Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 21

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Fenthion review
Proof Hansard page: 45

Senator BACK asked:

Senator BACK: Just for clarification, the writer of the data that is going to be presented to
you now communicated with us to say that Ms Schipp of the APVMA had in fact been
offered access to this data during the public submission period of the Fenthion review, but it
was rejected on the grounds that the data was not collected in a controlled situation and
therefore not scientifically accurate. I just wonder if you could give us advice, not now but on
notice, as to what the circumstances are, or what your requirements are, during a public
submission process because clearly the information is now to be handed to you. My concern
is that in fact there may have been some miscommunication or whatever. But that could,
indeed, have been provided to you during the public submission process.
Mrs Bennet-Jenkins: We are happy to provide that on notice, yes.

Answer:

Australian Pesticides and Veterinary Medicines Authority (APVMA) requirements are that
results from controlled field trials are required for the setting of a new Maximum Residue
Limit (MRL). The APVMA officer conveyed that requirement to the person enquiring.

Information, such as individual spray records, individual residue testing information, and
results of random quality assurance testing programs is not normally offered to the APVMA,
as it is information confidential to individual growers. Such information cannot be disclosed
or made public. In addition, many jurisdictions do not require growers to keep such
information. In most cases, such information is incomplete and insufficient to enable the
APVMA to adjust proposed restrictions to be applied during a suspension period or a final
review outcome.

In the case of fenthion, further discussions with growers and an assessment of existing
information revealed that this was not the case. The APVMA therefore agreed to assess the
documented history of use at lower than label rates, with confirmatory QA testing and
individual grower residue testing information. The APVMA found it had sufficient
information, together with a commitment to generate further controlled residue field trial data
within the next 12 months, to enable it to develop alternative use instructions for the
suspension period. The requirement to provide results from controlled field trials, current use
and for confirming a new MRL remains.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 22

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: antimicrobial resistance
Proof Hansard page: 50

Senator DI NATALE asked:

Dr Bryce: The APVMA has taken on the job of collecting information on the sales of
antibiotics for veterinary use. This is a different question, though, than the question you are
asking about surveillance of antimicrobial resistance.
Senator DI NATALE: So you do not play any role in collecting and analysing the results of
testing for residues or, for example, the emergence of antimicrobial resistance amongst
bacteria and so on?
Dr Bryce: That is correct.
Senator DI NATALE: Who does that?
Mr Koval: Dr Bryce mentioned that there was a survey done in 2003-04, I think. I am not
aware of a survey done since then, but I am happy to take that on notice and have a look at
that. In terms of testing the residues of products, we do that through our residue survey which
looks at antibiotics. I am not quite sure, and I will have to go and talk to the development
people in our food division or our animal biosecurity division, about whether or not that then
is looked at from the point of view of resistance. As Dr Bennet-Jenkins mentioned, it is a
whole-of-government thing and is done across portfolios and, when a new antibiotic is
considered for use in animals, the Department of Health and Ageing look at it. They do an
antimicrobial risk assessment. The Department of Health and Ageing are very, very
conscious of the impact on human health and in their advice to APVMA I am sure that that is
considered. But I will have to take that on notice for you in terms of how detailed our
analysis is within the department.
Senator DI NATALE: Okay, I look forward to that. Let me ask about a few other things, for
example, off-label use where a drug is prescribed in a way that is outside the guidelines for
that substance. For example, I understand that in veterinary practice it is not illegal to
prescribe a drug that might be registered for one class of animals—cattle—for another class,
such as other food-producing animals—pigs, sheep et cetera. Is that correct?

Answer:

National monitoring of antimicrobial residues in livestock products is the responsibility of the
industry-funded Australian Government National Residue Survey. Recent antimicrobial
resistance surveillance included the Department of Agriculture, Fisheries and Forestry ‘Pilot
Surveillance Program for Antimicrobial Resistance (AMR) in Bacteria of Animal Origin’ in
2007. Surveys, research and other input into animal origin AMR have also been recently
undertaken by some state and territory governments and universities.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 22 (continued)

In June 2012, SAFEMEAT (a partnership between the red meat and livestock industry with
Australian Government and state and territory governments) committed to conduct new
research to quantify the prevalence of antimicrobial resistant bacteria in the cattle meat
supply chain. The report from this work is expected to be submitted in early 2014.

