The Chief Executive Officer, National Registration Authority, P.O.Box E240, Kingston, ACT , Australia 2604 Fax (06) 272.4753 Int. +61 6 272.4753 28th November 1997 Dear Madam/Sir, I am aware that the NRA may be in the process of considering the licensing of RCD/RHD coated baits for use in Australia.The RCD/RHD baits are a unique and novel product, very different from the RCD/RHD injectable virus which is currently the only lawful product available for the deliberate spread of RCD/RHD in Australia. I demand full disclosure of the nature and make-up of the RCD/RHD baits and that full public consultation be allowed in the consideration process of allowing or disallowing the approval for use in Australia by the NRA of RCD/RHD coated baits. 4 out of 5 major calicivirus groups are already known to infect humans and no guarantees can be given that RHD/RCD will never infect any other species. Any proposal to deliberately increase the levels of RCD/RHD in the environment must be scrutinized extremely carefully and independently. If evidence exists that non-target species may be put at risk by the deliberate use of such baits, the approval of the RCD baits should be disallowed by the NRA. Further facts concerning the RCD/RHD virus are as follows: 1. The origins (mutation or non-rabbit host) of RHD in China in 1984 remain unknown. 2. The genetic determinants and mechanisms resulting in a rapid and bloody RHD induced death are unknown. 3. The modes of RHD transmission across ocean channels and between continents are unknown. 4. The mechanisms of RHD transmission, which is sometimes rapid and sometimes leap-frog (hundreds of kilometers), are unknown. 5. The reason for failure of RHD to transmit even under contact conditions in fenced enclosures (Wardang Island) are unknown. 6. The host range of RHD is virtually certain to extend well beyond rabbits (Geelong experiment showing 2-17 fold antibody increases in 11 test species using purported subimmunogenic virus doses) but remains unknown. 7. Diagnostic reagents for RHD lack the specificity and sensitivity to carry out adequate epidemiologic assays, particularly in non-rabbit species including humans. 8. RHD vaccines for rabbits in Spain are reported over time to have become less protective. 9. RHD vaccines are not available to protect any non-rabbit species at risk, including humans. 10. RHD has not been shown (using proven and acceptable scientific methods) to be caused by a calicivirus alone; therefore, the infectious makeup of RHD is unknown. 11. RHD cannot be propagated in cell culture. Yet, that was a stated essential CSIRO requirement to be met before infectivity studies were to be carried out (1994 BRS report). 12. RHD may have already impacted human health (see Dr. Cherrys' Report submission to the NZ Government MAF authority)and the extent of the suspected threat to human health is unknown. 13. In Australia, RHD is uncontrollable, unpredictable, and often unreliable as a rabbit control agent. I demand a full and open public consideration process to be allowed by the NRA in considering the approval/disapproval of the licensing of RCD/RHD baits as a veterinary chemical product in Australia. Regards,