CDC Import Permit Guide for Human Samples
Biological Specimen
Key takeaways
A CDC import permit is needed when a human-derived material is known or reasonably expected to contain an agent that can cause communicable disease in humans.
Material that is not known or suspected to be infectious can enter without a permit if it travels with an importer certification statement, except bat and nonhuman primate specimens.
Since January 20, 2026, CDC accepts new permit applications only through BioPermit, and the permit is issued to the US importer, who needs a SAMS account.
APHIS rules can apply on top of CDC rules when the shipment contains or was exposed to livestock or avian material, and FDA review applies to tissues and cells intended for human use.
CDC publishes no standard processing time, so apply early, answer information requests quickly and renew at least 30 days before a permit expires.
A CDC import permit is required when you import human-derived material that is known or reasonably expected to contain an infectious biological agent, such as a blood sample from a patient with a suspected viral infection or a cell line engineered with a vector that may still be infectious. If the material is not known or suspected to be infectious, or it has been rendered noninfectious, it can usually enter without a permit as long as it is accompanied by a CDC importer certification statement. That single decision, permit or certification, shapes the rest of the import: the paperwork, the timeline and how customs and the carrier handle the package.
This guide explains how importing human biological materials works in practice for research labs, diagnostic companies and clinical teams. It covers the CDC rule itself, how cell lines such as HeLa are assessed, where USDA APHIS and FDA requirements overlap, which documents you need to import human samples into the US, and how to plan around a permit timeline. The rules described here were checked against CDC, eCFR and APHIS sources as of October 2026.
Who regulates human-derived materials entering the US
Several agencies can have a say in the same shipment, and each looks at a different risk. Knowing which one applies to your material saves the most time.
CDC Import Permit Program. Regulates materials that are infectious to humans under 42 CFR 71.54. This covers infectious biological agents, infectious substances and vectors, including human blood, tissue, body fluids and cell cultures when they may carry a human pathogen.
USDA APHIS Veterinary Services. Regulates materials that could carry livestock or poultry disease. APHIS defers human specimens themselves to CDC, but it can still regulate a human cell culture grown in animal-derived media or exposed to livestock or avian disease agents.
FDA. Reviews products intended for human use. Human cells, tissues and cellular and tissue-based products (HCT/Ps) offered for import must be reported to FDA and held until FDA makes an admissibility decision.
US Customs and Border Protection (CBP). Processes the entry itself, applies the documentation and invoice rules, and acts on holds placed by the other agencies.
A CDC permit does not replace any of the others. The regulation says plainly that holding a CDC permit does not satisfy USDA permitting requirements for materials that may also pose hazards to agriculture. Treat each agency as a separate check.
When do you need a CDC import permit?
You need a CDC import permit when the material you are importing is an infectious biological agent, an infectious substance or a vector, and none of the exclusions in 42 CFR 71.54(f) applies. In plain terms, if the human-derived material is known or reasonably expected to contain a microorganism, virus, fungus, protozoan or prion that can cause communicable disease in a human, the import permit CDC issues must accompany it.
The regulation also lists the situations where no permit is required. The ones that matter most for human samples are:
A diagnostic specimen (human tissue, blood, body discharges, fluids, excretions or similar material) that the importer does not know or suspect contains an infectious agent, accompanied by an importer certification statement. Bat and nonhuman primate specimens are excluded from this exemption.
Material that consists only of nucleic acids that cannot produce infectious forms of any infectious agent, again with an importer certification statement.
A product that is cleared, approved, licensed or otherwise authorized under the Federal Food, Drug, and Cosmetic Act, Section 351 of the Public Health Service Act or the Virus-Serum-Toxin Act.
A select agent whose import has already been authorized under the select agent rules in 42 CFR 73.16 or 9 CFR 121.16.
Two cases cause most of the confusion. The first is nonhuman primate material, which always needs a permit unless it has been rendered noninfectious. The second is genomic material. CDC states that nucleic acids that can produce infectious forms of an infectious agent, such as positive-sense RNA viral genomes, require a permit even though they are "only RNA." If you cannot rule out an infectious agent, plan for a permit.
