Questions and Answers for Importers on the Regulations for the Importation of Nonhuman Primates (42 Code of Federal Regulations [CFR] Part 71.53)

The final rule updating regulations for the importation of NHPs is effective on April 16, 2013, 60 days after publication to the federal register.

42 CFR 71.53 was originally published in 1975. CDC regulations for the importation of NHPs have been developed and revised to address the health risk they pose to humans. Over time, CDC has issued guidance (e.g., reports, letters, and guidelines) to supplement these regulations and to manage the importation of NHPs. The purpose of the final rule is to consolidate and formalize these practices.

The regulations apply to any person importing a live NHP into the United States, including currently regstered importers and any person or organization applying to become a registered importer, as well as any person or organization importing NHP products, such as trophies or biological samples.

HHS delegates to CDC's Division of Global Migration and Quarantine (DGMQ) the responsibility for administering the foreign quarantine regulations (42 CFR Part 71). Since 1975, section 71.53 of these regulations has prohibited the importation of NHPs except for scientific, educational, or exhibition purposes.

Yes, the final rule continues the general prohibition on importing live NHPs except for science, education, or exhibition purposes. NHPs may NOT be imported as pets under any circumstances.

• Scientific refers to the use of NHPs for research following a defined protocol and other standards for research projects as normally conducted at the university level.
• Educational refers to the use of NHPs in the teaching of a defined educational program at the university level or equivalent.
• Exhibition refers to the use of NHPs as part of a public display open to the general public during routinely scheduled hours in a facility that meets or exceeds Association of Zoos and Aquariums (AZA) accreditation standards.

No person shall accept, maintain, sell, resell, or otherwise distribute imported NHPs (including their offspring) for use as pets, as a hobby, or for occasional display to the general public.

Any person who violates these regulations may be punished by a fine of up to $100,000 if the violation did not result in the death of a person. The fine may be up to $250,000 per violation if the death of a person has resulted. Individuals may also be imprisoned for up to 1 year. Organizations may be fined up to $200,000 per violation not resulting in death and $500,000 per violation resulting in death. These penalties are criminal in nature and would thus be imposed by a court, not administratively by HHS or CDC. These penalties are not new, but merely reflect changes in statute that have occurred since the regulations were first published in 1975.

CDC reviewed and responded to all public comments received on the NPRM. To view the responses, please see section III of the Final Rule.

Below is a summary table showing each of the changes in the final rule. Click on a specific provision for more information about that requirement. The requirements are in one of three categories:

• Requirements marked "Former" are ones that importers have been required to follow prior to this final rule through various measures, including the 1975 final rule.
• Requirements marked "Revised" are ones that have been modified from the 1975 final rule.
• Requirements marked "New" are new practices required of importers that have been added to the final rule.

Summary of changes to the regulations for importation of NHPs

Importers must make all records used in the importation of NHPs available to CDC during scheduled site visits or within 1 hour of unscheduled visits to assess compliance with these regulations. These records would include facility, vehicle, equipment, and business records, including employee health records and animal health records. An importer must maintain records in an organized manner, either electronically or in a central location that is at or in close proximity to the NHP facility, to allow CDC to inspect the records during site visits.

On April 20, 1990, CDC published a notice in the Federal Register requiring importers to have a special permit for importing cynomolgus macaques, Rhesus macaques, and African green monkeys. This special permit requirement was established in response to the potential risk of filovirus infections associated with these species. This final rule incorporates the requirements of the special permit. CDC has withdrawn the special permit, and importers will be regulated under this single comprehensive final rule.

An importer may bring live NHPs into the United States only through a port of entry where a CDC quarantine station is located. An importer who is unable to comply with this requirement may seek permission from CDC to enter through an alternate port. For example, an importer using ground transport across the U.S. border or a charter flight that is unable to land at a major airport may be granted permission to do so on a case-by-case basis. Under this final rule, approval by CDC must be obtained in writing.

To register as an importer, the following must be submitted to CDC:

• Completed application form
• Statement of intent describing the number and types of NHPs intended for import during the registration period
• Copy of all written standard operating procedures (SOPs) (as specified in the final rule)
• Copy of any current registrations, licenses, and/or permits that may be required from the United States Department of Agriculture (USDA) and United States Fish and Wildlife Service (USFWS)
• Signed self-certification stating that the importer is in compliance with the regulations contained in this section and agrees to continue to comply with these regulations.

