Chapter 3Performance management report

Strategy 1: Use robust risk-based methods to scientifically evaluate pesticides and veterinary medicines used in Australia

The law requires all pesticides and veterinary medicines sold in Australia to be registered by the APVMA.

All manufacturers of these products must apply to the APVMA to register their products and obtain approval for product labels before the products can be supplied, sold, distributed or used in Australia.

Companies or individuals who hold a registration for a pesticide or veterinary medicine must also seek approval for any variation to the product, an additional claim made about it, or changes to its label.

In most states, registered products must be used for only those purposes that are specified on the label. In practice, situations often arise where chemicals are needed for a use that is not specified on a label; these are often termed ‘off-label’ uses. The APVMA can consider applications for permits for the legal use of chemicals in ways that are different to the uses set out on the product label. In certain circumstances, such as for research purposes, the limited use of an unregistered chemical may also be allowed by permit.

Registrations and permits are based on a rigorous and independent evaluation of scientific information about the safety and efficacy of products. The APVMA grants registration or issues a permit if the evaluation of a product has shown that it is not likely to be harmful to target crops or animals, to users, consumers and the environment. The evaluation also has to demonstrate that the product is effective, suitably formulated, and that its label contains adequate instructions. The APVMA must also assess whether using the product may unduly prejudice trade.

These careful evaluations ensure that the general community and users of pesticides and veterinary medicines can be confident that the products are safe and effective when used according to label instructions.

Due to the specialist nature of pesticides and veterinary medicines, the APVMA has two separate programs, the Pesticides Program and the Veterinary Medicines Program. Each contains the specialist expertise needed to assess agricultural chemical products and veterinary chemical products, respectively.

Pesticide product applications

The APVMA met its stated target for 2010–11 and finalised 86 per cent of applications for pesticide products within the statutory timeframe (Table 5). This is an improvement of 4 per cent compared with the timeframes achieved last year. Timeframe performance in the third quarter (at 88 per cent) and the fourth quarter (at 91 per cent) was particularly strong. Overall timeframe performance for applications requiring technical assessment (five months or more) improved by 6 to 23 per cent, depending on the class of application (Table 5). A detailed breakdown of the number of applications received, finalised and still in progress is provided in Appendix B.

In addition, some 19 per cent or 275 more applications were finalised, the average clock time to finalise classes of applications five months or more decreased by 0.5–2.9 months, and the average elapsed time decreased by 1–2.7 months for the 2–3-month, 5-month and 6–8-month classes of applications.

A key priority for the APVMA this year was to focus on the assessment process, in particular on the screening of applications. As a result, the screening timeframe performance increased by 2 per cent (target 5 per cent), and 22 per cent more applications were passed into evaluation within the stated 30-day timeframe during 2010–11 than in the previous year.

Table 5: Pesticide product finalisations for 2010–11

Class of
application

2009-10
Total
finalised

2010–11

Total
finalised

No. finalised
in timeframe

% in timeframe

Average clock time to finalise
(months)

Average elapsed time to finalise (months)

Received before 1 July 2005

16

7

1

14

13–33

71–94

Modular

8

5

5

100

0.1

18.4

2 to 3 months

1114

1430

1327

93

1.6

4.4

5 months

172

163

94

58

6.2

14.8

6 to 8 months

83

71

34

48

8.3

16.9

9 to 12 months

60

50

30

60

10.0

23.4

13 to 15 months

11

13

7

54

17.6

31.4

TOTALS

1464

1739

1498

86

NOTE: Statistics do not include 261 applications received in screening that were either withdrawn by the applicant or treated as withdrawn in 2010–11. Although the APVMA did not accept these applications for evaluation, it regards them as finalised.

During 2010–11, some 261 applications were received in screening during the year or previous years and were either withdrawn by the applicant or treated by the APVMA as having been withdrawn. This means that the APVMA, for various reasons, did not accept these applications for evaluation.

New pesticide technology for Australian agriculture

Thirteen new pesticides were approved in 2010–11 (an increase from the 11 in 2009–10). These include:

  • a new herbicide containing the new active constituent foramsulfuron for use on turf
  • a new plant growth regulator containing the new active constituent S-abscisic acid for use on grapevines; this was evaluated as a global joint review project with other overseas regulatory agencies
  • a new herbicide containing the new active constituent prodiamine for use on turf
  • a new mosquito control product containing the new active constituent polydimethylsiloxane
  • a new fungicide containing the new active constituent metrafenone for use on cucurbits and grapes
  • a new pest control product containing the new active constituent chloroxylenol for control of toads
  • a new biological pesticide containing the new active constituent Cydia pomonella granulosis virus for the control of codling moth in apples.

Major extensions of use into food producing situations include:

  • extension of tebuthylazine to post emergent use on triazine resistant canola
  • extension of pyroxsulam and cloquintocet-mexyl to triticale and cereal rye
  • extension of prohexadione-calcium into bioregulation of shoot growth in cherries
  • extension of etoxazole for control of various pests of citrus, wine grapes, tomatoes and capsicums
  • extension of spinetoram to stone, pome, citrus and various other fruits, vegetables and forestry
  • extension of imazalil for use in poultry producing situations
  • extension of fluquinconazole use in cereals and to set appropriate export slaughter and animal feed intervals
  • extension of carfentrazone-ethyl to use in various tree, vine and nut crops
  • extension of flupropanate to set maximum residues levels in milk
  • extension of pyraclostrobin to various tree nut crops.

The Pesticides Program is currently assessing 29 new chemicals, of which nine are global joint review projects.

Veterinary medicines product applications

The Veterinary Medicines Program exceeded its stated target for 2010–11 and finalised 93 per cent of applications for veterinary medicine products within the statutory timeframe (target 86 per cent). This is an improvement of 5 per cent compared with timeframes achieved last year. A detailed breakdown of the number of applications received, finalised, and still in progress is provided in Appendix B.

