Canada Gazette, Part I, Volume 154, Number 49: GOVERNMENT NOTICES

December 5, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to amend the Domestic Substances List, deleting 22 non-eligible living organisms

Notice is hereby given that the Minister of the Environment, pursuant to subsection 105(2) of the Canadian Environmental Protection Act, 1999,footnote a intends to delete 22 living organisms referred to in the annexed proposed Order from the Domestic Substances Listfootnote b as these living organisms do not meet the criteria prescribed in subsection 105(1) of the Act.

Public comment period

Any person may provide comments within 60 days of publication of this Notice. Any person who objects to the deletion of a living organism from the Domestic Substances List should, for each living organism of interest, provide substantiating documentation to demonstrate that the living organism proposed for deletion meets the criteria prescribed in subsection 105(1) of the Act using the Domestic Substances List nomination form (PDF). Additional guidance concerning the documentation to support the eligibility of a living organism is available in the New Substances Program Advisory Note 2015-05.

The annexed proposed Order lists the confidential accession numbers of the living organisms proposed to be deleted from the Domestic Substances List. Any person who manufactures or imports a living organism that they believe to be on the proposed Order may seek confirmation from the New Substances program by providing a Notice of bona fide manufacture or import of the living organism.

Comments must cite the Canada Gazette, Part I, and the date of publication of this notice. Comments can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window, by mail addressed to Pascal Roberge, Acting Executive Director, Program Development and Engagement Division, Environment and Climate Change Canada, Gatineau, Quebec K1A 0H3, or by email to eccc.substances.eccc@canada.ca.

Pursuant to section 313 of the Act, any person who provides information in response to this notice may submit, with the information, a request that it be treated as confidential.

Jacqueline Gonçalves
Acting Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment

Proposed Order 2021-105-01-01 Amending the Domestic Substances List

1 Part 7 of the Domestic Substances Listfootnote b is proposed to be amended by deleting the following:

Column 1


Confidential substance identity number

Column 2

Inanimate biotechnology product and living organism identified by their masked name in accordance with the Masked Name Regulations footnote c

18115-7

Alcaligenes species

Espèce alcaligenes

18116-8

Alteromonas species

Espèce alteromonas

18117-0

Pseudomonas species 1

Espèce pseudomonas 1

18118-1

Bacillus species 2

Espèce bacillus 2

18119-2

Bacillus species 3

Espèce bacillus 3

18120-3

Bacillus species 1

Espèce bacillus 1

18121-4

Bacillus species 4

Espèce bacillus 4

18122-5

Bacillus species 5

Espèce bacillus 5

18123-6

Pseudomonas species 2

Espèce pseudomonas 2

18124-7

Flavobacterium species

Espèce flavobacterium

18125-8

Micrococcus species

Espèce micrococcus

18126-0

Pseudomonas species 3

Espèce pseudomonas 3

18127-1

Pseudomonas species 4

Espèce pseudomonas 4

18128-2

Thiobacillus species

Espèce thiobacillus

18129-3

Bacillus species 7

Espèce bacillus 7

18130-4

Cellumonas species

Espèce cellumonas

18131-5

Enterobacter species

Espèce enterobacter

18132-6

Nitrobacter species

Espèce nitrobacter

18133-7

Nitrosomonas species

Espèce nitrosomonas

18134-8

Pseudomonas species 5

Espèce pseudomonas 5

18135-0

Pseudomonas species 6

Espèce pseudomonas 6

18136-1

Rhodopseudomonas species

Espèce rhodopseudomonas
COMING INTO FORCE

2 This Order would come into force on the day on which it is registered.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 20490

Significant New Activity Notice

(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2, under section 83 of the Canadian Environmental Protection Act, 1999;

Whereas the substance is not specified on the Domestic Substances List;

And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.

The Honourable Jonathan Wilkinson
Minister of the Environment

ANNEX
Information Requirements

(Section 85 of the Canadian Environmental Protection Act, 1999)

1. The following definition applies in this notice:

“substance”
means siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2.

2. In relation to the substance, a significant new activity is

3. Despite section 2, a use of the substance is not a significant new activity if the substance is used

4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:

5. The information referred to in section 4 will be assessed within 90 days after the day on which it is received by the Minister of the Environment.

Transitional provisions

6. Despite section 2, in the period between the date of publication of the present notice and December 10, 2021, a significant new activity is

7. For greater certainty, in respect of calendar year 2021, the quantity of substance that is used before December 10 of that calendar year is not considered for the purposes of section 2.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice.)

Description

This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2. The Notice is now in force and is a binding law. It is therefore mandatory for a person who intends to use the substance for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.

A SNAc Notice does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

Applicability of the Significant New Activity Notice

The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.

ln order to address human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of consumer products or cosmetics intended for applications that generate airborne particles of less than or equal to 10 micrometres when the concentration of the substance is greater than or equal to 1% by weight. The notice also requires notification in relation to the distribution for sale of consumer products or cosmetics containing the substance. For example, notification is required if a person plans to manufacture or distribute an aerosol consumer product or cosmetic containing the substance that would spray or release airborne particles of the substance of less than or equal to 10 micrometres in size and where the concentration of the substance in the consumer product or cosmetic is greater than or equal to 1% by weight.

A SNAN is required 90 days before the use of the substance in a significant new activity.

Activities not subject to the Notice

The following activities are not significant new activities:

Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Activities involving the use of the substance as a research and development substance or a site-limited intermediate or an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).

Information to be submitted

The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct risk assessments within 90 days after the complete information is received.

The earlier assessment of the substance identified potential concerns associated with uses of the substance in consumer spray applications or cosmetics that generate respirable airborne particles of less than or equal to 10 micrometres. This alkyl siloxane/silicone elastomer substance is composed of water-insoluble molecules and has a high molecular weight, which can potentially cause pulmonary complications if inhaled. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before a significant new activity is undertaken.

The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Transitional provision

A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured the substance up to 1 000 kg and started activities with it in concentrations that are equal to or greater than 1% by weight in the product matrix. The Notice comes into force immediately. However, if the substance is used to manufacture or distribute for sale consumer products to which the Canada Consumer Product Safety Act applies, or cosmetics as defined in the Food and Drugs Act, which release or spray the substance in airborne particles of less than or equal to 10 micrometres in size, a threshold of more than or equal to 1 000 kg per calendar year applies and a concentration greater than or equal to 1% by weight applies for the period between the publication of the Notice and December 9, 2021. On December 10, 2021, the threshold will be lowered.

Compliance

When assessing whether a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant safety data sheets (SDSs), formerly “material safety data sheets” (MSDSs). More details are contained in the Regulations Amending the New Substances Notification Regulations (Chemicals and Polymers) and the Export of Substances on the Export Control List Regulations for reference to this amendment.

Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to a SNAc notice due to human health or the environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person who is in possession of or that has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of the Act, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance. The Substances Management Advisory Note “ARCHIVED - Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.

Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

For further information, please contact the Substances Management Information Line (eccc.substances.eccc@canada.ca (email), 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).

The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 15 substances specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas the 14 substances identified in Table 1 of the annex below are substances in the Phthalate Substance Grouping identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999, or were otherwise identified as priorities based on other human health concerns;

Whereas 14 additional substances identified in Table 2 of the annex below were not assessed individually, with the exception of DEHP, but were included within the scope of this assessment because of their potential to contribute to cumulative risk from combined exposure to phthalates;

Whereas DEHP is a substance already listed on Schedule 1 of the Canadian Environmental Protection Act, 1999 and was previously found to be harmful to human health, but there was insufficient information to conclude on its potential to cause harm to the environment;

Whereas a summary of the screening assessment conducted on five substances pursuant to paragraphs 68(b) and (c) of the Act and on nine substances pursuant to section 74 of the Act is annexed hereby;

Whereas significant new information for DEHP, which is information related to characterizing environmental risk, has become available and has been analyzed pursuant to section 68 of the Act, is annexed hereby;

And whereas it is concluded that the 14 substances in the Phthalate Substance Grouping identified in Table 1 do not meet any of the criteria set out in section 64 of the Act;

And whereas it is concluded that DEHP meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) are releasing a proposed risk management approach document for DEHP on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.

