Regulatory Interpretation

Date: April 1, 2016

Subject: Regulatory Interpretation for “SRA approved laboratorians working at unregistered facilities with excluded levels of toxins”

This is in response to an email request dated March 14, 2016, for a regulatory interpretation regarding (1) whether a laboratorian may work at an unregistered entity with excluded amounts of toxins; and (2) whether a Principal Investigator may work at an unregistered entity with excluded amounts of toxins.

The request stated that the non-registered government facility in which the laboratorian or Principal Investigator would like to work purchases and utilizes excluded amounts of toxins and is not registered with the Federal Select Agent Program. The request also stated that the facility owns the toxin, controls the operations and the inventory of the excluded amounts of toxins.

One of the criteria for a select toxin to be excluded from the requirements of the select agents and toxins regulations (42 CFR Part 73) is that the aggregate amount of toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the amounts listed in 42 CFR §73.3(d)(3). For purposes of this regulatory interpretation, the FSAP is assuming that the non-registered facility is neither a commercial manufacturer nor a distributor of a select toxin.

Therefore:

  • A laboratorian may work at an unregistered entity with excluded amounts of toxins so long as the toxin possessed by the unregistered entity is under the control of a Principal Investigator (as that term is defined by 42 CFR §73.1) or treating physician or veterinarian that is affiliated with the unregistered entity; and the aggregate amount of the toxin does not, at any time, exceed the amount specified in the select agent regulations (§73.3 (d)(3)).
  • A Principal Investigator (as that term is defined by 42 CFR §73.1) may work at an unregistered entity with excluded amounts of toxins so long as the toxin possessed by the unregistered entity is under the control of a Principal Investigator that is affiliated with the unregistered entity; and the aggregate amount of the toxin does not, at any time, exceed the amount specified in the select agent regulations (§73.3 (d)(3)).