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Genetically Modified Organisms (GMOs) & FSANZ

Community Affairs Committee
Budget Estimates for 2008-09 (Supplementary hearings)

Senator SIEWERT-I have a number of areas I want to talk about, but I want to talk about genetic engineering, GMO and the report Greenpeace has just released, and labelling. The issues that Greenpeace raises in its report are around safety and safety assessment but also labelling. I understand Senator Colbeck wants to talk specifically about labelling as well-is that correct?

Senator COLBECK-Yes.

Senator SIEWERT-So maybe we should start with labelling and then move on to safety assessments.

Ms Halton-As you wish. Just be aware, Senator, that labelling has a policy and a regulatory dimension. So depending on the question, it may or may not be a FSANZ or a department question. We will just see how we go.

Senator SIEWERT-That is fine. If it is a department question, where should I be asking?

Ms Halton-That end of the table. They are there.

Senator SIEWERT-So as long as we have everyone at the table, that is fine. You can play traffic warden.

Ms Halton-Yes. It is all good.

Senator SIEWERT-Where are we up to with the states around labelling? The last time I asked this question around labelling we got to the point where we all had a common understanding, or I understood from your answers that you could not do anything about labelling until it got referred from the states. Where are we with the issue around improving labelling for genetically modified products?

Ms Addison-The states still have made no reference through any of the food ministerial council processes for a request for a review of labelling in terms of genetically modified organisms.

Senator SIEWERT-Is the position still maintained that the current policy is the appropriate policy, or are you looking at labelling that requires all genetically modified material to be identified on the label?

Ms Addison-We are not currently doing any work on genetically modified labelling.

Senator SIEWERT-None at all? I will find the government's exact commitment shortly in terms of genetically modified organisms and their commitment to actually guaranteeing that nothing is released before they are safe, for a start.

Senator COLBECK-Can I help you? This is their policy here.

Senator SIEWERT-Do you want to read it out?

Senator COLBECK-It states:

Labor will also ensure that the process for assessment of GM crops includes careful consideration of health and environmental risks.
Safe and beneficial standards must be established beyond reasonable doubt and standards must be met to the satisfaction of the government, the scientific community, the consumer community and the farming community. 

This is out of the agriculture policy, so I know that we are coming from a slightly different direction, but there is specific reference in there under the heading of ‘Food labelling and genetically modified crops'.
So my question is: has there been any instruction passed through from the government for action with respect of this? I might take a little bit of contest with what Ms Addison said about who can actually put issues on the table. I know that the states all have a capacity to do that, but surely the Commonwealth has also the capacity to put issues on the table for discussion. Has there been any direction? I think we had some discussion at the last estimates about the list of promises and whether or not they were held and understood. So are there any directions here with respect to labelling? I can expand my question out to basically get it out of the way, because there is some discussion with respect to the labelling of seafood. It states:

A Rudd Labor Government will review the provisions of the Food Standards Code relating to seafood to ensure they adequately address the known risks. There are four dot points that talk about country-of-origin labelling, strengthening compliance arrangements, working with the organic sector and also an Australian grown label, which comes under the Trade Practices Act, so that might not be something that affects this portfolio.

Senator McLucas-Sorry, I am not sure what your question is, Senator.

Senator COLBECK-I am asking what action has been taken on all of those promises that were made at the election. These are election commitments. We have had our discussions at previous estimates about the importance of your commitments. My question is: has any action been taken to progress those promises? That is the issue that I have and I presume-

Senator McLucas-By way of assistance, I can advise you that on 5 May this year the Biotechnology Ministerial Council met. Those ministers, of whom I am one-the parliamentary secretary-agreed that the government considers that GM technology can play an important part in helping to deal with emerging challenges, including those arising from climate change and the pressure on global food supplies and the management of pests and diseases as well as benefiting the environment through reduced chemical use, and consumers through development of products with enhanced health benefits. Australia needs to equip itself to benefit from the opportunities offered by this technology while maintaining the ability of individual producers to choose whether or not to adopt it and individual consumers to choose not to buy GM foods.
The government considers GM crops should not be approved for commercial release unless they are safe to health and the environment. Similarly, GM foods should not be approved for sale unless they have been assessed as safe. The government supports the existing national framework for management and regulation of GM crops and food, which includes careful assessment of health and environmental risks. Once a GM crop has been assessed and found to be safe for commercial release, decisions on whether to allow its production in part or all of a state or territory are a matter for that jurisdiction. The government recognises that there continues to be some level of concern in the community on a range of issues relating to GM crops and food and that there needs to be a well-informed public debate on these issues.

