Questions and Answers for Importers on the Regulations for the Importation of Nonhuman Primates (42 Code of Federal Regulations [CFR] Part 71.53)
The Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) published a final rule on February 15, 2013, detailing changes to the regulations for importation of nonhuman primates (NHPs) into the United States. A final rule represents the end of the rulemaking process, when all public comments have been submitted and reviewed and the Agency publishes a finalized regulation to the Federal Register. This final rule outlines the requirements for the importation of NHPs into the United States to prevent the spread of communicable disease from NHPs to humans.
When are these regulations effective?
The final rule updating regulations for the importation of NHPs is effective on April 16, 2013, 60 days after publication to the federal register.
Why were the NHP regulations updated?
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.
Who is affected by these regulations?
The regulations apply to any person importing a live NHP into the United States, including currently registered 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.
What is CDC's role in carrying out NHP regulations?
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.
Does the final rule continue the general prohibition on importing live NHPs except for science, education, 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.
What are considered "scientific, educational, or exhibition" purposes for importing NHPs?
May I sell, resell, or otherwise distribute the offspring of an imported NHP for a purpose other than science, education or exhibition?
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.
What are the penalties for violation of these regulations?
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.
Where can I view the responses to the comment that I submitted to the Notice of Proposed Rule Making (NPRM) for this rule?
CDC reviewed and responded to all public comments received on the NPRM. To view the responses, please see section III of the Final Rule.
What are the changes to the regulations for importation of NHPs?
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.
|Requirement||Formerly Followed||Revised||New||Summary Details|
|✔||Importers must make NHP records available for inspection by CDC during scheduled site visits or within 1 hour of unscheduled visits.|
|✔||Importers will no longer have to obtain a separate special permit in order to import African green, Rhesus, or cynomolgus monkeys into the United States, but all importers will be required to meet all the standards that were previously listed on the special permit.|
Ports of entry into the United States
|✔||Entry of NHPs into the United States is restricted to those ports of entry where CDC Quarantine Stations are located, except in limited circumstances approved in writing in advance by CDC.|
Becoming a registered importer with CDC
|✔||In order for potential NHP importers to become registered, they must submit an application form and accompanying documents to CDC.|
Worker protection plans
|✔||Registered importers must have a written worker protection plan.|
Employee illness reporting
|✔||Importers must contact CDC immediately to report any suspected zoonotic illness in an employee.|
Crating, caging, and transporting NHPs
|✔||Importers must meet specific requirements for crating, caging, and transporting NHPs.|
Ground transportation vehicles
|✔||Importers must establish, implement, maintain, and adhere to standard operating procedures for vehicles transporting NHPs.|
|✔||Importers must quarantine all NHPs for at least 31 days after arrival at a U.S. quarantine facility.|
Design and operation of animal-holding facilities
|✔||Animal-holding facilities must meet specific requirements for security, airflow, and disinfection.|
|✔||Three tuberculin skin tests (TSTs) are required for all imported NHPs to decrease the risk for human exposure to tuberculosis.|
Health reporting requirements for NHPs
|✔||Importers must notify CDC within 24 hours of any illness or death of NHPs in quarantine facilities.|
|✔||Importers must notify CDC at least 7 days before importing a shipment of NHPs.|
|✔||Any Old World NHPs that die or are euthanized during the 31-day quarantine period must be tested for filovirus antigen.|
|✔||All animal acts entering the United States that include an NHP must be registered with CDC.|
|71.53 (p) and 71.53 (q)
Zoo-to-zoo and laboratory-to-laboratory transfers
|✔||Quarantine requirements are removed for zoo-to-zoo and laboratory-to-laboratory transfers that meet certain criteria.|
In transit shipments
|✔||For NHPs not intended for import into the United States, brokers must notify CDC of all scheduled in transit shipments and must adhere to new infection control requirements while the NHPs are in the United States.|
Revocation and reinstatement of importer's registration
|✔||An importer's registration can be revoked if requirements are not met and can be reinstated by following specific procedures.|
NHP trophies, skins, or skulls rendered noninfectious
|✔||NHP trophies, skins, or skulls may be imported without obtaining a permit if they are accompanied by documentation describing the treatment that rendered them noninfectious.|
NHP blood, skulls, skins, bodies, or tissue that has not been rendered noninfectious
|✔||NHP products (including skulls, skins, bodies, blood, or tissue) that have not been rendered noninfectious are considered to pose a potential human health risk and may only be imported with a permit.|
What are the record inspection requirements for importers?
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.
Is the special permit for importing NHPs still applicable to importers?
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.
What are the port of entry (POE) requirements for importation of NHPs?
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.
What documentation is required to become a registered NHP importer with CDC?
To register as an importer, the following must be submitted to CDC:
For information on how to become a registered importer of nonhuman primates, call 404-498-1670.
What are the requirements for a worker protection plan and personal protective equipment (PPE)?
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.
How should an importer report employee illness?
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.
What are the requirements for SOPs and equipment for crating, caging, and transporting NHPs?
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.
What are the requirements for ground transportation vehicles?
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.
What is the required time for an NHP to be quarantined?
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
What are the requirements for the design and operation of animal holding facilities?
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:
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.
What are the tuberculosis (TB) testing requirements for NHPs?
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.
What are the health reporting requirements for NHPs?
Under the final rule, an importer must ensure that CDC is notified within 24 hours of the occurrence of any of the following events.
|Any illness or death of NHPs in quarantine facilities or following a zoo-to-zoo or laboratory-to-laboratory transfer||By telephone, text, or e-mail|
|Any illness or death of NHPs from time of embarkation from country of origin to release from CDC quarantine||By telephone, text, or e-mail. Include cause of death for each NHP.|
|Any NHP testing positive for filovirus antigen or antibody||By telephone, text, or e-mail|
|Any positive or suspicious tuberculin skin test results, necropsy findings, or laboratory results||By telephone, text or e-mail|
What is required for release of NHPs from CDC Quarantine?
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.
What are the requirements for shipment pre-notification?
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.
What are the changes to CDC requirements for filovirus testing and NHPs?
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 [hyperlink to web page created for this].
What are the requirements for registering NHP animal acts?
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.
What are the changes for zoo-to-zoo and laboratory-to-laboratory transfers?
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.
What are the requirements for in transit shipments of NHPs?
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.
What procedures are required for revocation and reinstatement of an importer's registration?
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.
What are the requirements for importing NHP products that have been rendered noninfectious?
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.
What are the requirements for importing NHP products that have not been rendered noninfectious?
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 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.
Where can I find more information about these regulations?
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.