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Rural and Regional Affairs and Transport Legislation Committee
Australian Pesticides and Veterinary Medicines Authority

Australian Pesticides and Veterinary Medicines Authority


ACTING CHAIR: We welcome to the table officers of Australian Pesticides and Veterinary Medicines Authority. We note that you are at a much earlier spot in the agenda than is customary. Hopefully that pleases you.

Senator HEFFERNAN: Can I have the call to do something off the page before we start? Minister, I would just like to congratulate your department and you in particular for getting questions back on time in a pattern that has always been consistent. While I am doing that, I would also like to point out that with everyone else—Transport, Minister Albanese and Regional—we got theirs on Friday late in the afternoon and as a consequence our secretariat had to process those through Friday night. This is a consistent pattern also, as you know. There is a date set. Congratulations: you keep to your date. But I think it is absurd and a disgrace to the processes of parliament that with others consistently—it is not a one-off—on the last working day before estimates the questions turn up and, as a consequence, processing them and making sense of them is very difficult. It is all I wanted to say.

Senator Ludwig: Can I just add that, as a senator, I do recognise the workload of the secretariat. That is why we comply with the Senate orders not only because they are Senate orders, and they do require to be complied with, but also it gives an opportunity to senators to utilise these estimates so that they have responses, they can follow up on those responses and it does not add to the workload of the secretariat. In terms of other members, I always will continue to advocate for those other members to put the questions in on time.

Senator HEFFERNAN: Thank you very much, Minister.

Senator BACK: Ms Arthy and Dr Bhula, good morning. Can you please give the committee an update on the circumstance with fenthion, which was approved under limited circumstances for the fruit season in Western Australia last year? Can you advise us as to what action is being taken in advance of this year and what other states or territories may also be the subject of these considerations, please?

Dr Bhula : There is not much more to update since the last estimates hearings, Senator, in relation to fenthion. We are expecting to get some residue tests submitted to the authority probably about June or July. In terms of the suspension, as you know, we have two sprays still allowable in Western Australia through fruit and other orchard uses. We have an occupational health and safety report and an environment assessment which is yet to be published. If by August we do not actually have any further information or any new assessments to publish, we will be continuing the suspension for another 12 months up until the end of October next year.

Senator BACK: Continuing the suspension—do you mean continuing the usage under the same regulated conditions?

Dr Bhula : Yes, that is correct.

Senator BACK: Are there other areas in Australia that are also the subject of the same provisions or restrictions and where are they?

Dr Bhula : The eastern states also have a restricted use regime, which is again new instructions under permit that run for the same period of 12 months up to the end of October. We are expecting also to receive residue test results as well as any indication of how the product has behaved with the more restricted spray regime.

Senator BACK: I have no other question on fenthion unless others do.

Senator WILLIAMS: In regard to fenthion, in a nutshell, what is the basic problem that the APVMA sees with this chemical?

Dr Bhula : The restrictions that we put in place at the end of last year were basically to bring the maximum residue levels down for a number of commodities where those residues then led to a dietary exposure concern against new health standards that have been set by the Office of Chemical Safety and the department of health.

Senator WILLIAMS: So it is all about reducing residues?

Dr Bhula : It is about reducing residues.

Senator WILLIAMS: And yet you did extend the withholding period from three to 21 days—is that correct?

Dr Bhula : For some situations withholding periods were extended and in other situations the number of sprays were limited and restricted.

Senator WILLIAMS: What was this residue found to be doing wrong? What was the threat to human health? Why?

Dr Bhula : For a number of the commodities we found that the dietary exposures with the existing maximum residue limits at the time were way above the health standards that had been set by the department of health. These were not just twice or three times; we are talking about 10, 15 or 20 times over the health standards.

Senator WILLIAMS: How long has this chemical been around?

Dr Bhula : It has been around for 40-odd or 50-odd years now.

Senator WILLIAMS: In previous years over that period had you seen any situations where the residue was at extreme levels before?

Dr Bhula : There were situations where residues were found that exceeded the maximum residue limits that had been in place, yes.

Senator WILLIAMS: Why were the changes not taken up then?

Dr Bhula : The chemical started under review in 1998 and we worked through the different assessments at that time. Part of the period from 2000 on was to allow industry to generate new residue data to represent the use patterns in Australia, because the chemical manufacturer that responded to the review actually did not have any local data. So over a period of three or four years—this is from 2007 through to about 2010—Horticulture Australia Ltd generated a whole raft of new studies to provide to the APVMA.

Senator WILLIAMS: This is obviously used by fruit growers for fruit fly control. Is there any action being taken or are you working with industry to come up with a solution or alternative chemical? Fruit fly is a huge problem in New South Wales. It is not a problem in South Australia. I wish it was the same all over Australia. What action is the department or APVMA taking to see that there is a suitable chemical to control fruit fly?

Dr Bhula : A lot of the industry groups have been funding researches, as, indeed, have the state agriculture departments in New South Wales, Queensland and Western Australia. We are expecting there to be permit applications put to the APVMA this year for alternative fruit fly control chemicals.

Senator WILLIAMS: When the permit application is put to you, how long could it be before that chemical—a newly designed or invented chemical—would be approved? Would that be two or three years?

Dr Bhula : No, under permit it could be done within three to six months.

Senator BACK: Can I move to the chemical Tri-Solfen, approved for use after mulesing. Can you give us your guidelines in terms of the use pattern by operators and any occupational health and safety concerns or conditions that you are aware of or impose?

Dr Bryce : As you are probably aware, Tri-Solfen is approved for use as a once-off treatment for mulesed lambs. Can you be a bit more specific with your question, please?

Senator BACK: I am interested in possible risk to operators. The once-off obviously applies to the lamb. My interest lies in the possible risk to operators—given that they might mules a couple of thousand lambs a day—either ingestion or absorption of chemical may be. Have you done any work at all to establish the safety of the product from the operator's point of view?

