Lunenfeld-Tanenbaum Research Institute

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Lunenfeld-Tanenbaum Safety

 

Human Pathogens and Toxins Act and Regulation Information  


HPTA/R                                                                                                                           TDG Information

Risk Assessments                                                                    


Human Pathogens and Toxins Act and Regulations (HPTA/R)

The HPTA/R regulates research activities with human pathogens and toxins such as: possessing, handling, storing, transferring and disposing of these agents. In addition, primary attention is directed toward the biosecurity risks and dual-use associated with these biohazardous agents.

Failure to comply with the HPTR by one laboratory may result in the revocation of the entire LTRI license. This would affect all labs and could postpone research indefinitely. Catastrophic failure to comply may result in heavy fines and jail time to individuals.

Compliance with the HTPA/R includes all labs following the LTRI safety program with the following additions:

1.   Annual Biological Laboratory Inspections

2.   Documentation of Internal/External Material Transfers

3.   Documentation of Lab Specific Training

4.   Review of Projects for Dual-Use Potential

5.   Advance Inventory Requirements

Annual Biological Laboratory Inspections - Click HERE to see the inspection list. An allowance of 4weeks will be given to correct any non-compliance. After such time, the inspection will be escalated to the Director of Research Operations followed by the Director of Research.

Documentation of Internal/External Material Transfers - All labs must keep a record the import/export of Containment Level 2 materials. This includes materials received from or sent to both internal labs (down the hallway) and external labs (another University). Transfer of CL2 materials requires the Biological Safety Officer of BOTH institutions to be informed.  

To help with this please use the following forms BEFORE sending/receiving material:

·    Internal Transfer Form 

·    External Transfer Form 

Documentation of Lab Specific Training - All labs must keep a document capturing the dates and times staff was trained on specific equipment and SOPs. This is NOT a list of training taken through the Safety department but training given by a mentor to new staff/students on equipment or process that are used in your specific lab.

To help with this please use this form: Lab Specific Training Record Template

Dual-Use Potential - All projects that are undertaken should be reviewed for Dual-Use potential. This addresses the concern that certain types of research may have the potential to be used or applied maliciously with detrimental consequences to public health and safety, the environment, or national security.

Includes all aspects of the research process:

·        End-products from research

·        Knowledge (i.e. data, models, and information)

·        Methodologies (i.e. tools and techniques)

·        Results (i.e. intended or unintended products and by-products)

To help determine if what you are doing could be at risk for Dual-use please see the Public Health Agency of Canada’s Decision Tree. 

Advanced Inventory Requirements - Include a complete inventory of your CL2 materials, including the materials Identifying Name, Risk Group, Location and quantity if necessary. In addition, the lab must keep an up-to-date list of any Security Sensitive Biological Agents. This list is requested annually by the Safety Department during your inspection.

To help with generating and maintaining an inventory please see the links below:

·        PHAC Inventory Requirements

·       Security Sensitive Biological Agents and Toxin List 

Other links to help navigate the HPTA/R requirements:

·        Canadian Biosafety Standards (2nd Edition, 2015)

·        Canadian Biosafety Handbook (2nd Edition, 2016)

·        LTRI Biosafety Policy

·        LTRI Biosafety Manual 

·        Pathogen Safety Datasheets

Transportation of Dangerous Goods

Every lab should have one person trained in the shipping and receiving of dangerous goods. It is the responsibility of this individual to ensure correct packaging and documentation of any material/substance sent via FedEx, UPS or another transport company.

Please contact LTRI safety if you are interested in becoming the trained member for your lab.

If you require help packaging and documenting material for shipment please refer to the below documents.

·        How to package Dry Ice correctly

·        How to package Category B shipments correctly

·        Additional information on how to package Category B or Exempt Patient Specimens

Please remember that any containment level 2 transfers must be accompanied by an Internal/External Transfer Form (please see above).

Biohazardous Agent Risk Assessments

Risk assessments (RAs) should be completed by a team of individuals who have a good working knowledge of the area or process. These include the worker, the lab manager/supervisor and safety personnel.

A RA is a thorough look at your workplace to identify those things, situations, or processes that may cause harm. After identification is made, evaluation of the likelihood and severity of the risk is performed. Following this we decide what measures should be in place to prevent or control the harm from occurring.

For an in depth look at how to create a RA refer to the Local Risk Assessment Training module in BioRaft.

In general, a RA should include:

·        Identification of the hazard

·        Evaluation of the likelihood and severity of an injury or illness occurring

·        Consideration of normal operational situations as well as non-standard events such as shutdowns, power outages, emergencies, etc.

·        Review of health and safety information about the hazard such as: SDSs, manufacturer’s literature, testing results, etc.

·        Identification of actions needed to eliminate or control risk

    A blank RA form is available for Lab-specific Risk Assessments – Click HERE