In addition to the improvement in timeframe performance, 33 per cent or 264 more applications were finalised (Table 6).

Screening timeframe performance improved by 6 per cent (target 5 per cent) and 21 per cent more applications were passed into evaluation within the stated 30-day timeframe during 2010–11 than in the previous year.

Table 6: Veterinary medicine finalisations for 2010–11

Class of
application

2009-10
Total
finalised

2010–11

Total
finalised

No. finalised
in timeframe

% in timeframe

Average clock time to finalise
(months)

Average elapsed time to finalise (months)

Received before 1 July 2005

14

5

2

40

1–19

70–91

Modular

1

2

2

100

0.9

3.5

2 to 3 months

561

811

791

98

0.9

5.1

5 months

160

171

146

85

4.8

14.0

6 to 8 months

46

58

36

62

9.5

24.0

9 to 12 months

22

24

15

63

10.1

27.0

13 to 15 months

8

5

4

80

13.4

30.3

TOTALS

812

1076

996

93

NOTE: Statistics do not include 129 applications received in screening that were either withdrawn by the applicant or treated as withdrawn in 2010–11. Although the APVMA did not accept these applications for evaluation, it regards them as finalised.

Veterinary medicines achievements

New products for the animal health industry

During 2010–11, the Veterinary Medicines Program registered a new anthelmintic sheep drench that contains the new active constituent monepantel, an amino-acetonitrile derivative anthelmintic. Other products based on active constituents not previously registered in veterinary medicines in Australia that were registered during 2010–11 are:

  • a product for horses with Cushing’s Syndrome, containing pergolide mesylate, a chemical used for Parkinson’s disease treatment in humans
  • a range of anti-inflammatory medicines for dogs and cats based on the non-steroidal anti-inflammatory drug robenacoxib
  • a vaccine to immunise broiler breeder poultry birds as an aid in the control of Clostridium perfringens Type A-induced necrotic enteritis
  • an intranasal liquid vaccine for use as an aid in the control of bovine herpesvirus 1 infection in feedlot cattle.

Other activities and initiatives of the Pesticides and Veterinary Medicines assessment and registration teams are described over page.

Initiative – Measure deficiencies in applications

The APVMA has established a mechanism to monitor errors and deficiencies in applications and has commenced analysing the results. Initital results were presented to the Industry Liaison Committee meeting in November 2010.

Continuous improvement – Revision of MORAG

Vet MORAG Guideline 47 (Data requirements and guidelines for registration of new veterinary immunobiological products) was updated to include matters relating to bracketing, extension of shelf life and in-use stability under the Chemistry and Manufacture section of the Guideline.

Guideline 48 (Requirements and guidelines for a particular batch shelf-life or dose variation permit for a registered veterinary chemical product) was amended to include immunobiological products.

Changes to Volumes 5A (Residues) and 5B (Trade) were delayed due to resource constraints and so that material from the APVMA’s risk analysis framework, which is currently under development, could be incorporated into these MORAG changes.

Continuous improvement – Respond to outcomes to audits

During 2010–11, the APVMA established the Data Protection Project in response to an internal audit report on the administration of data protection.  The aim of the project is to improve the APVMA’s administration of data protection by implementing the recommendations from the audit.  The project is managed by the APVMA’s Data Protection Advisory Group, comprising senior executives from the APVMA’s Corporate, Veterinary Medicines and Pesticides programs, together with the APVMA’s General Counsel.  The APVMA’s Executive Management team and Audit Committee also monitor the progress of the project.

Initiative – Implement Early Harvest Reforms

Framework for low-risk product classes

The APVMA developed a registration model (using a template) for a class of equine electrolyte products—‘Oral electrolyte products for the treatment of horses in exercise’. This was published as an example of how the APVMA can facilitate the registration of low-risk pesticides and veterinary medicines at reduced cost.

MRL in Food Standards Code

Changes to the governing legislation of both the APVMA and Food Standards Australia New Zealand (FSANZ) to allow the APVMA to directly vary Standard 1.4.2 of the Australia New Zealand Food Standards Code came into effect on 1 March 2011 (see page 32).

New labelling framework

Under the new label approval arrangements implemented in July 2010, the APVMA considers and approves only those matters that are prescribed as relevant label particulars in the legislation and regulations. This has simplified the approval of labels and increased the ease of label changes by allowing registrants to make certain changes to their labels without making an application to the APVMA.

Relevant Label Particulars and statutory conditions

As a result of the July 2010 legislative reform, the APVMA has simplified the approval of labels and increased the ease of label changes by allowing registrants to make certain changes to their labels without making an application to the APVMA.

Under the new arrangements, the APVMA considers and approves only those matters that are prescribed as relevant label particulars in the legislation and regulations. The consideration of the relevant label particulars relates primarily to ensuring that the label will contain adequate instructions for the safe and effective handling, use and storage of a product.

The APVMA no longer considers factors such as the size, shape and colour of the label, use of logos, warranty and company information. These elements are now governed by statutory conditions of label approval. These statutory conditions apply to all previously approved labels and all labels that may be approved in the future. Registrants are responsible for ensuring that their marketed product labels contain all of the relevant label particulars and that they comply with all the statutory conditions. Under the new arrangements, a registrant may make certain changes to their label as long as the marketed product label continues to include the relevant label particulars, does not contain information that is contrary to the relevant label particulars, and all information complies with the statutory conditions. This gives registrants a greater degree of flexibility in making label changes that involve label size, shape, graphics, font, layout, logos and marketing information. The task of marketplace checking and auditing marketed product label compliance with the statutory conditions has been allocated to the Compliance team.

