Policy Statement

Date: February 23, 2015

Subject: FSAP Policy Statement: When APHIS and CDC Import Permits Not Required for the Importation or Interstate Transportation of Select Agents

The Federal Select Agent Program (FSAP) is a collaboration between the Center for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) to regulate the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins). The FSAP administers the select agents and toxins regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services (CJIS).

Policy Statement:
As provided for in 42 CFR §71.54 (f)(1), a permit for the importation of infectious biological agents, infectious substance, and vectors is not required for an item if it is a biological agent listed in 42 CFR Part 73 as a select agent and its importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16.

Notwithstanding the permit requirements in Part 122 and 9 CFR 121.16, APHIS has determined that a permit is not required from APHIS for the importation or interstate movement of a select agent listed in 9 CFR 121.3 and 121.4 provided that the importation and/or interstate movement of these select agents are authorized for transfer in accordance with 42 CFR 73.16 or 9 CFR 121.16(b).

This policy statement is effective March 26, 2013.

Authority:
Regulations promulgated pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.) and the Virus-Serum-Toxin Act (21 U.S.C. 151-158) provide that no organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof.  However,  no permit is  required  for importation of biological products  for which an import permit has been issued pursuant to 9 C.F.R. Part 102  or for transportation of organisms produced at establishments licensed under  the Virus Serum Toxin Act.  (9 C.F.R. 122.2)

Section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) authorizes the Health and Human Services (HHS) Secretary to make and enforce such regulations as in her judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions of the United States and from one State or possession into any other State or possession.  For purposes of carrying out and enforcing such regulations, the HHS Secretary may authorize a variety of public health measures, including inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures.   

Under 42 CFR §71.54, CDC may issue a permit to allow for the importation of an infectious biological agent capable of causing communicable disease in a human, an infectious substance that is capable of causing communicable disease in a human, or a vector capable of transferring an infectious biological agent to a human into the United States when appropriate biosafety measures are in place for working safely with these materials.

Any question concerning this policy may be addressed by contacting the Federal Select Agent Program at lrsat@cdc.gov or AgSAS@aphis.usda.gov.

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Robbin S. Weyant, PhD, RBP (ABSA)
Captain, USPHS (Ret.)
Director, Division of Select Agents and Toxins
Department of Health and Human Services
Centers for Disease Control and Prevention
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Freeda E. Isaac, DVM
Director, Agriculture Select Agent Services
United States Department of Agriculture
Animal and Plant Health Inspection Service