Senator COLBECK-That sounds to me like the communique out of that ministerial council meeting.

Senator McLucas-I am not sure that it is described as a communique but it is the result of that meeting.

Senator COLBECK-It sounds like it is communique language to me-and that is fair enough-but it really does not address the question that Senator Siewert is asking and particularly that I am asking. Senator Siewert is asking specifically with respect to genetics; I am asking with respect to seafood safety standards, which comes under the Food Standards Code as well, and also the country-of-origin labelling. I am adding a couple of layers onto Senator Siewert's question-I understand that-but I do not think it addresses Senator Siewert's questions about action.

Senator SIEWERT-No, it definitely does not.

Senator COLBECK-Because the Food Standards Australia ministerial council would be the one that would deal with that and that would be health ministers and agricultural ministers. I am positive that the Commonwealth would have the capacity, as does each of the states individually, to put an issue on the table if they wanted to pursue that. There has to be agreement around the table for that occur-I understand that-but I am interested to know whether the action has occurred to put the issue on the table.

Senator SIEWERT-In fact, is it on the agenda for Friday?

Senator McLucas-No, it is not on the agenda for Friday. But let us not forget that every assessment for genetically modified food in Australia is assessed for safety by FSANZ.

Senator SIEWERT-We will get there in a minute because, as you know, there is extreme doubt about whether the safety assessment is, in fact, adequate.

Senator McLucas-We are happy to answer those questions.

Senator SIEWERT-I have a series of them on that one. But the point is that consumers still demand the right to know what is in the food they are eating. I think Australia has a long way to go in terms of their safety assessment as it relates to GMO, or genetically engineered products or materials in products. But despite that, consumers demand the right to know. Not only that, New South Wales said when they agreed to release GM canola that they would seek better labelling standards. If it is not on the agenda, they obviously have not spoken to the Commonwealth about getting those better standards.

Ms Addison-That is correct, Senator.

Senator SIEWERT-And the Commonwealth is not taking any initiative, either, in terms of trying to get better labelling standards that actually come a bit closer to what other countries are prepared to label on their products.

Senator McLucas-Maybe we could get some discussion about what other countries do. Yes, we are different to some but not to others.

Mr McCutcheon-I just want to clarify the question. You are talking about what other countries do in respect of labelling or in respect of the food safety assessments?

Senator SIEWERT-What I am asking is: what is Australia doing about improving our standards so that all genetically modified ingredients are put on labels so that consumers have a choice? I already know what is and is not included on the label. We have been through that lots of times. The point is that not all ingredients that are genetically modified are noted on the labels of products.

Dr Brent-I think what you are talking about here is labelling for the presence of DNA or protein or the process that was used to produce the food. We label for the presence but not the process. That means that highly refined sugars and oils are not labelled even though the process of genetic engineering was used to produce that food. You do not label because you cannot detect any DNA or protein in there. So that is the current state of our labelling. In countries like the EU, for example, they have gone to processed based labelling.

Senator SIEWERT-Exactly, and 90 per cent of consumers want full labelling. There has still been no work done by the Commonwealth. Do you intend to take it to the states?

Senator McLucas-The question, Senator Siewert, is how would you enforce it? I have spent a lot of time thinking about this. How do you enforce a system which is not trackable one way or the other?

Senator SIEWERT-Sorry?

Senator McLucas-You cannot test it one way or the other. I recognise the EU has gone down this path, but if a food manufacturer uses a genetically modified food and it is refined to the point that you cannot actually identify the difference in the DNA-let us talk about canola oil-then if you put a label on it that says, ‘This product has no genetically modified canola in it,' or ‘This product does have genetically modified canola in it,' you cannot track that. You cannot work out using the final product whether that is true. That is the difficult thing.

Senator SIEWERT-You could require manufacturers to actually notify whether genetically modified organisms or processes have been used. There could be mandatory reporting for a start.

Senator McLucas-Yes, I understand that, but if someone wants to break the system the enforcement is almost impossible.

