Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 103
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Comparison of cost of registering chemicals in Australia and elsewhere Proof Hansard page: 77 (22/05/2012)
Senator BACK asked: Senator BACK: One of the particular concerns I had, Mr Koval—perhaps you can correct
the figures if I am wrong—is the actual costs associated with establishing pharmaceutical and
biological products in Australia compared to other countries; I am only speaking now of food
animal products. The quote that has been given to me is that, for pharmaceuticals for the farm
animal product sector, our costs of establishing these pharmaceuticals in Australia is 66 per
cent higher than Europe and 23 per cent higher than the USA; and for vaccines, biologicals, it
is almost four times higher than Europe and seven times higher than the USA. Do those
figures compute and confirm the information you have?
Mr Koval: No. I have heard stories or rumours or comment that an international study has
been done that is yet to be released which is looking at the cost comparison of registering a
veterinary product in Australia compared with like international regulators. I have not seen a
copy of that report as yet. As I understand it, when the report came out three or four years
ago, we compared very favourably. But the reform package is designed to try to lower the
cost where we can by increasing efficiencies. So, as we go forward, we think the cost to
industry will drop. I am happy to take that one on notice and see whether we can do some
comparison with international regulators, if that is of use.
Answer: We are not aware of the details of the costs of registering veterinary medicines in Australia
versus other countries.
However, in 2007, the Animal Health Alliance (Australia) Ltd, in conjunction with the
International Federation of Animal Health (IFAH), commissioned an international survey to
benchmark the regulatory environment facing animal health companies. The survey found
that the APVMA was a quality regulator making science based decisions to a world class
standard in an open and transparent manner. The survey also found that industry saw the
regulatory framework in Australia as much less of an obstacle to innovation in the animal
health industry than in other countries. Overall, the survey ranked the APVMA as marginally
behind the USA and well ahead of other Organisation for Economic Co-operation and
Development country regulators.
The Department of Agriculture, Fisheries and Forestry understands that the results of a new
IFAH Benchmarking Survey, carried out in 2011, will be released soon.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 122
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Requirements for spray applications by state
Proof Hansard page: 118 (22/05/2012)
Senator NASH asked:
Senator NASH asked: In terms of spray application requirements?
Senator Ludwig: Well more than that even, across all of the-many of the issues around agvet
chemicals they are a different many.
Senator NASH asked: Could you take on notice and state by state provide for us the
different requirements in terms of spray application?
Senator Ludwig: If it is possible, there are many that fit. There are multiple.
Senator NASH asked: In so far as it is possible, I am just generally interested in the
differences across the states.
Senator Ludwig: We will have a look at it, it is significant. That is the problem is it is.
Answer: Each state and territory has its own requirements for spray application, which are written in
state legislation for control of use of agvet chemical products. A table summarizing state
controls is provided at
Attachment 1.
The controls are generally in relation to user training, powers to restrict application
equipment or methods for applying pesticides, licensing of commercial operators, record-
keeping requirements, neighbour notification, offences for causing off-target harm or injury,
offences for advising another party to use a product in such a way that residues exceed
mandated levels.
Each state department responsible for handling spray application inquiries provides
information on its website. For example, a brochure published by the NSW Environment
Protection Agency is available at:
www.environment.nsw.gov.au/resources/pesticides/10978Pesticidefactsheet.pdf
Similarly, the Victorian Department of Primary Industries has factsheets at:
www.dpi.vic.gov.au/agriculture/farming-management/chemical-use/agricultural-chemical-
use/spraying-spray-drift-and-off-target-damage
The Queensland Department of Fisheries and Forestry also has factsheets at:
www.daff.qld.gov.au/4790_4906.htm
Biosecurity South Australia has information on its website:
www.pir.sa.gov.au/biosecuritysa/ruralchem/using_chemicals_safely
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 122 (continued)
ATTACHMENT 1: NATIONAL USE CONTROLS IN FORCE FOR AG & VET CHEMICALS IN AUSTRALIA as at March 2012
AGRICULTURAL CHEMICAL CONTROLS
Ag Chemical Control
QLD
NSW (EPA)
ACT
VIC
TAS
SA
WA
NT
Use of unregistered chemicals
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
prohibited
General off-label use prohibited
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Prohibited for
Except for
Vic restricted
specifically
use chems e.g.
exempted
S7 chemicals
horticultural
plus restrictions
crops grown
on rate,
under
frequency, and
approved QA
all label
schemes.*
prohibitions.
