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Team:HZAU-China/Safety/New Ideas
From 2013.igem.org
Introduction : When we decided to take the first step to join the IGEM, I thought there will be much challenge for me to overcome. In the first two months, we had no idea to start our evaluation. Thank goodness, after we had a talk with a teacher whose major is studying transgenic rice, he provided some good advise for us. That is the beginning of our Biosafety Evaluation.
1 Some good websites or laws for the coming competitions.
Website :
https://2013.igem.org/Safety/Risk_Group_Table
http://www.gov.cn/zwgk/2005-06/20/content_7808.htm
http://www.foodmate.net/law/qita/163478.html
http://www.biosino.org/law/law57.htm
http://www.foodmate.net/law/chukou/1736.html
http://ime.bmi.ac.cn/
http://www.who.int/csr/delibepidemics/WHO_CDS_CSR_LYO_2004_11/en/
http://www.biosafety.org.za/
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html)
2 The safety rules of factory :
After we knew the way to evaluate the biosafety level of our parts, then we decided to visit some factories to get the answer about actual production . What’s more, we created a questionnaire on the Internet to proved the social acceptability caused by our wonderful idea . The people who were invited to fill in our questionnaire had different background. So we can get convincing response from them, and in the end ,we received the result we expected.
3 Communication between experimented schools
We still had some communication with different schools and specialists from different relevant filed. They gave us some brilliant suggestion. And we took the echelon construction into our attention.
4 The brief information of evaluation (Parts)
Our iGEM project is usually working with a non-infectious host organism (Biosafety level 1 or 2) so you may concentrate more on the engineered parts, devices and systems.
From an engineering and scientific point of view, risk assessment deals with the probability that a certain hazard is going to happen. In risk assessment: Risk = probability x hazard
And for parts,we must pay more attention to the hereditary stability and the influence to the environment as well as non-target organisms.
The most common question are as follows:
1 When it comes to unusual breeding animal species in domestic, you should describe the nature environment of the animal and other concerned information in detail.
2 Whether the ecological correlationship with other microorganism in ecosystem will be infected by human and animal causative agent such as virus. Including influence of the change of ecologic environment on this (these) relationship and negative influence that probably cause or increase by that on the heath of animals and human.
3 In the geographical distribution of domestic and natural habitats, Will natural distribution change because of certain conditions change?
4 Whether does it have the ecological specificity, such as in the environment adaptability?
5 The impact on the ecological environment and its potential hazard degree;
6 If is there a possibility of genetic variation? Or does it have an adverse effect on animal health, human health or the environment?
7 The mechanism of action of animal applying genetically modified microorganisms and the safety to animal
8 The survival prospects in vivo of target and non target animal.
9 The effects of target and non target animal.
10 The drift of host and vector.
5 Identifying safety issues in your project:
The factors of interest in a risk assessment dealing with biological material include: pathogenicity, route of transmission, agent stability, infectious dose, concentration, origin of the potentially infectious material, availability of information, availability of an effective prophylaxis, availability of medical surveillance, experience and skill level of at-risk personnel. Your iGEM project is usually working with a non-infectious host organism (Biosafety level 1 or 2) so you may concentrate more on the engineered parts, devices and systems.
From an engineering and scientific point of view, risk assessment deals with the probability that a certain hazard is going to happen. In risk assessment: Risk = probability x hazard Probability:
Could there be an unplanned event or series of events involving your project, resulting in either death, injury, occupational illness, damage to equipment or property, or damage to the environment? How likely is that going to happen?
Does your project require the exposure or release of the engineered organism to people or the environment (e.g. as medicine, for bioremediation)?
6 Common problems are raised frequently during the competition.
1 Could your device, when working properly, represent a hazard to people or the environment?
2 Is your engineered organism infectious? Does it produce a toxic product? Does it interfere with human physiology or the environment?
3 What would happen if one or several bioparts change their function or stop working as intended (e.g. through mutation)? How would the whole device or system change its properties and what unintended effects would result thereof?
4 What unintended effects could you foresee after your engineered organism is released to the environment?
5 Try to think outside the box, what is the absolute worst case scenario for human health or the environment, that you could imagine?
6 How can a safety issue be reported that was discovered in a certain bio-circuit and that was not foreseen (emergent) so other people can learn from that experience?
7 How can safety and security aspects be integrated into the design process so the design software automatically informs the designer in case the newly designed circuit exhibits certain safety problems?
Risks need to be seen in conjunction with the benefits. Although we would like to decrease the risk to absolute zero, this is hardly possible. So the question is not so much if something is safe or not, but rather if it is safe enough! Deciding whether a risk is acceptable or safe enough is no easy task and people may have different opinions. A whole professional field, so called risk management deals with that issue.
