Safety
Biosafety is one of the major concerns of the filed of synthetic biology and the iGEM competition, and it's also the basis of any successful scientific researches and experiements. Being fully aware of the significance of safety, our team has strived to ensure bio-safety in all processes of our project. During the design, testing, execution procedure, we have always followed the safety guidelines provided by the iGEM Committee. More detailed explainations are elaborated below:
Why Our Product is Safer?
Our team recognizes the problem that many current chemical detectors are lack in bio-safety and may cause harm to the user and the surrounding environment. Therfore, our team aims to make a chemical detector that involves minimal risk to bio-safety. In order to help our detector to go out of the lab and into real-life applications, meanwhile preventing any biosfety issues, we put a lot of safety considerations into the design and execution of our products:
Materials
The core reaction involved in our product (a low-cost chemical testing kit) is the color reaction between bacterial endogenous ß-galactoglycase and X Gal indicator. The main bacteria used for the reaction is Escherichia coli, which is a completely controllable and understood culture that has been fully studied and commonly used throughout the history. Other substances in the kit include X-Gal and the solid bacterial medium. Since X-gal is the substrate of ß-galactose, and bacteria medium is made of agar, their existence won't bring any harm toward organisms or the surrounding environment.
Detection
The entire detection process of our product involves four major steps: the cultivation of E.coli, the centrifugation of the bacteria, the insertion of promotors and the addition of x-gale. No dangerous, explosive, infectious or radioactive chemical reaction will occur during the detection. All the materials needed are provided for the user in a sealed kit, except for the sample to be tested, which should be brought by the user. No engineered strains or other materials will be taken outside the laboratory in any cases. After the detection process, all the materials used will be disposed and destroyed using proper methods, as explained below.
Waste Disposal
The disposal of waste will be requested to follow stringent instructions. The main waste in the operation process comes from the sediment at the bottom after centrifugation, which are all unsplit Escherichia coli. These discarded waste must be disposed of in properly labeled waste containers that marks biohazardous. Then, either the waste removal company or the laboratory itself should take and dispose the waste after incineration or other proper treatments to make sure it's free of infectious organisms.
Hardware
Centrifuges used to produce centrifugal liquids have the potential for high pressure explosions. When the centrifuge tubes are not evenly distributed or the sample is weighed incorrectly, there is a risk of explosion or machine failure, which can only be stopped manually by pressing a button, and it is dangerous. However, the centrifugation process is necessary for most of the bacteria experiments, so our team innovated a plastic centrifuge, which can be centrifuged by hand rotation and without scratching or explosion. When the tube is not evenly distributed, it only affects the product or the tube is thrown out, thus it significantly reducing the risk.
And we designed the reagent kit with a sponge as a cushioning material to protect the tubes and a low-powered heating wire that is well insulated from electricity to prevent any accidents.
Through the above approaches, we managed to adress the safety issues of the previous chemical detectors and built a safe and applicable model for future products or researches.Read Our Hardware Page
Experimental Safety
Before beginning the experiment, our team has carefully studied the Chinese biosafety law and is fully conscious of our duty to undertake legal responsibility of bio-safety, to maintain social security, and to protect biological resources and the ecological environment. Therefore, we did the following actions in order to perform our responsibilities and ensure absolute bio-safety in lab.
Preparations
In view of the importance of laboratory safety, we received training on standard experimental procedures and common operating rules for biological laboratories. We take a number of steps to ensure that every team member has access to a safe environment to conduct engineering biology research.
We considered carefully about the biological materials we use and selected standard biological laboratories and instruments after proper risk assessment. In order to ensure the smooth progress of the experiment, all members conducted online virtual laboratory exercises. Before entering the laboratory, all members are required to sign responsibility of laboratory safety management regulations to understand the lab rules and know their responsibilities. We also received security training from professions, including but not limited to how to use biosafety equipment, disinfection and emergency measures.
