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Literature research on "bigger picture" issues

"Human Practices is the study of how your work affects the world, and how the world affects your work" -- Peter Carr, Director of Judging

There are some underlying logics in people's legal and ethical standards that we do not yet understand. Without understanding it, we may not be able to essentially understand the source of ethical problems and eliminate people's concerns. Although we have talked to many experts, we found that we are only able to understand some of the scattered knowledge, but not to form a systematic understanding. Therefore, we decided to do some literature research on laws and ethical problems.

Laws and Regulations

Overview

We looked into laws related to synthetic biology, genetically modified products and gene editing. We learned that laws have two features.

First, laws do not protect all interests. Most laws consider only the interests of people, such as human health or the ecological environment, instead of whether the genes of the microorganisms or the plants themselves are altered.

Second, laws is lagging. At present, there is no written laws, so the judicial personnel can not make a judgement. Only scholars of the think tank in the biological field of legislation and responsible for the formulation of administrative regulationsare are studying this.

Legal interests that may be involved in the project

Direct impact: life and health of specific people

- Consumer consumption of crops: food safety law

- Consumer use of crop by-products: consumer protection law

Indirect impact: public interest

- Environment: Environmental and resource protection law

mainly focuses on whether the technology and crop metabolites will pollute farmland, water, etc.

Gene editing legal regulation

In gene editing legal regulation, there are several representative paths. They are the productivist path represented by American law, the processist path represented by EU law and the separate regulatory path.

The relaxed model

The relaxed model represented by American law, also known as the productivist path.

In 1986, the United States "Biotechnology Governance Coordination Framework" established a productionist biotechnology legal governance path based on the principle of substantial equivalence, focusing only on the GM plant itself as the final product, and not considering the use of gene technology in the production process. As long as the composition of GM plants is consistent with that of plants produced using conventional production methods, it is considered safe and there is no need for differential regulation of Gmos and their products.

In 2021, the U.S. Department of Agriculture amended the Coordinated Framework for Biotechnology Governance to create the SECURE Rule, which no longer has no right to regulate gene-edited plants, but instead provides regulatory exemptions: as long as the gene-edited plants have genetic variations that can be obtained using conventional breeding methods, there is no need to regulate them.

Advantages

SECURE rules provide a clear, transparent, science-based process that reduces the regulatory burden on researchers and businesses, reduces administrative costs, and shortens the timeline for the development of new plant varieties.

Disadvantages

It does not pay attention to the safety of the gene-edited plants themselves, nor does it care whether it is fully supported by scientific evidence. Developers and enterprises are likely to abuse the system to develop a large number of gene-edited plants, resulting in a loss of confidence of the public and trading partners, as well as regulatory disorder. Food safety and consumers' right to know cannot be guaranteed.

The restrictive mode

The restrictive mode represented by EU law, also known as the process path.

The EU Directive on the Intentional Environmental Release of Genetically Modified Organisms establishes a legal regulatory system for genetically modified plants based on the precautionary principle of risk, that is, when there is an unpredictable or irreversible risk, in order to protect human and animal health and the environment, effective supervision measures should be taken to prevent risks.

In 2018, the Court of Justice of the European Union ruled that products induced by mutations using technologies or methods such as gene editing are genetically modified organisms and are required to follow the approval procedure for genetically modified plants.

Separate regulatory path

Separate regulatory path, which is more productionism.

Argentina was the first country in the world to legislate on new plant breeding technologies, enacting a special law in 2015 to clarify the rules governing the development of gene-edited plants.

Britain announced in May 2022 the gene technology for accurate breeding act, in March 2023 by and take effect. The Act applies to plants and animals that are genetically modified using traditional processes, and clearly classifies gene editing and genetic mutations generated based on nature and radiation as traditional processes, and transgenes involving the transfer of foreign genes as non-traditional processes, so as to separate gene-edited plants from the category of transgenes.

China has also initiated separate legislation on gene-edited plants.

On January 24, 2022, the Ministry of Agriculture issued the "Guidelines for Safety Evaluation of Gene-edited Plants for Agricultural Use "(Trial) (" Guidelines for Safety Evaluation of Gene-edited Crops "), which for the first time officially divided genetically modified crops and gene-edited crops, making it clear that gene-edited plants without introducing foreign genes should apply the guidelines. The Guidelines for Safety Evaluation of Transgenic plants should be applied to transgenic plants with the introduction of exogenous genes. To a certain extent, this can be seen that the Chinese government recognizes and attaches importance to gene editing technology. However, unlike countries such as the United States and Argentina, which directly stipulate that eligible gene-edited crops are not subject to GMO regulation, China's regulation of gene-edited crops is still carried out under the GMO legal framework, except that the safety evaluation system has special provisions for gene-edited crops. Therefore, before analyzing the special regulations on gene editing crop breeding, we need to clarify the legal supervision on GM crop breeding in China and the safety evaluation system of GM plants therein. China's attitude towards genetically modified crops are rather cautious. Safety evaluation of genetically modified crops need to go through experimental research, pilot test, environmental release, productive test and application of security certificate. Almost every stage needs to be reported or approved by the agricultural authorities, and environmental release and production tests themselves take longer. Take Ruifeng 125, a transgenic insect-resistant and grass-tolerant maize, as an example. It took ten years from its production in the laboratory of Zhejiang University in 2009 to its obtaining the safety certificate in January 2020. The guidelines for the Safety Evaluation of Gene-edited Crops cut some links and could significantly shorten the approval process. At the same time, this also marks that China will begin to approve gene-edited crops, which is a milestone for the research and development of biological breeding technology and industrial promotion in China.

