Frequently Asked Questions

The Import Permit Program (IPP) uses a secure electronic information system, eIPP, to conduct all program business. This two-way portal, accessible by both the program and those seeking import permits, is used to submit and share information. As of September 2018, the only way to apply for a CDC import permit is by using this system. Additional information can be found here.

All potential applicants are required to have a SAMS (Secure Access Management Services) account – which protects the security of the information by requiring users to enter a user ID and password, or other secure credentials, before providing access to the system – in order to access the eIPP system to apply for a permit.  If you do not yet have a SAMS account but would like to establish one in order to submit a new application, please contact us.

Only applications submitted via eIPP will be accepted.

Real-time status updates are available on the permittees dashboard in eIPP. Options that can appear include:

• Draft – Application has been started, but not submitted. Will not be reviewed by CDC until submitted.
• Submitted – Application was successfully submitted to CDC.
• Under Review – The application has been reviewed by CDC and is pending additional action.
• Request for Information – Information has been requested in the applications general discussion section within eIPP. The application cannot be processed until the information is received.
• Approval Requested – The initial review of the application is complete and the approved permit is pending.
• Approved – The permit has been approved and can be retrieved from eIPP.
• Denied – A permit will not be issued for the application that was submitted and reviewed.
• Revoked – The approved permit is no longer valid and may not be used.
• Closed – The application was administratively closed in the event that a permit was not required or that essential information needed for review of the application was not supplied within 30 days of the request.

No. Currently, only one user can be connected to a SAMS/eIPP account. Information cannot be transferred between accounts.

No. Currently, SAMS accounts cannot be transferred from one individual to another. The permit cannot be transferred to someone else at the company. Therefore, someone at the company would need to obtain a SAMS account and submit an application to obtain a permit.

Yes, but your contact information will need to be updated under the account settings tab within eIPP. Changes to your account username/email must be requested by contacting the eIPP Help Desk.

Yes. After an application has been saved as a draft and an application number has been generated, you are able to upload supporting documents using the “Upload Attachment” feature that is displayed at the bottom of the application below the discussion section.

Required fields are marked by red asterisks (*) in eIPP. Applications can be saved as a draft, but can only be submitted when all required fields are completed.

Additional assistance with filling out the application is available from the Import Permit Program by email at importpermit@cdc.gov or telephone at (404) 718-2077.

Yes. The application must be resubmitted in eIPP.

If the imported material is being sent from more than one sender, select “Add Sender & Add Template” to add additional senders. Currently, there are no limits on the number of senders that can be entered.

If your facility will receive multiple agents, select “Add Infectious Biological Agent & Add Template” to include the scientific name of all known/suspected infectious biological agents in Section D, items #5-11. Currently, there are no limits on the number of agents/vectors that can be entered.

“Infectious biological agent” is defined as 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.

If the specific agents are not known, it is acceptable to list the genus and species of the vector in Section D, item #5 (e.g., non-human primates such as rhesus macaques should be listed as Macaca mulatta and bats such as Egyptian fruit bats should be listed as Rousettus aegyptiacus).

All requests for renewal of an existing import permit require the submission of a new application and current digital signature of the permittee via eIPP. To prevent lapses in the import permit status, it is recommended that permit renewal applications be submitted at least 30 days prior to the expiration date on the current permit.

Once approved, a downloadable PDF of the permit will be available in eIPP. Since eIPP currently does not have an email alert feature to notify account holders of status changes or to automatically email the approved permit, it is recommended that account holders check the status of their application daily.

The e-Tool will assist you in determining if an import permit is needed to import infectious biological agents, infectious substances, and vectors into the United States.

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.
• Statements affirming:
  1. The material is not known or suspected to contain an infectious biological agent, and
  2. One of the following:
     • How the person knows that the material does not contain an infectious biological agent, or
     • Why there is no reason to suspect that the material contains an infectious biological agent, or
     • A detailed description of how the material was rendered noninfectious.

No. Currently, there is no fee for processing a CDC import permit.

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.

The CDC import permit is issued only to the importer located in the United States. The importer must take measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious substances.

Yes, other import restrictions can exist. The importation of specific animals and animal products from specific geographical areas into the United States is currently restricted. Contact the U.S. Fish and Wildlife Service, U.S. State Department for additional information. Please also see https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/african-rodents.html

DGMH’s guidance provides recommended methods for rendering animal products to be used as hunting trophies noninfectious.

