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- Answers to frequently asked questions (FAQ) regarding the importation of non-infectious toxins, specimens, and animals can be found below.
- The information includes guidance about which non-infectious materials require an import permit.
According to the import permit regulations, an import permit is not required for a diagnostic specimen (with the exception of bat or nonhuman primate specimens) not known by the importer to contain, or suspected by the importer of containing, an infectious biological agent and accompanied by a certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious. What needs to be included in the certification statement?
To facilitate clearance of materials that do not require a CDC import permit, each shipment must be accompanied by a certification statement from the sender or the recipient of this material.
The certification statement should include a detailed description of the material and statements affirming:
- The material is not known or suspected to contain an infectious biological agent, and
- One of the following:
- How the person knows that the material does not contain an infectious biological agent.
- Why there is no reason to suspect that the material contains an infectious biological agent.
- A detailed description of how the material was rendered noninfectious.
- How the person knows that the material does not contain an infectious biological agent.
Where can I find information on CDC/Division of Global Migration Health's Recommended Methods for "Rendering Animal Products to be Used as Hunting Trophies Noninfectious"?
DGMH's guidance provides recommended methods for rendering animal products to be used as hunting trophies noninfectious.
Is an import permit required to import unregulated amounts of a select toxin? Note: An "unregulated amount" of a select toxin would be those amounts listed in 42 CFR § 73.3(d)(3).
No. CDC Import Permit Program does not currently regulate the importation of a toxin.
Is an import permit required to import dead animals not known to be infectious to humans?
No. An animal not known to contain (or suspected of containing) an infectious biological agent or has been rendered noninfectious would not require a CDC import permit. However, other regulations such as APHIS or U.S. Fish and Wildlife Service regulations may apply to the importation of this material.
Is an import permit required to import adult worms which cannot infect humans?
No. Organisms or parasites that are not infectious to humans do not require a CDC import permit. However, other regulations may apply to the importation of this material.
Is an import permit required to import material that has received approval from the U.S. Food and Drug Administration?
No. Any product that is cleared, approved, licensed, or otherwise authorized under any of the following laws would not require a CDC import permit:
- The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
- Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262).
- The Virus-Serum-Toxin Act (21 U.S.C. 151-159).
Is an import permit required to import genomic material?
It depends. Nucleic acids that can produce infectious forms of any infectious biological agent would require a CDC import permit. For example, viral genomes which consist of positive sense RNA are infectious when the purified viral RNA is applied to permissive cells in the absence of any viral proteins. In some cases, viral genomes which are composed of double-stranded DNA are also infectious [e.g., genome of Cercopithecine Herpesvirus 1 (Herpes B virus)].
Nucleic acids that cannot produce infectious forms of any infectious biological agent and are accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent would not require a CDC import permit.