21 May 2003
FINAL ASSESSMENT REPORT
Executive Summary and Statement of Reasons
An application was received from Dow Agrosciences Australia Pty Ltd on 1 August 2001, seeking approval for food derived from insect-protected and glufosinate-ammonium tolerant corn line 1507 under Standard 1.5.2 - Food Produced Using Gene Technology. A mandatory pre-market safety assessment is required under this Standard.
The new genetic traits confer (a) protection against certain insect pests and (b) tolerance to glufosinate-ammonium herbicide. Corn line 1507 has been developed primarily for cultivation in the Northern Hemisphere, but food derived from this line could eventually enter the market in Australia and New Zealand via imported products, when grown on a commercial scale. Corn line 1507 is currently approved for use in other countries such as Canada, the United States and Japan, and has permission for importation into South Africa and Korea.
Issues
Safety assessment
FSANZ has completed a comprehensive safety assessment of corn line 1507 as required under the standard. Corn line 1507 contains two new genes,cry1Fandpat, each derived from soil bacteria. Thecry1Fgene encodes an insecticidal protein that, like otherBtproteins, is highly selective in controlling Lepidopteran insects. Thepatgene encodes an enzyme that inactivates the herbicide, allowing the plant to grow in the presence of the herbicide. The herbicide tolerance trait was also used to identify appropriate plants during development and therefore antibiotic resistance marker genes were not required in this case.
Food derived from corn line 1507 has been evaluated according to the safety assessment guidelines prepared by FSANZ. The assessment considered the following aspects of the food: (1) the nature of the genetic modification; (2) general safety issues such as history of use and the potential for transfer of antibiotic resistance genes to microorganisms in the human digestive tract; (3) characterisation of novel proteins including toxicological and allergenicity issues; and (4) comparative compositional analyses and nutritional impact of the food. On the basis of an assessment of the available information, it is concluded that corn line 1507 is as safe and wholesome as food produced from other commercial corn varieties
Labelling information for consumers
Under Standard 1.5.2, certain food fractions derived from corn line 1507 will require labelling where novel DNA and/or protein is present in the final food. Some highly processed products such as corn oil or maize starch are not expected to contain protein or DNA and therefore are unlikely to require a label.
Impact of regulatory options
Two regulatory options were considered: either (1) no approval, or (2) approval of corn line 1507 based on the conclusions of the safety assessment. The regulatory decision was considered to have a potential impact on consumers, government and various sectors of the food industry.
Following an assessment of the potential impact of each of the options on the major parties, the conclusion was that the potential benefits to industry and consumers in approving corn line 1507, outweighed the costs to all parties. Option 2, to approve corn line 1507, was therefore identified as the preferred option.
Consultation
FSANZ undertook two rounds of public consultation in relation to this application. In response, 39 submissions were received during the first round, and 6 were received in the second round. The majority of the first-round submissions were opposed to the application primarily for concerns about the safety of the food and the potential impact of the GM crop on the environment. Several submissions expressed the concern that GM crops in general could potentially lead to a rise in the use of herbicides. There was also criticism of the labelling regime for GM foods, which does not require labelling on some highly processed foods.
While the majority of the second-round submissions supported the application, two were opposed due to a broad opposition to gene technology based on both environmental and safety concerns. The food safety concerns raised in submissions have been addressed in this Final Assessment Report. Where appropriate, reference to other government agencies has been provided in relation to issues beyond the legal responsibilities of FSANZ.
As with other GM applications, comments on the safety assessment were sought from two external reviewers. In general, the reviewers agreed with the conclusions of the safety assessment of corn line 1507. Specific comments have been addressed in the safety assessment report or in this report.
Conclusions/Statement of Reasons
In relation to food derived from corn line 1507, FSANZ recommends the adoption of the draft variation for the following reasons:
- based on the available information, there are no public health and safety concerns associated with the genetic modification used to produce insect-protected and glufosinate-ammonium tolerant corn line 1507;
- food derived from corn line 1507 is equivalent to food from other commercially available corn varieties in terms of its safety for human consumption and nutritional adequacy ;
- labelling of certain food fractions derived from corn line 1507 will be required if novel DNA and/or protein is present in the final food;
- the benefits of permitting food derived from corn line 1507 in Australia and New Zealand primarily accrue to the food industry and to consumers, and are considered to outweigh the costs to government, consumers and industry; and
- the proposed amendment to the Australia New Zealand Food Standards Code (the Code) is consistent with the section 10 objectives of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) and the regulatory impact assessment.
The commencement date of the draft variation will be the date of gazettal.
Full Report [ pdf 426 kb]