Fact sheet: Release of unapproved genetically modified (GM) corn

(21 April 2005)

A small quantity of a GM corn variety, known as Bt-10, was accidentally grown and released into the food and animal feed supply in the United States (US) between 2001 and 2004. Although Bt-10 corn is not approved for such release in Australia or in other countries including the US, there is a small chance that some may have been present in animal feed or processed food exported to Australia during this period.

A large agricultural biotechnology company, Syngenta, is responsible for inadvertently producing several hundred tonnes of Bt-10 corn over a four-year period between 2001 and 2004. The accidental distribution of the unapproved Bt-10 corn, was reported in an article published in the scientific journal, Nature, on 22 March 2005. Although Syngenta disclosed the information to the US authorities in late 2004, it has only recently come to the attention of Australian authorities, including FSANZ.

According to Syngenta, the amount of seed produced from Bt-10 corn would have constituted only a very small fraction (0.01%) of the total corn acreage planted in the US over the four year period. While unlikely, Syngenta has stated that extremely small amounts of harvested Bt-10 grain (0.002%) could have been used in animal feed or in processed food products that may have been exported from the US to countries including Australia. Australian quarantine controls require all imports of corn feed to be devitalised and crushed.

The Bt-10 corn is very similar to Bt-11 corn, a genetically modified corn variety that has been approved for food use in Australia since August 2001. Bt11 is also approved for import for food and feed use in the European Union, Switzerland, New Zealand, Taiwan, the Philippines, China, Russia and Korea.

FSANZ sought and received scientific information relating to Bt-10 corn from Syngenta. This information allowed FSANZ to conduct a safety assessment of Bt-10 and compare its characteristics to the approved Bt-11 corn. The two varieties have been modified in the same way and produce the same novel proteins. The presence of a non-functional antibiotic resistance marker gene (BLA) in Bt-10 corn, that is not present in Bt-11, has no impact on the safety of food produced from Bt-10 corn. FSANZ has previously assessed this marker gene for safety and its use is approved in Australia for use in a number of food commodities.

FSANZ has concluded that there are no food safety concerns with corn products imported from the United States since:

FSANZ will be formally contacting Syngenta and other biotechnology companies to advise them that they are expected to provide early information on any issues of possible concern regarding GM foods.

21 April 2005