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Application A614 – Food Derived from Glyphosate-tolerant Cotton Line GHB614 – Draft Assessment Report

23 September 2008

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.

NZFSA has had the safety assessment prepared by FSANZ reviewed by the Institute of Environmental Science and Research Limited (ESR). As a result of this review, there are two comments we wish to make on the Draft Assessment Report (DAR):

• There is an inconsistency in the DAR. The Executive Summary states that the novel protein, 2mEPSPS, was detected in linters from cotton line GHB614, whereas the results of the assessment of processed cottonseed products in Table 5, Section 4.3.2 of the Safety Assessment indicate non-detection of the 2mEPSPS protein in linters. This inconsistency should be corrected.

• The sections of the Safety Assessment that describe acute oral toxicity studies (Section 4.4.3) and compositional analysis of the transgenic cotton line (Section 5) describe results and draw conclusions that are not supported by either data presented in the DAR or by reference to specific studies. For example, the raw data for combined site comparisons is presented in the assessment without inclusion of calculated statistical p-values. The data presented in the assessment is hard to follow with respect to the discussion of results. From the tabulated data presented for combined site comparisons it would appear that the only analytes to show a statistically significant difference for both site and treatment were the amino acids cystine and methionine and this difference was described as close to the cut-off for significance at the p<0.01 level. The discussion of results suggests that there were other analytes that showed statistically significant differences between sites or treatments, but data for these results is not readily apparent in the tables presented. It is also stated that T-tests comparing the analyte values for non-GM control samples and transgenic samples derived from either sprayed or unsprayed plants showed no significant difference between any of the analytes tested, however, data is not presented in the assessment to confirm this (refer to section 5.3). It is suggested that in the Final Assessment Report, that data be included or references given to studies in order to enable verification of the results given.

Yours sincerely