Yes. The novel H7N9 Influenza A virus has caused infections in both humans and birds. APHIS and CDC have authority over the importation of all microorganisms which cause, or have the potential, to cause disease in animals or humans respectively, and so both agencies will issue permits for the novel H7N9 influenza A virus. For further information, please contact APHIS at 301-851-3300 (Option 1) or CDC at 404-718-2077.

CDC will not issue a permit for Asian lineage H7N9 low path avian influenza until a USDA/APHIS permit has been obtained. Please see https://www.aphis.usda.gov/animal_health/downloads/organisms_and_vectors/newasian-lineage-h7n9-requirements.pdf for more information. Please upload a copy of your approved USDA/APHIS permit into eIPP.

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.

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.

Animals – 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).

Arthropods – Any living insect including crustaceans, spiders, scorpions, etc. capable of being a host or vector of human disease.

Snails – Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.

Bats – All live bats. See below for further information on obtaining an import permit for live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service. For additional information, see https://www.fws.gov/permits/?ref=topbar.

Non-human primate material – All non-human primate material (e.g. blood, plasma, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious.

Please note that the described material may require a permit from the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or be prohibited from importation under the USDA regulations. Information on USDA transport or import permits is available at https://www.aphis.usda.gov/aphis/ourfocus/importexport.

• Select agents listed in 42 CFR Part 73 and if its importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16.
• With the exception of bat or nonhuman primate specimens, diagnostic specimens 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.
• With the exception of live bats or bat or nonhuman primate products, animal or animal products 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.
• 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.
• 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.
• Product that is cleared, approved, licensed, or otherwise authorized under any of the following laws:
  • The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or
  • Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262), or
  • The Virus-Serum-Toxin Act (21 U.S.C. 151-159).

Yes. The novel H1N1 influenza virus has genetic components of both swine and avian influenza viruses in it which result in causing infections in those species. APHIS has authority over all organisms which cause or have the potential to cause disease in animals; therefore, they issue permits for novel H1N1 influenza. For further information, contact APHIS at 301-734-3277.

The issuance and expiration dates located on the import permit pertain only to the dates that the importer is allowed to import into the United States the infectious biological agents, infectious substances, and vectors listed on the import permit. The conditions for importation and continued possession listed on the permit remain in effect until the importer is no longer in possession of the imported material.

In most cases, an import permit may not be required. Diagnostic specimens that are 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 would not require a CDC import permit.

No. CDC Import Permit Program does not currently regulate the importation of a toxin.

Yes. Any diagnostic specimen known, or suspected by the importer of containing, any infectious biological agent would require a CDC import permit.

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.

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.

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.), or
• Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262), or
• The Virus-Serum-Toxin Act (21 U.S.C. 151-159).

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.

Yes. Any sample known, or suspected by the importer of containing, an infectious biological agent would require a CDC import permit. This product would not meet the exemption because the product is not approved or cleared by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

However, if the material is not known to contain or suspected of containing an infectious biological agent, or has been rendered noninfectious, it would not require a CDC import permit. The material must be 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.

You should safeguard the material and immediately report the incident to the CDC Import Permit Program either by email at importpermit@cdc.gov or by telephone at (404) 718-2077.

No. However, please note that the exportation of biological agents of human, plant, and animal diseases may require a license from the Department of Commerce. Information may be obtained by calling the Department of Commerce Bureau of Export Administration at 202-482-4811 or through the internet at www.bis.doc.gov/Licensing.

“Guidance for Importation of Human Remains into the United States for Interment or Subsequent Cremation” is available at http://www.cdc.gov/quarantine/human-remains.html.

If the CDC Import Permit Program requires an additional permit for subsequent transfers of any infectious biological agent, infectious substance or vector within the United States, the requirement will be listed as a condition of issuance on the import permit.

To initiate the process for an additional permit, the recipient must submit an application through eIPP.

Yes. Since the requirement for approval of subsequent transfers of imported materials within the United States was noted as a condition on the issued permit to the importer, the recipient is required to obtain a CDC import permit to receive this material.

To initiate the process for a permit, the facility would need to submit an application through eIPP.

The USDA’s Animal and Plant Health Inspection Service (APHIS) permits are required for the import, transit and release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms. Information on the APHIS permitting requirements is available at https://www.aphis.usda.gov/aphis/resources/permits.

A permit to import, or receive through subsequent transfer, is valid only for the time period indicated on the issued permit. The issuance and expiration dates located on the import permit pertain only to the dates that the importer is allowed to import into the United States the infectious biological agents, infectious substances, and vectors listed on the import permit. The conditions for importation and continued possession listed on the permit remain in effect until the importer is no longer in possession of the imported material.