Lab
During the experiment, we strictly obey the rules of the lab, such as wearing a silicone gloves, lab coats, masks as learnt beforehand. As for the use of samples and biomaterials, according to Articles 45 and 47 of Chapter 5 of the Biosafety Law of the Republic of China, experiments on pathogenic microorganisms should be carried out in corresponding grade laboratories and waste should be treated to prevent pollution. Therefore, all water samples used in the experiment are brought from the wild without harming the surrounding environment. The whole experiement doesn't involve the use of any explosives, toxin factors, sharp objects, corrosive substances etc., and it does not require transportation of living organisms or unsafe samples. No human or living organism experiment is conducted. No engineered strains or other materials has been taken outside the laboratory and the waste are all disposed according to the rule.
COVID-19 Precautions
Following epidemic prevention and control regulations is the responsibility of all citizens. Therefore, during the offline experiment period, all of our team members closely observe the rules of the local community, wearing maskes condcuting daily nucleic acid testing and temperature measurement to ensure everyone's health. No living organisms related to the coronavirus is used in the experiment. After the experiment, the laboraties are cleaned and sterilized following the standard.
Legislation Proposal
Inspiration
To ensure the safety of our detecting system, the bacteria used during the detection process is, as stated before, non-pathogenic E. coli, which is already a relatively safe and controllable microbe. We also designed a sealed kit to prevent escaping of the bacteria. However, if not handled properly, E.coli can still be released from the lab, leading to unintended consequences. For non-pathogenic E.coli, the impact of escaping might not be severe, but for more dangerous microorganisms used in more advanced laboratories, the consequence of mishandling can be tremendous and fatal. Therefore, our team realizes that the legislation related to the diposal of engineered bacteria strains deserve our attention.
Starting from this idea, our team members made a massive amount of researches on the internet not only on strains preservation and disposal, but also on other aspects of biosafety and its legislation. We also conducted questionnaire survey and interviews to gain more information from the public and professionals, which is elaborated below. During these research process, we recognized more possible improvements with the current Chinese biosafety laws, and hence determined to organize our ideas into a standard legislation proposal.
Researches
In order to explore the topic in a deeper depth, we made an interview with Dr. Tim Wang, Dr. Huirong Chen, who are both professions in biology. We discussed about current biosafety issues and legislation problems. Dr. Wang pointed out that "the public has a low awareness about biosafety issues, as they often think that biosafety is far from their life." Therefore, we decided to create a education section in our proposal to advise for awareness-raising activities.
Moreover, since our team recognizes that there is a lack of public awareness about biosafety, we hope to make use of some primary statistical data to support our opinion. Therefore, we designed and delievered an online questionnaire focusing on studying Chinese people's their knowledge toward the biosafety. We hope that the findings can inform strategies to increase people's perception towards biosafety, and help us to build our final legal proposal.
We also conducted literature researches using online database to search for secondary information from academic journals and books. These research papers give us insights about improving biosafety legislation and regulation. For instance, in Elizeus et al. (2019)'s research paper, the authors found through their survey results that "the majority of respondents indicated inadequate guidelines dissemination, lack of financial resources, inadequate personnel, lack of equipped laboratories and lack of instructional materials among major barriers." From this quote, we are able to see the existing problems of biosafety management system and the difficulties related to biosafety that experimenters often encouter.
Problem
After conducting these researches, we formed a deep understanding of the current major biosafety regulation and management problems, summarizing as:
1. Imperfect standard for management of engineered bacteria
2. Unsound biosafety management and response system
3. Lack of knowledge and public awareness
For each problem, we gives several corresponding solutions and advices, which are presented below in our final legal proposal.
Final Proposal
Bacteria Lysis
Microbial safety issues are closely related to public health and ecological safety, so comprehensive control of microbial threats has far-reaching implications for social security. Our team hopes to have a positive impact on China's biosafety laws through various types of practice and exploration.
