Policy Statement

Date: April 6, 2017

Subject: FSAP Policy Statement: Application of the phrases “conclusion of patient care” or “delivery of patient care by health care professionals has concluded” as used in the select agent regulations

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 Division (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).

Select agent waste generated during the delivery of patient care is excluded from the regulations as long as it has been decontaminated or transferred for destruction within seven calendar days of the conclusion of patient care (See §331.3(d)(8), §121.3(d)(8), §121.4(d)(8), §73.3(d)(11), and §73.4(d)(8)).

The clinical or diagnostic specimens collected from a patient infected with a select agent are exempted from the requirements of the select agent regulation as long as material is transferred in accordance with Section 16 or destroyed on-site by a recognized sterilization or inactivation process within seven calendar days after delivery of patient care by heath care professionals has concluded (See Sections 5(a)(3) and 6(a)(3)).

Policy Statement:

It is the policy of the Federal Select Agent Program (FSAP) that for an individual who has been admitted to a medical facility, that individual’s “conclusion of patient care” and the point when “delivery of patient care by heath care professionals has concluded” is when that individual has been released from the medical facility where treatment was being provided.  The select agent regulations regarding select agent waste generated during the delivery of patient care apply only to the treatment of humans.  Accordingly, specimens or waste associated with that individual (e.g., tissue samples, body fluids, fomites and any other contaminated material likely to transmit an infection to people through the environment if it is unable to be decontaminated) must be destroyed or transferred to a registered entity within seven days after an individual’s release from a medical facility.

This policy statement is effective April 6, 2017.

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. 

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