§ 71.53 Requirements for importers of nonhuman primates.

(a) Purpose. The purpose of this section is to prevent the transmission of communicable disease from nonhuman primates (NHPs) imported into the United States, or their offspring, to humans. The regulations in this section are in addition to other regulations promulgated by the Secretary to prevent the introduction, transmission, and spread of communicable diseases under 42 CFR part 71, subpart A and 42 CFR part 70.

(b) Scope. This section applies to any person importing a live NHP into the United States, including existing importers, any person applying to become a registered importer, and any person importing NHP products.

(1) Importers must make their facilities, vehicles, equipment, and business records, including employee health records and animal health records, used in the importation of NHPs, available to HHS/CDC for inspection during operating business days and hours, and at other necessary and reasonable times, to enable HHS/CDC to ascertain compliance with the regulations in this section.

(2) Nothing in this section supersedes or preempts enforcement of emergency response requirements imposed by statutes or other regulations.

(c) Acronyms, initialisms, and definitions.

(1) For the purposes of this section:

AAALAC means the Association for Assessment and Accreditation of Laboratory Animal Care International.

AZA means the Association of Zoos and Aquariums.

CITES means the Convention on International Trade in Endangered Species.

ELISA means enzyme-linked immunosorbent assay, a type of laboratory test that measures antibodies or detects antigens for specific pathogens.

HHS/CDC means U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, or an authorized representative acting on its behalf.

IACUC means Institutional Animal Care and Use Committee.

MOT means mammalian old tuberculin, a biological product used as a diagnostic tool in the evaluation for mycobacterial (TB and related bacteria) infections.

NIOSH means the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services.

PPE means personal protective equipment, such as gloves, respirators, and other devices used in preventing the spread of communicable diseases.

SOPs means standard operating procedures.

TB means tuberculosis.

TST means tuberculin skin test.

USDA means United States Department of Agriculture.

(2) For purposes of this section, the terms listed below shall have the following meanings:

Animal act means any use of NHPs, including offspring, for entertainment in which the NHPs are trained to perform some behavior or action and are part of a routinely scheduled show, performance, or exhibition, open to the general public.

Breeding colony means a facility where NHPs, including offspring, are maintained for reproductive purposes.

Broker means a person or organization within the United States that acts as an official agent of an exporter of NHPs from another country, or as an intermediary between such an exporter and an importer of NHPs.

Cohort means a group of NHPs imported together into the United States.

Director means the Director of the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, or an authorized representative.

Educational purpose means the use of NHPs, including offspring, in the teaching of a defined educational program at the university level or equivalent.

Exhibition purposes means the use of NHPs, including offspring, as part of a public display open to the general public during routinely scheduled hours in a facility that meets or exceeds AZA accreditation standards.

Importer means any person importing, or attempting to import, a live NHP into the United States, including an applicant to become a registered importer. Within the meaning of this section, “importer” includes any person maintaining a facility or institution housing NHPs during quarantine. Within the meaning of this section, “importer” also includes the agent of any animal act, laboratory, or zoo that is subject to or carries out responsibilities in accordance with the regulations in this section.

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.

Lab or laboratory means a facility in the United States accredited by AAALAC or licensed by USDA, conducting research using NHPs, having foreign based facilities, and intending to transfer or transferring one or more NHPs that were originally part of an institutionally approved, ongoing protocol, from its foreign-based facility into its United States facility for purposes related to that specific research project.

Licensed veterinarian means a person who has graduated from a veterinary school accredited by the American Veterinary Medical Association's Council on Education, or has a certificate issued by the American Veterinary Medical Association's Education Commission for Foreign Veterinary Graduates, or has received equivalent formal education as determined by the HHS/CDC; and has received training and/or experience in the care and management of nonhuman primates.

Medical consultant means an occupational health physician, physician's assistant, or registered nurse, who is knowledgeable about the risks to human health associated with NHPs.

Nonhuman primate or NHP means all nonhuman members of the Order Primates.

NHP product or Product means skulls, skins, bodies, blood, tissues, or other biological samples from a nonhuman primate, including trophies, mounts, rugs, or other display items.

