A481-DAR-Executivesumm

10/03

16 July 2003

DRAFT ASSESSMENT REPORT

Full report [ pdf 241kb ]

Executive Summary and Statement of Reasons

An Application was received from Bayer Cropscience Pty Ltd on 13 November 2002 seeking approval for food derived from genetically modified (GM) soybean lines A2704-12 and A5547-127 under Standard 1.5.2 - Food Produced Using Gene Technology of the Australia New Zealand Food Standards Code (the Code). Standard 1.5.2 requires that GM foods (refer to Standard 1.5.2 for the definition of a GM food) undergo a pre-market safety assessment before they may be sold in Australia and New Zealand.

The new genetic trait in soybean lines A2704-12 and A5547-127 confers tolerance to glufosinate ammonium herbicide. Tolerance to the herbicide is achieved by expression in the plant of a bacterially derived enzyme that specifically inactivates the herbicide, allowing the plants to survive and grow following herbicide application.

Soybean lines A2704-12 and A5547-127 have been developed for cultivation in the major soybean growing regions of the world including the United States and Canada, but food derived from these soybeans could enter the market in Australia and New Zealand via imported products, once it is grown on a commercial scale and approved for use under the Code.

Safety assessment

FSANZ has completed a comprehensive safety assessment of food derived from soybean lines A2704-12 and A5547-127 as required under the Act. The assessment included consideration of: (i) the genetic modification to the plant; (ii) the safety of any transferred antibiotic resistance genes; (iii) the potential toxicity and allergenicity of any new proteins; and (iv) the composition and nutritional adequacy of the food, including whether there had been any unintended changes.

No potential public health and safety concerns were identified in the assessment of food derived from soybean lines A2704-12 and A5547-127. Therefore, on the basis of all the available evidence, including detailed studies provided by the applicant, it has been concluded that food derived from soybean lines A2704-12 and A5547-127 is as safe and wholesome as food derived from other soybean varieties.

Labelling

If approved, food from soybean lines A2704-12 and A5547-127 will require labelling if novel DNA and/or protein (refer to Standard 1.5.2 for the definition of novel DNA/protein) are present in the final food. Ingredients derived from soybean likely to satisfy this criterion are whole soybeans, soybean meal, and soy lecithin. Refined soybean oil is unlikely to contain either novel DNA or protein, in which case it would not require labelling. Labelling addresses the requirement of section 10 (1)(b) of the Act; provision of adequate information relating to food to enable consumers to make informed choices.

Impact of regulatory options

Two regulatory options were considered in the assessment: either (1) no approval; or (2) approval of food from soybean lines A2704-12 and A5547-127 based on the conclusions of the safety assessment. Following an assessment of the potential impact of each of the options on the affected parties (consumers, the food industry and government), Option 2 is the preferred option as it potentially offers significant benefits to all sectors with very little associated cost. The proposed amendment to the Code, giving approval to food from soybean lines A2704-12 and A5547-127, is therefore considered of net benefit to both food producers and consumers.

Consultation

In response to the invitation to comment on the Initial Assessment Report, nine submissions were received from the public. Six of these were not in favour of approving soybean lines A2704-12 and A5547-127. The remaining three submitters expressed support for the application, contingent on a satisfactory safety assessment.

Statement of Reasons

An amendment to the Code to give approval to the sale and use of food derived from soybean lines A2704-12 and A5547-127 in Australia and New Zealand is recommended on the basis of the available scientific evidence for the following reasons:

• the safety assessment did not identify any public health and safety concerns associated with the genetic modification used to produce herbicide tolerant soybean lines A2704-12 and A5547-127;
• food derived from soybean lines A2704-12 and A5547-127 is equivalent to food from other commercially available soybean varieties in terms of its safety for human consumption and nutritional adequacy;
• labelling of certain food fractions derived from soybean lines A2704-12 and A5547-127 will be required if novel DNA and/or protein is present in the final food;
• a regulation impact assessment process has been undertaken that also fulfils the requirement in New Zealand for an assessment of compliance costs. The assessment concluded that the amendment to the Code is of net benefit to both food producers and consumers; and
• the proposed draft amendment to the Code is consistent with the section 10 objectives of theFood Standards Australia New Zealand Act 1991(FSANZ Act) and the regulatory impact assessment.

It is proposed that the draft variation come into effect on the date of gazettal.

Full report [ pdf 241kb ]