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THE
ORCBS
> Biological
Safety
> Programs & Guidelines
>
REGULATORY
REFERENCE FOR THE USE OF BIOLOGICAL MATERIALS
This document is intended to serve
as a resource for identification of specific regulatory and containment
considerations when assessing biological material use in the MSU
research setting. Please note that the document 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:
Table of Contents
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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, Ph.D. or John Parmer for
further information at 355-0153. More information regarding select
agents/high consequence pathogens requirements is available at
this website under the "select agents" link.
- 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.
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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.
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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. Included
are lists of representative genera and species known to be pathogenic;
mutated, recombined, and non-pathogenic species and strains are
not considered. Non-infectious life cycle stages of parasites
are excluded. 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/ohs/biosfty/imprtper.htm.
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/vs/ncie.
For information regarding
export of any materials on this list, please go to the Department
of Commerce at http://www.commerce.gov.
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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.
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Human-Derived
Materials
Work with these human-derived
materials requires compliance with the Bloodborne Pathogens standard.
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.orcbs.msu.edu/biological/bio_toc.htm
or contact the ORCBS Biosafety Staff at 355.0153.
Laboratory manipulations
of these materials must be minimally conducted at BSL-2, which
requires completion of biosafety training through the ORCBS 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.
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