Dr Bryce : As part of the registration of the product an assessment was carried out by the Office of Chemical Safety in the department of health. They assess occupational health and safety risks and their recommendation was that the product was safe to use from an occupational health and safety perspective. There have been some reports of operators suffering from headaches, but when they have been investigated by us we have not been able to establish that there has been any causal connection between the use of the product and the symptoms that were shown. Very few cases have been reported.

Senator BACK: On notice, would you be able to give us more details of those that you might have had a look at or investigated. So it would fall to your agency to undertake those investigations, would it, rather than Health or—

Dr Bryce : Where we have an adverse experience reported to us, we normally make an assessment of whether there is a connection or a likely connection between the use of the product and the adverse experience that has been reported. The reports that have come to us have been more in the nature of allegations and our view is—or my personal view is—that in some cases they are allegations from people who are opposed to the use of the product.

Senator BACK: When you say allegations—

Dr Bryce : It has been difficult for us to establish the facts of the adverse experiences as they have been reported to us.

Senator BACK: So that I can get my head around that, in a circumstance where people have had an adverse health experience, they would report that to APVMA?

Dr Bryce : Yes, they can report that direct to us. In general, the reports we have received have not been direct reports from the people who have been affected.

Senator BACK: I see—so the reports have been presented to you by people other than those—

Dr Bryce : Some of them have been in, for example, Western Australian newspapers.

Senator BACK: What have been?

Dr Bryce : Some of the allegations that Tri-Solfen is causing health problems.

Senator BACK: So they have not made them directly to you?

Dr Bryce : Yes.

Senator BACK: They have?

Dr Bryce : No, I am saying that it is correct that they have not.

Senator BACK: Okay. But actual cases of people themselves believing themselves to be affected adversely as you say, with headaches or whatever the symptoms are, you have had none or very few?

Dr Bryce : Very few. If you like, we can take it on notice and give you the exact information on that.

Senator BACK: I would appreciate that. How long has the chemical been used and approved for use?

Dr Bryce : It has been used since 2005 under a minor use permit and then it was registered in 2012 I believe.

Senator BACK: From that minor use permit period through to the time it was actually registered, would you be in possession of knowledge of whether or not its use has increased? That would be presumably the company that would sell it that would—

Dr Bryce : The company that sells it obviously would be in possession of that information. We would have information on the value of sales of the product for the period where it has been registered, but we do not actually—because levies are not charged on products when they are available under permit, we may not have that information. I might add that, over that period before the product was registered, we understand there were over five million doses used and over that period we had five respondents who had reported possible adverse reactions in humans.

Senator BACK: So, in that seven-year period with five million doses, you had five instances?

Dr Bryce : Yes, we did, and none of those were attributed by us definitely to the use of the product.

Senator BACK: I wonder if I can now just go to a more general topic and that is the new legislation that has now passed through the House of Representatives and has yet to come to us in the Senate. I am just not sure, Ms Arthy, who might be able to respond to my questions. They come from industry and I am seeking your response to some of the quotes that have been presented to me: the bill will increase registry burden for agricultural chemical products, resulting in fewer, more expensive products for farmers and less incentives to bring new technologies to the market. Is that a concern that has been raised with APVMA and, if so, how would you respond to it?

Ms Arthy : As the matter is related to legislation before the house, it is probably not appropriate for the APVMA to comment. Perhaps I can pass that to my departmental colleagues.

Senator Ludwig: I am happy to answer. No, it does not increase the regulatory burden. In fact, what it is designed to do is reduce it. I can see that you have been talking to a range of people who have made submissions, but have a look at the whole process. We have gone through an extensive process of exposure drafts of the legislation through the Senate committee which I referred it to for that opportunity for everyone to have input. I think where we have landed, quite frankly, is a piece of legislation that will give the opportunity for the APVMA to continue the reform agenda for agvet chemicals while maintaining—this is an important issue—the occupational health and safety of employees, farmers and producers in the field who use these chemicals and, ultimately, the consumers, who also do not want to be exposed to risk.

Senator BACK: The concern expressed to the committee—and it has been the observation overseas—is that the reregistration process becomes onerous and expensive for some chemicals that might only have a seasonal use or a use in certain seasons and so the decision by the manufacturer is to not bother seeking reregistration. When a need for that chemical comes along, of course, it is no longer available. Is that an area, Minister, that you believe is a valid concern?

Senator Ludwig: I think the comparison with overseas jurisdictions is not a valid comparison. I think the reregistration scheme that is embodied in the legislation actually is transparent, it allows people to understand the process and it also takes into account some of the criticisms that you make to make sure that the reregistration scheme actually works effectively, otherwise you end up in an area where there are some chemicals that have never been reviewed, as I understand it. In other words, they have been out on the shelf for use without being used. So the reregistration scheme that we have put in place does not automatically remove them and does not automatically drop them out, so they stay there even though they have been there a very long time and the APVMA can then prioritise. They can do a risk analysis of those chemicals that are what you might put on the more—you always have to be sensitive about how you describe this—that you think might actually require a good look to see whether or not they are still fit for purpose and still meet people's occupational health and safety needs and that they still do not put at risk farmers who use these chemicals and they do not put at risk consumers who then consume produce produced by farmers. Nobody would like to see these chemicals lead to adverse outcomes for consumers in the longer term. It is not good for business but it is also not good for the consumers. It also means that ultimately you do need to look at chemicals again, otherwise what you are advocating is that we should not look at chemicals at all—we should just leave them on the shelves and let them continue on, irrespective of what evidence is out there about these chemicals. I do not think anyone would accept that position. So that is why a reregistration scheme is a sensible option. What we have come to is a system that allows the reregistration scheme not to be onerous but to be reasonably fair.

Senator BACK: But, with respect, if there are adverse reports about any chemical, you do not have to wait for a reregistration process for the APVMA to examine the efficiencies or the risks, or the risks to occupational health and safety under current legislation. That does not prevent you from actually examining that chemical and, indeed, should it be found to be a risk either to people or to the environment or not be effective, APVMA does not have to wait for a reregistration process to act on that chemical, do they?