Notice is also hereby given that the ministers will consider using information-gathering mechanisms, such as those outlined in the Act, to track changes in exposures and commercial activities on 20 phthalate substances.

Notice is further given that the ministers propose to take no further action at this time under section 77 of the Act for DUP in the Phthalate Substance Grouping identified under subsection 73(1) of the Act.

Notice is further given that the ministers propose to take no further action on DIDP in the Phthalate Substance Grouping.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX
Summary of the screening assessment of the Phthalate Substance Grouping

Pursuant to sections 68 and 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of 14 phthalate esters (phthalates), known collectively as the Phthalate Substance Grouping. Substances in this grouping were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. This screening assessment follows the August 2015 publication of four state of the science (SOS) reports and an approach document for cumulative risk assessment (CRA) of phthalates, and it presents information relevant to concluding on the substances in this grouping under section 64 of CEPA.

The Chemical Abstracts Service Registry Numbers (CAS RNfootnote 1), Domestic Substances List (DSL) names and acronyms for phthalates in the Phthalate Substance Grouping screening assessment are listed in the table below.

Table 1: Substances in the Phthalate Substance Grouping
CAS RN DSL name Acronym Subgroup
131-11-3 table a2 note a 1,2-Benzenedicarboxylic acid, dimethyl ester DMP Short-chain
84-69-5 table a2 note a 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester DIBP Medium-chain
5334-09-8 1,2-Benzenedicarboxylic acid, cyclohexyl 2-methylpropyl ester CHIBP Medium-chain
84-64-0 1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester BCHP Medium-chain
84-61-7 1,2-Benzenedicarboxylic acid, dicyclohexyl ester DCHP Medium-chain
523-31-9 1,2-Benzenedicarboxylic acid, bis(phenylmethyl) ester DBzP Medium-chain
68515-40-2 1,2-Benzenedicarboxylic acid, benzyl C7-9-branched and linear alkyl esters B79P Medium-chain
27987-25-3 1,2-Benzenedicarboxylic acid, bis(methylcyclohexyl) ester DMCHP Medium-chain
71888-89-6 table a2 note a 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich DIHepP Medium-chain
27215-22-1 1,2-Benzenedicarboxylic acid, isooctyl phenylmethyl ester BIOP Medium-chain
16883-83-3 1,2-Benzenedicarboxylic acid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl ester B84P Medium-chain
68515-48-0 table a2 note a / 28553-12-0 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich; 1,2-Benzenedicarboxylic acid, diisononyl ester DINP Medium-chain / Long-chain table a2 note b
26761-40-0 / 68515-49-1 table a2 note a 1,2-Benzenedicarboxylic acid, diisodecyl ester; 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich DIDP Long-chain
3648-20-2 1,2-Benzenedicarboxylic acid, diundecyl ester DUP Long-chain

Table a2 note(s)

Table a2 note a

This substance was not identified under subsection 73(1) of CEPA, but was included in this assessment as it was considered a priority on the basis of other human health concerns.

Return to table a2 note a referrer

Table a2 note b

For the purposes of the health review, DINP was included with the medium-chain phthalate esters subgroup, and for the purposes of the ecological review, it was included with the long-chain phthalate subgroup (see Environment Canada, Health Canada 2015c for more details).

Return to table a2 note b referrer

Phthalates in the Phthalate Substance Grouping assessment were divided into short-chain, medium-chain and long-chain subgroups, depending on the length of the carbon backbone in the ester side groups. The primary basis for the subgroups from a health hazard perspective was a structure activity relationship (SAR) analysis using studies related to certain events in the mode of action for phthalate-induced androgen insufficiency during male reproductive development in the rat. From an ecological perspective, subgrouping was based primarily on differences in log Kow and water solubility and their resulting effects on bioaccumulation and ecotoxicity. Phthalates within each subgroup are likely to have similar chemical properties, while toxicological properties are largely, but not exclusively, similar. The above table also identifies the subgroup to which each phthalate in the grouping was assigned.

Fourteen additional phthalates on the DSL were included within the scope of the screening assessment in the context of their potential to contribute to cumulative risk from combined exposure to phthalates. Substance identity information for the additional phthalates considered in this assessment is provided in the table below. Thirteen of the 14 additional phthalates were not assessed individually and therefore no conclusions for them, under section 64 of CEPA, were made. The remaining substance, DEHP, was previously assessed in 1994 under the Priority Substance List (PSL). This previous assessment concluded that DEHP is harmful to human health and meets the criteria under paragraph 64(c) of CEPA. However, at that time, there was insufficient information to provide an ecological conclusion. Information has since become available to support a conclusion on its potential to cause harm to the environment.

Table 2: Additional phthalates considered in the evaluation of cumulative risk
CAS RN DSL name Acronym Subgroup
84-66-2 1,2-Benzenedicarboxylic acid, diethyl ester DEP Short-chain
131-16-8 1,2-Benzenedicarboxylic acid, dipropyl ester DPrP Medium-chain
84-74-2 1,2-Benzenedicarboxylic acid, dibutyl ester DBP Medium-chain
85-68-7 1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester BBP Medium-chain
84-75-3 1,2-Benzenedicarboxylic acid, dihexyl ester DnHP Medium-chain
111381-89-6 1,2-Benzenedicarboxylic acid, heptyl nonyl ester, branched and linear 79P Medium-chain
27554-26-3 1,2-Benzenedicarboxylic acid, diisooctyl ester DIOP Medium-chain
117-81-7 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester DEHP Medium-chain
68648-93-1 1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters 610P Long-chain
117-84-0 1,2-Benzenedicarboxylic acid, dioctyl ester DnOP Long-chain
68515-43-5 1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters D911P Long-chain
111381-91-0 1,2-Benzenedicarboxylic acid, nonyl undecyl ester, branched and linear D911P-2 Long-chain
85507-79-5 1,2-Benzenedicarboxylic acid, diundecyl ester, branched and linear DIUP Long-chain
68515-47-9 1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich DTDP Long-chain

Results from a CEPA section 71 survey for 2012 determined that 6 of the 28 phthalates being considered in the assessment (DINP, DIDP, DUP, DEHP, D911P and DIUP) were manufactured in and/or imported into Canada in quantities greater than 10 000 000 kg/year, while 7 (BCHP, CHIBP, DBzP, DMCHP, BIOP, DnHP and DPrP) were below the reporting threshold of 100 kg/year. Manufacture and import quantities for the remaining 15 phthalates were in the range of 10 000 to 1 000 000 kg/year. Phthalates are used in a variety of consumer, commercial and industrial products in Canada, including plastics, paints and coatings, adhesives and sealants, automotive parts, electronics, and personal care products.

Water is expected to be the primary receiving medium for phthalates, although some release into air may also occur. When released into the environment, short-chain phthalates are predicted to distribute into water, air and soil, while long-chain phthalates will distribute mainly into soil and sediment with lesser proportions present in the water column. Substances in the medium-chain subgroup exhibit a range of physical-chemical properties; therefore, the predicted distribution among environmental media varies across the substances.

Phthalates biodegrade and are not expected to persist in the environment, although degradation rates vary with phthalate molecular size and physicochemical properties, substrate concentration and environmental conditions. Degradation proceeds more slowly under low oxygen conditions, such as may occur in sediment and soil, potentially increasing exposure times for organisms residing in these media. As well, information on Canadian phthalate use and release patterns suggests that exposure to phthalates in the Canadian environment may be continuous. Due to rapid biodegradation, exposure to phthalates will be greatest for organisms inhabiting areas close to release sites.

In the environment, phthalates are bioavailable but do not have high bioaccumulation and biomagnification potential given a high rate of biotransformation in biota. Most long-chain phthalates demonstrate low hazard potential in aquatic and terrestrial species, while short- and medium-chain phthalates exhibit moderate to high hazard potential. While narcosis is an important mode of toxic action for phthalates, particularly under short-term exposure, there is strong evidence that some phthalates may also elicit longer-term chronic adverse effects through other, specific modes of action. In particular, some phthalates may have the ability to affect the normal functioning of endocrine systems in organisms. While strong in vivo evidence of effects on endocrine systems in aquatic organisms has only been demonstrated for a small number of medium-chain phthalates, evidence suggests that many medium-chain phthalates and some short-chain and long-chain phthalates possess properties that could allow them to adversely influence endocrine activity under some conditions.

