42 C.F.R. § 71.54

Current through November 30, 2024

Section 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.

42 C.F.R. §71.54

78 FR 7678 , Feb. 4, 2013