APHIS/CDC Select Agent Workshop on November 16, 2012

On September 14, 2012, the Department of Health and Human Services (HHS) published a notice in the Federal Register announcing the 2012 Select Agent Workshop. The Federal Select Agent Program will broadcast the workshop via webcast-only on Friday, November 16th from 9:00a.m. to 5:00p.m (EST). The workshop will cover the following topics: changes to the select agent regulations, occupational health, information and physical security, personnel suitability, Bioterrorism Security Risk Assessment Form (FD-961 form), and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1). All who wish to participate in the webcast must register for the workshop. There is no charge for registration. A confirmation notice will be sent upon processing. Registration forms are due no later than October 16, 2012. The webcast link, agenda, and supporting information will be sent to registered participants prior to the workshop.

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.