Policy Statement

Date: October 19, 2016

Subject: FSAP Policy Statement: Extension of Time Request to Possess Select Agents and Toxins Identified as a Result of Diagnosis or Verification due to Shipping Difficulties

The Federal Select Agent Program (FSAP) is a collaboration between the Centers 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).

Authority:

For biological agents and toxins determined by HHS to have the potential to pose a severe threat to public health and safety (HHS and Overlap select agents and toxins), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) exempts clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation. 42 U.S.C. § 262a (g)(1).

For biological agents and toxins determined by USDA to have the potential to pose a severe threat to animal health or animal products (USDA and Overlap select agents and toxins), the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. § 8401) exempts clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation. 7 U.S.C. 8401 (g)(1).

In accord with sections 5 (a)(1) and 6 (a)(1) of the select agents and toxins regulations, unless directed otherwise by the HHS Secretary or APHIS Administrator, within seven calendar days after identification, the select agent or toxin is transferred in accordance with section 16 of the select agent regulations or destroyed on-site by a recognized sterilization or inactivation process.

Policy Statement:

The Federal Select Agent Program (FSAP) recognizes the difficulties that entities are currently facing in shipping select agents and toxins and has implemented a new policy to help entities meet the requirements for possession and transfer of select agents and toxins once these materials are newly identified from diagnostic or verification testing.

It is the policy of FSAP to allow a clinical, diagnostic laboratory or other entity that possesses a select agent or toxin contained in a specimen presented for diagnosis or verification to extend their time of possession of that select agent or toxin up to 28 calendar days after identification.  The purpose of the extension of time will be to allow these entities adequate time to transfer or destroy the identified select agent or toxin to a registered entity.

To obtain this extension, a written extension of time request must accompany the submission of an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin).  The written extension of time request must describe why the select agent or toxin should be transferred rather than destroyed, the difficulty an entity is facing in shipping a select agent or toxin, confirm that no additional work will be performed with the material containing the select agent or toxin, and provide a detailed description on how the select agent or toxin material will be secured until the select agent or toxin is transferred.

This policy statement is effective October 19, 2016.

This policy statement will be provided to the Responsible Official via SA Gram for each registered entity on or before the effective date; and to the Responsible Official for each newly registered entity during the registration process.  A copy of this policy statement may also be found at http://www.selectagents.gov.

Any questions 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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Samuel S. Edwin, PhD
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