A single national framework for the regulation of agricultural chemicals and veterinary medicines - regulatory model

1. In 2008 the Productivity Commission released a report on the regulation of chemicals and plastics ¹. In response, the Council of Australian Governments (COAG) directed the Primary Industries Ministerial Council (now the Standing Council on Primary Industries [SCoPI]) to develop a single national framework to improve the efficiency and effectiveness of the regulation of agricultural chemicals and veterinary medicines (agvet chemicals).
   
   
2. These reforms aim to address current variations in states and territory regulation, relating to:
   • licensing and competency requirements for chemical users and fee–for–service users ²,
   • limited and inconsistent monitoring of chemical residues, including varying levels of integration with state, federal and private sector monitoring systems,
   • variation in access to chemicals restrictions, including off–label use restrictions and application of additional chemical controls,
   • compliance and enforcement of chemical use in accordance with registered and other permissible uses and,
   • record–keeping requirements for chemical use.
     
     
3. SCoPI is required to deliver a regulatory model, funding model and an Intergovernmental Agreement (IGA) for the proposed single national framework by December 2012.
   
   
4. Following extensive policy discussions and consultation with stakeholders, the proposed regulatory model contains harmonised models for licensing, training, access to agvet chemicals and a national produce monitoring program.
   
   
5. The proposed overarching governance arrangements for this framework specifies that:
   
   • control–of–use powers and responsibility is retained by states and territories with uniformity achieved through harmonised jurisdictional legislation,
   • there is increased jurisdictional involvement in governance of the Australian Pesticides and Veterinary Medicines Authority (APVMA)
   • arrangements are formalised through a recommitment to an amended IGA and
   • a new strategic policy committee for agvet chemicals is created under COAG/SCoPI to oversee the development and implementation of the national system, on the understanding that the new committee replace one or more of the current committees under the PISC framework.
     
     
6. The proposed licensing model details minimum harmonised requirements, where:
   • all fee–for–service providers (e.g. pest controllers, ground and aerial applicators, sheep dippers) are required to be licensed
   • both fee–for–service businesses and individuals within those businesses are required to be licensed
   • licensing will not be required for users of Restricted Chemical Products (RCPs) and Schedule 7 (S7) chemicals who are not operating a fee–for–service business (general users, including farmers), except when specifically required due to regional need
   • licenses will be issued by the jurisdiction for registration of a business or for an individual, based on their primary location/residence
   • fees and charges will be set by each jurisdiction
   • all jurisdictions will automatically recognise licences issued in other jurisdictions and
   • individual jurisdictions will be responsible for auditing and compliance within their own state; and any suspension or cancellation of a licence or a right to operate in a particular jurisdiction will automatically apply in other jurisdictions.
     
     
7. In addition to the proposed licensing model, the following proposed harmonised minimum training requirements are included:
   • All fee–for–service providers are required to hold, as a minimum, Australian Qualifications Framework (AQF) Level 3 competency determined to be appropriate for the occupation as a condition of licence.
   • All users of RCPs and S7 chemicals are required to hold, as a minimum, AQF Level 3 competencies determined to be appropriate for the use of the product (but with no licensing requirement).
     
     
8. To support proactive risk management, the framework includes nationally consistent recordkeeping of chemical use and user audits. Although some users of RCPs and S7 will not require licenses, these users will still be required to maintain records of chemical use. This element would also help to identify regional issues to inform produce monitoring, traceback and compliance programs.
   
   
9. The harmonised access to chemicals model is split into requirements for agricultural chemicals and veterinary medicines. The proposed veterinary prescribing and compounding rights model outlines a harmonised system which allows veterinarians to compound and prescribe an extension of label uses for prescription, non–prescription and unregistered veterinary products subject to certain conditions. The proposed access to agricultural chemicals model outlines minimum nationally harmonised access to chemicals provisions for allowing limited variations on approved use instructions for crops or situations (also known as ‘off–label’ use). This element also incorporates the nationally consistent recordkeeping arrangements for users of agricultural chemicals.
   