The permit is issued to the importer in the United States, not to the foreign sender. A permit may also carry conditions, for example that any later transfer of the material to another US facility needs its own CDC permit. CDC can inspect the importer's facility before issuing a permit to confirm that biosafety measures match the hazard.
CDC import permit for human blood and cells
The CDC import permit human blood cells question comes up often because blood products are imported for both research and diagnostics. Whole blood, plasma, serum, peripheral blood mononuclear cells (PBMCs) and buffy coats follow the same rule as any other diagnostic specimen. If the donor is known to be infected, or the material comes from a study where infection is suspected (for example a hepatitis, HIV or emerging virus cohort), the import needs a permit. Blood from healthy, screened donors that is not known or suspected to contain an infectious agent can enter with an importer certification statement. The deciding factor is what the importer knows or should reasonably suspect about the material, not the sample type alone.
What is a CDC importer certification statement?
A CDC importer certification statement is a written statement from the importer that confirms the imported material is not known to contain, or suspected of containing, an infectious biological agent, or that it has been rendered noninfectious. It is what allows a qualifying diagnostic specimen or noninfectious nucleic acid to enter without a permit. It is not a permit and CDC does not issue one in response.
According to the CDC importer certification statement page, the statement should include:
A statement that the material is not known or suspected to contain an infectious biological agent, or has been rendered noninfectious.
A detailed description of the material being imported.
One of the following: why you believe the material is not infectious, how you know it is not infectious, or a detailed description of how it was rendered noninfectious.
CDC provides a fillable template with these fields. You may see it saved under a file name that ends in "508." That suffix refers to Section 508 of the Rehabilitation Act, which sets accessibility standards for federal digital documents. It is not a form number and does not change what the statement must say.
In practice, the statement should travel with the shipment so that customs and the carrier can see it, and a copy should sit in your import file. Good statements are specific. "Formalin-fixed, paraffin-embedded tumor blocks from 40 de-identified donors, fixed in 10 percent neutral buffered formalin for at least 24 hours" is far more useful than "human tissue, non-infectious." If material was inactivated, describe the method. CDC says inactivation methods should be scientifically supportable and validated as applied, and that facilities should keep records supporting the inactivation.
Do human cell lines like HeLa need an import permit?
Human cell lines like HeLa need a CDC import permit only if the cells are known or suspected to contain a human infectious agent. A well-characterized commercial line that is not suspected of carrying such an agent can generally be imported with an importer certification statement instead. CDC's permit decision tool asks the same questions for every eukaryotic cell line: is it commercially available, was it genetically modified with a viral vector, and could an infectious agent or vector still be present?
HeLa is a useful example because of its biology. The manufacturer's ATCC product page for HeLa (CCL-2) notes that HeLa cells have been reported to contain human papillomavirus 18 sequences, and the line is handled at biosafety level 2. Integrated viral sequences are not automatically the same as an infectious agent, but the importer is the one who must make and document that judgment. If you conclude that no permit is needed, the certification statement should explain why, for example by referencing the source repository, authentication and testing records.
The situation changes for engineered lines. CDC's decision tree flags lines built with viral vectors such as lentivirus. If the vector may still be present and infectious to humans in the cells being shipped, a permit is required. Novel or newly derived lines from donors with a known or suspected infection also need a closer look.
Importing human cell lines into the US: the USDA layer
When importing human cell lines into the US, check the culture history as well as the cells. APHIS guidance for animal products that do not require an import permit says cell lines can enter without a USDA permit when they are not derived from livestock or avian species, are for in vitro use, have not been exposed to livestock or avian disease agents exotic to the US, and do not produce or contain genes of those agents. The shipper or producer must provide a statement covering the material's identity, intended use, whether it is recombinant and that it does not come from a facility working with exotic livestock or avian viruses. APHIS asks that this statement be available to the inspector at the port, not packed inside the shipping container.