Yes, it is legal to do this, to varying degrees, under state and territory laws.

Rural and Regional Affairs and Transport Committee
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Agriculture, Fisheries and Forestry

Question: 24

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Technical report to a work order
Proof Hansard page: 52

Senator COLBECK asked:

Mr Matthew: There is a current arrangement with the successor agency to SEWPaC.
Senator COLBECK: I want to go to clause 3B.5 which says:
The Agency's obligations to provide the Final Technical Report in relation to a Work Order
allows for three working days after the day on which the Work Order is due to be finalised
and dispatched by the Agency to the APVMA.
To me that is saying, 'We set a date when we want the stuff done, but you can give it to us
three days after that if you like.' Am I interpreting that correctly?
Mr Matthew: I am sorry, I do not actually have a copy of the SLAs with me. I will have to
take on notice how that provision is being interpreted.
Senator COLBECK: Well how does it work in practice if you set a date? It says:
The Agency's obligations to provide the Final Technical Report in relation to a Work Order
allows for three working days after the day on which the Work Order is due to be finalised
and dispatched by the Agency to the APVMA.
Why would there be a clause like that in the service agreement? Why do you not just set a
date for when you want the work completed?
Mrs Bennet-Jenkins: Senator Colbeck, we might have to go back and look at the whole
service level agreement and answer that more fully on notice.

Answer:

The three working days is an allowance for the transmission of data as hardcopy to the
agencies that need to conduct assessments, and for the return of technical assessment reports
and any associated data. The material invariably contains valuable commercially confidential
information, and the dossiers can be too large to be able to be processed through the secure
Commonwealth email system (Fedlink).

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 67

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: R & D expenditure
Proof Hansard page: 121

Senator BACK asked:

Senator BACK: One of the points not made earlier today was that the notation that
expenditure on R&D as a percentage of total turnover in Australian industry has declined
from between nine and 10 per cent in 2006 to 7.7 per cent in 2011. From your observations
and experience, would you regard that as an inaccurate comment or do you think that that too
ought to be the subject of further scrutiny?
Mr Koval: I will have to have a look at the report. I do not recall that comment about
expenditure. This is a percentage of expenditure of the total animal health product market, the
portion of research as the total animal health market, which is down to only six per cent or
seven per cent now. I do not know whether Mr Parnell would have any comments to make.
Mr Parnell: No, I do not have anything to add.
Mr Koval: I will have to have a look at that on notice and get back to you, if I can.

Answer:

The methodology used in the 2011 International Federation for Animal Health benchmarking
survey is not transparent, and therefore the figures on R&D expenditure may be inaccurate
and should be considered further.

Reforms proposed in the Agricultural and Veterinary Chemicals Legislation Amendment Bill
2012, among other things, improve the regulation of agricultural and veterinary chemicals by:
improving the consistency, efficiency and transparency of chemicals assessments and
reconsiderations; aligning regulatory effort with chemical risk; and removing disincentives
while providing greater incentives for companies to invest in innovation. Together, these
measures are aimed at encouraging the development of newer, safer chemicals, which will in
turn support investment in research.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 197

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Service agreements cost recovery
Proof Hansard page: Written

Senator BACK asked:

1.  Is the Price Waterhouse Coopers review of the APVMA finalised?
2.  How has the APVMA responded to the PwC observation that cost recovery is
significantly lower than the level of reimbursement required under the current cost
recovery arrangements?
3.  The PwC review in 2008 also found that cost recovery guidelines were not being met and
that there was an “intention to amend as appropriate the various fees to better align with
the cost recovery arrangements however, due to events beyond the control of the
APVMA, no such alignment occurred”. What were these events and has this situation
been rectified?
4.  Data presented in the PwC draft report shows that corporate services cost nearly as much
as the registration process. What consideration has been given to removing costs from
corporate services (public affairs, principal scientist, human resources, finance and
corporate)?
5.  Has any interagency or inter-organisational benchmarking of cost ratio between service
delivery (eg registration of chemicals) and corporate overheads (eg corporate services)
been undertaken?
6.  If not, why not?
7.  If so, what did it find?

