Ethical Implications of Biotechnology and Genetic Engineering

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Genetic engineering refers to the manipulation of an organism's DNA through the introduction of foreign elements into its genetic code. This can be done by combining genes from different species or by introducing new genes depending on the situation.[1] Genetic engineering has led to the creation of new plant and animal varieties and the improvement of existing ones. For example, scientists have developed genetically modified crops that are resistant to pests and diseases, which helped to increase food production and improve food security. Additionally, genetic engineering has been used in the medical field to develop new treatments for genetic disorders and diseases.


The earliest examples of genetic engineering go back to the Neolithic period when artificial selection was(link) used to breed plants and animals with the most desired traits. Gregor Mendel was another pioneer of genetic engineering, who discovered genetic inheritance. Since then discoveries and advancements in DNA sequencing, plasmid technology, and CRISPR Cas-9 all have spearheaded the development of new genetic technologies.

Genetic engineering regulation varies by country, while most of the world evaluates the application of each genetically modified organism (GMO) on a case-to-case basis. Additionally, several controversies exist surrounding the use and sale of GMOs, including labeling and accessibility.[2]


Genetic Engineering Techniques

Genetic engineering not only allows for the manipulation of an organism’s genetic information, but it also allows for the insertion, deletion, silencing, and exemplification of a variety of genetic traits.

Plasmid Technology

At this time, the most common genetic engineering technology makes use of the insertion of the genes of plasmids(LINK) derived from common and harmless strains of laboratory bacteria such as E. Coli. These plasmids are the main driver of the communication of genetic information between organisms [3]. They are physically separated from the DNA of the bacteria and plasmids have the ability to reproduce without the help of the host bacteria. The characteristic that makes plasmids so viable within genetic engineering is the fact that when a foreign DNA fragment is inserted within the cyclical structure of the plasmid, it makes copies of the inserted gene.[4]

A plasmid is a small circular DNA molecule found in bacteria and some other microscopic organisms. [4]

When these modified plasmids are inserted into a superior organism, scientists are able to use them in a way that amplifies the hosts' resistances, growth rates, ability to silence unwanted mutations, and others. This technology is very widespread, as scientists have created software that records the DNA sequences of plasmids that have a variety of functions.[5]

One example of how plasmid technology is still being applied in genetic engineering is within agriculture. Here, plasmids are used to develop crops more resistant to disease, pests, and environmental stressors. This has the potential to increase crop yields and reduce the need for chemical pesticides, making agriculture more sustainable and environmentally safe. Another way plasmid technology is used in agriculture is to develop crops more tolerant to environmental stressors, such as drought and high temperatures. This has the potential to improve food security in regions susceptible to environmental stressors and can help reduce the risk of crop failures. [6] Additionally, plasmid technology is being used to produce crops with a higher nutritional value when compared to their unmodified counterpart. These plants have the ability to improve the quality of life for those who do not have consistent access to vitamin and nutritionally-rich foods. Lastly, plasmid technology is being used to develop more efficient crops using resources, such as water and fertilizer. This has the potential to reduce the environmental impact of agriculture and improve sustainability. Plasmid technology still holds significant potential and applications, offering a wide range of benefits. Despite this, the risks associated with these still need to be addressed and thoroughly studied. [6]

CRISPR Cas-9 Technology

CRISPR Cas-9 technology is an adaptation of a previously existing genome editing system used by a specific type of bacteria for immune defense. When this host cell would be infected with a pathogen, the bacteria would create a pattern known as a CRISPR array. This array would allow the bacteria to remember the virus based on this pattern, by being able to assign the Cas-9 enzyme to break down the pathogen. This recognition allows the bacteria to much more efficiently fight off the pathogen or similar pathogens.[7]

New technology has adapted this defense system in order to edit DNA in foreign cells. In this instance, scientists modify the CRISPR with a portion of code that attaches itself and the Cas-9 enzyme to the target cells DNA. When this system is introduced, the Cas-9 protein cuts the DNA at a specified location. The scientists also code in one of two options. The first is to allow the host cell to repair the faulty DNA via its own cellular machinery. The second is to introduce a customized DNA sequence and replace it where the Cas-9 protein cut the DNA. This effectively grants the ability to either have the cell self-heal faulty DNA, or to introduce new DNA while simultaneously removing the old DNA.[7]

This technology is different and much newer than plasmid technology for gene editing, so it is currently only used in clinical trials on microogoranisms and animals. Scientists predict that when perfected, this technology could provide an alternative solution to diseases such as cystic fibrosis, Fabry’s disease, sickle cell anemia, and many other genetic related diseases.[7]


Risks Associated with Genetic Engineering

Although genetic engineering holds the potential for significant benefits, there are also several risks associated with genetic engineering that should be carefully considered.