Senator Ludwig: No, you can. If there is information that is available that says this is an at-risk chemical that has a severe—or 'at-risk'; we will just use the non-provocative language—APVMA would be duty-bound to look at the particular chemical and do a review.

Senator BACK: Exactly.

Senator Ludwig: But what you are then saying is that we will leave it to an ad hoc system. So without a reregistration scheme it would then be ad hoc. Ad hoc would mean that it is only when someone in an overseas jurisdiction looked at a particular chemical and said, 'There's a problem with this.' It may have already been out in the domain for some time—the exposure of that might have already come to light or the adverse consequences of that might have already come to light. I do not think in a modern world we should rely on an ad hoc system that just bubbles up in overseas jurisdictions if there is a problem. What this does is put in place a framework that says, ultimately, if there are long-term use chemicals on the shelves that have not been reviewed and we know that they are probably high risk or some of them medium risk, we should then risk assess.

You do not start off with a reregistration for a new chemical or one that is maybe relatively benign, but for those ones that were produced in the fifties and sixties, where there is at least some concern or some at least peer reviewed writing about them, you may want to start looking at those in a more systematic way and allow APVMA to get on with the job of doing that rather than leaving it to what the industry seems to be suggesting to you is an ad hoc system, which is that you simply leave them on the shelves and wait for a flag to happen overseas and then get the APVMA to look at it and that will be the solution. I do not think that is sensible.

Senator BACK: Thank you.

Senator SIEWERT: We have just been talking about the reregistration process. Have you yet worked out how you are going to tackle that reregistration process and what chemicals you are going to deal with first?

Ms Arthy : The simple answer is no. We are working through the processes at the moment as the regulations are being developed. We need to have things in place by 1 July next year and before then we will work out really the batting order of the chemicals that will be up. Essentially the theory is that we will look at these older chemicals first and we will look at them in terms of clumps around active constituents. So we are still working out exactly which chemicals fall into that.

Senator SIEWERT: Can I ask what time line there is then? I want to come back to that 1 July next year time line, but what time line are you working on to work out the process and what consultation process are you using to work that out, if there is one? How are you talking to stakeholders about that?

Ms Arthy : It is quite difficult to answer that given that the legislation is not passed. So—

Senator SIEWERT: I understand that.

Ms Arthy : In many ways I can only have an academic and theoretical conversation with you. What I can say is that, once the legislation is passed, there will be considerable consultation, particularly with our state and territory regulatory partners, and then we will be going out and making sure that it is communicated very clearly to stakeholders. From memory we are required, once the registration scheme starts, to give 12 months notice. From there on there is quite a process that we go through by which what we are doing is going to be made public with lots of opportunities for people to consult.

Senator SIEWERT: I just want to go back to that 1 July date to note that that date of starting has been pushed back. So, while some of us have some concerns about that because we think this process is overdue, that does give industry more time or stakeholders more time to work out what is going on.

Senator Ludwig: There is a balance there. I struggled with coming to this decision. I preferred the earlier start date, quite frankly, but industry was saying effectively that they do need time. APVMA I think does need to get the form right and therefore it does seem to be a sensible place to land. This was an amendment that was done in the house, but I think the coalition was also amending it in the same way at the same time, from memory, although I am happy to be corrected. I think it would be ultimately unreasonable and unwise to have the APVMA commence a new regulatory framework without them having adequate time to train their staff and get their IT in place. I am very confident that the APVMA could meet those deadlines, but I think that for all industry and the APVMA it is more sensible to allow just that little bit of extra time given that it is a new system. You would not want them to be trying to find workarounds while they are delivering a new system. We can have time to do that.

Senator SIEWERT: Thank you. I do understand. As I said, I have concerns and I would like to see it sooner rather than later. I understand the issues. I suppose then we are seeking assurance that the process we just talked about will be up and ready to go on 1 July next year.

Ms Arthy : Yes, Senator.

Senator SIEWERT: Thank you. In terms of registration of unmanageable chemicals, has the process been worked out yet or are you—I am sure you are thinking about it, so it is a bit rude of me to ask. What are your initial thoughts on how you are going to handle that process?

Ms Arthy : I think I have to come back to the fact that the legislation is still going through the house, so we do not have a definitive decision in terms of what we may be required to implement. I am just looking at my departmental colleagues as to whether there is anything from a policy perspective.

Mr Koval : What was the question?

Senator SIEWERT: Your thinking around the reregistration of unmanageable chemicals.

Mr Koval : You are talking about the concept of unmanageable risk?

Senator SIEWERT: Yes.

Mr Koval : The view we have taken about unmanageable risk is that the regulatory framework should look at risk. In any chemical, as the APVMA goes through the assessment process either through the initial assessment, the review or the reregistration process, if there is unmanageable risk then it should not be on the market. By definition if we actually have a strong regulatory framework that actually looks at risks and how to manage those risks, if you cannot manage those risks then the chemical should not be registered.

Senator SIEWERT: Will you then be prioritising those that already have flags up, as the minister describes, on them?

Mr Koval : Through the reregistration process, as Ms Arthy has mentioned, we have to go through a prioritisation stage in conjunction with APVMA. One of those things is a question of risk.

Senator SIEWERT: Thank you.

Senator WILLIAMS: Will agricultural chemicals—traflan, Roundup and any of those—have to be reviewed every five to seven years, Minister, once this agricultural and veterinary chemicals bill passes the Senate and is signed off on?

Senator Ludwig: It depends on the particular chemical and the time. So there will be a reregistration process—

Senator WILLIAMS: For all chemicals?

Senator Ludwig: Let us go through the work. Perhaps we could explain. I do not have the bill before me, but it is not about reviewing. It will depend on the particular chemical involved and the risk that it has to consumers and it will then depend on whether it has ever been looked at before. You would agree that, if a chemical is in the high-risk category and has never been looked at before, maybe it should be. I would be surprised if we said otherwise. It would then go through what is called a reregistration process. The reregistration process would then have a look at whether or not it required a long process or short process depending on the nature of the chemical. For a chemical in high use that was relatively benign and that we have a lot of data about, I suspect it would be almost be a straight-through kick.

