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USDA Updates Select Agent Regulations

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January 19, 2017 – The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is announcing updates to its select agent program regulations.  These updates will help ensure the program remains effective in the future, and address challenges faced over the past few years. 

Additionally, APHIS reviewed the select agents and toxins list, as required every two years by the Agricultural Bioterrorism Protection Act of 2002, and is republishing the list without changes, at this time.

USDA and the Department of Health and Human Services share joint responsibility for the oversight of select agents and toxins.  Within those two departments, APHIS and the Centers for Disease Control and Prevention (CDC) manage the Federal Select Agent Program (FSAP), which oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.

In line with its FSAP responsibilities, APHIS carefully reviewed its existing regulations and is proposing updates that would provide greater program oversight and increased accountability for those in possession of select agents.  These updates address the inactivation of select agents, biocontainment and biosafety, security, training, incident response, and records.   

The updates will provide APHIS with greater knowledge about regulated entities’ actions and strengthen protections against inappropriate select agent releases.  Specifically, the updated regulations include:

• Additional requirements to ensure that when a select agent is treated to become nonviable or noninfectious that it is done successfully; 
• Recordkeeping requirements for the final disposition of all select agents; 
• Requirements that biosafety and biocontainment plans include a description of the safeguards in place to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; decontamination procedures; waste management procedures; and procedures for handling select agents and toxins in the same spaces as non-select agents and toxins in order to prevent unintentional cross-contamination; and 
• Requirements for training of workers, accessibility of laboratory-specific biocontainment and/or biosafety manuals, and availability of contact information for anonymous reporting of any containment or security concerns workers may have. 

In January 2016, APHIS published a rule that proposed the above updates to the regulations.  It also proposed that six select agents (Bacillus anthracis (Pasteur strain); Brucella abortus and Brucella suis; Peronosclerospora philippinensis (Peronosclerospora sacchari); Phoma glycinicola (formerly Pyrenochaeta glycines), and Sclerophthora rayssiae) be removed from the list.  After considering input from subject matter experts and Federal advisory groups, additional security and policy concerns were raised, and, as a result, APHIS has decided not to finalize the proposed changes to the contents of the list at this time.

This rule is posted in today’s Federal Register, and may be viewed online at https://www.federalregister.gov/documents/2017/01/19/2017-00857/agricultural-bioterrorism-protection-act-of-2002-biennial-review-and-republication-of-the-select.  The new regulations will be effective February 18.

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