Select Agent Regulations
The National Select Agents Registry Program, part of the Federal Government Center for Disease Control and Prevention (CDC) Division of Select Agents and Toxins, 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.
Recently, the Select Agent regulations have been amended. The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on October 05, 2012 . All provisions of the final rules supersede those contained in the previous final rules. (This information comes directly from the National Select Agent Registry Webpage. On December 4, 2012, the following Sections of became effective: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 17, 18, 19, 20, and 21. On April 3, 2013, the following sections will become effective: 11, 12, 14, and 15. See the Emerging Compliance Issues/ Concerns for information on how the regulations have changed.
Applicable Laws and Regulations
Amended Regulations Effective December 4, 2012
9 C.F.R. Part 121, TITLE 9--ANIMALS AND ANIMAL PRODUCTS, CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE, PART 121- POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
Emerging Compliance Issues/ Concerns
HHS Federal Register Notice, Vol. 77 Friday, No. 194 October 5, 2012, Part III, Department of Health and Human Services, 42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Final Rule; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
Regulatory Impact Analysis, Regulatory Impact Analysis & Final Regulatory Flexibility Analysis, Final Rule; Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Reorganization of the Select Agent and Toxin List; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
National Select Agent Registrywebpage, on the Federal Government Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
Select Agent Regulations webpage, on the Federal Government Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
Guidance Documents for Final Rules Compliance Assistance on the National Select Agent Registry Webpage, hosted on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
Anonoymous Reporting of Select Agent Regulation Violations
The information contained on the SUNY Compliance website is for general campus guidance only and is not intended, nor can be relied upon, as legal advice or the imposition on SUNY campuses of specific policies or requirements. The site is intended to be an informational-only clearinghouse for some of the laws, rules, and regulations that may impact the State University of New York’s campuses. Additionally, given the rapid, changing nature of laws, rules and regulations, there may be delays or omissions contained on this site which therefore cannot be relied upon as complete. For complete compliance information, consult your campus compliance officials or the SUNY Compliance Administrator. For legal advice, consult your lawyer.