Frequently Asked Questions

Application forms are available at the following link:
CDC – IPP-Import Permit Applications

A guidance document for applicants filling out the import permit application is available here:
CDC -IPP-Guidance – Request to Import Biological Agents or Vectors of Human Disease
CDC -IPP-Guidance – Request to Import or Transport Live Bats

Completed applications may be submitted by EITHER mail, fax or e-mail to:

Centers for Disease Control and Prevention
Import Permit Program
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: 404-471-8333
Email: importpermit@cdc.gov

NOTE: It is not necessary to mail in the original copy of a permit application after submission via fax or e-mail. Duplicate applications sent either via fax or email will result in slowing down the review and approval of applications.

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 60 days prior to the expiration date on the current permit.

If an applicant is unsure of the port of entry, the applicant should note “Unknown” for the question.

A guidance document for applicants filling out the import permit application is available here:
CDC – IPP-Guidance – Request to Import Biological Agents or Vectors of Human Disease
CDC – IPP-Guidance – Request to Import or Transport Live Bats

Additional assistance is available by email (importpermit@cdc.gov) or telephone (404) 718-2077).

Yes. Application forms are available here.

If the imported material is being sent from more than one sender, please check the box in Block 13 on the application and list all additional senders on the Continuation form available at here. Please include all required information (Blocks 1-12) for each additional sender.

If more than 4 agents are being listed under block 3 (Scientific name of known/suspected biological agent(s)*, please use the “SECTION E continuation form (Description of Additional Imported Biological Agents)” available at: http://www.cdc.gov/od/eaipp/importApplicationForms.htm.

*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.

No, import permits cannot be amended. For any changes to an import permit, the applicant must submit a completed application form. The forms are available here.

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 is responsible for assuring that the foreign personnel package, label, and ship the infectious material according to Federal regulations and international standards. Shipping labels with the universal biohazard symbol and a copy of the issued CDC import permit should accompany the package being imported into the United States. The permit and labels inform the U.S. Customs and Border Protection personnel and quarantine officers of the package contents. Please see below for further details on package labeling and other shipping requirements.

The importation of specific animals and animal products from specific geographical areas into the United States is currently restricted.

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.

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

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.

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.

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 http://www.fws.gov/permits/importexport/importexport.shtml

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:
http://www.aphis.usda.gov/import_export/index.shtml.

• Select agents listed in 42 CFR Part 73 and its importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16.
• Diagnostic specimen 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.
• Animal or animal product 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, and so they do issue permits for novel H1N1 influenza. For further information, contact APHIS at 301-734-3277.

Probably not. 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 CDC Import Permit.

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

No. Animal or 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 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. A CDC import permit is not required for select agents and toxins listed in 42 CFR §§ 73.3, .4 or 9 CFR § 121.4 as long as its importation has been authorized in accordance with 42 CFR § 73.16 or 9 CFR § 121.16.

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).

Possibly. 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 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 it would not require CDC Import Permit.

You should safeguard the material from theft, loss, or release, and immediately report the incident to the CDC Import Permit Program at: email (importpermit@cdc.gov) or telephone 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 in block 5.

To initiate the process for an additional permit, the recipient must submit an application to the CDC Import Permit Program. Application forms are available here.

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: http://www.aphis.usda.gov/permits/index.shtml.

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 60 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, CDC Import Permit Program recommends that the permittee maintain records of shipments until the importer is no longer in possession of the imported material.

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.

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 inactivant. 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. The method may stand as a separate laboratory protocol or standard operating procedure or be incorporated into the laboratory biosafety manual. 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 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 (404-471-8333) or mail:

CDC Import Permit Program
1600 Clifton Rd, Mailstop A-46
Atlanta, GA 30333

Possibly. The criteria used to determine those “high-risk” entities to be inspected include facilities that applied to import infectious biological agents which are capable of causing serious or potentially lethal disease in humans via the aerosol route. 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 probably not require an additional inspection. Inspections are be conducted to ensure that the importer has biosafety measures in place that are 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.

The CDC’s Import Permit Program will only inspect those rooms associated with the import permit application 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 notification will be by telephone and then followed up by an official “Notice of Inspection” letter.

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

An importer must demonstrate appreciation for the many risks which bats pose to the public health and all 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; and
6. An SOP detailing what will be done with the Bats when they are no longer being used for Science, Education, or Exhibition.

