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Biosafety Issues

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Introduction on Biosafety

The procedures, policies and principles which are adopted to safeguard the environment and humans are called biosafety. It can also be said to be containment principles, strategies, and practices that are used or practised to prevent exposure to pathogens and toxins. The primary objective behind these biosafety measures is to keep a check on harmful biological agents, chemicals, radiation, etc. These biosafety measures have earned so much importance because of their benefits to public and environmental safety. 

Rules and Monitoring Body for Biosafety

The people should be made aware of the rules, regulations, and monitoring bodies. As researchers, the one who has all knowledge about biosafety issues and measures which should be taken care of to perform all these activities. An agreement was adopted by 167 countries including many countries of the United Nations on biosafety issues named “The Cartagena Protocol on Biosafety” and its enforcement was done in the year 2003. 

The main aim of this protocol is given below:

1. One of its aims is to ensure the safe movement of living modified organisms across boundaries.

2. It also functions by framing and sharing the principles and methods for risk assessment by taking biosafety measures i.e. by clearinghouses. 

Authorities that Regulate Biosafety Measures

There are so many authorities like the Genetic Engineering appraisal committee(GEAC), Institutional Biosafety Committee(IBSC), State Biotechnology coordination committee and many more that regulate biosafety measures. A few of them are listed below with their description.


A. The Biotechnology Regulatory Authority of India (BRAI): 

The main aim of this regulatory body is to regulate the use of genetically modified organisms (GMOs), as per the rules of the Bill introduced in the Parliament in 2013.



This authority had signed the Cartagena Protocol and by this protocol, a regulating body was set up.

C. National Technical Commission on Biosafety(CTNBio):

CTNBio is formed under the Ministry of Science and technology. The duties of this authority include forming regulations and guidelines to facilitate biotechnology work at different stages ensuring biosafety. Thus,  protecting human health and the environment from any unintended adverse effects.

Advantages of Biosafety Issues

Following the biosafety rules is a must to avoid any biosafety issues. Some of the advantages of biosafety issues are listed below:


A. Eliminating Risk: 

It stops organisms from direct exposure to any kinds of pathogens, harmful rays. Etc. 


B. Use of a High-Efficiency Particulate Filter: 

Here we use HEPA to stop organisms or human beings from coming in direct contact with these harmful particulates. These filters can also trap various viruses, bacteria and other microorganisms too. 


C. Inbuilt Ventilation System: 

It stops the entry of harmful gases, which can destroy your lungs if you breathe in.

D. Giving a Sterile Environment. 

E. Using Rubber Gloves.


Significance of Biosafety

Modern research is constantly being carried out on exotic microbes and discoveries are researched upon. However, if such research practices are not monitored, they can be a huge threat to humanity. Biosecurity and Bioterrorism are two new major trending issues that have arisen recently in the wake of research on lethal agents and microbes. They need to be kept under control for the interest of human and environmental safety. Biosafety is thus necessary to ensure the safe use of research and technology.


Different Levels of Biosafety

Biosafety is categorized into different levels on the basis of biocontainment precautions made to protect laboratory personnel as well as the surrounding environment and the community. These levels are being set up on the basis of organisms that are being researched in the given laboratory settings. 


Now, an obvious question. What is a biosafety laboratory? Biosafety laboratories are carefully designed laboratory environments with a variety of highly specific technological types of equipment where infectious or potentially infectious agents are contained for research purposes.


The designated authority body forms these biosafety lab levels as a method to exhibit specific controls for the containment of microbes and biological agents. Each new Biosafety level builds on the previous level thereby forming layer upon layer of constraint barriers. This ensures strict monitoring of the research practices.


The following criteria are imperative to determine the lab levels.

  1. The severity of infection.

  2. Transmissibility.

  3. Nature of work conducted.

  4. Origin of microbe.

  5. Risks related to containment.

  6. Agent in question.


The reason that these biosafety levels are necessary is that they decide the type of work practices that are allowed to take place in a particular lab setting. The four biosafety levels are explained below.


Biosafety Level 1:

It is considered to be the lowest biosafety level and applied on those organisms which are least treated to the laboratory workers along with the surrounding or environment. At this level, they are not segregated from the general buildings. Organisms that come under biosafety level 1 are E.coli, skin bacteria, yeast.


In this laboratory setting, research takes place on benches without the use of special contaminant equipment. At this level, it is not required to be isolated from the surrounding activities.


However, it requires immediate decontamination after spills. Infection based materials are to be decontaminated prior to disposal.


