CDC Import Permit: What It Covers

A CDC import permit is federal authorization, issued under the CDC Import Permit Program, that must be obtained before certain infectious biological materials, agents, or vectors of human disease can be brought into the United States. It is a biosafety and public-health control, separate from customs clearance, shipping paperwork, or your institution’s own biosafety approval — and importing a covered material without one is a violation of federal regulation, not just an institutional policy lapse.

This guide covers what the CDC Import Permit Program actually regulates, who is required to hold the permit, how the application process works, and how it relates to the other approvals (USDA APHIS permits, DOT/IATA shipping rules, Select Agent Program registration, and your Institutional Biosafety Committee) that often get confused with it.

What the CDC Import Permit Program is

The CDC Import Permit Program (IPP) is administered by the Division of Select Agents and Toxins (DSAT), within CDC’s National Center for Emerging and Zoonotic Infectious Diseases. Its legal basis is 42 CFR Part 71.54, the federal regulation governing the importation of etiologic agents, hosts, and vectors capable of causing human disease. The program exists to prevent the introduction and spread of communicable disease into the United States through imported research, diagnostic, and clinical materials — it is a public-health control, not a customs or trade-compliance program, even though a shipment without the required permit can also be held or refused entry at the port of arrival.

What requires a CDC import permit

A permit is generally required to import into the United States:

Infectious biological agents — bacteria, viruses, fungi, parasites, prions, and other agents known or reasonably believed to be capable of causing disease in humans.
Materials known or suspected to contain such agents — this includes many clinical specimens, cultures, isolates, and certain environmental samples collected outside the US.
Vectors of human disease — arthropods or other animals capable of transmitting a human pathogen.

The determining factor is not the shipment’s declared purpose (research vs. diagnostic vs. reference use) but whether the material itself falls within the regulation’s definition. Institutions that regularly receive international shipments of clinical isolates, reference strains, or field-collected specimens should assume a permit determination is needed unless CDC guidance or DSAT staff confirm otherwise for that specific material.

What a CDC import permit does not cover

The Import Permit Program is easy to conflate with several adjacent, but legally distinct, approval regimes:

USDA APHIS permits — required separately for animal and plant pathogens, livestock disease agents, and other materials that pose an agricultural rather than human-health risk. Some shipments require both a CDC import permit and a USDA APHIS permit.
DOT and IATA dangerous goods regulations — govern how an infectious substance is classified, packaged, and labeled for transport (see Category A vs. Category B classification and IATA Dangerous Goods Regulations). Complying with shipping regulations does not substitute for holding a required import permit, and vice versa.
Federal Select Agent Program registration — a separate, more stringent regulatory track (42 CFR Part 73, jointly administered by CDC and USDA APHIS) that applies if the material is on the HHS/USDA Select Agent List. A select agent shipment can require both Select Agent Program authorization and a CDC import permit.
Institutional Biosafety Committee (IBC) approval — your institution’s own review of the work under NIH Guidelines or institutional policy. IBC approval is typically a prerequisite CDC expects to see referenced in the permit application, but it is not itself federal authorization to import the material.

Who needs to apply

The CDC import permit is issued to the importer of record in the United States — typically the receiving principal investigator, laboratory director, or institution, not the foreign sender or the courier. The permit holder is the party accountable for the conditions of the permit, including how the material is handled, stored, and used once it arrives. If a lab regularly receives shipments from multiple international collaborators, the permit is generally tied to the receiving lab and the specific agent(s)/material(s) covered, not to each individual sender.

How to apply: the eIPP system

Applications are submitted through CDC’s electronic Import Permit Program (eIPP), an online system that replaced the earlier paper-based application process. A complete application typically requires:

Identification of the specific agent(s) or material(s) to be imported, including species/strain-level detail where applicable.
The intended use (research, diagnostic, reference, etc.) and destination facility.
The biosafety containment level at which the material will be handled, consistent with the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).
Shipper and consignee information, including the country and facility of origin.
Evidence of institutional biosafety oversight (e.g., IBC protocol number) where applicable.

Because CDC reviews each application against the specific agent, use, and containment plan described, applications should be prepared with the same level of specificity as an IBC protocol — a vague or incomplete description is one of the most common causes of delay.

Timing and planning

CDC’s own guidance is to apply well in advance of the planned shipment date rather than treating the permit as a last-minute formality; review involves a substantive biosafety assessment, not an automatic issuance, and processing time can vary with application completeness and the nature of the material. Labs that anticipate recurring shipments of the same material from the same source should build permit renewal and amendment lead time into their procurement and collaboration planning, the same way they would for an IATA dangerous goods shipment or a dual-use export control review.

Permit conditions and compliance

An issued CDC import permit is not a one-time approval that is then forgotten. It typically specifies conditions the permit holder must continue to meet: the containment level at which the material is handled, restrictions on transfer of the material to other parties or locations, and recordkeeping obligations. Importing a covered material without a valid permit, or outside the conditions of an existing permit, is a violation of 42 CFR 71.54 and can result in the material being refused entry, seized, or destroyed, in addition to potential civil or criminal liability under the Public Health Service Act. Institutional biosafety and export-control offices generally treat CDC import permit conditions as part of the same compliance record maintained for IBC protocols and Select Agent Program registrations.

Frequently asked questions

What is the CDC Import Permit Program?

It is the federal program, run by CDC’s Division of Select Agents and Toxins under 42 CFR 71.54, that authorizes the importation into the United States of infectious biological agents, materials that may contain them, and vectors of human disease.

How do I apply for a CDC import permit?

Applications are submitted through CDC’s electronic Import Permit Program (eIPP) system, which requires details on the agent or material, intended use, containment level, and shipper/consignee information. Institutions typically route this through their biosafety or research-safety office rather than having an individual investigator apply independently.

Do I need a CDC import permit for a diagnostic specimen or research sample from another country?

If the specimen or sample is, or may reasonably be suspected to be, infectious to humans, it is likely covered. Because the regulation turns on the nature of the material rather than its intended use, confirm the determination with your institution’s biosafety office or DSAT rather than assuming a research or diagnostic label exempts a shipment.

Is a CDC import permit the same as a Select Agent Program registration?

No. They are separate regulatory tracks that can both apply to the same shipment. The Select Agent Program (42 CFR Part 73) governs possession, use, and transfer of agents on the HHS/USDA Select Agent List; the CDC Import Permit Program governs bringing a covered material into the country in the first place.

Who is responsible for holding the permit — the sender or the receiving lab?

The receiving US institution or investigator (the importer of record) holds the permit and is accountable for its conditions, not the foreign sender or shipping carrier.

CDC Import Permit Program: What It Covers and How to Apply

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