For answers to frequently asked questions about the importation of infectious biological materials that could cause disease in humans, please refer to the information below. Should you have any further questions, please contact us at importpermit@cdc.gov.
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.
How can I check the status of my application?Real-time status updates are available on the permittees dashboard in eIPP. Options that can appear include:
Can other individuals (e.g., compliance officer or administrative assistant) with a SAMS account be linked to my account so they can make changes on my behalf?
No. Currently, only one user can be connected to a SAMS/eIPP account. Information cannot be transferred between accounts.
The permit holder at my company is about to retire. Can their SAMS account and permit be transferred to someone else at the company?
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.
I’m moving to a different university. Can I still use the same SAMS account for my import permits?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.
Can I upload supporting documents in eIPP?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.
How do I ensure a complete application is submitted to the CDC Import Permit Program?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.
If my information does not change on my import permit, do I need to still complete an application to renew it?
Yes. The application must be resubmitted in eIPP.
How do I account for multiple senders shipping imported materials to our facility?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.
How do I account for multiple agents that our facility will receive?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.
How do I list animals that are vectors of disease?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).
I have an existing import permit that is about to expire. How do I request a renewal?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.
Do I need an import permit?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.
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:
No. Currently, there is no fee for processing a CDC import permit.
Is a CDC import permit required for the interstate transfer of an infectious biological agent?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.
What are the responsibilities of the importer once an import permit has been issued?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.
Are there any restrictions on what infectious biological agents, infectious substances, or vectors can be imported into the United States?
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
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 a USDA/APHIS and HHS/CDC import permit required for the novel H7N9 influenza virus strains?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.
What type of material requires a CDC import permit?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.
What type of animal vectors would require an import permit?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 .
Which types of materials do NOT require an import permit?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.
Do the issuance and expiration dates located on the import permit affect the permit conditions for importation and continued possession listed on the import 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.
Is an import permit required for a human urine sample being imported for drug testing purposes?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.
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 for a diagnostic specimen that is suspected to contain a select agent?Yes. Any diagnostic specimen known, or suspected by the importer of containing, any infectious biological agent would require a CDC import permit.
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:
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.
Is an import permit required for an infectious biological agent after dosing the infectious biological agent with an investigational new drug product under review by U.S. Food and Drug Administration?
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.
What if my facility receives an infectious biological agent, infectious substance, or vector that is not listed on my CDC import permit?
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.
Does the CDC Import Permit Program regulate the exportation of infectious biological agents, infectious substances, and vectors of human disease outside of the United States?
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 .
Where can I find the “Guidance for Importation of Human Remains into the United States for Interment or Subsequent Cremation?”
“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.
How would an importer know if authorization for subsequent transfers of imported materials within the United States is needed?
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.
Does a recipient within the United States need a CDC import permit to receive an infectious biological agent, infectious substance or vector from a facility that imported the material if the condition was indicated on the issued permit for the importer?
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.
Besides a CDC import permit, when would a United States Department of Agriculture (USDA) permit be needed for importing an infectious biological agent, infectious substance or vector?
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 .
How long is an import permit valid to import an infectious biological agent, infectious substance or vector into the United States?
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.
Is there a requirement for maintaining records of imported shipments for a specific amount of time?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 our facility does not plan to receive any more imported material from outside the United States, does our facility have to renew our permit?
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.
Does the issuance of a CDC import permit allow the importer to “hand carry” the imported material into the United States?
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).
What method should my facility use to render infectious biological agents non-infectious?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.
Where can I find information on Middle East Respiratory Syndrome (MERS), the viral respiratory illness first reported in Saudi Arabia in 2012, including recommendations for safety working with the virus?
Information from CDC on the MERS CoV is available at http://www.cdc.gov/coronavirus/mers/.
What is the process if my permit request gets denied, suspended or revoked?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.
Is SARS-CoV-2 considered a select agent?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.
How should vials be labeled when working with SARS-CoV-2 to ensure that they are not confused with regulated SARS-CoV?
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.
What areas will CDC inspect as it relates to my import permit application?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.
How will my facility be notified if an inspection is required?Upon review of the application for import permit, the CDC Import Permit Program will contact your facility if an inspection is needed.
Will checklists be published for entities to review prior to inspections?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.
Is an import permit required to transfer bats within the United States?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.
What are the requirements for importation of live bats into the United States?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:
What application do I need to complete if I wish to import live bats or transfer live bats within the United States?
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.
What are some of the specific measures required to ensure that infectious biological agents, infectious substances, and vectors are shipped safely?
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.
What happens if a package containing an infectious biological agent, infectious substance, or vector is lost or damaged during shipment?
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.
Is our facility allowed to reuse shipping and packaging material?Please refer to the Department of Transportation regulations (See 49 CFR 173.22 and 24) where it refers to the integrity of the packaging.
How to package and label shipment containing imported infectious biological agents, infectious substances, and vectors?
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.
The outer container of all Category A infectious substance packages must display the following:
