Date: January 6, 2017
Subject: FSAP Policy Statement: Acceptable conditions for allowing a “restricted person” access to an area in which select agents or toxins are used or stored
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).
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) requires the HHS Secretary to deny access to such agents and toxins by any individual whom the Attorney General has identified as a restricted person. 42 U.S.C. § 262a (e)(2)(C).
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) requires the APHIS Administrator to deny access to such agents and toxins by any individual whom the Attorney General has identified as restricted persons. 7 U.S.C. 8401(e)(2)(C).
In accord with section 10 of the select agents and toxins regulations, an individual's access approval will be denied or revoked if the individual is within the definition of a “restricted person” found in 18 U.S.C. § 175b (d).
Access to a select agent or toxin by a restricted person is prohibited. There may be occasions, however, when an entity needs to provide a restricted person access to an area in which a select agent or toxin is stored or in use. It is the policy of the Federal Select Agent Program (FSAP) that a registered entity may allow a “restricted person” into an area containing a select agent or toxin only if the entity meets all of the following conditions:
- The restricted person is never allowed to have access to any select agent or toxin. An individual will be deemed to have such access at any point in time if the individual has possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin. See section 10 (b) of the select agent regulations.
- The entity’s security plan specifically addresses how the entity will safeguard select agents and toxins against theft, loss, release, or unauthorized access when a restricted person is present in an area containing a select agent and toxin.
- The entity’s Responsible Official receives prior notification of the individual’s need for access to the area in which a select agent or toxin is stored or in use and approves the entry of the restricted person into an area containing a select agent or toxin.
- For all registered areas the restricted person will enter, the entity secures all select agents and toxins against unauthorized access while the restricted person is in a registered area (e.g., select agents or toxins are removed from the area or agents and toxins are secured in containers that would not allow access by the restricted person) as described in the entity’s security plan.
- The restricted person is continuously escorted and monitored by an entity representative with FSAP approval to access select agents and toxins. The designated entity escort must be aware of their duty to not allow the restricted person access to a select agent or toxin.
Section 17 (Records) of the select agent regulations requires that access logs must be in place to record the name and date/time of entry into the registered area where select agent and toxin are present to include the name of the escort and the name of the restricted persons.
This policy statement is effective January 6, 2017. This policy statement replaces the current guidance on this matter and will become an enforceable requirement upon the effective date.
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.