In partnership with the Animal Care & Use Program, the department of Occupational Safety & Environmental Health (OSEH), and the Unit for Laboratory Animal Medicine (ULAM), the U-M Institutional Biosafety Committee (IBC) has approved new guidance regarding the containment housing practices required for animals administered human-derived substances (tissues, fluids, cells, or cell lines).
All animals that are administered human-derived substances must now be housed under ABSL-2 conditions unless those substances have been documented to be free from blood-borne pathogens and other specific human viruses as described below.
Documentation that the human-derived substances used in your laboratory are free from pathogens of concern is the key to being able to house the animals used in those studies under standard (ABSL-1) conditions. If not already performed by the supplier, you can have such testing done by commercial laboratories.
- For human-derived substances obtained from vendors/repositories that routinely screen for human pathogens (e.g., ATCC), investigators may submit the screening results from the vendor.
- For human-derived substances obtained from vendors that do NOT routinely screen for human pathogens, investigators must have the substances screened.
- Please note that human-derived substances obtained directly from patients cannot be tested, and therefore must be moved to ABSL-2 housing.
ULAM has worked with both Charles River Laboratories and IDEXX-RADIL to enable an appropriate panel to be tested at a discounted price. Details on these panels are outlined here:
|Charles River (U-M custom)||IDEXX-RADIL (U-M custom)|
|HPV||HPV 16||HPV 16 and 18|
|Pricing & Submission Instructions||View Charles River||View IDEXX-RADIL|
Please note: Links marked with a lock icon can only be accessed using valid Level-1 U-M login credentials.
ABSL housing classifications are defined as:
- ABSL-2: Human tissues (normal or diseased), body substances (e.g., stool, blood, urine), cells, or cell lines.
- ABSL-1: Human cells or other body substances that have been demonstrated to be free from blood-borne pathogens and other infectious agents (i.e., through screening and documentation of screening results).
Having the testing completed and/or requesting documentation from your material provider, and providing the documentation to the Animal Care & Use Office (ACUO) by the time your laboratory is required to house these animals under ABSL-2 conditions is strongly recommended.
For those laboratories currently working with human-derived substances, testing documentation should be obtained and submitted to the ACUO no later than November 30, 2016. Laboratories that are NOT currently using human-derived substances in their work, but anticipate doing so in the future, will be required to answer additional questions when submitting a new eRAM application after October 31, 2016.
This will enable your laboratory to operate more efficiently and without any unnecessary expenses; it will also enable ULAM to better estimate the number of animals that must now be housed under ABSL-2 conditions, and prepare accordingly.
ACUO/ULAM/OSEH may, upon verification of screening results, re-classify animal housing containment to ABSL-1. Screening results must be maintained by investigators and made available to ACUO/ULAM/OSEH upon request.