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To prevent the transmission of monkeypox, a rare viral disease, today the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued an interim final rule to establish new restrictions and modify existing restrictions on the import, capture, transport, sale, barter, exchange, distribution and release of African rodents, North American prairie dogs and certain other animals in the United States.
“This interim measure further enhances HHS’s efforts to protect the public health by preventing the spread of communicable diseases,” said FDA Commissioner, Mark B. McClellan, M.D., PhD. “Today’s actions will minimize the likelihood of additional problems related to monkeypox.”
Earlier this year, an outbreak of monkeypox linked to exotic animals caused
37 confirmed, 12 probable, and 22 suspect cases in the United States.
" Emerging infectious diseases which originate in animals – such
as monkeypox, plague and West Nile virus -- continue to pose a significant threat
to public
health here in the United States,” said CDC Director Dr. Julie Gerberding. “Sound
public health calls for us to take action to protect the public from diseases
that can be spread by exotic animals.”
Monkeypox is a communicable viral disease that occurs primarily in rain forest regions of central and west Africa. Discovered in 1958 in Africa, monkeypox was first reported in prairie dogs and humans in the United States in May 2003. Individuals began contracting monkeypox primarily as a result of contact with prairie dogs that had contracted monkeypox from diseased imported African rodents. Investigations implicated a shipment of imputed animals from Ghana that arrived in Texas on April 9, 2003. This shipment contained approximately 800 small mammals of nine different species, including six genera of African rodents, which came in contact with prairie dogs.
In June 2003, CDC implemented an immediate embargo on the importation of all rodents from Africa. As a public health measure, FDA, along with the CDC, prohibited the transportation in interstate commerce or sale or offering for sale or any other type of commercial or public distribution, including release into the environment, of prairie dogs, and the following rodents from Africa: tree squirrels; rope squirrels; dormice; Gambian giant pouched rats; brush-tailed porcupines, and striped mice.
This interim rule is an increased measure by both agencies to prevent the possible transmission of monkeypox from imported animals and from those currently in the U.S. that may have become infected. As outlined in the interim rule the CDC will restrict the importation of these animals, and the FDA will restrict domestic interstate and intrastate movement of these animals, with exemption procedures to accommodate special circumstances.
A comment period of 75 days will be provided on the interim final rule. Written
comments can be submitted to FDA at: Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville,
MD 20852.
Comments can also be submitted electronically through www.fda.gov/dockets/ecomments.
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