Synthetic Biology as a Tool for Problem Solving
The use of such advanced scientific tools must be preceded by a risk assessment and careful planning of experiments to ensure that all procedures are conducted with appropriate safety measures in place. Our team, in collaboration with our educational supervisors and advisors, made every effort to ensure that the entire project was carried out as safely as possible.
Once we selected the topic for our project, we began considering how to ensure safety, especially while working with Edwardsiella piscicida strains.During the experiments ,we ensured that there was no biological containmination.We were fully awared that preventing contamination outside the lab was our top priority.
Risks of the Transgenic Technology
Risks of the transgenic techonology majorly involves gene pollution.For example, insect-resistant/herbicide-resistant genes may drift to wild plants through cross-pollination, potentially disrupting biodiversity and ecosystem balance.To prevent gene pollution from happening,we established physical containment: 50-meter isolation zones for field trials to prevent gene flow.Besides that,we also have longitudinal monitoring protocol,through which we can track gene transfer via PCR screening of the surrounding flora.
Working with Bacteria
We also worked with Edwardsiella piscicida strains, all of which are classified as Risk Group 1 organisms (non-pathogenic and low risk to humans).
Despite this, several risks must be considered when working with these strains, such as the spread of antibiotic-resistant genes to other bacteria, unintended overexpression of proteins, allergic reactions in some individuals or accidental release of the GMOs into the environment. That's why we inactivate them after use and follow Good Microbiological Practice (GMP) guidelines.
Overview of Laws and Regulations
Aquaculture vaccine research must be conducted in strict accordance with relevant national laws and regulations. The following sections outline the key provisions and compliance requirements that the research must adhere to, focusing on three core areas: biosecurity, veterinary drug administration, and animal epidemic prevention.
4.1 Law of the People's Republic of China on Biosecurity
4.1.1 Applied Research and Achievement Transformation
The state encourages applied research to drive basic research, promotes the integrated development of the two, and supports the transformation of technologies into practical applications such as aquaculture vaccines. This research aligns with this goal and has a clear application-oriented focus and compliance foundation.
4.1.2 Enterprise Scientific and Technological Innovation
The state supports enterprises in leading technological innovation, increasing R&D investment, and provides tax incentives. Enterprises participating in this vaccine research can leverage these policies to obtain resource support and enhance the industrialization potential of the research.
4.1.3 Scientific and Technological Personnel
The state protects the rights and interests of scientific and technological personnel and improves the incentive mechanism. The research team can receive corresponding incentives through achievement transformation, and the research results can be used for professional title evaluation, providing development guarantees for researchers.
4.1.4 Safeguard Measures
The state promotes the industrialization of scientific and technological achievements through financial investment, encouraging social capital, and supporting financial institutions. This research can rely on these safeguard measures to apply for financial and policy support, addressing resource needs during the R&D process.
4.1.5 Supervision and Management
The state strengthens the development of scientific research integrity and ethics, establishes a supervision system, and requires research to pass ethical review and comply with resource-sharing regulations. This is a core supervision requirement that must be followed throughout the design and implementation of this research.
4.1.6 Legal Liability
Actions that violate scientific research integrity and ethics are strictly prohibited, and research must comply with legal, regulatory, and ethical standards. This clarifies the bottom-line requirements and legal consequences for non-compliance, providing constraints for conducting research in a compliant manner.
4.2 Regulations on the Administration of Veterinary Drugs
Aquaculture vaccines fall under the category of veterinary drugs. This Regulation specifies the technical standards and management norms that vaccines must meet throughout the entire chain of R&D, production, operation, and use:
4.2.1 Research and Development of New Veterinary Drugs
The state encourages the R&D of new veterinary drugs, requiring R&D to comply with safety evaluation and quality management standards, and mandates applications for clinical trials and product registration. This is a key approval link for transitioning this vaccine from laboratory research to practical application.
