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Notice given 15 August 2005

1083  Senator Stott Despoja: To ask the Minister representing the Minister for Health and Ageing—

(1) In the Food Standards Australia New Zealand (FSANZ) fact sheet on Bt-10 published on 21 April 2005, there is reference to Syngenta producing ‘several hundred tonnes’ of Bt-10. Can the Minister explain why this figure differs so dramatically from Syngenta’s own published figure of over 150 000 tons.

(2) The fact sheet on Bt-10 indicates that the amounts of Bt-10 that might have come into Australia are ‘extremely small’. Apart from the claim by Syngenta on the total amount of Bt-10 corn produced (Syngenta has estimated around 150 000 tons): (a) what documents or data have formed the basis for this conclusion; (b) has FSANZ confirmed this figure; if so, what data forms the basis for that confirmation; (c) what amounts of Bt-10 have possibly come into Australia; (d) what is the basis for the estimate; if no estimate has been made, why has no work been done to ascertain the amounts that have or may have entered Australia; (e) what foods are most likely to have been imported into Australia containing Bt-10; and (f) in how many different products.

(3) What steps have been taken to ascertain whether any Bt-10 has been imported into Australia during the 4 years in which it was illegally produced and distributed.

(4) Can a description be provided on how the safety assessment undertaken by FSANZ for Bt-10 differs from the normal food safety assessment processes and why.

(5) Under what provisions of the Food Standards Australia New Zealand Act 1991 or Code did FSANZ: (a) review Bt-10; and (b) determine that no testing of imports or food products was required.

(6) Given that the Act provides for urgent assessment of a food under Division 5, following a declaration of ‘urgency’ under section 24 in that division, has FSANZ made any declaration of urgency.

(7) Is it the case that allowing a product to possibly remain on supermarket shelves and to continue to be imported into the country while an assessment is being undertaken, circumvents established processes.

(8) Given that the fact sheet claims that FSANZ has no health or safety concerns regarding Bt-10, has Syngenta ‘demonstrated’ the safety of Bt-10, which would appear to be a higher standard.

(9) Was all the data received from Syngenta produced according to good laboratory practice; if not, why not.

(10) The critique Dr Jack Heinemann has produced, located at, of two Syngenta documents released by FSANZ, Western Blot Analysis of Cry1Ab and PAT Proteins Expressed in Field Corn - Report No. SSB-112-05 - a Western blot analyses of leaf extracts of Event Bt-11 and Event Bt-10-derived corn plants … Sequencing of the Bt-10 insert and comparison with the previously reported Bt-11 sequence, Report No. SSB - 104-05, makes a number of findings apparently at odds with conclusions of FSANZ. Has FSANZ read that critique; if so, how does FSANZ respond to the critique’s conclusions regarding Bt-10 and Bt-11.

(11) Does FSANZ have a comprehensive dossier of quality assured raw experimental data for Bt-10; if not, why not.

(12) Given that the FSANZ website located at ediareleasespublications/factsheets/factsheets2002/faqsongmfoods6august1632.cfm indicates that FSANZ undertakes comparative analysis of the ‘molecular, toxicological and nutritional and compositional properties of the food to the non-GM form’, was such an analysis done for Bt-10 corn.

(13) Can a list be provided of the documents upon which FSANZ relied for its safety assessment.

(14) Given that the FSANZ safety assessment of Bt-10 was based on documents received from Syngenta, did FSANZ receive safety studies carried out on Bt-10 from Syngenta; if so, did this include: (a) human feeding studies; (b) animal feeding studies; if so, were any of the animal feeding studies long-term (at least several months); and (c) did this study include: (i) any feeding studies using the whole corn, (ii) any studies of allergenicity, (iii) generational feeding studies, and (iv) cancer studies.

(15) Did FSANZ receive: (a) molecular characterisation of Bt-10 from Syngenta; (b) a genetic profile of Bt-10; and (c) a complete and certified history of the planting and shipments of Bt-10.

(16) Did FSANZ require or seek any independent verification of the data provided by Syngenta; if so, can details be provided on how verification was provided.

(17) Given that the FSANZ fact sheet on Bt-10 indicates that Bt-11, which has been approved for human consumption in Australia, and Bt-10, produce identical novel proteins, what data forms the basis for that conclusion.

(18) Do identical proteins in different genetic structures and inserted in different locations in a plant cell express themselves identically.

(19) Is it the case that Northrop King (later taken over by Syngenta) applied for unregulated status of Bt-11 in 1995 and that in the appendix to that ‘petition’, a comparison of Bt-10 and Bt-11 showed that Bt-11 produced about 7 times more toxin protein than Bt-10; if so: (a) is FSANZ familiar with this report; and (b) does FSANZ agree that this would strongly indicate significant protein differences between the two constructs.

(NOTE: reference - Pilancinski W and Williams D. Petition for Determination of Non-regulated Status for: Insect protection corn expressing the Cry1Ab gene from Bacillus thuringiensis var. kurstaki 1995.)

(20) What steps has FSANZ taken to ensure that no future imports contain Bt-10; if no steps have been taken, can FSANZ: (a) guarantee that no Bt-10 corn is being produced in the United States of America (US); and (b) that Bt-10 seed is not widely distributed in corn producing areas in the US.

(21) (a) Is it the case that in its assessment of Bt-11, FSANZ indicates that the most likely source of Bt-11 coming into Australia would be in processed corn foods such as syrups, flours, oils, chips etc; and (b) is this also the most likely source of Bt-10 arriving in Australia.

(22) Has the department tested or commissioned, or requested testing of, any of these foods to determine if Bt-10 is present; if not, why not; if so, can details be provided on: (a) the number of tests; (b) what foods were tested; and (c) the results.

(23) Is it the case that the European Union has imposed a certification requirement on corn imports that are most likely to contain Bt-10 because the import of Bt-10 is unlawful; if so, as Bt-10 is also unlawful in Australia and it is possible that Bt-10 is being imported into Australia, why has FSANZ not imposed a similar requirement on corn imports most likely to contain Bt-10 (i.e. processed foods).

(24) Given that the FSANZ fact sheet notes that FSANZ was not informed of the Bt-10 mistake until some 4 months after the US Government was notified, has any explanation been sought from Syngenta or the US Government to explain the failure to immediately notify countries that may or do import Bt-11 products.

(25) How many Genetically Engineered (GE) foods or crops are: (a) being produced or trialled in the US that are not approved for use in Australia; and (b) have the potential to enter the world food chain.

(26) How many of these crops do not have validated detection tests.


 (27) Given that it is well established that the US does not have segregation or coexistence systems to separate GE and non-GE crops and foods, does not have stringent testing requirements to prevent contamination and that the US system is not preventing unknown and untested GE organisms from entering the food chain, what steps are being taken in Australia to deal with these potential unwanted imports.