Please note that all requests for renewal of an existing import permit require the submission of a new application and current signature of the permittee. To prevent lapses in the import permit status, it is recommended that permit renewal applications be submitted at least 30 days prior to the expiration date on the current permit.

There is no regulatory requirement in the import permit regulations for maintaining records of shipments for a specific amount of time. However, the CDC Import Permit Program recommends that the permittee maintain records of shipments for at least 3 years.

If your facility will no longer be importing infectious biological agents, infectious substances, or vectors of human disease into the United States, your facility should not complete an application to renew your facility’s import permit. However, the conditions specified on the permit apply until you no longer possess the material.

No. The issuance of an import permit is not an authorization to hand carry the imported material into the United States. The shipment of infectious biological agents, infectious substances, or vectors of human disease into the United States must be packaged, labeled, and shipped in accordance with all federal and international regulations. When traveling by air, the biological materials must be declared to the airline and cannot be concealed in checked luggage. Contact the airline and U.S. Customs in advance to ensure compliance with their policies and procedures.

No person may carry a hazardous material in the cabin of a passenger-carrying aircraft or on the flight deck of any aircraft, and the hazardous material must be located in a place that is inaccessible to persons other than crew members. Hazardous materials may be carried in a main deck cargo compartment of a passenger aircraft provided that the compartment is inaccessible to passengers and that it meets all certification requirements for a Class B aircraft cargo compartment in 14 CFR 25.857(b) or for a Class C aircraft cargo compartment in 14 CFR 25.857(c).

The facility should use a scientifically supportable method. The method used to cause permanent loss of biological activity must be reliable and based on the agent’s sensitivity to the inactivating method. An acceptable method may consist of traditional methods that have been generally recognized in the scientific community and published in the scientific literature or a method developed in-house, but that method should be validated as applied. While there is no requirement to notify CDC prior to rendering an agent non-infectious, the facility should incorporate a practice of maintaining records on file in support of materials being non-infectious.

Information from CDC on the MERS CoV is available at http://www.cdc.gov/coronavirus/mers/.

An applicant who wishes to make an appeal would have 30 calendar days after receiving the denial to submit the appeal in writing to the CDC Director. The appeal must state the factual basis for the appeal and provide any supporting documentations to justify the appeal (e.g., documents that demonstrate the facility has the appropriate biosafety measures in place for working safely with the requested imported material). CDC will issue a written response, which would constitute final agency action.

The applicant can submit the appeal to the CDC Director through the CDC Import Permit Program by email (importpermit@cdc.gov), fax [(404) 718-2093] or mail:

CDC Import Permit Program
1600 Clifton Rd, Mailstop A-46
Atlanta, GA 30329

It depends. In general, a CDC import permit is not required for breast milk from a healthy human when being imported for personal use. However, if the breast milk is being imported for research or diagnostic purposes and is reasonably expected to contain a biological agent that is infectious to humans (e.g., human immunodeficiency virus), then a CDC import permit is required.

SARS-CoV-2 is not a select agent identified in the select agent regulations. Therefore, the possession, use and transfer of SARS-CoV-2 is not regulated by the Federal Select Agent Program (FSAP).

On February 11, 2020, the International Committee on Taxonomy of Viruses (ICTV) announced that taxonomically, what has previously been referred to as 2019-nCoV should now be referred to as SARS-CoV-2. The “Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group” https://www.biorxiv.org/content/10.1101/2020.02.07.937862v1 indicates that SARS-CoV-2 is not a descendent of SARS-CoV (a select agent), but is genetically closely related.

The select agent regulations currently govern the possession, use and transfer of viruses identified as SARS-CoV, not viruses identified as SARS-CoV-2. The positive strand RNA genome of SARS-COV is also a select agent because this genomic material represents nucleic acids capable of generating infectious virus.

As the Federal Select Agent Program gains more information about the SARS-CoV-2, we will reassess the select agent status as needed. Any changes in the select agent status of SARS-CoV-2 will be published in the Federal Register.

Vials should be accurately labeled as SARS-CoV-2 to ensure that there is a clear distinction between the regulated virus (SARS-CoV) and the unregulated virus (SARS-CoV2).

It depends. The Centers for Disease Control and Prevention’s Import Permit Program may inspect an entity to verify 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. Laboratories that have been inspected by either HHS/CDC or the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA/APHIS) under the HHS or USDA select agent regulations (42 CFR Part 73, 9 CFR Part 121, or 7 CFR Part 331) will not require an additional inspection.

The CDC’s Import Permit Program will only inspect locations where the imported material will be used and stored 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.

