Advisory Board Communiqué—3 April 2013

The APVMA advisory board appointed in November 2012, met formally for the first time on 3 April 2013 in Canberra.

APVMA chief executive officer, Kareena Arthy, updated the board on how the APVMA is preparing to respond to the agricultural and veterinary chemical amendment legislation that is currently being considered by the Australian Parliament.

Ms Arthy also discussed with the board a number of initiatives to improve the timeliness, consistency, predictability and transparency of the APVMA’s decision-making.

The APVMA’s role in minor-use permits

The board discussed the role of the APVMA in approving minor-use permits for registered agvet chemicals. Minor-use permits are usually sought to enable access to chemicals by smaller industries where there is insufficient economic return for registrants to justify the costs in obtaining broader registration uses.

The APVMA works very closely with industry and other government agencies to undertake regulatory risk assessments for minor uses and to issue permits for such uses.

The board identified the need for leadership from the agriculture and chemical industries and from government to ensure a coordinated and streamlined process is in place, particularly in identifying and filling priority ‘all of industry’ minor use gaps.

The board agreed to provide further advice on the key elements of an effective minor-use system to inform discussions about the ongoing role of the APVMA.

Key issues: veterinary antimicrobials; bees and pesticides; nanoregulation readiness

The board received three information papers on issues that may be discussed further at future meetings:

  • Regulation of veterinary antimicrobials in Australia—antimicrobial agents are essential drugs for human and animal health and welfare, but indiscriminate and non-therapeutic use can result in the selection of bacteria that are resistant to many modern antibiotics. The paper summarised how veterinary antimicrobials are regulated in Australia, including importation, registration and post-registration activities (such as on-farm quality assurance programs run by livestock industries themselves, Australian Veterinary Association prudent use initiatives and pharmacovigilance).
  • Risks to bees from neonicotinoid insecticides—regulators in Europe and North America are considering tighter regulation of neonicotinoid insecticides based on concerns about the possible impacts of these insecticides on the health of honey bees and other insect pollinators. The paper outlined the work under way by the APVMA to assess the possible risks to Australian bees. This includes a review of the science literature, meetings with the chemical industry, apiarists, research organisations, academics, government and overseas agencies and developing an overview of current regulatory approaches. The review will conclude with a report containing recommendations for strengthening existing risk management measures.
  • Nanoregulation readiness—the APVMA is doing considerable work to prepare for the possible regulation of nanoscale chemicals and products. The paper considered the likely levels of risk to be managed, the extent of the APVMA’s regulatory responsibilities, definitions of what is meant by nanoscale technology, possible data requirements and methodologies for assessing nanoscale chemicals and products and monitoring of chemicals and products in the market place.

Future topics for discussion

Board members advised Ms Arthy about a number of issues that may benefit from further discussion, including the APVMA’s specific roles and responsibilities in the context of the overall chemical regulatory system, the future of consultative arrangements, improved industry training and change management matters.

The next board meeting is scheduled for 27 June 2013.

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