Friday 21 November 2014
Dr Joseph Morrall
Department of Agriculture
Agvet Chemicals Policy
Sustainability and Biosecurity Policy Division
GPO Box 858
CANBERRA ACT 2601
By email: agvetreform@agriculture
Dear Dr Morrall,
Re: Proposed reform to pet food and stock feed regulation
Thank you for the opportunity to comment on the proposed reform to the regulation of certain stock foods and pet foods.
Animal Medicines Australia seeks an effective and efficient system of regulating veterinary chemicals according to the latest scientific knowledge and on the basis of risk. The current system of regulation of veterinary chemicals places a heavy emphasis on pre-market technical assessment aimed at safeguarding human and animal health, and ensuring that risks to the environment and trade are kept within acceptable limits. These outcomes of regulation are of paramount importance, but in many areas they can be achieved in a more cost effective manner.
The proposal, the subject of these comments, is to exclude from registration certain nutritional and digestive stock food and pet food products that are considered to be of low regulatory concern when produced in accordance with certain criteria. The proposal will not affect any product containing antibiotics (other than for feed preservatives), hormones or vertebrate animal material for consumption by ruminants. Any product that is not voluntarily consumed by an animal will not be covered by the reform proposal. Importantly, the model proposed does not involve removing all regulation. To qualify for exclusion from registration, a product must meet a set of criteria defining
what may be contained in the product (ingredients), how the product must be manufactured, what material is to appear on its labels, and what claims or representations may be made in relation to its effect on an animal. If all of these criteria are not satisfied, the product will need to be registered.
This ‘self-determination’ model is an attractive option for the regulation of the specific class of product it touches on, however there are certain gaps in the network of regulation proposed. Our concerns relate to the extent to which an effective compliance network will indeed operate.
In the remainder of this submission we will highlight a range of issues that must be addressed before Option B could be considered suitable for implementation.
1. Attitude of state jurisdictions toward excluded nutritional and digestive products In a regulatory scheme characterised by a partnership between Commonwealth and State and Territory governments, cooperation is essential. With responsibility for control of use vested in State and Territory governments, any measure that excludes certain products from pre-market assessment by the Commonwealth agency will be reliant for its effectiveness on the monitoring and compliance efforts of the state jurisdictions. In this context, the submissions made by the Department of Agriculture and Food of Western Australia (DAFWA) and the NSW Department of Primary Industries have direct consequences for the immediate viability of Option B in the Regulatory Impact Statement.
We note with concern the submissions made by DPI and DAFWA, particularly insofar as they express doubt over whether the jurisdictions will have power to perform compliance and monitoring activities in relation to excluded nutritional and digestive products. Perhaps of greater concern is DAFWA’s statement that they have no intention of performing such activities. As Option B depends on the more effective utilisation of controls other than pre-market direct regulatory engagement, it will be important that the concerns of the states be addressed in order to provide sufficient assurances that misapplication of the self-determination principle will be detected and remedied. This will be important to ensure consumer and producer support for Option B. It will also mitigate the risk that major trading partners might erroneously perceive Option B to involve a lowering of Australia’s robust food safety systems.
2. Treatment of direct fed microbials in ingredient criterion The Regulatory Impact Statement asks a specific question regarding whether direct fed microbials that would fall within the operation of the self-determination option ought to be treated differently. In light of the submission made by Dr Stephen Page, we answer this question in the affirmative. Antimicrobial resistance is an issue that Animal Medicines Australia and its members take very
seriously, and Dr Page’s concerns should be addressed in any amendment to the preferred option. As only probiotic preparations approved by the European Food Safety Authority (EFSA) appear on the European Register of Feed Additives (to which reference may be had in satisfying the ingredient criterion of the self-determination model), it would seem appropriate to limit the direct fed microbials capable of qualifying for self-determination to those appearing on this list. Those not appearing on the list would continue to require registration.
3. Implications of reform for cost recovered agency As we have discussed with the Department prior to these written comments, Animal Medicines Australia is concerned about the potential impact of rapid implementation of Option B on the operational capacity of the APVMA. The APVMA is a cost recovered agency, and the exclusion of a large number of products from the register is expected to reduce the overall revenue of the agency.
This is not an argument against the design of Option B, but an appeal for consideration to be had of operational realities when decisions are made regarding implementation. The APVMA is currently in a transitional phase, and is still negotiating the implementation of the last round of major reforms to the agricultural and veterinary chemicals regulatory system. Prior to any decision being made regarding implementation, we would expect an assessment to be made of the potential impact of such a reform on operations to ensure that they do not in fact cause a net loss in productivity.
We have also questioned the appropriateness of a situation whereby the registrants of agvet chemical products would subsidise compliance activities for the excluded class of substances. While we have consistently argued for public funding of compliance and monitoring on the basis that it represents a public good, the current policy setting has the agvet chemical industry paying the cost of compliance.
If that is the policy, then it would seem justifiable for a contribution to be sought from manufacturers of excluded nutritional and digestive products to these activities.
An option that might address this would be to require a notification to be made to the APVMA to the effect that a self-determination decision has been made. An annual fee could be attached to products falling into this category that is based on the average cost of compliance activity for excluded nutritional and digestive products. Alternative option In the event that barriers to the successful implementation of Option B are considered to be nsurmountable within the current framework, Animal Medicines Australia would support pursuit of Option C (utilising the listed chemicals and standards provisions of the Agvet Code) as a means of delivering significant reductions in the cost of registration while retaining a pre-market gatekeeper role for APVMA in respect of these products. As NSW DPI have noted, the perception-related risks to do with trade would not be present in Option C. Cost recovery-related concerns that we have raised would also be addressed.
Chief Executive Officer