The APVMA is preparing to publish a Labelling Standard in 2011 that will replace the current Ag Labelling Code and Vet Labelling Code. This Standard will assist registrants with ensuring that they are compliant with the statutory conditions.

The statutory conditions also impose certain record-keeping obligations on registrants. These records will allow the APVMA to check a registrant’s compliance with the statutory conditions through a combination of targeted audits and marketplace checking.

The simplification of the APVMA’s label approval process has resulted in an improved percentage of applications finalised within the statutory timeframe from the beginning of the 2010–11 financial year, when the labelling reforms were introduced. This improvement in meeting timeframes was achieved without increasing staff numbers, despite an increase in applications from the 2009–10 financial year: the Pesticides Program experienced an increase of 23 per cent in the number of applications received and a 19 per cent increase in the number of applications finalised; the Veterinary Medicines Program experienced a 22 per cent increase in the number of applications received and a 33 per cent increase in the number of applications finalised. The greatest improvement in meeting timeframes was seen in the Pesticides Program, since agricultural chemical labels tend to be larger and more complex. In addition, both the clock-on time and elapsed time for most classes of applications was reduced.

Figure 4: Financial year and quarter

Figure 4: Financial year and quarter

Permits and Minor Use

Permits that may be considered by the APVMA are for one of four purposes:

  • Minor Use—which applies to situations usually involving low acreage, small portions of high acreage crops, or animal species that are not covered by the product label
  • Emergency uses—for situations such as outbreaks or exotic pests and diseases
  • Research—which allows chemical products to be used in research trials for scientific purposes, such as determining suitability of a product for a new use or generating data necessary to register a product
  • Export—which allows the holder to possess and supply an unregistered chemical product or an unapproved active constituent for export purposes only.

Pesticide permits completed

During 2010–11, a total of 416 pesticide permits were finalised, of which 315 (76 per cent) were completed within the statutory timeframe. The target of 85 per cent was not met due to an increase in the number of emergency requests. Of the permits finalised, approximately 69 per cent of applications were for Minor Use permits, 14 per cent were for research purposes, and 17 per cent for emergency uses.

This year, the APVMA assessed 65 emergency use permits, some of which were complex to process. This was an increase from 28 to 65 applications or 132 per cent more applications. As a result, there were fewer permits finalised overall.

The time taken to assess permit applications depends on the complexity of the proposed use and required risk assessment. Longer timeframes apply to applications requiring assessment of residues data or assessment by other government agencies.

Emergency uses

2010–11 presented a higher-than-normal number of emergency use permit requests. APVMA liaised closely with affected industries, state and Commonwealth departments and chemical suppliers in assessing a total of 65 emergency use applications. These evaluations were also more complex than is normally the case, and many permits involved multiple product and crop combinations. For instance, 23 of the emergency permits required residue assessments totalling 73 individual uses, 11 of which required emergency trade consultation.

Other permit activities

The following is a summary of prominent activities and emergency use needs that the APVMA engaged with and considered during the year.

Locust plagues

The year began with significant involvement in preparedness activities in combating the 2010 locust plague, which had the potential to affect agricultural industries across several states. The APVMA participated in several meetings, in particular with the Australian Plague Locust Commission, relevant state agencies, SAFEMEAT, the Grains Research and Development Corporation (GRDC), and Horticulture Australia Limited. These liaison activities assisted in the issue of several emergency use permits and collaboration in the development of extension material to inform end users of approved options for cereal, pulse, oilseed and pasture cropping situations. These materials also outlined the need for responsible chemical use and, in particular, advice in the appropriate management of livestock associated with treated areas. The APVMA hosted a workshop for key state and Commonwealth authority extension personnel to discuss the management of residues in livestock.

Floods

The year also brought a welcome change for drought-affected industries, with extensive rainfall across most eastern states. Although positive, it presented problems of its own. Apart from flood damage to many regional communities and agricultural producers, the increased period of prolonged rainfall also inflicted high disease pressure and strain on the availability of fungicides in the market. Permit approvals were sought and issued across many industries, including several for alternative fungicide options to be used in pulse crops, grapes, citrus, strawberries and pre-harvest desiccation aids in certain broadacre crops. Rapid approval of these permits required a number of emergency trade consultations.

Myrtle rust

Myrtle rust (Uredo rangelii) is a newly discovered exotic disease that affects plants belonging to the family Myrtacea. Currently found in the identification in New South Wales, it poses significant threats to many native plant industries and also amenity plants, including native bushland species. Commercial native plant industries under threat from the disease include many producer industries such as tea tree, nursery, ornamental, forestry and native food producing crops. The APVMA participated in several meetings and workshops during the year with both the Office of the Chief Plant Protection Officer and state departments of primary industries, Plant Health Australia, Nursery & Garden Industry Australia, and other affected plant industries to discuss control programs and the required research and development, and to advise on permit requirements for the approval of fungicides. In response, the APVMA issued permits for the use of several fungicides in many of the situations and affected industries described above.

Mouse plague

Agricultural producers in South Australia, Victoria and New South Wales also battled a significant mouse plague that placed considerable pressure on the availability of registered baiting options. The APVMA engaged with relevant industry groups, including state farmer associations, state departments, the GRDC, and chemical manufacturers and suppliers in discussing requirements for the consideration of alternative baiting options. The APVMA assessed and issued permits to allow mouse-control activities, including alternative packaging types and new situations in which registered baits containing zinc phosphide could be used, allowed baits to be manufactured with unsterilised grain, approved an unregistered zinc phosphide bait to be manufactured at regional locations, and allowed baits prepared with bromadiolone and coumatetralyl to be supplied for use.

