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Env. Ministry committee proposes deregulating some genetically edited organisms

An Environment Ministry expert committee to consider regulations on organisms produced through genome editing methods meets in Tokyo's Chiyoda Ward, on Aug. 20, 2018. (Mainichi)

Certain organisms with edited genomes would be freed from regulations on genetically modified organisms (GMOs) under recommendations put together on Aug. 20 by an Environment Ministry expert committee, though the edited organisms would have to be reported to the government.

The final set of committee recommendations are expected to be submitted by March next year.

The committee has deemed that a distinction is necessary between genome editing that adds an outside gene to the genetic code of an organism, and editing that eliminates or disables sections of the organism's genome but inserts nothing new. Organisms produced using the former method, the committee concluded, could impact the environment by interbreeding with pre-existing species and creating hybrids, and therefore required regulation under legislation based on the international Cartagena Protocol on Biosafety. However, cutting out a part of an organism's genetic code to deprive it of specific functions does not need regulation as genetic damage that gives birth to a new species also occurs in nature. The committee also judged that even organisms created by adding genes do not need regulation as long as the alteration does not become permanent.

If certain types of genetically edited organism are freed from restrictions, the researchers and businesses making them will no longer have to submit safety data on their creations to the government for official approval. This will save those developing such edited organisms time and money, but could lead to consumers refusing to buy products made through genome editing methods if they come to believe there is no oversight or regulation guaranteeing the products' safety.

More than 30 percent of respondents to a survey of people with food industry experience conducted by the Cabinet Office's Food Safety Commission of Japan said that, even if a genetically modified crop had been evaluated by the government for safety, they would still "feel anxious" about it. In fact, there are currently no GMO crops being grown commercially in Japan.

What emerged from the Environment Ministry expert committee discussions was the need for reporting to the government. The committee's Aug. 20 report demanded the creation of a thoroughgoing information management system on organisms with edited genomes, under which the type and purpose of all organisms that fell outside GMO restrictions would have to be reported to the authorities with an exception of those produced at closed facilities for microorganisms. One committee member told the Mainichi Shimbun, "We judged that there needed to be some kind of management system in place to earn consumers' trust."

Overseas nations including Australia and the United States also plan to remove restrictions on organisms created through genome editing methods that do not include additional genes. In the U.S., the administration of President Barack Obama had planned to regulate genetic editing of organisms, but the Donald Trump administration looks instead to be promoting the technology. However, this is not the world standard.

In late July, the European Union (EU)'s top court ruled that crops created using genome editing methods should in principle come under existing law regulating GMOs. The EU had been considering the issue with input from environmental groups and agricultural associations. There are cases of crop improvement engineering where an outside gene is inserted to enable genome editing even if a specific patch of code is damaged. This engineered organism is then cross-bred with regular versions of the species, and the inserted gene is eliminated in the offspring. This method apparently played a large part in the EU court's decision that such organisms fall under the union's definition of GMOs.

Meanwhile, New Zealand is revising its regulations covering crop types created using genome editing, while other countries are taking their own approaches.

For both agricultural products and processed foods intended for export and those that are processed overseas, makers must obey all the regulations in each locale.

"It's a problem if the regulatory frameworks are different in the place the raw materials come from and the place the factory is located," commented one export head at a major processed food company, adding, "if possible, I'd like to see nations bring their regulations into line."

(Japanese original by Kazuhiro Igarashi, Science & Environment News Department, and Kosuke Hatta, Brussels Bureau)

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