Senator WILLIAMS: What if you had a lobbyist group that is very anti-chemical for whatever reason and pro-organic and they are a group that gets together with you and lodges a complaint about every farm chemical that we use in the nation? Would that force you into a position where you would have to review every farm chemical then, if you had a list of complaints from GetUp! or whatever or they came forward with a lot of complaints?

Senator Ludwig: Then what you are actually advocating for is for this system, because what this system does is put a framework around it. They can do that now and you do not have any protection. If they decided to pick on chemicals now then you have no protection and no framework. You run the risk that they could force you into those circumstances. This system says that a reregistration process, depending on the nature of the chemical, is seven to 15 years. So seven to 15 years might be for one—

Senator WILLIAMS: Is the reregistration maximum 15 years?

Senator Ludwig: Yes, and with that 15-year reregistration, again, if it is a benign chemical, it might be a relatively straightforward process, not particularly significantly onerous and very easy to do. If it is a high-risk chemical and it should be looked at then I would expect that you, like me, would be advocating that we should look at it because it would put farmers and consumers at risk. I am sure you do not want to then sell farmers chemicals that are likely to cause injury.

Senator WILLIAMS: No, and I do not want to be adding more cost to those chemicals that have been very good for years and trouble free. You only have to look at the—

Senator Ludwig: That is what the system is for.

Senator WILLIAMS: Hang on, Minister—the state farming organisations, the National Farmers' Federation, AUSVEG and Growcom all oppose this legislation. Were those groups consulted before this legislation was put in the House?

Senator Ludwig: Absolutely—in fact, I consulted with them directly myself. So what you have is—

Senator WILLIAMS: You obviously did not listen if they oppose it.

Senator Ludwig: I listened very carefully. Also, the Senate committee had an opportunity and I am sure you had an input into that as well. But it is interesting to see that the producers of chemicals are now with the NFF on this issue. I am not sure why that is. They make these decisions themselves. What I am about is making sure of two things: that we then have a regulatory framework that protects those chemicals that are valuable to producers and that continue to allow them to operate; and that it also then protects the environment, protects the consumers and protects farmers from risks of having to use adverse chemicals that they do not have any data on, that have not been reviewed, that have sat on the shelves for a long time and nobody quite knows, and we wait for an ad hoc outcome from an overseas jurisdiction to find out that they cause cancer, nervous disorders and we then say, 'Gee, we should look at that now.' I do not think that is acceptable, quite frankly, in today's world—not at all—and I do not think you would either.

Senator WILLIAMS: No. It will add a lot of costs, though, to some chemicals, no doubt, with these reviews?

Senator Ludwig: As you know, with chemicals they are an internationally set price, by and large. They respond to market pressures. What we have said is that new chemicals, particularly, get a good IP period where they can protect their IP for a period of time. Usually what happens over the life of a chemical is that it then comes off its IP and it becomes generic. Generic manufacturers usually drive a lower price. All of that is market forces. What we do not want to do is intrude into the way chemicals and total protection systems are used by farmers and how the companies produce their profits. What we want to do, as the APVMA should do, is ensure that they are safe to use, that the labels and the way the farming community uses those particular chemicals are both occupationally safe for them and their workers and safe for consumers.

Senator WILLIAMS: You would think that would be the case, Minister, when you register the chemical in the first place.

Senator Ludwig: What about a chemical that has been sitting on a shelf since 1960 and the data simply was not available or it has been lost? How many times do chemical companies now seek to find out from APVMA what their chemicals are nowadays? I would ask Ms Arthy to just comment on that. You would be surprised.

Senator WILLIAMS: We all agree that we want safe chemicals. I have been very suspicious about some of the early backline that, as a sheep lice controller et cetera, I have used myself. We are all on the same page as long as the safety does not come at an extreme cost to the users. My concern is that these costs will be passed on to the primary producers who are already suffering terribly, whether it be from the seasons, the high dollar or low commodity prices, and they have been through a financial drought for a decade now. That is my concern.

Senator Ludwig: I share your concern too. That is why we have tried to work very hard through the consultative process to structure a scheme that actually does not add cost and that actually meets the obligations that I think people require—that is, consumers, farmers and, quite frankly, chemical companies, which have an obligation to ensure that they do have chemicals that are safe to use and do not cause unnecessarily harm over long-term exposure. In doing that, I think that the comments that the Senate committee made on the system around reregistration and the comments that industry has made are all taken into account to make sure that it really does try to remove the red tape.

What happens now is that you could have an ad hoc chemical review and you could be pressured into multiples of those. Quite frankly, at the moment I would say that they are expensive to do and time consuming and can take certainly a lot of resources. That is the current system. A new system allows streamlined processes where, if they are chemicals that have good data around them, have good experience, are safe to use and have all of the background information and there is no red flag on them, they will find the reregistration process relatively benign. If they are old chemicals—

Senator WILLIAMS: Acting Chair, is this time limited?

ACTING CHAIR: Yes, it is.

Senator WILLIAMS: I am just wondering about the minister's response. Is it time limited? Do we have a bell on it?

Senator Ludwig: You asked the question.

Senator HEFFERNAN: I will interrupt. Are we actually applying a tougher regime for reregistration of farm chemicals than for human pharmaceuticals? Does the pharmaceutical industry have to go through the same regime of reregistration?

Senator Ludwig: I am not familiar with the pharmaceutical process. I imagine—

Senator HEFFERNAN: I suspect that we are giving a higher regime to farmers.

Senator Ludwig: I would not go there, because this is also about the end-user consumers who use and eat a range of products that farmers produce. They would want to know that the chemicals that farmers use ultimately are then safe for them to consume in products. That is where I would put it.

Senator IAN MACDONALD: My question is about diuron. I preface my questions by saying that the cost of using diuron for the cane farming industry is $14 to $34 a hectare. The alternative treatments are $103 to $160 per hectare. In these times of difficulties with our farming industries, I would just keep that in mind. Can you just briefly tell me where we are with the diuron banning?