Results from an analysis of risk quotients comparing estimated potential exposures for individual phthalates (predicted environmental concentration [PEC]) with their potential for adverse effects (predicted no-effect concentration [PNEC]) determined that all 14 phthalates in the Phthalate Substance Grouping present a low risk of causing adverse effects to aquatic species given current exposure levels in the Canadian environment. One additional phthalate, DEHP, has the potential to cause adverse effects in populations of aquatic organisms in Canada at current exposure levels.

In addition, tissue residue analyses were conducted for phthalates having dietary uptake as the primary exposure pathway. The results indicated that maximum tissue concentrations based on solubility limits will be lower than levels associated with adverse acute or chronic lethality effects due to narcosis. A cumulative risk analysis using the Sum of Internal Toxic Units (ITUs) approach determined a highest total ITU value of 0.2. This value was considered to be conservative as it assumed maximum internal tissue concentrations and highest predicted exposure levels for each of the 28 phthalates examined in the assessment. The results indicate there is no ecological concern due to cumulative effects based on lethality and a narcotic mode of action.

For the general population in Canada, exposure estimates derived from biomonitoring data, when available, were compared to environmental media and food exposure estimates. The principal source of exposure to DMP is expected to be breast milk and food, with indoor air and dust also acting as contributors. Dermal and inhalation (aerosol) exposure to personal care products were also evaluated for adults and infants. Sources of exposure for medium-chain phthalates are indoor air, dust, food and breast milk. Given the information received indicating that a portion of these substances in manufactured items may come in contact with skin, exposure scenarios were identified to characterize dermal exposure for adults and infants. Finally, DIBP and DINP may also be present in children’s toys and articles; therefore, oral exposure from mouthing these products was also evaluated. The principal source of exposure to DIDP and DUP for the general population is expected to be house dust (oral ingestion) as well as food and beverages for DIDP (oral ingestion). Exposure scenarios were identified to characterize dermal exposure for adults and children for both long-chain phthalates.

With regard to human health, the health effects data for medium-chain phthalates show that there is evidence of effects in animal studies that includes developmental, reproductive and systemic effects related to the liver and kidneys. Of these, depending on the phthalate in question, the critical effect for risk characterization is developmental effects on males, as the available evidence is strongest for effects on the development of the reproductive system, such as indications of feminization in males, reproductive tract malformations, and effects on fertility related to a relatively well-studied mode of action called the “rat phthalate syndrome” (RPS). This syndrome has been associated with the lowest levels of exposure to this subgroup examined to date in animal studies. The health effects database for short-chain and long-chain phthalate esters shows no evidence of adverse effects on the development of the reproductive system in males. The critical levels selected for risk characterization for DMP were mainly related to mild changes in brain weights after chronic dermal exposure. The health effects database for long-chain phthalates shows that the critical effect for risk characterization is effects on the liver.

Comparisons of estimates of exposure to the 10 medium-chain phthalates in the Phthalate Substance Grouping from various sources, such as environmental media, food, contact with plastic articles (PVC, polyurethane, polyester, etc.), toys and/or personal care products, as well as biomonitoring levels (if available) for all age groups with the appropriate critical effect levels, result in margins of exposure (MOEs) that are considered adequate to address uncertainties in the exposure and health effects databases. Further, these margins are also considered protective of potential reproductive effects not only in males exposed at older life stages but also in females, in addition to effects in other organ systems. Comparisons of estimates of exposure to DMP from environmental media, food, and personal care products, as well as biomonitoring levels for all age groups, with the appropriate critical effect levels, result in MOEs that are considered adequate to address uncertainties in the exposure and health effects databases. Comparisons of estimates for exposure to DIDP and DUP from various sources such as environmental media, food and contact with plastic articles as well as from biomonitoring levels, as available, with critical effect levels result in margins that are considered adequate to address uncertainties in the exposure and health effects databases. Those margins are also protective of potential limited developmental and reproductive effects of DIDP and DUP toxicity not only in males, but also in females, as well as other systemic effects.

Results of the CEPA section 71 industry survey indicate that CHIBP, BCHP and BIOP are not currently in use above the reporting threshold of 100 kg, and the likelihood of exposure to the general population in Canada is considered to be low. Hence, the potential risk to human health is considered to be low for these three substances.

On the basis of the information available, there is evidence that phthalates in the medium-chain subgroup have a common mode of action, as they elicit effects on the developing male reproductive system indicative of RPS. Although the MOEs associated with the original 10 medium-chain phthalates included in this assessment are currently considered adequate on an individual substance basis, these MOEs do not address potential risk from concurrent exposure to these and other similar phthalates. As mentioned above, an additional 5 phthalates (BBP, DBP, DEHP, DnHP, and DIOP) were considered in the evaluation of cumulative risk for human health given information indicating that their mode of action is likely to be similar to that of phthalates in the medium-chain subgroup, as well as evidence that they may represent a potential for exposure to the general population of Canada.

A CRA, using a conservative, lower-tiered hazard index (HI) approach has been conducted and indicates no concern for potential cumulative risk of medium-chain phthalates for the general Canadian population, specifically the more sensitive subpopulations (pregnant women/women of childbearing age, infants, and children) at current exposure levels. The HI values for the three subpopulations with the highest estimated exposure levels are all below 1. Hence, further refinement to a higher-tiered assessment is not necessary at this time.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from the 14 phthalates in the Phthalate Substance Grouping (DMP, DIBP, CHIBP, BCHP, DCHP, DBzP, B79P, DMCHP, DIHepP, BIOP, B84P, DINP, DIDP and DUP). However, there is a risk of harm to the environment from one additional phthalate, DEHP. DEHP was previously assessed by Environment Canada and Health Canada in 1994 under the Priority Substances Assessment Program. The assessment concluded that DEHP is harmful to human health in Canada. However, a conclusion for potential harm to the environment could not be determined at that time because of insufficient information.

It is concluded that the 14 substances in the Phthalate Substance Grouping do not meet the criteria under paragraph 64(a) or (b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is concluded that DEHP meets the criteria under paragraph 64(a) of CEPA as it is entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. However, it is concluded that DEHP does not meet the criteria under paragraph 64(b) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends.

On the basis of the information presented in this screening assessment, it is concluded that all 14 phthalates in the Phthalate Substance Grouping do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Also, the previous conclusion made in the 1994 PSL assessment of DEHP, that it meets the criteria under paragraph 64(c) of CEPA, remains valid.

Overall conclusion

It is concluded that DEHP meets one or more of the criteria set out in section 64 of CEPA, and that the other 14 substances in the phthalate substance grouping do not meet any of the criteria set out in section 64 of CEPA.

DEHP has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

Consideration for follow-up

While exposure of the general population and the environment to 20 of the 28 substances is not of concern at current levels, these substances are associated with human health or ecological effects of concern. Therefore, there may be concern if exposure levels were to increase. Follow-up activities may involve including the substance in future information gathering initiatives, such as a mandatory survey under section 71 of CEPA.

The Government will use the data gathered through these follow-up activities to prioritize further information gathering or risk assessment of these substances, if required.

The screening assessment and the risk management approach document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Proposed guidelines for Canadian drinking water quality — Guidance on waterborne pathogens

Pursuant to subsection 55(3) of the Canadian Environmental Protection Act, 1999, the Minister of Health hereby gives notice of proposed guidance on waterborne pathogens. The proposed guidance document will be available from December 5, 2020, to February 3, 2021, on the Health Canada consultation web page. Any person may, within 60 days after publication of this notice, file with the Minister of Health written comments on the proposed document. Comments must be sent by email at HC.water-eau.SC@canada.ca.