Label prohibitions mandatory
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
(offence to use contrary to a “DO
NOT…” statement whether a
Restraint or not (any differences
shown)
Lower rate / frequency of use
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
permitted
Use for different pest in label
Yes
No
No
Yes
Yes
Yes
Yes
Yes
crop/situation permitted
Agency can apply use controls on
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Restricted Chemical Products (RCP)
Except for Vic
By Health
restricted use
Dept and only
chems
if in Appendix
J.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 122 (continued)
Ag Chemical Control
QLD
NSW (EPA)
ACT
VIC
TAS
SA
WA
NT
Power to further restrict use
Yes
Yes
No
Yes
Yes
Yes
S7 - as above
Yes
(implement RCP controls)
Power to restrict application
Yes
Yes
No
Yes
Yes
Yes
As per label
Yes
equipment (method used to apply
pesticide)
General user (farmer/commercial)
RCP only
Yes
Commercial
Restricted Use
No
S7 & RCP
Proposed
Commercial,
training required
only
Chemicals -
only
S7 & RCP
includes RCPs
only
Licensing of commercial operators
Yes
Aerial only
Yes
Yes
Yes
Yes
Yes
Yes
(Licensed Pest
Dept. Health
Except PCOs
Control
by Health Dept
Operators
(PCOs) by
Workcover)
Commercial insurance required for
No
Aerial only
No
No
Aerial only
No
Aerial only
No
licensed (aerial) operators
Treatment records required
Commercial/
Yes
No
Yes
Commercial /
Only for
Commercial
Yes
contractors
occupational
commercial
(aerial and
Except home
plus where
only
operators
ground and
and garden
required by
(Dept Health).
certain
Reg’s
Legal power
restricted e.g.
available for
1080,
other users.
strychnine)
Neighbour notification (by
No
Yes
Yes
Yes
Power for
Power
Proposed if on
No
owner/applicator) required
(unless label
Limited to
(S7 only)
Limited to
specific
available
label or RCP
Unless label or
(actual or optional)
requires)
public
schools,
specific issues
authorities or
hospitals and
e.g. S7
common
aged care
residential area
services
Neighbour notification required
Yes
Only if
Only if label
1080 only
1080 only
Only if
1080 and
1080 only
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 122 (continued)
Ag Chemical Control
QLD
NSW (EPA)
ACT
VIC
TAS
SA
WA
NT
(actual or optional) for vertebrate
(Other
specified in a
requires
required by
strychnine
pest poisons
legislation)
Control Order
label.
only
Power
available.
Employer / employee (eg owner,
Yes
Yes
No
Yes
Yes
Yes (limited)
Yes
Yes
contractor, employee) liable for
(to limited
Includes other
Issue
misuse offences
extent)
person causing
dependent
or permitting
harm
Offence for causing off-target injury
Yes
Yes
Only if label
Yes
Yes
Yes
Proposed
Yes
or harm
If licensed user
specifies
Compliance
(current for
Crops and
or within a
Orders. Also
phenoxys and
animals.
hazardous area
under Public
Health laws)
Other offence
Health, EPA &
different law
OH&S laws
applies
Offence for advising to use such that
Yes
No
No
Yes
Yes
No
No
Yes
residues exceed mandated levels
Offence for advising another party in
Yes
Yes
No
Yes
Yes
No
No
Yes
a manner so that the legislation (other
than residues) is breached
APVMA deemed permits and related
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
instructions have effect
APVMA suspension notices and
Yes
Yes
Yes
Yes
Yes
Yes.
Yes
Yes
related instructions have effect
may require
Gazettal
Order to effect
required for
immediate
suspension
APVMA label grazing / fodder
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
controls (“WHPs”) have effect for
chemical users
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 122 (continued)
Ag Chemical Control
QLD
NSW (EPA)
ACT
VIC
TAS
SA
WA
NT
Users required to keep use records?
No
Yes
No
Yes
Yes
No
Proposed
Yes
(The Livestock Production Assurance
(Some for QA
Except where
(Two years)
program requires records)
and OHS)
label/permit
requires. Can
require records
Persons allowed to recommend off-
Standards
No
No
Yes
No
No
No
No
label use?
officers or
May be liable
Except as
(As per Agvet
Except as
Except as
officers of the
for residues or
allowed by
Code)
allowed by
allowed by
crown
adverse
legislation e.g.
legislation e.g.
legislation e.g.
outcomes
lower rate or
lower rate or
lower rate, NT
frequency, pest
WA not on
not on label
not on label
label
In NSW, animal external parasiticides applied externally are currently defined as agricultural chemical products (pesticides) but being reviewed.