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 is responsible for assuring that the foreign personnel package, label, and ship the infectious material according to Federal regulations and international standards. Shipping labels with the universal biohazard symbol and a copy of the issued CDC import permit should accompany the package being imported into the United States. The permit and labels inform the U.S. Customs and Border Protection personnel and quarantine officers of the package contents. Please see below for further details on package labeling and other shipping requirements.

The importation of specific animals and animal products from specific geographical areas into the United States is currently restricted.

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 germs that cause communicable and other diseases in humans. The most significant of these germs are Nipah virus and viruses that cause communicable diseases such as Ebola, Marburg Hemorrhagic Fever, Sudden Acute Severe Respiratory Syndrome (SARS), and rabies.

The “Application for Permit to Import or Transport Live Bats” is for the importation and/or transport of live bats within the United States.

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.

The CDC’s Import Permit Program will only inspect those rooms associated with the import permit application 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.

There are several domestic and international regulations that govern the shipment of infectious substances. These include:

Domestic Regulations

• Department of Transportation. 49 CFR Part 171-180, Hazardous Materials Regulations . Applies to the shipment of infectious substances in commercial transportation to, from, or within the United States. These regulations also authorize, with certain conditions and limitations, the commercial transportation of hazardous materials in accordance with the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), the International Maritime Dangerous Goods Code (IMDG Code), Transport Canada’s Transportation of Dangerous Goods Regulations (Transport Canada TDG Regulations), and the International Atomic Energy Agency Regulations for the Safe Transport of Radioactive Material (IAEA Regulations). See 49 CFR 171.12(a) and 49 CFR Part 171, Subpart C. Information on these regulations may be obtained by calling (800) 467-4922 (Toll free) or (202) 366-4488 from 9:00 AM to 5:00 PM Eastern time, or at: http://www.phmsa.dot.gov/hazmat.
• United States Postal Service (USPS). 39 CFR Part 20, International Postal Service (International Mail Manual), and Part 111, General Information on Postal Service (Domestic Mail Manual). Regulations on transporting infectious substances through the USPS are codified in Section 601.10.17 of the Domestic Mail Manual and Section 135 of the International Mail Manual. A copy of the Domestic and International Mail Manuals may be obtained from the Government Printing Office by calling Monday through Friday, 7:30 a.m. – 9:00 p.m. EST: (202) 512-1800 or (866) 512-1800 (Toll free). The Domestic Mail Manual is available at : http://pe.usps.com/text/dmm300/dmm300_landing.htm. The International Mail Manual is available at: http://pe.usps.gov/text/imm/welcome.htm.
• Occupational Health and Safety Administration (OSHA). 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens. These regulations provide minimal packaging and labeling requirements for blood and body fluids when transported within a laboratory or outside of it. Information may be obtained from your local OSHA office or at: http://www.osha.gov/.

International Regulations

• Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions). International Civil Aviation Organization (ICAO). Applies to the shipment of infectious substances by aircraft and is recognized in the United States and by most countries worldwide. The HMR recognize and authorize the Technical Instructions as an alternative to complying with the HMR for packaging, marking, labeling, classifying, and describing hazardous materials transported by aircraft and by motor vehicle either before or after being transported by aircraft. See 49 CFR Part 171, Subpart C. A copy of these regulations may be obtained from the ICAO Document Sales Unit at (514) 954-8022, Fax: (514) 954-6769, E-mail: sales_unit@icao.int, or at: http://www.icao.int.
• Dangerous Goods Regulations. International Air Transport Association (IATA). These instructions are issued by an airline association, based on the ICAO Technical Instructions, and followed by most airline carriers. However they do not have official standing under the HMR. A copy of these regulations is available at: http://www.iata.org/index.htm or http://www.who.int/en/, or by contacting the IATA Customer Care office at: Tel: (514) 390-6726 or (800) 716-6326 (Toll free), Fax: (514) 874-9659, or E-mail: custserv@iata.org.
• The International Maritime Dangerous Goods Code. International Maritime Organization (IMO). This code is of mandatory application for all 155 contracting parties to the International Convention for the Safety of Life at Sea (SOLAS). Information on this code is available at: http://www.imo.org/Pages/home.aspx.
• The Letter Post Manual . Universal Postal Union (UPU). This manual reflects the United Nations Recommendations using the ICAO provisions as the basis for shipments. The manual can be found at http://www.upu.int/en/activities/letter-post/letter-post-manual.html.

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