December 5, 2020

David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Executive summary

Many types of pathogenic microorganisms can spread through contaminated or inadequately treated drinking water to cause human illness. Some are present in human or animal feces and can cause gastrointestinal illness when fecally contaminated water is consumed. Others are naturally found in aquatic environments and can cause opportunistic infections when the conditions in engineered water systems allow them to multiply and spread primarily to individuals who are susceptible to infection. The health effects caused by these opportunistic pathogens are diverse and range from respiratory illness to infections of the eye, skin, central nervous system or gastrointestinal tract.

A basic understanding of the different types of waterborne pathogens — their sources, the measures that are important for their control and the people that are most at risk of becoming sick — is necessary for effective drinking water management and for preventing outbreaks of waterborne disease. Health Canada completed its review of waterborne pathogens of potential human health concern. This guidance document was prepared in collaboration with the Federal-Provincial-Territorial Committee on Drinking Water and describes these organisms, their health effects, how they are transmitted and best practices to ensure safe drinking water.

Assessment

Setting maximum acceptable concentrations for the pathogens described in this document remains impractical and is not necessary in order for drinking water utilities to adequately manage risks. Implementing a source-to-tap approach is a universally recommended strategy for reducing the concentration of waterborne pathogens in drinking water and controlling their potential risks. Important elements of this strategy include source water protection, treatment and disinfection requirements based on health-based treatment goals for enteric protozoa (Giardia and Cryptosporidium) and enteric viruses, and managing microorganism survival and growth in drinking water distribution systems. Maintaining microbiological control in water systems in buildings and residences is also a critical component of providing safe drinking water at the consumer’s tap. The intent of this document is to provide stakeholders, such as provincial and territorial regulatory authorities, decision makers, water system owners and operators and consultants with guidance on waterborne pathogens that are not addressed in the guidelines for Canadian drinking water quality, with the objective of minimizing public health risks in Canadian water systems.

International considerations

Drinking water guidelines, standards and/or guidance from other national and international organizations may vary due to the date of the assessments as well as differing policies and approaches.

International organizations have not established numerical limits for these waterborne pathogens in drinking water. The United States Environmental Protection Agency, the World Health Organization (WHO), the European Union and the Australian National Health and Medical Research Council all recommend a risk management strategy based on a multiple barrier approach to prevent the entry and transmission of these waterborne pathogens. The WHO and Australia have developed fact sheets providing information on waterborne pathogens that may contaminate the water supply.

DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH ACT

Notice of annual increase of Health Canada’s Drug Master Files and Certificate of Pharmaceutical Product fees

Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, updates the fees that are payable for the provision of Drug Master Files and Certificate of Pharmaceutical Product services by 2%.

The current fees and the fees updated as of April 1, 2021, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).

Services Fee as of April 1, 2020 Fee as of April 1, 2021
Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) $92 $94
New Master Files (file registration) $1,273 $1,298
Drug Master Files — letter of access $180 $184
Drug Master Files — update $552 $563

DEPARTMENT OF HEALTH

FINANCIAL ADMINISTRATION ACT

Notice of annual adjustment of fees for dealer’s licences

Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the Fees in Respect of Dealer’s Licences Regulations, the fee for Dealer’s Licences: Human Drugs will increase by the annual 2% amount, rounded up to the nearest dollar. Under section 17.1 of the Service Fees Act (a fee is adjusted in each fiscal year — on the anniversary of a date that is selected by the responsible authority with respect to the fee before the first adjustment — by the percentage change over 12 months in the April All-items Consumer Price Index (CPI) for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year), the Dealer’s Licence: Veterinary Drugs (as per the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations) will be adjusted by the CPI. Health Canada has chosen April 1 as the anniversary date. The CPI is -0.2%.

The current fees and the fees updated as of April 1, 2021, are listed below.

Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).

  Fee as of April 1, 2020 Fee as of April 1, 2021
Dealer’s Licence (human drugs) $5,394 $5,502
Dealer’s Licence (veterinary drugs) $1,824.27 $1,820.62

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of annual adjustment of the Fees in Respect of Drugs and Medical Devices Order

Notice is hereby given, under subsection 30.61(1) of the Food and Drugs Act, that in keeping with section 4.1 of the 2020 Fees in Respect of Drugs and Medical Devices Order, every fee outlined in the Order is to be adjusted annually by the Consumer Price Index (CPI). The CPI is calculated based on the percentage change over 12 months in the April All-items CPI for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year. The CPI for this year is -0.2%.

Most fees in the Fees in Respect of Drugs and Medical Devices Order are currently being phased in over four or seven years.

The current fees and the fees updated as of April 1, 2021, are listed below.

Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).

Human Drug Submission Review
Fees for Examination of a Submission — Drugs for Human Use — Schedule 1
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
New Active Substance 9 $400,288 $437,009
Clinical or Non-Clinical Data and Chemistry and Manufacturing Data 9 $204,197 $224,242
Clinical or Non-Clinical Data Only 9 $90,864 $95,796
Comparative Studies 9 $53,836 $55,737
Chemistry and Manufacturing Data Only 9 $27,587 $30,609
Clinical or non-clinical data only, in support of safety updates to the labelling 9 $19,442 $19,404
Labelling Only 9 $3,816 $4,320
Labelling Only (Generic drugs) 9 $2,010 $2,006
Administrative Submission 9 $432 $539
Disinfectant — Full Review 9 $5,712 $7,126
Labelling Only (Disinfectants) 9 $2,507 $2,502
Drug Identification Number Application — Labelling Standard 9 $1,616 $1,613
Fees for Examination of a Submission — Drugs for Veterinary Use Only — Schedule 2
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
DIN application
Information, other than that referred to in the item below, to support an application for a drug identification number, including the submission of labelling material for a second review, if required 21 $918 $1,146
Published references or other data 21 $638 $797
Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug 21 $320 $400
Notification — Veterinary health product
Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product 21 $486 $486
New drug submissions (NDS)
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species) 21 $20,375 $25,419
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species 21 $12,342 $15,398
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species 21 $29,631 $36,966
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species 21 $40,125 $50,057
Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration 21 $3,698 $4,614
Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength 21 $612 $764
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1 000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 21 $27,783 $34,660
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1 000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 21 $37,040 $46,208
For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration 21 $3,698 $4,614
For food-producing animals (once an acceptable daily intake with a safety factor of 1 000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species 21 $18,513 $23,096
Chemistry and manufacturing data for a non compendial medicinal ingredient of a drug 21 $6,171 $7,700
Chemistry and manufacturing data to support one strength of a single dosage form 21 $6,171 $7,700
Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the item above 21 $3,086 $3,851
Documentation to support a change of manufacturer 21 $320 $400
Supplement to a new drug submission (SNDS)
Efficacy data to support an additional indication in one animal species 21 $16,053 $20,027
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species 21 $12,342 $15,398
Efficacy and safety data (in the intended species) to support an indication in another animal species 21 $20,375 $25,419
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species 21 $29,631 $36,966
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species 21 $40,125 $50,057
Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species 21 $9,869 $12,312
Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration 21 $3,698 $4,614
Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength 21 $612 $764
For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species 21 $3,698 $4,614
For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species 21 $18,513 $23,096
For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period 21 $9,257 $11,548
For the concurrent use of two drugs in a species of food-producing animal, residue depletion studies to determine if an extension to existing withdrawal periods is required 21 $7,409 $9,243
Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process 21 $6,171 $7,700
Chemistry and manufacturing data to support a change in formulation or dosage form 21 $3,086 $3,851
Chemistry and manufacturing data to support a change in the packaging or sterilization process 21 $2,462 $3,072
Chemistry and manufacturing data to support an extension of the expiry date 21 $1,850 $2,309
Chemistry and manufacturing data to support the concurrent use of two drugs 21 $1,850 $2,309
Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form 21 $612 $764
Documentation to support a change to the brand name of a drug 21 $320 $400
Abbreviated new drug submission (ANDS) or supplement to an abbreviated new drug submission (SANDS)
Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form 21 $3,698 $4,614
For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product 21 $3,698 $4,614
Chemistry and manufacturing data for a non compendial medicinal ingredient of a drug 21 $6,171 $7,700
Chemistry and manufacturing data to support a single dosage form 21 $6,171 $7,700

