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

Docket ID: APHIS-2009-0070
Agency: Animal and Plant Health Inspection Service (APHIS)
Parent Agency: Department of Agriculture (USDA)
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.
RIN: 0579-AD09
Impacts and Effects: None
CFR Citation: 7 CFR 331,9 CFR 121
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2013
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 7 USC 8401
Legal Deadlines: None
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: No
Included in Regulatory Plan: No
ActionDateFR Citation
ANPRM07/29/201075 FR 44724
ANPRM Comment Period End08/30/2010
NPRM10/03/201176 FR 61228
NPRM Comment Period End12/02/2011
NPRM Comment Period Extended12/15/201176 FR 77914
NPRM Comment Period Extended End01/17/2012
Final Rule10/05/201277 FR 61056
Final Rule Effective12/04/2012
Notice: Agency Information Collection Activities; OMB Approval Received02/15/201378 FR 11138
Remaining Provisions of Final Rule Effective04/03/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Category: Select Agents
Keyword(s): USDA, agriculture
Type: Rulemaking
Program: Select Agent Program

Primary Documents

View All  (6)
Comment Period Closed
Jan 17, 2012 11:59 PM ET
Proposed Rule
Posted: 12/15/2011
ID: APHIS-2009-0070-0062
Comment Period Closed
Jan 17, 2012 11:59 PM ET
Proposed Rule
Posted: 10/03/2011
ID: APHIS-2009-0070-0035
Comment Period Closed
Aug 30, 2010 11:59 PM ET
Proposed Rule
Posted: 07/29/2010
ID: APHIS-2009-0070-0001
Comment Period Closed
Posted: 05/12/2014
ID: APHIS-2009-0070-0075
Comment Period Closed
Posted: 02/15/2013
ID: APHIS-2009-0070-0074

Supporting Documents

View All  (4)
Comments Not Accepted
Supporting & Related Material
Posted: 10/03/2011
ID: APHIS-2009-0070-0036
Comments Not Accepted
Supporting & Related Material
Posted: 08/30/2010
ID: APHIS-2009-0070-0013
Comments Not Accepted
Supporting & Related Material
Posted: 08/30/2010
ID: APHIS-2009-0070-0014


View All  (65)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Charles L Divan
Branch Chief, Agriculture Select Agent Program
301 851-2219
4700 River Road, Unit 2, Riverdale, MD 20737-1231
Riverdale, MD 20737-1231
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.