Canada Gazette, Part I, Volume 151, Number 30: Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act

July 29, 2017

Statutory authority

Human Pathogens and Toxins Act

Sponsoring agency

Public Health Agency of Canada

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The risk grouping and taxonomy of some of the human pathogens included in those that are listed in Schedules 2 to 4 of the Human Pathogens and Toxins Act (HPTA) require updating to maintain the integrity of the human pathogens and toxins regulatory regime.

Background

The Minister of Health is responsible for the administration and enforcement of the HPTA and its Regulations, the Human Pathogens and Toxins Regulations (HPTR) and does so through the Public Health Agency of Canada (PHAC). The HPTA, which was enacted in 2009, came into full force with the HPTR, on December 1, 2015. Together, the HPTA and HPTR establish a regulatory regime to protect the health and safety of the public against the risks posed by human pathogens and toxins.

These regulatory amendments are required since Schedules 2 to 4 of the HPTA had not been examined since the HPTA was enacted in 2009. In light of new scientific knowledge, PHAC reviewed the schedules, in consultation with the Ministerial Advisory Committee on Human Pathogens and Toxins, and determined that some of the taxonomy and risk groupings of the human pathogens on the schedules require updating.

Pursuant to the HPTA, a human pathogen is a micro-organism, nucleic acid or protein that is able to cause disease in a human. In administering the HPTA and HPTR, PHAC classifies human pathogens into four risk groups, based on their risk to human and public health, as follows:

The HPTA applies only to those human pathogens falling within Risk Groups 2 to 4 regardless of whether they are listed in the schedules of the HPTA. Key representative examples of regulated human pathogens are listed in Schedules 2 to 4, and Part 2 of Schedule 5 of the HPTA. These schedules represent a non-exhaustive list of human pathogens regulated under HPTA and HPTR, and serve as a foundational reference point for Risk Groups 2 to 4 classifications for both domestic and international stakeholders.

Under the HPTA, the Minister of Health has the authority to add or delete human pathogens from Schedules 2 to 4 by regulation. Prior to making any additions or deletions to the schedules of the HPTA, the Minister is required to consult with an advisory committee. In 2015, the Minister's Advisory Committee on Human Pathogens and Toxins was established by PHAC to provide scientific advice.

Objectives

The objective of the proposed Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act is to amend the list of human pathogens in the schedules of the HPTA so that they are more accurate and up to date, to maintain the integrity of the human pathogens and toxins regulatory regime.

Description

Between March and December 2016, using a human pathogen risk assessment methodology, PHAC reviewed Schedules 2 to 4 of the HPTA to identify whether there were any misclassifications of human pathogens as well as any errors in nomenclature and taxonomy, in consultation with the Ministerial Advisory Committee.

These proposed regulatory amendments reflect the advice of the Ministerial Advisory Committee. The proposed regulatory amendments include additions or deletions of several human pathogens from Schedules 2 to 4 on the following basis:

1. The taxonomy of the biological human pathogen has changed (105 pathogens within the schedules, e.g. “Virus Hantaan” would be changed to “Hantaan hantavirus”).

In these cases the incorrect name is proposed to be deleted. The new name is either

2. The human pathogen appears multiple times under different pseudonyms (4 pathogens within the schedules, e.g. Brucella canis is considered to be a synonym of Brucella melitensis).

In these cases, the duplicate name is deleted.

3. There is insufficient data available about the human pathogen to definitively determine that the human pathogen falls within the definition of the particular risk group classification (11 pathogens within the schedules, e.g. Água Preta virus).

In these cases, the human pathogen is deleted from the schedule, but would continue to be classified under the relevant risk group definition as a precautionary measure.

4. A risk assessment determined that the human pathogen belongs to a different risk grouping (26 pathogens within the schedules, e.g. Coxsackievirus is no longer recognized as a species).

In no case did a risk assessment determine the human pathogen to belong to a higher risk group. Where a change in risk grouping is determined, the human pathogen is deleted from one schedule and added to a lower risk group schedule, or removed entirely if it is considered to be a lower risk than a Risk Group 2 pathogen. To that effect,

As a result of these reclassifications, regulated parties would have the option of continuing to conduct controlled activities with the reclassified Risk Group 2 human pathogens in the containment zone under the Risk Group 3 licence, or transferring the reclassified Risk Group 2 human pathogens to a containment zone under a Risk Group 2 licence.

Any administrative changes to HPTA licences resulting from the reclassifications will be deferred by PHAC until licence renewal. There is no change required to laboratory procedures as a result of these proposed amendments.

A list of approximately 10 000 human pathogens classified by risk group is currently available to regulated parties via the Biosecurity Portal, and is proposed to be made publicly available before these amendments are brought into force.

