Biohazardous Material Use Authorization

Effective: Moved to Policy Library from UPM 12.12(3)
Updated/Revised: September 7, 2022
Contact: Office of Research Ethics (ORE)

Introduction

Biohazardous materials are materials of biological origin that could potentially cause harm to humans, domestic or wild animals, or plants. Examples include recombinant DNA; transgenic animals or plants; human, animal or plant pathogens; biological toxins (such as tetanus toxin); human blood and certain human body fluids; and human or primate cell cultures.

The Institutional Biosafety Committee (IBC) has responsibility for reviewing the biological and public health safety programs at Iowa State University and sets policies that comply with federal, state, and local regulations. The IBC members are appointed by the Vice President for Research.  

The IBC reviews research projects to ensure compliance with National Institute of Health (NIH) and Biosafety in Microbiological and Biomedical Laboratories guidelines. An institution receiving NIH funding for any of its projects involving recombinant or synthetic nucleic acid molecules must follow NIH Guidelines in all projects involving recombinant or synthetic nucleic acid molecules.

Policy Statement

The Institutional Biosafety Committee (IBC) must approve and issue a biohazardous materials use authorization for any teaching or research project that involves:

• use of recombinant or synthetic nucleic acid molecules, including transgenic animals or plants;
• use of human or animal pathogens (e.g., bacteria, viruses, fungi, prions, parasites);
• use of soil, seed, plants, plant pathogens (e.g. bacteria, viruses, fungi, or parasites) or other material received under a USDA APHIS compliance agreement or permit;
• use of biological toxins;
• administration of experimental biological products to animals;
• field releases of plant pests received under a USDA APHIS PPQ permit;
• field releases of genetically modified organisms that are under a USDA APHIS PPQ or BRS permit (e.g. not commercially available GMOs).

The Department of Environmental Health and Safety consults with PIs about the following:

• Permitting process for the Department of Agriculture Veterinary Services
• Permitting process for Plant Protection and Quarantine
• Biotechnology Regulatory Services permitting
• Centers for Disease Control and Prevention permit application and renewal process for faculty and researchers

Resources