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Frequently Asked Questions about Etiological Agent Import Permits

  1. What is the federal regulation that governs the importation of etiologic agents?

The importation of etiologic agents is governed by the following federal regulation:

USPHS 42 CFR - Part 71 Foreign Quarantine. Part 71.54 Etiologic agents, hosts, and vectors.
(a)  A person may not import into the United States, nor distribute after importation, any etiologic agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director.
(b)  Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of U.S. Customs Service of a permit issued by the Director (Centers for Disease Control and Prevention).

Thus, any etiological agent, host, or vector of human disease that is imported into the United States must be accompanied by a CDC import permit.

  1. What requires a CDC import permit?

Etiologic agents - It is impractical to list all etiologic agents, but it is any infectious agent known or suspected to cause disease in humans.

Biological materials-

  • Unsterilized specimens of human and animal tissues (such as blood, body discharges, fluids, excretions or similar material) that contain  human pathogens
  • Specimens of human and animal tissues (such as blood, body discharges, fluids, excretions or similar material) that have not been rendered non-infectious or are suspected to contain human pathogens

Hosts and Vectors-

  • Animals-any animal known or suspected of being infected with an organism capable of causing disease in humans 
  • Bats-all live bats 
  • Arthropods-Any living insect or other arthropod that is known or suspected of containing a human pathogen
  • Snails-Snail species capable of transmitting a human pathogen
  • Non-human primate trophies, skins or skulls - Any non-human primate trophy, skin, or skull that has not been fully taxidermied or treated so that it is non-infectious.
  1. Is a CDC import permit required for further distribution after importation of etiologic agents, hosts, or vectors (excluding live bats)?

Once a CDC import permit is issued for the importation of material covered by 42 CFR 71.54, a separate import permit is not required for subsequent distribution of that imported material unless Section 5 of the CDC Import Permit is specifically marked to prohibit further distribution.

The transfer of a select agent or toxin must be authorized by the either the CDC or the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs prior to a transfer. A select agent or toxin can only be transferred under the conditions proscribed in the Select Agent Regulations (7 CFR part 331, 9 CFR part 121, and 42 CFR part 73).  In addition, a Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors issued by APHIS may be required prior to the interstate movement of materials related to animals or plants.

  1. Where can I obtain an application?

The applications to Import or Transport Etiologic Agents, Hosts, or Vectors of Human Disease and to Import or Transport Live Bats are available at:

http://www.cdc.gov/od/eaipp/importApplicationForms.htm

You may also directly contact our office via phone at 404-718-2077 or by facsimile at 404-718-2093 to obtain an application package.
To import or transport non-human primate trophies, skins or skulls, individuals would use the application for permit to Import or Transport Etiologic Agents, Hosts, or Vectors of Human Disease which are available at
http://www.cdc.gov/od/eaipp/importApplicationForms.htm.
The Guidance for importation of Non-Human Primate Trophies is available at:
www.cdc.gov/od/eaipp/primateTrophies.htm.

  1. How should import permit applications be submitted?

The applications for the CDC import permit may be submitted through mail or fax using the following information. It is not necessary to submit a permit application through both mail and fax.

The contact information for CDC Import Permit Program is following:
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop A-46 Atlanta, GA 30333

Phone: 404-718-2077
FAX:      404-718-2093

Please allow at least 15 working days to process import permit applications, renewals and modifications before inquiring about the status of your permit request. Import permit applications, renewals and modifications are processed in the order they are received.  Incomplete or illegible applications will result in significant delays and/or denial of a permit. 

  1. How long is the CDC import permit valid once it has been issued?

There are two types of import permits that are issued to importers requesting to import and transport etiologic agents, hosts, or vectors of human disease: “Multiple Use Importation” permits and “Single Use Importation” permits. The “Multiple Use Importation“ permits are issued for twelve months and “Single Use Importation“ permits are issued for six months depending on the importation into the United States. This information is obtained from the applicant’s response to Section D “Type of Permit and Shipment Information” of the application for permit to Import or Transport Etiologic Agents, Hosts, or Vectors of Human Disease.
http://www.cdc.gov/od/eaipp/importApplicationForms.htm

  1. Can the CDC import permit be changed or amended after the permit is issued?

Yes.  To amend the CDC import permit, a written request and a copy of the CDC import permit indicating the requested change needs to be faxed to 404-718-2093.  Please allow for 15 working days to complete the request. Please call 404-718-2077 for further questions about amending a permit.

