Dr McDaniel replied to the following questions asked by Professor Yvonne Van Roy:

1)How much do you believe we should know about a virus before it should be considered for use as a biological agent?

2)Do you believe that much is known about RCD?

3)How long would it be before any spread to another species might be detected?

4)Can you tell me what procedures are in place in the USA to assess and decide about the release of viruses such as RCD?

If you have any other comments you think would be helpful, please include them. I have attached a copy of a useful article from our “North and South” magazine which outlines the debate here. Very many thanks for your help.
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Dr Harless McDaniel,
Assistant Director (recently retired)
Program Planning & Development,
USDA/APHIS
USA

September 2, 1996

From:Harless A. McDaniel

To:Prof. Yvonne Van Roy

Re:Your Fax dated 9-3-96 requesting my comments on Calicivirus.

Following is my response to your questions:

1) I am not sure when I would be willing to see a known highly pathogenic or lethal virus released among a dense population of susceptible hosts. I doubt if it can be measured in, “How much”. It always seems that every time we find something new scientifically, it raises more questions than it answers. Foreign animal disease prevention and responses are somewhat similar to war and military strategies. There is always a risk, the question is, is the risk worth taking. Military strategist and others spend much of their time and resources conducting risk analysis. Formulas for conducting risk analysis (or risk management) vary from very simple to very complex. I believe this the best approach to decision-making on this issue. However, I do believe there is sufficient information known about caliciviruses at this time to conduct a valid risk analysis study. The most significant missing information concerns the marine phase of these agents. These viruses can infect fish and marine mammals as well as terrestrial life forms. The most significant questions are where does mutations usually occur and what factors are most likely to induce mutations. Do they occur on land or in the sea. With thousands of rabbit carcasses contaminating the run-off water, the causative virus will get back to the sea. What happens next is the most important question in my opinion. My suggestion is to select the risk assessment process and formula that best fits the rabbit calicivirus disease, provide the information that is available, seek the missing information, and as soon as the results of MEANINGFUL RISK ASSESSMENT STUDIES are known, accept the results and proceed.

2) I believe there is much more known about the disease (symptoms, lesions, etc) than about the etiology. I am not aware of any form of disease this virus causes in any species except rabbits, but I am not aware of any meaningful studies to determine pathogenesis in other species. I understand caliciviruses can be readily adapted to growth in a variety of cell culture systems. This might indicate that as they survive in fish cells at ambient temperature, they retain the capacity to infect a variety of mammalian cells as various opportunities arise. THIS NEEDS FURTHER INVESTIGATION.

3) I do not have any idea about "how long". Nature does not seem to be time-conscious. However this could and should be included in any risk analysis studies conducted.

4) I am not aware of any procedures, rules or policies in the USA that would ever allow the release of any pathogen such as this in nature. On the contrary, we have many rules to prevent such a release. Perhaps the nearest thing would be the pox virus vectored rabies vaccine for wildlife. Only after very convincing studies that any biological vector would not transmit to other animals was it allowed to be used in wildlife.

We have many problems in wildlife. Too many deer are causing thousands of automobile accidents, too many starlings are very messy, and too many racoons are transmitting rabies just to mention a few of our over-population problems. However I do not believe release of any pathogenic microorganism as a population control measure has ever received any serious consideration in the USA.

Finally, I was amazed to see how many issues had been raised and addressed in the article you sent me. However I was also amazed at how many of the responses seemed to lack scientific support.

Sincerely,

Harless A. McDaniel, DVM, PhD