• DIYbio Kits Available on the Internet - Genetic Engineering for Home Use?
• Which statutory regulations have to be observed in do-it-yourself biology?
• Does genetic engineering work of DIY biologists endanger public safety?

DIYbio Kits Available on the Internet - Genetic Engineering for Home Use?

DIY BIO Source: © www.diybio.org - (CC BY-SA 3.0)

So-called Do-it-yourself biology (short: DIYbio) refers to a movement that began in the United States and seeks to make biotechnology, including genetic engineering available to everyone.

The supporters of this movement want to participate in biotechnological opportunities of genetic engineering independently of industrial or research institutions. A self-portrayal of the emergence of the DIYbio movement and the motivation behind it can be found in the 2013 published report of the Wilson Center, an independent research facility of the US Congress in Cambridge, Massachusetts.

As part of this movement, especially North American companies are currently offering experiment kits worldwide through online retail sites that can be used to perform simple microbiological as well as genetic engineering experiments. These kits can be purchased and used by individuals as well as schools, for example.

In Germany, requests for statutory regulation and the risk assessment of such kits were addressed by the highest state authorities of the federal states. As a result, in January 2017, the BVL (German Federal Office of Consumer Protection and Food Safety) published an Expert Report on Genetic Engineering with DIY Kits and the ZKBS (Central Committee on Biological Safety) issued an opinion on three such kits.

Generally, the following applies: If a DIY kit contains genetically modified organisms (GMOs) or if they are produced using the kit, genetic engineering laws will apply. Pursuant to § 3 paragraph 2 of the German Genetic Engineering Act (GenTG) working with such kits is considered genetic engineering. According to § 8 paragraph 1 number 1 of the GenTG, this may only be carried out in genetic engineering facilities in compliance with the corresponding safety measures.

Regardless of the applicability of genetic engineering laws, care should be taken with these kits for microbiological considerations as well. A report by the Bavarian State Office for Health and Food Safety (LGL), which, among other things, is responsible for monitoring the safety of genetic engineering facilities in Bavaria (Germany), caused quite a stir in March 2017: Two randomly examined ‘DIY Bacterial Gene Engineering CRISPR kits’ by the US-based company ‘The ODIN’ revealed different, facultative pathogenic (non-genetically modified) bacteria of risk group 2. These showed in part multiple antibiotic resistances. The regional council of Tübingen has had such a kit examined independently of the LGL and has come to the same conclusions. This finding is contrary to the manufacturer's information, according to which the kit should contain only non-pathogenic bacteria of the strain Escherichia coli K12 (risk group 1). Already the storage of such a contaminated kit is not permitted in Germany according to § 44 of the German Infection Protection Act (IfSG) without appropriate permits. Proper licensing requires a professional qualification for dealing with pathogens. Further information on this can be found in the Rapid Risk Assessment (RRA) of the European Centre for Disease Prevention and Control (ECDC) dated May 2017.

In its RRA the ECDC recommends purchasing only DIY kits from companies with a quality control system who comply with the World Health Organization (WHO) Guidance on Regulations for the Transport of Infectious Substances for packaging, labelling and documenting goods.

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Which statutory regulations have to be observed in do-it-yourself biology?

a) Genetic engineering regulations

If DIY biologists perform genetic engineering operations, these are subject to the requirements of two EU Directives. Directive 2009/41/EC on the contained use of genetically modified microorganisms regulates the handling of GMOs within genetic engineering facilities, such as laboratories. In addition to microorganisms, directive 2001/18/EC on the deliberate release into the environment of genetically modified organism also covers animals and plants and stipulates, among other things, the legal conditions for temporary and limited releases (field trials) and certain forms of market releases (trade, cultivation, etc.).

These two directives have been transposed into German law by the GenTG and its ordinances. The GenTG always applies when generating or working with GMOs and aims to protect against potential risks caused by genetic engineering and to create the legal framework for their research and use. Besides the above-mentioned experimental kit, DIY biology also includes kits that can be used to determine specific human genotypes or produce genetically modified, luminescent brewing yeasts.

The GenTG states that genetic engineering operations may only be carried out after prior notification or registration and authorization, and only in suitable, officially monitored laboratories (genetic engineering facilities) under the supervision of a competent project leader and in compliance with specific structural and safety-related technical specifications. This includes any handling of a GMO, even if it is just for storage. The expertise of the project leader and the technical supervision by authorities should ensure that any hazard to humans and the environment is avoided. Similar regulations apply throughout the EU. However, in some countries outside the EU, genetic engineering operations are allowed without the need for registered laboratories.

If genetic engineering operations are performed outside of a genetic engineering facility in Germany, it constitutes a misdemeanour pursuant to § 38 paragraph 1 number 2 of the GenTG, which can result in fines of up to EUR 50,000. If unauthorized GMOs are released into the environment, it is considered a criminal offence according to § 39 paragraph 2 number 2 of the GenTG, which is punishable with imprisonment up to three years or with a fine.

DIY kits containing GMOs may not be imported into or stored in Germany unless they are intended for use in a suitable genetic engineering facility. The provisions for the transport of dangerous goods may apply to the transport of DIY kits containing GMOs. The Dangerous Goods Regulations (IATA DGR), which contain the provisions for the transport of hazardous goods by air, must be observed as well as the Ordinance on the National and International Transport of Dangerous Goods by Road, Railways and Inland Waterways (GGVSEB), which is based on the German Transport of Hazardous Goods Act.

b) Other legislation

Regardless of the requirements of genetic engineering laws, further legal requirements for the handling of pathogenic microorganisms, cell cultures, active substances or chemicals used for certain methods, as well as the analysis of DNA sequences, especially human DNA, may need to be considered. Among other things, in Germany this includes

the Infection Protection Act (IfSG), which aims to prevent and control infectious diseases in humans and which must be observed when dealing with relevant pathogens,

the Animal Pathogen Regulation (TierSeuchErV), which aims to protect animals, including pets and freshwater fish, from communicable diseases,

the Biological Agents Ordinance (BiostoffV), which serves to protect workers working with biological agents (e.g. microorganisms*) that can endanger human health,

the Hazardous Substances Ordinance (GefStoffV), which protects humans and the environment from harmful substances such as numerous chemicals,

the Plant Protection Act (PflSchG), which protects plants, plant products and humans and animals against hazards, in particular caused by the use of pesticides, but also against harmful organisms

as well as

the Genetic Diagnostics Act (GenDG), which governs genetic testing in humans and the use of genetic samples and data. It regulates, for example, that genetic examinations for diagnostic or predictive purposes may only be performed by a physician.

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Does genetic engineering work of DIY biologists endanger public safety?

The question of a possible threat to public safety caused by the genetic engineering operations of DIY biologists has already been addressed by politicians and security authorities. Regulatory monitoring of DIY initiatives is necessary: A global survey conducted by the Wilson Center found that out of 210 DIY biologists, 12 (6%) work with risk group 2 organisms.

DIYbio initiatives exist worldwide. The first community lab was opened by the non-profit organization Genspace in 2010 in Brooklyn, NY, with more to follow. Meanwhile in Europe, there are public, registered community labs, for example in Amsterdam, Paris, London, Graz, and Prague. There is currently no such laboratory in Germany. If DIY biologists work in public, registered community labs (in Europe with the status of a genetic engineering facility), governmental safety monitoring can minimize any potential risks for the experimenters and the public.
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* A layperson may not be able to identify microbiological hazards due to the lack of expertise and technical capabilities. For example, distinguishing pathogens in DIYbio kits from non-pathogens by mere visual inspection is very difficult or impossible.


published: September 2017