Documentation to support

(a) a change of manufacturer, in the case of an abbreviated new drug submission;

or

(b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission

 21 $320 $400
Preclinical (investigational) new drug submission (IND)
Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species 21 $6,171 $7,700
Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated 21 $4,935 $6,157
For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 21 $18,513 $23,096
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1 000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 21 $27,783 $34,660
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1 000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species 21 $37,040 $46,208
For food-producing animals (once an acceptable daily intake with a safety factor of 1 000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species 21 $9,257 $11,548
Chemistry and manufacturing data to support a single dosage form containing a non compendial medicinal ingredient 21 $6,171 $7,700
Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient 21 $3,086 $3,851
Emergency drug sale
Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal 21 $51 $51
Information and material to support the sale of a new drug to be used in the emergency treatment of a food producing animal 21 $102 $102
Experimental studies certificate
Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food producing animal 21 $980 $979
Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food producing animal 21 $490 $490
Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal 21 $2,958 $2,953
Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal 21 $490 $490
Notifiable change or protocol review
Information and material to support an application for a Notifiable change 21 $1,658 $2,069
A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate 21 $1,658 $2,069
Fees for Examination of an Application for an Establishment Licence — Drugs for Human Use — Schedule 3
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
Fabrication — Sterile Dosage Form 33 and 41 $41,626 $41,647
Importation 34 and 42 $27,359 $28,975
Fabrication—Non-Sterile Dosage Form 35 and 43 $27,000 $28,308
Distribution 36 and 44 $12,560 $13,855
Wholesaling 37 and 45 $4,937 $6,159
Packaging/Labelling 38 and 46 $6,061 $6,049
Testing 39 and 47 $2,560 $3,194
Foreign Site (each) 40 $918 $917
Fees for Examination of an Application for an Establishment Licence — Drugs for Veterinary Use Only — Schedule 4
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
Fabrication — Sterile Dosage Form 33 and 41 $40,198 $40,407
Importation 34 and 42 $10,715 $13,367
Fabrication — Non-Sterile Dosage Form 35 and 43 $8,782 $10,957
Distribution 36 and 44 $4,835 $6,031
Wholesaling 37 and 45 $1,933 $2,412
Packaging/Labelling 38 and 46 $6,061 $6,049
Testing 39 and 47 $1,315 $1,641
Foreign Site (each) 40 $765 $917
Fees for Right to Sell Drugs for Human Use — Schedule 6
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
Disinfectant 52 $1,285 $1,342
Non-Prescription 52 $1,623 $2,018
Drug other than one referred to in item 1 or 2 (above) 52 $1,836 $2,749
Fees for Right to Sell Drugs for Veterinary Use Only — Schedule 7
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 2 - DRUGS
Veterinary Drug 56 $312 $367
Fees for Examination of an Application for a Medical Device Licence — Schedule 8
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 3 – MEDICAL DEVICES
Applications for Class II licence 60 $450 $478
Applications for Class II licence amendment 60 $272 $272
Applications for Class III licence 60 $7,477 $8,895
Applications for Class III licence (near patient) 60 $12,851 $16,032
Applications for Class III licence amendment — changes in manufacturing 60 $1,903 $2,375
Applications for Class III licence amendment — significant changes not related to manufacturing 60 $6,608 $7,543
Applications for Class IV licence 60 $24,345 $24,699
Applications for Class IV licence amendment — changes in manufacturing 60 $1,903 $2,375
Applications for Class IV licence amendment — significant changes not related to manufacturing 60 $8,057 $9,964
Applications for Class II, Class III or Class IV licence or licence amendment — private label medical device 60 $147 $147
Fees for Examination of an Application for an Establishment Licence — Medical Devices
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 3 – MEDICAL DEVICES
Medical Device 71 $4,590 $4,581
Fees for Right to Sell Licensed Class II, III or IV Medical Devices
Fee Category Section in Fees in Respect of Drugs and Medical Devices Order Fee as of April 1, 2020 Fee as of April 1, 2021
PART 3 – MEDICAL DEVICES
Medical Device 77 $381 $381

DEPARTMENT OF HEALTH

PATENT ACT

Notice of annual increase of fee pursuant to Certificate of Supplementary Protection Regulations

Notice is hereby given that, in keeping with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee will increase by the annual 2% amount, rounded up to the nearest dollar.

The current fee and the fee updated as of April 1, 2021, are listed below.

Any inquiries or comments about the updated fee can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).

  Subsection in Certificate of Supplementary Protection Regulations Fee as of April 1, 2020 Fee as of April 1, 2021
Certificate of supplementary protection 9(1) $9,564 $9,756

DEPARTMENT OF FOREIGN AFFAIRS, TRADE AND DEVELOPMENT

STATE IMMUNITY ACT

Order Accepting the Recommendation of the Minister of Foreign Affairs Concerning the Two-Year Review of the List of State Supporters of Terrorism

Whereas subsection 6.1(7)footnote d of the State Immunity Actfootnote e requires that the Minister of Foreign Affairs review the list established under subsection 6.1(2)footnote d of that Act in consultation with the Minister of Public Safety and Emergency Preparedness two years after its establishment and every two years after that to determine if there are still reasonable grounds, as set out in that subsection 6.1(2), for the foreign state set out on the list to remain set out on the list;

Whereas, on September 7, 2018, six years had elapsed since the establishment of a list by the Order Establishing a List of Foreign State Supporters of Terrorismfootnote f pursuant to subsection 6.1(2)footnote d of the State Immunity Act footnote e;

And whereas, pursuant to subsection 6.1(7)footnote d of the State Immunity Act footnote e, the Minister of Foreign Affairs, in consultation with the Minister of Public Safety and Emergency Preparedness, reviewed the list as it existed on September 7, 2018;

Therefore, notice is given, pursuant to subsection 6.1(9)footnote d of the State Immunity Act footnote e, that the Minister of Foreign Affairs completed the review and that the Islamic Republic of Iran and the Syrian Arab Republic will remain listed as foreign state supporters of terrorism in the schedule to the Order Establishing a List of Foreign State Supporters of Terrorism footnote f.

Ottawa, November 20, 2020

François-Philippe Champagne
Minister of Foreign Affairs

DEPARTMENT OF TRANSPORT

AERONAUTICS ACT

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 14

Whereas the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 14 is required to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public;

Whereas the provisions of the annexed Order may be contained in a regulation made pursuant to sections 4.71footnote g and 4.9footnote h, paragraphs 7.6(1)(a)footnote i and (b)footnote j and section 7.7footnote k of the Aeronautics Actfootnote l;

Whereas, pursuant to subsection 6.41(1.1)footnote m of the Aeronautics Actfootnote l, the Minister of Transport authorized the Deputy Minister of Transport to make an interim order that contains any provision that may be contained in a regulation made under Part I of that Act to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public;

And whereas, pursuant to subsection 6.41(1.2)footnote m of that Act, the Deputy Minister of Transport has consulted with the persons and organizations that that Deputy Minister considers appropriate in the circumstances before making the annexed Order;

Therefore, the Deputy Minister of Transport, pursuant to subsection 6.41(1.1)footnote m of the Aeronautics Actfootnote l, makes the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 14.

Ottawa, November 23, 2020

Michael Keenan
Deputy Minister of Transport

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 14

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

aerodrome security personnel
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (personnel de sûreté de l’aérodrome)
air carrier
means any person who operates a commercial air service under Subpart 1, 3, 4 or 5 of Part VII of the Regulations. (transporteur aérien)
checked baggage
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (bagages enregistrés)
COVID-19
means the coronavirus disease 2019. (COVID-19)
document of entitlement
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (document d’autorisation)
elevated temperature
means a temperature within the range set out in the standards. (température élevée)
foreign national
means a person who is not a Canadian citizen or a permanent resident and includes a stateless person. (étranger)
non-passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des non-passagers)
passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des passagers)
peace officer
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (agent de la paix)
Regulations
means the Canadian Aviation Regulations. (Règlement)
restricted area
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (zone réglementée)
screening officer
has the same meaning as in section 2 of the Canadian Air Transport Security Authority Act. (agent de contrôle)
standards
means the document entitled the Transport Canada Temperature Screening Standards, published by the Minister, as amended from time to time. (normes)

Interpretation

(2) Unless the context requires otherwise, all other words and expressions used in this Interim Order have the same meaning as in the Regulations.

