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Australian Pesticides and Veterinary Medicines Authority

CHAIR —I welcome officers from the Australian Pesticides and Veterinary Medicines Authority. Are there any questions?

Senator XENOPHON —In a media release dated 12 October this year, APVMA announced the registration of endosulfan had been cancelled in Australia, in part due to new environmental information that emerged as a result of endosulfan’s nomination to the Stockholm Convention on Persistent Organic Pollutants. Can the authority give more information about the information that it received that led to the ban? When did APVMA originally receive this information? Perhaps I will ask those questions and I will ask you about carbendazim later.

Dr Bennet-Jenkins —The APVMA always keeps a watching brief on new international information in terms of chemicals that we have registered. In the case of endosulfan we became aware of new information in the submissions that were made to the Stockholm convention on the nomination for listing of endosulfan as a persistent organic pollutant. With those submissions came quite a long list of reference material which we reviewed and we found several new references that we had not seen or assessed in Australia. Similarly, when New Zealand made its regulatory decision in late 2008, there were also several studies that Australia had not seen or assessed. We then obtained the full study reports and forwarded those to the respective departments that provide us advice—the department of environment and the Department of Health and Ageing—and those reports were received this year. They were finalised and published on our website in September and were the basis of our decision in October.

Senator XENOPHON —Further to that, at the last estimates I asked you questions in relation to carbendazim. You indicated last time that the APVMA was undertaking a review of that because there were a number of health concerns in terms of reports overseas and, I think, concerns here in Australia. When is a community consultation phase likely to take place? Where are you up to with that, including community consultation, reviewing the literature and any further assessments in terms of the possible health effects of carbendazim?

Dr Bennet-Jenkins —We are very close to the finalisation for public consultation of the carbendazim review. I indicated at the last meeting that it would be around September-October that that report would be out for public comment.

Senator XENOPHON —This year?

Dr Bennet-Jenkins —This year. There have been some delays in that because we needed to get some refinements to the occupational health and safety report. We anticipate that will be finalised for public comment within the next six months. We were actually reviewing carbendazim together with a related chemical called thiophanate-methyl, which breaks down to carbendazim in plants in the environment, and because there was no further work that needed to be done with thiophanate-methyl we actually went ahead and published that report in August. We divided it up so that we could at least get the information out that we were able to for public comment. That public comment period, as far as I am aware, has now closed and we are looking at those comments and looking to finalise that component of the review very soon.

Senator XENOPHON —This review has been going on since May 2007 or thereabouts?

Dr Bennet-Jenkins —Yes, it has been going on for a few years.

Senator XENOPHON —You can understand why some of the committee would say that seems to be an inordinately long time for a review process.

Dr Bennet-Jenkins —With carbendazim, though, because of the concerns that we had right at the beginning of the review and then also during the process of the review, we actually took regulatory action to address the immediate concerns.

Senator XENOPHON —The schedule 7.

Dr Bennet-Jenkins —We suspended registrations and issued new warnings in relation to the chemical. We have done that on two occasions and those registrations continue to be suspended. The suspension allows continued use but in a restricted fashion. More recently, we have taken some uses away. As we have gone along and found evidence that has concerned it, we have actually acted on that. It is just that the publication of the very final report for public consultation and finalising the report is still ongoing.

Senator XENOPHON —Could you give an approximate time line as to when the final report will be published in relation to this?

Dr Bennet-Jenkins —I would say it is imminent—in the next six months, if not earlier.

Senator XENOPHON —So before the next estimates the report should be out, which is three or four months away?

Dr Bennet-Jenkins —We expect it to be out, yes.

Senator XENOPHON —Thank you.

Senator BACK —I just wonder if you could give me some idea: if a manufacturer wanted to vary the acceptable conditions for the use of a vaccine, how would they go about that? For example, I am thinking of a vaccine which at the moment has a 21-day interval between a primary dose and a booster dose. If, upon their own work, they came to the realisation or the belief that they could shorten that interval, what process would they go through to have that accepted by your organisation?

Dr Bennet-Jenkins —They would submit an application for a variation to the existing registration, with their supporting data, and we would look at that submission and advise them what components we would need to assess. The efficacy and safety, I would presume, would be the primary components that we would look at. We would review that data and make a decision based on the robustness of the data.

Senator BACK —If they wanted to vary it to the extent of getting licence or acceptance for just one dose only, for a shorter period of coverage, they would presumably present the same data to you, would they, and give an indicator?

Dr Bennet-Jenkins —Yes, and put their argument to us and their justification for why they believe that change is justified. We would look at it in the first instance. If we do not have the expertise in-house, we would send it out to a relevant expert in the field to give us advice.

Senator BACK —Within Australia or outside Australia?

Dr Bennet-Jenkins —Usually within Australia, but we have used overseas persons when necessary.

Senator BACK —The time frame for such an exercise would probably be contingent on the quality of the information they gave you.

Dr Bennet-Jenkins —And the size of the job and the complexity of the job. I would not be able to provide comment on that.

Senator BACK —No, just in general terms. Typically, is it months?

Dr Bennet-Jenkins —It is, typically, for variations. They can vary between, say, five and probably 13 months, but it would probably be more around the five- to eight-month time frame for that type of application.

CHAIR —There are no further questions for APVMA. I thank you very much, officers, and call RIRDC.

[9.52 pm]