RE: Submission in response to Department of Agriculture and Water Resources AgVet Chemicals Regulation Reform Proposals

Transcription

1 AgVet Chemicals Regulation Reform Department of Agriculture and Water Resources GPO Box 858 Canberra ACT 2601 Via 2 December 2015 Dear Sir / Madam, RE: Submission in response to Department of Agriculture and Water Resources AgVet Chemicals Regulation Reform Proposals Cotton Australia welcomes the opportunity to comment on the Department of Agriculture and Water Resources (DAWR) proposed AgVet chemicals regulation reforms. Cotton Australia is the key representative body for Australia s cotton growing industry. The cotton industry is an integral part of the Australian economy, worth over $1.25 billion in export earnings in the season, and employing on average 10,000 people annually. The Australian cotton industry is internationally recognised as innovative, dynamic, successful and responsible. Australian cotton is world leading for yield and quality and is underpinned by a sciencebased best management practice system that is supported by scientifically sound regulation. The industry collaborates with research and development providers, technology providers, consultants and growers to implement agricultural chemical and transgenic trait stewardship programs to deliver responsibly produced fibre and seed to ensure competitiveness of the Australian crop. For example, our internationally regarded resistance management plans for insecticides, transgenic insecticidal (Bt) crops and over-the-top herbicides have helped to delay development of widespread resistance. This has been achieved through continued access to efficacious product, science based regulation of these products, ongoing consultation with technology providers and high industry adoption/compliance. Although the current Australian Pesticides and Veterinary Medicines Authority (APVMA) framework is considered to be sufficient for the delivery of science-based regulation of agricultural and veterinary chemicals, Cotton Australia welcomes moves to align regulatory effort with risk and improve the transparency and consistency of decisions for delivery of innovative and safe AgVet products. As such, Cotton Australia supports the three stated objectives of the chemicals regulation reform: 1. align regulatory effort and burden with chemical risk, improving regulatory efficiency and reducing unnecessary red tape; 2. improve access to chemicals, both new uses for existing chemical products and new chemicals entering the market; and 3. improve the national system for regulating chemicals. Cotton Australia is supportive of streamlining regulation of AgVet chemicals. Cotton Australia is however, concerned that several of the proposed reforms in their current state may not maintain the scientific rigour of the current regulatory framework. Specifically, our primary concerns relate to the ability of the Cotton Australia submission to DAWR AgVet chemicals regulation reform Page 1

2 APVMA to regulate agricultural chemicals in an efficient, transparent and consistent manner that is in keeping with the risks posed to Australian natural environments and agricultural landscapes. Cotton Australia encourages the DAWR and the APVMA to continue to work with industry to deliver a risk-based, efficient and robust regulatory framework for agricultural chemicals without compromising scientific rigour. It is the only approach that will maintain the long-term sustainability and competitiveness of Australian agricultural industries. Cotton Australia s recommendations for the proposed reforms are summarized below, with further detail provided in the following section of the submission. Recommendation 1: Cotton Australia supports a risk-based approach for utilisation of overseas regulatory decisions however, recommends consideration of provisions to allow final decision making power to reside with the APVMA. Recommendation 2: Cotton Australia supports development of a risk-based approach to regulation in preference to adjusting scope of regulation. Recommendation 3: Cotton Australia supports the APVMA continuing efficacy assessments. In the event that a risk-based adjustment to efficacy testing is considered, Cotton Australia would advocate the importance of additional stakeholder consultation. Recommendation 4: Cotton Australia strongly supports the preservation of a centralised process for trade assessment of agricultural chemicals. Recommendation 5: Cotton Australia supports the development of crop groupings for AgVet chemicals. Recommendation 6: Cotton Australia is generally supportive of provision of assessment services and strongly supports final decision making power residing with the APVMA to ensure a scientifically robust, consistent and transparent process. Recommendation 7: Cotton Australia is supportive of the APVMA s altered proposal to retain export certificates for registered products and requests guidance in respect to avenues for obtaining government endorsed export certificates for unregistered products. Recommendation 8: Cotton Australia supports the DAWR to continue to pursue (in conjunction with the Department of Health), improvements to timeliness for poisons scheduling decisions. Recommendation 9: Cotton Australia does not support the proposal reform in its current state and format for the APVMA to discontinue the regulation of transgenic traits. Cotton Australia recommends the DAWR undertake further consultation with the cotton industry to provide additional information and assurances in respect to continued regulation of genetically modified crops. Cotton Australia submission to DAWR AgVet chemicals regulation reform Page 2

