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Legal Challenges and Opportunities in Regulating Biotechnology and Nanotechnology for Environmental Protection: A Comparative Analysis of International and National Frameworks

Writer's picture: Aequitas VictoriaAequitas Victoria

Paper Code: AIJACLAV15RP2024

Category: Research Paper

Date of Submission for First Review: Nov 16, 2024

Date of Publication: December 21, 2024

Citation: Mr. Rishabh Tomar, “Legal Challenges and Opportunities in Regulating Biotechnology and Nanotechnology for Environmental Protection: A Comparative Analysis of International and National Frameworks", 4, AIJACLA, 160, 160-174 (2024), <https://www.aequivic.in/post/legal-challenges-and-opportunities-in-regulating-biotechnology-and-nanotechnology-for-environmental>

Author Details: Mr. Rishabh Tomar, Assistant Professor, UILS, Chandigarh University




Abstract

The fast growth of biotechnology and nanotechnology has great potentials in environmental conservation through realization of new techniques of pollution and waste management and sustainable use of resources. But the new technologies also raised new regulatory issues because the new technologies are associated with potential threats to ecosystems and human health. The purpose of this paper is to review legal developments and considerations for the biotechnology and nanotechnology regulation for environmental conservation in the international and national levels. 

In this paper, the discussion of the identified loopholes in the existing systems of regulation is based on the analysis of the current laws, with the emphasis on the absence of the preventive principle in the current legal systems. The analysis also features the EU legal framework in chemicals as a highly prescriptive one, the US approach as considerably more flexible than that of EU, and the new legal measures and models in developing countries.

The paper also considers global treaties concerning biotechnological and nanotechnological effects on the environment, for instance, the Convention on Biological Diversity and the Nagoya Protocol. Furthermore, ethical and social aspects remain a focal point in the paper as well as the issue of public involvement regarding the regulation. Thus, by pointing out the directions of possible enhancements of the existing legal regulation, this paper furthers the understanding of how and in what manner the law can and should progress to address the emerging technologies and support the promotion of the environment and sustainable development.

Keywords: Biotechnology, Nanotechnology, Environment, Technology, Development.


Introduction:

Overview of Biotechnology and Nanotechnology 

Biotechnology relates to the utilization of biological systems or components to design or redesign products and processes for certain application. It covers many areas like genetic engineering, bioinformatics, and synthetic biology, and has the most needed role in dish environmentalism wherein new solutions to pollution, waste management, and resource depletion are discovered.[1] For instance, bioremediation which is a process that involves the use of microorganisms to eliminate hazardous wastes is an ecological means of managing wastes.

Nanotechnology is used in altering material at atomic or molecular level normally at a size range of 1-100 nanometers. There is highly optimistic understanding of the role in the future in benefiting the environment, for example for designing new generations of the filters of water and air, as well as for creating substances that can decrease pollution at the level of nanocatalysts.[2] Also, resource reusability is another avenue whereby nanotechnology can boost resource sustainability by developing efficient material and energy systems that consume less resources. It is evident that biotechnology and nanotechnology are two revolutionary transformational technologies which if well governed contributes positively to environmental degradation and sustainable development.

Technological Advances and Legal Challenges

For a long time, biotechnology and nanotechnology have been held as having the ability to revolutionize the ways in which the environment can be preserved and protected through the advancement in procedures such as pollution prevention, the appropriate use of resources and optimizing the efficiency of waste disposal.[3] Biotechnology has for instance allowed for the creation of specific organism forms with specific capabilities of breaking pollutants and enriching the soil.[4] Nanotechnology, or the capability to run operations on materials at the molecular level, presents enhanced strategies for water treatment, pollution identification and sustainable energy solutions.[5] 

However, those advances carry serious vices too. GMOs can be escaped to the environment and this have bad effects such as reduced bio-diversity, interferes with habitats. Nanomaterial, however, has proven to be potentially hazardous to the human and wildlife as much as their effects to the ecology are unknown.[6] These potential dangers underscore the importance for the development of robust laws that accommodates the opportunities of the use of biotechnology and nanotechnology as well as their risks. It is our legal obligations’ expectation that they adapt to these technologies and the problems and environmental sustainability that accompany them.[7]

Purpose of the Paper

The main goal of this article is indeed to analyze the current legal compliance of both Biotechnology and Nanotechnology particularly in relation to environmental conservation. Since these emerging technologies have attractive application in pollution control, waste management and efficient use of resources they also have certain threats to environment and human health that need to be appropriately regulated. This article seeks to understand what laws are missing in the current legal systems, which includes the absence of preventive measures, as well as compare and contrast the existing regulations of the EU, USA and developing nations. Therefore, with examples of the present shortcoming in current legal systems in the international treaties like Convention on Biological Diversity and the Nagoya Protocol, the article seeks to find out the gaps that require improvement and the ways to achieve this. Finally, it aims at offering a better perspective on how institutions of law can be strengthened in order to address new technologies in a manner that will respect aspects of the environment and ethics.


