Frequently Asked Questions (FAQs): Regulations

This page provides Canadians and businesses with basic information about select Public Health Agency of Canada (PHAC) acts and regulations.

The Human Pathogen and Toxins Regulations under the Human Pathogens and Toxins Act

1. What is the purpose of the Human Pathogens and Toxins Act and Human Pathogens and Toxin Regulations?

The Human Pathogens and Toxins Act (HPTA) establishes a regime to protect the health and safety of the public against risks posed by human pathogens and toxins. It provides the Public Health Agency of Canada (PHAC) with a legal framework to manage and control the use of human pathogens and toxins.

The Human Pathogen and Toxins Regulations (HPTR) establish the administrative details that outline how PHAC will implement the legal framework set-out in the HPTA. The HPTR authorizes a range of controlled activities with human pathogens and toxins through licensing and security clearances. In general, the HPTA and the HPTR are intended to:

  • Improve federal oversight of activities with human pathogens and toxins in Canada;
  • Establish national requirements for safe and secure handling of human pathogens and toxins;
  • Provide assurance that individuals with access to a prescribed list of security sensitive human pathogens and toxins have an appropriate security clearance; and
  • Exempt activities which pose low risk to public health and safety.

2. What are the key elements of the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations?

The HPTA sets out a framework for:

  • Licensing;
  • Security screening;
  • Biological safety officers; and
  • Regulatory authorities.

The HPTA requires that a person hold a licence to conduct any of the following controlled activities:

  • Possessing, handling or using a human pathogen or toxin;
  • Producing a human pathogen or toxin;
  • Storing a human pathogen or toxin;
  • Permitting any person access to a human pathogen or toxin;
  • Transferring a human pathogen or toxin;
  • Importing or exporting a human pathogen or toxin;
  • Releasing or otherwise abandoning a human pathogen or toxin; or
  • Disposing of a human pathogen or toxin.

The HPTA further establishes restrictions on access to facilities to persons not holding an appropriate security clearance. Section 33 of the Act requires that no person shall enter the part of a facility where controlled activities are authorized with prescribed Risk Group 3 and 4 human pathogens or prescribed toxins unless they hold a security clearance or they are accompanied and supervised by someone who holds a security clearance. HPTR prescribes the subset of Risk Group 3 and 4 human pathogens and toxins, which are also referred to as Security Sensitive Biological Agents (SSBA). These SSBAs are categorized based on an international consensus of high risk agents that require specific control measures designed to restrict access.

The HPTR sets out various other requirements for licensing, security clearances and exemptions. For example, licences are issued using a risk-based approach. This means that the term of a licence can vary from one to five years depending on the Risk Group of the human pathogen.

The HPTR includes exemptions to the licensing requirement to reduce the regulatory burden in areas that are considered low risk and/or considered in the public interest such as facilities dedicated to diagnostic testing and veterinary clinics. For example, the HPTR exempts persons conducting certain diagnostic activities if human pathogens are not cultivated, produced, or when production occurs it is done in a sealed container that is decontaminated before disposal. Any facility exempt from the licensing requirement of the HPTR however, remain subject to the HPTA and therefore the facility must take all reasonable precautions to protect the health and safety of the public when they are conducting controlled activities with human pathogens or toxins (section 6, HPTA).

3. Who do the Human Pathogens and Toxins Act and Human Pathogen and Toxins Regulations apply to?

The HPTA and HPTR apply to organizations and individuals conducting activities with human pathogens and toxins. This includes universities, public health laboratories, industry, hospitals, and diagnostic services for human and animal health.

4. How does this legislation affect Canadian businesses?

There will be a range of costs per laboratory, depending on whether they were previously regulated or had voluntarily adopted the national standards. While there are no licence application fees, there are key costs associated with administrative efforts when applying for, and upholding a licence. There are also costs associated with the administrative duties of the Licence Holder's Biological Safety Officer. There may also be costs related to implementing security requirements for the 60 laboratories that handle the highest risk human pathogens and toxins.

It has been estimated that the total cost for implementing the HPTA and HPTR for regulated parties will be approximately 300 dollars per laboratory, totaling approximately 2.4 million dollars overall in the first year. This cost is expected to decrease over time.

