From: Deb ONeill [DOneill@gf.state.az.us]
Sent: Friday, January 16, 2004 12:26 PM
To: fdadockets@oc.fda.gov
Subject: Comments on Docket No. 2003N-0400

A hard copy of our comments will follow.

 

January 16, 2004

 

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, Maryland 20852

 

To Whom It May Concern:

 

Please accept the following comments on the interim final rule 21 CFR 1240.63, African rodents and other animals that may carry the monkeypox virus (Rule; Federal Register Vol. 68, No. 213). While the Arizona Game and Fish Department (Department) agrees that certain restrictions should be initiated in response to the monkeypox outbreak, some of the limitations outlined in the Rule lessens our ability to manage wildlife effectively. The Department supports increased safety measures designed to stop the spread of the monkeypox virus, however we have some specific concerns and comments regarding the Rule. 

 

  1.. Restricting wild-to-wild translocations  In most cases, wild-to-wild translocations of prairie dogs are conducted to prevent them from being killed as the result of development activities. Prairie dogs are not typically kept overnight, but instead turned loose at another site soon after capture. Since they are released almost immediately, there is little if no chance of them encountering other domestic or wildlife species. Because prairie dogs are susceptible to the plague virus, trappers and handlers currently take safety precautions to limit direct handling of these species to reduce their potential exposure to the plague virus. Additional safety measures are not needed to prevent the spread of monkeypox as measures are already being enforced. 
 

The Department believes that wild-to-wild translocations of prairie dogs should be allowed. 

 

  2.. Capture definition confusing  The Rule does not consider capture to be the act of immobilizing a prairie dog, taking measurements or biological samples (such as blood samples), and then releasing the prairie dog. Then the Rule states, it would be illogical to prohibit wild prairie dogs from being transported but still allow them to be captured. An infectious animal could transmit the monkeypox virus to humans during its capture, just as it could transmit the monkeypox virus when a human handled the animal during transport. The latter quote seems to contradict the previous quote; clarification of capture is necessary. 
The Rule does not consider shooting as a form of capture therefore, it is allowed. The Rule recommends that appropriate carcass disposal rules should be followed after shooting prairie dogs. However, the Rule also states that it applies regardless of whether an animal is alive or dead because dead animals could still harbor the monkeypox virus and could be infectious, so the agency cannot ignore such dead animals as a potential source for infection. This latter quote apparently contradicts the recommendation for proper carcass disposal.

 

The Department believes that trappers and handlers of prairie dogs are properly trained and take all the necessary precautions to prevent transmission of diseases to people or other animals. Wild-to-wild translocations and capture and release for purposes of research should be allowed.

 

  3.. Shooting prairie dogs  The Rule states individuals sometimes shoot prairie dogs because their burrows may present a hazard to cattle and horses. This is speculation and does not belong in the Rule. Hunters shoot prairie dogs for a variety of reasons; the Rule does not need to specify a circumstance. 
 

  4.. Captive animals used for educational purposes  Prairie dogs that have been captive and used for educational and informational purposes before the monkeypox outbreak should be exempt from this Rule given the length of the monkeypox virus incubation period (3 months). These animals are typically housed with other animals of known origin or maintained alone. Trained personnel handle prairie dogs during transport and educational programs. 
 

Prairie dogs that were captive animals prior to the monkeypox outbreak, and have not been exposed to listed animals (as stated in the Rule), should be exempt from this Rule.

 

  5.. Black-footed ferrets  The multi-state black-footed ferret breeding and reintroduction program relies on wild caught prairie dogs for preconditioning and food for ferrets. Black-footed ferrets primarily feed on prairie dogs in the wild and the breeding program strives to be consistent with natural ferret diet by providing prairie dogs to captive ferrets. These prairie dogs are wild caught and brought to a quarantine facility where they are held for 14 days before some are euthanized and frozen for ferret food. Those not euthanized are reserved to be fed alive to ferrets and to maintain burrow systems. Agencies and companies have trained individuals that capture, transport, and maintain prairie dogs for this purpose. 
 

Prairie dogs taken directly from the wild for purposes supporting the black-footed ferret breeding and reintroduction program should be exempt from this Rule.

 

  6.. States not involved in the monkeypox outbreak  There are several states within prairie dog range that were not affected by the monkeypox outbreak. Provided the interim final rule regarding the importation of listed species, 42 CFR 71.56: African rodents and other animals that may carry the monkeypox virus (Federal Register Vol. 68, No. 213), is effective, there should not be additional concern that monkeypox will be introduced to wild populations of prairie dogs. 
 

States that were not affected by the initial monkeypox outbreak should be exempt from the Rule. 

 

The Department, as well as other affected federal and state agencies, needs the flexibility to effectively manage wildlife resources. In the Departments case, this Rule drastically interferes with our State mandated obligations to manage wildlife species. 

 

Thank you for considering our comments. Please contact Bill Van Pelt, Nongame Mammals Program Manager, at (602) 789-3573 or bvanpelt@gf.state.az.us if you have any questions.

 

Sincerely, 

 

 

 

Duane L. Shroufe

Director

 

DLS:do

 

cc:        Jim de Vos, Research Branch Chief, WMRS

            Terry Johnson, Nongame Branch Chief, WMNG