Dr Bhula : The diuron review was completed at the end of last year. We have a permit in place which goes out to the end of November this year where products can still continue to be used under restrictions that were put in place in 2010. The position we are in at the moment is that chemical manufacturers are currently changing their labels to meet the new diuron use restrictions.

Senator IAN MACDONALD: I understand that a lot of the concern with the use of diuron was about the impact on the Great Barrier Reef. Is that correct?

Dr Bhula : The impact on the reef was actually ruled out in a report that we published in 2011. That was no longer a concern. It was more run-off in concentrations in primary and secondary streams that was then the subject of the restrictions that we put in place in November 2011.

Senator IAN MACDONALD: So the impact on the barrier reef is not an issue and not a reason for the banning?

Dr Bhula : It was part of the reason, but the review had ruled that out earlier on in the piece.

Senator IAN MACDONALD: Why did the review rule that out?

Dr Bhula : The review ruled that out in that the concentrations that were found in the reef or detected in the reef were not of any concern in terms of aquatic organisms and plants.

Senator IAN MACDONALD: But you are saying that the concern is the streams and rivers nearby to the cane farmers in relation to that?

Dr Bhula : That is right.

Senator IAN MACDONALD: What research and science were used to make that decision? Can you give me a broad answer simply?

Dr Bhula : The environment assessment relied on a lot of monitoring information that was conducted through the Great Barrier Reef Marine Park Authority as well as data that was generated under the Reef Rescue program. So we were using up-to-date monitoring information for about the past three years going back to about 2010.

Senator IAN MACDONALD: I understand that in particular Ingham canegrowers and certainly the Canegrowers organisation generally is making further submissions in relation to the use of diuron because of the reason I mentioned before—the cost of alternatives is just prohibitive and it will be another nail in the coffin of one of Australia's rural industries. There have been complaints to me that the research done by GBRMPA and others was done at times of flooding and at peak tides that create a sort of a false high reading.

Dr Bhula : I would have to take that on notice. I could not comment on that. But we have said that, when we completed the review, based on any monitoring information that would come through in the next three to five years under any work that is done under the Reef Rescue plan or through the Great Barrier Reef Marine Park Authority, we would reconsider again. We have completed this part of the review. However, we would rely on future monitoring information and data to look at the chemical again if that were the situation.

Senator IAN MACDONALD: I am pleased to hear that. The potential environmental impacts are what again? Can you just broadly help me with that?

Dr Bhula : Impacts on aquatic organisms, species and ecosystems and primary and secondary streams.

Senator IAN MACDONALD: You are aware that the cane farmers have entered into the Reef Rescue program enthusiastically and they have tried to do the right thing. They tell me that they have a lot of whatever you call them—traps—before the riverbanks and the creek banks. They have gone out of their way to try to be model citizens and they feel like they are getting it in the neck as a reward for their, I would suggest, better than normal attempt to comply with the concerns.

Dr Bhula : We understand the concerns of the cane farmers. When we put the restrictions in place in the first season, we took into account the rate restrictions that were already in the Queensland state legislation at that time.

Senator IAN MACDONALD: I see that one of their recommendations—they recommended that the Queensland government regulations be evaluated in APVMA's review of diuron. Was that done?

Dr Bhula : Yes, that is correct.

Senator IAN MACDONALD: It was? Okay. I will return to this at some later time. When is the next review? It is underway now, is it?

Dr Bhula : No, the review itself, based on all of the monitoring information that we received up until last year, is now complete. What we have said is that, if there is new monitoring information that would be made to the APVMA to change any of our decisions, we could look at it again.

Senator IAN MACDONALD: So you are waiting for someone else to come to you with new data?

Dr Bhula : That is always open.

Senator IAN MACDONALD: You do not initiate the review; you expect either canegrowers or GBRMPA or someone like that to—

Dr Bhula : That is right. As far as we are concerned, that environmental component of the review is complete. If at a later time further information is made available then that could be presented either through the chemical manufacturer or the canegrowers or the Great Barrier Reef Marine Park Authority.

Senator IAN MACDONALD: Finally, again, you can only take a guess at this and I appreciate that, but to review a decision—is that a lengthy process? If irrefutable evidence were produced to you tomorrow, when would APVMA in the normal course of events be able to make a determination on it?

Dr Bhula : In general terms it really depends on the aspects of risk that we are assessing. In the case of diuron we are only looking at environmental impacts. If new information were given to us tomorrow, we would just run that information back through the assessment process and we could probably have another outcome in nine months, say.

Senator IAN MACDONALD: All right. Thank you very much. That has been very helpful.

Senator EDWARDS: I just wanted to quickly go to the issue of spray drift and the interaction between broadacre farming and the horticulture and viticulture sectors. I just wanted a bit of an update because I believe that in May the Standing Council on Primary Industries met and there was going to be this discussion. What was the outcome?

Dr Bhula : I will have to pass that to our departmental colleagues, I am afraid.

Senator Ludwig: When was it supposed to be talked about?

Senator EDWARDS: In May. At the last estimates you said it was going to be an agenda item in May. It did not make the agenda?

Mr Koval : I was not aware it was supposed to be an agenda item in May.

Senator EDWARDS: Look, I do not want to bog the discussion down but I pulled May from you on Monday, 11 February at our last estimates:

… in May we will be going to the Standing Council on Primary Industries and agricultural ministers from around the country. We are taking to them a package of reforms that has already been agreed among the ministers—things like harmonisation of licensing.

And so on. That is in your very own evidence, Mr Koval.

Mr Koval : Sorry, Senator, I think you are talking about the COAG reforms and about harmonisation of control of use.

Senator EDWARDS: Harmonisation of spray drift policies as well.

Mr Koval : We were talking about harmonisation and control of use, which goes through to the control of use of chemicals in all instances. There is a working group on spray drift. What we went to the Standing Council on Primary Industries with in May is the framework. We got agreement around the framework for harmonisation of regulatory control. That is what was agreed in May. It was not specific to spray drift.

