Code of Federal Regulations Title 42. Public Health § 42.1003.920 Determinations regarding the amount of penalties

(a) The Responsible Official participated in or knew, or should have known, of the violation;

(b) The violation was a contributing factor to an unauthorized individual's access to or possession of a select agent or toxin, an individual's exposure to a select agent or toxin, or the unauthorized removal of a select agent or toxin from the person's physical location as identified on the person's certificate of registration;  or

(c) The person previously received an observation, finding, or other statement of deficiency from the Department or the Department of Agriculture for the same or substantially similar conduct.