Updates to the Regulations for the Importation of Nonhuman Primates
The Centers for Disease Control and Prevention (CDC) is proposing to update its regulations governing the importation of nonhuman primates (NHPs) into the United States. NHPs are all nonhuman members of the order Primates, including, but not limited to, animals commonly known as monkeys, chimpanzees, orangutans, gorillas, and apes. On January 5, 2011, the Department of Health and Human Services (HHS) and CDC published a Notice of Proposed Rulemaking (NPRM) detailing proposed changes to the regulations for Importation of Nonhuman Primates into the United States (42 CFR 71.53).
Protecting health through nonhuman primate importation regulation
Since 1975, with help from federal partners, CDC has prohibited the importation of live NHPs except for science, education, or exhibition purposes. These restrictions were created because NHPs can carry infectious diseases that are harmful and sometimes fatal to humans. Examples of these infections include Shigella, Salmonella, Ebola, herpes B virus, tuberculosis (TB), yellow fever, and many others.
Time for revision
Over time, various measures (e.g., reports, letters, guidelines), have been used to support implementation of these regulations. The purpose of the proposed update is to consolidate and formalize the many measures that have been used to manage the importation of NHPs. The proposed regulations clarify the process for importing NHPs and explain all requirements importers must take to prevent the spread of disease from NHPs to humans.
Key proposed changes
The proposed regulations apply to all people who import NHPs into the United States, including existing importers and those importing NHP products.The proposed regulations extend existing requirements for the importation of some species of NHPs to cover all species, add some new requirements for importation of NHPs, and reduce the frequency at which NHP importers must renew their special permits. The regulations propose to:
- Expand filovirus testing requirements to all Old World NHPs (native to Africa and Asia) that die or are ill during quarantine with clinical signs consistent with a filovirus infection in order to decrease the risk for of human exposures. Filoviruses can cause severe hemorrhagic fever and include Ebola virus and Marburg virus.
- Require all importers to institute worker protection plans.
- Remove quarantine requirements for laboratory-to-laboratory and zoo-to-zoo transfers that meet certain criteria.
- Require standards for in-transit shipments while NHPs are in the United States, including added broker responsibilities for infection control.
- Require entry through ports where quarantine stations are located.
- Add the requirement that animal acts which include NHPs register with CDC.
- Add requirements for crating, caging, and transporting to protect transportation staff and importers from exposure to disease from NHPs before they enter into quarantine.
- Require a permit for the importation of NHP products, such as trophies and biological samples, to protect people who purchase or use these materials. NHP trophies, skins or skulls may be imported without a permit if they are accompanied by documentation describing the treatment method that rendered them noninfectious.
- Simplify the importation process by removing the requirement that a separate special permit be renewed every 180 days. All registrations are to be renewed every 2 years.
The public comment period ended on April 25, 2011. CDC is now working toward finalizing the proposed rule.
For more information and to read the proposed regulation on importation of NHPs, visit the Notice of Proposed Rulemaking on Regulations for the Importation of Nonhuman Primates website.