Possession, Use, and Transfer of Select Agents and Toxins

We are amending an interim final rule published on December 13, 2002, that established requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. The requirements were established to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The December 2002 interim final rule established a phase-in period for certain requirements to allow entities to comply without causing disruption or termination of research or educational projects. The phase-in for entities that on February 7, 2003, were already conducting activities under a certificate of registration issued under 42 CFR 72.6, or already were lawfully possessing select agents and toxins, required entities applying for registration with the select agent program, and individuals requiring access to select agents and toxins, to undergo a security risk assessment by the Attorney General before November 12, 2003. The regulations also provided that an entity that on February 7, 2003, was not already conducting activities under a certificate of registration issued under 42 CFR 72.6, or was not already lawfully possessing select agents and toxins, would be eligible for registration to possess, use, or transfer select agents and toxins as soon as the entity met all of the applicable requirements of Part 73, including the requirement for the Attorney General to conduct a security risk assessment. We are now amending the applicability requirements to allow for the issuance of provisional registration certificates for all entities, and provisional grants of access for all individuals, from whom, prior to November 12, 2003, the Attorney General has received all of the information required by the Attorney General to conduct a security risk assessment if those entities and individuals otherwise meet all of the requirements of Part 73. This action is necessary to ensu