Policy Statement:
Meaning of the phrase: “a deviation from a validated inactivation procedure or a viable select agent removal method”

Date: May 12, 2017

Subject: FSAP Policy Statement: Meaning of the phrase: “a deviation from a validated inactivation procedure or a viable select agent removal method”

Policy Statement:

It was and is the intent of the FSAP that the use of the phrase “a deviation from a validated inactivation procedure or a viable select agent removal method” means “a failure of a validated inactivation procedure or a viable select agent removal method.”

This policy statement is effective May 12, 2017.

Authority:

For biological agents and toxins determined by HHS to have the potential to pose a severe threat to public health and safety (select agents and toxins), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) directs the promulgation of regulations to establish and enforce safety procedures for the possession and use of select agents and toxins, including measures to ensure proper training and appropriate skills to handle such agents and toxins.  42 U.S.C. § 262a(c)

For biological agents and toxins determined by USDA to have the potential to pose a severe threat to animal health or animal products (select agents and toxins), the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401) directs the promulgation of regulations to establish and enforce safety procedures for the possession and use of such select agents and toxins, including measures to ensure proper training and appropriate skills to handle such select agents and toxins.  7 U.S.C. 8401(c)

Zoonotic select agents and toxins are regulated by both HHS and USDA.  See 42 C.F.R. § 73.4 and 9 C.F.R. § 121.4.

Federal regulations require the Responsible Official (RO) to “investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material.” The regulations state that if the RO is “unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives a report of any inactivation failure after the movement of material to another location, the Responsible Official must report immediately by telephone or email the inactivation or viable agent removal method failure to CDC or APHIS.”  See 42 C.F.R. § 73.9(a)(8), 9 C.F.R. § 121.9(a)(8), 7 C.F.R. §331.9(a)(8).