Conflict

(3) In the event of a conflict between this Interim Order and the Regulations or the Canadian Aviation Security Regulations, 2012, the Interim Order prevails.

Definition of face mask

(4) For the purposes of this Interim Order, a face mask means any non-medical mask or face covering that meets all of the following requirements:

Face masks — lip reading

(5) Despite paragraph (4)(a), the portion of a face mask in front of a wearer’s lips may be made of transparent material that permits lip reading if

Notification

Federal, provincial and territorial measures

2 (1) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be subject to a measure to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

Quarantine Act Order — other country except United States

(2) A private operator or air carrier operating a flight to Canada departing from any other country except the United States must notify every foreign national boarding the aircraft for the flight that they may be prohibited from entering Canada under the Order made by the Governor General in Council, under the Quarantine Act, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country other than the United States).

Quarantine Act Order — United States

(3) A private operator or air carrier operating a flight to Canada departing from the United States must notify every foreign national boarding the aircraft for the flight that they may be prohibited from entering Canada under the Order made by the Governor General in Council, under the Quarantine Act, entitled Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States).

Quarantine plan

(4) A private operator or air carrier operating a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that the person may be required, under an order made under section 58 of the Quarantine Act, to provide to the Minister of Health, before boarding the aircraft and by the electronic means specified by that Minister, a quarantine plan or contact information.

False declarations

(5) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be liable to a monetary penalty if they provide a confirmation referred to in subsection 3(1), (2) or (3) that they know to be false or misleading.

Confirmation

Federal, provincial and territorial measures

3 (1) Before boarding an aircraft for a flight between two points in Canada or a flight to Canada departing from any other country, every person must confirm to the private operator or air carrier operating the flight that they understand that they may be subject to a measure to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

Quarantine Act Order — other country except United States

(2) Before boarding an aircraft for a flight to Canada departing from any other country except the United States, a foreign national must confirm to the private operator or air carrier operating the flight that, to the best of their knowledge, they are not prohibited from entering Canada under the Order referred to in subsection 2(2).

Quarantine Act Order — United States

(3) Before boarding an aircraft for a flight to Canada departing from the United States, a foreign national must confirm to the private operator or air carrier operating the flight that, to the best of their knowledge, they are not prohibited from entering Canada under the Order referred to in subsection 2(3).

False declaration

(4) A person must not provide a confirmation under subsection (1), (2) or (3) that they know to be false or misleading.

Exception

(5) A competent adult may provide a confirmation referred to in subsection (1), (2) or (3) on behalf of a person who is not a competent adult.

Prohibition

4 A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must not permit a person to board the aircraft for the flight if the person is a competent adult and does not provide a confirmation that they are required to provide under subsection 3(1), (2) or (3).

Foreign Nationals

Prohibition

5 A private operator or air carrier must not permit a foreign national to board an aircraft for a flight that the private operator or air carrier operates to Canada departing from any other country.

Exception

6 Section 5 does not apply to a foreign national who is permitted to enter Canada under an order referred to in subsection 2(2) or (3).

Health Check

Non-application

7 Sections 8 to 10 do not apply to either of the following persons:

Health check

8 (1) A private operator or air carrier must conduct a health check of every person boarding an aircraft for a flight that the private operator or air carrier operates by asking questions to verify whether they exhibit any of the following symptoms:

Notification

(2) A private operator or air carrier must notify every person boarding an aircraft for a flight that the private operator or air carrier operates that the person may not be permitted to board the aircraft if

Confirmation

(3) Every person boarding an aircraft for a flight that a private operator or air carrier operates must confirm to the private operator or air carrier that none of the following situations apply to them:

False declaration — obligation of private operator or air carrier

(4) The private operator or air carrier must advise every person that they may be liable to a monetary penalty if they provide answers, with respect to the health check or a confirmation, that they know to be false or misleading.

False declaration — obligations of person

(5) A person who, under subsections (1) and (3), is subjected to a health check and is required to provide a confirmation must

Exception

(6) A competent adult may answer all questions and provide a confirmation on behalf of a person who is not a competent adult and who, under subsections (1) and (3), is subjected to a health check and is required to give a confirmation.

Observations — private operator or air carrier

(7) During the boarding process for a flight that the private operator or air carrier operates, the private operator or air carrier must observe whether any person boarding the aircraft is exhibiting any symptoms referred to in subsection (1).

Prohibition

9 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Period of 14 days

10 A person who is not permitted to board an aircraft under section 9 is not permitted to board another aircraft for a period of 14 days after the refusal, unless they provide a medical certificate certifying that any symptoms referred to in subsection 8(1) that they are exhibiting are not related to COVID-19.

Temperature Screening — Flights to Canada

Application

11 (1) Sections 12 to 19 apply to an air carrier operating a flight to Canada departing from any other country and to every person boarding an aircraft for such a flight.

Non-application

(2) Sections 12 to 19 do not apply to either of the following persons:

Requirement

12 (1) Subject to subsection 19(2), an air carrier must conduct a temperature screening of every person boarding an aircraft for a flight that the air carrier operates. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) The air carrier must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Notification

13 (1) An air carrier must notify every person boarding an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation

(2) Before boarding an aircraft for a flight, every person must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

14 (1) If the temperature screening conducted under subsection 12(2) indicates that the person has an elevated temperature, the air carrier must

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the air carrier must not permit the person to board the aircraft.

Period of 14 days

15 A person who is not permitted to board an aircraft under section 14 is not permitted to board another aircraft for a flight to Canada for a period of 14 days after the refusal, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

16 An air carrier must calibrate and maintain the equipment that it uses to conduct temperature screenings under subsection 12(2) to ensure that the equipment is in proper operating condition.

Requirement — training

17 An air carrier must ensure that the person using the equipment to conduct temperature screenings under subsection 12(2) has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

18 (1) An air carrier must keep a record of the following information in respect of each flight it operates:

Record keeping — training

(2) An air carrier must keep a record of the name of every person who has received training under section 17, as well as the contents of the training.

Retention period

(3) The air carrier must retain the records referred to in subsection (1) for a period of 90 days after the day of the flight.

Ministerial access

(4) The air carrier must make the records referred to in subsections (1) and (2) available to the Minister on request.

Definition of authorized person

19 (1) For the purposes of this section, authorized person means a person authorized by a competent authority to conduct temperature screenings at an aerodrome located outside of Canada.

Exception

(2) An air carrier may rely on an authorized person to conduct the temperature screening under subsection 12(1), in which case subsection 12(2) and sections 13, 14, and 16 to 18 do not apply to that air carrier.

Notification

(3) The air carrier must notify every person boarding the aircraft for the flight that they are not permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Period of 14 days

(4) If the temperature screening indicates that a person has an elevated temperature, that person is not permitted to board an aircraft for a flight to Canada for a period of 14 days after the temperature screening, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Equipment

(5) The air carrier must ensure that the equipment used to conduct those temperature screenings is calibrated and maintained so that the equipment is in proper operating condition.

Temperature Screening — Aerodromes in Canada

Definition of screening authority

20 (1) For the purposes of this section and sections 21 to 31, screening authority has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012.

Application

(2) Sections 21 to 31 apply to all of the following persons:

Non-application

(3) Sections 21 to 31 do not apply to any of the following persons:

Requirement

21 A person entering a restricted area within an air terminal building from a non-restricted area within the air terminal building must do so at a passenger screening checkpoint or non-passenger screening checkpoint.

Requirement — temperature screening

22 (1) A screening authority must conduct a temperature screening of every person who presents themselves at a passenger screening checkpoint or non-passenger screening checkpoint within an air terminal building for the purpose of entering a restricted area from a non-restricted area and of every person undergoing a screening at a non-passenger screening checkpoint outside an air terminal building. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) Following a rest period of 10 minutes, the screening authority must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Notification — consequence of elevated temperature

23 (1) An air carrier must notify every person, other than a crew member, who intends to board an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation — consequence of elevated temperature

(2) Before passing beyond a passenger screening checkpoint to board an aircraft for a flight, every person other than a crew member must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

24 (1) If the temperature screening conducted under subsection 22(2) indicates that the person has an elevated temperature, the screening authority must

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the screening authority must deny them entry to the restricted area.

