are performed as an external certification organization. Specifically, we check whether or not institutions are conducting appropriate animal experiments based on animal welfare and a scientific point of view in accordance with the Act, the Standard, and the Basic Policy prescribed by each ministry concerning the implementation of animal experiments in order to promote voluntary management of animal care and use at each institution.

In July 2008, the Japan Health Sciences Foundation (hereinafter referred to as the “Foundation”) established the Center for Accreditation of Laboratory Animal Care and Use, and started the external evaluation and certification of institutions, where animal experiments are performed, under the jurisdiction of MHLW in conformity with the “Basic Policy on Animal Experimentation Performed at the Institutions under the Jurisdiction of MHLW”.

Furthermore, the accreditable units have been expanded to include any institutions, where animal experiments are performed, that wish to be accredited by the Foundation since 2012.

This business was succeeded to in Japan Pharmaceutical Information Center (hereinafter referred to as the “Center”) with dismissal of the Foundation on March 31, 2021, and the business is continued by similar practical use.

Policy and features

The purpose of this project is to examine the results of self-inspections on the care and use of laboratory animals in compliance with the Standard based on the Act, and to accredit institutions in order to promote animal welfare through the establishment and implementation of a proper animal welfare system at each institution.

Specifically, evaluating committee members check whether or not institutions comply with the requirements set forth in the Standard and the Basic Policy of each ministry through the document review and the dialogue with the staff at each institution during the site visit. Evaluating committee members take the characteristics of the facility, the implementation policy on animal experimentation, the standards stipulated in the institutional guidelines, etc. into consideration when assessing the animal care and use program in order to promote animal welfare at each institution.

Evaluating committee members will present items to be considered and/or corrected during the accreditation period of the following 3 years. The accredited institution should respond to the comments.

In addition to the Act, the Standard, and the Basic Policy as stipulated by each ministry, the evaluation is also performed based on the "Guidelines for Proper Implementation of Animal Experiments" (Science Council of Japan, June 1, 2006) and Manual of Standards relating to the Care and Keeping and Reducing Pain of Laboratory Animals (Animal Protection Management Office, General Affairs Department, Natural Environment Bureau, Ministry of the Environment, October, 2017).

Evaluation criteria

The evaluation is carried out based on whether or not institutions conform to the Standard and the Basic Policy of each ministry holding jurisdiction over the accreditable institution. The detailed items to be assessed are shown in the format "Self-Assessment Report", which is based on the Basic Policy. The accreditable institution is required to submit the "Self-Assessment Report" at the time of application.

The accreditation is carried out at the Evaluation Committee consisting of experts in animal experiments and experts in laboratory animals based on the results of the site visits performed by the evaluating committee members commissioned by the Foundation. The Evaluation Committee is established at the Center for Accreditation of Laboratory Animal Care and Use of the Foundation.

Validity period of certification

The validity period of certification is 3 years. It is not required for the accredited institution to report the activities to the Foundation every year during the validity period unless the accredited institution was asked to respond to the comment(s) made at the time of certification within the designated time frame.
When the accredited institution wishes to continue the certification, it is required for the accredited institution to reapply during the validity period of the certification. The Foundation will carry out the assessment and evaluate whether or not the certification be continued.
In case that the accredited institution has changed the name or has discontinued the operation during the validity period, please notify the Foundation of such changes as soon as possible. We will make changes as needed.

Fees

Inspection fee：It is required for the accreditable institution to pay for the travel expenses of the evaluating committee members and the actual expenses related to the evaluation at the Evaluation Committee, and we will request the accreditable institution to pay the fee after the site visit.
Registration fee: The accreditable institution will be requested to pay for the certification after the institution is accredited by the Evaluation Committee. It is required for the accredited institution to pay the fee at the time of registration (valid for 3 years). The registration fee is divided into two categories according to the total area of the facilities (including incidental facilities): 1,100,000 yen (including consumption tax) for facilities of 1000 square meters or larger 935,000 yen (including consumption tax) for facilities of smaller than 1000 square meters. Please contact the secretariat of the Foundation for further information such as how to calculate the total area.

Accredited Facilities