In VIC, “RUCP” includes S7 Agchem products, particular specified chemicals, eg atrazine, metham sodium and esters of 2,4-D, 2,4-DB, MCPA and triclopyr.
In WA, many of the controls are exerted by the Health Department, not WA Ag.
In SA *Regulations to restrict the general nature of these exemptions are scheduled for 2008. The exemption provisions are still in place.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 123
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Date of refusal of dimethoate application Proof Hansard page: 121
Senator COLBECK asked:
Dr Bennet-Jenkins: Certainly. The APVMA have received an application for a permit,
though the details of that application are not published but we are able to share some of the
information about that permit for you. That was, as you have stated, an application to allow
the use of dimethoate on tomatoes that were to be exported to New Zealand. We have refused
that application because of the concerns about public health and residues. The very reasons
why we no longer permit that use on tomatoes in Australia. The applicant has now sought a
reconsideration of our decision to refuse that application and that process is still ongoing.
Senator COLBECK: When was the refusal?
Dr Bennet-Jenkins: I think it was probably towards the end of last year, but I would have to
take on notice the exact timing. I don't have that with me.
Answer: The permit application was refused on 23 December 2011.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 214
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Chemical Regulation Reform Proof Hansard page: Written
Senator COLBECK asked:
1. Agforce raised concerns in their draft legislation submission that off patent products will
be lost to industry just because of the mandatory review process.
2. How will the Department of Agriculture, Fisheries and Forestry ensure that chemical
options are not lost to the industry because of the automatic review process?
Answer: The scheme is designed to minimise impacts on affected industry while being effective at
ensuring the ongoing safety of agricultural and veterinary chemicals.
The scheme applies an expiry date to existing approvals and registrations calibrated to the
risks involved in using the chemical and invites applications to extend the approval or
registration. The application process is low cost (less than $100 pa) and unlike schemes
overseas does not require the generation of costly data to support the application. The
Australian Pesticides and Veterinary Medicines Authority (APVMA) decides whether to
grant the application. A decision not to grant the application will be based on whether there
are reasonable grounds, founded in evidence, to believe that the chemical would pose an
unacceptable risk to human or environmental health.
The scheme complements the existing chemical review scheme by sorting out those
chemicals that need to be fully reviewed. The only way a chemical can be lost to the market
is if the registrant chooses not to make a re-registration application or if the APVMA finds,
following the re-registration application and chemical review process, that the chemical is not
suitable for registration and use.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 215
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Chemical Regulation Reform Proof Hansard page: Written
Senator COLBECK asked:
1. Do you agree with the Animal Health Alliance in their submission on the draft legislation
that the Regulation Impact Statement has clearly identified the differences in regulatory
processes and activities needed by the APVMA to manage risk for agricultural chemicals
compared to veterinary chemicals?
2. Please explain your answer.
3. Are agricultural chemicals and veterinary chemicals currently managed differently in the
registration process?
4. Can agricultural chemicals and veterinary chemicals be dealt with under the one
regulatory structure proposed in the new legislation without any disadvantage in cost or
regulatory burden to either group of chemicals?
Answer: 1. The Department of Agriculture, Fisheries and Forestry agrees that the regulation impact
statement clearly shows that there are some differences in regulatory processes and
activities. For example, the Australian Pesticides and Veterinary Medicines Authority
has separate programs for agricultural chemicals and veterinary medicines. However,
while the Regulation Impact Statement does not explicitly say that the same legislative
tests apply to agricultural chemicals and veterinary medicines, it shows that the same
legislative requirements apply.
2. Please refer to the answer to Question 1.
3. Yes.
4. Yes, there will continue to be sufficient flexibility for the Australian Pesticides and
Veterinary Medicines Authority to equitably accommodate the differing requirements of
various classes of chemicals.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 216
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Chemical Regulation Reform
Proof Hansard page: Written
Senator COLBECK asked: AUSVEG in it submission on the draft legislation said,
“Australian vegetable growers rely on a range of targeted crop protection products to
effectively combat pests and disease. As a representative body for Australian vegetable
growers, AUSVEG holds great concerns that the proposed reforms will act as an economic
disincentive for companies to register or re-register vital crop protection products in
Australia. Our concern is that Australia’s many vegetable growers will have access to a
diminished range of crop protection tools and bear the brunt of registration and bureaucratic
costs imposed by the APVMA, which will be passed on by companies to the grower.
The current proposed reforms of a continuous, periodic review process will only serve to
increase the ongoing costs for registration, even where there are no concerns of risk.”
1. Will an increase in the costs of registration by about 30% further reduce the availability
of crop protection tools?