Veterinary medicine permits

The Veterinary Medicines Program had 69 permit applications in process at 1 July 2011. During the year, 244 applications were received, and 260 applications were finalised, of which 247 (95 per cent) were finalised within the statutory timeframe. Of the permit applications finalised, 228 permits were issued and 32 applications were withdrawn. The permits were issued for the following purposes:

  • 54 per cent of permits were Minor Use permits for off-label use of registered and unregistered veterinary medicines and autogenous vaccines
  • 33 per cent of permits were issued to extend the shelf life of specific batches of registered veterinary product and to generate residue, safety and efficacy data to support applications for registration
  • one of the trial permits was issued to conduct trials with the bacterium Wolbachia sp. to ascertain whether it could reduce the transmission of dengue fever in humans. The bacterium is inserted into the Aedes aegypti mosquito, which is responsible for transmitting dengue fever
  • 11 per cent of permits were to allow export of unregistered veterinary chemical products
  • 1 per cent were for emergency uses.

Scientific assessment performance

Each chemical product that is submitted to the APVMA for registration is subject to rigorous scientific assessment before it can be approved. Specialist staff in the APVMA assesses the chemistry of the product and its ingredients, how it was manufactured, and any residues it leaves behind after use. The APVMA also commonly seeks specialist advice from a number of Australian Government agencies and, where appropriate, consults with state and territory departments and other specialist organisations.

Assessment of chemistry requirements

When evaluating applications to approve active constituents or register products, the APVMA must be satisfied that the constituents and manufacturing process for a product are assessed and appropriate.

Pesticides chemistry

During 2010–11, 135 active constituent applications and 236 product applications were received requiring a chemistry assessment. In comparison with 2009–10, this was an increase of 25 per cent in the number of applications that required a chemistry assessment.

During 2010–11, 159 active constituent applications and 188 product applications were finalised, which is an increase compared to the 96 and 181 applications finalised in the previous year. The timeframe performance for active constituent applications was 17 per cent within timeframe, well below the target of 50 per cent. This is due to a higher throughput of applications being finalised (89 per cent more applications were finalised than in the previous year), with a high number of applications being overdue due to a backlog in the previous year.

By continuing to use external consultants to undertake preliminary chemistry evaluations for new active constituent approvals, the Chemistry team has been able to focus on product assessments and reducing the number of applications classed as ‘work in progress’ for active approvals.

Veterinary pharmaceutical chemistry

During 2010–11, the Pharmaceutical Chemistry team aimed to improve its timeframe performance whilst maintaining its number of outputs. The Pharmaceutical Chemistry team increased the percentage of evaluations meeting the chemistry assessment specific timeframe by 44 per cent (65 per cent in 2010–11; 45 per cent in 2009–10). Forty-five (21 per cent) fewer evaluations were completed than in 2009–10, and an unchanged number of applications were still in progress. Eleven fewer evaluations (6 per cent) were received in 2010–11. In addition, seven permit assessments were also finalised in 2010–11.

During the second half of the year, external reviewers did the initial evaluation for approximately 18 per cent of the received evaluations.

Assessment of residues in product evaluations

When evaluating applications to register products or grant permit approvals, the APVMA must be satisfied that the products can be used safely. A dietary exposure assessment is conducted to establish whether the use of a product on food crops or animals will be acceptable against relevant health standards, namely the Acceptable Daily Intake and the Acute Reference Dose. Products are not registered unless the dietary exposures, assessed using internationally recognised methods, are found to be acceptable against established health standards.

The APVMA evaluated pesticides residue data for 30 applications for product registration, 75 applications for permits, and 23 applications for emergency permits, resulting in 299 amendments to the APVMA Maximum Residue Limit (MRL) Standard.

The APVMA evaluated veterinary residue data for 16 applications for product registration, 10 for permits and one for an emergency permit, resulting in 51 amendments to the APVMA MRL Standard.

The APVMA continued to implement harmonisation initiatives with other Australian Government and international agencies. The Japanese Positive List is a five-year project initiated in 2006–07 through DAFF, with support from relevant industry organisations in 2006–07. The project has aimed to provide information to the Japanese Ministry of Health, Labour and Welfare to support the establishment of MRLs in Japan that are based on Australian use patterns and registrations.

In 2010–11, the APVMA provided information to Japanese authorities in relation to MRLs for 85 agricultural chemicals and veterinary medicines.

The Taiwanese Bureau of Food Safety asked for information from Australia to help establish MRLs for pesticides in crop commodities. The APVMA provided information on ten agricultural chemicals to assist with this process.

APVMA MRL Standards adopted

The 2008 Productivity Commission report into the Regulation of Chemicals and Plastics recommended direct adoption of APVMA MRL Standards into the Food Standards Code. Council of Australian Governments (COAG) endorsed the Productivity Commission recommendations as follows:

COAG agrees to the recognition, for domestically grown produce, by Food Standards Australia New Zealand of the Australian Pesticides and Veterinary Medicines Authority’s residue risk assessments and to the promulgation of the resulting maximum residue limits to the Food Standards Code.

Changes to the governing legislation of both the APVMA and FSANZ to allow the APVMA to directly vary Standard 1.4.2 of the Australia New Zealand Food Standards Code came into effect on 1 March 2011. The APVMA has been working closely with FSANZ to implement these changes. A total of 202 MRLs are currently being considered under the new legislation. It is expected that the APVMA will make its first direct variations to Standard 1.4.2 early in the 2011–12 financial year.

Compliance with MRLs in food commodities for pesticides and veterinary medicines

The portfolio budget statement target is 99 per cent compliance with MRLs in food commodities for pesticides and veterinary medicines, which is monitored and reported by the Australian National Residues Survey. A summary of the results of residues testing conducted by the National Residues Survey in 2009–10 is available at http://www.daff.gov.au/agriculture-food/nrs/publications/annual-reports/nrs-annual-report-2009-2010.

