From: Alvin W. Smith, DVM, PhD Professor, Oregon State University College of Veterinary Medicine Laboratory for Calicivirus Studies Corvallis, Oregon 97331 Fax 541 737 2730
October 7, 1996
National Registration Authority
First Floor Industry House
10 National Circuit
Barton ACT
ATTN: Joan Ashton
Dear NRA/Joan Ashton:
I note in the conclusion section of your NRA Community Brief "Registration of rabbit calicivirus injection to control pest rabbits in Australia" that if information becomes available which points to a problem with the product the NRA can suspend or withdraw the registration.
For that reason, I am providing you additional new information which brings into question the host specificity and safety of the product and I am therefore providing you with the basis for immediately suspending or withdrawing registration of the product.
Much can be said about numerous errors and pieces of misinformation in the NRA community briefing document. Some are as follows:
1. The product is named "Rabbit Calicivirus Injection". Even the product name could be in error. The purity is not proven in that without in-vitro amplification of the virus there is no reliable data to prove that the product is not contaminated with parvovirus and/or other viruses.
2. It is stated that the "Environmental Protection Agency considered environmental impacts," but this statement easily misleads one into believing that an Environmental Impact Assessment was accomplished for the product. This did not occur.
3. It is stated that "it has not been known to infect or cause death in any other animal species in the wild". Rabbit hemorrhagic disease killed a wild hare in China and that animals' tissue produced rabbit hemorrhagic disease in exposed rabbits and this was reported in the literature cited but these unwanted pieces of evidence were ignored. Also in Europe foxes and hares both became mildly infected based on rabbit hemorrhagic disease antibody presence.
4. The Department of Health and Family Services document regarding human health was much more guarded than stated in the NRA briefing (see attached correspondence for the exact quote cited in the BRS report). State Chief Medical Officer Adams had, after numerous qualifications, no objection to the "controlled release" of the virus. He apparently did not understand that it was an "uncontrolled releasing" of the virus that was being approved. The release of the virus couldn't even be "controlled" on Wardong Island when held under several layers of biocontainment. It did escape.
5. It is stated "no infection or evidence of illness was shown (in over 30 species tested by the CSIRO)." We note here that the wording carefully avoids saying "no evidence of infection" in these species. There was a great deal of evidence of infection in some of the 34 test species and under the Biological Control Act that alone should automatically block the approval of rabbit hemorrhagic disease as a biological agent.
6. It is stated "antibodies were detected in the blood of two species - Kiwi (but not emu) and mice" (please note the disclaimer statement following this paragraph which should be a red flag to all readers). The BRS report data, if reliable, clearly shows that mice, bush rats, brown falcons, ferrets, pigeons, Silver gulls, Northern brown bandicoots, one wombat, all four echidnas, and one but probably all seven short-tailed bats developed an antibody response following rabbit hemorrhagic disease injection.
Given this brief overview the bulk of the "new evidence" to be addressed is found in the BRS document itself, and is in the form of the specific data in the BRS document. The attached letter addressed to Mrs. Marguerite Wegner is in response to her specific questions and provides the bulk of the discussion regarding the "new evidence". In addition to her asking for my general assessment of the suitability of rabbit hemorrhagic disease as a biological agent, there were three specific questions asked by Mrs. Wegner. These questions are vital to the approval of rabbit hemorrhagic disease as a biological agent (Biological Control Authority) and an agricultural and veterinary chemical (NRA).
The three questions were:
1. Has the BRS Report (August 1996) shown that Australian scientists have undertaken all the necesssary tests to prove RCD as being species specific to the European rabbit?
2. Has the BRS report shown that RCD will not infect any species other than the European rabbit? (Please provide a brief analysis of the ELISA test results as listed in the tables, especially where blood samples taken prior to RCD exposure are as high as 40% - already positive to rabbit hemorrhagic disease).
3. Has the BRS Report shown that humans will not be infected by RCD?
The detailed answers are appended. In summary, the NRA was led to believe only mice and Kiwi developed antibodies as a simple result of an immune reaction to foreign protein when the Kiwi received 300 times the planned dose. In fact, if the BRS data are reliable they show nine other test species also developed antibodies to rabbit hemorrhagic disease when they did not receive the larger virus dose given the Kiwi. The most obvious interpretation of this data (ie these animals were infected by rabbit hemorrhagic disease) was withheld. Officials are now in the indefensible position of having to insist that all the following species, humans, hares, foxes, dogs, mice, bush rats, brown falcons, ferrets, pigeons, Silver gulls, bandicoots, wombats, echidnas, Kiwis, and bats developed rabbit hemorrhagic disease antibodies in the absence of infection.
In other words, officials appear to be superimposing their own answers without regard for the scientific data rather than letting the data speak for itself. Furthermore, all specific data is withheld in the BRS report on the human serology testing and is available only to select "inside" reviewers. If the human antibody data is as entangled, and wrongly reported as the test animal serology data, this must be immediately opened for unbiased peer assessment.
The NRA has no rational or moral responsibility left on this subject except for the immediate suspension of rabbit hemorrhagic disease registration prior to the scheduled 9 October 1996 release in New South Wales. Time is very short.
My heart is with you and your people. God help you all. Your country is being led down a one way street of unknown risk.
Highest regards,
Alvin W. Smith, DVM, PhD Professor
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