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From 2011.igem.org

Safety

1. Would the materials used in your project and/or your final product pose:

a. Risks to the safety and health of team members or others in the lab?

b. Risks to the safety and health of the general public if released by design or accident?

c. Risks to environmental quality if released by design or accident?

d. Risks to security through malicious misuse by individuals, groups or states?

As in every lab there are harmful chemicals in our lab, which pose potential risks to humans or the environment. Therefore special caution and preparation is necessary. Everyone, who is working the lab, is trained by the safety officer to the rules of good practice with chemicals and organic material Chemicals are safely stored as obligated. Solvents are stored in explosion protected lockers and toxic substances are locked away. We always apply the lab code, like wearing gloves, lab coats and protection glasses. For our safety we have a fume hood in our iGEM lab.

In our project we are using bisphenol A which is a potentially teratogenic chemical. To avoid contact with BPA we always wear appropriate protection (gloves, protection glasses, lab coat) and only work with BPA containing samples under a cleanbench or an extractor hood. The BPA container is stored together with other harmful substances (like e.g. ethylacetate which we use for BPA extraction) in an explosion protected locker so everyone in the lab knows that this is a dangerous substance which has to be handled with care. All BPA containing waste is collected together with other harmful substances (e.g. solvents) and is disposed by a department in our university which is responsible for the disposal of chemicals.

When working with ethidium bromide special rules apply in our lab. The work with ethidium bromide is only allowed in a marked area in one room. Nothing is allowed to be touched with the same gloves, which were used in this area. There are working instructions available in every room for harmful substances. To protect the environment, all harmful or pollutant chemicals are collected separately and disposed by the chemical disposal department of our university.

To sum up, we minimize the risk for all people working in the lab and the environment by applying the lab code and all safety rules. There are no risks to the general public or security concerns through malicious misuse.

Specifically, are any parts or devices in your project associated with (or known to cause):

• pathogenicity, infectivity, or toxicity?
• threats to environmental quality?
• security concerns?

The bacteria we are currently working with are defined as biosecurity stage 1 (S1). Our produced GMOs (genetically modified organisms) are therefore harmless to the user, mankind and the environment. Thus they are GRAS - generally regarded as safe. We are not working with any pathogenic, infective or toxic BioBricks, there are no known threats for the environment and no security concerns. For the unlikely case of accidental release we do not expect any consequences. The E. coli K12 strains we are working with are security strains, adapted to specific growth conditions. We can provide these conditions in the lab, but the bacteria would die if released to the environment.

Further we are working in a biosecurity laboratory of the stage 1 (S1). The building is designed to prevent the release of bacteria. We reduced the risk of contamination of the environment or staff members by desinfection, autoclavation and using of protection clothes. There is no possible access for the public. Every person working in the lab is trained and instructed by the safety rules for laboratories S1.

2. If your response to any of the questions above is yes:

a. Explain how you addressed these issues in project design and while conducting laboratory work.

b. Describe and document safety, security, health and/or environmental issues as you submit your parts to the Registry.

See above for detailed explanations.

3. Under what biosafety provisions will / do you operate?

• Every single person in the lab is trained on their work.
• Every working person in the lab is trained on safety issues.
• We have a safety and a disinfection officer at our lab.
• No unqualified personal has access to the lab.
• No public access to the lab.
• We reduced the risk of contamination of the environment or staff members by desinfection, autoclavation and using of protection clothes.
• In case of emergency there are telephones, fire extinguishers, defibrillators and alarm buttons around the lab.
• We only used organisms of the risk stage 1, which do not harm either mankind nor the environment.
• Constantly low pressure, no open windows => no organism can get in or out
• Desinfection of all working places after work (everyday)
• Autoclavation of waste (solid/liquid)
• No pipetting with the mouth

a. Does your institution have its own biosafety rules and if so what are they? Provide a link to them online if possible.

