What is likely to happen in distributing genome edited foods - Small companies can also take advantage of genome editing technology, which has the potential to dramatically enhance food production, but...

Genome edited and genetically modified

Foods produced using genetic (genome) editing will be distributed as early as this summer.

On March 18 the Research Committee of the Ministry of Health, Labour and Welfare (MHLW) finalized a report stating that many agricultural and marine products produced by breeding using genome editing technology will not be required to undergo a safety review and will be permitted to be sold as foods after notification.

Genome editing technology involves the use of DNA-snipping enzymes to destroy or replace genes. In 2013 CRISPR/Cas9 was developed as a DNA-snipping enzyme, leading to the expansion of fields where genome editing technology is applied, and the expansion of its potential.

Conventional genetic modification technology has been used to breed cultivars that are resistant to agrochemicals or disease by inserting genes from an unrelated organism into a crop such as maize and soybeans. This achieved artificially what could not occur in the natural world: the insertion of genes from another organism into a crop.

On the other hand, genome editing technology aims to improve varieties by snipping the genes of those crops themselves.

Of course, it is possible to insert genes from an unrelated crop into a crop after the original genes are snipped, as done by conventional genetic modification technology. However, the distinctive feature of genome editing technology is to accelerate breed improvement by halting the function of target genes simply by snipping the target genes. It is different from inserting genes from an unrelated organism into a target organism. Breeding involves only the engineering of the organism's own genes.

It is explained that this is no different from mutational changes and changes that occur in traditional breeding techniques that cross-breed different cultivars.

I explained about regulatory restrictions imposed on conventional genetic modification technologies in my report "The US approaches Japan in regulations on GM foods" (November 5, 2018). With regard to genetically modified (GM) foods, first of all, their safety is reviewed.

In the report I explained that the US, Japan and the EU had different approaches as to whether mandatory labeling was required for GM crops and foods whose safety has been confirmed, and that the US was considering introducing similar restrictions to those of Japan. I am going to explain again in reference to the concerned paragraphs.

In 2016 the US enacted a law requiring labeling for GM foods. Pursuant to this law, the US Department of Agriculture (USDA) is considering what kind of foods require labeling.

The law does not use the word genetically modified organism (GMO) but instead uses the word "bioengineered food" which has a wider meaning. "Bioengineered food" is defined as a food "(1) that contains genetic material that has been modified through in vitro recombinant DNA techniques; and (2) for which the modification could not otherwise be obtained through conventional breeding or found in nature." In other words, bioengineered food not only includes the existing GM crops and GM foods but also includes food produced using genome editing. The key point would be whether "genetic material that has been modified" exists or not. Unlike the EU, which requires labeling also for soy sauce and oil that do not contain bioengineered substance, USDA identifies these products to be exempted from restrictions as Japan has.

The US, the EU and Japan view genome edited foods in the same manner as they do conventional GM foods. The EU plans to deal with genome edited foods in the same way as GM foods, requiring mandatory labeling for genome edited foods whose safety has been confirmed.

The EU tries to restrict foods and agricultural products based on the process by which they are produced. On the other hand, Japan and the US believe that restrictions should be imposed based on the characteristics of the final products, not the processes used to produce them.

The decision made by the MHLW this time is in accord with restrictions imposed on GM foods. In other words, if genome editing technologies involve insertion of genes from another organism to produce foods as genetic modification technologies do, the products will be subject to a safety review for distribution like a GE product. Unlike them, most foods derived from genome editing technologies are difficult to differentiate from ones with mutational changes that can occur naturally, and, therefore, are not subject to a safety review. Developers, etc. can distribute their products after submitting notification.

The Consumer Affairs Agency will consider the regulation of labeling. Logically, one would assume that mandatory labeling will not be required for foods derived from genome editing technology that contain no transgenic genes, which is consistent with restrictions on GM foods. (note; After this article was published, it was reported that the Japanese government is considering the labelling requirement of gene edited food. If this is true, it is not only inconsistent with the labelling regulation of GMO but it requires unverifiable labelling of material whose existence cannot be detected.)

The potential to dramatically increase food production

Apart from governmental restrictions, how should we think of agricultural products and foods derived from genome editing technologies?

It is a fact that humans have been taking advantage of the natural mutation of genes. Without it, agricultural activities such as crop cultivation and livestock breeding would not have been practiced. Perfect examples are cereals including rice and wheat. Naturally all living things have a desire to reproduce. Cereals try to multiply as much as possible by widely distributing seeds through the air. You may remind yourself of dandelions that blow off their fluff.

However, this kind of habit of living things was extremely inconvenient to humans who wished to use cereals for food. Once seeds of cereals were scattered, it was difficult to collect them.

One day humans discovered a cereal which did not drop seeds due to natural mutation, and immobilized it. According to the laws of nature, agricultural products including cereals which we currently eat are abnormal. They are varieties which would not have survived in nature without the involvement of humans.

Part of fruits and vegetables have been extremely enlarged to increase portions which we can eat. Dairy cows have large udders to produce more milk. Japan's famous nishiki carp are prone to attack from natural enemies. It would be very difficult for them to survive in the nature.

Genome editing is technology to artificially induce mutation that occurs naturally. But is it possible to think that there is no problem because induced mutation is the same as natural mutation?

A Chinese researcher ignited controversy after claiming to have created babies by genome editing embryos. Can it be acceptable if it is not humans but food?

There is concern that CRISPR/Cas9 acts on off-target genes. How can we ensure the safety of genome editing technology?

While there are issues as discussed above, genome editing technology may contribute to a dramatic increase in global food production.

Various people have advocated the potential of IT and AI technologies to enhance the efficiency of agricultural production and to increase yields. However, the changes they can bring about in agricultural production are no more than gradual or incremental, such as a 10% cost reduction, a 10% yield increase, and so on. Besides, among those people who praise technologies, few have actually applied them on the ground. In fact, if they try to apply one, they will understand that there are variousproblems to be resolved.

On the other hand, genome editing technology contains the elements of a major breakthrough, doubling yields straightaway. It is like jumping up to an upper floor all at once instead of going up stairs one step at a time. Further, the technology involves only a change of varieties. By applying the same agricultural techniques as before other than seeds or animals, outputs will become unprecedented.

Small companies can take advantage of genome editing technology as well

Another distinctive feature of genome editing technology is, unlike GM technology, that anybody can easily make use of it. It is, however, difficult to predict whether it will lead to positive or negative consequences.

GM crops were developed by a handful of large companies. Monsanto, a leading company in the field, has benefited from the sale of both agrochemicals and seeds of GM crops by developing GM crops that are resistant to their agrochemicals for weed prevention and control. Conversely, as product development incurred enormous expense, the company would have been unable to recover its investment unless its crops had been of that nature.

Contrary to this, small companies are the ones engaging in the application of genome editing technologies in the US. This is because it does not require huge investment. For this reason, few large companies approach the Federal Government for wider utilization of genome editing technology.

It is a positive aspect of genome editing technology that it can be applied and utilized in a variety of ways. On the other hand, given that anybody could take advantage of the technology, it will be extremely difficult to regulate it when a problem arises. It is just like an issue associated with the proliferation of nuclear arms. This is a negative aspect of technology.

In addition to the concern of consumers that they will be forced to eat foods that are not safe, there are many issues such as environmental impacts to be examined in genome editing technology. Despite that, I feel that people are little interested and debates are sluggish.

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(This article was translated from the Japanese transcript of Dr. Yamashita's column in "Webronza" on March 20, 2019.)