September 8, 2008
FDA Removes Its Portion of Interim Final Rule Banning African Rodents, Prairie Dogs and Other Animals
The Food and Drug Administration (FDA) announced today that it is removing its restrictions on certain African rodents and prairie dogs that can carry or spread monkeypox because it has determined that such measures are no longer needed.
The FDA’s decision to remove its restrictions is based on several factors:
There have been no new cases of monkeypox in the United States since an outbreak in 2003.
A risk assessment published in 2006 suggests that the risk of further domestically acquired human monkeypox cases in the United States is low.
The Centers for Disease Control and Prevention (CDC) has a rule which prohibits the importation of all African rodents. The monkeypox virus entered the United States in 2003 through diseased African rodents. When the African rodents were co-housed with prairie dogs in the pet trade, the prairie dogs acquired monkeypox and, in turn, transmitted the disease to humans. The CDC rule remains in effect.
The FDA and the Centers for Disease Control and Prevention (CDC) jointly implemented restrictions in 2003 in response to an outbreak of human monkeypox in the United States. Monkeypox, a rare viral disease found mostly in central and western Africa, can be fatal in humans. It is transmitted through contact with the blood, bodily fluids, or rash of an infected animal. Rodents can carry the monkeypox virus with no symptoms or signs of infection. Health officials linked the 2003 outbreak to a shipment of 800 small mammals imported from Ghana to a Texas distributor. The infected animals spread the disease to humans across several states. There were 72 possible human cases of monkeypox during the 2003 outbreak, 47 of these were confirmed by laboratory tests. There were no deaths, although some patients were hospitalized and one patient required a corneal transplant.
The FDA and CDC joint-restrictions, issued first as an order in June 2003 and later as an interim final rule on November 4, 2003, created a complementary set of regulations intended to prevent the further introduction, transmission, and spread of the monkeypox virus. One set of regulations, administered and enforced by FDA, placed restrictions on the interstate movement of several species of African rodents and on prairie dogs within the United States. The second set of regulations, administered and enforced by CDC, placed restrictions on the importation of all African rodents imported into the United States.
FDA has consulted with CDC and has determined that the domestic restrictions placed on certain African rodents, prairie dogs and certain other animals are no longer needed. However, the CDC restriction on the importation of all African rodents remains in effect to prevent any re-introduction of the monkeypox virus into the United States.
For additional information, please see http://edocket.access.gpo.gov/2008/E8-20779.htm and http://www.fda.gov/oc/opacom/hottopics/monkeypox.html.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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