Introduction to Biosecurity and Biosafety:
Biosecurity is the prevention of misuse, loss, theft and unauthorized access, and intentional release of harmful agents like pathogens, their toxins, and the equipment involved in doing so. The Biological and Toxin Weapons Convention was formed in 1975 to address the bad use of bioweapons.
The biosecurity functions are at three levels:
- Political level: Here, the legislation is formed based on which biosecurity system is established.
- Administrative level: In this level, the Biosecurity Agency, dedicated to government and licensing activities, is established. Training begins at this level, with the employees of The National Biosecurity Agency can advise lawmakers.
- Institutional level: It includes academic institutes, research institutes, and diagnostic laboratories. The biosecurity officer provides training to his colleagues.
Key Elements of a Biosecurity System:
- Biosecurity legislation
- National biosecurity agency
- System for licensing and controls
- Biosecurity Culture
Biosecurty Phases and Timelines:
The phases and periods of the biosecurity system are as follows.
Gap analysis: Initial phase
In this phase, the biosecurity state is assessed, and the biosecurity needs of the country are identified. For gap analysis, the size of the community, i.e., research facility, pharmacy, hospital, etc, where the biosecurity will be working should be known. Questionnaires can be used to collect information about the state of biosecurity, and onsite visits can also be made. An example of gap analysis can be accessing the employee’s identity because they could have access to the control elements and reports of theft of elements from freezers.
Preparing biosecurity law: 6 months
For the preparation of Biosecurity law, it has to be clarified which government will perform the job: the Ministry of Health, or Department of State, or the Ministry of Defense. There has to be a balance between biosecurity needs and legitimate scientific freedom. Good communication is key because facilities should know about the creation of new laws. Different biosecurity agencies could have conflicting agendas, so they need to be resolved before the final biosecurity law is enacted. The law should be supplemented with an Executive Order drafted by the Agency. All relevant stakeholders, including the facility, military institutions with bioweapons, Political parties, local government, and educational institutions, should be involved in law law-making process.
Establishing National Biosecurity agency: 24 months
The biosecurity agency forms the executive order for the legislative body. The agency should advise the facilities to live up to the biosecurity standards. There has to be openness between the agency and facilities to share biosecurity problems. Agency staff should be competent in per specialty in the area of health, microbiology, and bio preparedness. The agency does case handling, drafting orders, casework reception, and clerical activities. The agency is involved in training biosecurity officers, performing site visits, and licensing the facilities. The executive order formed by the Agency includes: control list, licensing requirements, requirement for inventory control, transport, deposit, reporting of thefts, and can create additional regulations and penalties.
Practical implementation of Biosecurity: 30 months
After the biosecurity Agency is formed, facilities that want to be licensed under the biosecurity and want to be accredited should follow the procedure of licensing procedure. For this, the Agency creates necessary documents including: a license application form, a license template, and the name of a biosecurity officer. Caseworkers then handle the process of licensing.
Enforcement, education, and revision of law: 48 months
The so-formed biosecurity law is now enacted, and the agency can add or update the regulations. This has to be communicated to the participating facilities.
Biosafety Levels and Risk Group Classification:
The integration of containment and safety handling techniques, tools, and procedures to stop the accidental release of harmful chemicals is known as biosafety. Breach in biosecurity example: Plague killed an Illinois scientist in 2009. Biosafety comprises standard working principles, management policies, and engineering controls.
A biosafety level (BSL) is the level of biocontainment precautions that are required to handle dangerous biological agents in an enclosed facility. The levels of biosafety are set so as to prevent the lab personnel from any laboratory mishap through the integration of engineering controls, management policies, and standard work practices.
BSL is designed in ascending order based on the protection provided to the working personnel and the environment. The level of containment ranges from BSL-1 to the highest BSL-4 and gives a glance into why every laboratory cannot perform all the tests.
Based on the Biosafety levels ranging from BSL-1 to BSL-4, risk group organisms are categorized, i.e., Risk group 1, Risk group 2, Risk group 3, and Risk group 4, respectively.
- BSL-1 lab deals with Risk group 1 agents. In healthy individuals, these microbes are not known to regularly cause illnesses. E.g., nonpathogenic E coli, Bacillus subtilis, canine hepatitis virus, etc.
- BSL-2 lab deals with Risk group 2 microorganisms. These microorganisms are associated with human disease and are acquired from any human-derived fluids, tissues, but the diseases are preventable and curable. It poses low to medium risks to the laboratory personnel. Example: Salmonella species, Hepatitis B, Mumps, Measles, etc.
- BSL-3 lab deals with Risk group 3 agents. Although these organisms are curable, they can infect people through the respiratory system and produce severe or even fatal diseases. Example: Mycobacterium tuberculosis, SARS coronavirus, Yersinia pestis, Yellow fever virus, etc.
- BSL-4 lab deals with Risk group 4 agents like Nipah virus, Ebola. There are no immunizations or therapies for these hazardous and unusual substances, which provide a significant risk of aerosol-transmitted laboratory infections that can have life-threatening or even deadly outcomes.
Biosafety protocols like changing protective clothing and decontamination it before laundering, Institutional policies about how specimens should be collected and stored to prevent exposure to personnel, Immunization of laboratory personnel against common pathogens isolated in the laboratory, Biosafety manual with needed waste decontamination or medical surveillance policies, Biohazard A warning sign is posted outside the laboratory, an Eye wash station. Hands should be washed after working with microorganisms and before leaving the laboratory.
Primary and Secondary Containment Barriers:
Primary barriers include
- A Biosafety cabinet (BSC)
- Use of a respirator is recommended if there is a risk of infection through the air.
- Removal of wraparound gowns, scrub suits, lab coats, gloves, and face protection while leaving the laboratory.
- Use of Protective eyewear in procedures having higher chances of splashes and
- The use of Gloves while handling the specimens and disposing of them after use is adopted.
Secondary barriers include
- An Isolated zone or a separate building
- HEPA filter usage and decontamination system
- Air lock system and absence of windows or sealed windows
- Self-closing double doors
- Double door autoclave for glassware
- Eye wash station available near the exit
- An Air handling system to ensure negative air flow
References:
- Burnett, L. C., Lunn, G., & Coico, R. (2009). Biosafety: guidelines for working with pathogenic and infectious microorganisms. Current protocols in microbiology, Chapter 1(1), 111–1A.1. https://doi.org/10.1002/9780471729259.mc01a01s13
- Centre for Biosecurity and Biopreparedness (2015). An efficient and practical approach to biosecurity (1st edition). Centre for Biosecurity and Biopreparedness statens serum Institute