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Laws and Legislations - Some Interesting Points
The problem of antibiotic resistance
iGEM is the birth place of numerous great projects which are aimed at solving a problem. However, most of these remain purely theoretical because they require release of the genetically-modified organisms in the environment. One of requirements for GM organism release is that the released organism does not have antibiotic resistance markers:
'... shall not grant a consent to an application for the release or marketing of genetically modified organisms containing antibiotic resistance markers which may have adverse effects on human health and the environment...'
(Environmental protection: Genetically Modified Organisms (Deliberate Release) Regulations 2002, (2002)
And let's face it - all antibiotic resistance markers could have adverse effects because bacteria enjoy exchanging genes with other bacteria. And the bacteria with the newly acquired antibiotic resistance may be pathogenic.
However, when genetically manipulating organisms, the current legacy uses antibiotic resistance genes to distinguish between cells which have the DNA of interest and those that do not.
To help address this problem, we are developing selectable and counter-selectable markers which do not rely on the use of antibiotics and antibiotic resistance genes.
Practice makes perfect ... regulations?
One of the contributing factors to the antibiotic resistance point in the Environmental protection: Genetically Modified Organisms (Deliberate Release) Regulations 2002 (Environmental protection: Genetically Modified Organisms (Deliberate Release) Regulations 2002, (2002)) was arguably due to debates powered by an antibiotic resistance bacterial marker which was left in a GM maize plant in which it had no function (Marris, Swings and roundabouts (2000). This "mistake" opened a debate which lead to stricter but better regulations. So we ask: is this the only way to make regulations better and up to date?
If it is, the regulations for GM bacteria release are not going to be improved anytime soon since (as far as we are aware) no GM bacteria have been released in Europe so far (ARCHIVE: Part B consents granted to release genetically modified organisms, 2012).
The ambiguity of tracing and labeling
Tracing and labeling of GMO organisms as well as products derived from them is a regulation requirement (Regulation (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003, (2003)). Tracing origin and processing as well as package labeling ensures that consumers get to decide whether they want to use GMO derived product. This is where it gets ambiguous. Do the regulations require tracing and labeling of the GMO in the environment as well?
If they do not, why? How do we ensure that GMO are kept separate from other wild type organisms and prevent cross-pollination for example?
If they do, how are we ever going to release GM bacteria in the environment? Bacteria readily exchange genetic material. Thus, any trial at labeling GM bacteria is doomed to fail - so is tracing them.
Benefit vs Risk
This is how we evaluate everything - we compare the risks with the benefits and decide which one prevails.
Focus group research has shown that members of the public think that "risks need to be counter-balanced against each other and against the potential benefits" with respect to GMO release (Marris, 2001).
But the regulations tell a different story. The word "risk" appears 45 times in the Genetically modified organisms (deliberate release) regulations while the word "benefit" is not present (Environmental protection: Genetically Modified Organisms (Deliberate Release) Regulations 2002, (2002).
This begs the question of why the benefits are not taken into consideration?!
Environmental protection: Genetically Modified Organisms (Deliberate Release) Regulations 2002. (2002). Retrieved from Legislation.gov.uk: http://www.legislation.gov.uk/uksi/2002/2443/pdfs/uksi_20022443_en.pdf
Regulation (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003. (2003). Retrieved from Access to European Union law: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:268:0024:0028:EN:PDF
ARCHIVE: Part B consents granted to release genetically modified organisms. (2012, February 3). Retrieved from Department for Environment Food and Rural Affairs: http://archive.defra.gov.uk/environment/quality/gm/regulation/registers/consents/index.htm
Marris, C. (2000). Swings and roundabouts, Politeia, 22-37.
Marris, C. (2001). Public views on GMOs: deconstructing the myths. EMBO reports, 545-548.