Answer:

1.  PriceWaterhouse Coopers (PwC) completed an activity based costing study, rather than a
full review of cost recovery, in 2010-11. PwC is currently updating the study to reflect
2011-12 costs.

2.  This observation related to application fees which, due to Consumer Price Index (CPI)
increases over a number of years, have fallen below the Government’s target of
40 per cent recovery via fees. The Australian Pesticides and Veterinary Medicine
Australia (APVMA) has sought approval to return application fees to 40 per cent through
the next Cost Recovery Impact Statement (CRIS).

3.  The event referred to was the decision to vary the 2005 CRIS to increase fees by
10 per cent from 1 July 2010, rather than implement a new CRIS. The situation is
proposed to be rectified through a phased adjustment of fees over three years to align
with the current 40 per cent target and further consideration in a first principles review of
the APVMA’s cost recovery arrangements being conducted by the Department of
Agriculture, Fisheries and Forestry.

Rural and Regional Affairs and Transport Committee
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Agriculture, Fisheries and Forestry

Question: 197 (continued)

4.  All costs are continually reviewed to ensure the agency is operating efficiently. The
APVMA is participating in two separate external interagency benchmarking studies on
corporate services costs. The studies have not yet been completed. The PwC report
discusses ‘corporate overheads’ and their allocation. It is noteworthy these costs include
a variety of expenses that are not typically allocated to corporate services such as the
Executive, the Principal Scientists, expenses related to Freedom of Information (FOI)
requests, as well as property related costs for the entire agency (rent, light & power,
water, security etc) and depreciation.

5.  Please the response to question 4.

6.  Not applicable.

7.  No findings have been reported from the two separate external interagency
benchmarking studies on corporate services costs as they are not yet been completed.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 227

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Permit system for veterinary pharmaceuticals
Proof Hansard page: Written

Senator BACK asked:

1.  Is the purpose of the permit system to make pharmaceuticals that are uneconomic to
register due to small indication available to veterinarians?
2.  Is it specifically stated that the product should not be under regulatory review?
3.  Did the APVMA repeatedly over a number of years renew a permit for the use of
Pentosan Gold when the product was under review for registration?
4.  If so, why did the APVMA renew permits for Pentosan Gold (PG) via intra-venous (IV)
route when it had concluded the IV use was unsafe and its registration via this route had
been rejected by the APVMA?
5.  Was the APVMA aware that the permit holder of PG continued to widely advertise the
administration of this product by the IV route over an extended period in Australia at
conferences and over the internet where claims of efficacy were made when used via the
intravenous route?
6.  If so, what action did the APVMA take to require the permit holder to refrain from this
action, if the APVMA had determined its use by the IV route was unsafe and that
registration was not permitted for this use?
7.  Was the APVMA aware that this product with the Australian permit number was
marketed internationally?
8.  Is the APVMA aware of fatalities in horses after administration of PG with instructions
for IV after APVMA approval was only granted for the safer intramuscular (IM) or
subcutaneous (SC) injection routes?
9.  Did the APVMA withdraw the permit for intravenous use after it registered the PG via
the IM and SC route?
10. What action has the APVMA taken against the company for this abuse of process?
11. Can the APVMA assure the public that it investigates compliance issues in relation to
proper procedures for the use of permit products, such as individual records for their use?
12. Can the APVMA assure that they do not issue permits to untested and dangerous drugs.

Answer:

1.  Yes, that is one of its purposes.

2.  No.

3.  No. The Australian Pesticides and Veterinary Medicines Authority (APVMA) has never
issued a minor use permit for a product called Pentosan Gold to be used alone.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 227 (continued)

4.  The APVMA had not concluded that the product NV Pentosan Gold Injection for Horses
when administered via the intravenous route was unsafe.

5.  Yes. Advertising as described was not a breach of agvet legislation.

6.  Please see the responses to questions 4 and 5.

7.  Yes.

8.  Yes.

9.  No.

10.   There was no abuse of process. See answers to questions 4, 5 and 9.

11.  Yes. The APVMA may conduct compliance audits to verify that permit holders comply
with the conditions as specified in a particular permit. Accusations of non-compliance
with the legislation are taken very seriously by the regulator.