Senator EDWARDS: No worries. New South Wales and Victoria have reported a reduction in concern on spray drift because they have introduced some policy settings and educational programs and everything like that. Is it planned to be rolled out around the country? If it is so successful there, is the department focused on ensuring that best practice is observed around the country?

Senator Ludwig: Do they have reports or findings on that? Because they could bring it to the standing committee. What they could do is, as part of the harmonisation process, say this is a good model to undertake. But that would be a decision of the particular state or territory ministers in the harmonisation process. This would be one small area within that but I am always keen not to reinvent a wheel; I am always keen to find somewhere that is doing it well and—

Senator HEFFERNAN: The spray drift problem for broadacre farming has gone, by and large, because of controlling the droplet size.

Senator Ludwig: Yes. I was going to add that, Senator Heffernan. A lot of the modern farming practices now use very sophisticated machinery which—forgive me if I explain it badly—hold particular chemicals for removing weeds. They then have a system which identifies the weed through chlorophyll and then spots the weed; therefore there is no drift—

Senator EDWARDS: There is no question that technology—

Senator HEFFERNAN: But even for the chemicals that are not aimed at a particular weed, like a pre-emergent, the droplet size now—I used to be terrified of the drift coming in on a lucerne paddock or something but now even in a reasonable wind the droplet size has made the difference.

Senator Ludwig: And they have changed the way their nozzles are usually put—and different ways of managing that as well. Even the aerial spraying is significantly reduced as well because of the nature of the crops that they now put in.

Senator EDWARDS: All that considered—

Senator HEFFERNAN: Grapes love ester.

Senator EDWARDS: Yes. With 66 hectares wiped out with ester in the Riverland last year from 44 kilometres away and no responsible farmer, I would suggest that we have still got an issue with either education or those things. And there is nobody to sue for the loss of that crop. That is the practical side of what I am talking about. I am taking on board your answer to question No. 40 in the last round of estimates that New South Wales and Victoria report a reduction in concern on spray drift. I understand that it is a state issue but we do have at this level, I would have thought, an obligation to try to deliver what we know is best practice, or try to get them to observe it at least. I am not talking about regulation; I am just talking about a cultural issue.

Senator Ludwig: We are happy to feed that into the process.

Mr Tucker : As part of the harmonisation reform process, as good public servants we have established a committee to oversee the reform elements. I chair that committee and I am happy to put that issue to my state and territory counterparts as an issue for discussion.

Senator XENOPHON: I have some questions in relation to the levels of carbendazim allowed in imported juice and/or concentrate. Ms Arthy, what are the current levels of carbendazim allowed in imported juice or concentrate, and how does this compare to the most recent world standards?

Dr Bhula : That is a question for Food Standards. Food Standards Australia New Zealand did a risk assessment of imported juices and imported juice products.

Senator XENOPHON: Okay but I had an exchange with Mr McCutcheon from Food Standards Australia New Zealand on 15 February 2012. He said at that time—this is a letter from the parliamentary secretary—'The APVMA propose to reduce the MRL in the Food Standards Code to zero.' Is that right?

Dr Bhula : Through the carbendazim review, the APVMA reduced the MRL associated with the use in citrus fruit as part of our review decision because the use in Australia no longer existed. Subsequent to that there was the issue with a Brazilian fruit juice importation at the time. Food Standards Australia New Zealand undertook their own risk assessment, as they do for imported product, and set a new level for carbendazim in citrus.

Senator XENOPHON: Can you explain this to me. Mr McCutcheon said back on 15 February 2012, 'But in subsequent representations from the industry and in discussions with the APVMA—and this is about the zero limit—we asked them to pause or not implement that zero amendment to the code so that we could have a look at the public health and safety issues around this particular MRL and provide them with some further advice.' He then goes on to say that there were representations from industry—presumably that was some of the multinational food processors. What role has the APVMA played in relation to this?

Dr Bhula : The only role we played is that we had a proposal in place at the time that was going through the WTO through an SPS notification. Based on the presentations we had from Food Standards, we chose not to act to remove that standard at that time, to allow Food Standards time to do their own risk assessment and put a limit in place.

Senator XENOPHON: And what has happened to that risk assessment? While you say it is a matter for Food Standards Australia New Zealand there is obviously an exchange of information between the two entities.

Dr Bhula : It is very informal because it does not relate to the approved use of carbendazim in Australia. What happened was that Food Standards did their own risk assessment. There was a public notification of the new limit that they would set, and I understand—but we would have to take this on notice or talk to Food Standards—there is a new limit in place now.

Senator XENOPHON: If you could take it on notice, because I am aware that I only have another minute or so.

Dr Bhula : Okay.

Senator XENOPHON: This means that carbendazim is not allowed to be used by citrus producers in this country but we can have carbendazim in imported concentrate?

Dr Bhula : That is correct.

Senator XENOPHON: And do you see that as somewhat anomalous, from your point of view?

Dr Bhula : That would be expressing an opinion, I think.

Senator XENOPHON: I will ask the minister then. Ministers can express an opinion. Do you see that as anomalous, Minister—that carbendazim is banned for use by citrus growers in this country but we allow carbendazim in concentrate from overseas?

Senator Ludwig: As I understand it the fruit juicing industry also wants to—

Senator XENOPHON: No—the processors.

Senator Ludwig: Wait. The processors also want to access orange juice from overseas, because without that access they would not be able to take domestic fruit as well. The broader issue here is that APVMA does one task and FSANZ does another. They are two distinct bodies.

Senator XENOPHON: Minister, you are upsetting me now. When I visit fruit growers and see them rip up their trees, and when they are ploughing their fruit into the ground, do you honestly accept that position? Their price is so low and they are competing unfairly with these imports.

Senator Ludwig: I think it is more complex than you make it out to be.

Senator XENOPHON: There is nothing complex about ripping up a tree or ploughing fruit into the ground.

Senator Ludwig: No, and one would not want to support that. Do you think carbendazim is central to that issue—in other words, whether the tree gets ripped up? I do not think that is central.

Senator XENOPHON: It means you can have cheap imports that do not have the same standards as Australian producers. Senator Ruston has seen lots of trees getting ripped up as well.

