Credit: Susan Wolsborn

Japanese scientists face a year in jail and a ¥1 million (about $9,000) fine if they violate the extensive rules their government now has in place for using recombinant DNA technology. Some researchers say they are worried the restrictions and new local regulations will set back Japanese research in related fields.

The backdrop to the debate is a public sentiment that frowns on genetic modification. “There is an allergy to anything relating to recombinant DNA technology, especially in agriculture and food,” says Hideo Shinagawa, a microbiologist at Osaka University.

Concerns intensified in September 2003 with the implementation of the Cartagena Protocol on Biosafety, which attempts to ensure the safe shipping of genetically modified organisms. Japan already had guidelines on recombinant DNA research, but after signing the protocol, it turned the guidelines into binding laws, effective as of February.

“This is going to have a big impact on researchers whether they are doing basic science or applied research with plants and microbes,” says Hiroshi Kamada, a molecular biologist at the University of Tsukuba. “Research is going to move much more slowly.” Hamada predicts that scientists wanting to do such research will be forced to leave Japan. “There are so many things that remain unclear that many people will just stop doing this kind of research,” he says.

The law sets a standard for DNA sources and stipulates that researchers must apply through their institutions or to the central government to carry out recombinant DNA work. Some say the restrictions are excessive. “If you make a virus with a small piece of DNA, even linker DNA, [the experiment] needs to be approved—which is ridiculous,” says Yoshihiro Kawaoka, a virologist who splits his time between the University of Wisconsin and the University of Tokyo.

Under the new law, requirements on the labeling of research materials for shipping have become more burdensome (Nature 428, 6; 2004). Sending genetically altered viruses, bacteria and even plasmids will require more paperwork and some negotiation with the post office, says Shinagawa.

But some researchers and government officials say the new law has made things easier. “Everything in the application process is much clearer and more straightforward,” says Tadahito Kanda, a virologist at the National Institute of Infectious Diseases. Some restrictions have been dropped because of pressure from scientists. “The only people that will really be affected are those who weren't following the guidelines previously,” Kanda says.

Shinagawa agrees that many things have become less bureaucratic. For example, requirements that every room dealing with recombinant DNA have an autoclave and special safety cabinets have been relaxed so that only one autoclave and cabinet per building is necessary.

But researchers are also concerned because some local governments are going beyond the law to add their own restrictions. In March Hokkaido, Japan's northern island, put into effect its own guidelines asking researchers to steer clear of field trials with genetically modified plants. Similar ordinances are under consideration in the Shiga and Ibaragi regions. “In Japan, if one region makes an ordinance, movements to create the same ordinance in other regions will soon become active,” says Kamada.

Shinagawa and Kamada are part of a seven-person committee in Japan's Science Council that is trying to dissuade local governments from adding more restrictions. Other researchers are also taking action. On 30 April, 49 members of the Japanese Society of Breeding sent a letter to Hokkaido's governor urging her not to make binding rules against genetic modification, particularly those requiring applications at the local level. “The local government doesn't have the capacity to process applications,” says Kazuo Watanabe, a geneticist at Tsukuba University and one of the petitioners. “That means that certain research projects there could be brought to a halt.”