Vol. 151, No. 30 — July 29, 2017

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

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”:

Aerococcus ureinae

Arcanobacterium bernardiae

Clostridium difficile

Francisella novicida

Salmonella

Streptococcus salivarius

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

Aerococcus urinae

Bacteroides fragilis

Fusobacterium necrophorum

Rickettsia akari

Rickettsia conorii

Salmonella enterica

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

Adenovirus

Adénovirus humain

Avian influenza virus (excluding highly pathogenic strains)

Virus de la grippe aviaire (sauf les souches hautement pathogènes)

Coxsackievirus

Coxsackievirus

Epstein Barr virus

Virus d’Epstein Barr

Hepatitis A virus

Virus de l’Hépatite A

Hepatitis D virus

Virus de l’Hépatite D

Herpes simplex viruses

Virus Herpès simplex

Human coronavirus (excluding SARS-CoV)

Coronavirus humain (sauf le virus du SRAS)

Human herpesvirus 5 (cytomegalovirus)

Herpèsvirus humain de type 5 (cytomegalovirus)

Human herpesvirus 6 (roseolovirus)

Herpèsvirus humain de type 6 (roseolovirus)

Human herpesvirus 8 (Kaposi’s sarcoma-associated herpesvirus)

Herpèsvirus humain de type 8 (herpèsvirus associé au sarcome de Kaposi)

Human parvovirus

Parvovirus humain

Human rotavirus

Rotavirus humain

Influenza virus, types A-C (excluding Type A 1918 Spanish Flu and H2N2 strains)

Virus de la grippe (Influenza), types A-C (sauf la souche type A de la grippe espagnole et les souches H2N2)

Papillomaviruses

Papillomavirus humain

Parainfluenza virus (types 1-4)

Virus Parainfluenza (types 1-4)

Reoviruses

Reovirus

Respiratory syncytial virus

Virus respiratoire syncytial

Rhinovirus

Rhinovirus

Simian virus 40

SV40 (Simian virus 40)

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”:

Alphapapillomavirus

Alphapapillomavirus

Epstein-Barr virus

Virus d’Epstein-Barr

Hepatatitis delta virus

Virus de l’hépatite delta

Hepatovirus A

Hépatovirus A

Human alphaherpesvirus 1 and 2 (Simplexvirus)

Alphaherpèsvirus humain de types 1 et 2 (simplexvirus)

Human betaherpesvirus 5 (Cytomegalovirus)

Betaherpèsvirus humain de type 5 (cytomégalovirus)

Human betaherpesvirus 6A, 6B, and 7 (Roseolovirus)

Betaherpèsvirus humain de types 6A, 6B et 7 (roseolovirus)

Human gammaherpesvirus 8 (Kaposi’s sarcoma-associated herpesvirus)

Gammaherpèsvirus humain de type 8 (herpèsvirus associé au sarcome de Kaposi)

Human parainfluenza virus 1 to 4

Virus parainfluenza humain de types 1 à 4

Human respiratory syncytial virus

Virus respiratoire syncytial humain

Rhinovirus A to C

Rhinovirus de type A à C

Rotavirus A

Rotavirus A

Zika virus

Virus Zika

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”:

Aspergillus niger

Aspergillus oryzae

Sporothrix schenkii

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

Epidermophyton floccosum

Microsporum canis

Penicillium marneffei

Sporothrix schenckii

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

Giardia intestinalis

Toxoplasma gondii

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

Chronic wasting disease agent

Agent de la maladie du dépérissement chronique des cervidés

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

Brucella canis

Brucella ovis

Brucella suis

Chlamydia psittaci

Mycobacterium canettii

Neorickettsia sennetsu

Rickettsia akari

Rickettsia australis

Rickettsia conorii

Rickettsia japonicum

Rickettsia siberica

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

Chlamydophila psittaci

Orientia tsutsugamushi

Rickettsia japonica

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

African Horse Sickness virus

Virus de la peste équine

Água Preta virus

Virus Agua Preta

Akabane virus

Virus Akabane

Allpahuayo virus

Virus Allpahuayo

Andes virus

Virus Andes

Araguari virus

Virus Araguari

Batken virus

Virus Batken

Bayou virus

Virus du Bayou

Bear Canyon virus

Virus du Bear Canyon

Bermejo virus

Virus Bermejo

Bhanja virus

Virus Bhanja

Bijou Bridge virus

Virus Bijou

Black Creek Canal virus

Virus Black creek canal

Cabassou virus

Virus Cabassou

Cano Delgadito virus

Virus Cano Delgadito

Dhori virus

Virus Dhori

Dobrava-Belgrade virus

Virus Dobrava-Belgrade

Douglas virus

Virus Douglas

Dugbe virus

Virus Dugbe

Duvenhage virus

Virus Duvenhage

Enseada virus

Virus Enseada

Everglades virus

Virus Everglades

Flexal virus

Virus Flexal

Garissa virus

Virus Garissa

Germiston virus

Virus Germiston

Hantaan virus

Virus Hantaan

Herpesvirus ateles

Herpèsvirus ateles

Herpesvirus saimiri

Herpèsvirus saimiri

Highly pathogenic avian influenza virus

Virus de la grippe aviaire (Influenza) hautement pathogène

Human immunodeficiency virus

Virus de l’immunodéficience humaine

Human T-cell lymphotrophic virus

Virus T lymphotrope humain (HTLV)