By studying Chinese biosafety laws and regulations, we learned that waste produced in pathogenic microbiology laboratories should be strictly disposed of, otherwise it will affect people's lives and health and the stability of the ecosystem. In our designed experiments, the lysis module can help to deal with engineered bacterial. The arabinose or copper ion, which acts as a promoter, causes the ribosomal binding site to translate the lysis gene, and then the cell lyses and dies. It addresses the potential biohazards efficiently and reduces the possibility of accidental release of the modified bacteria into the outdoors.
In collaboration with Thinker_shenzhen's team, we provided the lysis module to help them improve their treatment method by using enzymes instead of engineered bacteria, greatly enhancing the safety and controllability of the experiment. Therefore, we offer our suggestion for the technical side of the biosafety law - using lysis modules to help dispose of waste living organism.
Strains Preservation, Use and Destruction
In addition, we also put forward a few points to improve the management standards of non-pathogenic engineering bacteria.
1. After the standard strains or passages with strains inoculated to ordinary agar slant culture, they should be transferred to 4 to 8 degrees in the refrigerator for preservation, and check its health at any time. When finding abnormal situation, using 121 Celsius for 45 mintues to inactivation and destruction.
2. Liquid paraffin preservation method. Liquid paraffin wax is sterilised at 121 celsius for 30 minutes, and the water is evaporated in a 40-degree thermostat. Under the laminar flow table with a sterile pipette to suck liquid paraffin to the strain tube, so that the paraffin is higher than the surface of the strain about 1cm to make the bacteria and air isolation. For preservation the tube should upright either in -20 Celsius or 2 to 8 celcius environment.
Improving biosafety laws and management standards can effectively prevent and respond to the threat of dangerous biological factors and related factors, help the stable and healthy development of biotechnology, people's lives and health and ecosystems in a relatively stable state.
Biosafety Management System
Recent years, the COVID-19 pandemic has led to devastating impact on every aspect of economic and social life. This is a major biosafety incident, and it has made people more aware of the serious consequences that can result from endangering biosecurity. However, it can be seen from this epidemic that countries do not have a perfect biosafety management and response system for sudden biological events, resulting in a high number of casualties and financial losses.
Recognizing these problems, our team put forward the following suggestions to improve the system and enhance the country's ability to respond to biosafety incidents:
1. Develop strategies for specific biosafety events, such as alien biological invasions, epidemic outbreaks, laboratory escapes, etc., so that relevant personnel, as well as the general public, can learn these strategies. If possible, conduct biosafety incident drills in relevant institutions or laboratories to ensure that there is no panic and orderly handling of potential biosafety incidents.
2. Strengthen biosafety training and knowledge dissemination for biological laboratory professionals, especially experimenters located in major institutions or senior laboratories. Establish a biosafety expert team and establish a relevant agency or department (National Association of Biosafety), such as the Center for Disease Prevention and Control (CDC), to conduct relevant research and make the most rapid and effective response when biosafety incidents occur.
3. Increase funding for biosafety-related research and encourage relevant government departments, private enterprises or individuals to conduct relevant research. These studies can analyze past large-scale biosecurity events, such as the COVID-19 outbreak, assess the benefits and drawbacks of past responses, learn lessons, and build on experience. These studies can help institutions or departments to develop and improve existing laws and better prepare for future biosafety events.
Education
Finally, through the questionnaire survey and interview we conducted, we recognizes a lack of public awareness of biosafety. Therefore, we offer the following recommendations for biosafety education:
1. Implement biosafety-related educational programmes and articles through the mass media (e.g. the internet, television, newspaper). Organize awareness-raising activities associated with biosafety in communities, firms and instituitions to increase people's knwoledge towards biosafety.
2. Conduct biosafety-related lectures or courses in primary and secondary schools to popularize the importance of biosafety and enable students to understand biosafety-related knowledge. Cultivate biotechonology talents by establishing vocational training programs in universities.
Influence
In general, our Legal proposal of the Biosafety is aimed at improving the relevant issues from three aspects: prevention and control of relevant technologies, tracking after escape and public education. In the future, we hope that our proposal will serve as a reference for the improvement of national policies and promote the improvement of national biosafety governance
Future Plan
On the basis of the above proposal, we will contact some Professional Legal and Policy Personnel to further improve the proposal and format it into a more standard legislative proposal. After that, we will either submit the appeal in written form to the petition authorities or submit the proposal online to the Shenzhen Justice Bureau Portal website so that the government or relevant authorities can read the proposal. We hope that this proposal will really help Enhance BioSafety in the country and do its part to enhance public and environmental safety.