2. Have you advised the minister of this issue and what was the advice?
Answer: 1. The Department of Agriculture, Fisheries and Forestry does not accept that registration
costs will increase by 30 per cent as a result of the better regulation reforms.
2. Not applicable.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 217
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Better Regulation Reform
Proof Hansard page: Written
Senator COLBECK asked: 1. Do you agree with Syngenta’s submission to the Draft legislation that all risk manuals
under the new risk-based framework must be owned and controlled by the APVMA to
prevent external agencies from introducing new requirements without notification
(“regulatory creep”) or adequate consultation?
2. Please explain the reasons for your answer.
3. Explain your reasons for agreeing or disagreeing with Syngenta on the ownership and
control of the risk manuals and risk based framework?
Answer: 1. Yes.
2. The Department of Agriculture, Fisheries and Forestry considers that the Australian
Pesticides and Veterinary Medicines Authority (APVMA) should, in making its
decisions, have to have regard to the risk framework that it establishes. While the Office
of Chemical Safety in the Department of Health and Ageing and the Department of
Sustainability, Environment, Water, Population and Communities will be closely
involved in the development and on-going maintenance of elements of the risk
framework; the APVMA will retain overall responsibility.
3. Please refer to the answer to Question 2.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 218
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Better Regulation Reform Proof Hansard page: Written
Senator COLBECK asked:
1. Has there been a cost benefit analysis of the sun setting registrations or mandatory review
process?
2. What research was done to support this approach?
3. What is the timeline for finalising the legislation?
Answer: 1. Yes
2. The Department of Agriculture, Fisheries and Forestry (DAFF) researched the basis of
the approvals that underpin the current inventory of products registered by the Australian
Pesticides and Veterinary Medicines Authority. DAFF also researched the approach that
regulators in comparable countries take to managing their agricultural chemical and
veterinary medicine inventories.
3. The legislation is scheduled for introduction later in 2012.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 240
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Performance Targets Proof Hansard page: Written
Senator COLBECK asked:
1. Do you have any statistics or data to support the claim that "The most common reason
applications are not finalised within statutory timeframes is because the applicant has
been required to correct the application several times" (QON 184 February 2012).
2. Apart from applicants not providing the required information, what are the other main
reasons that applications are not finalised within statutory timeframes?
3. Is the involvement of DAFF, SEWPaC, and DoHA with the APVMA processes another
reason for delays?
4. Registrants have advised they are often unsure of the precise requirements necessary to
achieve registration and that additional, unplanned requirements maybe required by other
agencies such as DSEWPaC. What guidelines or technical support is offered to
registrants to clarify information required by APVMA and DSEWPaC?
5. How is DAFF working with the APVMA to “improve the administrative efficiencies in
the way in which the APVMA seeks and receives advice from SEWPaC and DoHA?
6. What outcomes have been achieved?
Answer:
1. From 1 July 2005 to present, the Australian Pesticides and Veterinary Medicines
Authority (APVMA) has accepted and undertaken a full evaluation of approximately
7700 applications across all categories for both agricultural and veterinary chemical
products. Of these, sixty-five percent have required the issue of two or more notices to
address deficiencies in the applications before the APVMA could finalise the application.
2. Other main reasons for applications not being finalised within statutory timeframes
include:
-
applicants either varying their application or providing new data during the
evaluation process such that new or different issues need to be assessed;
-
there has been a significant increase in both administrative complexity, e.g.
implementation of the data protection scheme in 2005, and technical complexity,
e.g. introduction of the Joint Expert Committee for Food Additives and Veterinary
Drug Residues in Food methodology in 2006 for veterinary product applications;
-
unexpected increases in workloads. For example, during 2010–11 there was a
22 per cent increase in the number of applications lodged with the APVMA.
However, the recruitment, training and development of an evaluator takes up to
18 months.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 240 (continued)
3.
The APVMA has service level agreements with the Department of Sustainability,
Environment, Water, Population and Communities (SEWPaC) and the Department of
Health and Ageing (DoHA) to provide technical advice within agreed timeframes.
These timeframes ensure adequate time for the APVMA to review the advice,
incorporate this into its overall evaluation, seek public comment when required, and
prepare the final report for delegate determination. At times there have been delays in
the provision of this advice.
For some applications (e.g. imported vaccines), the APVMA may rely upon the DAFF
Biosecurity import risk analysis to assist it determine whether the product may be
harmful to animals, plants or the environment, which can delay APVMA processing.
4.