For information on how to become a registered importer of nonhuman primates, call 404-498-1670.

Under the new provision, importers must have a written worker protection plan for anyone whose duties may result in exposure to NHPs, including procedures for appropriate response measures in the event of an emergency. The proposed protection plan is designed to ensure that individuals who work with or around NHPs are educated on the risks and have the proper PPE to be protected from exposure to zoonotic diseases (diseases that can spread from animals to humans). Also, an importer must contact CDC immediately by telephone, text, or e-mail to report any suspected worker exposure to a zoonotic disease and must include procedures for contacting CDC in its worker protection plan.

An importer must contact CDC immediately by telephone, text, or e-mail to report any suspected zoonotic illness in an employee. Importers must also outline procedures for contacting CDC in their protection plan.

The importer must ensure that infection control measures are in place throughout transportation, not just after the NHPs reach a quarantine facility in the United States. Importers should adhere to equipment standards for crating, caging, and transporting live NHPs, as outlined in the USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and the International Air Transport Association standards. This provision is part of the performance-based approach, and the intent is for CDC to work with the importers to identify and develop SOPs that are effective in preventing the spread of communicable disease.

See the final rule for complete descriptions of the SOP and equipment standards for crating, caging, and transporting live NHPs.

When a shipment of NHPs arrives at a U.S. port of entry by aircraft, special vehicles must be used to transport the NHPs safely to a quarantine facility and ensure that these pre-quarantined NHPs do not pose a risk to human health. Likewise, a specialized ground transportation vehicle should be used when a shipment of NHPs destined for a quarantine facility enters the United States through a land border crossing. To ensure vehicles are operated with proper safeguards, the final rule requires that an importer establish, implement, maintain, and adhere to SOPs for ground transportation vehicles used to transport NHPs.

See the final rule for further guidance on ground transportation vehicles.

The requirements state that importers must quarantine all NHPs for at least 31 days after arrival at a U.S. quarantine facility. The 31-day quarantine may be extended if

• The importer or CDC suspects an NHP may be infected with zoonotic diseases, or
• The importer or CDC determines that there is a need for additional diagnostic testing.

An importer must maintain an adequate quarantine facility for holding NHPs during the required quarantine period. The quarantine facility must be easy to disinfect; have equipment and space for discarding and disinfecting all equipment, clothing, and caging; adhere to specific requirements for airflow, airflow indicators, and disinfection; and meet the following physical security requirements:

• The facility must be locked and secure, with access limited to authorized, trained, and knowledgeable personnel.
• Access to NHPs in quarantine must be limited to authorized personnel who are responsible for the transport, study, care, or treatment of the NHPs.

In addition, an importer must keep the number of workers involved in the care, transport, and inspection of NHPs to the minimum necessary to perform these functions.

The TB testing requirements included in the final rule mandate that, for each NHP in a quarantine facility, an importer must administer at least three tuberculin skin tests (TST) on the eyelid, using mammalian old tuberculin (MOT), with at least 2 weeks between tests, before the imported NHP is released from quarantine. TSTs must be read and recorded at 24, 48, and 72 hours, and a grading scale for interpretation of these tests must be listed in a (SOP) for TB testing. Importers must ensure that any group of NHPs imported together (cohort) with positive or suspicious TST reaction(s) in one or more animals remain in quarantine and receive at least five additional TSTs (each administered at least 2 weeks apart) following removal of the last affected NHP.

Under the final rule, an importer must ensure that CDC is notified within 24 hours of the occurrence of any of the following events.

The NHPs must complete the quarantine period and must have approval from CDC. Before release of any NHP, cohort, or mixed cohort* from quarantine, the quarantine facility's licensed veterinarian must report the health status of the NHPs to CDC by e-mail.

*A mixed cohort may occur if there is more than one species imported or groups of monkeys have arrived on different flights.

An importer must notify CDC in writing or by e-mail of a shipment of NHPs at least 7 calendar days before the planned arrival. The importer must give CDC information about the species and number of NHPs being imported, information about shipping, the type of animal identification being used, names and addresses of all persons/companies involved in the shipment, and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) permit.

Importers should visit the final rule for a detailed list of pre-notification requirements.

Filovirus testing has been expanded to include all Old World NHPs (NHPs native to Asia or Africa) in quarantine. These changes require antigen capture-testing for filovirus infection in any Old World NHPs that die during the quarantine period from anything other than trauma. Additionally, antibody testing is required for all Old World NHPs that exhibit signs consistent with a filovirus infection during quarantine; this testing must be done at the end of the quarantine period and before the cohort of NHPs is released from quarantine.