Of the 21,162 samples tested as part of random monitoring of animal and plant products, 98.3 to 100 per cent (average 99.7 per cent) complied with the relevant MRLs.

Advice from external agencies

In evaluating applications for registration, the APVMA receives advice from various Australian Government and state and territory government agencies on human health, toxicology and occupational health and safety, the environment, efficacy, target animal and crop safety, and genetically modified products and organisms. Formal service level agreements are in place between the APVMA and the agencies concerned to ensure that advice is provided in a framework that is cost-effective, accountable and has relevant performance measures.

Throughout 2010–11, the APVMA maintained and revised its service level agreements with the Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) and the Office of Chemical Safety and Environmental Health (OCSEH) of the Department of Health and Ageing. Services include assessments for registration and permit applications, assessments of chemicals under reconsideration and other professional advice. DSEWPaC delivered 60.8 percent of application assessments within the agreed timeframe and the OCSEH delivered 37.7 percent. The reduced output from the agencies in 2010–11was a result of staff shortages as well as unanticipated additional work for a number of registration assessments. Currently, all indicators show that the agencies should return to higher levels of ‘within timeframe’ performance during 2011–12.

The APVMA maintained its memorandum of understanding with the Office of the Gene Technology Regulator (OGTR) in 2010–11. The OGTR advises the APVMA on the effect of pesticides and veterinary medicines on genetically modified organisms and on genetically modified organisms that are part of pesticide and veterinary medicine products. The APVMA also provides comment on relevant draft risk assessments prepared by the OGTR.

The APVMA has maintained and revised the Efficacy and Target Animal/Crop Safety Reviewer’s Manual to assist reviewers and applicants in their understanding of assessment of efficacy and target animal and crop safety.

Deeds of standing offer

The APVMA supplements the scientific advice received from various Australian state and territory government agencies by external scientific service providers. The external scientific service providers are selected using a series of Australian Government policies that surround the expenditure of Commonwealth funds, including the 2005 Commonwealth Procurement Guidelines. These guidelines clearly require the APVMA to ensure that expenditure delivers value for money, encourages competition and is an efficient, effective and ethical use of resources.

The APVMA has maintained and revised the Manual for External Scientific Reviewers to assist external scientific reviewers in their understanding of assessment relating to reconsideration services, as well as registration applications relating to toxicology, occupational health and safety and efficacy.

Enhance the quality of regulatory science and deliver consistently high quality evaluations and advice

The APVMA maintains and enhances the quality of its regulatory science through its two Principal Scientists and by engaging scientists external to the APVMA, including its Science Fellows and Visiting Scientists.

The APVMA employs two Principal Scientists—one with the responsibility for pesticides and the other for veterinary medicines and nanotechnology. Dr David Loschke occupied the position of Principal Scientist, Pesticides until 17 September 2010, and the position was subsequently filled by Dr Les Davies (from 21 March 2011). Dr Phil Reeves is Principal Scientist, Veterinary Medicines and Nanotechnology. The Principal Scientists carry overall responsibility for improving the quality of scientific work in the APVMA, increasing domestic and international awareness of the APVMA’s scientific strength, and effectively managing science-related issues and projects in the APVMA. They provide advice on technical policy and strategic management issues across the APVMA. Their achievements in 2010–11 are listed in Table 7. In addition to these specific tasks and projects, the Principal Scientists provided input and advice on policy and strategic management issues across the APVMA.

Develop a risk framework

The APVMA substantially advanced the development of a risk analysis framework, a document that describes the process through which the APVMA makes its decisions about the safety and effectiveness of pesticides and veterinary medicines. The document will be finalised early in 2011–12.

Table 7: Achievements of the APVMA Principal Scientists in 2010–11

Objective

Performance

Improve the quality of scientific work in the APVMA

Spray drift concerns were again a focus of the Principal Scientist, Pesticides, in 2010–11. Achievements by Dr David Loschke included:

  • extending the APVMA Operating Principles In Relation to Spray Drift Risk, with additional scenarios for a wider range of droplet sizes and cropping situations

  • developing a supplementary Operational Notice for spray drift issues

  • providing training sessions and workshops in spray drift modelling and risk assessment for staff in the APVMA and its advisory agencies

  • developing policy for the operation of a drift reduction technology program for the APVMA.

Achievements of Dr Les Davies in relation to science quality included:

  • providing advice on quality of reports from APVMA’s advisory agencies (DSEWPaC and the Department of Health and Ageing) submitted to the APVMA as component reports of various reviews of existing agricultural chemicals
  • participating in a project to update and expand occupational health and safety exposure models to better estimate exposures arising from the application of agricultural chemicals.

The development of national and international guidelines and the establishment of an expert network in nanotechnology were a focus of the Principal Scientist, Veterinary Medicines and Nanotechnology.

Achievements by Dr Phil Reeves included:

  • contributing as the Australia–New Zealand representative of a VICH1 Expert Working Group to the development of four guidelines on metabolism and residue kinetics of veterinary drugs; the guidelines have been adopted for implementation in the European Union, Japan, the United States of America, as well as in Australia, Canada and New Zealand
  • contributing to the development of an APVMA guideline on veterinary disinfectants, with input from APVMA visiting scientists, Dr Joanne Devlin and Dr Marc Marenda
  • convening a focus group led by APVMA Science Fellow, Professor Nicholas Sangster, to consider the data requirements for certain generic veterinary parasiticides
  • convening a training workshop in antimicrobial drug resistance by APVMA Science Fellows, Professors Mary Barton and Glenn Browning
  • contributing as the Australia–New Zealand representative of the VICH Bioequivalence Expert Working Group to the development of a guideline on bioequivalence of veterinary medicines
  • establishing an APVMA Nanotechnology Expert Advisory Panel (NEAP) as a part of progressing the preparedness strategy for regulating agricultural and veterinary products of nanotechnology in Australia; funds received from the Department of Innovation, Industry, Science and Research under the National Enabling Technologies Strategy were used for these activities.