Senator SIEWERT-The same could be said for a number of products and a number of processes. You are relying on mandatory reporting in a number of these areas.

Senator McLucas-So how do you enforce it is the question I ask and I cannot answer that question. If a manufacturer is intentionally trying to hide the fact that they have used genetically modified canola then they can do it because we cannot test the final product and say that it has GM material in it because the refining process excludes all of the DNA that could be tracked.


Senator SIEWERT-It may just be a policy question I am asking. I want to take up where we left off in terms of labelling. We were up to the issue around traceability et cetera. I am just wondering whether either FSANZ or the department has done a review of how the process in Europe works. They use a traceability process so that each component has documentation of the nature of the materials. As I understand, it has been operating since 2004. So I am wondering: if Europe can make it work why we cannot-or has there even been a look at or a review of the process that they use?

Dr Brent-After the GM food labelling standard was approved by the ministerial council they put a proviso on that that three years after the approval of the GM food labelling standard a review would be
undertaken. That review was undertaken and that review also included a comprehensive summary of all of the GM food labelling regimes across the world, including the EU. The opinion that came out of the ministerial council was that Australia's current GM food labelling standard was fine, was operating properly, and they did not want any further work done on it at that time.

Senator SIEWERT-When was that review carried out?

Dr Brent-It was carried out three years after the approval. I am not exactly certain. I think it was around 2003.

Senator SIEWERT-The review was carried out in 2003?

Dr Brent-Yes.

Senator SIEWERT-Okay. If it was carried out in 2003, that is five years ago, and the year before the new standard came in in the EU. So my question still stands: have you looked at the new process that is used in the EU and the documentation process about the traceability issue?

Dr Brent-Actually, I think at the time of the review that we did for the ministerial council the EU had changed their labelling regime from the presence to the process. So we did look at that at that time.

Senator SIEWERT-Okay. Could you just clarify that for me, because I understand it is since 2004 and another process has been operating?

Dr Brent-Senator, I am not sure exactly what process you are alluding to in 2004, but we could take that on notice.

Senator SIEWERT-If you could, that would be appreciated because, as I understand it, the new labelling requirements came into practice in 2004.

Dr Brent-With regard to the process that goes on in Europe, it is quite a lengthy and convoluted process to get something changed. It is possible that at the time that we did the review for the council we already knew what was going to happen and it may have taken a while-until 2004-to get that into their legislation, but we can check that for you.

Senator SIEWERT-If you could, that would be appreciated. Is the review on the web?

Dr Brent-It was certainly made public.

Senator SIEWERT-I will find it on the web then. I do not want to ask for something that I can find myself.

Dr Brent-It was a very lengthy review.

Senator SIEWERT-Okay. Thank you. Can I go on to the Greenpeace report that was released yesterday and their comments around some of the approvals of some of the products that have been signalled in the report as being of concern. They are products, as I understand it, or components of products that FSANZ has approved. One of the ones they talk about is MON863 maize, which has been found to produce evidence of liver and kidney toxicity. Have you looked at the new information that has come out on that?

Dr Brent-The issues around MON863 have been looked at extensively over many, many years by many, many people. We have looked at that data very comprehensively, like other regulators around the world have, and we simply do not believe that there is good evidence that there is liver toxicity from MON863, and that is the view also of other regulators. That particular maize is approved in Canada, the US and Japan. I am not sure, but I think it has also been approved in the EU now. It has certainly been looked at by the European Food Safety Authority and they came up with the same view as all the other regulators around the world. So the evidence or the information that has been put out by some of those groups is not very well presented. It probably misinterprets what the data actually says.

Senator SIEWERT-I am not going to have time to go through all the products that they list-and I will put some on notice, because I appreciate the time-but another one they talk about is Bt63 GE rice. I
understand there is contamination of Chinese rice products with this particular product and that both the EU and New Zealand have been implementing testing regimes to test for this particular brand. Is Australia?