Ethical Problems

Even though we are all STEM students, we feel that social science discussions such as ethics are important to the advancement of science and technology. Therefore, in this year's Human Practices, we focused on communication and literature reading on ethical topics. Detailed discussions can be found in integrated human practices. Here's what we learned in literature.

Food security in countries with economic difficulties

American philosopher John Rawls saw that addressing the needs of the poor and vulnerable is about more than money — it is mostly about creating conditions under which liberty and opportunity can thrive. Climate change, a product largely of the accrual of capital wealth by rich nations, just adds to the asymmetry of stress. The developing world suffers the most from the negative impacts of climate change.

The resilience that must be built into some of the poorest countries will not come from loans from wealthy and populous countries, which may have a food deficit of their own, or institutions like the International Monetary Fund. It will be built upon self-confident people using open and shared scientific knowledge to pull themselves out of their misery.

At least within the scientific community, there is a helping hand because of rapid progress in embedding expertise in fields such as agro-climatology within countries most vulnerable to poverty and hunger. By making its voice heard, science can lead by example. [1]

Food security in countries with economic difficulties

There is a common view that changes in economic institutions are accommodations to prior technical innovation. A prominent example of this “technology-first” line of reasoning is the account by Demsetz of the emergence of private property among Native Americans engaged in the fur trade: new property rights, he wrote, “stem from the development of new technology and the opening of new markets, changes to which old property rights are poorly attuned.” By contrast, the author's interpretation is consistent with the idea that institutional change may predate and provide conditions for subsequent technical change. Examples of this “institutions-first” perspective include the contribution of institutions that sustained high wages in eighteenth-century England to induced labor-saving technical change and the industrial revolution; and the fact that premodern agrarian autocracies often required farmers to cultivate easy-to-expropriate-and-store cereals rather than root crops. [2]

Similarly, strict international standards for pesticide residues will force growers to choose new pesticides, and the emphasis on pesticide pollution, such as water eutrophication, will make green pesticides have a larger market. Our projects conform to the trend of economic and social development and have broad market prospects.

Synthetic Biology Ethics

Given that synthetic biology is an emerging technology with immense disruptive potential, discussions around the ethical, social, and safety implications are important to ensure public beneficence, while minimizing negative implications.

In the words of Peter Carr, iGEM Director of Judging, "Human Practices is the study of how your work affects the world, and how the world affects your work".

The holistic approach towards good molecular biology work should implement a comprehensive (risk) assessment of the experiment, the materials used, and the outcome of the experiment beyond actual chemical or biological threats. It is not only a question about safety and security, but also one about the societal impact of one's project and, vice versa, the impact of society on the work. Key considerations involve stakeholder opinions, availability of the product to all potential customers, as well as the economical and foremost the societal benefit. Recent discussions focusing on fundamental biological questions, such as how to classify highly engineered organisms and how to differentiate between ‘life’ and ‘machine’. [3]

As ethics are rarely taught in STEM (science, technology, engineering, and maths) study programs, participants usually start analyzing the ethical implications of their iGEM projects without prior knowledge of the field. Therefore, from early project stages on, students are required to reach out to experts and to closely interact with different stakeholders.

The Technicalization of Humans

When the development of science and technology, relying on its own power, gradually infiltrates into all human activities, and constructs its own advantageous system, becoming the background color of human survival or reshaping the environment of human life, they will in turn dominate people's way of thinking and ideas, and become a new horizon for judging other human activities, thus leading to profound changes in human values.

The one is the technicalization of human bodies. Whether we should adhere to this traditional moral imperative when humans have the ability to technologically modify or engineer our bodies is a subject of fierce debate among conservationists and transhumanists. The essence of these debates is the extent to which human life should be allowed to progress from biological evolution and cultural shaping to technological design, such as gene editing before birth and aesthetic body modification after birth. Conservationists advocate the establishment of the Convention for the Conservation of the Human Species to prohibit human modification; Transhumanism advocates the use of technology to overcome human biological defects and expand human abilities, and even the pursuit of immortality. The technicalization of the body has brought us a new understanding of human natural rights, fairness, justice and other issues.