   
10. The proposed regulatory model contains a harmonised, enhanced national monitoring and trace–back program for chemical residues in produce. This model would provide a nationally consistent base level of produce monitoring to maintain confidence in the agvet chemical system, and appropriately identify risks and respond to adverse events. Produce monitoring would also provide the evidence necessary to evaluate the proposed access to chemicals arrangements and assist in providing vital data to inform future reforms. The proposed model would link directly with existing compliance and enforcement processes in the jurisdictions and the APVMA and build on existing industry and government–run schemes.
    
    
11. Following COAG agreement, implementation of the above proposed models is anticipated to take approximately 18 months.
    
    
12. The above proposed framework outlines the general models for the licensing, training, monitoring and access to agricultural and veterinary chemical models. Further details of these models will be determined during the reforms’ implementation phases.
    
    
13. This implementation will require changes to state and territory control–of–use legislation. Some changes to Commonwealth legislation may also be required. Due to the different regulatory arrangements within each jurisdiction, harmonisation will be best achieved through the development of consistent and uniform drafting instructions for the amendment of existing legislation and regulations.
    
    
14. Further stakeholder consultation will be undertaken on details of the proposed models as part of these legislative changes.

15. The proposed regulatory model arises from the Council of Australian Governments (COAG) response to a 2008 Productivity Commission report on the regulation of chemicals and plastics. COAG directed the Primary Industries Ministerial Council [predecessor of the Standing Council on Primary Industries (SCoPI)] to ‘bring forward a proposal for a single national framework to improve the efficiency and effectiveness of the regulation of agricultural and veterinary chemicals.’
    
    
16. Of specific concern were highly variable regulatory requirements in relation to:
    1. licensing and competency requirements for chemical users and fee–for–service users (including aerial and ground applicators, contract sheep dippers and urban pest controllers),
    2. limited and inconsistent monitoring of chemical residues, including integration with state, federal and private sector monitoring systems,
    3. variation in use of off–label use systems and application of additional chemical controls;
    4. compliance and enforcement of chemical use in accordance with registered and other permissible uses and
    5. recordkeeping requirements for chemical use.
       
       
17. In developing the single national framework, there was also an expressed desire to minimise additional regulatory burden and to reduce burden where possible.
    
    
18. In August 2010, PIMC agreed to ‘A National Framework for the Assessment, Registration and Control–of–Use of Agricultural and Veterinary Chemicals’. This framework contains a set of principles and policy outcomes but no details of the proposed scheme. The Primary Industries Standing Committee (PISC), through the Product Safety and Integrity Committee (PSIC), the Animal Welfare Product Integrity Taskforce and the National Agvet System Policy (NASP) Taskforce, have since developed details of the proposed regulatory model, provided below.
    
    
19. In developing these model details, PISC subcommittees consulted widely to best inform policy discussions. Formal stakeholder consultation on a number of proposed reform elements occurred in March 2011 in the form of a Consultation Regulation Impact Statement (RIS). More than 70 public submissions were received from a range of stakeholders. PSIC also held stakeholder meetings in March 2011 to further inform policy and engage in discussion of the issues identified in the Consultation RIS. Resulting stakeholder views are recorded in the Decision RIS, which will be publically released following COAG’s decision.

Governance arrangements

Current situation

20. Under the National Registration Scheme (NRS), states and territories are responsible for control–of–use regulation, with registration and assessment conferred to the Commonwealth and undertaken by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
    
    
21. Arrangements between the Australian Government (the APVMA) and jurisdictions (excluding the ACT) are formalised through the Agricultural and Veterinary Chemicals (Administration) Act 1992, CTH (the Administration Act) and an Intergovernmental Agreement (IGA). The original IGA was agreed under Section 9 of the Administration Act and signed by Agriculture/Primary Industries ministers for each jurisdiction (excluding ACT) in 1995.