Cells grown in fetal bovine serum can be eligible under these conditions, but separately shipped animal-derived media, sera or reagents may need their own USDA review. If anything in the box is of livestock or avian origin, confirm the applicable APHIS guideline before shipping.
HeLa cells shipping customs regulations and other customs points
HeLa cells shipping customs regulations are mostly the general import rules applied to a biological product. The commercial invoice must describe the merchandise accurately, give the quantity and state a value even when nothing was sold. Under 19 CFR 141.86, an invoice for goods not shipped under a purchase must still show a value for each item. Writing "no commercial value" with no figure is a common reason for questions at entry.
Cell lines are classified in the Harmonized Tariff Schedule like other goods, and the correct code depends on what the material is. Mercury's guide to HS 3002 for blood products and cell lines walks through that classification. Frozen cells usually ship on dry ice or in liquid nitrogen dry shippers, which brings its own dangerous goods labeling for the refrigerant, separate from the biological material.
Biological materials import requirements at a glance
The table below summarizes the biological materials import requirements for the most common human-derived shipments. Use it as a starting point, then confirm the specific case with the agency or your broker.
Material | CDC requirement | Possible APHIS involvement | Possible FDA involvement |
|---|---|---|---|
Blood, serum or PBMCs from donors not known or suspected to be infected | Importer certification statement, no permit | Only if mixed with or exposed to livestock or avian material | Only if intended for human use |
Blood, tissue or fluids known or suspected to contain a human pathogen | CDC import permit through BioPermit | If the agent can also infect animals | Rarely, unless for clinical use |
Commercial human cell line not suspected of carrying an infectious agent (for example HeLa, HEK 293) | Importer certification statement, no permit | Shipper statement under APHIS guidance for cell cultures | Not for in vitro research |
Cell line engineered with a viral vector that may still be infectious | CDC import permit | If livestock or avian components are involved | Not for in vitro research |
DNA or RNA that cannot produce infectious forms | Importer certification statement, no permit | Usually none | Usually none |
Fixed tissue such as FFPE blocks or slides, inactivated by a documented method | Importer certification statement describing the inactivation | Usually none | Usually none |
Human cells or tissues intended for implantation or transfusion | Depends on infectious status and authorization | Usually none | FDA notification and hold until admissibility decision |
Any nonhuman primate material | CDC import permit unless rendered noninfectious | Possible | Possible |
The pattern is consistent. CDC asks whether the material could be infectious to humans, APHIS asks whether animal material or animal disease is involved, and FDA asks whether a human will receive it.
FDA review for tissues and cells intended for human use
Research material and clinical material follow different paths once FDA is involved. Under 21 CFR 1271.420, when an HCT/P is offered for import, the importer of record must notify FDA before or at the time of import and provide enough information, including data filed in CBP's Automated Commercial Environment, for FDA to decide admissibility. The HCT/P must be held intact under conditions that prevent communicable disease transmission until FDA decides. It may travel under quarantine to the consignee while FDA reviews the paperwork. Some reproductive tissue and peripheral blood stem cells regulated only under Section 361 of the Public Health Service Act are excluded from this hold in most cases.
Investigational cell therapies and other biologics have additional requirements beyond the scope of this guide. If a shipment is for a clinical trial, confirm the IND status and the FDA entry data with your sponsor's regulatory team and your customs broker before the material leaves the origin country.
What documents are needed to import human samples into the US?
The documents needed to import human samples into the US depend on the permit decision, but most shipments need the same core set: the CDC permit or an importer certification statement, a commercial or pro forma invoice, the air waybill, any USDA statement or permit, and FDA entry information when the material is for human use. Having all of them ready before pickup prevents the most common holds.
CDC import permit or importer certification statement. The permit is downloaded from BioPermit by the US importer. The certification statement is completed by the importer and kept with the shipment.
Commercial or pro forma invoice. A detailed description, quantity, country of origin and a value for every item, as required by 19 CFR 141.86.
Air waybill or carrier shipping document. The description must match the invoice and the dangerous goods classification of the package.
USDA documentation when relevant. An APHIS VS permit, or the shipper's statement required by the applicable APHIS guideline for cell cultures or animal-derived components.