The APVMA’s
Manual of Requirements and Guidelines sets out the requirements and
guidelines for registering veterinary and agricultural products in Australia. The Manual
is available at www.apvma.gov.au/registration/morag/index.php.
The SEWPaC Environmental Manual is available at the Environment and Heritage
Council website at
www.ephc.gov.au/sites/default/files/CMgt_NChEM__ERAGM_for_Agricultural_and_
Veterinary_Chemicals_200902.pdf
The APVMA and agencies are available for pre-submission meetings or to respond to
enquiries regarding proposed new products and uses and to advise on specific
applications and data requirements. Applicants also have the opportunity to make an
application to the APVMA to advise on the suitability or otherwise of proposed trial
protocols and methodologies.
Under the better regulation reforms, the APVMA is developing a risk framework,
which is a compendium of documents, that will provide applicants with the detailed
requirements for registering agricultural chemicals and veterinary medicines.
Framework documents are being made available progressively at
www.apvma.gov.au/about/work/better_regulation/risk_compendium/volume2.php.
These reforms will also introduce a formal opportunity for pre-application assistance so
that applicants can determine the precise requirements necessary in their specific case.
5.
In order to improve the administrative efficiency of the interactions between the
APVMA and other agencies including SEWPaC and DoHA, the department led a series
of meetings between the APVMA, SEWPaC and DoHA to map and better understand
the interactions. The Australian Government has also committed $800 000 over three
years to establish an Independent Science Panel to assess and report publicly each year
on the efficiency and effectiveness of the APVMA including the performance of the
interactions between the APVMA and other agencies including SEWPaC and DoHA.
6.
The mapping of the interactions between the APVMA and other agencies has identified
a range of areas where improvements in administrative efficiency are possible.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 240 (continued)
The APVMA is working with the other agencies to develop new Service Level
Agreements to formalise new arrangements.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 241
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Service Agreements, QON 186 February 2012
Proof Hansard page: Written
Senator COLBECK asked: 1. Has the APVMA reached a decision regarding the public release of service agreements
with the DSEWPAC and the DOH?
2. If not, when is a decision likely?
3. When was the FOI request made for these documents to be released?
Answer: 1. Yes.
2. Not applicable.
3. The request for information was made on 23 February 2012.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 242
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Risk Frameworks, QON 188 February 2012 Proof Hansard page: Written
Senator COLBECK asked: 1. Is the Compliance and Enforcement Framework complete?
2. Is the Registration Framework complete?
3. If so, please provide copies of these and any other completed risk frameworks.
4. Is the Reconsideration Framework on track to be released by mid July 2012?
Answer:
1. This framework is substantially complete and a draft has been published. However, its
finalisation, and that of the other documents that make up the risk compendium, is subject
to passage of the legislation.
2. As a result of extensive stakeholder consultation, the draft legislation that impacts on this
framework is being modified.
3. Framework documents are being made available progressively at
www.apvma.gov.au/about/work/better_regulation/risk_compendium/volume1.php.
4. Please refer to the answer to Question 2.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 243
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: New bill Proof Hansard page: Written
Senator COLBECK asked:
1. What role did you play in the consultations to the new bill?
2. What role have you played in the development of the bill?
3. Did you give any advice on the development of the bill and specifically whether the
mandatory review of chemicals would add to the regulatory burden of the organisation?
4. Did you advise the Minister against or raise concerns with any parts of the new legislation?
5. If so on what issues?
Answer: 1. The Australian Pesticides and Veterinary Medicines Authority (APVMA) supported the
Department of Agriculture, Fisheries and Forestry (DAFF) during the public consultation
on the draft Agricultural and Veterinary Chemicals Amendment Bill 2011 (draft Bill)
between November 2011 and February 2012. APVMA staff attended meetings with
stakeholders and responded to questions about how the proposed reforms would affect
the APVMA’s day to day operations.
2. The APVMA provided detailed input to DAFF on the development of all aspects of the
draft Bill. This included regular meetings as well as workshops on the drafting
instructions and drafts of the Bill. The APVMA supported DAFF in its discussions with
the Office of Parliamentary Counsel.
3. The APVMA does not provide policy advice on these issues. DAFF, as the responsible
department consulted with the APVMA on how aspects of the draft bill might be
operationalised.
4. Please refer to the answer to Question 3.
5. Not applicable.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 252
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Use of Gloricide in Australia
Proof Hansard page: Written
Senator SIEWERT asked: Gloricide is a mix of 2,4-D formulas and metsulfuron methyl formulas plus other additives
that are legal as individual chemicals but have not been approved for use in this combination.
