CHAPTER 9

BIOLOGICAL SAFETY

12.0 NOTIFICATION OF USE FOR BIOLOGICAL AGENTS AND RECOMBINANT DNA

 

12.1  Introduction

12.2  Select Agent Use

12.3  Changes to the Select Agent Registration

12.4  Select Agent List / Agents Regulated by CDC


12.1       Introduction

A Notification of Use for Biological Agents must be submitted to the UTMB Biological Safety Committee and Recombinant DNA (rNOU) form must be submitted to the UTMB Institutional BioSafety Committee for review and approval when the project meets the following criteria:

Biological Agents:  An NOU must be completed and submitted for all Class 2 and above pathogens and all human products, human tissues and human cell lines.  

Recombinant DNA:  An rNOU must be completed and submitted for all rDNA Class 1 and above.  When genes are propagated in living cells, submission of an NOU for a biological agent and for the rDNA is required.  

Select Agents:  Select Agent use requires that an NOU be completed for the biological agent and rDNA.  Select agent users must comply with regulations issued by the Health and Human Services, Centers for Disease Control and Prevention and the U. S. Department of Agriculture.

 

12.2       Select Agent Use

Specific steps for compliance are as follows: 

·         Before submitting the Form 961 and finger print cards for new staff to the FBI, the University must notify the CDC Select Agent Program of the change to the University’s registration.  Security Risk Assessments

·          (Form 961) cannot be submitted until the University receives a unique identification number for the employee being added.  Once Form 961 is submitted it may take up to 45 days for approval to be granted.

·         Access to a select agent laboratory cannot be granted until the Security Risk Assessment has been completed and approval is granted by the CDC/USDA Select Agent Program.

·         Laboratories handling select biological agents must meet requirements outlined in the CDC/HHS publication Biosafety in Microbiological and Biomedical Laboratories, current edition.

·         Laboratories are subject to inspection by CDC/USDA or their designee for compliance with the regulation.

·         Select agents must be destroyed or deactivated in the laboratory and documented

·         Storage of select agent material requires the creation of an inventory to be kept up to date and regularly inspected by EHS.  Access to the inventory needs to be secured and limited.

·         Laboratories will comply with documentation and notification requirements when ordering or transferring agents.

·         Laboratories will develop a Chemical Hygiene Plan and meet requirements outlined in the OSHA Lab Standard (29) CFR 1910.1450 “Occupational Exposure to Hazardous Chemical in Laboratories”) when using toxins.

·         Laboratories using select agents will maintain strict security in select agent storage as well as maintaining a locked laboratory at all time. Access to those laboratories will be restricted to authorized personnel and documented.

·         Clearance from the Department of Justice will be required for all select agent users; contact EHS Biological and Chemical Safety at ext 21781 for more information.

·         Permits are required for transfer or transportation of select agent material.

 

12.3       Changes to the Select Agent Registration

Contact Environmental Health and Safety when changes to staffing (adding or deleting), lab assessments and use of select agents occurs.  EHS will coordinate the notifications with the CDC/USDA Select Agent Program

 

12.4       Select Agent List / Agents Regulated by CDC

Agents regulated by CDC 

(a) HHS select agents and toxins:

(b) Overlap select agents and toxins:

 

USDA only agents and toxins 

Livestock

Contact EHS/Biological and Chemical Safety at extension 21781 for assistance prior to commencement of work with a select agent.