Genetic Warfare & Biological Weapons

It is important to consider both the pros and cons that could result from the creation of biological weapons. On the one hand, these weapons can be used for defense against foreign weapons used for bioterrorism. These weapons can have the potential to save lives that traditional military-grade weapons could not stop.[8]

However, the development of these weapons and their use in warfare also pose serious questions surrounding ethics. These issues include the fact that these weapons could be used to target groups of people based on specific genetic traits. Additionally, the long-term health and environmental effects of these types of weapons are unknown and could have unintended and catastrophic results.[9]

The creation and implementation of these weapons also bring about issues of access, control, and development. As with all weapons, their falling into the wrong hands could lead to mass destruction, death, and potentially genocide. An example of these weapons falling into the wrong hands is during the Second World War, the Japanese military approved and carried out the poisoning of over a thousand water wells across various Chinese villages. This act was done in order to study cholera and typhus outbreaks.[9]

Lastly, the creation and use of these weapons bring about a debate concerning “Just war”, which concerns the judgment and justification of how, why, and by what means war is carried out. [10]These weapons, depending on their intended use and destructive power could breach the stipulation that means of warfare must be proportional and necessary, and that the use of such weapons much not cause unnecessary harm to civilians or non-combatants. [11]

Environmental Risks

Again, it is important to consider both the potential benefits and drawbacks that could result from the use of genetic engineering in the environment.

On the positive side, using genetic engineering has the potential to provide complex solutions to a variety of environmental issues such as certain aspects of climate change as well as a loss of biodiversity.[12] For example, genetic engineering can be used to modify existing crops in order to become more resistant to a variety of diseases and pests, reducing the need for harmful pesticides and herbicides.[13] Additionally, genetic engineering can be used to create crops that are more drought-resistant, helping to mitigate the effects of drought and famine in vulnerable regions.[14]

However, the use of GMOs in the environment can also pose significant environmental risks. Without thorough and extensive testing, GMO products can have unintended consequences on the surrounding environment. This includes but is not limited to the displacement of native species, the creation of invasive species, and the spread of harmful genes to other organisms.[15] Additionally, the long-term impacts of GMO products on the environment are not yet fully understood, and there is a potential for unforeseen consequences that could have negative impacts on the environment.

Economic Risks

Lastly, it is important to consider the economic risks associated with genetic engineering, as it concerns the intersection of the scientific and economic areas of GMOs.

Generation of human anti-thrombin III by transgenic goats [16]

GMOs do possess a great ability to bring about economic benefits within the agricultural domain, by creating and expanding industries, which all stimulate economic growth.[17] For example, depending on the GMO product, genetic engineering can be used to develop new and improved medicines, leading to improved health outcomes and reduced healthcare costs.[16] Additionally, genetic engineering can be used to create crops that are more productive and efficient, leading to increased food security and reduced food prices.

Nevertheless, the use of GMOs can also have negative economic effects. Although the possibility of GMOs stimulating economic growth, this growth and benefit may not be spread evenly across all people. The monopolization of biotechnology, specifically GMOs, can empower governments and corporations who seek to dominate food markets, while simultaneously exploiting vulnerable populations and nations.[18] This commercialization of genetic engineering can result in reduced competition, increased prices, as well as reduced access to the benefits of GMOs.[18]

For example, countries such as Zambia experienced both political and economic pressure from several prominent western governments and companies. These organizations pressured the Zambian government to accept donations of maize grain. The government refused due to the fear that the modified maize plants may contaminate the local Zambian maize that already existed.[19]

Privacy and Confidentiality

Another debated aspect of genetic engineering is privacy and confidentiality. One’s genetic information is unique to each person, and concerns arise with how the personal information is stored, collected, and used.

