Restricted experiments may not be carried out with a select agent or toxin unless first approved by the HHS secretary and subsequently conducted in accordance with any recommended conditions. Two types of experiments are defined as restricted: those experiments utilizing rDNA that (1) deliberately transfer a drug resistance trait to a select agent that is not known to acquire the trait naturally, if such trait could compromise the use of drugs to control disease agents in humans, veterinary medicine or agriculture; and (2) deliberately contain genes which code for the biosynthesis of select toxins lethal for vertebrates at an LD50 of less than 100 nanograms/kilogram body weight.
In order to obtain approval to carry out restricted experiments, the PI must submit a written request, containing supporting scientific data, to the RO who will interface with CDC. The PI will be informed in writing of the decision granting or denying the request. The HHS Secretary has the right to revoke approvals to conduct restricted experiments and to revoke the certificate of registration if the PI or the University does not comply with the suggested recommendations.