Proposed model

22. Overarching governance arrangements, where:
    1. control–of–use powers and responsibility is retained by states and territories with uniformity achieved through harmonised jurisdictional legislation
    2. there is increased jurisdictional involvement in governance of the APVMA
    3. arrangements are formalised through a recommitment to an amended IGA and
    4. a new strategic policy committee for agvet chemicals is created under COAG/SCoPI to oversee the development and implementation of the national system, on the understanding that the new committee replace one or more of the current committees under the PISC framework.
       
       
23. The proposed governance model contains limited changes to existing governance arrangements. By retaining control–of–use powers, states and territories are able to provide responsiveness and flexibility in the face of regional differences. However, the proposed model will improve on existing arrangements by ensuring that unnecessary regulatory differences between jurisdictions are reduced.
    
    
24. Under the proposed governance model, jurisdictions’ roles, responsibilities, commitments and accountabilities will be formalised through the amended IGA. This will lead to a stronger connection between agvet chemical regulation undertaken by the Australian Government and states and territories.
    
    
25. To ensure consistency in implementation of individual framework elements, a new strategic policy committee for agvet chemicals will be created. This committee will uphold the COAG Approved Principles of addressing state–Australian Government partnerships and providing for flexibility, adaptability, co–regulation and integration with other regulatory frameworks. Following implementation of the proposed reforms, this committee will continue to operate to maintain harmonisation and strengthen the connection between control–of–use and registration.

Current situation

26. Currently, licensing and training requirements and their regulation differs between states and territories. This places an undue regulatory burden on businesses operating across borders, a common situation for many aerial sprayers and some ground sprayers, as well as other fee–for service businesses.
    
    
27. At present these individuals and businesses need to comply with multiple varied requirements for both licensing and training, and pay multiple licence fees. These differences can lead to a higher regulatory burden than under an integrated national scheme.

Proposed model

28. The proposed licensing model contains the following minimum harmonised requirements:
    1. all fee–for–service providers (e.g. pest controllers, ground and aerial applicators, sheep dippers) are required to be licensed
    2. both fee–for–service businesses and individuals within those businesses are required to be licensed
    3. licensing will not be required for users of Restricted Chemical Products (RCPs) and Schedule 7 (S7) chemicals who are not operating a fee–for–service business (general users, including farmers)
    4. licenses will be issued by the jurisdiction for registration of a business or for an individual, based on their primary location/residence
    5. fees and charges will be set by each jurisdiction
    6. automatic recognition of any jurisdictional licence will exist in all other jurisdictions and
    7. individual jurisdictions will be responsible for auditing and compliance within their own state; and any suspension or cancellation of a licence or a right to operate in a particular jurisdiction will automatically apply in other jurisdictions.
       
       
29. In addition to the proposed licensing model, the following proposed harmonised minimum training requirements are included:
    1. All fee–for–service providers (e.g. pest controllers, ground and aerial applicators, sheep dippers) are required to hold, as a minimum, Australian Qualifications Framework (AQF) Level 3 competency determined to be appropriate for the occupation as a condition of licence.
    2. All users of RCPs and S7 chemicals are required to hold, as a minimum, AQF Level 3 competencies determined to be appropriate for the use of the product (but with no licensing requirement). Although these users will not require licenses, they will still be required to maintain records of chemical use.
       
       
30. The new strategic policy committee will be responsible for determining the specific training requirements during the implementation phase for the proposed system.
    
    
31. In August 2010, COAG agreed that the proposed competence and training model should be consistent across jurisdictional boundaries, linking access to chemicals to user competency; where the level of competence required is commensurate with the identified risk. Where appropriate, consideration should also be given to industry initiatives as the instrument to ensure compliance.
    
    
32. The proposed licensing and training models address COAG policy principles by recognising greater risks from the use of high risk chemicals (RCPs and Schedule 7 chemicals) and fee–for–service use, as requiring at least AQF Level 3 competencies appropriate for the occupation/product. Additional risks of fee–for–service use are recognised by the additional requirement for licensing of both businesses and individuals.
    
