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August 2020
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Abstract: BIOSAFTY, BIOSECURITY, and BIORISK management system are common biorisk terms that related to support each other.
Laboratory biosafety is a mixture of principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release incorporation with biosecurity which is protection, control, loss, theft, misuse, division or intentional release of pathogens. This biorisk management system should be applied in our labs through well trained and qualified person. CWA 15793 is a comprehensive framework for managing biorisks developed through international collection. Shipping infectious substances and biological specimens according to IATA (INTERNATIONAL AIR TRANSPORT ASSOCIATION) roles.

IATA (INTERNATIONAL AIR TRANSPORT ASSOCIATION) roles Objectives: Using biorisk management system is so important to reduce the safety and security risks associated with biological agents in our labs. This can be applied by Implementing a comprehensive biorisk management system in order to manage the risk yb using AMP (assessment, mitigation, performance) model.
Risk characterization is the process of identifying the factors that contribute to risk and determining the likelihood and consequences of it. Complete analysis of the different hazards, threats and situations that can affect risk will increase the robustness of the risk characterization process. Import and export of the biological agents in and out of our labs should be applied according to IATA from a certified person. Training courses for lab workers.
A. Biorisk Management: AMP Model:
Assessment, Mitigation, and Performance.
Biorisk Assessment: Is a process of identifying the hazards and evaluating the risks associated with biological agents and toxins, taking into account the adequacy of any existing controls, and deciding whether or not the risks are acceptable.
Overview: A biological risk assessment is an analytical procedure designed to characterize biological risks in a facility, laboratory or unit within it, or other type of operation dealing with potential pathogens or toxins.
Generally, we can classify biological risk assessments into two types:
Biosafety risk assessment:
• A biosafety risk assessment is an analytical procedure designed to characterize safety risks in a laboratory.
Biosecurity risk assessment:
• A biosecurity risk assessment is an analytical procedure designed to characterize security risks in a laboratory.
Biorisk Mitigation: Actions and control measures that are put into a place to reduce or eliminate the risks associated with biological agents and toxins.
Mitigation is most effective when based on a thorough risk assessment. There are five generally recognized categories of control measures:
Elimination or substitution is the most effective means of mitigating risk; generally followed by engineering controls; administrative controls; practices and procedure; and finally PPE.
It takes a combination of mitigation measures; in addition to the risk assessment. The effectiveness of mitigation also must be judged on your ability to implement them.
Biorisk Performance: The implementation of the entire biorisk management system, including evaluating and ensuring that the system is working the way it was designed. Another aspect of performance is the process of continually improving the system.
B. Shipping Infectious Substances & Biological Specimens
Infectious Substance Transport
Transport – movement of biological material.
Transport can occur
• Across international borders
• Within a country
• Within a facility
Definitions of some terms according to IATA Dangerous Goods Regulations.
1. Dangerous Goods:
Articles or substances which are capable of posing a risk to health, safety, property or the environment
Those goods which meet the criteria of one or more of the nine UN hazard classes
These classes are: Class 1 Explosives
Class 2 Gases
Class 3 Flammable Liquids
Class 4 Flammable Solids
Class 5 Oxidizing substances and Organic Peroxide
Class 6 Substances affecting health
6.1 Toxic Substances
6.2 Infectious Substances
Class 7 Radioactive Material
Class 8 Corrosives
Class 9 Miscellaneous Dangerous goods
2. Infectious substances: are substances which are known or are reasonably expected to contain human or animal pathogens such as:
Cultures which are the result of a process by which pathogens are intentionally grown.
Patient Specimens which are those collected directly from humans or animals. Examples include: blood, sputum, urine, tissue biopsy, swabs, and body parts
3. Category A:
An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in healthy humans or animals.
4. Category B:
An infectious substance which does not meet the criteria for inclusion in Category A. Examples of Proper Shipping Names
Category A
UN 2814 – Infectious substance, affecting human
UN 2900 – Infectious substance, affecting animals only
Category B
UN 3373 – Biological substance, Category B
Dry Ice
UN 1845 – Dry ice
UN 1845 – Carbon dioxide, solid
References: 1. CWA 15793 (laboratory biorisk management standard guideline)
2. jennifer, G., M. Reynold.2015. Laboratory biorisk management.

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