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Rural and Regional Affairs and Transport Legislation Committee
13/02/2012
Estimates
AGRICULTURE, FISHERIES AND FORESTRY PORTFOLIO
Australian Pesticides and Veterinary Medicines Authority

Australian Pesticides and Veterinary Medicines Authority

CHAIR: Welcome; and questions, Senator Back.

Senator BACK: Thank you, Chairman. Ms Bennet-Jenkins, I wonder if you could give me some advice. A constituent approached me with regard to three products that they are trying to get registered. They are biological insecticides, fungicides and an anti-transpirant product. Can you tell me, do they have to engage the services of an agent to deal with APVMA for the purposes of getting approval or certification for these products?

Mrs Bennet-Jenkins : Good evening, Senator. In terms of if they are an Australian company or an Australian resident, they would not need to get a consultant or a representative to act on their behalf. However, if they are an overseas company that does not have a representative within Australia, they do need to appoint somebody in Australia who will be the legal entity who will be holding the registration on their behalf.

Senator BACK: If I can assist that process, yes, they are an Australian company. The products are from outside Australia but they are an Australian company. It seems as though, from my dialogue with this person, they have just had the most enormous difficulty. If I can clarify even a stage further, they have a permit from AQIS, which they got in 2011, to import each of these quarantine materials. They do not seem to have been able to progress. In fact they have engaged the services of a scientist in Western Australia who worked for them to get the AQIS permit but they do not seem to have been able to progress with APVMA, so I seek your counsel as to how I can advise that they should proceed.

Mrs Bennet-Jenkins : Certainly the data requirements for registrations in Australia can be difficult for some newcomers into the system. We do have a manual of requirements and guidelines to assist applicants. We can also provide assistance, if they need it specifically from us, in terms of what they have to provide. On occasions we recommend to them that they use a registration consultant, a scientist, to help them. I do not have any records or notes here on the specific cases but we would be very happy to assist that person if that is required, if we can have some details.

Senator BACK: Without favouring anyone, having had that discussion you could provide them, if they needed it, with a list of consultants who could assist them?

Mrs Bennet-Jenkins : We do not hold a list of consultants. That is something he would have to try and find himself.

Senator BACK: All right, but you could presumably advise him on the qualifications that a consultant would need?

Mrs Bennet-Jenkins : Yes, we could do that.

Senator BACK: I am aware that others have questions. Dr O’Connell, I am glad you are back in the room because I think my question following on is more of a general one. You were outside the room but I was just explaining to Ms Bennet-Jenkins that this particular constituent does have a permit from AQIS to import these particular biological, non-chemical insecticides and fungicides but has had difficulty with APVMA. We will no doubt get him through that but I just want to read briefly, if I may, from the documentation that came to him from AQIS, and ask if it is not possible to surely be able to assist importers to some degree. I am quoting here:

It is the importer’s responsibility to identify, and to ensure it has complied with, all requirements of any other regulatory organisations and advisory bodies prior to and after importation including The Australian Customs Service, The Department of Health and Ageing, Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, Department of the Environment, Water, Heritage and the Arts, Food Standards Australia New Zealand and any state agencies such as Departments of Agriculture and Health and Environmental Protection authorities. Importers should note that this list is not exhaustive.

Import conditions are subject to change at the discretion of the Director of Quarantine.

Is there some central body to whom an Australian company, intending to import quarantine materials into Australia, can go to get themselves through that labyrinth? If there is not, do you agree with me that there could or should be some clearing house which could assist Australian companies for the importing of these products? That seemed to me to be an exhaustive list.

Dr O'Connell : I am very sympathetic to the issue of trying to step through regulatory red tape. I do not think it is related directly to quarantine or AQIS. What you are really talking about is getting approvals to import into the country and manage yourself through the full regulatory requirements of Commonwealth and state agencies. This could certainly do with a single point of entry but I do not know that the creation of such a thing is related particularly to the quarantine function but it is rather a requirement for importers to ask government to simplify its regulatory access.

Senator BACK: You would agree, though, that your department really would be the lead department in such a process, should we be able to develop it?