BACKGROUND

Development of Biotechnology and Nanotechnology

Biotechnology in fact originates from the old past, the advanced uses were in the areas of agriculture and fermentation in which civilization used biological aspects in crop farming and foods production. However, the use of biotechnology may be traced back in earlier periods than the twentieth century but the spread and development of the biotechnology products could be regarded to have begun in the twentieth century when Watson and Crick discovered the structure of DNA in 1953. This was the foundation of gene manipulation and later on advanced to establishment of recombinant DNA process in 1970’s which gave scientists ability to alter genes revolutionizing medicine, agriculture and even environmental control.[8]

Nanotechnology is comparatively newer field, though was actually named when physicist Richard Feynman proposed the concept to the scientific community in 1959 in his speech titled ‘There is Plenty of Room at the Bottom’. Succeeding the development of scanning tunneling microscopy in the 1980s, thus giving the capabilities to maneuver individual atoms, became prevalent. Nanotechnology consider as a remarkable potentiality in the 1990s and 2000s when it applied in the material science and electronics, biotechnology, hence, nanoscale material have been developed in protective environment, medical service, industrial utilization field.[9] 

Both fields have undergone transformation and provided solutions for critical environmental problems yet, they involve issues to do with safety, regulation and ethics.

Environmental Impacts

The applications of the biotechnology and nanotechnology have been found to have the following advantages in environmental management. Biotechnology helps to improve the process of waste disposal dealing with the microbial breakdown of pollutants that cause bioremediation and minimize the impact of industrial processes on the environment.[10] It complements through producing nanomaterial that enhances water filtration, carbon absorption and soil cleaning and efficiency of available resources.[11] Both technologies breed unique solutions in the recycling process and the optimization of the use of natural resources resulting in minimal energy utilization.[12]

However, adoption of these technologies has some drawbacks. Biotechnology may bring GMOs in environment thus affecting the ecosystems and local species.[13] Ironically, the dangers of the technology come in the release of nanoparticles into the environment, so little is still known about the impacts of the particles on ecosystems or the health of people. These particles may settle in the bottom of water bodies and in the soil affecting particle associated microbial life and food webs.[14] In both cases, there is increased debate regarding the short and long-term consequences of the technologies, and therefore, they require proper regulation and supervision.

Need for Legal Regulation

It is crucial for the development of biotechnology and nanotechnology to be put under legal frameworks because these technologies have a potential of having positive impacts on the environment and at the same time harming the ecosystem and the health of citizens. Biotechnology and nanotechnology are effective in pollution control, waste management and in sustaining resources however with no regulation in place they bring along with them unexpected secondary effects like disturbance in the natural ecosystem, pollution and impairment of human health over the long run.[15] These risks can only be addressed through proper regulatory structures, structures that compel organizations to have their technological applications undergo robust safety evaluation before being adopted especially in cases where environmental and public health impacts are an issue.

In addition, the use of legal means is significant for the optimization of biotechnological and nanotechnological developments taking into consideration the principles of sustainable development. Laws should thus be made to outlines such technological applications in a way that they will help in the protection of the environment and in a similar manner the laws must meet the international sustainability objectives.[16] Thus, the role of regulation is two-dimensional: ensuring society protection from negative impact due to innovation while at the same time encouraging organizations to adopt more efficient methods of utilizing resources without negative consequences to the environment. It can therefore be seen that the facilitation of precautionary principles into the systems of law are capable of providing support in establishing the scales between creativity and protection of the environment.


