Update: Safety of MON810 and NK603 corn lines
November 2008
Greenpeace International announced the release of a new unpublished report entitled Biological effects of transgenic maize NK603x MON810 fed in long term reproduction studies in mice, completed in October 2008. The aim of the study, sponsored by the Austrian Government and carried out by researchers at the University of Vienna, aimed to examine the potential effects of the stacked GM corn crop known as MON810xNK603 in long term feeding studies using mice. The study reports a reduction in fertility in the mice fed GM corn relative to those fed conventional corn. The study concludes that similar animal reproduction studies should therefore be included in the safety assessment of GM food and feed.
FSANZ has obtained the full report and is reviewing the data and statistical analyses presented in the report to ascertain whether the findings could have any impact on the previous safety assessment of corn lines MON810 and NK603. As the European Food Safety Authority (EFSA) has also previously released favourable assessments of these lines, it is likely that they will also evaluate the Austrian report.
Background
The corn crop used in the Austrian mouse reproduction study is a conventionally bred cross of two independent genetically modified (GM) corn lines MON810 and NK603. Corn line MON810 carries one new genetic trait which makes the corn plants more resistant to attack by certain insect pests, particularly the European corn borer. Corn line NK603 carries one new genetic trait which makes the corn crop tolerant to spraying with glyphosate herbicide. Once an independent GM crop line has undergone assessment and is approved, it may be used in any conventional plant breeding program without further assessment. The MON810xNK603 crop is known as a stacked line with both the insect-protection and herbicide-tolerant traits.
Food from insect protected corn line MON810 (known as YieldGard corn) was assessed by Food Standards Australia New Zealand (FSANZ) as Application A346, and the safety assessment did not identify any public health and safety concerns. The amendment to Standard 1.5.2 – Food produced using Gene Technology of the Australia New Zealand Food Standards Code (the Code) permitting food derived from corn line MON810 in the Australian and New Zealand food supply came into effect in October 2000. A copy of the Final Assessment Report for Application A346 is available from the FSANZ website.
FSANZ assessed food from glyphosate tolerant corn line NK603 as Application A416, and the Final Assessment Report is also available from the FSANZ website. The safety assessment concluded that food derived from corn line NK603 was as safe for human consumption as food from other commercial corn varieties. The amendment to Standard 1.5.2 in the Code permitting corn line NK603 in Australia and New Zealand came into effect in June 2002.
The FSANZ assessments of corn lines MON810 and NK603 followed the standard protocol for conducting food safety assessments of GM foods. At the time, FSANZ evaluated all available safety data including an acute oral toxicity study in mice of the novel insecticidal protein present in MON810 corn, and an acute oral toxicity study in mice of the novel protein in NK603 corn. In addition, feeding studies using broiler chickens, pigs and rats did not show any adverse effects when fed diets containing NK603 corn. Both lines have received regulatory approval in a number of overseas countries including Canada and the United States.
The protocol used by FSANZ to evaluate GM food safety is based on scientific principles developed at the international level by expert bodies such as the FAO/WHO, the OECD and Codex. Similar assessment protocols for GM foods are used by food regulators in Canada, Japan, the United States and by the European Food Safety Authority (EFSA) who provide risk assessments of foods and feeds to the European Commission (EC).
FSANZ is aware that the Austrian government has imposed numerous moratoria on corn line MON810 and certain other GM crops over a number of years and for a variety of reasons. On 8 May 2008, based on favourable conclusions issued by the EFSA, the EC forced Austria to lift its moratorium on MON810 corn with respect to importation for human food and animal feed uses. Austria has extended its moratorium only on the cultivation of MON810 corn in that country.