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EHS > Biological Safety > Programs & Guidelines

Regulatory Reference for the Use of Biological Materials

This document is a resource for identification of specific regulatory and containment considerations when assessing biological material use in the MSU research setting. It is a compilation of lists of materials identified by several state and federal agencies as having specific guidelines or regulatory requirements for the use and/or transfer of these materials. Additional requirements may apply based on individual circumstance. For more information, please contact the personnel below:

DHHS / USDA Select Agents / High Consequence Pathogens / Toxins List

Infectious agents and toxins that appear on this list are considered by the Centers for Disease Control (CDC) or the United State Department of Agriculture (USDA) as having the potential to pose substantial harm or a severe threat to human, animal or plant health or plant products.

Possession and transfer of materials on this list (with the possible exception of toxins) requires registration with, and approval of the appropriate regulatory authority by way of the MSU Responsible Official prior to undertaking such activities. Contact Jamie Willard-Smith, Ph.D. (RSO) for further information at 355-0153. More information regarding select agents/high consequence pathogens requirements is available at http://www.selectagents.gov.

USDA Restricted Animal Pathogens

The importation, possession, or use of these agents is prohibited or restricted by law or by U.S. Department of Agriculture regulations or administrative policies.

Michigan Department of Agriculture Reportable Animal Diseases

These are transmissible diseases and toxicological conditions of animals that have the potential for serious consequences to human and/or animals either because of health or economic impacts.

NIH List of Human Etiologic Agents

These are biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans. Work with these agents is likely to require BSL-2 containment conditions as a minimum. Shipping or receiving these agents internationally is also likely to require a permit.

For more information ragarding import permits for agents infectious to humans, please go to http://www.cdc.gov/od/eaipp/.

For information regarding import of animal-derived materials that may contain infectious agents, or any zoonotic agents on the list, please go to http://www.aphis.usda.gov/import_export/index.shtml.

For information regarding export of any materials on this list, please go to the Department of Commerce at http://www.commerce.gov.

USDA APHIS Regulated Plant Pest List

The agents listed in this table are considered to be environmental release threats to agriculture by the USDA. To work with these agents or ship them across state lines or internationally, a USDA Plant Pathogen & Quarantine (PPQ) permit outlining conditions of use and containment requirements is likely to be required. For information regarding PPQ permits, please go to http://www.aphis.usda.gov/ppq/permits.

Human-Derived Materials

Work with these human-derived materials requires compliance with the Bloodborne Pathogens standard.

  • Blood
  • Semen
  • Vaginal Secretions
  • Spinal Fluid
  • Fluid Surrounding the Lungs
  • Pericardial Fluid
  • Synovial Fluid
  • Any Body Fluids where Visible Blood Contamination is Present
  • Unfixed Tissues (other than intact skin)
  • Human Cells and Cell Cultures

All personnel at risk of exposure must be included in the MSU BBP Exposure Control Program that requires initial and annual retraining and offer of the hepatitis B vaccination program. Please review the information at http://www.ehs.msu.edu/biological/bio_toc.htm or contact the EHS Biosafety Staff at 355-0153.

Laboratory manipulations of these materials must be minimally conducted at BSL-2, which requires completion of biosafety training through EHS and specific facility and administrative controls. A summary of BSL-2 requirements can be found here.

Other Materials of Interest

The following items also bear additional regulatory consideration based on inherent risks associated with the nature of the source or the need for biocontainment of genetically modified organisms. Contact the EHS Biosafety Officer below.

  • Unfixed human brain tissue from dementia patients - CDC permit required if shipping internationally; BBP standard applies; Contact the EHS Biosafety Staff (355-0153) for more information.
  • Genetically-modified lab animals that are not commercially available - Permit requirements may apply if shipped internationally; IBC registration required for use of these animals in research; contact the EHS Biosafety Staff (355-0153) for more information.
  • Genetically-modified plant materials that are not commercially available - Permit requirements may apply if shipped across state lines or internationally; IBC registration required for use of these plant materials in research; contact the EHS Biosafety Staff (355-0153) for more information.
  • Any plant, animal or insect species that is not native to the state of Michigan - Contact the EHS Biosafety Staff (355-0153) for assistance in identifying the appropriate regulatory agencies.
  • Environmental samples from other states or countries that may contain biological organisms that are infectious or exotic - Contact the EHS Biosafety Staff (355-0153) for assistance in identifying the appropriate regulatory agencies.


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