LEGAL FRAMEWORKS FOR BIOTECHNOLOGY AND NANOTECHNOLOGY

International Treaties and Agreements

a. Convention on Biological Diversity (CBD)

CBD is one of the most significant global treatise whose objective focus on the utilization and protection of biological diversity. It has a relevant role to play in biotechnological regulation particularly on the utilization of genetic resources and the preservation of ecosystems. The CBD offers countries a framework on how to address the effects of biotechnology so that the benefits do not come at the cost of the bio-diversity. One of the conditions of the CBD in relation to biotechnology is the Cartagena Protocol on Biosafety that regulates movement of LMOs emanating from biotechnology. It is accomplished to avoid negative impacts of such organisms on biological variety taking into account health issues and threats in the environment.[17] The Nagoya-Kuala Lumpur Supplementary Protocol expands the issue of the liability and compensation for the harm done to the biodiversity by LMOs. Through its approach to use of biotechnological products and innovations, the CBD ensures that development and utilization of the products is safe on the environment.

b. Nagoya Protocol

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits under the CBD strengthens prior law in biotechnology, which is the access to genetic resources and the sharing of benefits. This agreement is important because most of the biotechnological applications involve genetic resources many from bio diverse countries. The protocol works towards the guaranty that owners of such resources, especially in the consumer areas as pharmaceuticals or agricultural biotechnology, pay adequate price to the source country. This is done through the Access and Benefit Sharing (ABS) provisions, which define the terms, on issues such as access to genetic resources, and sharing of the benefits that stem from utilization of such resources.[18] It also encompasses statutory and legal requirements for nations and/native peoples, such as observance of national ABS, which makes the exploitation of genetic resources equitable and contributing to local economy and these result in economic growth and sustainable utilization of resources.[19] 

Rendering control on the usage of genetic resources and sharing the distribution of fair share of profits through two documents that is CBD and Nagoya Protocol accordingly makes a balance on the developments of biotechnological sectors making a control on the sustainability of global biodiversity.

National Frameworks

a. European Union (EU)

The EU follows a very active supervise model in regulating biotechnology and nanotechnology especially through its REACH Regulation on the (Registration, Evaluation, Authorization and Restriction of Chemicals). REACH is one of the advanced and research-driven regulatory systems for chemical substances which primarily focuses on human health and the environment, to avert potential risks linked to chemicals, including nanomaterials.[20] Besides, the EU has another directive on biotechnology – Directive 2001/18/EC concerning the deliberate release into the environment of GMOs There is a rather strict precautionary principle in this activity of the EU.[21] Such regulations show that EU cares for stringent supervision and preventive action vis-à-vis environmental consequences of new technology advancements.

b. United States (US)

However, as for the US, this organization uses the approach more liberal and in many ways it does not adhere to the precautionary principle. It is shared across different agencies for instance the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The chemicals and nanomaterials are controlled under Toxic Substances Control Act (TSCA) where companies are supposed to report possible environmental effects of using various substances but the review process, most of the time is not as stringent as in EU.[22] On the other hand, the FDA controls the application of biotechnology in food and Drugs especially through its Food, Drug, and Cosmetic Act (FDCA), it has the functions of ensuring the safety and efficacy of the products.[23] The US system stresses on Innovation along with managing risk associated with it which, according to many is better suited for willingness to adopt new technologies.

c. Developing Countries

There are serious issues associated with the regulation of biotechnology and nanotechnology and these vary with the development context of the country. Most of them are not technically equipped, and do not possess the institutional framework that is necessary for elaborate regulation.[24] Some countries like India and Brazil are advancing with such regulations like India’s Biotechnology Regulatory Authority Bill, though the enforcement issues result from a lack of funds and reliance on the international standard-setting processes.[25] In many developing countries, there is economic development focus, which makes the regulation to be relatively liberal than that of the developed countries.


LEGAL GAPS AND CHALLENGES

Lack of Preventive Principle

The downplays of the precautionary and preventive principles in present legal frameworks creates a lot of difficulties in the tackling of new risks in areas such as the environmental, health, and technological sectors, among others. Without these principles, regulatory responses are more typically satisfying corresponding to an adopted reactive model where potential harm is allowed to take place before regulatory action is instigated. This is especially so in issues such as climate change or artificial intelligence especially given the irreversible impacts of delayed interventions.[26] Further, interventions are not so proactive or are unable to develop strategies that can be used to prevent such risks as those related to new technologies and the environment. Such an attitude is not proactive, and often it is not suitable to address modern threats with their specific features, which emphasizes the need for thoughtful legal activities aimed at the establishment of the PPER in legal and regulatory activities.[27] It is important to note that the adoption of proactive risk management frameworks is effective in managing for uncertainties before they reach the harm point.

