GB/T 43051-2023Laboratory animal - General requirements for biosafety in animal experiment (English PDF)

Foreword

This document was issued on 7 September 2023 by the State Administration for Market Regulation; Standardization Administration of the PRC and takes effect on 1 April 2024.

It is a GB/T standard: recommended rather than compulsory, but it is the text a Chinese reviewer applies when assessing a submission.

1 Scope

GB/T 43051-2023 sets the general biosafety requirements for animal experiments. An animal facility is the hardest biosafety case there is: the pathogen is inside a living, moving, shedding host, the procedures that generate aerosols are the routine ones, and the waste stream includes bedding, carcasses and a great deal of contaminated air. China has built a large number of animal facilities including high containment ones, and their safety depends as much on the competence of the staff and the assessment of each procedure as on the engineering. The standard sets the quality requirements for the laboratory animals, the qualifications required of the practitioners, the requirements on the animal experiments themselves, the risk assessment and risk control, and the management requirements. It took effect on 1 April 2024.

This document stipulates quality of laboratory animals, qualifications of laboratory

animal practitioners, animal experiment requirements, risk assessment and risk control,

management and other general requirements related to biosafety in animal experiment.

This document applies to the management of laboratory animals, laboratory animal

practitioners and experimental processes when conducting animal experiments such as

inspection, testing, and evaluation in biosafety laboratories; as well as the daily

management of the laboratory.

2 Normative references

The contents of the following documents, through normative references in this text,

constitute indispensable provisions of this document. Among them, for dated references,

only the edition corresponding to that date applies to this document. For undated

references, the latest edition (including all amendments) applies to this document.

GB 14922.1 Laboratory animal - Standards and monitoring for parasitology

GB 14922.2 Laboratory animal - Microbiological standards and monitoring

GB 14925 Laboratory animal - Environment and housing facilities

GB 19489 Laboratories - General requirements for biosafety

GB/T 35892 Laboratory animal - Guideline for ethical review of animal welfare

GB 50346 Architectural and technical code for biosafety laboratories

GB 50447 Architectural and technical code for laboratory animal facility

Classified Catalog of Animal Pathogenic Microbes (issued by the former Ministry

of Agriculture on May 24, 2005)

Catalog of Human-Transmitted Pathogenic Microbes (issued by the former Ministry

of Health on January 11, 2006)

It shall comply with the requirements of GB 14922.1 and GB 14922.2. Laboratory

animal production organizations shall provide relevant testing certificates.

4.1.3 When animal experiments last for more than three months, the organization using

laboratory animals shall regularly conduct microbial and parasite testing of laboratory

animals. It shall pay special attention to the monitoring of zoonotic diseases AND

conduct dynamic records.

4.2 Experimental animals

4.2.1 It shall come from organizations or suppliers with animal production and breeding

licenses AND be accompanied by relevant qualification certificates.

4.2.2 There shall be health examination and quarantine certificates.

4.2.3 There shall be a zoonotic disease quarantine certificate for the animal.

4.2.4 For special reasons, certain experimental animals (such as rare animals), which

cannot be sourced from organizations or suppliers with animal production and breeding

licenses, require approval from the regulatory authorities for purchase and use. The

authorities shall establish corresponding measures, to ensure the biosafety of animal

facilities and laboratory animal practitioners (such as providing necessary protective

equipment, etc.).

4.2.5 It shall be ensured that the clinically observed physical health status is good; such

as no abnormality in activity, mental state, feeding, etc.; no damage or abnormality in

the head, eyes, ears, skin, limbs, tail, coat, etc.; no abnormality in secretions and

excretions, etc.

4.2.6 During the experiment, it shall regularly test animal pathogenic microorganisms.

It shall pay special attention to zoonotic disease monitoring AND keep dynamic records.