12.  Products supplied to the market under permits are tested and assessed as safe. However,
research permits regulate research and development of registered or unregistered agvet
products or for other genuine scientific purposes. Therefore, some permits are issued for
products in early stages of development so they can undergo testing under appropriate
controls, usually in research facilities.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 228

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Registration of untested drugs
Proof Hansard page: Written

Senator BACK asked:

1.  Did the APVMA inform the applicants that their application for registration of PG via the
IV route would be refused?
2.  Did the APVMA subsequently register PG via the IM and SC route?
3.  Did the APVMA register PG without undertaking or considering safety studies in the
horse by either the IV or IM route?
4.  Did the APVMA register Nature Vet PG without clinical studies demonstrating efficacy
via the IM and SC route?
5.  Did the APVMA register Nature Vet PG, which is a combination of drugs, without
demonstration of any benefit of such a combination compared to one component alone?
6.  Did the APVMA publish details of its PG registration which described the registration
details for the dog?
7.  Did the APVMA accept the safety data on subcutaneous administration in the dog as
adequate for registration for IM use in the horse?
8.  Did the APVMA accept data on a component of PG N-acetyl glucosamine which was a
different route, different species and different structural and pharmacological
characteristics as evidence of efficacy?
9.  Was the APVMA aware that the company seeking registration of Nature Vet PG was sold
to the French multi-national pharmaceutical company CEVA?
10. Was it not evident that the registration of PG the companies (Nature Vet) leading product
would affect the sale and its terms?
11. Did parties representing Nature Vet make application to the APVMA in relation to this
unusual registration process?
12. If so, what was the outcome? Who in APVMA made the decision to register this
pharmaceutical under these conditions of registration?
13. Does the APVMA agree that Australia’s reputation as a source of proven effective safe
and properly tested drugs for veterinary use can potentially be damaged if untested drugs
are registered and found subsequently to be ineffective, unsafe or dangerous for use?

Answer:

1.  Not applicable. The applicant did not apply for registration of Pentosan Gold (PG), to be
administered intravenously.

2.  No.

3.  No.

Rural and Regional Affairs and Transport Committee
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Agriculture, Fisheries and Forestry

Question: 228 (continued)

4.  Yes. Clinical trials are not required for all applications. A combination of published data
and in vitro data was assessed to support efficacy for the intramuscular route of
administration.

5.  Yes. There is no legislative requirement for the Australian Pesticides and Veterinary
Medicines Authority (APVMA) to consider the benefits of a combination of active
constituents compared to a product containing only a single active constituent, unless the
market claim for the combination product exceeds that of the product containing only
one active constituent.

6.  Yes, this was mistakenly published. The error was rectified and the correct advice
summary was published on 23 April 2012.

7.  No. Safety data for intramuscular use in the horse was provided, assessed and found to
support safe use in the horse.

8.  Yes. It is common for data packages to include background information such as publicly
available data on the use of active constituents in other dose forms, in other species and
for other uses as well as studies which used the formulation, in the intended species, via
the intended route.

9.  Yes.

10.  This is not a relevant consideration for the APVMA.

11.  The usual registration process was followed. This involves company representatives or
their agents interacting with the APVMA.

12.  See the response to question 11. The product was registered on 6 March 2012.

13.  Yes. Untested drugs are not able to be registered.

Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 231

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Use of gloricide
Proof Hansard page: Written

Senator HEFFERNAN asked:

