Key points
- The ÐÇ¿ÕÓéÀÖ¹ÙÍø Import Permit Program regulates the importation of infectious specimens, biological agents, and vectors.
- Regulations from the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) may also affect importation requirements.
- Follow the guidelines to determine which items require a ÐÇ¿ÕÓéÀÖ¹ÙÍø import permit.
Is a ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø import permit.
Are USDA/APHIS and HHS/ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø at 404-718-2077.
ÐÇ¿ÕÓéÀÖ¹ÙÍø will not issue a permit for 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.
What if my facility receives an infectious biological agent, infectious substance, or vector that is not listed on my ÐÇ¿ÕÓéÀÖ¹ÙÍø import permit?
You should safeguard the material and immediately report the incident to the ÐÇ¿ÕÓéÀÖ¹ÙÍø Import Permit Program either by:
- Email at [email protected].
- Telephone at 404-718-2077.
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 ÐÇ¿ÕÓéÀÖ¹ÙÍø before rendering an agent noninfectious. However, the facility should incorporate a practice of maintaining records on file to support materials being rendered noninfectious.