GB/T 43051-2023 English PDF (GB/T43051-2023)

GB/T 43051-2023: Laboratory animal - General requirements for biosafety in animal experiment
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GB/T 43051-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.020.30
CCS B 44
Laboratory animal - General requirements for biosafety in
animal experiment
ISSUED ON: SEPTEMBER 7, 2023
IMPLEMENTED ON: APRIL 1, 2024
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Quality requirements for laboratory animals ... 5
5 Qualifications of laboratory animal practitioners ... 6
6 Requirements for animal experiments ... 7
7 Risk assessment and risk control ... 9
8 Management requirements ... 11
Laboratory animal - General requirements for biosafety in
animal experiment
1 Scope
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.
5 Qualifications of laboratory animal practitioners
5.1 Basic requirements
5.1.1 It shall comply with laws, regulations, standards and institutional rules and
regulations related to laboratory animals, biosafety, and laboratory biosafety.
5.1.2 It shall have the corresponding professional education background or
organization-related training for the position being engaged in.
5.1.3 It shall meet health requirements for laboratory animal practitioners.
5.1.4 It shall obtain a laboratory animal practitioner position certificate or related
qualification certificate AND undergo biosafety training.
5.1.5 It shall be familiar with the risks of animal laboratory facilities, equipment,
experimental operations, etc.; master certain risk control knowledge and skills.
5.1.6 It shall have good animal experiment capabilities and biosafety protection
capabilities.
5.1.7 It shall be familiar with animal habits; understand the characteristics of test
samples; have the ability to identify and control risks.
5.2 Special requirements for performing animal experiments on pathogenic
microorganism activities
5.2.1 On the basis of meeting the requirements of 5.1, it shall master good biosafety
knowledge; receive specialized biosafety training; obtain competency confirmation.
5.2.2 It shall master good knowledge of laboratory animals and animal experiment skills;
including husbandry management, clinical observation, sample collection, anatomical
analysis, harmless disposal of tissue materials and carcasses, etc.
5.2.3 It shall master good knowledge and skills in raising laboratory animals; have the
ability to operate experimental equipment and deal with abnormal situations;
understand the performance requirements of facilities.
5.2.4 It shall comply with the requirements for laboratory practitioner management in
GB 19489.
6 Requirements for animal experiments
6.1 General requirements
6.1.1 Animal biosafety laboratory facilities and equipment shall comply with the
requirements of GB 19489, GB 14925, GB 50346, and GB 50447. The laboratory shall
be in good operating condition. The experimental equipment shall be in place.
6.1.2 The laboratory shall use internationally and nationally prescribed general
identification. The laboratory identification shall be clear, conspicuous, and easily
distinguishable. There shall be signs at the main entrance of the laboratory, which
clearly indicate the level of biological protection, the biological factors being operated,
the name of the person in charge of the laboratory, emergency contact information, and
internationally accepted biohazard symbols.
6.1.3 The laboratory shall obtain approval from the management department to allow
animal experiment activities.
6.1.4 The laboratory shall not engage in experimental activities beyond the scope of the
license; shall comply with the requirements of the "Catalog of Human-Transmitted
experimental operations in a timely manner; such as drug administration, sampling,
dissection, surgery, execution and other activities.
6.3.4 When conducting pathogen infection experiments, animals shall be anesthetized
before proceeding with the operation.
6.3.5 After each animal experiment, it shall clean and disinfect the relevant
experimental area environment and equipment. After all experiments, it shall carry out
a thorough terminal disinfection of the laboratory environment and equipment.
6.3.6 Animals shall be killed in compliance with the principles of euthanasia. All animal
tissues, carcasses, and related materials - which are subjected to high-level pathogenic
microorganism operations - shall be disinfected and sterilized before being harmlessly
disposed of by the waste disposal organization.
6.3.7 Animal tissues, carcasses, and related materials - which are subjected to low-level
pathogenic microorganism operations - need to be packed in medical waste garbage
bags, temporarily stored, and sent to a qualified harmless treatment organization for
disposal. All disposal need to comply with environmental protection requirements.
7 Risk assessment and risk control
7.1 Risk management
7.1.1 Animal experimental institutions/laboratories shall establish risk identification,
risk assessment, and risk control systems for animal experimental activities.