1.  What are APVMA’s regulations in regard to the use of gloricide?
2.  With regard to Gloricide and the use of banned herbicides in aquatic areas, can you advise
has the UNEP investigated whether Article III of the Rotterdam Convention has been
breached by mixing 2,4,5-T precursor products with Nitriles, Chlorines and changing
their “PH”, temperature and pressure?
3.  Environmental poisonings are occurring on a day to day basis by QLD Council
Contractors, they are using either a Metulfuron methyl or 2,4-D formula or another
insidious unregistered agricultural product called Gloricide, a mix of 2,4-D Metsulfuron
methyl and wetting agent, have you had any reports of misuse of gloricide, if so, please
provide a list of places and dates?
4.  Are you aware that the Sunshine Coast Regional Council has been using gloricide without
a lawful Permit by the APVMA and with no testing?  If not, do you intend to investigate?
5.  If you are aware, what were the penalties?
6.  Can you confirm that the majority of all Bush Regeneration work in Australia is under an
APVMA Minor Use Permit.  – what is a Minor Use permit.
7.  My understanding is that APVMA has not expressed permission to mix certain products
together in a 'Minor Use Permit ' as they have done for the control of a single species i.e.
Lippia, because the risks of doing so greatly increase the expected exposure - can you
explain why APVMA allows the mass unrestricted use and mixing of Endocrine Blocking
carcinogens, in a total oblivion to the risks and expected mass loss of life and breaches of
our various International Contracts.
8.  I understand APVMA allows Unregistered Chemical Products to be used without a
registration or Permit, especially in and around Aquatic Areas and Endangered Species of
Amphibians. It would appear as though with the APVMA warnings of keeping a 20 m
buffer from waterways with Glyphosate 450, the APVMA has allowed not only 2,4-D
and metsulfuron methyl to be used up to the edge and over waterways on mass, but
APVMA has allowed Gloricide to be used as well in those areas. Is this true or false,
please provide details

Answer:

1.  The Australian Pesticides and Veterinary Medicines Authority (APVMA) understands
that the name ‘Gloricide’ is used for a tank mix of two herbicides metsulfuron-methyl
and 2,4-D. The APVMA has issued a permit for the use of a range of herbicides for the
control of environmental weeds in non-agricultural areas in Queensland (Permit 11463)
that includes these two herbicides.

Rural and Regional Affairs and Transport Committee
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Agriculture, Fisheries and Forestry

Question: 231 (continued)

2.  The United Nations Environment Program is not responsible for investigating the use of
chemicals listed in Annex III of the Rotterdam Convention on the Prior Informed
Consent Procedure for Certain Hazardous Chemicals and Pesticides in International
Trade.

3.  No. The APVMA has conducted a compliance audit and found no breach of the
Agricultural and Veterinary Code Act 1994 by the permit holder. However,
control-of-use rests with the relevant state authority, in this case the Queensland
Department of Agriculture, Fisheries and Forestry (QDAFF).

4.  No. Control-of-use rests with the relevant state authority.

5.  Please see the response to Question 4.

6.  No. Minor use permits are defined through Regulation 3 and 57, Agricultural and
Veterinary Chemicals Code Regulations 1995. Minor use means a use “that would not
produce sufficient economic return to an applicant for registration of the product to meet
the cost of registration ... of the product for that use”.

7.  The mixing of registered products is generally permitted under state control-of -use
legislation, unless the APVMA-approved product label contains a statement expressly
prohibiting mixing.

8.  The APVMA does not allow unregistered products to be supplied or used without a
registration or permit. Tank mixes of registered products (i.e. where separate registered
products are mixed before application) are widely used and are not considered to be
unregistered products (see Question 7). Permit 11463 specifically states “only those
specific products which have label approvals currently in place for aquatic use, may be
used in or near aquatic areas”. Labels for products containing metsulfuron-methyl and
products containing 2,4-D do not specify any buffer zone to be observed when using near
aquatic areas. Product labels, however, contain a warning “DO NOT contaminate
streams, rivers or waterways with the chemical or containers”. Responsibility for
control-of-use rests with the relevant state authority, QDAFF.

link to page 19 Rural and Regional Affairs and Transport Committee
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Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 238

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic:  Dimethoate
Proof Hansard page: Written

Senator NASH asked:

1.  Has the APVMA been in discussions with the NZ Ministry of Primary Industries in
accepting tomatoes that have a lower level of Dimethoate for export into New Zealand?
2.  Food Standards Australia New Zealand media release from 26th September 2012 “Call for
submission on application to irradiate tomatoes and capsicums” is APVMA aware that
FSANZ is calling for submissions to irradiate tomatoes and capsicums?
3.  Would APVMA be likely to approve this method of treatment against Fruit fly when
DAFF Biosecurity and NZ Ministry of Primary Industry have both sent letters to FSANZ
approving this method of treatment?
4.  While the method of irridation is in the process of trying to get approval, what has the
APVMA done in when the current phytosanitary methods such as the use of Dimethoate
have been restricted because of Australia’s regulations of healthy levels of consumption
is a lot lower to what NZ government expects when receiving tomatoes from Australia?