1. Is the APMVA aware that this combination of chemicals is being used as a weed killer in
Australia?
2. Has the APVMA had any correspondence about this chemical combination? Has the
APVMA made any determination about whether this combination is legal to use?
3. If yes, what are the details of that determination? Have any conditions been placed on the
use of this combination of chemicals? Will the APVMA be undertaking any further
investigation into this combination of chemicals?
4. If no, will the APVMA be investigating the use of Gloricide in Australia and making a
determination? Can you give a timeline as to when a determination will be finalised?
Answer:
1. Yes. The mixture is used under a current permit (Permit 11463) to control weeds
according to the label instructions for use and the conditions of the permit. The permit
document is available at permits.apvma.gov.au/PER11463.PDF.
2. Yes.
3. The individual products are registered for weed control in a range of situations as
described on product labels. The permit contains the conditions under which the products
may be used, including any restrictions or restraints on use, such as in aquatic situations.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has no plans to
undertake any further investigation into this combination of chemicals.
4. The APVMA has no plans to undertake any further investigation into the use of
Gloricide in Australia.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 266
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Antimicrobial resistance
Proof Hansard page: Written
Senator DI NATALE asked: Data about antibiotics is collected by the Australian Pesticides and Veterinary Medicines
Authority from industry.
1. Is this data provided to the Authority on a voluntary basis only?
2. Is all data regarded as commercial in confidence? If not, what are the criteria for
deciding which data is commercial in confidence?
3. Does this commercial in confidence limitation apply to applications for use of antibiotics
as well? If yes, would it be correct to say that there is therefore no opportunity for
medical doctors to comment on such applications? Is the Authority or the Department
aware of whether this is the case in other countries?
Answer: 1. A range of different data requirements exist. Some, such as for an application, are
required by law while others are voluntary.
2. Not all data is commercial in confidence. The Agricultural and Veterinary Chemicals
Code Act 1994 includes a definition of confidential commercial information that reads as
follows:
Confidential commercial information, in relation to an active constituent for a proposed or
existing chemical product, or in relation to a chemical product or a constituent of a chemical
product, means:
(a) a trade secret relating to the constituent or product; or
(b) any other information relating to the constituent or product that has a commercial
value that would be, or could reasonably be expected to be, destroyed or
diminished if the information were disclosed; or
(c) information (other than trade secrets to which paragraph (a) applies or information
to which paragraph (b) applies) that:
(i) concerns the lawful commercial or financial affairs of a person, organisation
or undertaking; and
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 266 (continued)
(ii) relates to the manufacture, distribution or supply of the constituent or product;
and
(iii) if it were disclosed, could unreasonably affect the person, organisation or
undertaking in an adverse manner;
but does not include:
(d) the making of an application for a permit for the use of an active constituent for a
proposed or existing chemical product or for the use of a chemical product, if the
use of the product proposed in the application is:
(i) a minor use; or
(ii) an emergency use; or
(e) any prescribed information relating to the making of an application for a permit, as
mentioned in paragraph (d).
3. Yes
No
The Australian Pesticides and Veterinary Medicines Authority does not hold any
information on whether or how regulators in other countries consult with medical doctors
on applications.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 267
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Antimicrobial resistance
Proof Hansard page: Written
Senator DI NATALE asked: What proportion of antibiotics given to animals are for therapeutic treatment, disease
prophylaxis and growth promotion respectively? Please provide breakdowns by percentage.
Answer: The Australian Pesticides and Veterinary Medicines Authority is currently compiling a
detailed report on antibiotic usage covering the five financial years from 2005–06 to
2009–10. This will be published in the next few months and will contain the requested
information.
The most recent report available is for the years 1999–2000 to 2001–2002 and is published at
apvma.gov.au/publications/reports/docs/antimicrobials_1999-2002.pdf.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 268
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Antimicrobial resistance Proof Hansard page: Written
Senator DI NATALE asked: Is there a direct correlation between quantities of antibiotics given to animals and farming
method? For example do animals which are kept in feed lots or other intensive farming
systems require greater use of antibiotics? Please outline and provide any analysis performed
by the Department on this area.
Answer: The Department of Agriculture, Fisheries and Forestry has not conducted an analysis of
antibiotic use for different farming systems.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 269
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Antimicrobial resistance Proof Hansard page: Written
Senator DI NATALE asked:
Of all the antibiotics used in agriculture and for animals in Australia, including domestic pets,
which if any are related to the classes of antibiotics currently deemed to be "critically
important in human medicine" by the World Health Organisation?
