Photo/IllutrationA “biohacker” in Oakland, California, sells a kit that enables people to conduct experiments for genome editing at home. (Asahi Shimbun file photo)

The government has started working on legal and regulatory rules on dealing with genome-edited animals and plants.

In developing a regulatory system to govern genome editing, a new type of genetic engineering that involves changing an organism’s DNA, the government has to adopt an appropriately cautious, safety-first approach to ensure that there will be no harmful effects on biodiversity or human health.

Unlike early, less precise genetic engineering techniques, gene editing is aimed at changing DNA at a specific site in the genome.

The approach employs various techniques. A certain type of protein is used as “scissors” to cut the DNA at the target site to eliminate its specific gene function. Or new useful DNA is inserted into a specific location of the gene.

This method can be used to produce, for instance, a red sea bream with a larger amount of muscles, a tuna that is more docile and easier to breed, tomatoes less likely to rot and a high-yielding species of rice.

A broad array of research projects to apply gene editing for species improvement are under way.

Genome editing undoubtedly offers various benefits. But unregulated use of technology that can produce living organisms that don’t naturally exist should not be permitted.

Plants and animals that have been genetically modified with traditional genetic engineering techniques are subject to the so-called Cartagena Protocol, an international agreement to protect biodiversity, and also the Food Sanitation Law to secure food safety. Such plants and animals cannot be brought to the market unless they are checked and approved by the government.

But there are no established rules or regulations to govern genome-edited plants and animals.

In response to growing concerns about the possible consequences of gene editing, the government’s new “comprehensive innovation strategy,” which was officially endorsed by the Cabinet in June, calls for clarifying the legal status and treatment of gene-edited products by the end of March 2019.

An expert panel set up by the Environment Ministry for this purpose on Aug. 20 basically approved the ministry’s draft of proposed regulations on gene-edited products.

The proposal calls for making any animal or plant with new DNA inserted subject to the regulations under the Cartagena Protocol while exempting those that have only lost certain gene functions through genome editing.

The proposed exemption of gene editing to remove certain gene functions from the regulations is based on the view that the loss of a gene function should not raise concerns because such an event occurs naturally in mutation.

Other countries have made various responses to the issue.

Some countries, including the United States, have not imposed any regulations on gene editing, while the European Court of Justice ruled in late July that altering living things using genome-editing technology--including the simple elimination of gene functions-- should be considered to be genetic engineering and regulated accordingly.

Since it is a new technique, there is no ruling out unforeseen risks in gene editing.

There have actually been reports on unintended mutations as a result of gene editing.

The Japanese government should adopt the European Union’s precautionary approach and take preventive measures even for cases where the mechanism is not fully understood.

The Environment Ministry’s proposal would require parties involved in gene editing to submit in advance such information as the features and use of the gene to authorities even in cases that are not subject to the regulations.

It is important to plug all potential holes in the regulatory system to ensure swift and effective responses to any problem that may arise.

The ministry should decide on the rules to govern gene editing after hearing the views and opinions of not only experts but also consumers.

Regulating gene editing demands a sufficient dose of cautiousness required for dealing with such new technology that could entail various unexpected risks.

The Asahi Shimbun, Aug. 21