Dr O'Connell : No, not necessarily, because we only deal with some aspects of it, as is clear. We do not deal with all aspects of importation. Many goods are imported which are not ones that require our permitting in that sort of sense.

Senator BACK: My concern in all this is, as I say, that this particular person has got approval from AQIS for a two-year period from 13 April 2011 to 13 April 2013. I can see that, by the time they identify and then get through those myriad applications, it is going to be very close to the time when the AQIS permit will expire and we are back to a sort of Sir Humphrey Appleby process. But I do raise it and, Mrs Bennet-Jenkins, I will ask this person to make contact with APVMA.

Mrs Bennet-Jenkins : Thank you.

Senator BOSWELL: My question is about Diuron, which is a weedkiller. The one-week period of notice given to sugar growers and end-users of Diuron provides little time for them to schedule the application of Diuron as part of their weed management strategy that meets the appropriate crop cycle and weather conditions. One week is a bit light-on, isn’t it? Why did you only give them one week’s notice?

Mrs Bennet-Jenkins : I cannot exactly remember the timing, but I am sure that we gave them more than one week’s notice in terms of the proposed suspension action.

Senator BOSWELL: Is the no-use period currently prescribed in the Diuron suspension permit likely to appear on the new label conditions?

Mrs Bennet-Jenkins : These are specific new instructions that we issued along with the suspension of the Diuron use for an interim period while we assess a large number of submissions to the environment report. The assessment of those submissions has not yet been finalised, so the long-term use for Diuron has not yet been decided.

Senator BOSWELL: What scientific data supported the no-use period of 5 December 2011 to 31 March 2012 that appears on the suspension permit?

Mrs Bennet-Jenkins : An environment report was released in July last year which raised some concerns about the risks to the aquatic environment. That was put out for a period of public comment. We have received some 70 submissions that question some of the assumptions that were in that report and provide some new data. However, given that there was such a large body of evidence to assess and given the serious concerns raised in the environment report about the risks to aquatic environments, we put some interim risk mitigation measures in place to minimise the risks to the environment while we undertook the extensive assessment.

Senator BOSWELL: Can you tell me why growers are unable to use this effective tool under the suspension permit, and is this likely to continue on the new label conditions?

Mrs Bennet-Jenkins : It is particularly for cane growers during the high wet season summer period.

Senator BOSWELL: These questions are from the cane growers.

Mrs Bennet-Jenkins : Yes. There has been a suspension on the use of Diuron during the wet summer months because of the risk of contamination of the aquatic environment. It is the highest risk at that time. So there has been a no-use period put on the use of Diuron on sugarcane during the high-rainfall times. We are as yet not certain whether these will be the long-term restrictions that will be placed on the chemical. The outcome of the review is uncertain at this stage until we have assessed all the new information.

Senator BOSWELL: The cane growers in their submission on Diuron to the APVMA have demonstrated that a rate of 1.8 kilogram active per hectare per year is industry’s best practice. This rate is half the label rate and is used by more than 80 per cent of the industry. Is a rate of 1.8 kilograms likely to remain on the new label conditions?

Mrs Bennet-Jenkins : Again it is the same answer as previously. We have used that 1.8 kilograms of active per hectare as an interim risk mitigation measure. We are looking at all the data, including some new catchment monitoring results that we have received from Queensland for the years 2009-10 and 2010-11. All those monitoring results and the information are currently being assessed. We cannot make a determination just at this point on what the future use-rate for Diuron, or use for Diuron on sugarcane, will be.

Senator BOSWELL: I am sure the cane growers will appreciate your answers and I will forward them to them. Thank you very much.

Mr Grant : I might just be able to help you out with the first one, which was the period of time between the notification and the suspension. APVMA met with product registrants and user and grower groups in Brisbane in July 2011 and asked them to show cause why APVMA should not suspend the use of Diuron. That show-cause clause was extended until September 2011 so the industry had at least from July 2011 until the decision was made on 5 December as notice that that was APVMA’s actions or proposed actions.

Senator BOSWELL: Thank you for your help.

