Week 1. Principles and Practices

Lecture video

Link to the video lecture


For a possible project, setting up your lab, or running a project you are actually planning on doing, find out:

What rules / standards locally, nationally and internationally apply

Since we are three in the team, we decided to split and gather information separately. What are the rules for setting a biolab? As you will see there are many layers of regulations that usually overlap and contradict themselves. When that last thing happens (more often than you might think), the top Organization is true.

Local regulations

I did the local part because I have experience when I set up the fab lab. In Sitges (actually in most municipalties) there are two sources of information you have to look at when setting up any kind of business. These regulations only talk about activities that can be performed in a certain place, not about the specific regulations of each activity, which of course you must also follow.

  1. POUM (2006). The first one is the General Urban Plan. This is a long term document (changes every 10 to 20 years or so) that (among many other things) specifies what kind of activities you can do and what others you cannot do in a certain place. So for our place (Passeig de la Ribera 46) almost everything is allowed including a Biolab.

  2. PMU Uses of Historic Center (2008). But then there is another document that you have to look at and it is called the Historic Center Use Plan. This is something someone invented to quickly (it only requires the Mayor signature) restrict further the uses of the locations inside the Historic Center (the place where we are). This document says that our place can only be a bar, coffe shop, restaurant and art gallery. That's all. The rest of activities, everything from prostitution to education are forbidden. End of line. The most stupid thing about this is that when you ask anyone in the City Council why some activities like education are forbidden they don't know. But they don't do anything to change it either. It reminds me the last days of the Senate, so slow and unefficient that is actually unable to take any action (Star Wars Episode III).

So this is it. We are here, but we officially do not exist. The good thing about being illegal is that you don't have to worry about the rules anymore (some of them really stupid).

National (Spanish) regulations

  1. Real Decreto 1716/2011, November 18th. This law establishes the minimum requirements for license and use the biobanc content for biomedic spanish reseach
  2. Orden ECC/1404/2013, June 28th. Modify the Real Decreto 1716/2011 about mínimum requirements for license and use biobancs content for biomedics spanish reseach
  3. Law 14/2007, July 3rd. About Biomedical Research
  4. Real Decreto 65/2006, January 30th. Requirements for import and export biological samples
  5. Law 54/2003, December 12th. Ocupational hazards.
  6. Real Decreto 665/1997, May 12th. Carcinogens protection
  7. Real Decreto 664/1997, May 12th. Biologicals agents protection.
  8. Technic Guided. About hazards related to biological agents exposition.
  9. Law 9/2003, April 25th. About confinement, voluntary release and marketing of genetically modified organisms.

European regulations

  1. European Treaty number 164. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.
  2. Orden ECC/1404/2013, June 28th. Modify the Real Decreto 1716/2011 about mínimum requirements for license and use biobancs content for biomedics spanish reseach
  3. Directive 2008/98/EC on waste. European Waste Framework directive.
  4. Laboratory Biorisk Management Standard (Visit web page). (Download). CEN (CEN is the European Committee for Standardization, Comité Européen de Normalisation)/WS 055 - Guidance Document for CWA 15793:2008
  5. European directive 90/219/EEC. April 23th. Contained use of genetically modified micro-organisms

World regulations

  1. IHR (2005): a multi-hazard dimension. World Health Organization. Strengthening health security by implementing the International Health Regulations.
  2. Laboratory Biosafety Manual. World Health Organization.
  3. Paris, October 21th to November 12th 1997. 29 Session. Declaration about human genome and rights.
  4. International Risk Governance Council, Geneva, 2010. Guidelines for the Appropriate Risk Governance of Synthetic Biology.
  5. Ocupational Hazards in biotechnology. Introduction to Cartagena United Nations Protocol related to Bio Diversity.

Interstellar regulations

They don't exist, but I am sure there is someone working on it.

Where there are uncertainties / ambiguities around these rules

Although the regulations mostly focus on medicine or human food, it is very well regulated. But due to a big backlog between new advances in technology and its regulations, nowadays only a few of the procedures and guidelines are regulated.

Inside the European Union, the rules are especially difficult to set and often change because of the freedom to decision on every country member. For instance, among the 27 EU Member States, Spain is considered as the most pro‐GMO Member State. It is the only Member State within the EU where significant amounts of genetically modified crops are grown (about 25,000 hectares of GM maize). As Spain failed to implement Directive 98/81/EC into national law in due time, the European Commission took Spain to the European Court of Justice. The Court declared that by failing to adopt the laws and administrative provisions necessary to comply with the Directive, the Kingdom of Spain failed to fulfill its obligations under that directive and was thus ordered to pay the trial’s cost. In 2003 Spain finally implemented the Directive through the “GMO Act of 200378” and two separate Decrees (one Decree implementing the procedural and technical requirements and one Decree addressing stakeholder involvement).

The “GMO Act of 2003” transposes the Directive on contained use as well as the Directive on Deliberate Release. The scope of the transposing legislation is extended to include the contained use of GM plants and animals. The definitions of GM, GMM and contained use are the same as the corresponding definitions in the Directives. Political power in Spain is channeled by a central government and 17 autonomous communities. Thus there are 18 competent authorities (CA) for contained uses; one on the national level and seventeen in the autonomous regions. Some autonomous regions have additional regional ‘Bio‐safety committees’ that advise the regional CAs. Activities conducted by private sector companies and regional public research institutes are notified to the CAs of the autonomous regions, which coordinate with the National CA. Whereas activities conducted by the federal public research sector must be notified to the National CA, which coordinates with the CAs of the autonomous regions. In 2009 there were around 170 facilities that conducted contained use activities with GMOs.

Inspections are carried out before the authorization of an installation. They are conducted either by the autonomous regions or by the General State Administration, depending on the distribution of competence. During the inspection, the information provided by the notifier is verified and the containment measures are checked for their adequacy. If problems are detected, authorizations can be revoked or postponed until the problems are solved. In 2004 a minor accident occurred at the University of Navarre; a fire broke out in the air‐conditioning system of a class 3 laboratory. At that time GMM cultures were stored in a freezer which did not incur any increase in temperature owing to the fire. After the fire, the CA of Navarre conducted an inspection and issued a report restricting the GMM activity to zones that had not been affected by the fire until the original state of the laboratory was restored. (SynBERC and iGEM Version 9.1 January 10, 2012)

Who you would work with to resolve these ambiguities / uncertainties

In Spain, the Spanish Bioethics Committee.

The Spanish Bioethics Committee was created through Law 14/2007 of July 3rd on Biomedical Research (BOE July 4th) as a "collegiate, independent and consultative professional body, which will develop its responsibilities, with full transparency, on materials related to the social and ethical implications of Biomedicine and Health Sciences". The Committee was established on October 22nd 2008 and forms part of the Ministry of Health, Social Services and Equality.

Its mission is to issue reports, proposals and recommendations for public authorities at state and regional level on matters related to the ethical and social implications of Biomedicine and Health Sciences. Equally, it is responsible for establishing the general principles for the production of codes of good practice in scientific research and for representing Spain in supranational and international forums and bodies involved in bioethics.

Is the design of current regulations / norms sufficient to ensure societal benefits and mitigate harm?

My personal opinion is that the current regulation is sufficient, at least for Europe. Although, the main problem is we need to work towards an universal consensus and reduce the ammount of overlapped regulations, which are time consuming and very confusing to follow up due to its many layers and continuous changes.

Assignment review

On wednesdays we always have a review session of last week's assignment. Here is the link to this week assignments review.

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