Increase domestic and international awareness of the APVMA’s scientific strengths

APVMA’s Principal Scientists are actively engaged with the Australian and international scientific communities.

Dr Loschke:

  • liaised with the Organisation for Economic Co-operation and Development (OECD) Task Force on Biocides and prepared the final draft of a new OECD guidance document on how to demonstrate the efficacy of pool and spa disinfectants; this document was developed under Australia’s lead and is based on Australia’s own guidance document on this topic.

Dr Davies:

  • served as an expert member on the Toxicology Panel of the 2010 WHO/FAO Joint Meeting on Pesticide Residues (JMPR) in Rome (21–30 September 2010)
  • liaised with regulators in the US Environmental Protection Agency, the Canadian Pest Management Regulatory Agency, the United Kingdom Chemicals Safety Directorate and the German Institute for Risk Assessment about various pesticide issues
  • liaised with external Australian scientists on a number of issues (including agricultural use practices, the incidence of certain diseases in the population, and the interpretation of epidemiological studies).

Dr Reeves:

  • presented on bioequivalence at the 2011 Australian Veterinary Association Conference
  • served as the Australia–New Zealand representative on the VICH Expert Working Group on metabolism and residue kinetics of veterinary drugs and the VICH Bioequivalence Expert Working Group
  • was a guest lecturer at the University of Sydney, Charles Sturt University, and Monash University
  • served on two editorial boards
  • had a chapter accepted for publication in Chemical Residues of Veterinary Antibiotics in Food and co-authored a paper that has been accepted for publication in a peer reviewed, scientific journal.

Effectively manage science-related issues and projects in the APVMA

As part of their ongoing engagement in science issues at the APVMA, the following activities were carried out by the Principal Scientists:

  • further development of methods and standard approaches for spray drift risk assessment (Dr Loschke; see above)
  • working with APVMA Public Affairs to develop technical information for publication on the APVMA website; this information was prepared in response to various public or media concerns about pesticides during the year (Drs Loschke and Davies)
  • taking part in media interviews to explain APVMA’s regulatory approach to several pesticide issues (Drs Loschke and Davies)
  • development of a program for a national symposium on the use of epidemiology studies in regulatory risk assessment; this symposium will take place in August 2011 (Dr Davies)
  • contributing to the development of an APVMA risk analysis framework to advise stakeholders of the approach used by the APVMA in its chemical risk assessment tasks (Drs Reeves and Davies)
  • development of a strategy to improve regulatory science communication by the APVMA (Drs Reeves and Davies)
  • establishment of the Regulatory Science Network to improve communications about technical issues between Australian Government agencies involved in regulation (Drs Reeves and Davies)
  • contribution to the finalisation and adoption of four VICH guidelines on metabolism and residue kinetics of veterinary drugs (Dr Reeves; see above) and the development of a VICH bioequivalence guideline (Dr Reeves; see above)
  • continuation of a project whose aim is to determine the training needs of evaluators in the Veterinary Medicines Program and to deliver that training (Dr Reeves).

APVMA Science Fellows Program

The APVMA Science Fellows Program, which was established in 2006, has the primary objective of enhancing the quality of regulatory science and building public confidence in the APVMA. Science Fellows are eminent national and international scientists in key disciplines that are relevant to agricultural and veterinary chemical regulation. Five Science Fellows have been appointed for pesticides and eight for veterinary medicines (Table 8).

Science Fellows provide high-level independent advice on complex and contentious regulatory issues; assist in the development of regulatory science policy; provide advice in relation to staff training; and speak at APVMA Science Fellows symposiums.

The work of the Veterinary Medicines Science Fellows is supported by a Veterinary Medicines Expert Advisory Panel (VMEAP). The VMEAP meets only as required. In addition, expert working groups under the leadership of a Science Fellow meet as required and focus on specific issues in a certain field.

The scientific basis for the APVMA’s work is also supported by Visiting Scientists, whose main role is to deliver training to staff in the Veterinary Medicines Program. Staff can also access them for advice on scientific risk assessments when processing applications. All training materials presented by Visiting Scientists are placed in an electronic repository that can be accessed online by evaluators. To date, three Visiting Scientists have been appointed: Dr Michael Chambers in the field of clinical trial conduct and data analysis; Dr Joanne Devlin in the field of veterinary virology; and Dr Marc Marenda in the field of veterinary bacteriology.

Table 8: The APVMA’s Science Fellows as at 30 June 2011

Science Fellows

Expertise

Pesticides Program

Dr Andrew Hewitt

Spray Drift Science and Control

Dr Rai Kookana

Environmental Toxicology

Professor Stephen Powles

Herbicide Resistance Mechanisms

Professor Brian Priestly

Toxicology of Pesticides and of Mixtures

Professor Bernard Stewart

Carcinogenicity and Risk Communication

Veterinary Medicines

Dr Dieter Arnold

Residues of Veterinary Drugs in Foods

Professor Mary Barton

Antibiotics and Antibiotic Resistance

Professor Glenn Browning

Veterinary Vaccinology

Professor Colin Chapman

Pharmaceutical Sciences

Professor Terry O’Neill

Statistics

Professor Nicholas Sangster

Veterinary Parasitology

Professor Ted Whittem

Veterinary Pharmacology

Professor Philip Burcham

Nanoscience

APVMA science seminars

APVMA science seminars provide an opportunity for external experts to address technical and other staff about matters relevant to the work of the APVMA. Subjects can cover a broad range of topics including toxicology, ecotoxicology, product chemistry, agricultural use practices, and control-of–use issues. Seminars also provide an opportunity for APVMA staff to share their knowledge and expertise with other APVMA staff. The seminar program contributes to the continuous learning and development of staff and helps increase internal interactions that acknowledge available in-house expertise.

