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October 2017 Biosafety Bits

 

In this issue:


October is National Biosafety Month!

The NIH Office of Science Policy recently announced that it will again observe and promote October as National Biosafety Month.  During National Biosafety Month, institutions are encouraged to highlight the importance of biosafety and to undertake activities to strengthen their biosafety programs.  During previous National Biosafety Months, NIH has promoted themes such as transparency, laboratory accountability, and public engagement. This year, the theme is “promoting biosafety through good governance.”

A new federal guidance document entitled, “Guiding Principles for Biosafety Governance”, articulates best practices for biosafety and biosecurity governance based on current regulations, policies, and guidelines.  This document also establishes a comprehensive biosafety management framework and summarizes oversight at all levels, from Federal to institutional to the individual scientists who are conducting research.  Finally, the guidance stresses promotion of biosafety through education, communication, and collaboration,  all of which are central to the UT Biosafety Program’s mission.

How can you help promote biosafety?  

  1. Disclose all projects involving biohazards, including recombinant & synthetic nucleic acids, to the UT Biosafety Program.
  2. Communicate the risk of biohazards to all lab personnel, students, and visitors, and ensure they are properly trained in and adhere to prudent safety procedures.
  3. Report spills, accidents, injuries, exposures, and ‘near misses’ to the Biosafety Office.
  4. Maintain records: institutional approvals, federal permits, SOPs, detailed agent inventories, training certificates, etc.

Biosafety Audit Notes

Why do we call them “audits”?

The word “audit” comes from the  Latin “auditus “ which means “hearing”.  The new Biosafety audit approach requires the presence of the PI, or his/her designee, so that a conversation can take place.  Hopefully this approach will allow greater understanding of lab processes  and will help to minimize misunderstandings  and frustrations that may arise when unexamined assumptions are made by the auditor.

Audit Findings

Improvements seen during the  2016-2017 audit cycle include:

  1. Most absorptive chairs have been removed or replaced.
  2. BSL-2 manuals have been updated.
  3. Exposure response postings have been updated.
  4. Fewer needles are being recapped unless specifically exempted.  In the case of some BSL-1 labs, the one-handed scoop technique is being used in lieu of recapping.
  5. Gaps in training are being addressed
  6. Chemical splash goggles are being made available by the labs for processes that pose a risk of hazardous material splash or splatter.

…and much more

Opportunities that still exist are…

  1. Ensuring lab-specific training has been completed and is filed in the lab for review during audits.
  2. Ensuring the spill response plan is easily accessible  in the event of an emergency
  3. Ensuring labs covered by the Bloodborne pathogen (BBP) regulations have trained their personnel to access the current year’s Exposure Control Plan either online or in hardcopy.

2017-2018 Audit Cycle

  1. During the 2017-2018 audit cycle, autoclave validations are being checked.  If you have questions regarding the autoclave validation process, please contact  Jessica Woofter at 974-5547.
  2. In BSL-2  labs, Risk Group 2 (RG-2) agents and permitted materials must be secured.  Freezers within secured BSL-2 labs do not need to be locked if proper lab security measures are followed.  Shared units must be placarded with content owner’s contact information.  If  RG2 storage is in a common, unsecured area, the unit(s) must be locked at all times and placarded with content owner’s contact information.
  3. Refresher training will be largely based on audit findings during the previous audit cycle.  Also, new starting in October 2017 is the inclusion of personnel working in labs that receive an audit during the year regardless of the operating Biosafety level.

iMedRIS Pointer of the Month

Annual Updates

Principal investigators are required to submit an annual update for each IBC-approved registration.  Annual updates are important to the compliance process as they apprise the Biosafety Office and IBC of any changes to approved project(s), laboratories, or personnel.

Submitting an Annual Update form is a quick and easy process, click here to access the secure site to download the guide.


Refresher Training Announcement & Other Training Opportunities 

Annual Refresher Training

The 2017 annual refresher training will be distributed the week of October 16th.  This year’s training features reminders on prudent lab practices based on laboratory audit findings, as well as refresher material covering the OSHA Bloodborne Pathogens Standard.  All personnel listed on IBC-approved protocols, as well as those working in CVM clinical diagnostic labs, and those holding federal permits for receipt and containment of biological materials, are expected to complete the training (note: those completing training within 60 days prior to distribution will be exempted).

Principles of Biosafety & Bloodborne Pathogens

The “Principles of Biosafety” course covers biological hazards, risk assessment, safety practices appropriate for biosafety levels (BSL) 1 & 2, and the OSHA Bloodborne Pathogens Standard.  Those working in BSL-2 labs, under federal permits with containment provisions, or in CVM clinical laboratories are required to complete this training.  Additional information about biosafety training can be found at biosafety.utk.edu/biological-safety-training/.

To view the training calendar or register for upcoming trainings, go to biosafety.utk.edu/events/.

iMedRIS Training

All IBC registrations, amendments, and annual updates are now managed through the iMedRIS online submission system.  iMedRIS training for faculty and staff is available at  your convenience. Go to https://biosafety.utk.edu/imedris-training/ to register for training.


Regulatory Reminders

Shipping Dry Ice

Dry ice (or carbon dioxide, solid) is classified by the US DOT and International Air Transport Association (IATA) regulations as a Class 9 hazardous material because it can act as a contact, explosion, or suffocation hazard if improperly packaged.   Resultantly, shipping regulations indicate that those who prepare packages or paperwork for shipments containing dry ice must be trained and certified for this function.  Contact the Biosafety Office for additional information on dry ice or biological hazard shipping training.

Biological Materials Permits

If you have received biological materials or are conducting research under a federally-issued permit (e.g. USDA APHIS, CDC), you are legally responsible for meeting all of the outlined conditions in the permit.  Failure to do so could result in civil liabilities (fines) for you and/or the university.  Let the Biosafety Office assist you in meeting your regulatory obligations by sending us a copy of your permit(s).


Additional Information

For additional information, contact the Biosafety Office at utbiosafety@utk.edu or (865) 974-5547.

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