    
33. In developing the proposed model, a range of options for a harmonised licensing and training model were considered. This included the licensing and training of all fee–for–service providers (e.g. pest controllers, ground and aerial applicators, sheep dippers) as well as all users of RCPs as classified by the APVMA and S7 chemicals as classified in the Standard for the Uniform Scheduling of Medicines and Poisons. However, it was noted that this option would be result in additional regulatory burden on some occupational users (i.e. farmers).
    
    
34. It is important for both individuals and businesses to be licensed for a number of reasons. Individual fee–for–service operators often work for a number of businesses under a range of employment or contractual relationships. They are also the ones who will receive the training in chemical use and usually be responsible for chemical application errors. On the other hand, businesses are also legally accountable for errors, and maintain chemical use records and implement quality management systems. A majority of jurisdictions already require both individuals and jurisdictions to be licensed, especially in the case of aerial and ground sprayers.
    
    
35. These requirements reflect a minimum requirement, however individual states may implement additional licensing and competency requirements to users residing within their jurisdiction to allow for regional need.
    
    
36. With respect to licensing, accreditation and training requirements, emphasis in the proposed national framework is on areas of regulatory difference where the greatest benefit can be achieved through harmonisation. Broadly, these potential benefits take the form of reductions in risk and improved industry productivity from more efficient use of chemical products. Training, licensing and accreditation systems can have significant costs, both to participants (course fees, value of time spent on courses and travel costs) and administrative costs. Therefore, the concentration in the scheme needs to be on those areas where the greatest reduction in risk is likely to flow from training or accreditation requirements.
    
    
37. Implementation options included the possibility of the Australian Government or the recently developed National Occupational Licensing Authority (NOLA) to take on licensing. The option of the Australian Government taking on licensing was not considered feasible this would result in a reduction in the flexibility to address regional need and would also eliminate a significant source of funds for the states and territories. Similarly, the option of using the NOLA to manage licensing would be likely to result in a considerable implementation delay. Some jurisdictions are yet to endorse the enabling legislation required for the NOLA to operate and the NOLA’s initial focus was to be on areas other than agriculture. Consequently, the proposed model of minimum harmonised licensing and training requirements would be implemented through cross–jurisdictional recognition.

Current situation

38. Jurisdictions vary in the degree of control over use of veterinary chemicals. However, all states and territories currently:
    1. restrict non–veterinary users to following the label directions for major food (or trade) species and
    2. allow veterinarians to use/authorise off–label use in major food species where animals are under the care of the veterinarian and that veterinarian carries some liability for their action (with the exception of the ACT).
       
       
39. Some jurisdictions have a limit on the number of major species animals that may be treated by a veterinarian with an unregistered veterinary chemical.
    
    
40. Unlike agricultural chemical users, veterinarians are able to compound their own veterinary drugs, and prescribe and on–sell unregistered veterinary chemicals to others without restriction or the necessity to have the product registered/approved by the APVMA. A major concern in this regard is off–label use in food–producing animals, where illegal residues may jeopardise trade in animal food products or where veterinarians are compounding veterinary drugs and on–selling to other veterinarians, thus avoiding national assessment and registration requirements.

Proposed model

41. The proposed veterinary prescribing and compounding rights model outlines a harmonised system which allows veterinarians to compound and supply a veterinary chemical product subject to certain conditions; prescribe an extension of label uses for prescription and non–prescription products; use or prescribe the use of unregistered products for food producing species in limited circumstances.
    
    
42. In order to bring about consistency across the national agvet chemical regulatory scheme and minimise the risk to trade, public health and the environment, the proposed scheme will standardise the following components/definitions across jurisdictions:
    1. a nationally consistent definition list of the major food species, similar to the APVMA’s major crops list, but likely to include cattle, sheep, pigs and poultry,
    2. situations where animal owners (or the person responsible for management of the animal) are able to treat major or minor food species without the necessity to seek veterinary direction to vary from the approved label use situation,
    3. consistent interpretation of ‘single animal’ and definition of ‘single animal’ treatments,
    4. restrictions on the sale of unregistered products compounded by a veterinarian to animals under their direct care or within their practice,
    5. restricted use on food species of unregistered products, or products compounded by a veterinarian, to animals under the direct care of the veterinarian.
    6. a requirement for any use of a registered veterinary product not to be contrary to any specific label restraint, prohibition or permit condition.
       