Senator COLBECK: I have one question just to follow on from that. It is not specifically on Diuron but it provides an example. This is in the broader scale of considering use of particular actives. In your consideration of the registration or otherwise of these chemicals, do you take into account the broader potential environmental impacts of the chemical not being available? There is an impact from the chemical, and I think that has been discussed by Senator Boswell. The label rate is 3.6. The industry has said they can work with it at 1.8 kilograms per hectare. But if that chemical were not available and other broader effects on the environment might occur from the operations that would be occurring as part of the farming operations, do you take those broader impacts into account when you are assessing the utilisation or otherwise of the chemical?

Mrs Bennet-Jenkins : No. The legislative framework does not allow us to consider the risk-benefits or the risks of what alternatives the farmers might need to turn to if they lose a particular access to a tool, so it is very much specific for the risks presented by the use of a particular chemical.

Senator COLBECK: That is as the legislative framework is designed at the moment?

Mrs Bennet-Jenkins : Yes.

Senator COLBECK: Is there any consideration around that matter as part of the new framework?

Mr Grant : Not at this stage. It is not proposed as part of the Better Regulation Reforms.

Senator COLBECK: And that process is currently part of the public consultation process?

Mr Grant : Yes. The draft legislation has been out for public comment for nearly three months. That consultation period closes on 29 February.

Senator COLBECK: I asked this question earlier in relation to illegal logging and I will ask it again now. It is a second example within a month. Why isn’t the consultation on that bill coming to Tasmania?

Mr Grant : It is coming to Tasmania.

Senator Ludwig: That’s a good answer.

Mr Grant : There is a session proposed in Tasmania tomorrow.

Senator COLBECK: When was that added to the list?

Mr Grant : A week ago, two weeks ago.

Senator COLBECK: So it was published—

Mr Grant : We can go on. There was originally no proposed consultation in Tasmania.

Senator COLBECK: That is correct.

Mr Grant : When we sat down to work out where the consultations should be we analysed the sorts of interests in submissions that had been made to date around the Better Regulation consultations. There were very few submissions and consultations that had previously been made from Tasmanian constituents about the reforms. At that stage we decided that there was not the sort of interest in a Tasmanian consultation that we had anticipated. The industry then raised their concerns and we responded with the scheduling of a meeting.

Senator COLBECK: The initial ones were Perth, Brisbane, Canberra, Adelaide, Melbourne and Sydney, and you have added one for tomorrow in Tasmania. Where is that being conducted?

Mr Grant : Launceston, I think.

Senator COLBECK: I can send that back to all the emails that came to me complaining about it.

CHAIR: They probably waited until you were out of the state.

Senator COLBECK: Both of us who reside in one neck of the woods were getting the emails.

CHAIR: No, I meant the department. Okay, that is a joke.

Senator COLBECK: I did laugh. I might not have completely got it but I did laugh. So when do the submissions close on that process?

Mr Grant : On 29 February.

Senator COLBECK: When is it proposed for this legislation to be brought forward?

Mr Grant : At the moment it is scheduled for introduction in the autumn sitting but that will depend upon the nature of the submissions that we receive. If there is a significant amount of detail that needs rewriting, or evidence that the draft legislation is not doing the sorts of things that we think it should, or if industry points out unidentified consequences of the legislation which mean it requires significant redrafting, it may not be possible to bring it in in autumn. The current proposal is autumn introduction.

Senator COLBECK: What are the key issues that have been raised with you so far?

Mr Grant : Various parts of industry have different concerns. CropLife and its members are concerned about the potential costs of the new system. They are concerned about—

Senator COLBECK: They are suggesting something like an extra 30 per cent. That is their suggestion.

Mr Grant : Correct. They are suggesting cost increases. They have some concerns around data protection. If you ask environmental groups, they have some issues around the re-registration or the continuation programs. There is a range of different concerns expressed, according to the stakeholders. A lot of those concerns go back to the policy issues rather than specifics of the legislation, so it will be a matter for the government, a judgement call as to what sorts of considerations will be given to all those submissions.