Jurisdictional Conflicts

Jurisdictional conflicts are common scenarios whereby national laws conflict with international agreements thus opening possibilities of regulatory arbitrage. They result from extra-legal factors including differences in legal systems, priorities or political consideration in the international system. For instance, quite often national legislation on data protection might be incompatible with international trade legal norms, and thus it might involve certain discrepancies as to the protection of informational rights for the great number of multinational corporations.[28] Likewise, environmental regulations may experience difficulties in areas where states’ policy priorities align with economic development at the cost of international climate obligations.[29] Such conflicts may result in the creation of unfair practices of regulatory arbitrage whereby business entities utilize the lowest standard jurisdiction to enable avoidance of strict rules set at the global level. Solving such duality call for harmonization, for instance, towards implementing national laws that are in compliance with the international agreements, historically this it is politically and legally challenging.[30] Such regulatory leeway’s need to be closed with the help of international collaboration to establish an effective global governance to stop using such gaps.

Ethical and Social Concerns

When it comes to biotechnology and nanotechnology, there are a number of ethical and social issues to be solved such as the concept of environmental justice, the public’s participation, and social responsibility. Socio-technical issues come up as these technologies might impact negatively on the vulnerable populations. For instance, through the use of nanomaterials in agricultural applications the soil might get contaminated and adversely affect the lives of low income farmers in the rural areas.[31] These processes also involve public participation on decisions, which is also very scarce and lack transparency hence causing mistrust.[32] A social equity issue comes about where these technologies favor the developed nations or some groups and leave the rest struggling in aspects like health care, food, and the environment.[33] Such issues need sound regulatory frameworks centered on stakeholders, fairness, and the environment through which advancements in Biotechnology and nanotechnology will be socially responsible.

Public Participation

The decisions, particularly, relating to the emerging technologies including AI and nuclear power, should be accessible to public input in order to promote the transparency, credibility, and democracy. Nevertheless, the legislation concerning the participation of the public diverges from one country to another. According to AI, the European Union’s Artificial Intelligence Act (AIA) suggests including public participation in order to analyze the risks of AI technologies.[34] Likewise, the environmental impact assessments (EIA), compulsory in many countries to nuclear projects, entail the public participation according to the international standards of the Aarhus Convention.[35] Nevertheless, issues of say on how the process and the resultant decision will be in an ascertainable fashion still remains a cause for concern. For example, the level of citizens’ participation in technological decisions in India is low, there are no sufficient legislative instruments that stimulate people’s actions. This usually results in development of a gap between the intended project and the public, which culminates in lack of trust as well as time delays in the implementation of the projects.[36] To broaden a public participation in decision making there is need to strengthen these laws so that they can better address the public needs.


Comparative Analysis

EU vs. US Approach

Looking for similarities and differences in the EU and US regulation, it is necessary to state that the approaches differ in terms of the philosophies. EU uses the prescriptive system where it has comprehensive, precise standards that are implemented throughout all those who are members of EU. This approach is clearly seen in the GDPR since it guarantees better consumer protection, fosters harmonization while setting clear responsibilities for the companies. Nonetheless, the model that has been implemented by the EU is rather rigid and can actually slow down the growth and development of new and innovative concepts, ideas and products, and it also leads to tremendously high levels of compliance that the small firms have to adhere to.

In contrast to this the US employs a more liberal system which more resembles the sectoral system. Not all regulations are created the same; some of them stem from a particular sector, for example, healthcare (HIPAA), or finance (GLBA), which grants more freedom to adapting and cultivating innovative ideas to the businesses. This system is a little more dynamic in terms of addressing emerging technologies and the market needs of the economy but hits the problem of variance in the type of protection based on the sector or state. In its absence, critics have questioned the protection of the consumers while also complaining about fragmentation of regulatory frameworks.

While the prescriptive institution typical for the EU maintains strong and similar consumer expectations it can be unbeneficial for business adaptability. On the other hand, the US has a more flexible system enabling innovation and development; however, it is possible to receive insufficient protection of consumers. Possibly the combination of these approaches could produce an optimal form of flexibility and protection.

Developing Countries

Challenges that characterize the regulation process in developing countries relate to restricted resources, weak institutional environment and international trade commitments. Constraints such as lack of financial might and lack of technological support hinders governments from implementing legislations which can support comprehensive regulatory measures. This leads to voids in aspects that include environmental legal frameworks, labor laws, and corporate governance among others. Unfortunately, many regulatory agencies lack sufficient funding, personnel, and capacity to effectively oversee compliance and manage noncompliance.

