Japan will allow gene-edited foodstuffs to be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, if recommendations agreed on by an advisory panel yesterday are adopted by the Ministry of Health, Labour and Welfare. This would open the door to using CRISPR and other techniques on plants and animals intended for human consumption in the country.
“There is little difference between traditional breeding methods and gene editing in terms of safety,” Hirohito Sone, an endocrinologist at Niigata University who chaired the expert panel, told NHK, Japan’s national public broadcaster.
How to regulate gene-edited food is a hotly debated issue internationally. Scientists and regulators have recognized a difference between genetic modification, which typically involves transferring a gene from one organism to another, and gene editing, in which certain genes within an organism are disabled or altered using new techniques such as CRISPR. That’s why a year ago, the U.S.Department of Agriculture concluded that most gene-edited foods would not need regulation. But the European Union’s Court of Justice ruled in July 2018 that gene-edited crops must go through the same lengthy approval process as traditional transgenic plants.
Now, Japan appears set to follow the U.S. example. The final report, approved yesterday, was not immediately available, but an earlier draft was posted on the ministry website. The report says no safety screening should be required provided the techniques used do not leave foreign genes or parts of genes in the target organism. In light of that objective, the panel concluded it would be reasonable to require information on the editing technique, the genes targeted for modification, and other details from developers or users that would be made public while respecting proprietary information.
The recommendations leave open the possibility of requiring safety evaluations if there are insufficient details on the editing technique. The draft report does not directly tackle the issue of whether such foods should be labeled. The ministry is expected to largely follow the recommendations in finalizing a policy on gene-edited foods later this year.
Consumer groups had voiced opposition to the draft recommendations, which were released for public comment in December 2018. Using the slogan “No need for genetically modified food!” the Consumers Union of Japan joined other groups circulating a petition calling for regulating the cultivation of all gene-edited crops, and safety reviews and labeling of all gene-edited foods.
Whether consumers will embrace the new technology remains to be seen. Japan has approved the sale of genetically modified (GM) foods that have passed safety tests as long as they are labeled. But public wariness has limited consumption and has led most Japanese farmers to shun GM crops. The country does import sizable volumes of GM processed food and livestock feed, however. Japanese researchers are reportedly working on gene-edited potatoes, tomatoes, rice, chicken, and fish. “Thorough explanations [of the new technologies] are needed to ease public concerns,” Sone said.
*Correction, 22 March, 3:25 p.m.: This story has been updated to note that the U.S. Department of Agriculture, not the U.S. Food and Drug Administration, decided not to regulate gene-edited foods.