Despite how this information is collected, there are several benefits to sharing this information. These include its use in the diagnosis and treatment of medical conditions. For example, genetic testing and identification can help identify people who are at risk of developing certain conditions, allowing them to take preventive measures or receive early treatment.[20] As mentioned previously, this information could be used for the wrong purposes, as this information can be used to create genetic weapons or technologies to target specific groups of people.[21]

Access to this information can also be used to determine or track one’s ancestry or familial relationships, which could have unintended consequences. For example, individuals may not want to share this information with others, particularly if they fear discrimination or stigma. Companies that already have access to this data for voluntary individuals include 23 and Me, AncestryDNA, MyHeritage DNA, and others.[22]


Legislature and Regulation of Genetic Engineering

Regulation of genetic engineering includes laws and international agreements that aim to protect human health, environment, as well as ecosystems across the globe. These regulations vary by country and type of GMO, but they typically prohibit the use of genetic engineering for commercial gain. The legislature also typically ensures that GMOs are only used for the purpose of advancing scientific knowledge. Furthermore, they also require that any genetically modified organisms are thoroughly tested and evaluated before being released into the environment.

Regulation in the United States

There are three governing bodies that create and ammend legislation in the United States surrounding genetically modified organisms. Those agencies are the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA). In addition to creating laws and regulations surrounding GMOs, these three organizations also monitor the impact of GMOs on the environment. [23]

How GMOs are Regulated in the United States: Governing Bodies [24]


The FDA regulates GMO foods, in order to assure that they meet the strict food safety standards that apply to all non-GMO foods. Regardless of how or where the food is created, the FDA is also responsible for enforcing the regulations on those who produce, process, store, move, and sell the food. Concerning GMOs, the EPA regulates the safety of the materials used to protect GMO food and plants from pests, insects and disease. They also regulate subtances that extend the shelf life of GMO foods. In this situation, the USDA is mainly responsible for making sure that the modifications an growth of new GMO products do not hinder or negatively affect other plants or food.[23]

Other Regulatory Processes Around the World

In Europe, the European Union (EU) has implemented the Directive on the Legal Protection of Biotechnological Inventions, which arranges legal protection for biotechnological inventions and governs the use of GMO based products in Europe. The legislation is designed to balance industry, public health, and the environment, and provides for a coordinated patent system for biotechnological inventions. [25]

In Canada, the regulation of genetic engineering is governed by the Canadian Environmental Protection Act, the Health of Animals Act, and the Food and Drugs Act. These legislations provide the framework for the regulation of genetically modified organisms (GMOs) and ensure their safe use in the environment and in food-grade products. [26]The Canadian Food Inspection Agency is responsible for enforcing these regulations and ensuring that GMOs are labeled and their health and environmental impacts are assessed before they are approved for use. [27]

In Australia, the regulation of genetic engineering is governed by the Gene Technology Act of 2000 and the Gene Technology Regulations of 2001. These acts provide laws and regulations for GMO products. [28] Additionally, they provide a framework that includes the assessment of GMOs' potential risks to human health and the environment. The Office of the Gene Technology Regulator is responsible for enforcing these regulations and ensuring that GMOs are labeled and their health and environmental impacts are assessed before they are approved for use. [29]

In China, the regulation of genetic engineering is governed by the Regulations for the Administration of Agricultural Genetically Modified Organisms and the Regulations for the Administration of Medical Genetically Modified Organisms. These regulations provide a framework for the development, production, and use of GMOs, including their safety assessment and labeling requirements. The Ministry of Agriculture and Rural Affairs and the National Medical Products Administration are responsible for enforcing these regulations. [30]

In India, the regulation of genetic engineering is governed by the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1989. These rules provide laws for the regulation of GMOs, including the assessment of their potential risks to human health and the environment, and the labeling requirements for GMOs. The Department of Biotechnology in India is responsible for enforcing these laws and regulations. [31]