Technical seminars on the following topics were presented in 2010–11:

  • Sensitivity of Australian Birds to Fipronil Insecticide (Ms Malsha Kitulagodage, University of Wollongong; Friday 25 February 2011)
  • Who POP’ed the dugong? A story of Dioxin Impurities in Pesticide Formulations (Dr Caroline Gaus, National Research Centre for Environmental Toxicology, University of Queensland; Friday 13 May 2011).

Nanotechnology

During 2010–11, the APVMA received funds from the Department of Innovation, Industry, Science and Research under the National Enabling Technologies Strategy. These funds were used for:

  • capacity building, with a focus on staff training and development and the establishment of the NEAP
  • preparing to regulate agricultural and veterinary products containing nanotechnology.

Three APVMA Fellows in Nanoscience were recently appointed to serve on the NEAP (Table 9). The NEAP will play a critically important role in the provision of advice to the APVMA on applications as well as developments in international research and regulation.

The development of data requirements for nanomaterials will remain a priority for the APVMA as nanotechnologies continue to evolve. Workshops involving the APVMA and the advisory agencies that will address data requirements for nanomaterials are planned for 2011–12.

Table 9: The APVMA’s Fellows in Nanoscience as at 30 June 2011

Fellows IN NANOSCIENCE

Expertise

Dr John Miles

Chemistry of nanomaterials

Professor Michael Roberts

Public health (toxicology)

Professor Mike McLaughlin

Environmental health (ecological toxicity and fate)

International engagement activities

The APVMA continues to monitor international development. In addition to attendance on international committees, the APVMA also receives visits from overseas experts and from regulators, and APVMA staff embark on fact-finding missions with their overseas counterparts.

Continue international cooperation

During 2010–11, the APVMA and its partner agencies worked with several overseas regulatory agencies in global joint reviews and in work-sharing of assessments for new pesticide active constituents. In the past year, the APVMA has taken part in eleven joint pesticide reviews of new active constituents and their formulated products. These joint reviews have been undertaken concurrently with the United States, Canada, Germany, the United Kingdom and New Zealand. Planning has also commenced for another four proposed joint reviews, which are expected to begin in 2011–12.

The role of the APVMA and its advisory agencies in global joint reviews is to be the primary reviewer for some assessments and the secondary reviewer for others. Global joint reviews deliver internationally robust assessments, consistency and predictability and an increased business-like approach for the applicants as well as for the regulatory agency. While the administration requires considerable investment from the regulators, the faster time to market globally benefits industry, manufacturers and users alike.

Dr Eva Bennet-Jenkins, CEO and Dr Allen Bryce, Program Manager Veterinary Medicines, participated in the Global Animal Health Conference held at the European Medicines Authority in London. Dr Bennet-Jenkins gave a presentation describing the global joint review model used for pesticides applications. Senior representatives from international animal health companies were positive about the opportunity of following a similar approach, whereby companies could nominate selected veterinary medicines to be evaluated in a cooperative effort by several major international regulators. Key overseas regulators have also expressed support for working with the APVMA to trial this approach.

Organisation for Economic Co-operation and Development

Dr Eva Bennet-Jenkins, the APVMA’s CEO has been appointed as Vice-Chair for the Working Group on Pesticides, a committee of the Organization for Economic Cooperation and Development (OECD).

The Working Group on Pesticides is the forum for national pesticide regulators from developed countries to discuss common issues about conventional and biological pesticides. It comprises representatives of OECD governments, the European Commission and other international organisations, the pesticides industry and the environmental community.

The Working Group on Pesticides supports the objectives of the OECD Pesticides Programme:

  • help OECD governments share the work of pesticide registration and re-registration, as the same pesticides are often used in many countries
  • harmonise the data and methods used to test and assess pesticide risks, so as to help governments work together and improve the quality of the data and the rigour of the assessments
  • help OECD governments reduce the risks associated with pesticide use, through a variety of actions to supplement pesticide registration and further reduce the risks that may result even when registered pesticides are used properly.

The APVMA attended and participated in meetings of the OECD Working Group on Pesticides, the Registration Steering Group, Risk Reduction Steering Group, Biopesticides Steering Group and the Expert Working Group on Compliance.

APVMA staff also attended several expert working group meetings and workshops for Minor Use, residue chemistry, veterinary medicine regulation, global joint review meetings with other government regulators, and compliance meetings.

The APVMA managed the project of drafting of new OECD guidance for the estimation of dermal absorption values for pesticides, Guidance Notes for the Estimation of Dermal Absorption Values. The objective was to harmonise guidance to assist in uniform interpretation of dermal absorption studies and guidance on estimating dermal absorption values in the absence of such studies. The project was completed in April 2011, when the document was ratified by the OECD test guideline program.

International engagement and Minor Use

The APVMA maintains its active involvement in international processes and forums associated with Minor Uses. An APVMA officer represented the APVMA at a meeting with the Northern European Union Technical Group on Minor Uses. The APVMA was Chair of the OECD Expert Group on Minor Uses, which initiated the following activities during 2010–11:

  • a survey on approaches and requirements for efficacy and crop safety
  • investigations into regulatory incentives for registration and approaches to liability for Minor Uses
  • development of OECD guidance documents on defining Minor Uses and solving Minor Use gaps.

The outcome of this work produced the three documents that are published on the OECD website;

  • Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses
  • OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results
  • OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of pesticide Minor Uses: Survey Results.