The other is the technicalization of human spirit. The tangible technicalization of spirit refers to obtaining spiritual comfort through emotional drugs or technology; The intangible technicalization of spirit refers to the perception of spiritual pleasure and spiritual satisfaction through intelligent devices and intelligent environment. The intangible technicalization of spirit has more potential and concealment than the visible technicalization. As we design and create smart devices and environments, we need to learn to live healthily in the order of smart artifacts. Our reflection on the extent to which humans should accept artificial emotions will put forward new ethical requirements for the research and development and promotion of robots such as social and nursing, and discuss whether human concentration and perception should be commercialized, and put forward ethical constraints on the industrial development of artificial worlds such as "metauniverse".

Science and technology development should place ethics first. The ethical challenges brought about by the development of contemporary science and technology are not only big issues concerning the future of human civilization, like the problems brought about by global warming, but also transform profound philosophical questions such as "what is a human being", "what kind of human being should be" and "what kind of human civilization should be shaped" into practical questions about how contemporary science and technology can ensure the healthy development of human civilization. When the concept of people-oriented ethical governance of science and technology becomes the perspective mirror for people to look at problems, our living environment will change from technical environment to humanistic environment. Although there is still a long way to go, this effort will certainly prove to be of profound significance for the future of human civilization. [4]

Opinions on Strengthening the Ethical Governance of Science and Technology

When formulating policies and strategies on innovation, research and development, and application of emerging technologies, we should not simply adopt a "technology first" approach, but fully consider the ethical risks and challenges that emerging technologies may cause. Management of science and technology should not only focus on benefits and outputs, but also on the realization of fundamental ethical values, such as whether scientific and technological achievements can improve people's health, protect the environment and maintain social security. Ethics workers should link theory with practice and use the theories and methods to analyze. We can first study and formulate a set of preliminary and temporary ethical norms and management methods, and adjust and improve them in time with the continuous enrichment of relevant knowledge and experience, so as to minimize the ethical risks that may be caused by emerging technologies. In addition, the self-supervision of scientists and scientific communities should be organically combined with the supervision of government authorities and relevant legislative bodies. The accountability and openness system should be strictly implemented in order to effectively respond to the ethical challenges that may be caused by emerging technologies.

Humanities and technology

There has always been a serious "pride and prejudice against science" (C.P. Snow) in the humanities, so this kind of reflection is often unfair, in the form of excessive bragging about the beauty of the pre-technological era, and negative views of the social and lifestyle changes caused by technological development.

I think there are probably two reasons for this, one is the mental stereotype. I like a quote from Saint Exupery: The only reason the past life seems to fit our nature is because it fits our language. People's cultural and psychological stereotypes need to be accumulated for a long time, so they must be lagging behind, which is no problem in the era of relative stagnation in ancient times. However, in an era of drastic changes, people will fall into the embarrassment of aphasia that the culture cannot keep up with the reality. The feeling of inability to grasp the reality naturally causes people's cultural psychological unease and fear.

The second reason is the split between the humanities and the sciences. With the development of science and technology, a small branch will spend a lifetime of energy, and generalists like Da Vinci are impossible to appear. A humanistic intellectual may know nothing about science, and the unknown is often dangerous. At the same time, as an intellectual, the capital of his life comes from the past cultural heritage, and he is more inclined to regard science and technology as a threat. As C.P. Snow pointed out, every literate person is an innate "Luddite", the man who destroyed the machines at the beginning of the Industrial Revolution. Interestingly, the literati who are more optimistic about the development of science and technology tend to have a certain background in science and technology, for example, C.P. Snow is a writer and a scientist; St. Exupery was a pilot; Lewis Thomas was a biologist and pathologist who wrote essays as a hobby... They are the few who can break down barriers and look both ways.

Again: reflection and vigilance are necessary, but don't dwell on the past. Life in the past has never been so beautiful, and human beings have never enjoyed so much security and welfare as they do today. Of course, there are problems in the current development path (such as the unlimited expansion of capital and material desires, resource shortage, environmental pollution, etc.), and it is more useful to face up to them and find ways to solve them than to fantasize and lament.

Reference

[1] Sir Ian L. Boyd, Saving the poor and vulnerable.Science370,383-383(2020).

[2] Samuel Bowles and Jung-Kyoo Choi. 2019. The Neolithic Agricultural Revolution and the Origins of Private Property. Journal of Political Economy 127, no.5 (October 2019)

[3] Christopher M. Whitford, Nils-Christian Lübke, Christian Rückert. 2018. Synthetic Biology Ethics at iGEM: iGEMer Perspectives. Trends in Biotechnology 36, no.10 (2018). 985-987

[4] Sumei Cheng. 2022. Properly face the ethical challenges brought about by the development of science and technology. Guangming Daily 2. (March 2022)

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