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USDA/APHIS RIN: 0579-AD09 Publication ID: 2012 
Title: Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations 
Abstract: In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action implements the findings of the third biennial review of the list. In addition, we are reorganizing the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health. Such tiering of the list allows for the optimization of security measures for those select agents or toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. We are also making a number of amendments to the regulations, including the addition of definitions and clarification of language concerning security, training, biosafety, biocontainment, and incident response. These changes will increase the usability of the select agent regulations as well as provide for enhanced program oversight. 
Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 7 CFR 331    9 CFR 121   
Legal Authority: 7 USC 8401   
Legal Deadline:  None
Action Date FR Cite
ANPRM  07/29/2010  75 FR 44724   
ANPRM Comment Period End  08/30/2010    
NPRM  10/03/2011  76 FR 61228   
NPRM Comment Period End  12/02/2011    
NPRM Comment Period Extended  12/15/2011  76 FR 77914   
NPRM Comment Period Extended End  01/17/2012    
Final Rule  10/05/2012  77 FR 61056   
Final Rule Effective  12/04/2012 
Remaining Provisions of Final Rule Effective  04/03/2013 
Additional Information: Additional information about APHIS and its programs is available on the Internet at
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Charles L Divan
Branch Chief, Agriculture Select Agent Program
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 2,
Riverdale, MD 20737-1231
Phone:301 851-2219