Biosafety Issues: Biosafety issues refer to the procedures, policies, and principles to be adopted to safeguard the environment and the human population. It refers to the containment principles, strategies, and practices that are adopted to prevent exposure to pathogens and toxins. Its main objective is to keep a check on harmful biological agents, toxins, chemicals, and radiation. With the advent of genetic engineering, biosafety measures have gained importance to ensure public and environmental safety.

The people should be made aware of the rules, regulations, and monitoring bodies. Researchers should be the first ones to have the complete knowledge of the biosafety issues and measures so that safety is ensured at the root level. A multilateral agreement “The Cartagena Protocol on Biosafety” has been adopted by 167 countries, including many countries of the United Nations. The protocol was enforced on 11th September 2003. It had the following objectives:

• It aimed at ensuring the safe movement of the living modified organisms across the boundaries

• Frame and share the principles and methodologies for risk assessment through Biosafety Clearing House

Importance of Biosafety Issues

The areas where genetic engineering practices are being carried out require prior approval from the regulatory authorities of the country. It is mandatory to follow the guidelines to minimize biosafety.

The awareness about biosafety has been increased among the researchers, producers of Genetically Modified Organisms, policymakers, administrators and environmentalists.

Efforts have been made by the OMICS Publishing Group USA, on publishing Biosafety journals and organizing international conferences to make everyone aware of the biosafety issues and the measures to rectify them. Though modern research is a boon to human population yet can be dangerous if not used wisely.

Biosecurity and bioterrorism are emerging issues nowadays that need to be checked upon in the interest of human and environmental safety. Biosafety is therefore important to ensure the safe utilization of technology.

Certain biosafety levels have been proposed for the laboratories depending upon the pathogenicity of the microbes being worked upon. These protect the environment and the surroundings from the hazards of such microbes.

Biosafety Levels

Biosafety Levels (BSL) are used to identify the protective measures needed in a laboratory setting to protect workers, the environment, and the public. The levels are defined in Biosafety in Biomedical Laboratories (the BMBL). Biosafety level designations in the BMBL outline specific practices and safety and facility requirements. There are many ways to combine equipment, practices, and laboratory design features to achieve appropriate biosafety and biocontainment. These are determined through biological risk assessments specifically conducted for each experimental protocol.

Risk assessments are conducted by evaluating the way in which the infectious agents or toxin is transmitted and its ability to cause disease, the activities performed in the laboratory, the safety equipment and design elements present in the laboratory, the availability of preventive medical countermeasures or treatment, and the health and training of the laboratory worker. For example, some procedures with an infectious agent or toxin may be conducted under BSL-2 conditions, but other procedures with the same infectious agent or toxin that increase the risk to the worker or environment, such as the creation of airborne droplets or sprays, or large scale production, may require that the work be conducted under BSL-3 conditions.

At any given biosafety level, there will be strict requirements for laboratory design, personal protective equipment, and biosafety equipment to be used. Standard Microbiological Practices are required at all biosafety levels and are good practice for experiments below the BSL-1 threshold. 

Activities and projects conducted in biological laboratories are categorized by biosafety level. The four biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with BSL-4 being the highest (maximum) level of containment. There are additional specific rules and designations for animal research (ABSL), agricultural research (BSL-Ag), and other types of research. These other types of labs require their own specific set of rules and regulationas, because they are dealing with larger organisms, such as plants, animals, and insects. 

Following are the biosafety levels described in detail:

Biosafety Level 1

This is the lowest biosafety level and is applied to the agents which pose the least threat to the laboratory workers and the environment. These are not isolated from the general building. The non-pathogenic strain of E.coli is worked at a Biosafety level 1.

The research is carried out on the benches without any special contaminant equipment. The biosafety level 1 facility are as follows:

• Mechanical pipetting

• Safe handling of sharps

• Avoiding splashes or aerosols

• Washing hands

• Prohibition on drinking, smoking and food in the laboratories

• Signs of biohazards

• Protective equipment such as gloves, goggles, lab coats, gowns

All the infectious materials should be decontaminated before being disposed of.

Biosafety Level 2

This includes agents that cause human diseases. For e.g., encephalitis virus, HIV, Staphylococcus aureus. Personnel working in these labs requires greater attention to prevent any injuries such as cuts, ingestions, etc.

