Recombinant and Biohazardous Materials

All use of biohazardous and/or recombinant materials must first be approved by the Institutional Biosafety Committee (IBC).

Definitions

Biohazardous Material

• An organism or samples from that organism that have the potential to cause disease in animals, humans, or plants.
• Animal (vertebrate and invertebrate) and/or human blood, tissue, bone or excreta; or animal and/or human and non-human primate cell lines.
• Bacteria, chlamydia, fungi, parasites, prions, rickettsia and viruses which cause disease in humans, animals (vertebrate and invertebrate), and/or plants.

Recombinant Material

• Molecules that (a) are constructed by joining nucleic acid molecules and (b) that can replicate in a living cell, i.e., recombinant nucleic acids.
• Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids.
• Molecules that result from the replication of those described above.

Recombinant Nucleic Acid Requirements

Prior to acquiring or conducting any work involving recombinant nucleic acids or with genetically modified plants or animals, either at or sponsored by, the University of Arizona, an Approval Holder (individual Principal Investigators approved for such work) must adhere to the following requirements: 

• Acquire appropriate permits and/or authorizations from outside agencies to include, but not limited to, the USDA/APHIS and the NIH RAC.
• Obtain approval from the University of Arizona’s Institutional Biosafety Committee (IBC).
• Complete the appropriate training offered by Research Laboratory & Safety Services (RLSS). RLSS is available for onsite training.
• Ensure that all their staff completes appropriate training from RLSS and are provided research specific training.

Once research has begun, the policies and procedures of the University of Arizona and all other applicable agencies must be followed. Inspections will be performed annually by RLSS.

For assistance contact Research Laboratory & Safety Services at (520) 626-6850 or rlss-bio-support@email.arizona.edu.

Human and Non-Human Primate Tissues and Cell Culture

All human and non-human primate blood, tissue cell lines and other potentially infectious material is handled at a minimum of biosafety level 2 (BSL-2).

This includes the following:

• Cell lines (primary and established) of human/primate origin.
• Cell lines derived from lymphoid or tumor tissue.
• Cell lines exposed to or transformed by any oncogenic virus.
• Cell lines exposed to or transformed by amphotropic packaging systems.
• Human clinical material (e.g., samples of human tissues and fluids obtained after surgical resection or autopsy).
• Mycoplasma-containing cell lines.

It is not acceptable to handle any of the above cell lines in a clean bench or horizontal laminar flow hood unless approved by RLSS.

Bloodborne Pathogens

Bloodborne Pathogens are any microorganism that is carried in the blood and can cause disease in humans.  Anyone whose job requires possible exposures to Bloodborne Pathogens is required to complete the Bloodborne Pathogen training offered by Risk Management and Safety. Risk Management and Safety maintains the University of Arizona Bloodborne Pathogen Policy and the Exposure Control Plan.

Safety Precautions for Handling Human Brain Tissue

All human brain tissue, including spinal cord material, must be treated as a potential contamination risk for certain biohazardous agents and handled with care. Human brain tissue can transmit prion diseases such as variant Creutzfeldt-Jakob Disease and Kuru.

Although prion diseases linked to handling brain tissue are rare, they are able to remain infectious for long periods in fixed tissues and require special treatment to ensure their destruction before discarding as waste.

If you are working with human brain tissue, you must:

• Obtain demographics of the sample to include where collected, reason, part of study, autopsy, etc., or obtain a pathology report.
• If no pathology report is available or demographics indicate the possible presence of prions, additional procedures are required to ensure complete destruction of any agent.
• The recommended procedure to ensure prion destruction is incineration. If this is not possible, autoclaving at 134 C° for a minimum of thirty (30) minutes is required.
• Chemical disinfection requires 1N NaOH immersion for one (1) hour, rinsing, followed by autoclaving at 121 C° for one (1) hour.
• Other methods of sterilization can be found in the below reference. If you wish to incinerate your material, you must contact Risk Management Services for assistance.

Reference:  WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. Report of a WHO Consultation, Geneva, Switzerland, March 1999.

Recombinant and Biohazardous Materials with Animals

All laboratory personnel and animal care handlers must be fully informed of the biosafety practices necessary to prevent an accidental exposure from an infected animal. It is the Approval Holder's responsibility to inform animal care staff associated with the research of the potential risks and appropriate biosafety practices.

All animals inoculated with human cells and most recombinant material are handled at ABSL-2 for 72 hours post inoculation. Review the guidelines to assist in determining containment level for viral vectors. Consult Research Laboratory & Safety Services if you have additional questions.

At a minimum, when handling animals containing recombinant and/or biohazardous material you must wear a laboratory coat and gloves. Additional personal protective equipment may be required.

All personnel working at ABSL-3 must be respirator fit tested in case there is a need to perform a procedure with a higher risk aerosolization as notated in the specific protocol.

Select Agents

Select Agents and Toxins are biological agents that the U.S Department of Health and Human Services and the US Department of Agriculture have declared to pose a severe threat to public health and safety. As part of the 1996 Anti-terrorism and Effective Death Penalty Act (PL 104-132), the CDC and the US Department of Health and Human Services issued a final rule in October 1996 regarding the transfer of Select Agents and Toxins that could be used in terrorist activities. The law requires additional requirements for facilities that utilize select agents and toxins in their research.

All researchers that want to conduct research with Select Agents or Toxins must first contact Research Laboratory & Safety Services for guidance on the registration process. Please plan for a minimum of six (6) months to complete the registration process.

Federal Select Agent Program

Physical Inventory Requirement

In 2014, there were several reported lapses involving biosafety practices in Federal laboratories. These lapses have prompted the Federal government to announce a new biosafety stewardship initiative designed to remind all laboratorians of the importance of constant vigilance over our implementation of biosafety standards.

As part of this initiative, the University of Arizona requires every laboratory to annually document all biohazardous material in their possession. This requires visual inspection of all freezers, including liquid nitrogen (LN2) Dewars. Any material that is unknown, unlabeled, or unnecessary must be disposed properly. Use the Annual Physical Inventory Check form to keep your inventory and file it with your biosafety documentation for inspection.

We recommend that each laboratory create an inventory list or freezer map of each freezer or liquid nitrogen storage location to assist with this annual process.

You can review the National Institutes of Health grantee notice at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-127.html