Influenza A H2N2

Virus de la grippe (Influenza) type A sous-type H2

Israel Turkey meningoencephalitis virus

Virus Israel turkey meningœncephalitis

Issyk-Kul virus

Virus Issyk Kul

Juquitiba virus

Virus Juquitiba

Khabarovsk virus

Virus Khabarovsk

Koutango virus

Virus Koutango

Kunjin virus

Virus Kunjin

Laguna Negra virus

Virus Laguna Negra

Lechiguanas virus

Virus Lechiguanas

Lymphocytic choriomeningitis virus

Virus de la chorioméningite lymphocytaire

Maporal virus

Virus Maporal

Mapuera virus

Virus Mapuera

Mayaro virus

Virus Mayaro

Mobala virus

Virus Mobala

Monongahela virus

Virus Monongahela

Mopeia virus

Virus Mopeia

Negishi virus

Virus Negishi

New York virus

Virus New York

Ngari virus

Virus Ngari

Oliveros virus

Virus Oliveros

O’Nyong-nyong virus

Virus O’Nyong-nyong

Oran virus

Virus Oran

Oropouche virus

Virus Oropouche

Pergamino virus

Virus Pergamino

Pirital virus

Virus Pirital

Piry virus

Virus Piry

Puumala virus

Virus Puumala

Rabies virus

Virus rabique

Rift Valley fever virus

Virus de la fièvre de la vallée du Rift

Rocio virus

Virus Rocio

Saaremaa virus

Virus Saaremaa

Sakpa virus

Virus Sakpa

SARS coronavirus (SARS-CoV)

Virus du syndrome respiratoire aigu sévère (SRAS-CoV)

Seoul virus

Virus Seoul

Sin nombre virus

Virus Sin nombre

Slovakia virus

Virus Slovakia

Somone virus

Virus Somone

Sripur virus

Virus Sripur

Thogoto virus

Virus Thogoto

Tonate virus

Virus Tonate

Topografov virus

Virus Topografov

Vesicular stomatitis virus

Virus de la stomatite vésiculaire

Wesselsbron virus

Virus Wesselsbron

Whitewater Arroyo virus

Virus Whitewater Arroyo

Xingu virus

Virus Xingu

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”:

Hantaan hantavirus

Hantavirus Hantaan

Human immunodeficiency virus 1 and 2

Virus de l’immunodéficience humaine de types 1 et 2

Lymphocytic choriomeningitis mammarenavirus

Mammarénavirus de la chorioméningite lymphocytaire

Rabies lyssavirus

Lyssavirus rabique

Severe acute respiratory syndrome-related coronavirus

Coronavirus du syndrome respiratoire aigu sévère

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”:

Blastomyces dermatitidis

Penicillium marneffei

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

Ajellomyces (Blastomyces) dermatitidis

Cryptococcus gattii

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

Bovine spongiform encephalopathy agent and other related animal transmissible spongiform encephalopathies agents

Agent de l’encéphalopathie spongiforme bovine et agents des autres encéphalopathies spongiformes transmissibles

Fatal Familial Insomnia agent

Agent de la maladie de l’insomnie fatale familiale

Gerstmann-Sträussler-Scheinker syndrome agent

Agent du syndrome de Gerstmann-Sträussler-Scheinker

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

Bovine spongiform encephalopathy agent

Agent de l’encéphalopathie spongiforme bovine

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

Absettarov virus

Virus Absettarov

Crimean Congo haemorrhagic fever virus

Virus de la fièvre hémorragique de Congo Crimée

Guanarito virus

Virus Guanarito

Hanzalova virus

Virus Hanzalova

Herpes B virus

Herpèsvirus simien B

Hypr virus

Virus Hypr

Junin virus

Virus Junin

Kumlinge virus

Virus Kumlinge

Kyasanur Forest virus

Virus de la forêt Kyasanur

Lassa fever virus

Virus de Lassa

Machupo virus

Virus Machupo

Omsk haemorrhagic fever virus

Virus Omsk

Russian spring-summer encephalitis virus

Virus de l’encéphalite verno estivale russe

Sabia virus

Virus Sabia

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”:

Crimean-Congo hemorrhagic nairovirus

Nairovirus hémorragique de Crimée-Congo

Guanarito mammarenavirus

Mammarénavirus Guanarito

Junin mammarenavirus

Mammarénavirus Junin

Kyasanur Forest disease virus

Virus de la maladie de la forêt de Kyasanur

Lassa mammarenavirus

Mammarénavirus de Lassa

Macacine alphaherpesvirus 1

Macacine alphaherpèsvirus 1

Machupo mammarenavirus

Mammarénavirus Machupo

Omsk hemorrhagic fever virus

Virus de la fièvre hémorragique d’Omsk

Sabia mammarenavirus

Mammarénavirus Sabia

Tick-borne encephalitis virus

Virus de l’encéphalite à tiques

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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