Importing Select Agents

In order for an entity to import Select Agents or toxins from outside the United States, the following is required:

1. The importer must hold a valid import permit from CDC in accordance with 42 CFR Part 71.54 (Importation of etiologic agents, hosts, and vectors). The application and instructions for obtaining import permits for etiologic agents is available through the CDC website at: http://www.cdc.gov/od/ohs/biosfty/imprtper.htm or by calling the CDC fax information service at 1-888-232-3299 and requesting document number 101000. Please note that additional permits may be required, such as those issued by the United States Department of Agriculture. Information on other permits that may be required can be found at: BMBL5 Appendix C.



2. The importer must be registered with the CDC or APHIS Select Agents Program in accordance with 42 CFR Part 73, 9 CFR 121, and 7 CFR 331 (Possession, Use, and Transfer of Select Agents and Toxins; Final Rule) for the Select Agents listed on the import permit application. The application for registration is available through this website at: http://www.selectagents.gov/Forms.html or by calling 404-718-2000.



3. In accordance with 42 CFR Part 73.14(a)(3) and 9 CFR Part 121.16(a), an APHIS/CDC Form 2 must be completed and submitted to the CDC Select Agents Program. Approval must be granted prior to the shipment of the Select Agents or toxins under the import permit. The APHIS/CDC Form 2 is available through this website at: http://www.selectagents.gov/Forms.html or by calling 404-718-2000.

The receiving/recipient Responsible Official (RO) must complete APHIS/CDC Form 2:

1. Completes Blocks 1 and 2 as instructed.



2. Completes Blocks 3 and 4 for sender, placing the "PHS Permit Number" in the Importation box.



3. Electronically submits or faxes APHIS/CDC Form 2 to CDC (Fax: 404-718-2096) for APHIS / CDC confirmation number.



4. The sender must comply with all applicable laws concerning importation, packaging, and shipping. Some additional permit and transportation regulations are found in Appendix C of the 4th edition of the CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories" (http://www.cdc.gov/od/ohs/biosfty/biosfty.htm).



5. After receipt of material, completes Block 4 with date the material was received and faxes completed APHIS/CDC Form 2 to APHIS / CDC within 2 days of receiving the Select Agents or toxin. If the Select Agents or toxin is not received within 48 hours of the expected delivery time or if the package containing Select Agents is leaking or otherwise damaged, then the receiver of the material must immediately report this information to CDC (Tel: 404-718-2000).



6. Retains paper record for 3 years.