7.1.2 It shall clarify specific requirements for ongoing risk identification, risk
assessment, and risk control in animal laboratories. It shall establish and maintain risk
assessment and risk control procedures; to enable ongoing hazard identification, risk
assessment and implementation of necessary control measures.
7.1.3 Risk assessment and risk control shall be carried out in accordance with relevant
regulations.
7.2 Risk identification and assessment
7.2.1 It shall evaluate the animal’s species, characteristics, infection pathogen
categories, and the safety of the feeding equipment for compliance.
7.2.2 It shall carry out the identification, assessment and control of risks to facilities
and equipment in biosafety laboratories.
7.2.3 When experimental activities involve genetically modified organisms (GMOs), it
shall assess the biological hazards they may cause.
7.2.4 Animal experimental institutions shall establish animal experiment biosafety
emergency plans and disposal measures AND control accidents.
7.2.5 It shall understand the residual risks or new risks after taking risk control measures
AND take necessary risk control measures.
7.2.6 Laboratory animal practitioners shall receive good training; including
professional training on laboratory animals and animal experiments, biosafety training,
and informed consent training, etc.
7.2.7 When conducting animal welfare ethical reviews, the laboratory animal use
management committee needs to pay attention to the key points of biosafety. The key
points are as follows.
a) Following the principles of animal care, laboratory animals shall not be
meaninglessly raised, abused, or killed indiscriminately. It shall stop animal
experiments that have no scientific significance, social value, or are unnecessary.
b) The review of animal experiment plans shall follow the requirements of GB/T
35892. The basic principle of welfare and ethical review of animal experiments
is to consider the welfare of animals and the interests of laboratory practitioners;
to comprehensively evaluate the biosafety risks that practitioners may involve in
animal experiments; and to evaluate whether protective measures are in place.
c) It shall emphasize the review of biosafety guarantees.
d) The review needs to pay attention to the types of laboratory animals, pathogen
types, and protection requirements. It shall be noted that, due to different
laboratory animal sizes, there are objective differences in feeding facilities,
equipment environments and safety controls.
e) For large animals such as sheep, cattle, horses and other experimental animals that
do not have national testing standards for microorganisms and parasites,
experiments shall be conducted in accordance with relevant requirements.
7.2.8 Risk identification and risk assessment shall be carried out by experienced
personnel with expertise in fields such as pathogenic microbiology, laboratory animal
medicine, clinical medicine, and health engineering.
7.2.9 Risk assessment shall be based on national laws, regulations, standards,
specifications, as well as guidelines and data issued by authoritative organizations.
7.3 Risk control
7.3.1 For the control of animal experiments, it shall take corresponding risk control
measures based on the risk assessment conclusions; including personnel protection,
e) Designate a person in charge of the safety of animal experimental activities; give
him the responsibility and authority to supervise all activities; including the
responsibility to develop, maintain, and supervise the laboratory safety plan; the
authority to prevent unsafe behaviors or activities; the right to report to
management departments;
f) Define the responsibilities, authorities, and relationships of laboratory animal
practitioners;
g) Arrange personnel with animal experiment capabilities. Based on their experience
and responsibilities in animal experiments, provide appropriate training and
supervision for laboratory animal practitioners.
8.1.3 The animal laboratory shall designate a project leader for each activity, who is
responsible for formulating the laboratory safety management system; including animal
experiment activity plan, risk assessment report, safety and emergency response
requirements.
8.1.4 The animal laboratory safety management system shall be adapted to the size of
the laboratory AND the complexity and risks of animal experimental activities.
8.1.5 Biosafety management system documents usually include management manuals,
work procedures, instructions and operating procedures, records and other documents;
as well as safety manuals for quick use by on-site laboratory animal practitioners.
8.1.6 All personnel in animal experiments shall be instructed to use and apply relevant
safety management system documents and their implementation requirements. And it
shall assess their ability to understand and apply them.
8.2 Management responsibilities
8.2.1 Animal laboratory managers shall be responsible for the safety of all personnel
and the environment. It shall establish a clear access system AND proactively inform
laboratory animal practitioners of the risks they may face in animal experiments. It shall
provide laboratory animal practitioners with opportunities for ongoing training and
continuing education and training, to ensure that animal practitioners are competent for
their assigned tasks.
8.2.2 Animal laboratory managers shall provide laboratory animal practitioners with
necessary immunization plans, regular health examinations, and medical protection.
8.2.3 Animal laboratory managers shall ensure that laboratory animal facilities,
equipment, materi...