       
43. Implementation will be achieved through harmonisation of existing legislation in each jurisdiction.
    
    
44. The ‘National Framework for the Assessment, Registration and Control–of–Use of Agricultural and Veterinary Chemicals’ noted that veterinary prescribing rights should enable protection of animal health and welfare while avoiding unacceptable risks to human health, trade or the environment, and that compounding rights should not deter registration of new veterinary products or use of existing registered products.

Current situation

45. The APVMA assesses, registers and reviews agvet chemicals for use in Australia. This assessment specifically takes into account products efficacy, concentration, application, target species and host animals or plants, assuming that the product is applied with good agricultural practice by competent users. As part of this process, a chemical label is approved which details specific use instructions. The APVMA also runs the permit system, allowing access to chemicals for uses which are not registered on–label.
    
    
46. Currently, state and territory control–of–use regulations differ on the extent to which agricultural chemical users are restricted to on–label or permit use patterns.
    
    
47. In August 2010, COAG agreed to policy principles for a national scheme for assessment, registration and control of use of agricultural and veterinary chemicals. The following principles should apply in respect to ‘access to chemicals’ under the proposed framework:
    1. Relating to the operating environment
       1. Regulation is efficient and ensures that all domestic or imported agvet chemicals are supplied and used safely and responsibly.
       2. Jurisdictional boundaries do not unnecessarily restrict access to agvet chemicals or increase the costs to business of using those chemicals.
       3. The national framework is such that participants in the chemical manufacturing industry and users have incentives to develop and operate efficiently.
       4. Regulation does not constrain development of particular activities or industries unless that constraint is a necessary part of risk management.
    2. Relating to permits and permissible uses
       1. The scheme allows uses outside the approved uses in certain circumstances or with specific approvals.
       2. The scheme contains a mechanism to restrict approved uses.
       3. Development of particular activities or industries is not constrained by the scheme unless that constraint is a necessary part of risk management.
       4. The scheme achieves a balance between the community’s right to know and commercial interests.

Proposed model

48. A hierarchical access to chemicals model (Figure 1) is proposed to achieve nationally consistent and harmonised minimum access to chemicals arrangements. This hierarchical model is based primarily on approved uses from registered products, supported by APVMA permits for unapproved uses and lastly could allow some limited variations to approved uses for crops or situations.

Figure 1.

49. The proposed harmonised conditions of where variations to label use instructions would be allowed are intended as minimum requirements. Under these arrangements, each jurisdiction would allow users to apply any registered chemical to its approved crop either for a different pest (i.e. other than that stated on the label/permit), at a lower application rate, with lesser frequency or mixed with another agricultural product.
    
    
50. These variations represent low risks which are effectively managed through the approved label instructions that explicitly prohibit use in that manner (e.g. ‘Do not mix with product X’). These variations to an APVMA approved use will be allowed for all registered chemicals (including Restricted Chemical Products [RCPs] and Schedule 7 [S7] Dangerous Poisons).
    
    
51. In addition to the above harmonised access to chemicals arrangements, jurisdictions would be able to allow additional chemical use patterns in response to regional need.
    
