The government is facing an unusual challenge — regulating a science that has not yet proved harmful.
The Environment Ministry and three other ministries are preparing a bill for submission to the Diet during its current session that would place living modified organisms — including genetically modified crops and engineered animals and microorganisms — under government control.
The bill would aim to prevent ecological damage caused by these organisms, such as by hybridization with surrounding wild species.
With pressure from the international community mounting, along with public disquiet regarding the government’s ecological ignorance, the proposed bill is expected to clear the Diet before the session ends June 18.
The bill is in line with the government’s plans to ratify the 2000 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which regulates international trade in products created through biotechnology.
As of Feb. 5, 42 countries had ratified the protocol. It will take effect after 50 ratify it, which is expected this year.
The United States, the world’s biggest producer and exporter of genetically modified crops, has not signed the treaty due to concerns over its potential negative impact on its biotech industries.
According to the International Service for the Acquisition of Agri-biotech Applications, a nonprofit group, genetically modified crops cover more than 50 million hectares worldwide, and this figure is getting bigger.
Technology currently in practical use can produce crops that are resistant to herbicides and immune to insects and viruses, while prospective technology could produce plants resistant to changes in the surrounding environment and engineered fish that would grow much faster than ordinary fish.
According to the Education, Culture, Sports, Science and Technology Ministry, more than 30,000 genetic engineering experiments are carried out annually in Japan.
Amid this rapid expansion of biotechnology, public concerns are mounting over the threat it could pose to ecological systems. Once released, LMOs are difficult to remove from the environment.
The world is generally moving toward a precautionary approach on engineered organisms, looking to secure sustainable biodiversity.
But experts are divided over the extent to which protective measures should be pursued, questioning how to balance the potential risks and benefits of LMOs.
“(Genetic engineering) is a new technology and even though there has been no report on obvious ecological damage, it is better to first place regulations if we want to secure its sound development,” said Masaaki Kobayashi, director of the Legislation Task Force for the Cartagena Protocol on Biosafety at the Environment Ministry.
Unlike other conventional environmental regulations that ban or limit the use of substances or technologies that have been proved hazardous, Japan’s planned legislation adopts a pre-emptive approach, Kobayashi added.
Under the protocol, signatories are required to assess LMOs’ effects on the environment before importing them.
After conducting environmental safety evaluations, each nation can decide whether to import on a case-by-case basis.
The bill going to the Diet would require domestic firms to conduct safety evaluations and obtain government approval before they release LMOs into the environment, for example, to cultivate genetically modified crops. The firms would also have to monitor the safety of LMOs after they are released.
The bill proposes a more moderate ordinance for LMOs intended for contained use in factories and research labs, under which firms and researchers would have to ensure that the LMOs remain in containment.
Should any recognizable effects on the environment be identified, appropriate countermeasures would be taken by the government.
The agriculture, education and trade ministries already have guidelines to control genetically modified organisms, but none are binding.
Because it deals with rapidly expanding new technology, the legislation should cover a broad area, moving beyond the existing guidelines.
But Toshio Iwakuma, a biology professor at Hokkaido University who also serves on an LMO advisory panel to the environment minister, said the planned bill is an inadequate measure to ensure environmental safety.
Iwakuma is well aware of the potential benefits of LMOs, but he is calling for stricter assessments in terms of ecological conservation.
Iwakuma also said concrete countermeasures should be prepared to deal with worst-case scenarios, such as LMOs intended for use in a contained environment accidentally escaping, and new types of LMOs emerging in the near future.
Proponents of freer use of LMOs, however, stress the possible effects that regulations could have on research and business activities.
“The existing LMOs have never created an environmental problem, so biotech firms are worried about how the regulations will be enforced,” said Takaharu Hatanaka, president of the Society for Techno-innovation of Agriculture, Forestry and Fisheries.
The food and agricultural industry group consists of more than 120 firms and organizations, including the Japanese unit of American biotech giant Monsanto Co.
Because LMOs’ environmental risks have not been confirmed, he believes the existing guidelines are enough to test the effects of genetically modified organisms.
For instance, under agriculture ministry guidelines, firms must test engineered crops in isolated fields, using various criteria to compare their characteristics with those of ordinary crops.
Should the proposed regulations be harsher than conventional guidelines, it could affect the advancement of this new technology.
Yet industry is keeping silent instead of voicing dissent, fearing negative publicity amid a wave of opposition toward genetic engineering.
“As a scientist, I think the bottom line is how far you go in taking the precautionary approach,” Hatanaka said.
Akihiro Hino, who helped outline safety steps on genetically modified crops at the agriculture ministry from 1994 to 1997, agrees.
“There are no living organisms in this world that won’t affect the environment,” said Hino, who now works for the food hygiene research team at the National Food Research Institute.
Because the public has not received balanced information on LMO technology, people do not know what is right or wrong, Hino said.
“(Gene modification) is indeed a new technology, so a standard is necessary to control its use,” but conventional safety evaluations already in place are reliable, Hino said.
Citing LMO technology aimed at producing arid-tolerant grass, Hino said experts hope the technology will help curb desertification and even recover green areas. But excessive growth might fuel concerns over biodiversity, he added.
“It is a matter of how you balance the potential benefits and risks of the technology,” Hino said.
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