Introduction To Biosafety 

Biosafety is a discipline that deals with the safe containment of infectious microorganisms (also called biohazards). It is a framework based on safety equipment, safe practices, and structures designed to protect workers, communities, and the environment from an unintentional release or accidental exposure to toxins and infectious agents. A biosafety program comprises of:

1. Actions that would have to be in place to identify a biological hazard
2. Assessment criteria to evaluate the risks to the health of people, wildlife, livestock, and the environment
3. Actions to minimize the risks to the health of people after the identification of the biological hazard

Good Laboratory Practices

Good Laboratory Practices (GLP) ensure researchers can maintain a high quality of non-clinical laboratory work with integrity. The pharmaceutical industry is where researchers test new drugs on animals before approval. GLP provides a framework for the perfect planning, performance, recording, monitoring, and reporting of laboratory studies. 

GLP applies only to non-clinical laboratory work. Good Clinical Practices (GCP) governs clinical studies. 

The elements that are an integral part of GLP are:

1. Personnel- The personnel carrying out the laboratory and handling the equipment should be appropriately qualified.

2. Facility- The equipment used for laboratory work must regularly undergo inspection checks and maintenance. Workers must also calibrate instruments at regular intervals.

3. Documents- Every laboratory must contain documents of written procedures for specific activities. There must also be documents that record and report the study’s findings.

4. Test and Control Articles- People use control articles to calibrate an instrument. Test articles record the stability, strength, purity, and other characteristics of each test/study.

Risks Related to GMOs

We can now transfer genetic material from any species into any organism through biotechnology. Modifying a single gene has the potential to affect the entire genome. Predicting the outcome of genetic modification is difficult. It could result in unintentional side effects, which biologists may not even recognize. Some of the risks include:

1. Genetic Contamination

GMOs introduced into the environment may interbreed with wild species. This interbreeding could forever alter a species’ natural behavior and interaction with its ecosystem.

2. Rivalry with Natural Species 

GMOs have a faster growth rate, providing them with a competitive advantage over biological species. Their rapid growth rate could make them an invasive species, destroying natural habitats.

3. Monitoring Problems

Once we release GMOs into the environment, it would be almost impossible to manage and eliminate if some unforeseen problem arose due to their introduction. 

International Rules & Regulations for Biosafety & GMOs

WHO (World Health Organization) has long recognized biosafety as an important international issue. Since 1983, WHO has regularly published manuals to help countries adhere to global biosafety standards. They ask countries to consider factors such as:

1. The potential result of exposure to a biohazard
2. The natural route the infection takes
3. Other possible routes of infection (such as ingestion, airborne, etc.)
4. The stability of the organism in the environment
5. The concentration of the organism/infection 
6. The presence of a host for the infection. The host could be a human or an animal
7. Previous clinical reports or reports on laboratory-acquired infections
8. Genetic manipulation of the organism causing the infection
9. Local availability of elements needed for a therapeutic intervention

Introduction To Bioethics

The use of biotechnology in modern times has raised many ethical concerns. These ethical issues need to be carefully considered by responsible figures in the industry and are referred to as Bioethics. If not, these issues pose a serious threat to humans, their health, well-being, society in general, and the environment. Some examples of ethical concerns regarding the use of biotechnology include:

1. Pre-birth Genetic Testing

Biotechnology offers an effective solution to parents risking transmitting a genetic disease to their baby. Parents can now decide which gene combinations they’d like their offspring to inherit and which ones they don’t want. However, there is a growing fear that some parents may misuse this biotechnological ability. Its misuse could occur by parents selecting desirable traits such as gender, hair color, and behavior. This could result in what some people are beginning to call ‘designer babies.’

2. Stem Cell Therapy

Before we understand the ethical concerns over stem cell therapy, let us first learn what stem cells are. These cells have not undergone differentiation, meaning they can divide and grow for long periods. There were some reports of embryos used in therapeutic cloning. Following this, the governments of many countries established strict regulations to govern stem cell research.

3. Mouse Bioassays

A mouse bioassay refers to the use of a mouse to determine food safety. Scientists extract material from a portion of food and inject it into a mouse. If the mouse lives, the food is safe for consumption, whereas the food is unsafe if it dies. Such complete disregard for an animal’s life is the prime bioethical concern in mouse bioassays. 

Ethical Issues Related to Reproductive & Cloning Technologies

Many people believe that an embryo deserves respect. The selection, manipulation, and destruction of genetic material in an embryo are highly unethical. Many babies born as a result of such procedures develop morbidities. Some core issues concerning reproductive technologies are:

1. Religion. Almost all religions believe that conception should occur naturally, i.e., via coitus. People view any other form of conception as ‘unnatural.’ 
2. Only the rich can afford to undergo reproductive treatment. A large section of the population does not have access to such technology. This creates inequitable access. 
3. The loss of embryos in IVF. IVF procedures create a surplus of embryos. Doctors select only a few of these with the best traits parents would like in their children. The rest of the embryos need to be destroyed owing to their non-usefulness. This destruction of so many embryos is very unethical. 

A majority of people worldwide condemn human reproductive cloning. This condemnation results from the physiological, social, and psychological risks associated with cloning. Many molecular tests must be conducted on a cloned embryo. These tests are necessary to check whether the cloned embryo is fully ready to be implanted within a mother’s womb. Aside from the several required tests, pregnancy from a cloned embryo is not guaranteed. Reproductive cloning is considered unethical since it is associated with a very high likelihood of loss of life. 

Issues To Transplants and Eugenics 

A transplant involves transplanting an organ or tissue from a donor to a receiver. Organs and tissues can either be transplanted from an ordinary being, a cloned being, or a different species altogether. Transplants mainly occur when a human has lost or damaged an organ or tissue and needs one. However, people have raised many ethical questions over transplants. They include:

1. Why should we treat our bodies as commodities?
2. Does a person who has abused their body through smoking and drinking deserve a new organ?
3. Should a person be given a second organ if a first transplant has failed in their body?
4. Who decides if organs should be given to one person instead of one organ each to several needy people?

Some of the ethical questions above result from the severe unavailability of donor organs. Most people are reluctant to get transplanted with an organ from another species and cloned beings. They fear this since these transplants could introduce new infections into their bodies. 

Eugenics refers to the selection of genes to improve a population’s health. Eugenics aim at improving the genetic composition of humans. Through eugenics, people can produce children with traits that benefit humans. Some issues surrounding eugenics include:

1. Compulsion or coercion from governments or third parties to change a person’s natural reproductive behavior.
2. Setting up unrealistic and arbitrary standards of human perfection.
3. The inequities that might arise from offering people the choice of eugenics.