5.  I refer to the WTO as it states on its website;
[1]On the assumption that they are technically and economically feasible and provide the
same level of food safety or animal and plant health - governments should select those
which are not more trade restrictive than required to meet their health objective.
Furthermore, if another country can show measures it applied provide that same level of
health protection; these should be accepted as equivalent. This helps ensure that
protection is maintained while providing the greatest quality and variety of safe foodstuffs
for consumers, the best availability of safe inputs for producers and healthy economic
competition.

WTO, Understanding the WTO Agreement on Sanitary and Phytosanitary Measures,
http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm

Wouldn’t the Australia Government be going against the WTO i.e. governments should
select those which are not more trade restrictive than required to meet their health
objective. Furthermore, if another country can show measures it applied provide that
same level of health protection; these should be accepted as equivalent. If the NZ
Government has showed evidence that increased levels of Dimethoate is acceptable to
NZ safety on human consumption levels, is it not correct that Australia is being as the
WTO states trade restrictive?

Rural and Regional Affairs and Transport Committee
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Agriculture, Fisheries and Forestry

Question: 238 (continued)

Answer:

1.  No. The Australian Pesticides and Veterinary Medicines Authority (APVMA) has no role in
the regulation of food in New Zealand.

2.  No. The APVMA has no role in the regulation of food irradiation.

3.  Please refer to the answer to question 2.

4.  The APVMA has no role in determining phytosanitary requirements. However, the
APVMA has issued a number of permits for chemical alternatives to dimethoate and
fenthion.

5.  Under the World Trade Organization (WTO) Agreement on the Application of Sanitary
and Phytosanitary Measures (SPS Agreement), WTO members have the sovereign right
to set their appropriate level of protection (ALOP). The measures that Australia has taken
in relation to dimethoate are consistent with the ALOP determined by Australia.

New Zealand’s measures in relation to dimethoate reflect New Zealand’s ALOP and are
without prejudice to Australia’s right to establish its own measures for this chemical
consistent with Australia’s ALOP.

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Question: 249

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Joint Expert Technical Advisory Committee on Antibiotic Resistance Progress
report
Proof Hansard page: Written

Senator DI NATALE asked:

According to the 2003 Joint Expert Technical Advisory Committee on Antibiotic Resistance
Progress report by the Commonwealth Interdepartmental JETACAR Implementation Group
(CIJIG) the Australian Pesticides and Veterinary Medicines Authority began a review of
selected macrolide antibiotics December 2001 because of concerns over the potential risk to
human health. The review was to provide the Authority with information to enable it to
determine whether the existing uses of these macrolide antibiotics should continue in
Australia.

Please provide a full copy of the final Report of this review. If such a Report does not exist,
why does it not exist and what happened to the review? What were the findings of the
review? Were those findings published or otherwise made publicly available? Was the review
completed or aborted before completion? If the review was not completed why not?

Answer:

No report is available as the reconsideration (i.e. review) of the macrolide antibiotics
(kitasamycin, oleandomycin and tylosin) is still in progress. Finalisation of this
reconsideration has been delayed to allow further consideration of new developments,
including the outcome of the Australian Pesticides and Veterinary Medicines Authority’s
(APVMA) reconsideration of a related antibiotic, virginiamycin.

The APVMA’s reconsideration of virginiamycin was finalised in April 2012. The APVMA’s
original decision was to limit the continued use of virginiamycin. This was based on the
advice of the Australian Government Department of Health and Ageing, which drew on the
Joint Expert Advisory Committee on Antibiotic Resistance report. However, that decision
was modified following an Administrative Appeals Tribunal ruling, to allow continued use of
products containing virginiamycin, provided they bear a mandatory prudent-use statement.

See www.apvma.gov.au/products/review/completed/virginiamycin.php for a copy of the
virginiamycin report.

Rural and Regional Affairs and Transport Committee
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Question: 252

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Growth promotants and prophylactic use of antimicrobials
Proof Hansard page: Written

Senator DI NATALE asked:

In Supplementary Estimates, the Authority asserted that “there is a grey area between growth
promotants and prophylactic use” of antimicrobials. Given that some countries such as
Sweden have banned antibiotic use as a growth promotant, how have they done this if the
definition is not clear? How does the Department inform itself of international policies on
antimicrobial resistance?

