DIY-BSL1 Manual Ecogen

Welcome
Are you a start-up, community lab, food hub, or others working with microbes, mushrooms, plant, animals or human cell lines, as well as gene editing with organisms that belongs under the ordinance of biosafety level 1 (BSL1) we help you here to legalize your practice to become officially registered, so you will not worry about your legal state as biohacker or community lab owner. Everyone who is working in this field should consider wisely to do so since transparency is a key to successfully open science program. If you ever thought of registering your practice and your lab officially, to protect you and your colleagues, here you are on the right side! Within the Databank of ECOGEN, you can register a one-time global notification (costs 100chf) about working with BSL1 safety level and off you go to have fun in all your greater experiments. If you have doubts or questions if your practice lies inside the ordinance of Biosafety, Hackteria will also advise you to read more into this article and contact us any time. We are providing consulting services as well as this open guidance, which will lead you through the process of registration on the ECOGEN Databank.

What is Ecogen and why YOU need to register
The Federal Coordination Centre for Biotechnology is a portal for all notifications and licence applications in accordance with the Containment Ordinance (CO) and the Ordinance on Occupational Safety in Biotechnology (OOSB).

Ecogen is a client portal (www.ecogen.admin.ch) which allows companies, universities, colleges, schools, medical service institutes, as well as DIYbio-Labs or community labs to register their practice of gene editing and other projects with living organisms which are under the safety biotechnology regulations (BSL 1-4). So this will help you to finally get legalized. If you hack the planet always make sure, you know what you do and you inform the officials about it pre-advance (transparency is the key to open-science)

What you need for registration is not only a plan but simply as that it will be based on three simple ingredients: an ADDRESS, a PERSON and a GLOBAL NOTIFICATION on your practice.

If you are not sure what your practice is and if it belongs under the safety regulations in biotechnology, please consider to get a free consultation by our official Bio Security Officer (BSO) Marc: marc(at)dusseiller.ch

To register your own DIYbio Lab it is a process similar to register a restaurant kitchen, much less complicated than it seems. Keep your protocol, safety first, dispose of your waste properly and stick to your security and hygiene lists for you and your work employees. The Ordinance of Biosecurity working with living organisms is applied throughout Switzerland, but each Province (Kanton) is separately in charge to observe what is happening locally and could check you anytime. Out of experience, the officials are not interested in checking the BSL1 Laboratories due to non-significance of the little ones. This means once you have done your Global Notification (Globalmeldung) on Ecogen, your absolutely safe to call yourself an officially registered biohacker! (LEGALIZE IT and be part of a greater global movement!) To write this manual we were working closely with the Federal Office for the Environment FOEN together and further workshops and information will follow.

--> Pls subscibe at the hackteria-forum [here]

Manual - one-time global notification
This is a site which leads you threw the process of legal registration of your DIYbio-Lab or DIY Community-Lab and practice in Switzerland threw the Ecogen Client Portal provided by the Swiss Government and to make sure we all follow the Nagoya Protokol and take responsibility in co-sculpting evolution.

Official Site
www.ecogen.admin.ch

READ ME FIRST - Legal Base
Overview of Swiss legislation on biotechnology

Ordinance on the Contained Use of Organisms (CO)

Ordinance on Occupational Safety in Biotechnology (OOSB)

Nagoya Protokol - Convention on Biological Diversity

Biosecurity Levels 1 - 4
Wikipedia - Biologische Schutzstufe (DE)

Biosaftety Level (EN)

Create your Login


First Step: Let's get started, to create your own Login - Request a NEW ORGANISATION To get a login for the online portal Ecogen the first step to do is to create a "New Organisation", where you will be asked to provide the address of your laboratory and the contact person. This is a process that will go threw the local Federal Office of Environment and will take at least 1-2 days time. You will be informed by Mail and receive your password. Follow the instructions.

When you enter the portal you will see the simple construction of the site, which also resembles a wiki-layout. The header is divided into three entries:
 * Ecogen
 * Public Register
 * About Ecogen

How this site is built up
Upper Header:




 * ECOGEN: Is your personal Section with all the Data you need to provide, where you can add notifications, change your address or enrolle new contacts, or create new organisms(BSO).
 * PUBLIC REGISTER: Is the database which makes visible all other institutions, companies, schools (Organisations) that registered inside the Federal Ecogen Portal. Need more friends? Go look for them.
 * ABOUT ECOGEN: Gives you more insight on the Portal, but as well as about the ordinances and information on the Federale Office of Environment (BAFU)

Side Box




 * NOTIFICATION: This is the main tool you will use to make a global notification about your practice. It will ask you to fill out a form with detailed questionary about what you will do inside your DIYbio Laboratory.
 * MASTER DATA: Here your Data is visible and how your DIYbio Laboratory is registered.
 * CHANGE ORGANISATION: Here you will be able to switch btw Organisational Units (only needed if you have more than one)
 * CHANGE PASSWORD: Here you can change your password
 * LOG OUT: no explanation needed.

So what you need once you have your own login, you will need to edit your MASTER DATA and make a NOTIFICATION/MELDUNG to get started. Those are the two important steps to get your final legalized registration.

