Human Pathogens and Toxins Act (HPTA)

Background

Human pathogens and toxins pose a small but significant risk to human health and safety, either through accidental or deliberate release. Accidental release can result from inadequate controls on activities such as possession, use, transfer or disposal. A deliberate release could be possible if there are inadequate security measures in place. To address these concerns, the Public Health Agency of Canada (PHAC) established a national safety and security program to protect the health and safety of the public against risks posed by human pathogens.

On December 1, 2015, the Human Pathogens and Toxins Act (HPTA) came into full force. This Act is one of the key pillars of a safety and security program for human pathogens and toxins along with the Human Pathogens and Toxins Regulations, the Canadian Biosafety Standards, as well as supporting activities, such as an expert advisory committee, training programs, compliance audits and outreach to promote capacity building amongst regulated parties. This program applies to everyone conducting specified activities with human pathogens and toxins whether imported or domestically acquired, including:

This program does not apply to:

• a human pathogen or toxin in an environment in which it naturally occurs, as long as it has not been cultivated or intentionally collected or extracted;
• a drug in dosage form whose sale is permitted under the Food and Drugs Act or a human pathogen or toxin contained in such a drug.

HPTA Program Components

To achieve public health and safety objectives, the Agency implements the HPTA requirements through the following:

1. Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations:
   • Obligations and prohibitions, such as an obligation to take reasonable precautions to protect the health and safety of the public when knowingly dealing with human pathogens and toxins; a ban on any activity with human pathogens and toxins listed in Schedule 5 (only smallpox is currently listed); a prohibition on intentionally releasing human pathogens or toxins
   • Licensing
   • Security clearances for Security Sensitive Biological Agents
   • Exemptions
2. Standards, Conditions of Licence, and Guidelines:
   • Roles and Responsibilities of Biological Safety Officers (also a component of the HPTR) Exposure Reporting and Analysis
   • Knowledge of pathogens and their associated risks
   • Guidelines for Exceptions and Emerging Risks
3. Supporting Activities:
   • Advisory Committee
   • Compliance Promotion
   • Compliance Verification and Monitoring
   • Enforcement
   • Capacity and Capability Enhancement

When developing the program, the Public Health Agency of Canada (PHAC) considered the levels of risk posed by human pathogens and toxins. This risk-based approach means that requirements for activities involving Risk Group 2 human pathogens will be less stringent than requirements for activities involving Risk Group 3 or 4 human pathogens.

Canadian Biosafety Standard (CBS)

The 2^ndedition of the standards originally published in Part I of the Canadian Biosafety Standards and Guidelines (CBSG), 2013 have been updated and published as the Canadian Biosafety Standard (CBS), 2^nd Edition.

The CBS sets out the physical containment, operational practice, and performance and verification testing requirements to ensure the safe handling and storing of human and terrestrial animal pathogens and toxins. The CBS continues the vision of the CBSG by updating several requirements in a risk, evidence, and performance based approach, as well as incorporating new information in the field of biocontainment engineering. In addition, the CBS includes several new requirements and information to support the full implementation of the HPTA and the HPTR. On December 1, 2015, the CBS replaced the CBSG. The CBS is used by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) to verify the ongoing compliance of regulated facilities with a licence for controlled activities with human pathogens and toxins or importing or transferring terrestrial animal pathogens.

The 2^nd edition of the guidelines, originally published in Part II of the CBSG, have been published in the Canadian Biosafety Handbook (CBH), 2^nd Edition. The CBH is a companion document to the CBS that provides guidance on how to achieve the biosafety and biosecurity requirements outlined in the CBS. The CBH systematically addresses the concepts required for the development and maintenance of a comprehensive risk-based biosafety management program.

In addition, the Canadian Biosafety Guidelines are a series of biosafety and biosecurity themed guidance documents developed by the PHAC and the CFIA that provide more details and recommendations on more specific topics.

Statements of Administrative Intent

The Agency has developed a number of Statements of Administrative Intent to provide a clearer understanding on various aspects of the Human Pathogens and Toxins program. The following Statements of Administrative Intent are an elaboration on specific applications of the HPTA.

1. Exclusions from the Human Pathogens and Toxins Act
2. Defining the term Micro-organism in the context of the Human Pathogens and Toxins Act
3. The Human Pathogens and Toxins Act Application to Helminths
4. Determining if Cells and Cell Lines are under the authority of the Human Pathogens and Toxins Act
5. Exemptions from the Licensing Requirements of the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations

Supporting Activities

An Advisory Committee is required under the HPTA, to provide technical advice on the risk classification of human pathogens and toxins. The advice of the Advisory Committee must be taken into account before amending any of the HPTA Schedules.

The Agency is committed to supporting regulated parties and to helping them achieve full compliance with the HPTA program. Resources are available through an online portal. The Agency's active participation and leadership in biosafety and biosecurity discussions is raising awareness and enhancing capacity for integrated biosafety and biosecurity programs, nationally and internationally.

The HPTA program also contains a wide range of other requirements such as the Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting to facilitate academic institutions with the development of internal accountability structures, under the HPTA and the HPTR.