Answer:
The table below lists antibiotics that are: used in human therapy that are also used in animals
in Australia, including domestic pets, which are listed as "critically important in human
medicine" by the World Health Organisation –
Antibiotic class
Active constituent
Aminoglycosides
Gentamycin
Streptomycin
Framycetin sulphate
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 269 (continued)
Cephalosporins (3rd &
Ceftiofur
A
4th generation)
Cefovecin
A
Macrolides
Erythromycin
H&A
Kitasamycin
A
Oleandomycin
A
Tilmicosin
A
Tylosin tartrate
A
Erythromycin
A
Tulathromycin
A
Spiramycin
A
Penicillins & Beta
Amoxycillin
H&A
Lactamase
Ampicillin
H&A
Benzyl penicillin
H&A
Clavulanic acid
A
Cloxacillin
A
Penethamate hydriodide
A
Potassium clavulanate
A
Procaine penicillin
A
Quinolones
Enrofloxacin
A
Marbofloxacin
A
Orbifloxacin
A
Ibafloxacin
A
Streptogramins
Virginiamycin
A
Tetracyclines
Chlortetracycline
H&A
Doxyxycline
H&A
Oxytetracycline
H&A
Tetracycline
H&A
All antibiotics used to treat animals are available on veterinary prescription only. To assist
veterinarians to make proper decisions about the use of antibiotics, the Australian Veterinary
Association has developed several guidelines on prudent and judicious use of antibiotics.
These guidelines help to ensure that antibiotics are used effectively to control and treat
animal disease while at the same time safeguarding public health.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 270
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Joint Expert Technical Advisory Committee on Antibiotic Resistance
(JETACAR)
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 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 this report.
Answer: A full copy of the 2003 Joint Expert Technical Advisory Committee on Antibiotic Resistance
(JETACAR) Progress report by the Commonwealth Interdepartmental JETACAR
Implementation Group (CIJIG) is available at
www.health.gov.au/internet/main/publishing.nsf/content/EA33D21F7C12F3D8CA256F1900
052727/$File/cijig_progress.pdf.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 271
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Report of the Joint Expert Technical Advisory Committee on Antibiotic
Resistance (JETACAR) Proof Hansard page: Written
Senator DI NATALE asked:
Recommendation 3 of the Report of the Joint Expert Technical Advisory Committee on
Antibiotic Resistance recommended that an appropriate government authority/ies control all
importers of antibiotics (for any use other than for human patients) and that they must
provide detail of distribution and information based on amounts of active ingredients, with a
stronger audit trail from importer to end user and that results are made public. Has the
recommendation been implemented and are the results available to the public, as
recommended?
Answer:
The government response to the Joint Expert Technical Advisory Committee on Antibiotic
Resistance report is accessible at
www.health.gov.au/internet/main/publishing.nsf/content/F57A4B816B1AA634CA256F1900
041160/$File/CWealth%20Govt%20Response%20to%20JETACAR.pdf. The government
response to Recommendation 3 focused on the reporting and auditing of antibiotic use in
humans and animals. The Australian Pesticides and Veterinary Medicines Authority
(APVMA) collects voluntarily supplied information from registrants on the quantity of
veterinary antimicrobial products sold in Australia. The APVMA has prepared a report based
on antimicrobial sales data for the period 2005–06 to 2009–10 and expects that it will be
published by the end of 2012.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 272
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Joint Expert Technical Advisory Committee on Antibiotic Resistance
(JETACAR) Proof Hansard page: Written
Senator DI NATALE asked:
Recommendation 4 of the Report of the Joint Expert Technical Advisory Committee on
Antibiotic Resistance recommended reviews of antibiotics which included risk analysis of
microbial resistance safety. I understand this has occurred for new veterinary antibiotics but
has this applied to existing antibiotics?
1. When data is collected regarding use of antibiotics, does the Authority always require
that the use is specified (eg growth promotant or prophylaxis)?
2. If the use of an antibiotic originally registered as a growth promotant is changed to
prophylactic use does this automatically trigger a thorough review of the efficacy of this
antibiotic as a prophylactic?
Answer:
Risk analysis of microbial resistance safety is undertaken for new veterinary antibiotics and
major extension of use for existing antibiotics.
1. Yes.
2. Such an application would be considered in the light of the Joint Expert Technical
Advisory Committee on Antibiotic Resistance’s (JETCAR) Recommendation 1, which
states that in-feed antibiotics used in food-producing animals for growth promotant
purposes, or other routine uses where duration and dose level are the same, or very
similar, should not be used unless they:
• are of demonstrable efficacy in livestock production under Australian farming
conditions; and
• are rarely or never used as systemic therapeutic agents in humans or animals, or are
not considered critical therapy for human use; and
• are not likely to impair the efficacy of any other prescribed therapeutic antibiotic or
antibiotics for animal or human infections through the development of resistant
strains of organisms.
