Import Permit Program (IPP)
Requesting permits to import Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) requires a CDC Import Permit application to be submitted electronically using the eIPP system (https://eipp.cdc.gov/). Subsequent transfers of previously imported material containing SARS-CoV-2 within the United States also require a CDC import permit.
- Import isolates or cultures of SARS-CoV-2.
- Import infectious substances (e.g., blood, bodily fluids, tissues) that are reasonably expected to contain SARS-CoV-2.
- Import nucleic acids capable of producing SARS-CoV-2 (i.e., full-length genomic RNA extracted from SARS-CoV-2).
- Samples from experimentally infected animals that were infected with SARS-CoV-2 have not been inactivated or tested negative for the virus.
A permit is required to transfer SARS-CoV-2 materials described above within the United States.
Permit Not Required
- Specimens or isolates/cultures of SARS-CoV-2 within the United States or its territories that were not generated from imported material.
- Nucleic acids encoding partial sections or fragments of SARS-CoV-2 incapable of producing infectious virus (i.e., partial or degraded SARS-CoV-2 genomic RNA).
- Diagnostic samples not known or suspected of containing SARS-CoV-2. See FAQ “Do I need an import permit” https://www.cdc.gov/cpr/ipp/faq.htm
The CDC Import Permit Program, or IPP, regulates the importation of infectious biological materials that could cause disease in humans in order to prevent their introduction and spread into the U.S. The program ensures that the importation of these agents is monitored and that facilities receiving permits have appropriate biosafety measures in place to work with the imported agents.
- Infectious biological agents capable of causing illness in humans
- Materials known or reasonably expected to contain an infectious biological agent
- Vectors of human disease (such as insects or bats)
[See Do I need an import permit? for more information.]
These items may be imported into the U.S. for a variety of reasons, including:
- Outbreak surveillance
- Research and development of diagnostics, vaccines, and therapeutics
- To benefit from unique laboratory testing available in the U.S.
- To support research to better understand the potential threats posed by these agents
Regulatory authority for the program is given to the Secretary of Health and Human Services through the Public Health Service Act, which allows for the development and enforcement of regulations to prevent the introduction, transmission, or spread of communicable disease from foreign countries into and throughout the U.S. or its possessions. The regulations (42 CFR § 71.54) require that anyone wishing to import infectious biological agents, infectious substances, or vectors must first obtain a permit issued by CDC.
For more information on the program, please click here.
For instructions on how to apply for an import permit, click here. Note that an inspection may be conducted before a permit is issued, in order to ensure the applicant’s facility has appropriate measures in place to minimize the accidental release of biological agents capable of causing human disease.
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