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Assessment and Accreditation Project for Laboratory Animal Care and Use

Project outline

In Japan, gThe Act Concerning Humane Treatment and Management of Animalsh (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. gThe Standard for Care and Management of Laboratory Animals and Alleviation of Painh (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 gThe Basic Policy on Animal Experimentation Performed at Research Institutionsh (Notice No.71, June 1, 2006), gthe Basic Policy on Animal Experimentation Performed at the Institutions under the Jurisdiction of MHLWh (Notification of the Director of the Health Science Division of the Minister's Office of Health, Labor and Welfare, June 1, 2006.), and gthe Basic Policy on Animal Experimentation at Research Institutions under the Jurisdiction of MAFFh (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 gFoundationh) 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 gBasic Policy on Animal Experimentation Performed at the Institutions under the Jurisdiction of MHLWh.

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 gCenterh) 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 feeFIt 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.

Flow of evaluation / accreditation

Application for assessment

Please download the "Application Form for the Assessment of Animal Experimentation Facilitiesh and the "Self-Assessment Report" from the following URL. Pease fill out the necessary information in the documents and send them to the Center for Accreditation of Laboratory Animal Care and Use of the Foundation by mail or email with attached PDF files.

Arrangement of the inspection schedule and preparation of the materials for assessment

The accreditable institution will be contacted by the Center for Accreditation of Laboratory Animal Care and Use of the Foundation regarding the schedule for the site visit. The site visit is usually performed in either 1 or 2 days according to the size of the facilities. Specifically, the evaluating committee members will check the status of the animal rearing facilities as well as laboratories where animal experiments are performed during the laboratory tour.
The materials to be submitted before the site visit, the materials to be shown at the time of the site visit, and the procedures of the site visit are described in the instruction for the site visit.

Implementation of inspection

The evaluating committee members check the documents such as the "Application Form for the Assessment of Animal Experimentation Facilitiesh, the "Self-Assessment Report", and other materials submitted before the site visit, and thereafter the evaluating committee members conduct site inspection in accordance with the "Points to be checked during the site visit". If any ambiguity arises regarding animal care and use during the deliberations in the Evaluation Committee, the Foundation may ask the accreditable institution to clarify the issues in writing.

Evaluation of inspection

After the site visit, the Evaluation Committee will decide whether or not the institution be accredited through deliberations by the Committee members. The accredited institution will receive a certificate together with the evaluation report at a later date.

Accredited Facilities

All the accredited facilities have been publicly announced, and the current accredited facilities are as follows.

List of Accredited Facilities

Inquiries: To the following Center by telephone, fax or email

Address:

Center for Accreditation of Laboratory Animal Care and Use
Japan Pharmaceutical Information Center
2-12-15, Shibuya, Shibuya-ku,
Tokyo 150-0002, Japan

TELF03-5466-1811 / FAXF03-5466-1814
E-mailFcalac@japic.or.jp