    
52. The proposed minimum harmonised arrangements assume the implementation of:
    1. A national risk–based monitoring program for treated agricultural produce (including animal feed commodities) to validate the effectiveness of the harmonised national framework based on compliance with the APVMA Maximum Residue Limit (MRL) Standard. The enhanced produce monitoring/violation traceback program and user audits will provide a base level of monitoring to evaluate and maintain confidence in the agvet system, appropriately identify risks and respond to adverse events.
    2. Minimum AQF–3 level competencies which are deemed appropriate for users of comparatively high risk chemicals i.e. RCPs and S7 Dangerous Poisons to mitigate the risks associated with their use.
    3. Nationally standardised recordkeeping requirements for chemical users to demonstrate compliance with Good Agricultural Practice (GAP) and aid in audits and compliance investigations;
    4. Nationally consistent compliance tools to facilitate consistent and efficient compliance monitoring and intervention; and
    5. Comprehensive general duty provisions in legislation placing positive obligations on all persons using chemicals to undertake risk assessment and manage risks about the use of chemical products which may impact on people, property, environment or trade. This includes specific safeguards that must be addressed if additional allowed variations to approved uses are undertaken.
       
       
53. The proposed model recognises the contributions to GAP of:
    1. Quality assurance schemes necessary for market access (both domestically and internationally) that require user competency, recordkeeping and attaining an acceptable residue status; and
    2. AQF–3 level or other industry skills training appropriate to the product/occupation which has already been taken up voluntarily by many chemical users.

54. The proposed model is a result of extensive considerations of alternative models, including models which allow additional variations to approved uses. These alternative models included an additional provision for non–RCP/S7 chemicals to be used on non–major crops other than those for which label or permit instructions are provided. This alternative option included restrictions on the allowed use.
    
    
55. In considering this alternative model, some of the potential restrictions considered included:
    1. In using a chemical on an off–label minor crop, the Australian MRLs would need to be complied with. This potential limitation was considered to support the existing APVMA permit process (i.e. GAP standards) as the means to obtaining an MRL if necessary.
    2. A potential limitation where variations contrary to specific label restraints, prohibitions or permit conditions would not be allowed as they would be contrary to existing risk assessments decisions taken by APVMA.
    3. A potential limitation where users would not be allowed to alter crop or situation use patterns for RCP or S7 chemicals without an APVMA permit. Consideration was given to whether the current definition of an RCP would need to be amended to declare a chemical to be an RCP if it posed a potential risk when used differently to its approved use instructions. However, it was noted that an increase in RCPs could have unintended flow–on effects (such as additional user competency requirements and reducing access to chemicals even further as more chemicals are defined as RCPs). Alternative options were also considered, including the creation of a controlled chemicals or controlled situation/crop provision, similar to the ‘restricted use chemical’ or agricultural chemical control area mechanism currently applied in Victoria.
    4. A potential limitation where users would not be allowed to alter crop or situation use patterns where alternative approved uses exist on labels and permits. (This was considered to support uses approved via registration/approval process and encourage future applications to APVMA.
    5. A potential limitation where the application method must be the same as the existing instructions on the approved label or permit for the chemical (for instance, a soil treatment could not be applied a foliar application).
    6. A potential limitation where variations would be restricted to crops within the same crop classification (i.e. use of chemicals registered for a cucurbit on other cucurbits).
    7. A potential limitation where variations would be restricted where use of non–food/feed registered chemicals would not be allowed in food crops or where a by–product from the crop is anticipated to be fed to animals.
    8. A potential limitation where variations would permit use variations for products currently approved for pest control uses in homes or public spaces (playing fields and lawns) can be used in homes or public spaces.
    9. Use of a general duty provision which would apply to all off–label uses and any consequences of that use. This application to off–label minor use would have significant implications. By requiring the user to take all reasonable and practicable measures to manage human health, environment and contamination risks and setting out criteria by which compliance with the duty is judged, the duty of care would impose a risk assessment process on the user. This process undertaken by individual users or grower groups would then lead to adoption of lower risk options.

56. These alternative considerations noted that an appropriate definition of minor use was required. The APVMA Guide for Determining Minor Uses currently determines which crops, animals and situations are major. The document recognises the legislative definition is challenging because the issue of ‘sufficient economic return’ is very subjective. It also provides chemical manufacturers with a rationale to not include uses on label. It could be argued that crops/uses which have been excluded from labels on this basis could be classified as minor. It was noted that the guide would need to be reviewed regularly so that borderline crops in particular are appropriately classified.
    
