The Ministry of Health has been involved with the officials working group convened by MAF assisting with the peer review of the Import Impact Assessment and Application to the Director General of Agriculture to import rabbit calicivirus under the Animals Act 1967 and to issue and Import Health Standard under the Biosecurity Act 1993 (Application and IIA).

The Ministry of Health sought the expert opinion of independent virologists regarding the scientific validity of the RCD Application provided by the Applicant Group.

The opinion received by the Ministry of Health indicates there are uncertainties surrounding the introduction of the new virus in the community, and the analysis and comments made question the scientific validity of the Application.

The Ministry of Health considers the scientific validity of the assessment of the Rabbit Calicivirus Disease provided by the Applicant Group to MAF to be questionable and does not support the introduction of the virus.

We strongly suggest that you arrange further independent review of the scientific studies.


Ministry of Health Comment

The Ministry of Health has been involved with the officials working group convened by MAF assisting with the peer review of the Application to Import Rabbit Calicivirus (RCD) into New Zealand.

The Ministry of Health provided written comments to MAF on the 19th July 1996 on the information provided on the Application and the known epidemiology and effects of human health. We suggested amendments to the release programme to prepare for anticipated public perception of risk. We also discussed the virological assessment and implications.

On 5 August 1996 in response to being provided with the revision of the Import Impact Assessment and Application to the Director General of Agriculture to approve the importation of Rabbit Calicivirus from MAF we noted that:

We are reluctant to see this document distributed more widely when fundamental concerns that fail to address the risk containment issues to the public are not addressed. By not providing this information, there is the implication that health issues have not been considered and do not matter.


Professor Alvin Smith

The Ministry of Health received an open letter directly from Professor Alvin Smith addressing the proposed approval and official release of Rabbit Haemorrhagic Disease (RCD) as a biological agent on 19 August 1996.

Professor Smith heads the calicivirus laboratory at Oregon State University and has experience in the area of Calicivirus research and in depth understanding of the natural history of the Caliciviridae family of viruses.

His letter addresses aspects of the RCD Applicant Group’s Application dated 27 June 1996, specifically relating to the virology of the RHD agent from a scientific viewpoint, and identifies many areas of concern in the experimental design and the methodology applied to RHD investigations carried out in Australia and New Zealand.


Independent virological assessment

We noted Professor Smith’s major reservations about the virological methods used by CSIRO, and sent the papers to three New Zealand virologists to review and provide independent comment from a virological viewpoint:

1.Dr Margaret Croxon
Pathologist in Charge
Department of Virology and Immunology
Auckland Hospital

2.Dr Lance Jennings,
Virologist
Canterbury Health Laboratories

3.Professor A R Bellamy
Director
School of Biological Sciences
Auckland University

Dr Croxson agreed with the opinion of Professor Smith that there are many major deficiencies in the studies described by the Applicant Group and that the data is inadequate to provide evidence that the virus does not infect other species. Dr Croxon suggested that an independent panel should be asked to review and comment on the scientific validity of the design of the experiments and the results obtained.

Dr Lance Jennings shared a similar viewpoint with Dr Croxon that the comments made by Dr Smith should be deliberated over by an independent panel of scientists, and noted that Dr Smith’s letter should be "taken seriously by the Ministry of Health".

Dr Bellamy notes that Dr Smith’s argument is sound from a scientific and virological viewpoint and concludes his assessment of the material provided to him by the Ministry of Health with the following summary of key points:

(a) Although presented in a more colourful manner than is necessary, much of what Dr Smith has presented in his criticism of the results and approaches adopted to date has a sound scientific basis.

(b) The data presented by CSIRO on the cross-species transmission of RCD is preliminary in nature and of rather poor quality. Better data would be required to enable the concerns expressed by Prof Smith to be addressed.

(c) The fact that the virus escaped quarantine indicates that there is insufficient knowledge available concerning the method of transmission. A better knowledge of the mechanism of transmission is required if the risk factors involved in exposure are to be properly evaluated.

(d) Insufficient information exists to enable the level of variation in the virus to be adequately assessed. This information should now be available quite soon given the availability of the complete sequence of the genome. The cloned gene should also enable better reagents to be developed which could be used to provide better epidemiological data.

(e) The accidental viral epidemic in Australia provides an excellent opportunity for the mechanism of transmission and cross-species susceptibility to be evaluated in a systematic manner under natural field conditions. From a virological standpoint, that work should be undertaken prior to any release contemplated in New Zealand.

Conclusion

Because of the uncertainties surrounding the introduction of the new virus in the community, and the analysis and comments made by Professor Bellamy and Drs Croxson and Jennings that question the scientific validity of the Application, the Ministry of Health does not support the introduction of the virus and considers that further independent review of the scientific studies should be undertaken.