  1. How do I request a CDC import permit to import the same etiologic agent from multiple senders from different countries?

Along with the application to request a CDC import permit, provide a list of addresses for senders of material (minimum of 6 foreign countries of origin) as justification for a “worldwide” permit. 

  1. How do I determine the biosafety level requested for Section E of the application for the CDC import permit?

The Biosafety in Microbiological and Biomedical Laboratories (BMBL) provides recommendations for safely working with a variety of human pathogens and describes standard and special microbiological practices, safety equipment, and facilities (constituting Biosafety Levels 1-4). The BMBL is available on the Internet at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm

  1. My import permit is expiring, when should I submit my request for a renewal?
    Requests for renewal of an existing permit and modifications will require the completion of a new application and current signature of the permittee. To prevent lapses in the import permit status, please submit renewal applications at least 30 days prior to expiration date of the current permit.
  1. What are the responsibilities of the importer?

The CDC import permits are 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 materials according to Federal and International regulations. 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 Service and U.S. Division of Quarantine Personnel of the package contents.

  1. What items are prohibited from importation into the United States?

The importation of certain animals and animal products from certain geographical areas into the United States is currently restricted. For information on embargoed items, go to www.cdc.gov/od/eaipp/embargos.htm.

  1. Is a CDC import permit required to transport live bats within the United States?

Yes. A CDC import permit is required for all transfers of imported live bats. This includes importation into the United States, transfer of bats from one address to another address in the United States or transfer of possession (regardless if bats change location). A CDC import permit is not required for captive bred bats. For further guidance to import and transfer live bats, refer to the application to Import or Transport Live Bats which is available at: http://www.cdc.gov/od/eaipp/importApplicationForms.htm.

  1. Is a CDC import permit required to import or transport non-human primate trophies, skins or skulls?

Fully taxidermied non-human primate trophies, or those that have been treated to render them non-infectious, may be imported without a CDC import permit.  A CDC import permit is required for all non-human primate material that has not been rendered non-infectious,.  To obtain information on importing non-human primates trophies, skins, or skulls, see www.cdc.gov/od/eaipp/primateTrophies.htm.

  1. Is a CDC Import Permit required to import material (e.g. blood, plasma, tissue, urine, feces) from non-human primates?

Yes. A CDC import permit is required for all imported material from non-human primates (e.g., blood, plasma, tissue, urine, feces).

  1. Does the CDC have any requirements for importing live animals or products made from civets, genets, and African rodents?

Civets, genets, and African rodents may only be imported for scientific, education, or exhibition purposes with permission granted from the Zoonoses Team in the Division of Global Migration and Quarantine. To obtain further information and guidance on the requirements, please call 404-639-3441.

  1. What are the requirements for bringing my pet dog into the United States?

Any animal known or suspected of being infected with an organism capable of causing disease in humans may require a CDC import permit.

CDC’s Foreign Quarantine regulations have requirements that apply to the importation of pets such as dogs into the United States. For more information on importation of pets, go to CDC’s Division of Global Migration and Quarantine website at www.cdc.gov/ncidod/dq/animal.htm.

  1. What are the packaging requirements for infectious material?

Infectious materials imported into this country must be packaged to withstand breakage and leakage of contents, and labeled, as specified in the following federal regulations:

  • DOT 49 CFR PART 173 - Transportation of Etiologic Agents
  • For international shipments, the International Air Transport Association (IATA) Dangerous Goods Regulations should be consulted.

The issued CDC import permit, with the proper packaging and labeling, will expedite clearance of the package of infectious materials through the United States Public Health Service Division of Quarantine and release by U.S. Customs.

  1. What other federal permits might be required to import etiological agents, biological materials, hosts, or vectors?
  1. Is a CDC import permit required for exportation of etiological agents, biological materials, hosts, or vectors outside the United States?

The export of a wide variety of etiologic 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/.