Facilities which are followed are biosafety level 1 are: 

A. Mechanical pipetting

B. Safe handling of sharps

C. Avoiding splashes of aerosols

D. Washing hands properly 

E. Prohibition on drinking, smoking and food in the laboratories

F. Signs of biohazards

G. Use of protective equipment such as gloves, goggles, lab coats, gowns

H. By removing all the infectious materials.


Biosafety Level 2:

These agents are responsible for causing human diseases, like the encephalitis virus, HIV, Staphylococcus aureus. One who works in such labs has to be very attentive, careful and take greater care to prevent themselves from any injuries such as cuts, ingestions, etc.


These labs not only include the same standard microbial practices as stated in level 1 but also include enhanced measures due to the potential risks of the above-mentioned microbes.


Precautions that are taken care of in level 2 are: 

A. All should use protective equipment like goggles, glasses, face shields, etc.

B. The process which can cause infections should be carried out in proper care.

C. Before disposing waste material should be decontaminated. 

D. Eyewash should be there along with the basin.

E. Biohazard signs should be provided.

F. The laboratory has self-closing lockable doors.

G. Access to such labs for outsiders should be denied.


Biosafety Level 3:

At this level, we do experiments on those pathogens which cause life-threatening diseases like West Nile virus, yellow fever virus, bacteria causing tuberculosis, etc.


At this level, the microbes are so moemntous that the work is often strictly controlled and registered with the appropriate government agencies. The workers working under Biosafety level 3 are also under medical surveillance. Also, access to such labs is strict and controlled at all times.


Precautions that should be taken at this biosafety levels are:

A. Equipment like respirators should be used.

B. All activities should be performed under biosafety cabinets. 

C. Each door should have access away from the general building.

D. A hands-free sink and eyewash should always be available near the exit.

E. Solid front wrap-around gowns, scrub suits and coveralls are often required.

F. Exhaust air should not be recirculated and there should be sustained directional airflow from clean areas towards potentially contaminated areas. 


Biosafety Level 4: 

At this biosafety level, humans work under high-risk zones i.e. in contact with exotic microbes. If one gets infected with these microbes, it can take their life too. So proper precaution is a must in level 4.


A Biosafety level 4 laboratory is extremely isolated often located in a restricted zone away from the residential premises.


Some of the biosafety measures, which should be followed are: 

A. Changing of clothes and should take shower lab work.

B. All used material should be properly decontaminated. 

C. Such experiments should be carried out under class 3 safety cabinets. 

D. The laboratory should have a dedicated supply and exhaust air, apart from vacuum lines and decontamination systems.

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FAQs on Biosafety Issues

1. Explain the Importance of Biosafety measures?

Biosafety measures is a practice that is based on containment principles, technologies, to prevent anyone from unintentional direct exposure from harmful pathogens, toxins, other accidental releases, etc. Because of this reason biosafety plays a very crucial role as it decreases the chances of having any life-threatening disease caused by biological agents.

2. Write a few Steps which are taken to Improve Biosafety Measures?

Some of the steps taken to improve biosafety measures are discussed below:

  • There should be proper approval for those areas where genetic engineering processes occur. 

  • It is necessary to follow biosafety guidelines. 

  • Biosafety seminars are conducted to spread awareness of biosafety measures among the researchers, producers of Genetically Modified Organisms, policymakers, administrators and environmentalists.

  • Different biosafety levels have been proposed for the laboratories depending on pathogens being used while doing experiments. 

3. What are the advantages and disadvantages of biosafety?

Biosafety has multiple advantages. Some of them are listed below.

  1. It lowers the risk and exposure to toxic and harmful elements.

  2. Inbuilt ventilation systems stop the entry of harmful microorganisms and gases thereby guarding human and environmental health.

  3. Biosafety provides a sterile environment.

  4. The usage of rubber gloves keeps humans safer and protected from pathogens.

  5. Using high-efficiency particulate filters like EPA prevents organisms or humans from being in direct contact with any harmful particulate matter. 

Since it is a practice developed to protect human and environmental health, Biosafety has almost no disadvantages.

4. What is the main aim of the Cartagena Protocol on Biosafety?

The primary aim of “The Cartagena Protocol on biosafety” is described below.

  • To enhance secure movement of living modified organisms across the boundaries. 

  • To deal with the framing and sharing of the methods and principles for risk assessment by taking biosafety measures by clearinghouses.

5. Explain the need for Biosafety practices?

With the advent of genetic engineering and constant development in the fields of biotechnology, it has also led to practices that can have adverse negative effects on human and environmental health. To protect human and environmental health, various regulatory authorities have come together and formed Biosafety rules to safeguard our planet and its lives from prevalent and unforeseen Biosafety issues. Biosafety guidelines are imperative to be in practice for reducing the risks of harmful biological agents on human health, setting rules to prevent animal infestations and prevent the transmission of harmful diseases from animal to humans, etc.

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