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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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4.2 Cyprinid herpesvirus-3

Part B: Amendments to the Poisons Standard not referred to an expert advisory committee

4. Delegate-only decisions on agricultural and veterinary chemicals

4.2 Cyprinid herpesvirus-3

Delegate's final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Poisons Standard by creating a new Appendix B entry for Cyprinid herpesvirus-3 as follows:

Appendix B - New Entry

CYPRINID HERPESVIRUS-3

Reasons for entry: a (low toxicity)

Areas of use: 1.10 (biological control agent)

Implementation date: 1 October 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:
    • Cyprinid herpesvirus-3 (CyHV-3) is a naturally occurring viral organism present in several countries and specifically targets the common carp. CyHV-3 is not infective or pathogenic in other fish or mammals, including humans.
    • There is no evidence of a fish virus causing any adverse effects in humans.
    • CyHV-3 genome appears stable relative to that of other known viruses.
    • CyHV-3 DNA sequence shares very little similarity with the sequence of mammalian herpes viruses.
    • CyHV-3 does not replicate above 28°C, hence mammalian body temperatures (mean ~38°C) are not compatible with CyHV-3 infectivity.
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • CyHV-3 will be used as a specific pesticide for the common carp for the purposes of the National Carp Control Plan.
  3. the toxicity of a substance:
    • CyHV-3 is not infective or pathogenic in humans or animals other than the common carp.
Applicant's scheduling proposal and reasons for proposal

An application was submitted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) to consider the scheduling of Cyprinid herpesvirus-3 (CyHV-3) in the Poisons Standard. The application proposed that CyHV-3 does not require scheduling.

The applicant's reasons for the proposal were:

  • CyHV-3 is a naturally occurring viral organism present in several countries and specifically targets the common carp. No other fish is affected by CyHV-3 and testing in other animals, including mammals, has demonstrated that CyHV-3 is not infective to them.
  • CyHV-3 is not currently present in the Australian environment. Since identification of CyHV-3 two decades ago, human exposure to the virus has been extensive across several countries through oral and dermal routes. Despite extensive human exposure to fish viruses in general, and to CyHV-3 in particular, there is no evidence of a fish virus causing any adverse effects in humans.
  • CyHV-3 genome appears stable relatively to that of other known viruses. CyHV-3 DNA sequence shares very little similarity with the sequence of mammalian herpes viruses.
  • CyHV-3 does not replicate above 28°C, hence mammalian (mean ~38°C) and bird body temperatures (mean ~40°C) are not compatible with CyHV-3 infectivity.
Background information for Cyprinid herpesvirus-3
Current scheduling status and scheduling history

Prior to this final decision CyHV-3 was not scheduled in the Poisons Standard. CyHV-3 has not been previously considered for scheduling.

Australian regulations

The Australian Government is embarking on a revolutionary, long-term plan to rid our waterways of the common carp, one of the country's most devastating pests. On 1 May 2016, the government announced that it is investing $15 million over two and half years to undertake further research, approval and consultation to develop a comprehensive National Carp Control Plan for a potential release of Cyprinid herpesvirus (carp herpesvirus) by the end of 2018. See the National Carp Control Plan on the Australian Government Department of Agriculture and Water Resources website for more information.

CyHV-3 is not currently approved by the APVMA.

CyHV-3 is not used in human therapeutics and therefore does not appear to be in any products on the Australian Register of Therapeutic Goods (ARTG) nor in the Therapeutic Goods (Permissible Ingredients) Determination.

International regulations

There do not appear to be international regulations for CyHV-3.

Substance summary

The Cyprinid herpesvirus-3 (or CyHV-3) is a naturally occurring viral organism in several countries. CyHV-3 is the causative agent of a highly contagious, fatal disease which specifically targets common carp.

Infectivity and pathogenicity

CyHV-3 is not infective or pathogenic in humans. The human health hazard of CyHV-3 is considered to be negligible.

Acute toxicity studies with CyHV-3 were not undertaken. Nevertheless, considering CyHV-3 has a negligible human health hazard, it is postulated that CyHV-3 would not reach a classification according to the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2018).

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • The applicant's scheduling application to amend the current Poisons Standard with respect to Cyprinid herpesvirus-3;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • Section 52E (1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; and (c) the toxicity of a substance.

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