Answer:

This statement was made in the context of categorising antibiotics by this type of use from
the available reporting, not in relation to defining use per se. The latter can be done on a case
by case basis. The Australian Pesticides and Veterinary Medicines Authority (APVMA) and
the Department attend international conferences to keep informed of international
developments in regard to antimicrobial resistance – most recently the Chief Veterinary
Officer (CVO) attended a regional workshop on ‘Antimicrobial Use and Resistance in
Livestock Production in the Asia-Pacific Region’ where the regional situation was reviewed,
and the APVMA’s Program Manager, Veterinary Medicines attended an ‘International
Conference on Responsible Use of Antibiotics in Animals’ in the Netherlands, and gave a
presentation on Regulation of Veterinary Antibiotics in Australia.

Also, the Department of Agriculture, Fisheries and Forestry is a member of relevant
international organisations and networks, and has an active environmental scanning network
which monitors, among other topics, international developments in antimicrobial resistance,
including in the European Union and the United States of America.

Australia is a member of the World Organisation for Animal Health (OIE) that works with
the Food and Agriculture Organization and World Health Organization to provide guidelines
and information to assist countries manage antimicrobial resistance. OIE disseminates
information about international developments to the CVO and his office.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 253 (continued)
Antimicrobial usage in salmonid production in Tasmania, 2003-12
Year
Oxytetracycline
Trimethoprim
Total Antimicrobial
Usage (kg)
Usage (kg)
Usage** (kg)
2003
-
32
285
2004
790
64
996
2005
845
21
878
2006
4453
44
4536
2007
8665
78
9295
2008
3381
165
4007
2009
2946
24
3281
2010
N/A
N/A
N/A
2011
139.75
127.49
267.24
2012*
42.5
57.04
138.54
* Data for January to June 2012
**Includes amoxycillin, chlortetracycline and oxolinic acid for 2003-2008; and
tylosin, florfenicol and chlortetracycline for 2009-2012
N/A: Not Available.
Under State and territory legislation, veterinarians may prescribe antibiotics off-label. Prior to
APVMA permits, all previous antibiotic use in aquaculture was off-label . Currently,
trimethoprim is prescribed off-label.

The APVMA informs itself of off-label use through reports from state and territory
agriculture departments and discussions with user groups and/or their representative bodies,
such as the Tasmanian Salmonid Growers Association Ltd, antibiotic registrants and
veterinarians practicing in the industry.

The APVMA has no capacity to conduct independent studies or research, but can commission
independent literature reviews. This was done as part of the re-considerations of the
approvals of the macrolides and of virginiamycin.

For permitted uses of antibiotics, there are provisions that require permit holders and the
prescribing veterinarians to report usage and monitoring information to the APVMA and
State Coordinators. Veterinary scripts are to be made available to the APVMA on request.

Individual minor use permits for florfenicol (PER9644), oxytetracycline (PER9665 and
PER9675) and tylosin (PER11829) were issued between December 2007 and
December 2010. An environmental assessment was conducted for each of these permits.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 253 (continued)

Large scale use refers to access of the antibiotic by several leases in all states through a minor
use permit. This is in contrast to other APVMA permits, such as research permits or other
minor use permits (e.g. PER11829), which impose limitations on matters such as the location
where the permitted product(s) may be used, the number of treatments, the number of animals
to be treated or the persons authorised to use the permitted product(s).

None of the environmental assessments is published.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 265

Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Agricultural chemicals – spray drift
Proof Hansard page: Written

Senator EDWARDS asked:

With reference to answers given to Written Questions on Notice 125 and 126 (Additional
February Estimates 2012), where the APVMA stated that there have been talks around
harmonising regulation of chemicals use as a part of the CoAG reforms.

1.  What has APVMA’s involvement been in the process of harmonising state regulations?
2.  What was APVMA’s advice to CoAG?
3.  Which other agencies are involved?
4.  What are the developments around harmonising regulation of chemical use?
5.  How likely are national regulations?
6.  How long will they take to develop?
7.  Has industry been consulted?
8.  If so, who has been consulted?