Senator Ludwig: We do have standards. We have APVMA, which sets the standard for chemicals use in Australia. You would not want to see a chemical used in Australia that would have adverse outcomes for people, would you?

Senator XENOPHON: I am not suggesting that. Do not verbal me, Minister.

Senator Ludwig: It seems to me that that is the point you were making.

Senator XENOPHON: You are verballing me. I am saying why do we allow—we ban carbendazim in this country for our producers. We have that clean, green image. Yet we bring in carbendazim-laced—

Senator Ludwig: Representing the minister for agriculture, for APVMA, it is a sensible position. If you want to talk about FSANZ and what they allow in terms of chemicals in food, that is outside of this portfolio and I really cannot comment on it. You have had an opportunity and you can talk to the department of health about that.

Senator XENOPHON: Okay. Finally, as minister for agriculture, do you acknowledge that this puts Australian producers at a real disadvantage because they do not have carbendazim but we can bring in imports with carbendazim?

Senator Ludwig: This is where we get into this difficulty of whether I am verballing you, because what you are advocating for is that APVMA should have a different threshold and be able to allow carbendazim to be used in this country, and I do not agree with that.

Senator XENOPHON: No, you are verballing me now.

Senator Ludwig: That is actually the position you are putting, whether you like it or not.

ACTING CHAIR: At this point we will go to Senator Siewert.

Senator SIEWERT: I want to go to bees and—I always say this wrongly—the neonicotinoids.

Senator COLBECK: Neonics for short.

Senator SIEWERT: Let us just say neonics. I know Senator Colbeck has a range of questions around this too. I want to go into where your process of examination is up to. I have specific questions around that. One of them is about the report that was prepared. You then responded and said you are doing a lot of things. I will ask about progress in a minute. But there was one area that you did not take up, which was: 'evaluate the increasing amount of data already being submitted with pesticide applications in order to better understand additional studies being conducted on pesticide effects on pollinators'. I am wondering why, from what I could tell from the work that you have said you are doing, you did not do that one. Or have I misunderstood what you are doing?

Dr Bhula : Could you repeat the last part of that, please, Senator?

Senator SIEWERT: One of the recommendations from the report that you commissioned was the potential activity to 'evaluate the increasing amount of data already being submitted by pesticide applications in order to better understand additional studies being conducted on the pesticide effects on pollinators'—in other words, reviewing the information that you are already getting. Have I misread what you have said you are undertaking as a result of that work? If I have, that is different; if I have not, why are you not doing that?

Dr Bhula : I will try to answer this as best I can. The report that we published in May basically looks at a range of factors. We looked at what our current bee protection label statements were looking like across a range of products. We also looked at all the data and information that had been published through the European Food Safety Authority as well as peer-reviewed journal articles in terms of effects on bee health and that kind of thing. We did look at the new types of studies that were being submitted as part of registration packages to the APVMA through our global joint review program. We have noticed that over time manufacturers are generating more and more bee studies, so we have a better understanding of the effects of, or the toxicity of, these pesticides at different stages of the bee life cycle. So we have done that but perhaps it is not entirely clear because some of these products are still under assessment and have not been registered yet.

Senator SIEWERT: So in other words that information is not out. What is the problem with doing it?

Dr Bhula : We publish that information as part of our public release summary before we register a new chemical. But we are just not at the point of having completed those assessments yet.

Senator SIEWERT: What you are saying is that that information is not in the public sphere yet?

Dr Bhula : Not yet, because we have not registered the products.

Senator SIEWERT: That is the products that you are currently working on?

Dr Bhula : Yes.

Senator SIEWERT: What about reviewing the past information you are already holding?

Dr Bhula : What we are planning on doing is having a workshop with our regulatory partners in June this year. Out of that will be a number of recommendations that we then come back and look at in a more open forum. This will be for people who are interested in bee health as well as chemical manufacturers, as well as our state and territory partners. And then after that we expect we will make a formal announcement at the end—sorry, that date was 24 July for the state workshop. After that we will be making a formal announcement towards the end of the year in terms of what we should be reviewing in a formal sense. Up until now all we have done is a literature review of all the information that is available.

Senator SIEWERT: So why the longer time? You have said the end of the year for that formal announcement of further work that you will do. Why that longer time frame?

Dr Bhula : The longer time frame is really to allow experts in the field as well as the honey bee industry, as well as our state and territory partners and APVMA, to get together and consider what are the triggers that are now leading us down a formal review on a chemical-by-chemical basis.

Senator SIEWERT: And once you have made that formal announcement towards the end of the year, what time frame for the more formal part of the process do you envisage?

Dr Bhula : I really could not say at this point. It would depend on what the outcomes of our regulatory workshops are. Because if we then start a review on a chemical-by-chemical basis we would have to set timelines against each of those chemicals that we are then assessing.

Senator SIEWERT: And presumably then you would do some sort of process of prioritisation about which chemicals would be first in that.

Dr Bhula : That is right, and on what basis.

Senator SIEWERT: Would that be part of the decision by the end of the year, or part of the subsequent work? If you are going to do a chemical-by-chemical review, presumably that is part of the more formal review. Does that make sense? You will not make that announcement by the end of the year—that is what I am trying to get to.

Dr Bhula : I think you are correct. Because it is a subject matter that cuts across a number of chemicals, what we would have to do is, as you said, make a determination of the priority of which chemicals we are going to do first and then set timelines in terms of which ones and in what order, over what period of time. But until we get to that regulatory workshop we really do not have an idea of how quickly or how slowly things might happen.

Senator SIEWERT: I apologise—I think I have confused you and myself. In the formal announcement at the end of the year, are you expecting that you will be saying, 'We need to do a more formal review. These are the chemicals that we're going to be reviewing'?

Dr Bhula : We should be able to identify what those chemicals are. But in what time frame would be the next step that we would have to look at, depending on manufacturers, data availability and that kind of thing.