Period of 14 days

25 A person who is denied entry to the restricted area under section 24 is not permitted to enter a restricted area at any aerodrome in Canada for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Denial — person intending to board aircraft

26 (1) If, under section 24, a screening authority denies entry to a restricted area to a person who intends to board an aircraft for a flight, other than a crew member, the screening authority must, for the purpose of paragraph 26(4)(a), notify the air carrier operating the flight that that person has been denied entry to the restricted area and provide the person’s name and flight number to the air carrier.

Denial — person not intending to board aircraft

(2) If, under section 24, a screening authority denies entry to a restricted area to a person who does not intend to board an aircraft for a flight, the screening authority must, for the purpose of subsection 26(5), provide the following information to the operator of the aerodrome:

Denial — crew member

(3) If, under section 24, a screening authority denies entry to a restricted area to a crew member, the screening authority must provide the information referred to in subsection (2) to the air carrier for the purpose of allowing the air carrier to assign a replacement crew member, if necessary.

Denial — air carrier requirements

(4) An air carrier that has been notified under subsection (1) must

Denial — aerodrome operator requirement

(5) The operator of an aerodrome that has been notified under subsection (2) must suspend the person’s restricted area entry privileges for a period of 14 days after the person was denied entry to the restricted area, unless the person provides a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — restricted area

(6) If, under section 24, a screening authority denies entry to a restricted area to a crew member or to a person who does not intend to board an aircraft for a flight, the crew member or that person must not present themselves at a passenger screening checkpoint or non-passenger screening checkpoint at any aerodrome for the purpose of entering a restricted area for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

27 A screening authority must ensure that the equipment that it uses to conduct temperature screenings under section 22 is calibrated and maintained so that the equipment is in proper operating condition.

Requirement — training

28 A screening authority must ensure that the person using the equipment to conduct temperature screenings under section 22 has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

29 (1) A screening authority must keep a record of the following information with respect to any temperature screening it conducts:

Record keeping — training

(2) The screening authority must keep a record of the name of every person who has received training under section 28, as well as the contents of the training.

Ministerial access

(3) The screening authority must make the records referred to in subsections (1) and (2) available to the Minister on request.

Temperature screening facilities

30 The operator of an aerodrome must make facilities available for temperature screening that are accessible without having to enter a restricted area.

Requirement — air carrier representative

31 An air carrier must ensure that the screening authority at the aerodrome has been provided with the name and telephone number of the on-duty representative of the air carrier for the purpose of facilitating the return of checked baggage to persons who are denied entry to a restricted area under section 24.

Face Masks

Non-application

32 (1) Sections 33 to 38 do not apply to any of the following persons:

Face mask readily available

(2) An adult responsible for a child who is at least two years of age but less than six years of age must ensure that a face mask is readily available to the child prior to boarding an aircraft for a flight.

Wearing of face mask

(3) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 35 and complies with any instructions given by a gate agent under section 36 if the child

Notification

33 A private operator or air carrier must notify every person who intends to board an aircraft for a flight that the private operator or air carrier operates that the person must

Obligation to possess face mask

34 Every person who is at least six years of age must be in possession of a face mask prior to boarding an aircraft for a flight.

Wearing of face mask — persons

35 (1) Subject to subsections (2) to (3), a private operator or air carrier must require a person to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — person

(2) Subsection (1) does not apply

Exceptions — flight deck

(3) Subsection (1) does not apply to any of the following persons when they are on the flight deck:

Compliance

36 A person must comply with any instructions given by a gate agent, a member of the aerodrome security personnel or a crew member with respect to wearing a face mask.

Prohibition — private operator or air carrier

37 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Refusal to comply

38 If, during a flight that a private operator or air carrier operates, a person refuses to comply with an instruction given by a crew member with respect to wearing a face mask, the private operator or air carrier must

Wearing of face mask — crew member

39 (1) Subject to subsections (2) to (3), a private operator or air carrier must require a crew member to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — crew member

(2) Subsection (1) does not apply

Exception — flight deck

(3) Subsection (1) does not apply to a crew member who is a flight crew member when they are on the flight deck.

Wearing of face mask — gate agent

40 (1) Subject to subsections (2) and (3), a private operator or air carrier must require a gate agent to wear a face mask during the boarding process for a flight that the private operator or air carrier operates.

Exceptions

(2) Subsection (1) does not apply

Exception — physical barrier

(3) During the boarding process, subsection (1) does not apply to a gate agent if the gate agent is separated from any other person by a physical barrier that allows the gate agent and the other person to interact and reduces the risk of exposure to COVID-19.

Deplaning

Non-application

41 (1) Section 42 does not apply to any of the following persons:

Wearing of face mask

(2) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 42 if the child

Wearing of face mask — person

42 A person who is on board an aircraft must wear a face mask at all times from the moment the doors of the aircraft are opened until the person enters the air terminal building, including by a passenger loading bridge.

Screening Authority

Definition of screening authority

43 (1) For the purposes of sections 44 and 47, screening authority means a person responsible for the screening of persons and goods at an aerodrome set out in the schedule to the CATSA Aerodrome Designation Regulations or at any other place designated by the Minister under subsection 6(1.1) of the Canadian Air Transport Security Authority Act.

Non-application

(2) Sections 44 to 47 do not apply to any of the following persons:

Wearing of face mask

(3) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under subsection 44(2) and removes it when required by a screening officer to do so under subsection 44(3) if the child

Requirement — passenger screening checkpoint

44 (1) A screening authority must notify a person who is subject to screening at a passenger screening checkpoint that they must wear a face mask at all times during screening.

Wearing of face mask — person

(2) Subject to subsection (3), a person who is the subject of screening referred to in subsection (1) must wear a face mask at all times during screening.

Requirement to remove face mask

(3) A person who is required by a screening officer to remove their face mask during screening must do so.

Wearing of face mask — screening officer

(4) A screening officer must wear a face mask at a passenger screening checkpoint when conducting the screening of a person if, during the screening, the screening officer is two metres or less from the person being screened.

Requirement — non-passenger screening checkpoint

45 (1) A person who presents themselves at a non-passenger screening checkpoint to enter into a restricted area must wear a face mask at all times.

Wearing of face mask — screening officer

(2) Subject to subsection (3), a screening officer must wear a face mask at all times at a non-passenger screening checkpoint.

Exceptions

(3) Subsection (2) does not apply

Exception — physical barrier

46 Sections 44 and 45 do not apply to a person, including a screening officer, if the person is two metres or less from another person and both persons are separated by a physical barrier that allows them to interact and reduces the risk of exposure to COVID-19.

Prohibition — passenger screening checkpoint

47 (1) A screening authority must not permit a person who has been notified to wear a face mask and refuses to do so to pass beyond a passenger screening checkpoint into a restricted area.

Prohibition — non-passenger screening checkpoint

(2) A screening authority must not permit a person who refuses to wear a face mask to pass beyond a non-passenger screening checkpoint into a restricted area.

Designated Provisions

Designation

48 (1) The provisions of this Interim Order set out in column 1 of Schedule 2 are designated as provisions the contravention of which may be dealt with under and in accordance with the procedure set out in sections 7.7 to 8.2 of the Act.

Maximum amounts

(2) The amounts set out in column 2 of Schedule 2 are the maximum amounts of the penalty payable in respect of a contravention of the designated provisions set out in column 1.