5. When did the Human Pathogens and Toxins Act and the Human Pathogen and Toxins Regulations come into force?

The Act and Regulations came into full force on December 1, 2015.

6. Where can I get more information?

Enquiries on the Human Pathogens and Toxins Act and Regulations may be sent to PHAC.pathogens-pathogenes.ASPC@canada.ca.

Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations

1. What is the purpose of this Regulation?

The Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations under the Department of Health Act aim to protect travellers from risks associated with water served on board passenger transportation.

2. Who do the regulations apply to?

The Regulations apply to operators of passenger conveyances in Canada that are authorized to carry at least 25 passengers, including:

  1. Aircraft;
  2. Vessels and buses with interprovincial or international itineraries; and
  3. Trains with interprovincial or international itineraries, or those declared to be a work for the general advantage of Canada.

3. What are the key elements of this Regulation?

This Regulation applies to water supplied on passenger conveyances for the purposes of drinking, hand-washing and oral hygiene, and for the preparation of food for passengers. Operators providing water to passengers for any of those purposes need to ensure that it is potable and is provided in sufficient quantity for its intended purpose.

Water and ice may be supplied from pre-packaged products, a potable water system, or from potable water containers provided that measures are taken to ensure that the water is free from contamination when it is taken from the water supply. It must also be handled in a manner that prevents the risk of contamination on-board.

Operators with on-board potable water systems must implement measures to ensure that systems are designed, constructed and operated to prevent the risk of contamination. These implementation measures must:

  • Protect systems during loading;
  • Prevent backflow;
  • Protect filling and cross connections;
  • Protect systems from tampering; and
  • Label system components.

Canadian operators and foreign operators of aircraft, trains and vessels with two or more stops in Canada in a single trip are required to routinely sample on-board potable water systems for E. coli. All operators need to take measures to correct suspected or confirmed contamination of on-board potable water systems. They also need to investigate the cause of contamination and assess whether or not other transportation in their fleet may have been affected.

Operators need to disinfect and flush systems routinely after extended periods out of use and after activities, such as repair and maintenance that may have introduced contamination (frequencies are related to routine disinfection and flushing schedules). Operators must also maintain records about water sampling results, disinfection and flushing, as well as corrective measures, investigations and assessments. Records must be readily accessible for review by an inspector for at least one year.

4. How does this regulation affect Canadian businesses?

This Regulation may have a financial impact on operators related to sampling of on-board potable water systems as well as record keeping.

5. What is the timeline for implementation?

These regulations came into force on September 23, 2016. PHAC is working closely with industry stakeholders to support compliance with regulatory requirements.

6. Where can I get more information?

More information about the Potable Water on Board Trains, Vessels, Aircraft and Buses Regulations is available by contacting PHAC's Travelling Public Program by email at tpp.ppv@phac-aspc.gc.ca, or by telephone at 1-877-742-2538.

Quarantine Act

1. What is the purpose of this legislation?

The Quarantine Act protects public health by taking comprehensive measures to prevent the introduction and spread of communicable diseases.

2. What are the key elements of this legislation?

The Quarantine Act authorizes the Minister of Health to establish quarantine stations and quarantine facilities anywhere in Canada, and to designate various officers including quarantine officers, environmental health officers, and screening officers. It also authorizes measures that can be taken in respect to international transportation and international travellers arriving in, or departing from Canada, as well as cargo on those transportation vehicles.

The Act also sets requirements for the import and export of cadavers, body parts and other human remains.

3. Who does the Quarantine Act apply to?

The Quarantine Act applies to travellers arriving in or departing from Canada, as well as cargo on such transportation that could be the source of a communicable disease.

4. How does this legislation affect Canadian businesses?

The Quarantine Act impacts business to the extent that it may limit the movement of persons and goods across Canada's border if there is a need to prevent the introduction and spread of communicable diseases.

5. When did the Quarantine Act come into force?

The Quarantine Act is fully in force as of June 22, 2007.

6. Where can I get more information?

More information about the Quarantine Act is available by contacting PHAC's Quarantine program by email at quarantine-quarantaine@phac-aspc.gc.ca.

For more information

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.

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