The fact that regulated parties have access to this list reduces the need for long lists of representative examples of Risk Groups 2 to 4 human pathogens to be included in the schedules.

“One-for-One” Rule

The “One-for-One” Rule does not apply, since the proposed amendments would not impose any administrative costs on industry.

Small business lens

The small business lens does not apply, since the proposed amendments would not impose any administrative burden on small businesses.

Rationale

Schedules 2 to 4 of the HPTA had not been examined since the HPTA was enacted in 2009. New scientific knowledge triggered PHAC to review the schedules, in consultation with the Ministerial Advisory Committee, and it was determined that some of the taxonomy and risk groupings of the human pathogens on the schedules require updating.

Updating the Schedules 2 to 4 of the HPTA will support PHAC in maintaining the integrity of the human pathogens and toxins regulatory regime.

The schedules represent key examples of human pathogens regulated under the HPTA and serve as a foundational reference point for risk group classifications for all stakeholders.

Since none of the proposed amendments represent an escalation of the risk classifications of the human pathogens in question, no impact on regulated parties is anticipated. PHAC would defer any required amendments to HPTA licences resulting from the amendments until licence renewal.

Coordinates

Centre for Biosecurity
Public Health Agency of Canada
100 Colonnade Road, AL: 6201A
Ottawa, Ontario
K1A 0K9
Fax: 613-941-0596
Email: PHAC.pathogens-pathogenes.ASPC@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Minister of Health, pursuant to section 9 of the Human Pathogens and Toxins Act (see footnote a), proposes to make the annexed Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act.

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Centre for Biosecurity, Public Health Agency of Canada, 100 Colonnade Road, AL: 6201A Ottawa, Ontario K1A 0K9 (fax: 613-941-0596; email: PHAC.pathogens-pathogenes.ASPC@canada.ca).

Ottawa, June 29, 2017

Jane Philpott
Minister of Health

Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act

Amendments

1 Schedule 2 to the Human Pathogens and Toxins Act (see footnote 1) is amended by deleting the following under the heading “Bacteria”:

2 Schedule 2 to the Act is amended by adding the following in alphabetical order under the heading “Bacteria”:

3 Schedule 2 to the Act is amended by deleting the following under the heading “Viruses”:

4 Schedule 2 to the Act is amended by deleting “Colorado tick fever viruses” under the heading “Viruses”.

5 Schedule 2 to the Act is amended by adding the following in alphabetical order under the heading “Viruses”:

6 Schedule 2 to the Act is amended by adding the following immediately before “Virus de la fièvre à tiques du Colorado” under the heading “Viruses”:

Colorado tick fever virus

7 Schedule 2 to the Act is amended by deleting the following under the heading “Fungi”:

8 Schedule 2 to the Act is amended by adding the following in alphabetical order under the heading “Fungi”:

9 Schedule 2 to the Act is amended by adding the following in alphabetical order under the heading “Protozoa”:

10 Schedule 2 to the Act is amended by deleting the following under the heading “Prions”:

11 Schedule 3 to the Act is amended by deleting the following under the heading “Bacteria”:

12 Schedule 3 to the Act is amended by adding the following in alphabetical order under the heading “Bacteria”:

13 Schedule 3 to the Act is amended by deleting the following under the heading “Viruses”:

14 Schedule 3 to the Act is amended by deleting “West Nile fever virus” under the heading “Viruses”.

15 Schedule 3 to the Act is amended by adding the following in alphabetical order under the heading “Viruses”:

16 Schedule 3 to the Act is amended by adding the following immediately before “Virus du Nil occidental” under the heading “Viruses”:

West Nile virus

17 Schedule 3 to the Act is amended by deleting the following under the heading “Fungi”:

18 Schedule 3 to the Act is amended by adding the following in alphabetical order under the heading “Fungi”:

19 Schedule 3 to the Act is amended by deleting the following under the heading “Prions”:

20 Schedule 3 to the Act is amended by adding the following in alphabetical order under the heading “Prions”:

21 Schedule 4 to the Act is amended by deleting the following under the heading “Viruses”:

22 Schedule 4 to the Act is amended by deleting “Ebola virus” under the heading “Viruses”.

23 Schedule 4 to the Act is amended by deleting “Marburg virus” under the heading “Viruses”.

24 Schedule 4 to the Act is amended by adding the following in alphabetical order under the heading “Viruses”:

25 Schedule 4 to the Act is amended by adding the following immediately before “Virus Ebola” under the heading “Viruses”:

Ebolavirus

26 Schedule 4 to the Act is amended by adding the following immediately before “Virus Marburg” under the heading “Viruses”:

Marburgvirus

Coming into Force

27 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

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