Dr Brent-I think Bt63 rice was one of the issues, one of the others, that they quote in that report. That report, by the way, we only received on Monday, so we have only had a quick look at it. Those are issues where there were accidental contaminations of unapproved events that happened in the US, for example. What we have done there is we have had a look at the available data from the companies and also from our regulatory colleagues, because we have MOUs with those colleagues and we can swap data and information on a daily basis. Those products are still illegal to be sold in Australia. They are not approved. Bt10, for example, and Bt63 are not approved. They are illegal to be sold. But on the basis of the data that we received, we did a risk assessment and our opinion was that if those products were coming into Australia, they would be coming in, if at all, in very, very small quantities and the risk to public health and safety was very, very small. So it is a case where they are safe but still illegal and out of compliance.

Senator SIEWERT-You have not asked AQIS to test for the presence of that particular rice in products coming in?

Dr Brent-Again, I would have to take that on notice, but I am pretty sure at the time we asked AQIS to put these products on their risk list to be looked at for imported foods.

Senator SIEWERT-So you did put it on their list?

Dr Brent-I would have to take that on notice, but I am pretty sure. That is normally what we would do- we would tell AQIS that something could be coming in and that they should be looking at it on their risk list.

Senator SIEWERT-If you could take that on notice, that would be appreciated because as I understand it they do not test for it unless you ask them to. Thank you.

Dr Brent-Senator, just as a clarification, when we give AQIS advice about what goes on the risk list, it is only when we consider it to be a human health and safety concern. In those cases, our advice was that there was no human health and safety concern so they may not have been put on the risk list, but we can take that on notice.

Senator SIEWERT-If you could, that would be appreciated because I understand in fact that New Zealand, for example, did and withdrew the product's availability in New Zealand.

Dr Brent-Again, I cannot comment on what New Zealand did at that time. We could use our networks to find that out for you.

Senator SIEWERT-If you could, that would be appreciated. Is the risk analysis that you did a publicly available document or is it a document that you could table?

Dr Brent-The risk analysis on Bt63 or Bt10?

Senator SIEWERT-The Bt63.

Dr Brent-Certainly when we did those risk assessments we put some information up on our website about our risk assessment opinion.

Senator SIEWERT-Again, I will go there. You do not need to table it. If it is there on the public record, I will go and find it. Thank you. There are a series of products that the report talks about so I will put those questions on notice. What I am also particularly keen to go through with you, though-and I will try to do it quickly, Chair-is what postmarket monitoring of the effects of GE food on human health you are doing. I am thinking about the allergic reaction and those sorts of things. Who is responsible for doing that?

Dr Brent-When we receive an application for approval of a GM food, we do in our view-and the view of WHO, FAO, Codex and other regulators around the world-a comprehensive safety assessment. Our opinion at the end result of that is that these foods are safe. During the safety assessment we look at the history of use and the safety of the donor organism and the host. We look at the potential for toxicity and allergenicity. We look at the molecular characterisation and the compositional analysis of the GM food compared to the non- GM food. So, having said that it is safe, we do not believe there is any necessity to look at postmarket monitoring.

Senator SIEWERT-So you do not do any-that is the bottom line?

Dr Brent-We do not do it because we do not believe it is necessary.

Senator SIEWERT-There have been allergic reactions to GE products, however, haven't there?

Dr Brent-I do not know where you are getting that information from, but our evidence certainly shows that there have been no allergic reactions to GM foods.

Senator SIEWERT-I have a whole heap of different papers that indicate allergic reactions to different GE products.

Dr Brent-In humans?

Senator SIEWERT-In humans, yes.

Dr Brent-I am sorry, but we are not aware of any of those allergic reactions and we do comprehensive scoping of all of the available evidence. I am happy to have a look at anything you have got there. We are always happy to look at new data, but every time we do a safety assessment of a GM food application we take all of the evidence into account. As I said, the same data and the same opinions have been a result of these assessments that have been done by the US FDA, Health Canada, Japan and the EU, so if there were really allergic reactions to GM foods I am sure all of those regulators would have found them. If there was any issue at all about allergenicity or toxicity or any human health and safety concern, FSANZ would not approve a GM food. I can assure you of that.

Senator SIEWERT-Have you ever knocked back a GM food?

Ms Halton-Senator, you say you have got a number of articles. We would actually be interested to see those.

Senator SIEWERT-I do not actually have them here, but I do have them in my office so I will make sure I send them.

Ms Halton-Thank you. That would be great.

Dr Brent-There have been some experiments done where people have looked at transferral of a brazil nut gene into another plant. They are experiments; they have never been commercialised. You have got to put it into context.

