2020 SA Grams

The Federal Select Agent Program (FSAP) has posted new Frequently Asked Questions (FAQs) to its website to clarify information about the regulatory requirements for when select agents and toxins are present or not present in registered laboratories.  The new FAQs can be found at https://www.cdc.gov/selectagent/faq-general.html and are also included below.

What are the regulatory requirements for a registered laboratory that has select agents and toxins present in the laboratory?

As a condition of registration, each entity is required to be in compliance with the regulations for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin or not. With regard to toxins, the entity registered for possession, use or transfer of a toxin must be in compliance with the regulations regardless of the amount of toxin currently in its possession.

What are the regulatory requirements for a registered laboratory that has no select agents and toxins present in the laboratory?

As a condition of registration, each entity is required to be in compliance with the regulations for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin or not.

The regulations do not require entities to:

  1. Maintain information about all entries (e.g., the name of the individual and date and time of entry) into areas where no select agents or toxins are present.
  2. Provide training for non-FSAP-approved individuals escorted into areas where no select agents or toxins are present.
  3. Provide escorts for non-FSAP-approved individuals who enter areas where no select agents or toxins are present.
Page last reviewed: December 18, 2020, 09:50 AM