Frequently Asked Questions concerning Etiologic Agent Import Permits

For detailed information and direction on how to complete all sections of the Application for Permit to Import or Transport Etiologic Agents Hosts or Vectors of Human Disease form, please refer to the guidance document available on the Import Permit Applications webpage. Should you have any further questions, please contact us at importpermit@cdc.gov.

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.

What type of material requires an Etiologic Agent 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.

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.

Is a USDA permit also required for pandemic novel H1N1 influenza virus strains?

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.

What are the requirements for importation of live bats into the U.S.?

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.

Which types of materials do NOT require an import permit?

• 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).

Where can I find the import permit application?

Application forms are available at the following link:
CDC - EAIPP-Import Permit Applications or www.cdc.gov/od/eaipp/

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

How do I submit the import permit application?

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

Centers for Disease Control and Prevention
Etiologic Agent Import Permit Program
1600 Clifton Road NE, Mailstop A-46
Atlanta, GA 30333
FAX: 404-718-2093
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.

Is there a fee for obtaining a CDC import permit?

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

Is a CDC import permit required for the interstate transfer of an etiologic 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 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.

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 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.

Are there any restrictions on material that can be imported into the United States?

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

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