The University of Texas at Austin
Institutional Biosafety Committee

POLICIES AND PROCEDURES
FOR THE USE OF BIOHAZARDOUS MATERIALS
(Recombinant DNA, Biohazardous Materials, Extreme Biological Toxins, Select Agents and Toxins)

Complete version of Policies and Procedures

Section 1.0 INTRODUCTION

1.1          Purpose
1.2          Policy
1.3          Scope
1.4          IBC Protocol with NIH for Research involving r DNA
1.5          Select Agent and Select Agent Toxin Registration
1.6          Definitions
1.6.1       rDNA and/or Biohazardous Materials
1.6.1.1    rDNA
1.6.1.2    Infectious Biological Agents
1.6.1.3    Select Agents and Toxins
1.7          Risk Assessment and Selection of Appropriate Safeguards
1.8          Biosafety Regulations and Guidelines
1.8.1       Responsibilities
1.8.2       Biological Safety Officer Duties 

Section 2.0 INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

2.1          IBC Responsibilities
2.1.1       IBC responsibilities from NIH Guidelines Section IV-B-2-b
2.1.2       Other related responsibilities
2.1.3       Experiments that require IBC approval
2.2          IBC Membership
2.2.1       General
2.3          IBC Chair
2.3.1       IBC Chair Appointment
2.3.2       IBC Chair Responsibilities
2.4          IBC Meetings
2.4.1       Regular Meetings
2.4.2       Emergency Meetings
2.4.3       IBC Materials
2.4.4       Quorum
2.4.5       Attendance
2.4.6       Minutes
2.5          IBC Records
2.5.1       Retention
2.6          Reporting
2.6.1       Internal Reporting Requirements for Incidents and Spills
2.6.2       External Reporting to NIH OBA
2.6.3       Other External Reporting
2.7          Compliance Oversight and Corrective Action

Section 3.0 RESEARCHER’s RESPONSIBILITIES

3.1          Risk Assessment
3.1.1       Risk Group Classification
3.1.2       Factors used in Consideration of Risk Group
3.2          Biosafety Level (Biological and Physical Containment)
3.3          General Responsibilities of the Researcher
3.3.1       Prior to Research Involving rDNA and/or Biohazardous Materials
3.3.2       During Research Involving rDNA and/or Biohazardous Materials
3.4          Specific Responsibilities rDNA
3.4.1       General Responsibilities
3.4.2       Submissions to NIH OBA
3.5          CDC Requirements –Select Agents and Toxins
3.6          Access to Laboratories

Section 4.0 IBC REVIEW

4.1          Protocol of Select Agents or Select Agent Toxins
4.2          Review of rDNA
4.3          Review of Incidents and Personnel Exposures
4.4          Notice of IBC Action
4.5          Length of Approval
4.5.1       rDNA and Infectious Agents (Excluding Select Agents and Toxins)
4.5.2       Select Agents and Select Agent Toxins
4.6          Modifications to Approved Protocols
4.7          Continuing Review of Approved Protocols and Notice of Termination
4.7.1       Continuing Review of Approved Protocols
4.7.2       Notice of Termination
4.7.2.1    Termination

Section 5.0 TRAINING

5.1          Mandatory Training of IBC Members
5.1.1       Training of the BSO
5.2          Training of Researchers and Research  Staff
5.3          Training Program Table

Section 6.0 EMERGENCY PLANS

Section 7.0 OCCUPATIONAL HEALTH & SAFETY, MEDICAL SURVEILLANCE

 

APPENDICES

FORMS:
A	rDNA Form [EID required]
B	Biosafety Form [EID required]
C	IBC Protocol Modification - use existing rDNA form
D	IBC Continuing Review and Termination Form - use existing rDNA form
E	Biological Incident Reporting Form (Revision September 2007)
PLANS:
F	General Laboratory Practices for BSL-2 Laboratories XXX Lab (Template)
G	BSL-3 Emergency Response Plan (Revision September 2007)
H	Reserved Space
GENERAL INFORMATION:
I	Experiments Exempt from rDNA Guidelines
J	HHS and USDA Select Agents and Toxins
LISTING:
K	IBC Membership Roster

 

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