APHIS/CDC Select Agent Workshop on November 16, 2011

On November 16, 2011, the U.S. Department of Agriculture (USDA), Animal and Plant
Health Inspection Service (APHIS) and Centers for Disease Control and Prevention
(CDC) Select Agent Programs and Federal Bureau of Investigation (FBI) conducted a
workshop at the Howard H. Baker Jr. Center for Public Policy of the University of
Tennessee-Knoxville. The workshop was held to provide specific regulatory guidance
related to the Federal Select Agent Program established under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002.

Workshop materials, including presentations slides that can be downloaded and archived
videos, can be found on the 'Training' link under the 'Resources' tab or by accessing the
following URL: http://www.selectagents.gov/Training.html.

Notice of Proposed Rulemaking- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review

The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published notices of proposed rulemaking and request for comments in the Federal Register regarding the biennial review and republication of the list of select agents and toxins. We are soliciting comments on the changes contained in the proposed rule which includes the reorganization of the select agent list into a tiered list, the establishment of appropriate practices to ensure reliability of personnel with access to Tier 1 biological select agents and toxins (BSAT) at registered facilities, and the establishment of appropriate practices for physical and cyber security for facilities that possess Tier 1 BSAT. We are also seeking comments on the Regulatory Impact Analysis (RIA) that accompanies the notices of proposed rulemaking.

APHIS Extension Notice(PDF 143K)

CDC Extension Notice(PDF 141K)

APHIS Federal Register Notice(PDF 223K)

CDC Federal Register Notice(PDF 241K)

APHIS/CDC Regulatory Impact Analysis (PDF 331K)

Anonymous Reporting

To provide a mechanism for you to report safety, security, or other concerns associated with select agents and toxins, Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline which offers a confidential means for reporting this vital information.  When reporting these issues to OIG, please ensure that you indicate it is a "Select Agent Program" issue.

OIG Hotline contact information:

Previous Spotlight Information

The National Select Agents Registry Program oversees the activities of possession
of biological agents and toxins that have the potential to pose a severe threat to public, animal
or plant health, or to animal or plant products. The NSAR currently requires registration
of facilities including government agencies, universities, research institutions, and commercial
entities that possess, use or transfer biological agents and toxins. On this website
you will be able to download application packages, submit forms electronically, view current
regulations regarding Select Agents, and access additional resource information.