Vol. 151, No. 26 — December 27, 2017

Registration

SOR/2017-282 December 13, 2017

HUMAN PATHOGENS AND TOXINS ACT

Whereas the Minister of Health is of the opinion that certain micro-organisms, nucleic acids and proteins are able to cause disease in a human and fall into Risk Group 2, 3 or 4 as defined in subsection 3(1) of the Human Pathogens and Toxins Act (see footnote a);

Whereas the Minister of Health is of the opinion that certain micro-organisms, nucleic acids and proteins listed in, or included in those listed in, any of Schedules 2 to 4 to that Act do not fall into the risk group to which the Schedule relates;

And whereas, pursuant to subsection 9(4) of that Act, the Minister of Health has consulted an advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act (see footnote b);

Therefore, the Minister of Health, pursuant to section 9 of the Human Pathogens and Toxins Act (see footnote c), makes the annexed Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act.

Ottawa, December 5, 2017

Ginette Petitpas Taylor
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”:

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 a mended 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”:

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”:

Blastomyces (Ajellomyces) dermatitidis

Cryptococcus gattii

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”:

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

Coming into Force

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

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

Background

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

These regulatory amendments are required because Schedules 2 to 4 to the HPTA have not been examined since the enactment of the HPTA in 2009. In light of new scientific information, 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 required 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 or not they are listed in the schedules to the HPTA. Key representative examples of regulated human pathogens are listed in Schedules 2 to 4, and Part 2 of Schedule 5 to the HPTA. These schedules represent a non-exhaustive list of human pathogens regulated under the HPTA and the HPTR, and serve as a foundational reference point for Risk Group 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 to the HPTA, the Minister is required to consult with an advisory committee. The Ministerial Advisory Committee on Human Pathogens and Toxins was established by PHAC in 2015 to provide scientific advice.

Objectives

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

Description

In 2016, PHAC used a human pathogen risk assessment methodology to review Schedules 2 to 4 to the HPTA, in consultation with the Ministerial Advisory Committee, to identify any misclassifications of human pathogens and any errors in nomenclature and taxonomy.

The Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act and the accompanying Regulatory Impact Analysis Statement (RIAS) were prepublished in the Canada Gazette, Part I (CGI) on July 29, 2017, for a 30-day public comment period.

The Agency received 12 sets of comments from three sectors: academia, industry and other federal government departments.

Some commenters provided additional corrections to the taxonomy of listed pathogens. Some commenters requested clarity about the effect of removing pathogens from Schedules 2 to 4 to the HPTA. In addition, due to the procedural requirements of amending statutory changes via regulations, some commenters expressed confusion about how the amended schedules would appear once the HPTA is amended. To reflect the advice of the Ministerial Advisory Committee and address comments received to correct taxonomic errors, the regulatory amendments include additions or deletions of several human pathogens from Schedules 2 to 4. The basis of these changes is outlined in the “Rationale” section.

As stated in the RIAS that accompanied the CGI consultation, the HPTA extends to all human pathogens that fall into Risk Group 2, 3 and 4, regardless of whether or not they are listed on the schedules. There is no requirement for the schedules to include reference to a large number of Risk Group 2 to 4 human pathogens since regulated parties have access to a list of approximately 10 000 human pathogens classified by risk group via the Biosecurity Portal.

To address requests for clarity about how the amended schedules would appear once the HPTA is amended, PHAC has developed a summary of the updated Schedules that will be sent via email to regulated parties.

“One-for-One” Rule

The “One-for-One” Rule does not apply since the Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act do not impose any administrative costs on industry and therefore do not change the Administrative Burden Baseline of the HPTA.

Small business lens

The small business lens does not apply, since Regulations Amending Schedules 2 to 4 to the Human Pathogens and Toxins Act do not impose any administrative burden on small businesses.

Any administrative changes to HPTA licences resulting from the reclassifications reflected in these regulatory amendments will be deferred by PHAC until licence renewal. These amendments will not require regulated parties to change their laboratory procedures.

Rationale

New scientific information led PHAC to review Schedules 2 to 4 to the HPTA, in consultation with the Ministerial Advisory Committee on Human Pathogens and Toxins. Some of the taxonomy and risk groupings of the human pathogens on the schedules require updating.

These regulatory amendments reflect the advice provided by the Ministerial Advisory Committee and the comments received during CGI consultation. The regulatory amendments include additions or deletions of several human pathogens from Schedules 2 to 4 on the following basis:

1. The taxonomy of the human pathogen has changed (e.g. “Virus Hantaan” is changed to “Hantaan orthohanta virus”).

In these cases, the incorrect name was deleted. The new name is either

2. The human pathogen appears multiple times under different pseudonyms (e.g. the listing of various influenza viruses).

In these cases, the name was 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 (e.g. Água Preta virus).

In these cases, the human pathogen was deleted from the schedule, but may 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. (e.g. Aspergillus niger was reclassified to a Risk Group 1 human pathogen).

In no case did a risk assessment determine that the human pathogen belongs to a higher risk group. In most cases where a human pathogen changed Risk Groupings, the human pathogen was deleted from the higher risk group schedule and added to a lower risk group schedule. In some cases, the human pathogen was removed entirely from the schedules for one of two reasons:

As a result of the Regulations:

PHAC will allow regulated parties to continue to conduct controlled activities with the reclassified Risk Group 2 human pathogens in the containment zone under their Risk Group 3 licence and will defer any administrative changes to HPTA licences resulting from the reclassifications reflected in these regulatory amendments until licence renewal. Alternatively, regulated parties may transfer reclassified Risk Group 2 human pathogens to a containment zone under a Risk Group 2 licence. These amendments will not require regulated parties to change their laboratory procedures.

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

The schedules are not required to reference a large number of Risk Group 2 to 4 human pathogens since regulated parties have access to a list of approximately 10,000 human pathogens classified by risk group. This list is currently available to regulated parties via the Biosecurity Portal.

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