The following practices should be carried out in a Biosafety Level 2 laboratory:

• Use of protective equipment such as goggles, glasses, face shields, etc.

• The procedures that can cause infections are carried out in biological safety cabinets

• The waste material should be decontaminated before disposal

• An eyewash and a sink should be readily available.

• Biohazard signs should be provided

Biosafety Level 3

This includes working on such pathogenic microbes that can cause serious disease through inhalation. For e.g., West Nile virus, yellow fever virus, bacteria causing tuberculosis, etc.

The common requirements in a BSL 3 laboratory include:

• Protective equipment including respirators is required

• All the work should be performed under proper biosafety cabinets

• The door should have access away from the general building

• The researchers are under medical surveillance and are immunized against certain microbes 

Level 4

This includes work with highly dangerous and exotic microbes. Infections through these microbes cannot be treated or immunized and are usually fatal. For e.g., Ebola and Marburg virus.

The common requirements in a biosafety level 4 laboratory are as follows:

• The researchers should change their clothes and shower while exiting

• All the materials should be decontaminated

• All the experiments should be carried out under class III safety cabinets

Table 1: Exposure Avoided by Biosafety Practices

The laboratory is isolated present in a separate building and the entry to this zone is restricted.

Biosafety Equipment

Biosafety equipment consists of both the materials and personal protective equipment that keeps laboratory personnel safe. Biosafety cabinets are a very important component of laboratory equipment that allows laboratory workers to safely handle infectious agent or toxins. Biosafety cabinets can be divided into several classes. Biosafety cabinets remain one of the key pieces of equipment to protect workers and the environment from infectious agents or toxins in biological laboratories.

Personal Protective Equipment is another very important component of biosafety equipment in the laboratory. Personal protective equipment includes gloves, masks, lab coats, and other wearable equipment (such as safety glasses and respirators) that protect laboratory workers from infectious agents and toxins in the laboratory.

Biosafety equipment can also include equipment used in building design to prevent the release of infectious agents and toxins. Examples of protective features in buildings include double doors and negative air pressure rooms. Air filtration and waste management systems can also be very important for biosafety. For more information on these types of equipment, please see biosafety laboratory design.

Needles, centrifuges, glass instruments, and other tools can all pose unique hazards to laboratory workers. Over time, the design of this equipment has changed to improve safety and reduce risks. Biosafety innovation is an ongoing process of hazard identification and design changes to address new or newly recognized risks.

Safety advances in biological laboratories have been made in the design of new equipment and in standard laboratory practices​ based on new information about biological hazards. The proper use of equipment, adherence to standard operating procedures, and good practices in the laboratory are all crucial to keeping laboratory workers, the community, and the environment safe.

A few examples of the ways safety equipment can reduce a laboratory worker’s risk of exposure are listed below and show how important well-designed equipment in laboratories is for ensuring safety (Table 1).

Pipettes

In the past, researchers would use “mouth pipetting” to suction liquid into a glass tube. This practice was a major source of laboratory acquired infections. The invention of bulb and mechanical pipettes was a major advance in preventing laboratory acquired infections.

Mouth pipetting poses a risk of exposure to the scientist. Now, scientists use different types of pipettes and aerosol barrier pipette tips that protect scientists from exposure to infectious agents or toxins or laboratory chemicals.

Needles and Other Sharps

Items present in a laboratory that could puncture the gloves and skin of a laboratory worker are a potential risk. Even in situations where there is no risk of infection, scalpels or needles can cause serious injuries to workers. In laboratories, needles, blades, and broken glass are referred to as “sharps” for disposal purposes. Over time, both technology and systems have changed to minimize the danger of handling sharps in the laboratory.

In many laboratories, work with needles is common, particularly if the laboratory is handling animals. There is a significant risk of accidental exposure to an infectious agent or toxin or chemical material if a worker sticks themselves with a used needle. As a safety precaution, some laboratories now use “retracting needles”. The needle retracts into the barrel following injection to protect healthcare workers and others from accidental needle stick injuries.

Clearly labeled containers are available for disposal of sharps, including needles, reducing the risk of accidental exposure or improper waste disposal. 

Reducing the amount of glass present so there are fewer materials that could break and puncture gloves or injure a worker can minimize risk. Pipettes, containers, and other tools are now frequently made of temperature -resistant plastic. This means that many items are single-use to avoid any possibility of contamination or improper cleaning.

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