3 1. Using overseas decisions as the basis for registration Cotton Australia strongly recommends that the decisions of international regulators should not be used as the sole justification for registering or cancelling a product/active ingredient for the Australian market. While there may be scope for utilisation of international decisions where exposure and environmental risks are identical to those in overseas jurisdictions, Cotton Australia supports provisions to transfer final decision making power to the APVMA. This may be achieved through provisions that allow the supply of information to independently satisfy the APVMA of relevant matters after a product is registered via trusted international regulatory bodies. This may be one of many strategies that would deliver regulatory efficiencies whilst protecting Australian agriculture from consequences of post-approval changes to registration made by overseas regulators. For unprotected cropping situations, risks cannot be extrapolated from international examples to the Australian natural and agricultural landscapes. Cotton Australia strongly recommends exclusion of unprotected cropping agricultural chemicals from automatic acceptance of overseas decisions. Recommendation 1: Cotton Australia supports a risk-based approach for utilisation of overseas regulatory decisions however, recommends consideration of provisions to allow final decision making power to reside with the APVMA. 2. Scope of regulation Cotton Australia strongly supports movement toward a risk-based approach to regulation in preference to limiting scope for assessment. Value may be gained from a risk-based framework that empowers the APVMA to focus resources on assessment and registration of products posing greater risk, such as those interacting between Australian natural and agricultural landscapes. Cotton Australia does not support reducing the scope of products regulated by the APVMA as this approach does not enable alignment of regulatory burden with risk. As such, development of the Centre of Excellence for Biosecurity Risk Analysis (CEBRA) risk-assessment tool and self-regulation of products of low regulatory risk is supported in preference to reducing scope for regulation. Recommendation 2: Cotton Australia supports development of a risk-based approach to regulation in preference to adjusting scope of regulation. 3. Removing efficacy assessment Cotton Australia is strongly supportive of the APVMA continuing its role to undertake efficacy assessments. The current process provides a high level of protection for Australian farmers as well as confidence for consumers. Removal of efficacy assessment from the APVMA s regulatory process is in direct contradiction to the science-based and risk-based frameworks that are core to the integrity of a regulatory system. Registration of inefficacious product exposes cropping industries to risk including crop failure, environmental pollution and residue issues with little apparent benefit. Removal of efficacy assessment Cotton Australia submission to DAWR AgVet chemicals regulation reform Page 3

4 may also comprise ability to implement robust resistance management plans and compromise the competitiveness and sustainability of Australian cropping industries. Cotton Australia agrees that that pursuing avenues of negligence law and contract law to cover losses are not appropriate and expecting producers to address efficacy issues through litigation is unreasonable. This reform proposal significantly underestimates the contribution of underlying scientific data in allowing producers and industries to provide advice and also trial agricultural chemicals under various systems. Cotton Australian strongly recommends that efficacy assessment should be retained, particularly for unprotected cropping. There may be scope for a risk-based approach for efficacy assessment however this would require further consultation before it could be supported. Cotton Australia encourages DAWR to consider alternate strategies for attracting investment in agricultural chemicals, in preference to removing efficacy requirements. Recommendation 3: Cotton Australia supports the APVMA continuing efficacy assessments. The risk to industry is too high if this responsibility is removed from the APVMA s regulatory oversight. In the event that a risk-based adjustment to efficacy testing is considered, Cotton Australia would advocate the importance of additional stakeholder consultation. 4. Removing trade assessment Cotton Australia is supportive of the multi-spectral and centralised assessment process that currently resides within the APVMA s trade assessment program and does not support the complete removal of the trade assessment process or transferral of assessment onto individual industries. As raised in the discussion paper, Cotton Australia strongly agrees that; changes to regulatory requirements around trade assessment should be pursued cautiously to avoid jeopardising opportunities for existing or new export markets and commodities; perception and reputation play an important role in international trading markets and; that initial APVMA trade assessments contain value if only to provide a baseline or starting point for further evaluation/discussion. In stark contrast to the discussion paper, Cotton Australia considers that the producer is not necessarily best able to respond to meet the demands of international markets and similarly, research and development corporations (RDCs) may not be well positioned to provide producers with relevant information on market demands and withholding periods. Further consultation would be required before this reform could be supported, including additional detail as to how the Australian Government will continue to assist Australian producers in maintaining access to existing markets and support expansion of exports of Australian produce into new markets in lieu of the current APVMA trade assessment process. Recommendation 4: Cotton Australia strongly supports the preservation of a centralised process for trade assessment of agricultural chemicals. Cotton Australia submission to DAWR AgVet chemicals regulation reform Page 4