References

  1. ↑ Encyclopædia Britannica, inc. (2022, December 4). Genetic Engineering. Encyclopædia Britannica. https://www.britannica.com/science/genetic-engineering
  2. ↑ Turnbull, C., Lillemo, M., & Hvoslef-Eide, T. A. K. (2021, February 2). Global regulation of genetically modified crops amid the gene edited crop boom – a review. Frontiers. https://www.frontiersin.org/articles/10.3389/fpls.2021.630396/full
  3. ↑ Encyclopædia Britannica, inc. (2016, May 24). Nuclear transfer. Encyclopædia Britannica. https://www.britannica.com/science/nuclear-transfer
  4. ↑ 4.0 4.1 Plasmid. Genome.gov. (2023, January 5). https://www.genome.gov/genetics-glossary/Plasmid
  5. ↑ Doghaither, H. A., & Gull, M. (2019, June 19). Plasmids as genetic tools and their applications in ecology and evolution. IntechOpen. https://www.intechopen.com/chapters/66546
  6. ↑ 6.0 6.1 Fang, J., Zhu, X., Wang, C., & Shangguan, L. (2016). Applications of DNA Technologies in Agriculture. Current Genomics, 17(4), 379–386. https://doi.org/10.2174/1389202917666160331203224
  7. ↑ 7.0 7.1 7.2 U.S. National Library of Medicine. (n.d.). What are genome editing and CRISPR-Cas9?: Medlineplus Genetics. MedlinePlus. https://medlineplus.gov/genetics/understanding/genomicresearch/genomeediting/
  8. ↑ Georgiev, Vassil St. “Defense Against Biological Weapons (Biodefense).” Edited by Vassil St. Georgiev, National Institute of Allergy and Infectious Diseases, NIH: Volume 2;Impact on Global Health, U.S. National Library of Medicine, 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122899/#:~:text=Biological%20warfare%20(germ%20warfare)%20is,has%20occurred%20throughout%20the%20centuries.
  9. ↑ 9.0 9.1 Frischknecht, Friedrich. “The History of Biological Warfare. Human Experimentation, Modern Nightmares and Lone Madmen in the Twentieth Century.” EMBO Reports, U.S. National Library of Medicine, June 2003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1326439/.
  10. ↑ “Just War Theory.” Internet Encyclopedia of Philosophy. https://iep.utm.edu/justwar/.
  11. ↑ Krickus, Richard J. “On the Morality of Chemical/Biological War.” The Journal of Conflict Resolution, vol. 9, no. 2, 1965, pp. 200–10. JSTOR. http://www.jstor.org/stable/173164
  12. ↑ How engineering animals and plants could help fight climate change. (n.d.). World Economic Forum. https://www.weforum.org/agenda/2021/10/deextinction-genetic-engineering-climate-change/#:~:text=Researchers%20are%20using%20genetic%20engineering
  13. ↑ Stearns, S. (2017, October 3). Genetic Engineering and Plant Protection | Science of GMOs. Uconn.edu; Science of GMOs. https://gmo.uconn.edu/topics/genetic-engineering-and-plant-protection/
  14. ↑ Khan, S., Anwar, S., Yu, S., Sun, M., Yang, Z., & Gao, Z. (2019). Development of Drought-Tolerant Transgenic Wheat: Achievements and Limitations. International Journal of Molecular Sciences, 20(13), 3350. https://doi.org/10.3390/ijms20133350
  15. ↑ 11.6: Invasive Species and GMOs. (2021, October 19). Biology LibreTexts. https://bio.libretexts.org/Courses/Fresno_City_College/Introduction_to_Conservation_Biology/11%3A_Pollution_Overharvesting_Invasive_Species_and_Disease/11.06%3A_Invasive_Species
  16. ↑ 16.0 16.1 Stearns, S. (2017, November 9). Pharmaceutical Use of GMOs | Science of GMOs. https://gmo.uconn.edu/topics/pharmaceutical-use-of-gmos/#:~:text=Genetically%20engineered%20(transgenic%2C%20GMO)
  17. ↑ Brookes, G., & Barfoot, P. (2014). Economic impact of GM crops. GM Crops & Food, 5(1), 65–75. https://doi.org/10.4161/gmcr.28098