  1. What are the requirements for importing select agents or toxins from countries outside the United States?

Only entities registered with the CDC or APHIS Select Agent Programs can be authorized to import select agents or toxins from outside the United States. The following procedure is required:

  1. Importation of select agents or toxins may require the intended recipient to obtain a valid USDA and/or PHS permit prior to the transfer (See 7 CFR Part 330.200, 9 CFR Part 122.2, and 42 CFR Part 71.54) The application and instructions for obtaining USDA transport or import permits are available through the APHIS website at: www.aphis.usda.gov/vs/ncie/ or the Plant Pest Program (PPQ) website at: www.aphis.usda.gov/ppq/permits/ or by calling 301-734-5960.  The application and instructions for obtaining CDC import permits are available through the CDC website at: www.cdc.gov/od/eaipp/ or by calling 404-718-2077. 
  2. The importer must be registered with the Select Agent Program for the select agent or toxin listed on the import permit application.
  3. In accordance with 42 CFR 73.16, the entity must submit an APHIS/CDC Form 2 to request prior authorization of a transfer of select agent(s) or toxin(s).  The recipient’s Responsible Official: 
    1. Completes Sections A and B as instructed.
    2. Completes Sections C and D for sender, placing the “APHIS Permit Number or PHS Permit Number” in block 3 of the form.
    3. Transmits the form via facsimile to APHIS (FAX: 301-734-3652) or CDC (FAX: 404-718-2093).
  4. After receipt of material, completes Section D with date the material was received and faxes completed APHIS/CDC Form 2 to APHIS or CDC within 2 days of receiving the select agent or toxin.
  5. Retain a copy of the completed form for 3 years.
  1. Is there a fee for obtaining a CDC import permit?

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

  1. Am I able to “hand carry” the imported material into the United States?

Imported material that meets the definition of Dangerous Goods and is subject to the International Air Transport Association (IATA) Dangerous Goods Regulations must not be hand carried by passengers or in checked or carry-on baggage. For further information on IATA Dangerous Goods Regulations, please refer to: http://www.iata.org/whatwedo/cargo/dangerous_goods/infectious_substances.htm.

Please Note That The Issuance Of A CDC Import Permit Is Not An Authorization To Hand Carry The Material.

  1. Is a CDC import permit required for importing laboratory mice into the United States?

A CDC import permit is generally not required for laboratory mice, rats, and hamsters reared under specific pathogen free (SPF) conditions. In addition, genetically altered animals (e.g., “knock-out” or “transgenic”) do not require a CDC import permit provided that the animals contain no pathogens known to be transmissible to humans. If the rodents are to be imported from Africa or are species of African origin, they may only be imported for scientific, education, or exhibition purposes with permission granted from the Zoonoses Team in the Division of Global Migration and Quarantine. To obtain further information and guidance on the requirements, please call 404-639-3441.

  1. Is a CDC import permit required for importing formalin-fixed specimens into the United States?

A CDC import permit is not required for non-infectious materials (e.g., formalin-fixed specimens, tissues or slides).

  1. Is a CDC import permit required for importing diagnostic specimens into the United States?

A CDC import permit is not required for human or animal diagnostic specimens (except for non-human primates) such as blood, urine, tissues in which there is no evidence or indication that such materials contain an infectious agent.

Please note that specimens from humans may be subject to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 C.F.R. 1910.1030) and that specimens from animals may require a permit from the USDA/APHIS. Biological products and biological waste regulated by other Federal agencies may not require a permit.

To facilitate clearance of materials that do not require a CDC import permit, it is recommended that each shipment of this material be accompanied by a signed statement, on official letterhead, from the person responsible for the shipment of this material with the following information:

  1. A description of the material;
  2. A statement that this material meets one of the above criteria (e.g., this material is not known or suspected to contain an etiological agent, host, or vector of human disease); and,
  3. Verification that it has been packaged, labeled, and transported in accordance with all applicable regulations. Note that other permits may be required (e.g., USDA).
  1. Is a CDC import permit required for importing non-infectious human stem cells or non-infectious human organs for transplantation?

No. A CDC import permit is not required for non-infectious material. Please call the CDC Import Permit Program at 404-718-2077 for further information.

 

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Page last modified: May 5, 2008
Page last reviewed: March 8, 2007