5 5. Crop Grouping Crop groupings may provide better access to agricultural chemicals for minor crops or minor uses and is supported by Cotton Australia. The current groupings based on residue profiles are supported. However, Cotton Australia is interested in investigating groupings based on pest/disease risk and would be interested in progressing these discussions with the DAWR and the APVMA at a suitable date. Recommendation 5: Cotton Australia supports the development of crop groupings for agricultural chemicals. 6. Contestable provisions of assessment services Recommendation 6: Cotton Australia is generally supportive of provision of assessment services and strongly supports final decision making power residing with the APVMA to ensure a scientifically robust, consistent and transparent process. 7. Streamlining import and export regulation Recommendation 7: Cotton Australia is supportive of the APVMA s altered proposal to retain export certificates for registered products. Guidance in respect to avenues for obtaining government endorsed export certificates for unregistered products would be welcomed as part of the feedback process for this reform proposal. 8. APVMA CEO as a poisons scheduling delegate Recommendation 8: Cotton Australia supports the DAWR to continue to pursue (in conjunction with the Department of Health), improvements to timeliness for poisons scheduling decisions. 9. Outstanding issues with legislation genetically modified crops The cotton industry, as represented by the Cotton Australia Transgenic and Insect Management Strategies (TIMS) Committee, requests additional consultation with the DAWR regarding the proposed changes to legislation dealing with genetically modified crops. Cotton Australia acknowledges that multiple registration requirements for transgenic traits are unnecessarily duplicated between the APVMA, Office of the Gene Technology Regulatory (OGTR) and Food Standards Australia New Zealand (FSANZ). However, other requirements such as efficacy and resistance management currently lie only within scope of the APVMA. Abrupt and complete removal of genetically modified plants from scope of the APVMA without a viable alternative may adversely and irreversibly affect the competitiveness and sustainability of the Australian cotton industry. Given these significant challenges, Cotton Australia requires additional information and assurances from the DAWR that these issues have been identified with appropriate alternatives established to avoid significant impacts on agricultural productivity. The cotton industry s TIMS Cotton Australia submission to DAWR AgVet chemicals regulation reform Page 5

6 Committee is available to discuss these issues and potential solutions at a date that is suitable for the DAWR. Recommendation 9: Cotton Australia does not support the proposal reform in its current state and format for the APVMA to discontinue the regulation of transgenic traits. Cotton Australia recommends the DAWR undertake further consultation with the cotton industry to provide additional information and assurances in respect to continued regulation of genetically modified crops. Conclusion Cotton Australia considers that the current regulatory system provides a scientifically based and technically competent framework for assessment and registration of agricultural and veterinary chemicals. A more streamlined, timely and transparent process for the registration of AgVet chemicals may improve market access for Australian producers, including cotton growers. Cotton Australia welcomes a transition to a risk-based approach to regulation to enable the APVMA to focus resources on products with inherently higher risk. Cotton Australia remains cautious of elements of reform proposing the removal of regulation for little identified benefit. Cotton Australia considers that all chemicals acting at an interface between Australian natural and agricultural landscapes, such as unprotected cropping, should continue to be regulated by the APVMA. Cotton Australia strongly supports proposed reforms that deliver value in terms of increased efficiency and transparency for regulation, and recommends they be prioritised and enacted at this stage. Reform that compromises the productivity, competitiveness, resilience or sustainability of Australian agricultural systems should undergo further consultation and ground truthing with industry and product providers prior to implementation. Cotton Australia looks forward to working with DAWR and the APVMA to improve the competitiveness and sustainability of Australian agriculture through delivery of a scientifically robust, technically apt, efficient and efficacious regulatory system for agricultural chemicals. Should you have any questions regarding our submission please do not hesitate to contact me on (02) or NicolaC@cotton.org.au. Sincerely, Nicola Cottee Research Direction and Stewardship Policy Officer Cotton Australia COTTON AUSTRALIA LIMITED ABN HEAD OFFICE SUITE 4.01, 247 COWARD ST, MASCOT NSW 2020 AUSTRALIA P F BRISBANE LEVEL 6, 183 QUAY ST, BRISBANE QLD 4000 TOOWOOMBA 115 CAMPBELL ST, TOOWOOMBA QLD 4350 NARRABRI LEVEL 2, 2 LLOYD ST, NARRABRI NSW