Senator SIEWERT-You do not actually test the products yourself, though, do you? You rely on industry data.

Dr Brent-That is right. We rely on industry data but also all of the available data from scientific literature from our regulatory colleagues, from the World Health Organisation and, as I said, the Food and Agricultural Organisation and the Codex Alimentarius Commission. I think it is fair to say that the overwhelming consensus of scientific opinion is that GM foods that have been approved are safe.

Senator SIEWERT-I think I would beg to differ on some of the evidence that I have read. Have you ever knocked back a GE product?

Dr Brent-The answer to that is no.

Senator SIEWERT-I understand some other food regulators in other countries have.

Dr Brent-I think I will answer that question by saying that, for just about every application-I cannot say every one-we have ever received on a GM food, our process is that if we require any clarification at all on any aspect of the assessment we go back to the applicant and ask for clarification. So that might be results on experiments that are not clear and so on. We do that on a routine basis between us and the applicant, but we do not publicise that. That just happens under our process.
Again, we also put in a lot of work up-front when we receive an application or when we receive advice from industry that they are going to submit an application. So we meet with them and we make sure that all of the evidence that we require under our guidelines is present in the application package. What Greenpeace may be alluding to is that when that same sort of process happens in Europe and the European Food Safety Authority requests some clarification from the applicant then that is made public. I think that is what they are alluding to but I am not sure. The answer is no, we have never knocked back an application, but for the majority of those applications we have asked questions and we always have that right to do so. We have the high ground in this process.

Senator SIEWERT-Are there any products that are banned elsewhere that you have approved in Australia?

Dr Brent-I think recently the Austrian government banned the growing of GM foods, GMOs. I am not sure they banned GM foods coming into Austria. But as far as I know there are no bans by other countries. Certainly all of the approvals that we have given-and, again, Greenpeace got it a little bit wrong in their report because they talked about 50 approvals; we have only given 36 to 38 so far, so they got that wrong-are also approved in the US, in Canada, in Japan and many of them in the European Union as well now.

Senator SIEWERT-All of the ones that you have approved have been approved in the EU?

Dr Brent-No, almost all of them-many of them. In the EU, they have approved at least greater than 20 GM foods. We have approved 38 and the US has approved up to 90.

Senator SIEWERT-Can we go back to the EU. Are there products there that have applied and been knocked back but we have approved-you say there are 20-or have they just not bothered to try to get them into the EU?

Dr Brent-What I can say is that quite a few of the approvals that we have given here have also been approved in the EU.

Senator SIEWERT-Quite a few but not all.

Dr Brent-Not all of them. As I said before, the EU are a little bit slow in terms of their approval system, and their approval system is quite convoluted. What happens over there is that an applicant will apply for a GM food approval through a member state and then that member state refers it on to the European Food Safety Authority for their scientific opinion. Then it has to go through other processes such as the European Parliament, the Council of Ministers and then the European Commission, so it takes a while. Also, history would show that in the past the European Commission and the European Union have been a bit slow in terms of that approval process.

Senator SIEWERT-Okay. Can we just go back to the Austrian example. Did they just ban the growing of GMOs or growing for GMO products?

Dr Brent-Again, I am not 100 per cent sure what they have banned, but I think it is the growing of GM foods. Bear in mind also that Austria has taken a unilateral decision against the EU on this. So the European Commission and the European Union could actually take Austria to court to reverse what they have done. I do not know whether they will or not, but that is the process that operates over there.

Senator SIEWERT-So, when we are told that a certain crop has been banned in Austria, is that because there is an across-the-board ban on the growing of GMOs?

Dr Brent-Again, I would have to take that on notice because that Austrian decision was taken, I think-I do not know-a month ago or so. So I think it is about the growing, but it could be across-the-board. I am not sure.


Senator SIEWERT-Okay. Just to clarify, there is no post-approval review of any of the products that you have already approved?

Dr Brent-There is no postmarket monitoring per se. There were attempts in the UK to do some research on this issue. The UK Food Safety Authority or agency actually commissioned some research to see how difficult it would be to do postmarket monitoring on GM foods. I think the result of that and the consensus was that it was virtually impossible to do that sort of work. I think the UK spent almost £1 million on that research and it was dropped.

Senator SIEWERT-Thank you.

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