Ms Arthy : Senator, it is not guaranteed that we will be looking to do a formal review of chemicals. I just need to make that clear so that there is not an expectation that we will be—

Senator SIEWERT: I take that point. If I understand correctly, that is partly up to the get-together or the process on 24 July and subsequent work after that, and then decision making.

Ms Arthy : That is right.

Senator SIEWERT: So in fact that first question I asked you about evaluating the increasing amount of data that you are getting—it sounds like you are actually doing that even though that has not formally been announced as part of the process or the next steps.

Dr Bhula : We are doing it in terms of the data that we receive for new chemicals, yes. That process has already started.

Senator SIEWERT: But not the past ones yet—okay. But that will be part of the process eventually? Do I understand that correctly?

Dr Bhula : That is correct.

Senator COLBECK: The concerns expressed in Europe versus the situation in Australia—as I understand it the use patterns are quite different and the use types are quite different in Australia to what they are in Europe. And of course we have already had, in other forums, discussions about the differences in how chemicals might react in different climates and regional circumstances and based on different use types. In the process that we are going through at the moment, is all of that sort of thing going to be considered as part of what we are looking at, including a lot of the available data that you have just spoken to Senator Siewert about around the impact on pollinators?

Dr Bhula : The difficulty, Senator, is that we do not have the same degree of adverse experience reporting in terms of bee deaths to have a very clear and tight trigger to start formal reviews of some of these chemicals. One factor that sticks out—and I am sure people have seen this in the media—is the lack of varroa mite, which does have an impact on honey bee health in general and increases the susceptibility of the bee to other pesticide exposures as well as just general food health and that kind of thing.

Senator COLBECK: So it is the issues around the combination of factors, including some that we do not have experience of here, and the fact that we still have a healthy bee population here in Australia, which is obviously not the circumstance that they have in Europe in particular and potentially other jurisdictions as well.

Dr Bhula : Yes, this is correct, and this is the difficulty we face in terms of the information that we put out in the public domain—why aren't we acting; why aren't we acting fast enough—for some people who are concerned. Then also, as I said to Senator Siewert, it is identifying the trigger to start a formal review of the neonicotinoids. That is where we are at the moment.

Senator COLBECK: How useful is the data that is coming through in the new chemical registrations in having a better understanding of what the impacts might be, with that extra research that is being done? I have seen comments from the bee industry, and also horticulture and agriculture generally, talking about additional data and research, all saying the same thing—calling for doing more work around it and having some anecdotal understanding of what might occur. I think Mr Bourke from the beekeepers association was talking about bees becoming disoriented when they become exposed to crops that have been treated with those products. How useful is the new data that is being generated as part of new registrations in getting a better understanding of this?

Dr Bhula : The new data that is being generated is actually very, very useful. We have seen over the last two years with an increasing number of bee studies that are being submitted to the department of environment that it then opens up a whole new way of looking at the impacts of the pesticides at different stages of the life cycle of the bee—so whether we are talking about the larvae in the hive or the adult bee—and then how the different exposures impact on general bee health. Again it is putting it, as you said, in combination with—we do not have varroa mite here in Australia, the bees are not sort of stuck within a monoculture where they have nowhere to escape in terms of going to contamination-free areas to seek food and food sources. So we do not have all of those impacts that are currently going on in North America and Europe and that is why—we are clean—it is a nice situation for manufacturers to come and generate data to see how these chemicals are impacting on healthy bees rather than the situation that they have in Europe, where the bee health has already declined and you have more and more factors impacting on that, which then causes the problem.

Senator SIEWERT: The reverse of that is then how does the pesticide then weaken the bees.

Dr Bhula : In the healthy environment?

Senator SIEWERT: Yes. And then make them susceptible to other diseases and pests. Presumably you will look at that as well.

Dr Bhula : This is a proposal we put to a couple of the large manufacturers that are having the problems in the European Union. We said, 'Come out here and do some of these studies out in the Australian environment and see what you find.' And that may well be a recommendation or an outcome of the meeting that we have with our regulatory partners.

Senator COLBECK: Are you actually seeing an increase in that level of research as a result of our unique situation?

Dr Bhula : Not in Australia itself but this is something that we could recommend to the larger chemical manufacturers as something that they should consider.

Senator COLBECK: I suppose that was my point: there is that opportunity in a particular environment that does not have a lot of those problems that they have in Europe to generate some of that data in a cleaner environment, as you say, to get a sense of what the malaise might be.

Dr Bhula : What the true impact is, yes.

Senator COLBECK: I want to go on to some questions around your environmental assessment costs and the cost recovery impact statement for 2013 to 2015. Level 1 costs increased from $12,605 to $16,516, which is a 31 per cent increase; level 2 from $3,255 to $5,443, a 67 per cent increase; and level 3 from $620 to $921, a 49 per cent increase. What has been industry response to the increases? Are they connected to the new legislation or is that a separate process?

Ms Arthy : I think it is fairly safe to say that industry always expresses concern about the cost of agencies, particularly when they see the costs go up. Mr de la Fosse can comment about the specific costing and how it happened—the increase. What I can say is that I am working very closely with both the agencies that provide the advice to look at how we can keep the cost down in future years. That is still very much a work in progress. I will hand over to Mr de la Fosse to go through the specifics of your question around why the increase.

Senator COLBECK: Can I just go to the last part of my question before we go to the detail of that. Are these increases connected to the new legislation or are they separate from that and is there a further process around the new legislation?

Mr de la Fosse : The return of the application fees over a two-year period to the notional level of 40 per cent cost recovery is unrelated to the reforms that are currently before parliament.

Senator COLBECK: So there will be a separate cycle around that process?

Mr de la Fosse : The current CRIS that has been approved puts that in place. So the fees will be returned in three stages to the policy level of 40 per cent cost recovery. The fees have slipped below that level since the last CRIS was completed. All these increases do is return those fees to the policy of 40 per cent cost recovery for application fees.

Senator COLBECK: That is for environmental costs?

Ms Arthy : That is for all costs. This CRIS was widely consulted on with industry, so they did know about it.

Senator COLBECK: Thanks. That will do me.

ACTING CHAIR: Thanks very much to officers from APVMA.