National Aquaculture Council

Response to the DAFF enquiry into: A National Scheme for Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals – Discussion Paper

National Aquaculture Council

Introduction

According to the Australian Bureau of Agriculture and Resource Economics (ABARE) the Australian aquaculture industry produces 62,500 tonnes of seafood worth $868 million. This is accounts for about 30% of Australia’s seafood production by value and volume.

The NAC members account for around 78% of the GVP and around 87% of the volume of Australian aquaculture production and include:

• Salmon (represented by the Tasmanian Salmonid Growers Association)
• Southern Bluefin Tuna (represented by the Australian Southern Bluefin Tuna Industry Association)
• Prawns (represented by the Australian Prawn Farmers Association)
• Abalone (represented by the Australian Abalone Growers Association)
• Oysters (represented by the Shellfish Industry Council of Australia)
• Barramundi (represented by the Australian Barramundi Farmers Association)
• Mussels (represented by the Australian Mussel Industry Association)
• Yellow Tail Kingfish and Mulloway (represented by the Australian Marine Finfish Farmers Association)

The aquaculture industry in Australia is a contemporary industry that has undergone rapid expansion in the last 20 years. As production has increased and the sophistication of operations has risen, there has been increased need for the use of fit for purpose chemicals and products (aquavet chemicals) for addressing animal health and welfare issues and farm management objectives. Obviously, the aquaculture industry wants to meet its regulatory obligations with respect to the use aquavet chemicals.

While the figures and the number and diversity of sectors may imply that the aquaculture industry is a large user of agricultural and veterinary chemicals (or aquavet chemicals). This cannot be further from the truth. The industry uses only small quantities of aquavet chemicals in relation to its size. At present the industry accesses aquavet chemicals via the APVMA minor use permit (MUP) process, and/or off-label prescriptions by aquatic veterinarians.

At the same time as the Australian industry has expanded, the aquaculture industry has also grown worldwide, but at a much faster rate. As the global aquaculture has grown there have been significant advances with respect to the use aquavet chemicals. As a consequence there is a significant body of international research available with regards to efficacy and human and environmental impacts of aquavet chemicals.

Issues

Approval Times

NAC members are frequently frustrated with the length of time it takes for the APVMA to provide a decision on applications, which appears to be a result of APVMA being under-resourced. NAC would therefore support improved funding for APVMA for the purpose of setting response targets.

Facilitating access to Aquavet chemicals

NAC understands that the current functions of the APVMA’s assessment and registration activities are to facilitate access to and use of agricultural and veterinary chemicals whilst limiting the risks to human health, target crops & animals, trade, and the environment.  At present, there appears to be disproportionate emphasis on “limiting the risk” compared with “facilitating access”.

Aquavet Chemical Registration

Like other minor sectors the aquaculture industry faces the dilemma of being a small market for aquavet chemicals. The result is that the producers of aquavet chemicals are reluctant to apply for full registration of aquavet chemicals in Australia as the potential revenue stream does not warrant the cost of the registration.
The NAC would support any mechanism that would allow a simpler route to full registrations of chemicals for minor use industries.

Use of international data packages

As mentioned above aquaculture is a significant global industry. As such significant risk assessment data exists overseas for aquavet chemicals, particularly in OECD countries. However at present, the APVMA is very reluctant to utilise such data. This policy is inconsistent with other agencies undertaking risk assessments where there is general acceptance of data from recognised ‘Competent Authorities’, for example in the import risk assessment process undertaken by Biosecurity Australia.
The NAC supports the APVMA adopting a policy whereby they are able to, at least in part if not in full, access and utilise overseas data for risk assessments. This would result in significant cost-savings in evaluating applications.

Precautionary Principle

The aquaculture industry (and presumably other farming sectors) takes the risks presented by aquavet chemicals to human health, target crops & animals, trade, and the environment very seriously. 

In the context of “appetite for risk” to the environment, APVMA seem to view the basic tenet of the Precautionary Principle quite selectively. The accepted wording from Principle 15 of the 1992 Rio Declaration states:
“Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”

In the aquaculture industry’s experience the APVMA does not seem to consider the parts of the principle that read ‘serious or irreversible damage’ and ‘cost-effective measures’ in its assessments. In the NAC’s experience, the APVMA fails to clearly define the ‘serious or irreversible damage’ it is seeking to prevent in its assessment and issuance of permits. This leaves the industry with the expensive and time-consuming task of providing evidence of which some or all may be irrelevant to the actual use of the aquavet chemical.

Risk Assessments

The NAC recognises that the APVMA does not have the full suite of appropriate expertise to fully assess permit applications. This obviously requires the APVMA to outsource assessment functions to other agencies.
The NAC supports the statement in the discussion paper that states “...one of the effects of this outsourcing...may be that different parts of an APVMA assessment are informed by agencies with different appetites for risk”.
This has certainly been the experience of the aquaculture industry.

The NAC would support the development of an assessment standard, if one does not already exist, in order to harmonise the ‘risk appetite’ across outsourced agencies. If this is not possible, then a mechanism should be adopted to weight individual agencies risk appetites in order to arrive at the APVMA’s own risk appetite.

Adoption of Codex MRL’s

NAC would like to see APVMA being able to adopt MRL’s for a chemical from Codex when requested from industry. In this way, industry may use a chemical in off label permit situations and not have the risk of residues being detected that are still within an internationally recognised MRL, but are however not defined and by default not legally allowed in Australia.

Off-Label Veterinary Prescriptions

The NAC would support the greater utilisation of veterinarians in the off-label prescription of aquavet chemicals.
However, Australia is chronically short of qualified aquatic veterinarians, let alone those that could make a risk assessment of all potential impacts of aquavet chemicals. This is not to say they aren’t competent it is just that the information to support such risk assessments is either unavailable or if it is, of little value. This is especially true for the environmental impacts.

Thus, if giving greater powers to veterinarians is considered as an option to streamlining the use of aquavet chemicals, then the NAC feels increased and better education of veterinarians is required. This is to ensure that both the veterinarians and their clients are adequately protected from potential legal action due to the unintended impacts of the aquavet chemical. This would include the provision of funding for the training of vets and for R&D to provide supporting data packages.