Importation of Infectious Specimens, Biological Agents, and Vectors Questions

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 in the U.S. will require an additional CDC import permit.

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 for additional information.

Are USDA/APHIS and HHS/CDC import permits 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 oversee the importation of all microorganisms which cause or may cause disease in animals or humans respectively. 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 without a USDA/APHIS permit. Please upload a copy of your approved USDA/APHIS permit into eIPP.

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

Yes. The novel H1N1 influenza virus contains genetic components of both swine and avian influenza viruses. It can cause infections in both 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.

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 to contain any infectious biological agent would 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 that contains or is suspected to contain an infectious biological agent requires a CDC import permit. This product would not be exempt because it does not comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

However, the material does not require a CDC import permit if it:

• Is not known to contain or is not suspected of containing an infectious biological agent.
• Has been rendered noninfectious.

The material must be accompanied by an importer certification statement confirming that it:

• Is not known to contain or is not suspected of containing an infectious biological agent.
• 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.
• 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, the exportation of biological agents of human, plant, and animal diseases may require a license from the Department of Commerce. For more information, contact the Department of Commerce Bureau of Export Administration at 202-482-4811 or www.bis.doc.gov/Licensing.

Besides a CDC import permit, when would a USDA permit be needed for importing an infectious biological agent, infectious substance, or vector?

APHIS permits are required for the import, transit, and release of:

• Regulated animals and animal products.
  
• Veterinary biologics.
• Plants and plant products.
• Pests.
• Organisms.
• Soil.
• Genetically engineered organisms.

Information on the APHIS permitting requirements is available.

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 permit's issuance and expiration dates show the only time period the listed items can be imported into the U.S. The listed conditions for importation and continued possession are in effect until the importer no longer possess the imported material.

Please note, all requests for renewal of an existing import permit require the:

• Submission of a new application.
• Current signature of the permittee.

To prevent lapses in the import permit status, submit permit renewal applications at least 30 days before the expiration date.

What method should my facility use to render infectious biological agents noninfectious?

The facility should use a scientifically supportable method. The method used to cause permanent loss of biological activity must be:

• Reliable.
• Based on the agent’s sensitivity to the inactivating method.

An acceptable method may consist of traditional methods that are:

• Generally recognized in the scientific community.
• Published in the scientific literature.
• Developed in-house.

The method should be validated as applied. There is no requirement to notify CDC before rendering an agent noninfectious. However, the facility should incorporate a practice of maintaining records on file to support materials being rendered noninfectious.

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.

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" 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 FSAP gains more information about 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. Accurate labeling ensures that there is a clear distinction between the regulated virus (SARS-CoV) and the unregulated virus (SARS-CoV-2).