Daily Rules, Proposed Rules, and Notices of the Federal Government
Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, “Enhancing Controls on Dangerous Biological Agents and Toxins” (sections 201 through 231), provides for the regulation of certain biological agents and toxins by the Department of Health and Human Services (subtitle A, sections 201-204) and the Department of Agriculture (subtitle B, sections 211-213). Additionally, the statute provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). For the Department of Health and Human Services(HHS), the Centers for Disease Control and Prevention (CDC) oversees entities that possess, use or transfer select agents and toxins that have the potential to pose a severe threat to public health and safety. The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) has a parallel program that oversees entities that possess, use or transfer select agents that have the potential to pose a severe threat to animal or plant health, or to animal or plant products . These two programs constitute the Federal Select Agent Program. The Federal Bureau of Investigation's (FBI) Criminal Justice Information Services conducts security risk assessments of (1) all individuals and nongovernmental entities that request to possess, use, or transfer select agents and toxins, (2) all individuals who need access to select agents and toxins.
The webcast announced in this notice is an opportunity for the regulated community (i.e., registered entity responsible officials, alternate responsible officials, and entity owners) and other interested individuals to obtain specific regulatory guidance and information on standards concerning biosafety, biosecurity and incident response issues related to the Federal Select Agent Program. Representatives from HHS/CDC, USDA/APHIS, and the FBI will be present during the webcast to address questions and concerns from the web participants.
Updates on the changes to the select agent regulations; occupational health, information and physical security; personnel suitability; FD-961 form, and changes to the APHIS/CDC Form 1 are among the issues that will be discussed. A question and answer session will take place after each topic.
Registration instructions are found on the Federal Select Agent Program Web site
Participants will be able to submit questions during the webcast at