Notice

(3) A notice referred to in subsection 7.7(1) of the Act must be in writing and must specify

Repeal

49 The Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 13, made on November 10, 2020, is repealed.

SCHEDULE 1

(Subsection 20(2))

Aerodromes
Name ICAO Location Indicator
Calgary International Airport CYYC
Edmonton International Airport CYEG
Halifax / Robert L. Stanfield International Airport CYHZ
Kelowna International Airport CYLW
Montréal / Pierre Elliott Trudeau International Airport CYUL
Ottawa / Macdonald-Cartier International Airport CYOW
Québec / Jean Lesage International Airport CYQB
Regina International Airport CYQR
Saskatoon / John G. Diefenbaker International Airport CYXE
St. John’s International Airport CYYT
Toronto / Billy Bishop Toronto City Airport CYTZ
Toronto / Lester B. Pearson International Airport CYYZ
Vancouver International Airport CYVR
Victoria International Airport CYYJ
Winnipeg / James Armstrong Richardson International Airport CYWG

SCHEDULE 2

(Subsections 48(1) and (2))

Designated Provisions

Column 1

Designated Provision

Column 2

Maximum Amount of Penalty ($)

Individual

Corporation
Subsection 2(1) 5,000 25,000
Subsection 2(2) 5,000 25,000
Subsection 2(3) 5,000 25,000
Subsection 2(4) 5,000 25,000
Subsection 2(5) 5,000 25,000
Subsection 3(1) 5,000  
Subsection 3(2) 5,000  
Subsection 3(3) 5,000  
Subsection 3(4) 5,000  
Section 4 5,000 25,000
Section 5 5,000 25,000
Subsection 8(1) 5,000 25,000
Subsection 8(2) 5,000 25,000
Subsection 8(3) 5,000  
Subsection 8(4) 5,000 25,000
Subsection 8(5) 5,000  
Subsection 8(7) 5,000 25,000
Section 9 5,000 25,000
Section 10 5,000  
Subsection 12(1)   25,000
Subsection 12(2)   25,000
Subsection 13(1)   25,000
Subsection 13(2) 5,000  
Subsection 14(1)   25,000
Subsection 14(2)   25,000
Section 15 5,000  
Section 16   25,000
Section 17   25,000
Subsection 18(1)   25,000
Subsection 18(2)   25,000
Subsection 18(3)   25,000
Subsection 18(4)   25,000
Subsection 19(3)   25,000
Subsection 19(4) 5,000  
Subsection 19(5)   25,000
Section 21 5,000  
Subsection 22(1)   25,000
Subsection 22(2)   25,000
Subsection 23(1)   25,000
Subsection 23(2) 5,000  
Subsection 24(1)   25,000
Subsection 24(2)   25,000
Section 25 5,000  
Subsection 26(1)   25,000
Subsection 26(2)   25,000
Subsection 26(3)   25,000
Subsection 26(4)   25,000
Subsection 26(5)   25,000
Subsection 26(6) 5,000  
Section 27   25,000
Section 28   25,000
Subsection 29(1)   25,000
Subsection 29(2)   25,000
Subsection 29(3)   25,000
Section 30   25,000
Section 31   25,000
Subsection 32(2) 5,000  
Subsection 32(3) 5,000  
Section 33 5,000 25,000
Section 34 5,000  
Subsection 35(1) 5,000 25,000
Section 36 5,000  
Section 37 5,000 25,000
Section 38 5,000 25,000
Subsection 39(1) 5,000 25,000
Subsection 40(1) 5,000 25,000
Subsection 41(2) 5,000  
Section 42 5,000  
Subsection 43(3) 5,000  
Subsection 44(1)   25,000
Subsection 44(2) 5,000  
Subsection 44(3) 5,000  
Subsection 44(4) 5,000  
Subsection 45(1) 5,000  
Subsection 45(2) 5,000  
Subsection 47(1)   25,000
Subsection 47(2)   25,000

INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA

RADIOCOMMUNICATION ACT

Notice No. SMSE-014-20 — Consultation on the Technical and Policy Framework for Licence-Exempt Use in the 6 GHz Band

Innovation, Science and Economic Development Canada (ISED), on behalf of the Minister of Innovation, Science and Industry (the Minister), is hereby initiating a Consultation on the Technical and Policy Framework for Licence-Exempt Use in the 6 GHz Band on the technical and policy framework for licence-exempt use of the 5925-7125 MHz frequency band (referred to as the 6 GHz band).

Submitting comments

To ensure consideration, parties should submit their comments no later than January 19, 2021. Respondents are asked to provide their comments in electronic format (Microsoft Word or Adobe PDF) by email at ic.spectrumengineering-genieduspectre.ic@canada.ca. Soon after the close of the comment period, all comments will be posted on the ISED Spectrum Management and Telecommunications website. ISED will review and consider all comments in order to arrive at its decisions regarding the above-mentioned consultation.

ISED will also provide interested parties with the opportunity to reply to comments from other parties. Reply comments will be accepted until February 22, 2021.

Paper submissions should be mailed to the following address:

Senior Director
Spectrum Planning and Engineering
Innovation, Science and Economic Development Canada
Engineering, Planning and Standards Branch
235 Queen Street, East Tower, 6th Floor
Ottawa, Ontario
K1A 0H5

All submissions should cite the Canada Gazette, Part I, the publication date, the title and the reference number of this notice (SMSE-014-20).

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on the ISED Spectrum Management and Telecommunications website.

Official versions of notices can be viewed on the Canada Gazette website.

November 19, 2020

Martin Proulx
Director General
Engineering, Planning and Standards Branch

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.

Governor in Council appointment opportunities

Position

Organization

Closing date

Member

Atlantic Pilotage Authority Canada

  

President and Chief Executive Officer

Atomic Energy of Canada Limited

  

Commissioner

British Columbia Treaty Commission

  

Member

Buffalo and Fort Erie Public Bridge Authority

  

Director

Business Development Bank of Canada

  

Director — Board Risk Committee Chairperson

Business Development Bank of Canada

  

President and Chief Executive Officer

Business Development Bank of Canada

  

President and Chief Executive Officer

Canada Development Investment Corporation

  

Commissioner for Employers

Canada Employment Insurance Commission

  

President and Chief Executive Officer

Canada Lands Company Limited

  

President

Canada Mortgage and Housing Corporation

  

Member of the Board of Directors

Canada Post

  

President

Canadian Commercial Corporation

  

Member

Canadian Cultural Property Export Review Board

  

Commissioner (full-time),
Commissioner (part-time)

Canadian Energy Regulator

  

Director

Canadian Energy Regulator

  

Chief Commissioner

Canadian Grain Commission

  

Commissioner

Canadian Grain Commission

  

Federal Housing Advocate

Canadian Human Rights Commission

  

Member

Canadian Human Rights Tribunal

  

Chairperson

Canadian International Trade Tribunal

  

Chairperson

Canadian Museum of History

  

Director

Canadian Museum of History

  

Permanent Member

Canadian Nuclear Safety Commission

  

Chairperson

Canadian Transportation Agency

  

Temporary Member

Canadian Transportation Agency

  

Chief Administrator

Courts Administration Service

  

Director

Farm Credit Canada

  

Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Vice-Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Director

Freshwater Fish Marketing Corporation

  

Chairperson

Great Lakes Pilotage Authority Canada

  

Director
(Federal)

Hamilton-Oshawa Port Authority

  

Member, Northwest Territories

Historic Sites and Monuments Board of Canada

  

Assistant Deputy Chairperson

Immigration and Refugee Board of Canada

  

Commissioner

Impact Assessment Agency of Canada

  

Member
(appointment to roster)

International Trade and International Investment Dispute Settlement Bodies

  

Chairperson

The Jacques Cartier and Champlain Bridges Incorporated

  

Chairperson

Laurentian Pilotage Authority Canada

  

Chairperson

Military Police Complaints Commission of Canada

  

Member

Military Police Complaints Commission of Canada

  

Director
(Federal)

Nanaimo Port Authority

  

Member

National Arts Centre Corporation

  

Secretary

National Battlefields Commission

  

Member

National Seniors Council

  

Member

Natural Sciences and Engineering Research Council of Canada

  

Member

Payments in Lieu of Taxes Dispute Advisory Panel

  

Director

Public Sector Pension Investment Board

  

Commissioner

Roosevelt Campobello International Park Commission

  

Member

Social Sciences and Humanities Research Council of Canada

  

President

Social Sciences and Humanities Research Council of Canada

  

Registrar

Supreme Court of Canada

  

Member

Telefilm Canada

  

Chairperson and Member

Transportation Appeal Tribunal of Canada

  

Member

Transportation Appeal Tribunal of Canada

  

Vice-Chairperson

Transportation Appeal Tribunal of Canada