Upon review of the application for import permit, the CDC Import Permit Program will contact your facility if an inspection is needed.

The CDC’s Import Permit Program checklists are posted on the CDC’s Import Permit Program website.

Yes. CDC limits the importation of bats under the authority of the Public Health Service Act (42 U.S.C. § 264) based on the significant public health risks associated with bats. Specifically, bats are known carriers of infectious biological agents that cause communicable and other diseases in humans. The most significant of these infectious biological agents are Nipah virus and viruses that cause communicable diseases such as Ebola, Marburg Hemorrhagic Fever, Sudden Acute Severe Respiratory Syndrome (SARS), and rabies.

If the bat is a native species of the United States, no permit is required to transfer the live bats. However, the CDC Import Permit Program requires a permit for the transfer of live bats within the United States if the bat was previously imported from outside of the United States. This requirement is listed as a condition indicated on the issued permit. To initiate the process for a permit, the facility would need to submit the “Application for Permit to Import or Transport Live Bats” through eIPP.

An importer must demonstrate an understanding of the risks which bats pose to public health and provide evidence of efforts taken to protect the importer and the public from such risks. In order to make the determination that an importer will protect public health, through this notice, and in addition to a completed application, CDC requires:

1. A Standard Operating Procedure (SOP) describing how the bats will be cared for, what personal protective equipment (PPE) will be worn during care, how the cages and exhibit will be cleaned, and how the waste will be handled for both the quarantine period and post quarantine.
2. An SOP describing how the bats will be contained and how escapes will be prevented.
3. An SOP for veterinary care, including procedures for what will be done with sick or dead bats, including a necropsy when a bat dies.
4. An SOP of an Occupational Health Plan including a risk assessment for exposure and a plan should an exposure occur.
5. An SOP explaining that the bats will not be re-distributed after importation.
6. An SOP detailing what will be done with the bats when they are no longer being used for science, education, or exhibition.

The Import Permit Program (IPP) uses a secure electronic information system, eIPP, to conduct all program business. This two-way portal, accessible by both the program and those seeking import permits, is used to submit and share information. As of September 2018, the only way to apply for a CDC import permit is by using this system. Additional information can be found here.

All potential applicants are required to have a SAMS (Secure Access Management Services) account – which protects the security of the information by requiring users to enter a user ID and password, or other secure credentials, before providing access to the system – in order to access the eIPP system to apply for a permit.  If you do not yet have a SAMS account but would like to establish one in order to submit a new application, please contact us.

Only applications submitted via eIPP will be accepted.

The specific measures required to ensure that infectious biological agents, infectious substances, and vectors are shipped safely are included in the Department of Transportation Hazardous Materials Regulations (49 CFR Parts 171-180). A condensed version of these measures can be found in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories.

Requirements for All Infectious Substances

The DOT regulations (49 CFR 171.15 and 171.16) require each person in physical possession of a hazardous material, including an infectious substance, to report specific types of transportation incidents that involve these materials. Immediate reporting by telephone to the National Response Center at 1-800-424-8802 is required for incidents where fire, breakage, spillage, or suspected contamination occurs that involves the shipment of infectious substances other than a patient specimen or regulated medical waste (See 49 CFR 171.15(b)(3)). In addition, a written report to DOT is required within 30 days of the discovery of the incident for any unintentional release of hazardous material from a packaging during transportation, including those covered under 49 CFR 171.15 (See 49 CFR 171.16(a)). DOT regulations also require packages that contain infectious substances to be accompanied by several forms of hazard communication, as applicable, as well as labeled to indicate the infectious hazard (See 49 CFR 172.432 for a depiction of the required label). This label currently includes a statement for reporting a damaged package.

Please refer to the Department of Transportation regulations (See 49 CFR 173.22 and 24) where it refers to the integrity of the packaging.

Imported infectious biological agents, infectious substances, and vectors classified as a Category A infectious substance must be packaged in accordance with the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180), and be accompanied by a shipping paper, marking, labeling, and note the appropriate emergency response information. Please see the Guidance for Completing the Shipper’s Declaration for Dangerous Goods for more information.

Labeling of Packages

The outer container of all Category A infectious substance packages must display the following:

• Sender’s name and address
• Recipient’s name and address
• Infectious substance label
• Proper shipping name, UN number, and net quantity of infectious substance
• Name and telephone number of person responsible for shipment
• Cargo Aircraft Only label (when shipping quantities of infectious substance over 50 ml or 50 g by aircraft)
• Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid, or Dry ice