  18. ↑ 18.0 18.1 National Geographic Society. (2022, May 20). Are Genetically Modified Crops the Answer to World Hunger? | National Geographic Society. Education.nationalgeographic.org. https://education.nationalgeographic.org/resource/are-genetically-modified-crops-answer-world-hunger
  19. ↑ Walters, Reece. “CRIME, BIO-AGRICULTURE AND THE EXPLOITATION OF HUNGER.” The British Journal of Criminology, vol. 46, no. 1, 2006, pp. 26–45. JSTOR, http://www.jstor.org/stable/23639328
  20. ↑ Bilkey, G. A., Burns, B. L., Coles, E. P., Bowman, F. L., Beilby, J. P., Pachter, N. S., Baynam, G., J. S. Dawkins, H., Nowak, K. J., & Weeramanthri, T. S. (2019). Genomic Testing for Human Health and Disease Across the Life Cycle: Applications and Ethical, Legal, and Social Challenges. Frontiers in Public Health, 7. https://doi.org/10.3389/fpubh.2019.00040
  21. ↑ Genetically Engineered Bioweapons: A New Breed of Weapons for Modern Warfare – Dartmouth Undergraduate Journal of Science. (n.d.). Sites.dartmouth.edu. https://sites.dartmouth.edu/dujs/2013/03/10/genetically-engineered-bioweapons-a-new-breed-of-weapons-for-modern-warfare/#:~:text=In%20the%20bioweapon%20industry%2C%20genetic
  22. ↑ 23andMe: Losing at digital privacy. (n.d.). Digital Innovation and Transformation. https://d3.harvard.edu/platform-digit/submission/23andme-losing-at-digital-privacy/
  23. ↑ 23.0 23.1 Center for Food Safety and Applied Nutrition. How GMOs are regulated. U.S. Food and Drug Administration. https://www.fda.gov/food/agricultural-biotechnology/how-gmos-are-regulated-united-states#:~:text=The%20U.S.%20Food%20and%20Drug,of%20GMOs%20on%20the%20environment
  24. ↑ Center for Food Safety and Applied Nutrition. How GMOs are regulated. U.S. Food and Drug Administration. https://www.fda.gov/food/agricultural-biotechnology/how-gmos-are-regulated-united-states#:~:text=The%20U.S.%20Food%20and%20Drug,of%20GMOs%20on%20the%20environment
  25. ↑ Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions.” Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions. | UNEP Law and Environment Assistance Platform. https://leap.unep.org/countries/eu/national-legislation/directive-9844ec-european-parliament-and-council-legal-protection#:~:text=by%20FAO%20%2F%20FAOLEX-,Directive%2098%2F44%2FEC%20of%20the%20European%20Parliament%20and%20of,legal%20protection%20of%20biotechnological%20inventions.&text=This%20Directive%20lays%20down%20provisions,in%20the%20field%20of%20biotechnology
  26. ↑ Government of Canada, Canadian Food Inspection Agency. “Government of Canada.” Government of Canada,Canadian Food Inspection Agency, / Gouvernement Du Canada, 9 Jan. 2023. https://inspection.canada.ca/eng/1297964599443/1297965645317
  27. ↑ Canada, Health. “Government of Canada.” The Safety of Genetically Modified (GM) Foods - Canada.ca, / Gouvernement Du Canada, 5 Aug. 2022. https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/safety.html
  28. ↑ Office of the Gene Technology Regulator. “How We Regulate Genetically Modified Organisms (Gmos)​.” The OGTR, Office of the Gene Technology Regulator, 12 Apr. 2022. https://www.ogtr.gov.au/about-ogtr/how-we-regulate-genetically-modified-organisms-gmos.
  29. ↑ Office of the Gene Technology Regulator. “About the OGTR.” The OGTR, Office of the Gene Technology Regulator, 30 June 2022. https://www.ogtr.gov.au/about-ogtr.
  30. ↑ Liang, Jingang, et al. “The Evolution of China's Regulation of Agricultural Biotechnology.” ABIOTECH, U.S. National Library of Medicine, 5 Dec. 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9755788/.
  31. ↑ “GM REGULATION IN INDIA.” Tnau Agritech Portal :: Bio Technology, https://agritech.tnau.ac.in/bio-tech/biotech_gmcrop_gmregulation.html.
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