The boundary between ‘prophylactic use’ and ‘therapeutic use’ is not always clear and so
such an application would receive careful scrutiny to ensure that it did not infringe on the
policy set out in the above recommendation.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 272 (continued)
An application of this type would be unlikely, because the veterinary chemical industry
is well aware of the JETACAR report and recommendations and of their implications.
Nevertheless, if an application was to be made to vary the use of a growth promotant to
include a prophylactic/therapeutic use, the application would be assessed like any other
application for a major extension of use.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 273
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Report of the Joint Expert Technical Advisory Committee on Antibiotic
Resistance Proof Hansard page: Written
Senator DI NATALE asked:
Recommendation 16 of the Report of the Joint Expert Technical Advisory Committee on
Antibiotic Resistance called for regularly updated “antibiotic use guidelines” both human
and veterinary. The recommendation also called for evaluation of the effectiveness of these
“guidelines” every 5 years. Have any updates or evaluations been carried out pursuant to this
recommendation? If yes, please provide.
Answer:
The Australian Pesticides and Veterinary Medicines Authority’s (APVMA) guideline on data
requirements for antibiotic resistance is incorporated in the Veterinary Manual of
Requirements and Guidelines (Vet MORAG) as
Part 10 - Special Data: Antibiotic
Resistance. This guideline has not been updated since it was published post-JETACAR in
1999. Australia has been an active participant in the development of OIE/FAO/WHO
antimicrobial resistance guidelines for managing antimicrobial resistance. The APVMA will
adopt these guidelines once they are finalised and published.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 274
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Antimicrobial resistance Proof Hansard page: Written
Senator DI NATALE asked: 1.
Is the Authority aware of whether polypeptides are fed to agricultural livestock in
Australia?
2.
If yes, are polypeptides used commonly?
3.
Is the Authority aware that polypeptides are now being used as last resort antibiotics in
human medicine because of growing resistance to other antibiotics?
4.
What is the Authority’s assessment of the risk of cross resistance?
Answer:
1.
Yes.
2.
The polypeptide zinc bacitracin is used widely for the treatment of necrotic enteritis
caused by the bacteria Clostridium perfringens (types A and D) and as an aid in the
prevention of necrotic enteritis in poultry. Zinc bacitracin is also incorporated in
ointments in combination with other veterinary chemicals to treat infections of the eyes
and ears of animals. All products that contain zinc bacitracin are used under veterinary
prescription only.
3.
Yes.
4.
The Australian Pesticides and Veterinary Medicines Authority has not conducted any
assessment on the risk of cross resistance of zinc bacitracin.
Rural and Regional Affairs and Transport Committee
ANSWERS TO QUESTIONS ON NOTICE
Budget Estimates May 2012
Agriculture, Fisheries and Forestry
Question: 293
Division/Agency: Agricultural Productivity Division/Australian Pesticides and Veterinary
Medicines Authority
Topic: Carbendazim Proof Hansard page: Written
Senator XENOPHON asked:
In November last year, the APVMA announced it was going to reduce the MRL of
carbendazim in the Food Standards Code to zero following a review of the fungicide's use.
This ‘ban’ would have come into effect from the second quarter of 2012.
However, after a result of discussions with FSANZ, it was announced in February 2012 that
there would be a ‘review’ of the ban.
a. Can you please indicate the process – for example, the representations and advice
received by the APVMA – that led to a review of the decision to ban carbendazim in
Brazilian orange juice concentrate imports?
b. Which groups/individuals provided this advice?
c. Did the APVMA agree with the advice, considering its initial decision to apply a zero
MRL?
d. Can you indicate how this review is progressing?
Answer: a. Following discussions with Food Standards Australia and New Zealand (FSANZ) the
Australian Pesticides and Veterinary Medicines Authority (APVMA) agreed to delay
amendment of the Food Standards Code (FSC) by 12 months to allow FSANZ to
complete a risk assessment and to recommend new MRLs for imported produce,
including Brazilian orange juice concentrate.
b. Names of interested parties that provided advice in respect of the separate FSANZ
process should be sought from FSANZ.
c. The APVMA has no role in the separate FSANZ risk assessment for imported produce or
in establishing a different limit for imported orange juice.
d. The APVMA review of carbendazim is continuing.
Document Outline