Title 42—Public Health--Volume 1
PART 71—FOREIGN QUARANTINE
§ 71.54   Import regulations for infectious biological agents, infectious substances, and vectors.
(a) The following definitions apply to this section:
Animal. Any member of the animal kingdom except a human including an animal product (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws).
Diagnostic specimen. Specimens of human and animal matter (including tissue, blood, body discharges, fluids, excretions or similar material), or environmental samples.
Genomic material. Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA) comprising the genome or organism's hereditary information, that may be single-stranded or double-stranded, and in a linear, circular, or segmented configuration and may be positive sense (same polarity as mRNA), negative sense, or ambisense (mixture of the two).
Infectious biological agent. A microorganism (including, but not limited to, bacteria (including rickettsiae), viruses, fungi, or protozoa) or prion, whether naturally occurring, bioengineered, or artificial, or a component of such microorganism or prion that is capable of causing communicable disease in a human.
Infectious substance. Any material that is known or reasonably expected to contain an infectious biological agent.
Select agents and toxins. Biological agents and toxins that could pose a severe threat to public health and safety as listed in 42 CFR 73.3 and 73.4.
Vector. Any animals (vertebrate or invertebrate) including arthropods or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws of an animal) that are known to transfer or are capable of transferring an infectious biological agent to a human.
(b) Unless excluded pursuant to paragraph (f) of this section, a person may not import into the United States any infectious biological agent, infectious substance, or vector unless:
(1) It is accompanied by a permit issued by the Centers for Disease Control and Prevention (CDC). The possession of a permit issued by the CDC does not satisfy permitting requirements placed on materials by the U.S. Department of Agriculture that may pose hazards to agriculture or agricultural production in addition to hazards to human health.
(2) The importer is in compliance with all of the permit requirements and conditions that are outlined in the permit issued by the CDC.
(3) The importer has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use.
(4) The importer takes measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious substances.
(c) If noted as a condition of the issued permit, subsequent transfers of any infectious biological agent, infectious substance or vector within the United States will require an additional permit issued by the CDC.
(d) A permit is valid only for:
(1) The time period and/or term indicated on the permit, and
(2) Only for so long as the permit conditions continue to be met.
(e) A permit can be denied, revoked or suspended if:
(1) The biosafety measures of the permit holder are not commensurate with the hazard posed by the infectious biological agent, infectious substance, or vector, and the level of risk given its intended use; or,
(2) The permit holder fails to comply with all conditions, restrictions, and precautions specified in the permit.
(f) A permit issued under this part is not required for an item if:
(1) It is a biological agent listed in 42 CFR Part 73 as a select agent and its importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16.
(2) With the exception of bat or nonhuman primate specimens, it is a diagnostic specimen not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and is accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious.
(3) With the exception of live bats or bat or nonhuman primate products, it is an animal or animal product being imported for educational, exhibition, or scientific purposes and is accompanied by documentation confirming that the animal or animal product is not known to contain (or suspected of containing) an infectious biological agent or has been rendered noninfectious.
(4) It consists only of nucleic acids that cannot produce infectious forms of any infectious biological agent and the specimen is accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent.
(5) It is a product that is cleared, approved, licensed, or otherwise authorized under any of the following laws:
(i) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ), or
(ii) Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262), or
(iii) The Virus-Serum-Toxin Act (21 U.S.C. 151-159).
(6) It is an animal or animal product listed in 42 CFR Part 71 and its importation has been authorized in accordance with 42 CFR 71.52, 71.53, or 71.56.
(g) To apply for a permit, an individual must:
(1) Submit a signed, completed CDC Form 0.753 (Application for Permit to Import Biological Agents or Vectors of Human Disease into the United States) to the HHS/CDC Import Permit Program.
(2) Have in place biosafety measures that are commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use.
(h) Issuance of a permit may be contingent upon an inspection of the importer's facility by the CDC to evaluate whether the importer's biosafety measures (e.g., physical structure and features of the facility, and operational and procedural safeguards) are commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector, and the level of risk given its intended use.
(i) Denial, suspension, or revocation of a permit under this section may be appealed to the CDC Director. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the CDC Director within 30 calendar days of the denial, suspension, or revocation of the permit. HHS/CDC will issue a written response to the appeal, which shall constitute final agency action.
§ 71.55   Importation of human remains.
(a) Human remains imported into the United States, or in transit within the United States and not intended for import, must be fully contained within a leak-proof container that is packaged and shipped in accordance with all applicable legal requirements.
(b) The provisions of 42 CFR 71.54 shall apply to all imported human remains known to contain or reasonably suspected of containing an infectious biological agent.
(c) Unless accompanied by a permit issued under 42 CFR 71.54, human remains imported into the United States must meet one of the following requirements:
(1) Human remains imported for burial, entombment, or cremation must:
(i) Be consigned directly to a licensed mortuary, cemetery, or crematory for immediate and final preparation prior to burial, entombment, or cremation; and
(ii) Unless embalmed, be accompanied by a death certificate or, if the death certificate is incomplete or missing, an importer certification statement confirming that the human remains are not known to contain or stating why the human remains are not reasonably suspected of containing an infectious biological agent.