Answer:

1.  The Australian Pesticides and Veterinary Medicines Authority (APVMA) has not had any
specific role in harmonising state and territory regulations as part of the Council of
Australian Governments (CoAG) agricultural chemicals and veterinary medicines (agvet)
reforms. The reform process has been managed by the Department.

2.  The APVMA has not provided any advice to CoAG.

3.  Other Australian Government agencies that have been involved in harmonising
regulations are the Departments of: Attorney General and Justice; Education,
Employment and Workplace Relations; Finance and Deregulation; Foreign Affairs and
Trade; Health and Ageing; Industry, Innovation, Science, Research and Tertiary
Education; Prime Minister and Cabinet; Regional Australia, Local Government, Arts and
Sport; and Sustainability, Environment, Water, Population and Communities.

4.  A regulatory model, funding model and intergovernmental agreement have been prepared
for CoAG’s endorsement. It is expected that a new single national framework for agvet
chemical reforms will be agreed this year.

5.  Following a CoAG agreement, it would be expected that jurisdictions would move
promptly to amend the necessary regulations.

6.  It is anticipated that implementation will take at least 18 months.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 265 (continued)

7.  Yes

8.  Industry stakeholders were given the opportunity to provide input throughout the reform
process including a Consultation Regulation Impact Statement for the CoAG agvet
chemical reforms, where stakeholders provided 70 formal submissions. The National
Agvet Systems Policy Taskforce, which includes Commonwealth and State and Territory
representatives, also held a workshop on the CoAG agvet chemical reforms in
September 2012, which was attended by 29 key stakeholder representatives.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 295

Division/Agency: Agricultural Productivity Division/Australian Pesticide and Veterinary
Medicine Australia
Topic: Usage levels of Diuron
Proof Hansard page: Written

Senator WATERS asked:

1.  Please provide an update on the process and evidence base leading to the recent decision
to change the authorised usage levels of Diuron.
2.   Please outline the effect of the change for landholders using Diuron.
3.   Please outline any research or knowledge APVMA has about alternatives to Diuron.

Answer:

1.  The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published
three environmental risk assessment reports related to diuron (2005, 2011, 2012).
Suspension action was taken in 2011 and continued in 2012, which modified the way in
which diuron could be used while the review is being completed.

The 2012 report, prepared by the Department of Sustainability, Environment, Water,
Populations and Communities (SEWPaC), took into consideration the information
provided in submissions to the APVMA (more than 100) when the 2011 environmental
assessment report was published. These submissions included newly available
environmental monitoring data from the reef monitoring program and scientific studies
not previously considered.

The new information and assessment approach undertaken in the 2012 assessment has
allowed the APVMA to make crop-specific recommendations. The more refined
crop-specific assessment approach has found runoff risk to be acceptable for some crops,
compared to the previous worst case scenario approach used in the report published in
2011. Full details are available at the following link:
www.apvma.gov.au/products/review/current/diuron.php

A final decision on the authorised use levels of diuron is expected to be made before the
end of November 2012.

2.  The proposed changes to the use of diuron as outlined by the APVMA in September
2012, if implemented, will impact materially on those industries and situations where the
continued use of diuron can no longer be supported (apples & pears, citrus, bananas
(high rates), citrus, coffee, driveways, paths, lanes, duboisia, factory sites, lucerne, non-
crop areas, ornamentals, paw paws, peas, perennial grass seed crops, phalaris,
pineapple (high rates), right of way, tea, vineyards). Alternative herbicides are approved
for use in these situations although they provide a shorter period of weed control in
comparison to diuron.

Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Supplementary Budget Estimates October 2012
Agriculture, Fisheries and Forestry

Question: 295 (continued)

The APVMA is proposing to vary labels to retain only those current uses that are
supported on environmental grounds (asparagus, bananas (low rates), bore drains,
cotton, irrigation channels, lupins, pulses, faba beans, sugarcane, pineapples, summer
fallows, wheat, barley, oats, triticale, cereal rye).

For uses that can continue, additional instructions, designed to reduce the potential for
runoff, will be included on labels.

3.  Information on registered herbicides and their approved uses can be found in the
APVMA’s public database of registered products (PUBCRIS). Other herbicide products
are registered for the control of weeds in those crops for which diuron is currently used.
See also the response to Question 2 above.

Document Outline