On February 12, 2013, HHS and CDC published a final rule establishing a user fee for filovirus testing on NHPs performed at CDC. CDC will charge a $540 user fee to cover the costs of performing the required filovirus antigen-capture testing on imported African green, cynomolgus, and rhesus monkeys that die during the mandatory 31-day quarantine period. For more information, visit the CDC website about the user fee.

All animal acts including NHPs that enter or leave and re-enter the United States must register with CDC and must meet all the requirements listed in the final rule. The importer must provide information and documentation to help identify the individual animals and to describe the conditions under which the NHPs are housed in the United States and all performance activities. Other requirements include documentation signed by a licensed veterinarian that describes the results of routine, yearly physical examinations of the NHPs. The exams must address routine elements and tests for conditions specified in the regulations, including a yearly tuberculosis test.

For those NHPs entering the United States through zoo-to-zoo or laboratory-to-laboratory transfers, the final rule eliminates the CDC-required 31-day quarantine period if the following criteria are met:

For zoos to qualify:

• The recipient zoo must be registered with CDC and must submit veterinary medical records documenting the NHP’s current and past health history, including testing for tuberculosis.
• Both the recipient and transferring zoos must be accredited by the Association of Zoos and Aquariums (AZA) or by a comparable accrediting agency.
• A specific and detailed travel itinerary must be submitted to CDC.

For laboratories to qualify:

• The laboratory must have both a foreign-based and a U.S.-based facility.
• NHPs must be part of an ongoing research project that has been approved by an Institutional Animal Care and Use Committee (IACUC).
• The recipient laboratory must be registered with CDC and must submit veterinary medical records documenting the NHP’s current and past health history, including testing for tuberculosis.
• U.S.-based laboratories must be licensed by the USDA; accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International is desirable.
• The foreign-based laboratory must be accredited by a comparable accrediting agency.
• Justification must be provided to CDC describing the reason a transfer to a U.S. laboratory is necessary (e.g., diagnostic equipment only available in the U.S.-based laboratory).
• A specific and detailed travel itinerary must be submitted to CDC.

Under this final rule, "in transit" means NHPs located within the United States that are not intended for import, whether scheduled or not, as part of the movement of those NHPs between a foreign country of departure and foreign country of final destination. The final rule requires that NHPs in shipments transiting through the United States be housed and cared for in a manner consistent with requirements for NHPs intended for import into the United States.

Procedures have been added to the final rule for revoking and reinstating an importer's registration. An importer's registration may be revoked if the Director of CDC or his/her designee determines that the importer has failed to comply with any of the applicable provisions of the regulation. The importer may request a written record review by the Director by filing a response within 20 calendar days of receiving notice from CDC. The Director will review the written record and issue a decision in writing to confirm the revocation or reinstate the importer's registration. As a condition of reinstating the registration, the Director may require inspection of facilities, examination of records, and other assurances of compliance with CDC's requirements. The Director's written decision shall constitute final agency action.

An NHP product means skulls, skins, bodies, blood, tissues, or other biological samples from an NHP, including trophies, mounts, rugs, or other display items. A permit is not required for the importation of NHP products if the product has been rendered noninfectious by one of the approved methods. Suitable methods to render a product noninfectious can be found in the regulation text.

Due to the risk to human health posed by untreated NHP products, a permit requirement for importing these items has been added to the final rule. NHP products as defined above that have not been rendered noninfectious are considered to pose a potential human health risk and may be imported only under the following circumstances:

• The product must be accompanied by a permit issued by the Director of CDC or his/her designee. Requests for permits should be accompanied by an explanation of the product's intended use and a description of how the product will be handled to ensure that it does not pose a zoonotic disease threat to humans. The Director of CDC or his/her designee will review the request for a permit, and accompanying materials, and issue a decision that shall constitute final agency action.
• The product may be imported only for scientific, educational, or exhibition purposes.
• The product may be received only by a facility equipped to handle potentially infectious NHP materials.

The product must comply with any other applicable federal requirements, including those relating to packaging, shipping, and transport of potentially infectious biohazards, as well as those for select agents. To learn more, please review the CDC select agent website.

For more information and to read the final rule on importation of NHPs, visit the Final Rule on Regulations for the Importation of Nonhuman Primates website.