(2) Human remains imported for medical examination or autopsy must:
(i) Be consigned directly to an entity authorized to perform such functions under the laws of the applicable jurisdiction prior to subsequent burial, entombment, or cremation; and
(ii) Unless embalmed, be accompanied by a death certificate or, if the death certificate is incomplete or missing, an importer certification statement confirming that the human remains are not known to contain or stating why the human remains are not reasonably suspected of containing an infectious biological agent.
(3) Human remains imported for any other purpose, unless embalmed, must be accompanied by an importer certification statement confirming that the human remains are not known to contain or stating why the human remains are not reasonably suspected of containing an infectious biological agent.
(d) The Director may suspend the importation of human remains under 42 CFR 71.63 if the Director designates the foreign country and determines that such an action is necessary to protect the public health.
§ 71.56   African rodents and other animals that may carry the monkeypox virus.
(a) What actions are prohibited? What animals are affected? (1) Except as provided in paragraphs (a)(2) and (a)(3) of this section,
(i) You must not import or attempt to import any rodents, whether dead or alive, that were obtained, directly or indirectly, from Africa, or whose native habitat is Africa, any products derived from such rodents, any other animal, whether dead or alive, whose importation the Director has prohibited by order, or any products derived from such animals; and
(ii) You must not prevent or attempt to prevent the Centers for Disease Control and Prevention (CDC) from causing an animal to be quarantined, re-exported, or destroyed under a written order.
(2) The prohibitions in paragraph (a)(1) of this section do not apply if you have written permission from CDC to import a rodent that was obtained, directly or indirectly, from Africa, or whose native habitat is Africa, or an animal whose importation the Director has prohibited by order.
(i) To obtain such written permission from CDC, you must send a written request to Division of Global Migration and Quarantine, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. You may also fax your request to the Division of Global Migration and Quarantine (using the same address in the previous sentence) at 404-498-1633.
(ii) Your request must state the reasons why you need an exemption, describe the animals involved, describe the number of animals involved, describe how the animals will be transported (including carrying containers or cages, precautions for handlers, types of vehicles used, and other procedures to minimize exposure of animals and precautions to prevent animals from escaping into the environment), describe any holding facilities, quarantine procedures, and/or veterinarian evaluation involved in the animals' movement, and explain why an exemption will not result in the spread of monkeypox within the United States. Your request must be limited to scientific, exhibition, or educational purposes.
(iii) We will respond in writing to all requests, and we also may impose conditions in granting an exemption. If we deny your request, you may appeal that denial. Your appeal must be in writing and be submitted to the CDC official whose office denied your request, and you must submit the appeal within two business days after you receive the denial. Your appeal must state the reasons for the appeal and show that there is a genuine and substantial issue of fact in dispute. We will issue a written response to the appeal, which shall constitute final agency action.
(3) The prohibitions in paragraph (a) of this section do not apply to products derived from rodents that were obtained, directly or indirectly, from Africa, or whose native habitat is Africa, or products derived from any other animal whose importation the Director has prohibited by order if such products have been properly processed to render them noninfectious so that they pose no risk of transmitting or carrying the monkeypox virus. Such products include, but are not limited to, fully taxidermied animals and completely finished trophies; and they may be imported without written permission from CDC.
(b) What actions can CDC take? (1) To prevent the monkeypox virus from spreading and becoming established in the United States, we may, in addition to any other authorities under this part:
(i) Issue an order causing an animal to be placed in quarantine,
(ii) Issue an order causing an animal to be re-exported,
(iii) Issue an order causing an animal to be destroyed, or
(iv) Take any other action necessary to prevent the spread of the monkeypox virus.
(2) Any order causing an animal to be quarantined, re-exported, or destroyed will be in writing.
(c) How do I appeal an order? If you received a written order to quarantine or re-export an animal or to cause an animal to be destroyed, you may appeal that order. Your appeal must be in writing and be submitted to the CDC official whose office issued the order, and you must submit the appeal within 2 business days after you receive the order. Your appeal must state the reasons for the appeal and show that there is a genuine and substantial issue of fact in dispute. We will issue a written response to the appeal, which shall constitute final agency action.
§ 71.63   Suspension of entry of animals, articles, or things from designated foreign countries and places into the United States.
(a) The Director may suspend the entry into the United States of animals, articles, or things from designated foreign countries (including political subdivisions and regions thereof) or places whenever the Director determines that such an action is necessary to protect the public health and upon a finding that:
(1) There exists in a foreign country (including one or more political subdivisions and regions thereof) or place a communicable disease the introduction, transmission, or spread of which would threaten the public health of the United States; and
(2) The entry of imports from that country or place increases the risk that the communicable disease may be introduced, transmitted, or spread into the United States.
(b) The Director shall designate the foreign countries or places and the period of time or conditions under which the introduction of imports into the United States shall be suspended. The Secretary or Director will coordinate in advance with other Federal agencies that have overlapping authority in the regulation of entry of animals, articles, or other things, as may be necessary to implement and enforce this provision.