Offspring means the direct offspring of any live NHPs imported into the United States and the descendants of any such offspring.

Old World Nonhuman Primate means all nonhuman primates endemic to Asia or Africa.

Pathogen means any organism or substance capable of causing a communicable disease.

Permitted purpose means the use of NHPs for scientific, educational, or exhibition purposes as defined in this section.

Person means any individual or partnership, firm, company, corporation, association, organization, including a not-for-profit organization, such as a sanctuary, or other legal entity.

Quarantine means the practice of isolating live NHPs for at least 31 days after arrival in a U.S. quarantine facility where the NHPs are observed for evidence of infection with communicable disease, and where measures are in place to prevent transmission of infection to humans or NHPs within the cohort.

Quarantine facility means a facility used by a registered importer of NHPs for the purpose of quarantining imported NHPs.

Quarantine room means a room in a registered import facility for housing imported NHPs during the quarantine period.

Scientific purposes means the use of NHPs including offspring for research following a defined protocol and other standards for research projects as normally conducted at the university level.

Zoo means:

(1) Within the United States, an AZA-accredited and professionally maintained park, garden, or other place in which animals are kept for public exhibition and viewing; or

(2) Outside of the United States, a professionally maintained park, garden, or other place in which animals are kept for public exhibition and viewing that meets or exceeds the accrediting standards of the AZA.

Zoonotic disease means any infectious agent or communicable disease that is capable of being transmitted from animals (both wild and domestic) to humans.

(d) General prohibition on importing nonhuman primates. (1) A person may not import live NHPs into the United States unless the person is registered with HHS/CDC as a NHP importer in accordance with this section.

(2) A person may only import live NHPs into the United States for:

(i) Permitted purposes, as defined under paragraph (c)(2) of this section; or

(ii) Use in breeding colonies, provided that all offspring will be used only as replacement breeding stock or for permitted purposes.

(3) A person may not accept, maintain, sell, resell, or otherwise distribute imported NHPs (including their offspring) for use as pets, as a hobby, or as an avocation with occasional display to the general public.

(e) Disposal of prohibited or excluded NHPs. (1) HHS/CDC may seize, examine, isolate, quarantine, export, treat, or destroy any NHP if:

(i) It is imported through a location other than an authorized port of entry;

(ii) It is imported for other than permitted purposes;

(iii) It is maintained, sold, resold, or distributed for other than permitted purpose;

(iv) It is imported by a person who is not a registered importer; or

(v) It is otherwise deemed to constitute a public health threat by the Director.

(2) For any NHP arriving in the United States through an unauthorized location, for other than the permitted purposes, or by a person who is not a registered importer, the person attempting to import that NHP, must, as approved by the Director and at the person's own expense, do one of the following:

(i) Export or arrange for destruction of the NHP, or

(ii) Donate the NHP for a scientific, educational, or exhibition purpose after quarantine at a HHS/CDC-registered facility.

(3) If the person attempting to import a NHP fails to dispose of the NHP by one of the options described in paragraph (e)(2) of this section, the Director will dispose of the NHP at the person's expense.

(4) Pending disposal of any prohibited or excluded NHPs, the NHP will be detained at the person's expense at a location approved by the Director.

(f) Authorized ports of entry for live NHPs. (1) An importer may import live NHPs into the United States only through a port of entry where a HHS/CDC quarantine station is located. The list of current HHS/CDC quarantine stations can be found at http://www.HHS/CDC.gov/quarantine/QuarantineStations.html.

(2) In the event that the importer is unable to provide for entry at a port where a HHS/CDC quarantine station is located, the importer may only import live NHPs into the United States through another port of entry if the Director provides advance written approval.

(3) If prior written approval is not obtained from the Director, the importer and excluded NHPs will be subject to the provisions of paragraph (e) of this section.

(g) Registration or renewal of importers. Before importing any live NHP into the United States, including those that are part of an animal act or those involved in zoo-to-zoo or laboratory-to-laboratory transfers, an importer must register with and receive written approval from the Director.