Regulatory issues concerning CRISPR/Cas9-modified plants

Hi there

First, I try to answer the question: What regulatory issues could be raised in using Crispr/Cas9-modified plants in the field. As written in my blog there is a pioneering discussion about the topic going on, how to deal with genetical engineering at the level of international and national law. In Europa, the authorities are currently debating on how to implement these newish methods in the existing law. 

Swiss law says: “Genetically modified organisms may be put into circulation only if the Confederation has granted authorisation.” (Gene Technology Act, Art. 12, BAFU) That means in general that the handling of this GMO’s is forbidden or at least very difficult, as is research. But in the same act there is this one sentence: “Genetically modified organism means organisms in which the genetic material has been altered in a way that does not occur under natural conditions by crossing or natural recombination.” (Gene Technology Act, Art. 5, BAFU) So in principle the Crispr/Cas9-method does not go under the term of genetic modified plants. Which leads to the conclusion that the Swiss regulation could allow genetic engineered plants.

To answer the question above: Regulatory issues should be carefully considered, but transparency must be given. Coexistence models could be conceived which specifically identify the attachment areas of the plants. In my opinion there is from today’s perspective no scientific reason to handle Crispr/Cas9 as strict as GMO’s, but a controlled cultivation makes sense, especially in the beginning phase of acceptance. The precautionary and polluter-pays principles apply. (GTA, Art. 2, BAFU)

But still even biotechnology scientists recommend at least a monitoring program of the ongoing researches, especially at on- and off-target mutations. (Lawrenson et al, 2015) And the Federal Council in Switzerland extended last year the moratorium against GMO’s until 2021, to have more time in the discussion about the future of GMO cultivation in Swiss agriculture. (media release, Bern, 29.06.2016) What shows how sensible the topic is. Nobody “wants to burn their fingers”, how the Swiss would say, at the same time, however, much is at stake. The latest news in the patent dispute is that the European Patent Office (EPA) allocate a patent to the Broad-Institute about Crispr-Cpf1 (a variation of the Cas9 enzyme). (NZZ-article, 02.03.2017) That these patents are cradles of gold is needless to say.

It’s hard estimate how the society will react in the coming ten years. There will always be a part of the society which is absolutely decline Gen technology out of emotional reasons. Will the research community succeed in conducting a fact-based discussion in public? Will the pressure from industry and medicine be too great to allow any discussion at all? Whatever the outcome, the next few years will be very interesting to follow.

Thanks for reading and commenting 

References:

Federal Act of 21 March 2003 on Non-Human Gene Technology (Gene Technology Act, GTA), 2004, Federal Office of Environment

Tom Lawrenson, Oluwaseyi Shorinola, Nicola Stacey, Chengdao Li, Lars Østergaard, Nicola Patron, Cristobal Uauy, Wendy Harwood, 2015: Induction of targeted, heritable mutations in barley and Brassica oleracea using RNA-guided Cas9 nuclease

Media release of the Federal Office, Bern, 29.06.2016, found (06.05.2017) at: https://www.admin.ch/gov/de/start/dokumentation/medienmitteilungen.msg-id-62442.html

Article in paper, Neue Zürcher Zeitung, found (06.05.2017) at: https://www.nzz.ch/wissenschaft/gentechnologie-die-eu-erteilt-crispr-patent-an-das-broad-institute-ld.148739