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is a trilateral (European Union – Japan – United States) program aimed at harmonising technical requirements for registration of veterinary products. Australia, New Zealand and Canada have observer status at VICH meetings, and New Zealand and Australia alternate representational leadership of our agencies at VICH. A New Zealand Food Safety Authority officer currently represents Australia and New Zealand, and from 2012 Dr Allen Bryce, Program Manager of Veterinary Medicines will represent both Australia and New Zealand at VICH; Dr Bryce attended the twenty-fifth meeting of the VICH Steering Committee in February 2011 to assist in preparing for this role. Dr Reeves—the Principal Scientist, Veterinary Medicines—represents Australia and New Zealand on a VICH expert working group that is developing new guidelines on assessment of drug residues in animal derived foods.

VICH is the only international forum that attempts to harmonise the technical requirements for registration of veterinary medicines and as such provides leadership for veterinary medicines regulators, and for the regulated industries, globally. The APVMA’s contributions to VICH processes have the same weight as those of the full members and APVMA’s participation in VICH processes helps to keep the APVMA’s data requirements for registering products in Australia consistent with those of comparable regulators. It also ensures that the needs of Australian industry and users are considered as VICH guidelines are developed.

Joint Meeting on Pesticide Residues in Food (JMPR) and Joint Expert Committee on Food Additives and Contaminants (JECFA)

JMPR and JECFA are international scientific expert groups that are jointly administered by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). During 2011, two monographs are being prepared within the pesticides residues team for the 2011 JMPR to consider. This is part of the training process for a new temporary advisor from APVMA to join the FAO panel of experts. As in previous years, Dr Les Davies will be attending as a member of the WHO panel of experts and Dr Raj Bhula continues to provide expertise as a peer reviewer for newer members of the FAO panel of experts.

Codex

The Codex Alimentarius is a series of food standards and related texts that aim to provide a high level of consumer protection and fair practice in the international trade of food and agricultural products. The organisation is charged with the development of the codex standards and related texts is the Codex Alimentarius Commission, which is an intergovernmental body jointly sponsored by the FAO and WHO. Membership is open to all member nations and associate members of the FAO or WHO and currently includes more than 160 countries. International non-governmental organisations, such as consumer, academic or industry bodies, may attend Codex meetings as observers.

Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF)

CCRVDF makes recommendations to the Codex Alimentarius Commission regarding management of risks arising from residues of veterinary drugs in food. The advice given by JECFA regarding maximum residue levels of veterinary drugs is incorporated by CCRVDF into its recommendations to Codex Alimentarius Commission.

The APVMA participates in CCRVDF as part of the Australian delegation. APVMA chairs the CCRVDF Working Group on Priorities, which determines the compounds to be evaluated by JECFA. The APVMA also has a representative on several other Working Groups, including a group looking at appropriate ways of managing veterinary medicines without setting values for acceptable daily intake or MRLs, and a group looking at ways of extrapolating MRLs for application to medications for Minor Uses and minor species. Participation in these groups contributes directly to development of Australian policies in these areas that will ensure Australia’s practices are consistent with those of Codex and the World Trade Organisation.

Being represented on these groups allows Australia to influence which veterinary medicines will be evaluated by JECFA and have MRLs determined. The existence of Codex MRLs is important in facilitating the export of Australian food commodities. In recent years, JECFA MRLs have been set for triclabendazole and monepantel; having these MRLs facilitates the export of sheep meats and benefits the Australian sheep meat industry.

Australia’s participation in CCRVDF and its committees has other benefits. It maintains Australia’s reputation as implementing international best practice in managing veterinary residues in food. It also provides an opportunity for liaison with the regulators of our major trading partners in animal commodities, and contributes to the operation of the international regulatory system for residues of veterinary drugs in food. These are major factors in maintaining confidence in the safety and quality of Australia’s exports of animal commodities.

Codex Committee on Pesticide Residues

The JMPR provides recommendations on MRLs to the Codex Committee for Pesticide Residues (CCPR) for the establishment of Codex MRLs for trade. This committee met in April 2011 in China. The Program Manager, Pesticides attended the meeting as the alternate delegation leader and as part of the Australian delegation. The APVMA provides technical expertise to the delegation in the form of participating in working groups such as the Electronic Working Group on Minor Uses and the working group for the revision of the Codex Classification, providing responses to technical policy issues such as the OECD MRL Calculator, and providing country comments on proposed standards. At the forty-third session of the CCPR, a presentation was given on the use of the concept of proportionality for estimating MRLs. Active participation at the CCPR, as well as the OECD, allows active monitoring of and contribution to technical issues related to setting MRLs.

More information on this Codex committee, Australia’s contribution to its work and meeting outcomes can be found on the DAFF website: http://www.daff.gov.au/agriculture-food/codex/committees/pesticide.

Other international activities

The APVMA has active working relationships with many international agencies and overseas regulators. These relationships assist the APVMA to uphold its mission by keeping us informed of international developments relevant to the APVMA’s work and ensuring that Australia’s regulatory framework meets standards for international best practice.

The APVMA works collaboratively with several overseas regulators on various projects and shared initiatives and actively participates in international fora on key regulatory matters and emerging issues.

The APVMA continues its international cooperation by formalising new international relationships and renewing existing agreements to facilitate the exchange of information and collaborative working with our overseas counterparts. Memoranda of understanding and similar agreements have been signed between the APVMA and some key global regulatory counterparts:

  • the New Zealand Food Safety Authority
  • the Veterinary Drugs Directorate of the Department of Health of Canada
  • Centre for Veterinary Medicines, the Food and Drug Administration in the USA
  • the Pest Management Regulatory Agency in Canada
  • the Veterinary Medicines Directorate in the United Kingdom
  • the United Kingdom Chemicals Regulation Directorate.

The APVMA is in the process of setting up new agreements for collaborative working and the exchange of confidential information with:

  • the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA) in China
  • the Veterinary Medicines Department of the European Medicines Agency
  • the Centre for Veterinary Biologicals in the United States.

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