FDA entry data when relevant. Required for HCT/Ps and other FDA-regulated products filed through ACE by the importer of record or their broker.
Dangerous goods documentation. Needed for Category A infectious substances and for dry ice, depending on the package contents and carrier.
Supporting records. Material transfer agreements, inactivation records or authentication certificates are not entry documents, but they support the certification statement if CDC or CBP asks questions.
Who files the entry matters too. The importer of record is responsible for the customs declaration and for agency data. Many labs appoint a licensed broker for this, and a customs brokerage service familiar with biological shipments can file the CBP and FDA data together. CDC permits are a separate step that the importer completes directly. Mercury's broader guide to US import permits covers permits from other agencies.
Packaging and classification
Packaging follows the transport classification of the material, not the import permit decision. A material can be noninfectious for CDC import purposes and still need to be packed as a biological substance for the carrier, or it may qualify as an exempt specimen. Mercury covers the details in separate guides on shipping UN 3373 samples safely and legally, on exempt human and animal specimens and on classifying biological shipments. CDC is clear that an import permit is not an authorization to hand carry material into the United States, so permitted material must still move through a carrier under the applicable federal and international shipping rules.
How long does a CDC import permit take?
CDC does not publish a standard processing time for an import permit, so there is no official number of days to plan around. How long a CDC import permit takes depends on how complete the application is, whether CDC sends a request for information, and whether CDC decides to inspect the importer's facility before issuing the permit.
What CDC does publish helps you plan. Since January 20, 2026, the BioPermit system has replaced eIPP, and no new applications are accepted in eIPP. Every applicant needs a SAMS account, which takes its own setup time if your lab does not have one. According to the CDC application FAQ, an application with an open request for information cannot be processed until you respond, and it can be administratively closed if essential information is not supplied within 30 days of the request. CDC also recommends submitting renewals at least 30 days before a permit expires, and permits issued under eIPP cannot be renewed in BioPermit. There is currently no fee for a CDC import permit.
Practical steps that shorten the wait:
Set up the SAMS account and BioPermit access for the US permit holder before the material is ready.
List every sender and every agent or material on the application, since BioPermit allows multiple entries.
Attach biosafety documentation and SOPs up front so CDC does not need to request them.
Assign one person to monitor the BioPermit inbox and answer requests the same week.
Do not schedule the shipment or book cold chain capacity until the permit shows as granted.
Permits are also tied to people. CDC states that a SAMS account and a permit cannot be transferred to another person, so if the permit holder leaves the organization, a new person must obtain an account and apply. For a timeline estimate on a specific application, contact the CDC Import Permit Program at importpermit@cdc.gov.
Common reasons human sample imports are delayed
Most delays come from a mismatch between what the material is and what the paperwork says. The most frequent one is a shipment that arrives without the permit or certification statement, or with a statement that is vague about the material and the reason it is not infectious. Invoice problems come next, usually a missing value or a description that does not match the air waybill and the package marking.
Agency gaps cause the longer holds. Undisclosed animal-derived components draw APHIS questions, and material intended for human use without FDA entry data will be held. Permit details matter as well, because an expired permit or a sender or material not named on the permit stops the shipment. For frozen material, the risk during any hold is that dry ice runs low because no replenishment was arranged.
If material arrives that is not listed on your permit, CDC asks facilities to safeguard it and report it immediately to the Import Permit Program. CDC also recommends keeping shipment records for at least three years, which makes later questions easier to answer.
For a wider view on avoiding holds, see Mercury's article on preventing customs delays in bio-med shipping.
How Mercury supports human sample imports
The CDC permit or certification decision belongs to the importer, but the shipment around it still needs careful coordination. Mercury handles biological specimen shipping for research and diagnostic customers, with customs brokerage for the CBP and FDA side of the entry, temperature-controlled transport, and dry ice replenishment for frozen material that may wait at the border. Sharing the permit or certification statement, the invoice and the material description with your logistics team before pickup is the simplest way to keep a human sample import moving.