Education
According to numerous relevant researches, current public awareness level of biosafety is quite insufficient as people are often inattentive to associated events and information. This ignorance may lead to severe consequences, endangering other living species, the ecosystem and even human beings. Therefore, to do our best to improve the present situation, our team organized various educational activities about biosafety to raise the public awareness of this issue.
Online Lecture
We held a online lecture on the topic of biosafety, facing audiences from all age groups and careers. Before the event, we designed and published poster of the lecture on various social media in order to expand the social influence. At the start the lecture, by showing the audience some events that is related to biosafety (invasion of alien organisms, casualties caused by improper experimental operations, etc.), we first illustrated our point that biosecurity is not sout of reach, but closely related to everyone's survival and development. Then we introduced the concept and categories of biosafety in more detail, especially the safety of genetically modified organisms related to synthetic biology. We also gave some information about national biosafety laws. At the end of the lecture, we answered some questions from the audience related to the topic. In general, this lecture succeeded in promoting public awareness of biosafety, educating people about biosafety and relevant legislation, and making people pay higher attention to the issue.
Bilingual Article
In order to further promote biosafety, we have also written a biosafety article with Chinese and English version, which provides a complete and in-depth introduction to biosafety. It not only introduces the concepts and categories of biosafety, but also describes the popularity of relevant laws and some famous security incidents in the past. Most importantly, the article also describes what ordinary people can do to maintain biosafety, calling on readers to understand, pay attention to and follow biosafety. By Posting and disseminating this article on social media, we aim to do everthing we can to raise public awareness of biosafety. We believe that, only when everyone masters biosafety knowledge, correctly deal with biosafety risks and understand and abide by the biosafety law, can we jointly build a strong global biosafety defense line.
Communication
Partnership
We have a close partnership with Thinker_shenzhen team and the lysis module shared by us have helped the Thinker_shenzhen to make a breakthrough in biosafety.
Thinker_shenzhen intends to use the live strain as a spray to treat skin diseases. However the genetically modified organisms release directly into the environment may bring many invisible hazards.There is a biosafety risk, after the exchange and discussion between the two teams, we think the lysis module can help Thinker_shenzhen to solve the problem. The strain produces titinase, and after the production is finished using arabinose as the promoter.The cleavage gene is translated at the ribosomal binding site, so the strain cleaves and dies, the titinase is released into the medium, which can be used to treat the patient after purification.
Roundtable Meeting
On August 12, we organized a roundtable meeting with several other iGEM teams on the topic of biosafety. We aimed to provide a platform for teams with the same safety concerns to exchange ideas and provide mutual help. During the meeting, each team first shared several biosafety issues that they faced during experiment design and execution phase. Heated discussion among the team members ensued where we shared our knowledge related to biosafety and brought up advices and solutions for safety issues. The purpose of this event is to unite iGEM teams to contribute to the future of biosecurity and synthetic biology.
Safety in Human Practice
When conducting interviews, lectures and other human practice activies, we always follow the rules and regulations of the relevant institutions. When conducting interviews, we are particularly aware of problems of privacy, informed consent and protection of vulnerable population. Therefore, the collection of all information during these activities, no matter in the form of pictures, words or voice recording, has obtained the participants' consent, and no personal information of the interviewees is exposed to the public. No questions related to minority groups is asked. We are sincerely respectful and grateful for those who engaged in these activities, and is fully aware of our responsibility to protect their right to privacy.
Conclusion
Our team has made efforts and made practical suggestions in three areas: management of engineered bacteria, improvement of biosafety systems, and education. We hope that we can make a positive impact on biosafety laws and regulations, so that more synthetic biology teams can conduct experiments in a secure manner.