4.2.2 Production of Veterinary Drugs
Production enterprises must obtain a production license, comply with quality management specifications, and ensure product quality. If the industrialization of the vaccine is promoted in the future, production qualification applications and quality control must be completed in strict accordance with this provision.
4.2.3 Operation of Veterinary Drugs
Business enterprises must establish purchase and sales records and are strictly prohibited from selling counterfeit or substandard veterinary drugs. This provides a basis for the circulation management of vaccines after they are launched, ensuring compliance at the product usage end.
4.2.4 Use of Veterinary Drugs
Users must comply with safe drug use regulations, establish medication records, and are strictly prohibited from using banned drugs. This clarifies the operational specifications for the final application of vaccines in aquaculture, avoiding the risk of abuse.
4.3 Law of the People's Republic of China on Animal Epidemic Prevention (Revised in 2022)
4.3.1 Prevention of Animal Epidemics
The state establishes an animal epidemic risk assessment system and implements compulsory immunization for severe epidemics. This provides a clear basis for the R&D direction of this vaccine—it must focus on the prevention and control of high-risk epidemics to align with national compulsory immunization needs.
4.3.2 Quarantine of Animals and Animal Products
The production and sale of vaccines must undergo quarantine, and products must be accompanied by quarantine certificates and marks. This ensures that vaccines themselves pose no risk of epidemic transmission and is a necessary prerequisite for vaccines to enter the market.
4.3.3 Legal Liability
Those who fail to implement compulsory immunization or illegally produce or sell vaccines will be punished in accordance with the law [13]. This further strengthens legal liability across the R&D, production, and application links of vaccines, forming a complete accountability system.
Analysis of Ethical Issues
On the basis of complying with the legal and regulatory framework, aquaculture vaccine research involves sensitive areas such as experimental animals and the application of genetic technology. It is necessary to further examine potential ethical risks, specifically from the following dimensions:
5.1 Ethical Issues Related to Experimental Animals
This research uses turbot as the experimental subject, and the protection of animal welfare and the rationality of animal use are core ethical concerns:
5.1.1 Inadequate Protection of Animal Welfare
During the experiment, turbot may face harm due to engineered bacteria enrichment, near-infrared light irradiation, and UCMs introduction (e.g., engineered bacteria affecting intestinal function, and the long-term safety of UCMs being unvalidated). This violates the welfare principle of "reducing animal suffering," and experimental procedures need to be optimized to minimize harm.
5.1.2 Doubts About the Rationality of Using Experimental Animals
If the experiment directly uses a large number of turbot without first verifying technical feasibility through in vitro models, it may lead to the overuse of experimental animals, which is inconsistent with the 3R Principle ("Replacement, Reduction, Refinement"). Alternative solutions should be prioritized to improve the ethical rationality of animal use.
5.2 Ethical Issues in the Application of Genetic Engineering Technology
This research relies on genetic engineering technology to modify strains, and the environmental impact and controllability of technology application are key to ethical review:
5.2.1 Environmental Risks of Genetically Modified Organisms
If engineered bacteria (E. coli, vaccine bacteria) leak into the natural environment due to improper operation, they may reproduce abnormally by virtue of their targeted adhesion ability, disrupting the ecological balance (e.g., competing for resources, affecting the genetic diversity of native microbial communities). Strict leakage prevention and control mechanisms need to be established.
5.2.2 Potential Uncontrollability of Genetic Modification
Although the single-component light-controlled system has a high success rate, unexpected mutations may occur during genetic modification, leading to the failure of the light-controlled switch of engineered bacteria. If out-of-control engineered bacteria over-enrich in turbot, they may cause unpredictable damage, which may further affect other organisms through the food chain. The stability verification of the modification process needs to be strengthened.
5.2.3 Ethical Issues in the Promotion of Technological Application
f vaccines are hastily put into aquaculture practice without fully verifying the long-term safety of engineered bacteria and their impact on fish populations and ecosystems, it may pose threats to aquaculture industry and consumer health (e.g., residual harmful substances, triggering unknown immune responses). A comprehensive safety assessment must be completed before promotion.