This is also compounded by lack of institutional capacities which pose a major challenge to the efforts. A large number of developing countries are faced with significant problems of weak and ineffective bureaucracy, corruption, and unstable political environment that leads to deterioration of the rule of law as well as erosion of public confidence in the governance institutions. The problem is compounded by the fact that many of the government agencies do not possess the necessary technical skills required in the formulation and implementation of these complex legislations especially in highly specialized sectors such as telecommunications, energy and financial services.

On the international level one has to consider the trade commitments that are made by bodies like the WTO and various free trade areas. Globalization makes developing countries compromise their domestic regulations with international standards despite the fact that the two may not harmonize with the country’s interests. For instance, environmental and labor standards that the trading partners require may not be convenient to the local economies hence creating a trade-off between compliance to regulations and economic welfare. These challenges call for specialized regulations which are tuned to allow development while at the same time fulfilling international requirements.

Global Harmonization

Efforts to achieve the global harmonization of legal processes and protection are challenging mainly because of conflicts of policy targets and the general economic environment. This is because there is a great variation when it comes to the national interest and culture that define legal systems. Civilized nations have different objectives in their nation’s social, economic, and politics setting priceless objectives. For instance, while the European Union has stringent data protection laws such as the GDPR, more to the point focusing on the power of the individual to protect and demand his/her rights while consuming services, other countries might consider ease of business and focus on economic growth, thereby allowing relatively less stiff laws. The other issue internal to the regions is the variation of economic development. This is due to the fact that developing nations may be financially drained to put mechanisms and regulations in place that probably developed nations can easily afford. This leads to a gap in enforcement capability and hence weak compliance standard across the borders. Besides, international trade and investment policies evolve in every country depending on the target economic policies, which makes it hard to harmonize on issues to do with intellectual property rights, environment, and even labor issues.

Finally the political factors leave no room for achieving legal integration. Government may not be in a position to harmonize its regulations with those of other countries due to issues of sovereignty or due to lobbying from domestic players. These disparities are likely to impede legal convergence, particularly where different countries have varying benefits of interest, and capabilities, as in the cases of environmentalism, taxation and corporate management. 


OPPORTUNITIES FOR ENHANCING LEGAL FRAMEWORKS

Integration of Preventive Principles

In order to enhance a proper implementation of stricter precautionary measures into a legal basis, it is important to declare the Precautionary Principle is implemented in a special manner throughout all the sectors including environmental protection, public health and emerging technologies, etc. There are still legal systems that require an analysis of risks in cases where activities can prove dangerous before they give their approval for the same and the company in question has to prove the safety of its operation. The EIAs and health impact assessments could be legally required for the projects that are likely to have a threat to the environment. Moreover, the concept of adaptive management policies should be adopted so that it provides the means of changing the regulations in case of the newly acquired knowledge or unpredicted effects of the management actions. The law should encourage industries to come up with sustainable innovations by giving grant or tax advantages to those industries that operate under precaution measures put in place. When people participate in the decision-making process involving procurements with more openness then everyone can be held to account. Legal requirements must also have penalties for failure to adhere to these measures, as well as a monitoring and reporting mechanism for possible risks to ensure the implementation of these measures strictly.

Strengthening Global Cooperation

International relations should be improved because we live in the world where globalization required addressing various issues, including climate change, cyber threats, expansions of pandemics, and imbalances in trades. International cooperation is meant for exchange of ideas, capacities and experiences among nations so as not to leave anyone behind. To this effect, international agreements like the Paris Agreement or the World Health Organization’s International Health Regulations offer guidelines that facilitate cooperation through coordinating state’s policies and ensuring conformity with established norms and policies across Member States. This co-ordination minimizes uncommonality and enhances effectiveness in tackling international challenges. In fields as comprehensive as environmental protection, mode of development and health, cooperation extends the capability of individual countries in the accomplishment of their goals. Furthermore, cooperation is an effective way to improve transparency, accountability and cooperation and to build strong partnership where nations are able to deal with problems that are beyond the individual country’s capacity and resources to address. United Nations goal is to create a stable environment of cooperation and reach common objectives for the benefit of all the countries across the globe.

