Regulatory update #153

23 July 2012

Agvet regulator responds to chicken vaccine concerns

New Australian research showing that poultry vaccines have recombined to produce more virulent viruses has prompted the Australian Pesticides and Veterinary Medicines Authority (APVMA) to examine regulatory controls over the approval and use of veterinary vaccines. The research study by Dr Joanne Devlin, Professor Glenn Browning and Dr Sang-Won Lee and colleagues at the Asia-Pacific Centre for Animal Health at the University of Melbourne and NICTA has been published in the international journal Science (external site).

The researchers found that two different types of vaccine viruses used to control a chicken respiratory disease—infectious laryngotracheitis or ILT—have recombined (crossed) to form two new virulent forms of the ILT virus.

The AVMA has informed state and Australian Government regulatory partners and is now working through the implications of these findings with the researchers, vaccine registrants and the poultry industry.

A number of short-term measures are being considered, including changes to product labels, which may result in restrictions on the use of two vaccines of different origins in the one animal population.

The APVMA will also assess all live virus vaccines currently registered by the APVMA in regard to the risk of recombination.

APVMA gets to grips with ‘multiples’

No, we’re not talking multiple births, but the knotty problem of how to conduct risk assessments for exposures to multiple chemicals.

Australian agvet chemical legislation is based predominantly on assessments carried out on individual substances. Since humans and their environments are exposed to a wide variety of substances, there are concerns in the general public about the potential adverse effect of the interactions between those substances when present simultaneously in a mixture.

To help build an understanding of these issues, we recently sponsored a ‘Workshop on Combined Exposures to Multiple Chemicals’ conducted by the Australasian College of Toxicology and Risk Assessment in Canberra.

The workshop, attended by 23 APVMA staff members, considered the Framework for the Assessment of Combined Exposures to Multiple Chemicals, which has been developed by the World Health Organization’s International Programme on Chemical Safety.

'Problem formulation' is an important component of the risk assessment process for chemical mixtures, involving a consideration of the nature of the likely human exposure to the chemicals under consideration.

Together with many other international jurisdictions, the APVMA will continue to monitor developments in this important area of regulatory risk assessment. The EC’s Health and Consumer Protection Directorate-General has published a consultation statement on Toxicity and Assessment of Chemical Mixtures, which provides further background on these issues.

APVMA extends the scope of the ongoing fipronil review to include environmental considerations

Fipronil is a broad spectrum phenyl pyrazole insecticide that is used in both agricultural and veterinary situations. A review of fipronil commenced in 2003 following reports of adverse experiences in humans and animals. The initial review focused on human and animal safety issues.

Since 2006, information has become available that identifies some significant environmental concerns associated with continued use of selected fipronil agricultural products. On this basis the APVMA has determined that consideration of environmental concerns is required and will be achieved through extension to the scope of the current review. This review will consider information on the following environmental aspects of product registrations for fipronil including, but not limited to:

  • Aquatic degradation
  • Persistence in environmental media (soil, water and sediment)
  • The partitioning in the environment eg deposition, adsorption
  • Toxicity to fish and aquatic invertebrates, sediment organisms, bees and non-target arthropods

The APVMA will also consider whether product labels carry adequate instructions and warning statements. Please note that the extended scope of this review does not include veterinary products or those agricultural products formulated as baits or gels for ant or cockroach control, fly bait stations containing fipronil or termite dusts.

For more information on the extension of the scope of the fipronil review or to make a submission of information to the fipronil review, please refer to the consultation webpage.

Reminder—open for public consultation

The APVMA is currently seeking comment on:


Advice Summaries published since last issue are listed below. For a complete list and further information, please refer to the Advice Summaries content on our website.

  • Farmalinx Flumetsulam 800 WG Herbicide
  • Cropro Chlortan 720 Fungicide
  • Sumiguard Insecticide
  • Vivando Fungicide
  • Agador Turf Nematicide And Miticide
  • Delaval Kontact Concentrate Post Milking Teat Sanitiser With Emollient
  • Rentokil Alpha Rapid Rodenticide
  • Tweak Yield & Quality Enhancer
  • Ilium 5% Tea Tree Oil Shampoo

Application Summaries are updated weekly. For a complete list, please refer to the Application Summaries content on our website.

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