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Application A1018 – Food Derived from High Oleic Acid Soybean Line DP-305423-1 – Assessment Report

23 October 2009

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

Safety Assessment

There are two areas where we consider that the data provided needs to be strengthened. First, the assessment includes comparative information supplied by the Applicant to support the safety of food derived from soybean line DP-305423-1. The information submitted by the Applicant allows for transparent comparison of soybean line DP-305423-1 with the control for most key components. However, full disclosure of the comparative data for vitamins and minerals has been omitted. As there are significant differences between the transgenic line and the control line for some of these components it is suggested that all of the data for the measured vitamins and minerals be provided and assessed in the Approval Report.

Second, the Safety Assessment Report only presents partial information on changes in fats and fatty acid intake. It omits to provide comparative information on either the absolute amount of saturated, polyunsaturated and monounsaturated fats in the population diet following the substitution, or their percent contribution to total dietary energy. NZFSA believes this information is necessary for the complete determination of the food-related health risk. The effects of substituting oils on blood cholesterol concentrations are well known and vary depending on the fatty acid content of the replacement oil. It is generally accepted that linoleic acid is more effective at improving blood lipids than oleic acid (Srinath Reddy, Katan 2004). This relationship is often summarised in predictive equations (Howell et al. 1997). As the soybean line DP-305423-1 is deliberately lowering linoleic acid and raising oleic acid concentrations in the food, this may present a risk to the exposed population that has not been considered in the Application and warrants further investigation.

Labelling consideration

We note that FSANZ has considered whether imposing additional labelling requirements in column 2 in the table to clause 2 of standard 1.5.2 (as set out in clause 7 (a) of standard 1.5.2) are appropriate in this case. FSANZ concludes that labelling that the product is ‘genetically modified’ is required, as the soybean line DP-305423-1 has been significantly changed with respect to its fatty acid profile. NZFSA agrees that the need for labelling of the oil as ‘genetically modified’ is triggered, due to the significantly changed fatty acid profile. In addition, Standard 1.2.2 of the Food Standards Code requires that food is labelled to indicate the true nature of the food, and standard 1.2.4 has a similar requirement in relation to the labelling of ingredients. This requires that the oil derived from soybean line DP-305423-1 will be appropriately labelled. A term that is likely to be chosen is ‘high oleic acid soybean oil’. This is the name used on much of the publicity associated with this product.

However, we do not consider that the proposed drafting (as provided in Attachment 1 to the Assessment Report) is adequate. If the variation proceeds as currently drafted, it might not be clear that this soybean oil needs to be labelled as ‘genetically modified’, partly because the entry for the other high oleic soybean oil has special conditions listed in column 2 in the table to clause 2 of standard 1.5.2. From a legal perspective there needs to be consistency to avoid legal ambiguity, or alternatively it needs to be made very clear in standard 1.5.2 that such foods will need to be labelled as 'genetically modified'. NZFSA suggests the following amendments to standard 1.5.2:

Either -

1) Insert the same special condition for soybean line DP-305423-1 as for food derived from high oleic acid soybean lines G94-1, G94-19 and G168; or

2) both -

(a) add an editorial note in column 2 for soybean line DP-305423-1, to the effect that the Division 2 (clause 4 and 5) labelling requirements apply, as the food has altered characteristics. Therefore all food derived from soybean line DP-305423-1, including extracted soybean oil, must be labelled as 'genetically modified'. In other words, although the soybean oil contains no novel protein or DNA, GM labelling is still required; and

(b) amend the entry for the food in column 1 to 'food derived from soybean line DP-305423-1 that has been genetically modified to be high in oleic acid'. This makes it clear that the food, and all food including oil derived from this soybean line, is genetically modified.

Additional comments

• The Assessment Report advises that "the previously approved soybean lines G94-1, G94-19 and G168 are no longer cultivated and therefore products derived from them are not available on the market". Therefore, if this is correct then these approved soybean lines need to be removed from the Code. It is highly undesirable to have redundant entries in the Code. We understand that FSANZ is considering carrying out a review of the table to clause 2 and removing any foods specified in column 1 that are no longer being manufactured. NZFSA strongly supports any review of the foods listed in column 1 of the table to clause 2.

• The inclusion of a Food Technology Report in the Assessment Report for this application would have been helpful, and could be considered for the Approval Report. This could include information on the current uses of unmodified soybean oil in New Zealand and Australia, and the expected food uses of the modified soybean oil and what oils (including hydrogenated oils) it might replace. This information could then be used to better inform the dietary modelling scenarios, to help determine the nutritional impact.

Yours sincerely

References:

Howell, W., McNamara, D., Tosca, M., Smith, B. & Gaines, J. 1997, "Plasma lipid and lipoprotein responses to dietary fat and cholesterol: a meta-analysis", American Journal of Clinical Nutrition, vol. 65, no. 6, pp. 1747-1764.

Srinath Reddy, K. & Katan, M.B. 2004, "Diet, nutrition and the prevention of hypertension and cardiovascular diseases", Public Health Nutrition, vol. 7, no. 1A, pp. 167-186.