    
57. Whilst the economic aspect of this definition does not account for exposure risks to human health, OH&S, or the environment, in practice for most minor crop uses, the OH&S and environmental assessments for major crops/situations are relevant. In addition many non food situations are currently described as ‘major’ including aquatic areas.

Consideration of potential flow–on effects of additional allowed uses/limitations

58. It was noted that some of the alternative options considered would result in a significant reduction in off–label use in Victoria due to limitations to current uses in major crops. In these alternative models, off–label use in minor crops and situations would be more constrained in Victoria and South Australia than is currently the case. However, industry would see benefits in continuing to obtain APVMA permits voluntarily for minor crops because they generate the necessary MRLs based on GAP to facilitate market access.
    
    
59. Concerns were raised that some alternative models would increase the amount of unassessed off–label use, reduce the need for the permit system to assess minor crop uses and increase the use of old established pesticides. It was considered that some additional variations may result in a need to vary current methods of assessment and review to consider any changes to risks to human health and trade. Human health risk assessments use specific use patterns to determine the appropriate study length to use, such as short–, medium– or long–term studies. Concerns were also raised that additional variations may result in use of more conservative exposure values when calculating margins of exposure to cover all unknown use patterns from off–label uses. This could result in more conservative decision–making and therefore limit access to new chemistry and cause the review of existing chemicals.

60. Concerns were raised that additional allowed variations may result in Australia being perceived negatively by trading partners. However, consideration was given to current experience in South Australia and Victoria, as well as the data available through the National Residue Survey, which had failed to find increased evidence of chemical residues as a result of the current approach to off–label use in these two jurisdictions. Specifically, the draft Decision Regulation Impact Statement (RIS) stated that:

61. ‘current residue monitoring data provide no evidence of increased risk to human health and produce trading from the proposed allowable variations to approved uses of chemicals under the proposed national scheme, compared to other existing chemical access systems. However, the current level of produce monitoring across Australia is deficient, as some jurisdictions do not conduct any produce monitoring and rely on industry programs for this purpose.’

62. It was considered that managing trade risk in export markets depends on the exporter managing the supply chain risks, i.e. sourcing only produce that complies with the standards for that market which will most likely be different from those that apply to the domestic market. The trade in primary produce commodities is subject to commercial market forces, and are not and do not necessarily need to be managed by government regulators.
    
    
63. It was noted that low level chemical residues detected in surveys for which there was no MRL in the Foods Standards Code have not resulted in food safety concerns. A structured process to provide for low level chemical residues in those crops which do not have MRLs would be beneficial, to avoid unnecessary denial of market access by food safety regulators.

63. The proposed minimum harmonised access to chemical arrangements would be reconsidered on review of the single national framework. The proposed produce monitoring program (outlined below) would help evaluate the effect of this access to chemicals arrangement and assist in providing vital data to inform future reforms (which may include a further harmonised access to chemicals model).

Current situation

64. The Australian Government currently administers several monitoring programs for agvet chemicals, including the National Residue Survey and the Food Standards Australia and New Zealand Australian Total Diet Survey. States and territories also undertake some produce monitoring to obtain data for regional and commodity trends. However, the level of monitoring varies significantly between jurisdictions and from year to year.
    
    
65. There are also a number of industry–run produce monitoring systems, including horticultural on–farm assurance programs (Freshcare Code of Practice) and chemical residue and microbial testing for growers and wholesalers (FreshTest). However, the focus of these programs is on major crops and areas of specific market interest, leading to significant gaps in current testing of produce.
    
    
66. Existing monitoring activities are not coordinated Australia–wide, leading to inconsistent risk management and duplication of effort. Current monitoring activities also lack a formalised feedback mechanism to inform APVMA permit, registration and assessment processes. An enhanced produce monitoring program coordinated across Australia is required to ensure an increased level of confidence for consumer safety, allay potential trade concerns and to ensure validation of chemical regulation.