Our University has an own health, work and environment protection management system, certified with the British standard „Occupational Health and Safety Assessment Series“ (BS OHSAS 18001):

[http://uni-bielefeld.agu-hochschulen.de/index.php?id=714 AGU (Arbeits-, Gesundheits- und Umweltschutz-Managementsystem)]

This System defines the [http://uni-bielefeld.agu-hochschulen.de/index.php?id=23 responsibilities] for Biosafety, the facilities for working with GMOs and project management. All rules comply with European, national and state laws. For further information see our lab rules and the operating instructions for working with GMOs in S1 labs:

Lab rules (in german

Operating instructions S1 Lab

b. Does your institution have an Institutional Biosafety Committee or equivalent group? If yes, have you discussed your project with them? Describe any concerns or changes that were made based on this review.

We don’t have a Biosafety Committee at our Institution, but the head of our department and iGEM Instructor Dr. Jörn Kalinowski is responsible for genetic engineering project management and therefore the biosafety officer. We discussed the project with him and he constantly oversees our project in matters of biosafety and biosecurity. As all our work is conducted in compliance with all relevant rules, regulations and laws there are no concerns.

c. Will / did you receive any biosafety and/or lab training before beginning your project? If so, describe this training.

Every person working in a laboratory has to be trained in general laboratory safety rules and in our case especially in the work with genetically modified organisms. This training is conducted before every lab course and repeated at least once a year. So before beginning our lab work we had a safety instruction featuring general lab guidelines, explanations on safety equipment, handling of harmful chemicals, waste management and acting in case of an emergency. Of special importance is the training in the work with genetically modified organisms. Documentations have to be performed according to national laws and there are special rules on handling, decontamination as well as disposal of GMOs to prevent release to the environment. The work with GMOs outside a laboratory with at least safety stage 1 (S1) is prohibited by law. Therefore everything that was in contact with GMOs has to be decontaminated before leaving the laboratory. Additionally to the standard instructions and training we asked the department for safety at work at our university to give us training in emergency situations and fire fighting. After a presentation on how to prevent fire and how to put out a fire we could practice with different fire extinguishers and a fire hose. Through the practical application of the different safety equipments we are now better prepared for the case of an emergency.

d. Does your country have national biosafety regulations or guidelines? If so, provide a link to them online if possible.

The [http://www.bvl.bund.de/DE/06_Gentechnik/gentechnik_node.html Federal office of consumer protection and safety] is the institution responsible for biosafety. All laws, regulations and guidelines can be found here:

• [http://www.bvl.bund.de/DE/06_Gentechnik/03_Antragsteller/08_Rechtsvorschriften/01_Deutschland/gentechnik_rechtsgrundlagen_national_node.html National German laws and regulations]
• [http://www.bvl.bund.de/DE/06_Gentechnik/03_Antragsteller/08_Rechtsvorschriften/02_Europa/gentechnik_rechtsgrundlagen_eu_node.html European regulations and guidelines]
• [http://www.bvl.bund.de/DE/06_Gentechnik/03_Antragsteller/08_Rechtsvorschriften/03_International/gentechnik_internationale_uebereinkuenfte_node.html International contracts and agreements]

[http://www.bvl.bund.de/EN/06_Genetic_Engineering/genetic_engineering_node.html Federal office of consumer protection and safety in English]

The ZKBS (Zentrale Kommission für die Biologische Sicherheit) is panel of experts appointed by the Federal office of consumer protection and safety. Their task is to check GMOs on risks for humans, animals and the environment as well as assess the work with genetic engineering and the used facilities.

[http://www.bvl.bund.de/DE/06_Gentechnik/02_Verbraucher/05_Institutionen_fuer_biologische_Sicherheit/02_ZKBS/gentechnik_zkbs_node.html ZKBS in German]

[http://www.bvl.bund.de/EN/06_Genetic_Engineering/ZKBS/01_Allg_Stellungnahmen/genetic_engineering_zkbs_allgStellungnahmen_node.html ZKBS in English]

Do you have other ideas on how to deal with safety or security issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?

Our approach is a cell free biosensor. One advantage is that no living organisms need to be used outside the lab for the application of our system. We want to provide S-layers as nanobiotechnological building blocks for cell free biosensors. By fusing different enzymes to these proteins, a variety of biosensors can be build. All GMOs can stay in the lab, therefore are grown under controlled conditions and only qualified personnel has access to them.