Senator COLBECK: How does this fit in around the COAG reform process, bearing in mind that the APVMA came into being as a combination of state authorities and there is still some wrangling over the relationship between the states and the Commonwealth around some of the chemicals and operations in use?

Mr Grant : Under the agreement that we made between the jurisdictions when the APVMA was established, there is a requirement to provide the states and territories with three months notice of consultation on draft legislation, ergo that is the three months we have now spent on the consultation process. We have also taken the opportunity to consult with them separately, both through the ministerial council process and through jurisdictional visits. The COAG reforms that I talked about earlier are complementary to this process. There are no crossovers or intersections that will mean you cannot deliver one and then the other sequentially. They will complement one another. We are working with the states and territories as part of a package of reform to the whole of the Agvet national system.

Senator COLBECK: But do those negotiations impact on risk assessment presumptions?

Mr Grant : Part of the new arrangements we are contemplating for the APVMA is for the APVMA to be more transparent about its risk management processes and that it will publish that transparency as part of our risk management framework. APVMA is currently developing such a framework and there are elements already on the website for consultation.

Senator COLBECK: What about issues around inconsistencies and inaccuracies in the consultation documents?

Mr Grant : Any particular issues that you have in mind?

Senator COLBECK: Contents of the regulation impact statement do not reflect the provisions in the exposure draft.

Mr Grant : I can take that on notice unless you have any further information on that.

Mrs Bennet-Jenkins : I understand that the regulation impact statement was produced some time ago for the purposes of government making a decision about the reforms, rather than it being part of the consultation process. The bill has been refined further—the sorts of agreements that were made in terms of what the reforms should contain. I understand that is why there is a little bit of a disconnect between the RIS and the final bill. It is really because times have moved on and there were further refinements in terms of how the bill could be constructed and still meet the policy intent.

Senator COLBECK: Is there no requirement for those two things to align under processes that you are utilising?

Mr Grant : As Mrs Bennet-Jenkins said—

Senator COLBECK: I understand what you are saying and I am—

Mr Grant : There are processes in our past and we are now on to the legislative process.

Senator COLBECK: I will have to put some of this on notice because I am not sure that I am going to get the detail that I am really wanting to deal with. I want to go to the issue of illegal imports. We did have a discussion about that at the last meeting; a relatively comprehensive one. I want to get a sense of what actions have been followed up and how you have expanded your work with Customs and what impact that is having in respect of finding what might not be legitimate chemicals.

CHAIR: I will just remind the officers there are two minutes to go, so if your answers could be nice and short, sharp and to the point, we would appreciate it. Thank you, Mrs Bennet-Jenkins.

Mrs Bennet-Jenkins : The situation is still the same as it was when I reported on this in October. We have had no evidence of widespread illegal imports of pesticides. We continue to work with Customs to look at particular areas where they might pick up issues that we should pay attention to but we have had no further noncompliance reports from the field to be followed up and investigated. Really it has gone very quiet in terms of reports of noncompliance. The more recent information is more about companies being concerned about dumping of chemicals. That is legitimately registered chemicals being sold in Australia below price.

Senator COLBECK: There is a formal process to deal with that, and that is the anti-dumping process. What specific processes have been put in place with Customs to actually highlight what might be occurring?

Mrs Bennet-Jenkins : We get monthly reports. We have particularly focused on glyphosate and we have been getting monthly reports and reviewing the imports of glyphosate, which we then check against the legitimacy. When we have had reports from the field and we have investigated those, we have traced them right back as far as we can to determine whether they are actually illegal imports. So far our investigations have always come up with the solution that it is a legal import.

CHAIR: I ask that all further questions be put on notice. On behalf of the committee, Dr O’Connell, to you and your officers, thank you very much for today. Minister, thank you.

Senator Ludwig : Thank you, committee. Thank you, Chair.

CHAIR: Hansard and broadcasting, another fantastic meeting. Thank you very much. And to the secretariat, whoopee, we will do it all again tomorrow! Thank you kindly. That concludes today’s hearing. The committee now stands adjourned.

Committee adjourned at 23:00