67. Although nationally consistent environmental monitoring of agvet chemicals may be implemented at a later stage, the initial focus within the single national framework would be on produce monitoring.
    
    
68. The proposed enhanced national produce monitoring and traceback program would:
    1. provide a nationally consistent base level of produce monitoring to maintain confidence in the agvet chemical system, appropriately identify risks and respond to adverse events
    2. be risk–based, targeted and responsive to contribute to the protection necessary for the safe use of chemicals, including allowable variations of chemical use (i.e. ‘off–label’ use)
    3. provide support mechanisms, including suitable data management and access protocols, for effective traceback and emergency response
    4. link directly with existing compliance and enforcement processes in the jurisdictions and the APVMA, informing their risk management policies and creating a nationally consistent monitoring framework
    5. be flexible enough to allow individual jurisdictions to monitor targets of local importance (whether environmental or produce related)
    6. build on existing industry and government–run schemes (including potential data sharing and reward/compliance arrangements), thus avoiding duplication of testing of particular commodities
       
       
69. Costs of the enhanced system would depend on the issues targeted and number of samples taken, and the ability to build on existing systems. It is anticipated that the recordkeeping arrangements proposed under the access to chemicals model would be integrated to assist with keeping costs low.
    
    
70. Sampling: The new national monitoring system will be underpinned by a risk management framework that will be developed early in implementation. The system would assess a variety of chemicals on individual crop samples from across Australia’s production systems nationally. Targeting specific issues as identified by jurisdictions (such as off–label use) would assist in reducing the range of commodities required to be tested. The proposed program can specifically assess high risk uses (e.g. off–label use on herbs) and allow for increased monitoring and traceback activities in the initial phases of the framework’s implementation to evaluate the proposed access to chemicals model.
    
    
71. For reliable results, a significant number of samples within a specific commodity would be required, with a significant number of tests per individual sample (e.g. a targeted focus on herbs with a significant number of herb samples tested with a significant number of tests per chemical issue). To achieve this, better coordination/communication will be developed across jurisdictions and industries.
    
    
72. Coordination: Coordination of monitoring effort would be through a single unit cooperating with jurisdictions. The unit would be either co–located with the APVMA or the NRS within the Australian Government Department of Agriculture, Fisheries and Forestry, providing access to experts in quantitative risk analysis and analytical chemistry, or located elsewhere. Ideally the proposed produce monitoring system would utilise data already provided to industry–run produce monitoring services (such as Freshtest), the NRS, as well as data obtained by state–run systems, which supplementary collections to fill the gaps or reduce overlap.
    
    
73. Existing state and territory managed monitoring systems would be incorporated into the enhanced system, provided the sampling and testing methodologies are undertaken in accordance with national requirements (for which agreed standards would be created). The national coordinating body could direct the jurisdictions to collect and analyse samples, with the data fed back to the coordinating body.
    
    
74. Tracebacks: States and territories would conduct traceback investigation of potential residue violations within their own jurisdiction. A greater number of traceback activities would be allocated within the initial phases of the monitoring program to allow for users’ lack of familiarity of new access to chemicals restrictions.

75. Following COAG agreement, implementation of the above proposed models is anticipated to take approximately 18 months.
    
    
76. The above proposed framework outlines the general models for the licensing, training, monitoring and access to agricultural and veterinary chemical models. Further details of these models will be determined during the reforms’ implementation phases.
    
    
77. This implementation will require changes to state and territory control–of–use legislation. Some changes to Commonwealth legislation may also be required. Due to the different regulatory arrangements within each jurisdiction, harmonisation will be best achieved through the development of consistent and uniform drafting instructions for the amendment of existing legislation and regulations.
    
    
78. Further stakeholder consultation will be undertaken on details of the proposed models as part of these legislative changes.

¹ Productivity Commission, 2008.
² Such as aerial and ground applicators, contract sheep dippers and urban pest controllers.