How to edit your Master Data


On the left sidebar, you will find a link with the Master Data if you click on it you will see the subentries "Organism", "Organisational unit", "Persons", "Locations" and "Request for modification". This is where you will add your coordinates.


 * Organism - this is only if you build new organisms which then will be inserted to the existing databank
 * Organisational unit - this is if you are a multitude of laboratories, to act individually, most of the cases we are small and don't need to add more units.
 * Persons - here you can add your colleagues and other people who are in charge of your LAB and take responsibility
 * Locations - this is if you have other laboratories or you are moving into a new location
 * Request of Modification - This is a Protokoll of all changes you made within the section of Person (f.Expl. changing your email address, home address) and Locations. The actual modifications have to be done directly threw the sidebar of LOCATION or PERSON and will be sent as copy to the FOEN/BAFU.


 * File:E_Location.jpg
 * File:E_OrganisationalUnit.jpg
 * File:E_Organisms.jpg
 * File:E_Persons.jpg
 * File:E_RequestforModification.jpg

How to create a Global Notification
 "Global notification of Class 1 activities under the ContainO / OOSB	Please note that the summary data collected in this global notification cannot be treated in confidence, as they fall in the category of information that shall in no case be confidential under Art. 24 para. 5 ContainO."

A ONE TIME GLOBAL NOTIFICATION COSTS YOU 100CHF

Here is where the real stuff is happening. So for making your practice legal and also to register to start your own gen modification projects, you need to hand in a global notification class 1 (BSL1) for working with non-pathogenic organisms. See the list and further explanation of Bio Security Levels here. There are few exceptions like working with Tempeh (Rhizopus oryzae) which is according to the list BSL2 but is considered to be safe as BSL1 organism to work within food production. We would like to inform you again, that this registration on BSL1 Level and making a global notification threw the Ecogen page is highly recommended, for reason of making the DIYbio scene more visible and transparent. Therefor again we would like to help you to do this and are writing this manual. The global Notification costs 100chf and if you finished the process you will be legal for an unlimited period of time. So you only need to do this once. In any case, you are uncertain if your practice is belonging in the realm of this legalization you can contact us any time and send us a mail to official Biosecurity Officer Marc: marc(at)dusseiller.ch



how to
To create a global notification (BSL1) it needs to go threw a list of questionary where they will ask you about the type of activities (Teaching, Production, Analyzis, etc.), Summary Details of the Organism you use (Natural Organism, GMO) in precisly what kind of organisms (Fungi, Bacteria, Viruses, Animals, Parasites, Cell lines?) If you are using cloning or expression systems and if so if they can be used classified as Groupe 1? If you use samples from the environment (air, water, soil, food)? If you use gene editing tools like CRISPR/CAS9

Peekaboo inside the questionary form:

File:Bildschirmfoto 2019-09-28 um 20.43.57.png

File:Bildschirmfoto 2019-09-28 um 20.44.59.png

File:Bildschirmfoto 2019-09-28 um 20.46.41.png

File:Bildschirmfoto 2019-09-28 um 20.47.53.png

File:Bildschirmfoto 2019-09-28 um 20.48.57.png

Addition: During your practice of finally legalized you DIYbio-lab, there could be the case, that you will improve your skills and add new practices in your portfolio, If you need to adjust your global notification with new practices (in case you start to produce new organism or aliens ), this can be done by a collective summary and modification of your existing global notification.



Examples
Examples of existing global notification protocols inside the DIYbio Lab Community:

Hackuarium: https://www.hackteria.org/wiki/File:FinalDocument_P1labnotifupdate.pdf

Hackteria: File:BSL1_Meldung_BiologieCommunityKurse.pdf

Links
ON DIYbio:

WIKI-PAGE on DIYBiology

DIY-BSL1:

Security Lists made by other DIYbio Labs in Switzerland:

Hackuarium

Meridiana

Gaudilabs

RANDELAB

Links for Wet Ware: Chemical Products and DIYBIO equipment:

WETWARE

[www.gaudi.ch GAUDILABS]

Links to other DIYbio Art Projects:

Collection of Open Source Art Projects

From the FOEN

[https://www.admin.ch/opc/de/classified-compilation/19994946/index.html Verordnung über Schutz vor Arbeitnehmer vor Mikroorganismen, etc. (SAMV)]

Einschliessungsverordnung (ESV)

Liste aller Bakterien, Viren, Pflanzen Einstufung

Magazin die Umwelt

Leitfaden für Schulklasse vom Bund empfohlen

Implementation guides for the use of organisms

ARTISTS Working with DIYBio:

Agapea

Spela Petric

Mary Magic

Art Loboratory Berlin

Maja Smrekar

Anna Dumitriu

Oron Catts

Paula Vanouse

Marta Demenezes

Contact for Further Questions
marc(at)dusseiller.ch

maya(at)sonmas.ch

Impression
This Manual was written by Maya Minder and Marc Dusseiller in friendly collaboration with the Federal Office of Environment (FOEN) in September 2019. We would like to thank for the generous support by the Federal Office of Environment (FOEN/BAFU)and all their help and willingness to make science more open, accessible and transparent.

Marc Dusseiller

Maya Minder

Bundesamt für Umwelt (BAFU)/ Federal Office for Environment (FOEN)