From Bio Journal - August 2015

Cartagena law regulations drastically relaxed

On 23 June 2015, the "Type 2 Usage" governed by the Cartagena laws were drastically deregulated. While "Type 1 Usage" refers to regulations for GMOs handled outdoors in agriculture and so on, "Type 2 Usage" refers to regulations for handling GMOs in closed systems such as factories and so on. It is now being required that Type 2 Usage be carried out according to GILSP (Good Industrial Large-Scale Practice), which stipulates regulations for large-scale production. GM microbes that combine hosts, vectors and inserted DNA that are considered to be "harmless" under GILPS can now be used without an application showing notification of use.

It is the requirement for prevention of proliferation, the "GILSP GMO Microbe (Notification)", that has been relaxed in this move. Genetic recombination is carried out through a combination of host, vector and inserted DNA, and anything other than that requires an individual approval procedure. Hosts, vectors and inserted DNA that have thus far been judged to "not require application due to being harmless" had been compiled into separate lists by METI and MHLW. These lists have been unified, and any item appearing on just one of the lists can now be used, and this has resulted in a huge increase in the number of GM microbes that can be used.

In addition, inserted DNA has thus far been restricted to what can be used in each particular host, but this restriction has also been removed. Hosts were also limited to the strain used thus far, but this restriction has also been removed. The procedure required when wishing to enter a new variety into the GILSP notification has also been simplified. Furthermore, in the case that only a small part of the identified products of inserted DNA had found actual uses, it was only possible to enter a part of them onto the list, but this limitation has now also been removed.

In a nutshell, it has now become possible to do whatever you want to without any kind of procedure required. Thus far, the production of unknown harmful substances and unknown toxicity due to changes in the microbes themselves, and so on, have been causes for concern with GM microbes, but now any kind of GM microbe can be used, with the exception of those examples clearly known to be harmful. This is not limited to medical treatment and the production of pharmaceuticals, but also covers the production of foodstuffs, food additives, and so on. As a result, our health is jeopardized and the safety of food is placed under threat.

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