Public Involvement and Transparency

For increased public contribution in the formulation of regulations, agencies should also improve on the dissemination of general information on regulatory measures for increased understanding through simple language. If the public is to be involved, this can be done through multiple avenues for example referendums, town hall meetings, or online forums, or even social media, therefore people with different opinions have the chance to contribute. Regulatory bodies should also aim at extending the comments’ period while ensuring that the public is provided with their feedback on the value they attach to their input.

The ethical considerations can be integrated better with the help of creating the ethicist councils that have members outside of the research facilities and all the subject and community-related experts. These boards may be in a position to assess the social, environmental and ethical consequences of the proposed regulations. Furthermore, to mitigate risks of compromise of ethical standards, there is a need to embrace other frameworks such as the ethical impact assessment which will help in determining possible harms/benefits or otherwise on the vulnerable groups. This helps to correct the situation, where technical expert opinion prevails over moral reasoning, thus resulting in regulatory decisions that reflect societal ethics.


Recommendations for Developing Nations:

The findings of this study indicate that, to adequately control biotechnology and nanotechnology, developing nations should pay attention to the enhancement of their capacity-building as well as legal reforms.

a. Capacity-building

Such measures are capacity-building initiatives such as funding in education and training with a view of developing human resource capacities within the scientists, engineers as well as policy makers. Setting up institutes for research at specialized areas will create more ideas and guarantee that local talent may also participate in improving on technologies. To enhance the existing knowledge Governments should engage international organizations to obtain knowledge and technical support that can assist in sharing knowledge improvement through research, capacity building, seminars, and forums.

b. Legal Reforms

The legal reforms should aim at the development of the all-encompassing legislation on Fintech while ensuring the consumers’ protection and sustainable use of environment. There is thus the need for governments to develop concrete measures in the safe development testing, and commercialization of biotech and nanotech products. This include formation of government or quasi-governmental authorities that oversee the level of compliance to safety measures within the occupations as well as the level of ethical practices within the occupations. The developing countries should also engage in formulating international policies and sync national policies with global policies that suit them the best while protecting their sovereignty.

Through increasing technical capability and putting in proper and clear rules and regulations, the developing countries can embrace the opportunities of the Biotechnology and nanotechnology for economic development as well as social improvement without facing dangerous consequences.


CONCLUSION

Legal risk issues and opportunities are peculiar to regulation of biotechnology and nanotechnology. These technologies include the processing of living organisms and materials at a molecular level with a number of risks and uncertainties associated with their effects on human health, safety and impact on the environment. The issues that can be associated with the legal aspects include absence of particular legal requirements, legitimate questions, ethical considerations as well as questions regarding the protection of industrial property. This is because, as stated earlier, traditional laws fail to capture the challenges provided by the modern and dynamic technologies in most cases. For example, patent laws may fall short in regulating biotechnological inventions, and liability regimes are generally unable to address the risks of nanomaterial.

On the other hand, there is potential in coming up with progressive measures to put in place to protect users. It can be seen that biotechnology is pegged for revolution in medicine, agriculture and environmental management whereas nanotechnology is expected to revolutionize energy, pollution management and better materials. Legal frames that allow innovation in industries advances protection of health of people and the environment. Flexible risk regulation could also means that new risks are addressed while existing ones are controlled therefore eliminating the stagnation of new technology development which results when set regulations are overly restrictive in their attempt to control risks.

There is need for future works to conduct legal research in such a manner that would develop feasible legal structures that can easily evolve with change in technology. Key areas include:

1.    Environmental Risk Assessment: Legal scholars should conduct research on the assessment methods where they could establish more elaborate models for the evaluation of biotechnology and nanotechnology products on the environment, and strive toward the setting up of international standards for sustainable applications following its prospects.

2.    Ethical and Social Governance: Future study should focus on finding ways on how the legal systems can factor in ethics especially in such areas as involving the public in the processes of decision-making and how to ensure that innovation moves hand in hand with fairness.

3.    Intellectual Property Reform: Patent laws require reconsideration as to take into account the peculiarity of biotechnological inventions, such as gene editing, synthetic biology to sustain innovation as well as fair competition.

4.    Liability and Accountability: This means that while policy development there should be more oriented to setting the principles of determining liability in the cases when harm in the form of the unhealthy effect was not intended but occurred due to the usage of nanomaterials or biotechnology exploitation.

That is why these steps are going to help shape the environment that will be favorable for new technologies, and at the same time, ensure that those technologies are healthy for the environment and society as a whole.


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